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15540 N
Virocid F, 20160333 TB 1
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 BESLUIT
Op 4 maart 2016 is van
Cid Lines N.V.
Waterpoortstraat 2
B-8900 IEPER
Belgium
een aanvraag tot toelating van de biocide op basis van niet geplaatste stof(fen) (overgangsrecht)
ontvangen voor het middel
Virocid F
op basis van de werkzame stoffen glutaaraldehyde, didecyldimethylammoniumchloride en
alkyl (C12-16) dimethylbenzylammoniumchloride.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.
Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen:
- Bijlage I voor details van de aanvraag en toelating;
- Bijlage II voor de etikettering;
- Bijlage III voor wettelijk gebruik;
- Bijlage IV voor de onderbouwing.
1.1 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.2 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is
voorgeschreven.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende
aanduidingen en vermeldingen op de verpakking te worden vermeld:
15540 N
Virocid F, 20160333 TB 2
� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I.
� Het toelatingsnummer.
� De etikettering zoals opgenomen in bijlage II bij dit besluit, deze moet volgens de voorschriften
op de verpakking worden vermeld.
� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in
bijlage III, onder A.
� De gebruiksaanwijzing, hetzij letterlijk, hetzij naar zakelijke inhoud, zoals opgenomen in bijlage
III, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
2 WETTELIJKE GRONDSLAG
Besluit art 89, tweede lid van EU 528/2012 jo art 130a, vierde lid Wet
gewasbeschermingsmiddelen en biociden (Wgb) jo art 4, tweede
lid Wgb (oud) jo art 121 Wgb (oud) jo art 44 Wgb (oud)
Classificatie en etikettering artikel 89, tweede lid, Verordening 528/2012, jo. artikel 130a,
vierde lid, WBB, jo. artikel 50 WGB oud
Gebruikt toetsingskader RGB (Hoofdstuk 10)
3 BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn
bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het
middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die
vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd
gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het
werkzaam is.
15540 N
Virocid F, 20160333 TB 3
Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de
Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes
weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College
voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.
Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift
opengesteld.
Ede, 9 februari 2018
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw
Voorzitter
15540 N
Virocid F, 20160333 TB 1
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
1 Aanvraaginformatie
Aanvraagnummer: 20160333 TB
Type aanvraag: aanvraag tot toelating van de biocide op basis van niet
geplaatste stof(fen) (overgangsrecht)
Middelnaam: Virocid F
Verzenddatum aanvraag: 25 februari 2016
Formele registratiedatum: * 11 april 2016
Datum in behandeling name: 30 november 2016
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2 Stofinformatie
Werkzame stof Gehalte
glutaaraldehyde 24,0 %
didecyldimethylammoniumchloride 5,0 %
Alkyl (C12-16) dimethylbenzylammoniumchloride 5,0 %
De werkzame stoffen Alkyl (C12-16) dimethylbenzylammoniumchloride en
didecyldimethylammoniumchloride zijn opgenomen in het reviewprogramma maar voor PT03 nog
niet geplaatst op de Unielijst van Goedgekeurde Werkzame stoffen volgens Verordening 528/2012.
De werkzame stof glutaaraldehyde is per 1-10-2016 opgenomen op de Unielijst van Goedgekeurde
Werkzame stoffen volgens Verordening 528/2012 en wordt op Europees niveau verdedigd voor de
aangevraagde PT3.
3 Toelatingsinformatie
Toelatingsnummer: 15540 N
Expiratiedatum: 1 december 2027
Biocide, gewasbeschermingsmiddel of
toevoegingsstof:
Biocide
Gebruikers: Beide
4 Verpakkingsinformatie
Aard van het preparaat:
Met water mengbaar concentraat
15540 N
Virocid F, 20160333 TB 1
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Virocid F
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
Alkyl (C12-16) dimethylbenzylammoniumchloride
didecyldimethylammoniumchloride
glutaaraldehyde
Pictogram GHS02
GHS05
GHS06
GHS08
GHS09
GHS07
Signaalwoord Gevaar
Gevarenaanduidingen H226 Ontvlambare vloeistof en damp.
H301 Giftig bij inslikken.
H314 Veroorzaakt ernstige brandwonden en oogletsel.
H317 Kan een allergische huidreactie veroorzaken.
H330 Dodelijk bij inademing.
H334 Kan bij inademing allergie- of astmasymptomen of
ademhalingsmoeilijkheden veroorzaken.
H335 Kan irritatie van de luchtwegen veroorzaken.
H410 Zeer giftig voor in het water levende organismen, met
langdurige gevolgen.
Voorzorgsmaatregelen P210 Verwijderd houden van warmte, hete oppervlakken, vonken,
open vuur en andere ontstekingsbronnen. Niet roken.
P260 Stof/rook/gas/nevel/damp/spuitnevel niet inademen.
P264 Na het werken met dit product ... grondig wassen.
P273 Voorkom lozing in het milieu.
P280 Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P301 + P310 NA INSLIKKEN: Onmiddellijk een
ANTIGIFCENTRUM/arts/... raadplegen.
P303 + P361 + P353 BIJ CONTACT MET DE HUID (of het haar):
verontreinigde kleding onmiddellijk uittrekken. Huid met water
afspoelen/afdouchen.
P304 + P340 NA INADEMING: de persoon in de frisse lucht brengen
en ervoor zorgen dat deze gemakkelijk kan ademen.
P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig
afspoelen met water gedurende een aantal minuten; contactlenzen
verwijderen, indien mogelijk. Blijven spoelen.
P342 + P311 Bij ademhalingssymptomen: een ANTIGIFCENTRUM of
een arts raadplegen.
Aanvullende
etiketelementen
EUH071 Bijtend voor de luchtwegen.
15540 N
Virocid F, 20160333 TB 1
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE III WG/GA van het middel Virocid F
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als middel ter bestrijding van:
- Bacteriën (exclusief mycobacteriën en bacteriesporen), gisten en virussen in
dierverblijfplaatsen en bijbehorende ruimten, inclusief transportmiddelen voor dieren.
Om verminderd functioneren van een Individuele Behandeling Afvalwater (IBA) bij toepassing van dit
middel op de boerderij te voorkomen, dienen afvalresten die het middel bevatten geloosd te worden
op de mestopslag of op de gemeentelijke riolering.
Draag adembescherming met beschermingsfactor 10 tijdens desinfectie.
De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
De te desinfecteren oppervlakken en materialen eerst grondig reinigen. Het middel toepassen door
middel van sprayen. Zorg dat de oppervlakken gedurende de gehele inwerktijd vochtig blijven.
Desinfectie van dierverblijfplaatsen en bijhorende ruimten voor dieren, met uitzondering van
transportmiddelen voor dieren:
Dosering: 0,25% (= 2,5 ml Virocid F aanvullen met water tot 1 liter)
Minimale inwerktijd: 30 minuten.
Desinfectie van transportmiddelen voor dieren:
Dosering: 0,5% (= 5 ml Virocid F aanvullen met water tot 1 liter)
Minimale inwerktijd: 5 minuten.
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
2
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE IV
RISKMANAGEMENT
Contents
1 Introduction ...................................................................................................................... 3
2 Identity ............................................................................................................................. 3
3 Physical and chemical properties ......................................................................................... 6
4 Analytical methods for detection and identification ............................................................. 13
5 Efficacy ........................................................................................................................... 17
6 Human toxicology ............................................................................................................ 21
7 Environment ................................................................................................................... 55
8 Conclusion ...................................................................................................................... 67
9 Classification and labelling ................................................................................................ 67
10 References .................................................................................................................. 68
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
3
1 Introduction
1.1 Applicant
Cid Lines N.V.
Waterpoortstraat 2
B-8900 IEPER
Belgium
1.2 Active substances
Alkyl (C12-16) dimethylbenzylammonium chloride (ADBAC), didecyldimethylammonium chloride
(DDAC) and glutaraldehyde.
1.3 Product
Virocid F
1.4 Function
Virocid F is a disinfectant (PT03)
1.5 Background to the application
This concerns an application for authorisation of a new biocidal product.
1.6 Intended uses
The proposed field of use of Virocid F is the control of:
• Bacteria (excluding mycobacteria and bacterial spores), yeasts and viruses in animal housings and
related places for animals, including animal transport vehicles, by spraying;
• Bacteria (excluding mycobacteria and bacterial spores) and yeasts in animal housings and related
places for animals, by fogging.
These uses are included in PT03.
1.7 Packaging details
1L, 10L, 20L, 60L, 200L, and 1000L in HDPE
2 Identity
2.1 Identity of the active substance
2.1.1 Alkyl (C12-16) dimethylbenzyl ammonium chloride
Common name ADBAC (non-ISO)
Name in Dutch Quaternaire ammoniumverbindingen, benzyl-C12-16-alkyldimethyl, chloriden
Chemical name Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides
CAS no 68424-85-1
EC no 270-325-2 [EINECS]
The active substance Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides is
included in the Union list of approved substances of EU Regulation 528/2012. For PT8 an AR is
available (June 2015, eCA Italy). For PT 1, 2, 3 and 4, a first draft CAR is available (March 2012).
The List of Endpoints below is taken from the AR on Quaternary ammonium compounds, benzyl-
(C12-16)-alkyldimethyl, chlorides (PT8, June 2015). Where relevant, some additional
remarks/information are given in italics.
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
4
Chemical name (IUPAC) Not applicable
Chemical name (CA) Quaternary ammonium compounds, benzyl-(C12-
16)-alkyldimethyl, chlorides
CAS No 68424-85-1
EC No 270-325-2
Other substance No. None
Minimum purity of the active substance as
manufactured (g/kg or g/l)
US ISC
940 g/kg (dry weight)
EQC
981 g/kg (dry weight)
Identity of relevant impurities and additives
(substances of concern) in the active
substance as manufactured (g/kg)
None
Molecular formula Cn+9H2n+14N.Cl (n = 12, 14, 16)
Alkyl chain lengths distribution:
Chain
Length Range
C12 39 - 76%
C14 20 - 52%
C16 < 12%
Molecular mass 340.0 – 396.1 g/mol
Structural formula
N+
RCl
-
R = C12H25
C14H29
C16H33
2.1.2 Didecyldimethylammonium chloride
Common name DDAC (non-ISO)
Name in Dutch didecyldimethylammoniumchloride
Chemical name N,N-Didecyl-N,N-dimethylammonium chloride
CAS no 7173-51-5
EC no 230-525-2 (EINECS)
The active substance didecyldimethyl ammonium chloride is included in the Union list of approved
substances of EU Regulation 528/2012. For PT8 an AR is available (February 2015, eCA Italy). A first
draft CAR is available for PT1 to 4 (January 2012, eCA Italy).
The List of Endpoints below is taken from the AR on didecyldimethylammoniumchloride (PT8,
February 2015). Where relevant, some additional remarks/information are given in italics.
Chemical name (IUPAC) N,N-didecyl-N,N-dimethylammonium Chloride
Chemical name (CA) 1-decanaminium, N-decyl-N,N-dimethyl-, chloride
CAS No 7173-51-5
EC No 230-525-2
Other substance No. 612-131-00-6 (Annex I Index number)
CIPAC: 859
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
5
Minimum purity of the active substance as
manufactured (g/kg or g/l)
US ISC
870 g/kg (dry weight)
EQC
979 g/kg (dry weight)
Identity of relevant impurities and additives
(substances of concern) in the active
substance as manufactured (g/kg)
None
Molecular formula C22H48NCl
Molecular mass 362.1 g/mol
Structural formula
N+
R Cl-
R
R = C10H21
2.1.3 Glutaraldehyde
Common name Glutaraldehyde (non-ISO)
Name in Dutch Glutaaraldehyde
Chemical name 1,5-pentanedial
CAS no 111-30-8
EC no 203-856-5 (EINECS)
The active substance glutaraldehyde is included in the Union list of approved substances of EU
Regulation 528/2012 for PT2-4, 6,11 and 12 (October 2016, eCA FI).
The List of Endpoints below is taken from the AR on glutaraldehyde (October 2016). Where relevant,
some additional remarks/information are given in italics.
Chemical name (IUPAC) 1,5-pentanedial
Chemical name (CA) Glutaraldehyde
CAS No 111-30-8
EC No 203-856-5
Other substance No.
Minimum purity of the active substance as
manufactured (g/kg or g/l)
Glutaraldehyde content in the aqueous solution is
in a range of 48.5-52.5 % (wt), 485-525 g/kg. The
theoretical dry weight specification: minimum
purity is 95.0 % (wt), 950 g/kg. The applicant
specific information and specifications are in the
confidential documents [Doc III A4.1/02
confidential (Dow) and Doc V Confidential (BASF) in
detail].
Identity of relevant impurities and additives
(substances of concern) in the active
substance as manufactured (g/kg)
The specifications are in the confidential
documents [Doc III A4.1/02 confidential (Dow) and
Doc V Confidential (BASF)].
Molecular formula C5H8O2
Molecular mass 100.11 g/mol
Structural formula
O O
H H
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
6
2.2 Identity of the biocidal product
Name Virocid F
Formulation type SL
Content active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC): 5.0%
w/w
Didecyldimethylammoniumchloride (DDAC): 5.0% w/w
Glutaraldehyde: 24% w/w
Packaging information:
Material Size / content Other information
Professional use HDPE 1L, 10L, 20L, 60L,
200L, 1000L
2.3 Overall conclusions identity
The identity of the active substances and the biocidal product is sufficiently described.
Data requirements
None.
3 Physical and chemical properties
3.1 Physical and chemical properties of the active substance
3.1.1 Alkyl (C12-16) dimethylbenzyl ammonium chloride
The List of Endpoints below is taken from the AR on Quaternary ammonium compounds, benzyl-
(C12-16)-alkyldimethyl, chlorides (PT8, June 2015). Where relevant, some additional
remarks/information are given in italics.
Melting point (state purity) US ISC
The a.s. did not melt, but was observed to
decompose starting at approximately 150°C
(96.6%)
EQC
Melting range at atmospheric pressure of
28.9–30.2 °C (99.2%)
Boiling point (state purity) US ISC
The a.s. decomposed before melting (96.6%)
EQC
No boiling point at atmospheric pressure
(1013 hPa). The test item decomposed at a
temperature >160 °C (99.2%)
Temperature of decomposition US ISC
> 150°C
EQC
> 160°C
Appearance (state purity) US ISC
Light beige solid (96.6%)
EQC
Crystalline, tenacious and sticky solid.
Hygroscopic behaviour. White colour. Faint
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
7
marzipan-like odour ( 94.4%)
Relative density (state purity) US ISC
D420 = 0.96 (96.6%)
EQC
D420 = 0.929 (94.4%)
Surface tension US ISC
31.3 mN/m at 20°C (test solution: 1 g/l
aqueous solution)
EQC
28.27 mN/m at 20 ± 0.5 °C (test solution:
1.0 g/l aqueous solution)
CMC: 0.5 g/L at 20 ± 0.5 °C
Vapour pressure (in Pa, state temperature) US ISC
6.03E-04 Pa @ 20°C (extrapolated)
8.57E-04 Pa @ 25°C (extrapolated)
4.22E-03 Pa @ 50°C (extrapolated)
EQC
< 1.5E-03 Pa @ 20°C (extrapolated)
< 5.8E-03 Pa@ 25°C (extrapolated)
Henry’s law constant (Pa m3 mol -1) US ISC
5.03E-07 Pa m3 mol -1 at 20°C
EQC
< 1.15E-06 Pa m3 mol -1 at 20°C
Solubility in water (g/l or mg/l, state
temperature)
US ISC
pH 5.5: 409 g/l at 20°C
pH 6.5: 431 g/l at 20°C
pH 8.2: 379 g/l at 20°C
EQC
455 g/l in doubled distilled water at 20.0 ±
0.5 °C
444 g/l in acidic or basic solution at 20.0 ±
0.5 °C
Solubility was found to be independent of
temperature
Solubility in organic solvents (in g/l or mg/l,
state temperature) (Annex IIIA, point III.1)
US ISC
ethanol: > 250 g/l at 20°C
isopropanol: > 250 g/l at 20°C
n-octanol: > 250 g/l at 20°C
EQC
isopropanol: 549 g/l at 10°C; 568 g/l at
20°C; 586 g/l at 30°C
n-octanol: 459 g/l at 20°C
Stability in organic solvents used in biocidal
products including relevant breakdown
products (IIIA, point III.2)
US ISC
Ethanol: Stable – < 5% loss over 2 weeks at
55 °C
Isopropanol: Stable – < 5% loss over 2
weeks at 55°C
(confirmed by supporting information)
EQC
Not required: no organic solvent is used in
the representative biocidal product
Partition coefficient (log POW) (state US ISC
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
8
temperature) Not determined (EC methods A.8 not
applicable for surfactants). Assessment by
KOWWIN is inaccurate (software database
very limited for surfactants). log POW could be
roughly obtained from solubility in n-octanol
and water. However, this calculation is of no
use with regard to environmental fate and
behaviour and secondary poisoning risk
assessment (experimental BCF available)
EQC
0.004 @ 20°C (calculated from individual
solubilities in n-octanol and water)
Dissociation constant (not stated in Annex IIA
or IIIA; additional data requirement from
TNsG)
Not applicable. The a.s. is fully dissociated in
water
UV/VIS absorption (max.) (if absorption > 290
nm state ε at wavelength)
US ISC
The UV/VIS absorption spectra were
consistent with the assigned structure of the
active substance.
EQC
No absorption above 290 nm in the neutral,
acidic and basic media
Photostability (DT50) (aqueous, sunlight, US ISC
The photolysis data available for DDAC are
adequate for this active substance. The test
substance is photolytically stable in absence
of a photosensitising agent.
EQC
No absorption above 290 nm in UV spectrum
Quantum yield of direct phototransformation
in water at > 290 nm
Not applicable: no adsorption above 290 nm
in UV spectra
Flammability or flash point Not flammable
Explosive properties Not explosive
Oxidising properties Not oxidising
Auto-ignition or relative self ignition
temperature
No self-ignition was observed up to the
maximum test temperature (≈400°C)
3.1.2 Didecyldimethylammonium chloride
The List of Endpoints below is taken from the AR on didecyldimethylammoniumchloride (PT8,
February 2015). Where relevant, some additional remarks/information are given in italics.
The List of Endpoints below is taken from the
AR on didecyldimethylammoniumchloride
(PT8, February 2015). Where relevant, some
additional remarks/information are given in
italics.Melting point (state purity)
US ISC
The melting range is from 188 to 205°C
(98.2%)
EQC
The melting range is from 94 to 100°C
(88.2%)
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
9
Boiling point (state purity) US ISC
The substance decomposes before boiling
(98.2%)
EQC
The substance decomposes under boiling
(88.2%)
Temperature of decomposition US ISC
ca. 280°C (98.2%)
EQC
> 180°C (88.2%)
Appearance (state purity) US ISC
Light-coloured solid with aromatic odour
(98.2%)
EQC
Clump building powder with hygroscopic
behaviour. White/slight yellowish colour.
Moderate mushroom-like odour (95.0%)
Relative density (state purity) US ISC
D420 =0.902 (98.2%)
EQC
D420 = 0.8651 (95.0%)
Surface tension US ISC
27.0 mN/m at 20°C (test solution: 1 g/l
aqueous solution)
EQC
25.82 mN/m at 20 ± 0.5 °C (test solution:
1.0 g/l aqueous solution)
CMC: 0.65 g/l at 20 ± 0.5 °C
Vapour pressure (in Pa, state temperature) US ISC
5.9E-06 Pa @ 20C (extrapolated)
1.1E-05 Pa @ 25C (extrapolated)
2.3E-04 Pa @ 50ºC (extrapolated)
EQC
< 1.5E-3 Pa @ 20C (extrapolated)
< 5.8E-3 Pa @ 25C (extrapolated)
Henry’s law constant (Pa m3 mol -1) US ISC
4.27E-09 Pa m3 mol-1 @ 20C
EQC
< 8.4E-7 Pa m3 mol-1 @ 20°C
Solubility in water (g/l or mg/l, state
temperature)
US ISC
pH 2.2: 500 g/l at 20 °C
pH 9.2: 500 g/l at 20 °C
EQC
645 g/l in doubled distilled water at 20.0 ±
0.5°C
625 g/l in acidic or basic solution at 20.0 ±
0.5°C
Solubility was found to be independent of
temperature
Toelatingsnummer 15540 N
Virocid F, 20160333 TB
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Solubility in organic solvents (in g/l or mg/l,
state temperature) (Annex IIIA, point III.1)
US ISC
acetone: > 600 g/l @ 20ºC
methanol: > 600 g/l @ 20ºC
n-octanol: > 250 g/l @ 20ºC
EQC
isopropanol:
942 g/l @ 10°C
906 g/l @ 20°C
953 g/l @ 30°C
n-octanol:
269 g/l @ 20°C
Stability in organic solvents used in biocidal
products including relevant breakdown
products (IIIA, point III.2)
ISC
ethanol: Stable < 5% loss for 14 days
at 55°C
isopropanol: Stable < 5% loss for 14 days
at 55°C
EQC
After 14 days at 54 ± 2 °C, DDAC is
concluded to be stable in isopropanol (also
confirmed by the accelerated storage
stability test on the isopropanol-based
biocidal product DDAC-50).
Partition coefficient (log Pow) (state
temperature)
US ISC
Not determined (EC methods A.8 not
applicable for surfactants). Assessment by
KOWWIN is inaccurate (software database
very limited for surfactants). log POW could be
roughly obtained from solubility in n-octanol
and water. However, this calculation is of no
use with regard to environmental fate and
behaviour and secondary poisoning risk
assessment (experimental BCFfish available)
EQC
-0.41 @ 20°C (calculated from individual
solubilities in n-octanol and water)
Dissociation constant (not stated in Annex IIA
or IIIA; additional data requirement from
TNsG)
Not applicable. DDAC is fully dissociated in
water
UV/VIS absorption (max.) (if absorption > 290
nm state ε at wavelength)
US ISC
ca. 0% after 30 days (direct)
ca. 7% after 30 days (indirect)
EQC
Not applicable: no absorption above 290 nm
in UV spectrum
CONCLUSION TO BE TAKEN INTO
ACCOUNT AT PRODUCT
AUTHORIZATION: stable (US ISC)
Quantum yield of direct phototransformation
in water at > 290 nm (point VII.7.6.2.2)
Not applicable
Flammability Not flammable
Explosive properties Not explosive
Oxidising properties Not oxidising
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Auto-ignition temperature US ISC
Relative self-ignition temperature of 195°C
EQC
No self-ignition observed up to 403°C
3.1.3 Glutaraldehyde
The List of Endpoints below is taken from the AR on glutarldehyde (October 2016). Where relevant,
some additional remarks/information are given in italics.
Melting point (state purity) Peak maximum ca. -18 ºC (BASF)
-18 to -21.2 ºC (50 % w/v ) (Dow)
Boiling point (state purity) 101.5 °C at 987.1 hPa (ca. 50 g/100 g aqueous
solution) (BASF)
100.7 ºC at 1013 hPa (50 % w/v) (Dow)
Temperature of decomposition 1.Peak:
Onset temperature: 85 °C
Peak temperature: 246 °C
2.Peak:
Onset temperature: 330 °C
Peak temperature: 385 °C
(BASF)
For Dow, there is no information, but this is not an
absolute requirement in case the temperatures of
melting and boiling have been determined,
according to Guidance on information
requirements.
Appearance (state purity) Free flowing clear liquid (50 % solution) (BASF)
Clear colourless liquid, sharp odour (50 % w/v)
(Dow)
Relative density (state purity) 1.129 (50 % solution) (BASF, Dow)
Surface tension ca. 68 mN/m at 20 °C, (0.1 % solution) (BASF)
72.4 mN/m at 20 ºC, (0.05 % solution) (Dow)
Vapour pressure (in Pa, state temperature) 44 Pa at 20 °C (BASF, Dow), 100 % glutaraldehyde
Henry’s law constant (Pa m3 mol -1) 0.0086 Pa×m3/mol (calculated by RMS)
Solubility in water (g/l or mg/l, state
temperature)
pH 5, 7, 9 (20.2+/- 0.1 °C): miscible (BASF)
pH not measured: ≥ 51.3 g/100ml at 21 °C (Dow)
Glutaraldehyde is not expected to ionize in water
based on its chemical structure, therefore testing
at different pH values was not considered
necessary (Dow).
Solubility in organic solvents (in g/l or mg/l,
state temperature)
Methanol: fully soluble
1,4-dioxane: fully soluble
at 20 °C and at 30 °C
(BASF)
Isopropanol: fully soluble (≥ 51.3 g/100 ml)
Acetone: fully soluble (≥ 51.3 g/100 ml)
Ethyl acetate: 59 g/100 ml
Dichloromethane: 70 g/100 ml
n-hexane: 0.19 g/100 ml
Toluene: 8.5 g/100 ml
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at 21 °C
(Dow)
Stability in organic solvents used in biocidal
products including relevant breakdown
products
Not applicable (organic solvents not used in
biocidal products)
Partition coefficient (log POW) (state
temperature)
pH 5 : -0.41 at 23 +/- 1 °C
pH 9 : -0.80 at 23 +/- 1 °C
pH 7 :-0.36 at 23 +/- 1 °C
(BASF)
pH not reported: -0.33 at 25 ºC
(Dow)
Hydrolytic stability (DT50) (state pH and
temperature)
See Ch. 4: Fate and Behaviour in the Environment
Dissociation constant Glutaraldehyde has no ionisable groups, and no
ionisation/dissociation in water is expected.
UV/VIS absorption (max.) (if absorption > 290
nm state ε at wavelength)
Medium λmax ε
[nm] [l*mol-1*cm-1]
neutral 234 14.9
neutral 282 5.9
acidic 234 14.5
acidic 282 6.1
basic 235 478.2
basic 283 22.3
max. at 234 nm. There are no peaks above 290 nm.
The ε is below 10 at wavelengths of 290 nm or
greater. (BASF, Dow)
Photostability (DT50) (aqueous, sunlight, state
pH)
See Ch. 4: Fate and Behaviour in the Environment
Quantum yield of direct phototransformation
in water at Σ > 290 nm
See Ch. 4: Fate and Behaviour in the Environment
Flammability Not flammable , 50% glutaraldehyde (BASF, Dow)
Auto Ignition Temperature = 395 °C at 1002 – 1006
hPa (BASF)
Explosive properties Not explosive (BASF, Dow)
3.2 Physical and chemical properties of the biocidal product
Appearance Clear, colourless liquid with aldehyde odour
Explosive properties No explosive properties
Oxidative properties Not oxidising
Autoflammability Not autoflammable
Flashpoint The applicant has reported two inconsistent values for the
flashpoint: 65 °C and 48 °C. No study report was provided,
however.
Based on the concentration of flammable constituents in
the product, it is expected the flash point of the product is
below 60°C, but exceeds 23°C. Therefore, H226 is assigned.
pH 1% solution pH (neat): 4.22
Particle size distribution Not applicable, not a solid
Surface tension No data
Viscosity < 50 mPa.s
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Relative density 1.030-1.070
Storage stability/Shelf life/Packaging Shelf life claim: 3 years
Tested at 54°C for two weeks in HPDE packaging.
Tested parameters: ADBAC content, DDAC content,
glutaraldehyde content, pH, and density.
All parameters remained within acceptable limits.
A long term stability study is started in February 2016.
Based on the provided data, shelf life is 2 years in HDPE is
assigned.
Technical properties Dilution stability and persistent foaming should be
determined for an SL. Experimental data on these
properties have not been provided. Since the product is not
expected to become unstable due to dilution, this is
acceptable for the dilution stability.
The product is expected to foam. It is not necessary to test
the persistent foaming because skin protection is already
prescribed.
Physical and chemical compatibility Not applicable, Virocid F does not come in contact with
other products.
3.3 Overall conclusions physical and chemical properties
The physical and chemical properties of the active substances and the biocidal product are
sufficiently described by the available information.
Shelf life is 2 years in HDPE.
Data requirements
None.
4 Analytical methods for detection and identification
The List of Endpoints below of Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl,
chlorides is taken from the AR (PT8, June 2015). Where relevant, some additional
remarks/information are given in italics.
The List of Endpoints below is taken from the AR on didecyldimethylammoniumchloride (PT8,
February 2015). Where relevant, some additional remarks/information are given in italics.
The List of Endpoints below is taken from the AR on glutaraldehyde (October 2016). Where relevant,
some additional remarks/information are given in italics.
4.1.1 Alkyl (C12-16) dimethylbenzyl ammonium chloride
Technical as (principle of method) US ISC
HPLC with evaporative light scattering
detection (ELSD). Confirmation by LC-MS
EQC
Analysis by RP-HPLC/DAD
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(confirmation of identity of each a.s.
constituent by spectral match versus
relevant standards)
Impurities in technical as (principle of
method)
US ISC
HPLC-ELSD (identification by LC-MS)
Titration method
IC coupled with conductivity detector; AAS
Karl-Fischer titration and GC/FID for process
solvents
EQC
RP-HPLC/MS-MS, with two ion transitions
considered (one as quantifier, one as
qualifier)
GC-MS
ICP-OES
Karl-Fischer titration
4.1.2 Didecyldimethylammoniumchloride
Technical as (principle of method) US ISC
HPLC with evaporative light scattering
detection (ELSD). Confirmation by LC-MS
EQC
Analysis by RP-HPLC/MS-MS [parent ion
(m/z): 326; daughter ions (m/z): 186, 57]
Impurities in technical as (principle of
method)
US ISC
HPLC-ELSD (identification by LC-MS)
Titration method
IC coupled with conductivity detector; AAS
Karl-Fischer titration and GC/FID for process
solvents
EQC
RP-HPLC/MS-MS, with two ion transitions
considered (one as quantifier, one as
qualifier)
GC-MS
ICP-OES
Karl-Fischer titration and HPLC/UV for
process solvents
4.1.3 Glutaraldehyde
Technical active substance (principle of
method)
Potentiometric titration (BASF)
HPLC-UV (Dow)
Titration (Dow)
For additional information required at product
authorisation see Doc IIA and the Doc IIIAs.
Impurities in technical active substance
(principle of method)
GC-MS-FID (BASF)
Karl-Fisher titration (BASF)
GC-TCD (Dow)
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IEC-CD (Dow)
For additional information required at product
authorisation see Doc IIA and the Doc IIIAs.
4.2 Analytical methods for analysis of the biocidal product
Preparation (principle of method) ADBAC and DDAC: HPLC-ELSD
Glutaraldehyde: HPLC-UV/Vis
4.3.1 Alkyl (C12-16) dimethylbenzyl ammonium chloride
Food/feed of plant origin (principle of
method and LOQ for methods for
monitoring purposes)
Not required.
Food/feed of animal origin (principle of
method and LOQ for methods for
monitoring purposes)
Not required.
Soil (principle of method and LOQ) EQC
Extraction with acetonitrile containing
1% TFA. After centrifugation and dilution
with water, analysis by RP-HPLC/MS-MS (two
mass transitions validated for each a.s.
constituent). LOQ = 0.05 mg a.s./kg
LOQ (for each individual constituent) =
0.0167 mg/kg
Water (principle of method and LOQ) EQC
Samples over SPE cartridges. After drying,
elution with acetonitrile : HPLC water (60:40,
v/v) + 1% HCOOH. Analysis by RP-HPLC/MSMS
(two mass transitions validated for each
a.s. constituent). LOQ = 0.1 μg a.s./L
LOQ (for each individual constituent) =
0.0133 μg/L
Air (principle of method and LOQ) Not required
Body fluids and tissues (principle of
method and LOQ)
Not required. The a.s. is neither toxic nor highly toxic
Based on the intended use analytical methods to determine residues of quaternary ammonium
compounds, benzyl-(C12-16)-alkyldimethyl, chlorides in food/feed of animal and plant origin are not
required.
Since the product is applied as spray, an HPLC-ELSD method to determine residues in air with an loq
of 40 µg/m3 has been provided. The method was validated and is acceptable.
4.3.2 DDAC
Food/feed of plant origin (principle of
method and LOQ for methods for
monitoring purposes)
Not relevant based on the intended use
Food/feed of animal origin (principle of
method and LOQ for methods for
monitoring purposes)
Not relevant based on the intended use
Soil (principle of method and LOQ) US ISC
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Extraction with propan-2-ol:water:
hydrochloric acid (90:10:0.1, v/v/v)
containing 0.01M ammonium formate prior
to dilution with water:hydrochloric acid
(100:0.1, v/v) containing 0.01 M ammonium
formate. Analysis by RP-HPLC/MS-MS
[parent ion (m/z): 326; daughter ions (m/z):
186, 43]. LOQ = 0.01 mg/kg (sandy loam
and clay)
EQC
Extraction with acetonitrile containing
1% TFA. After sonication and centrifugation,
dilution (factor 2) with water containing
1% TFA. Analysis by RP-HPLC/MS-MS
[parent ion (m/z): 326; daughter ions (m/z):
186, 57]. LOQ = 0.02 mg/kg
Water (principle of method and LOQ) US ISC
Dilution (factor 2) with propan-2-
ol:water:hydrochloric acid (90:10:0.2, v/v/v)
containing ammonium formate (0.02 M).
Analysis by RP-HPLC/MS-MS [parent ion
(m/z): 326; daughter ions (m/z): 186, 43].
LOQ = 0.1 μg/L (ground, drinking and
surface water)
EQC
Samples over SPE cartridges. After drying,
elution with 5 mL of acetonitrile. Dilution of
0.6 mL of the solution with 0.4 mL of water.
Analysis by RP-HPLC/MS-MS [parent ion
(m/z): 326.; daughter ions (m/z): 186, 57].
LOQ = 0.1 μg/L (ground and drinking water)
Enrichment over SPE cartridges. Elution with
acetonitrile and dilution (factor 2) with water
containing 02% TFA. Analysis by RPHPLC/
MS-MS [parent ion (m/z): 326;
daughter ions (m/z): 186, 57].
LOQ = 0.04 μg/L (surface water)
Air (principle of method and LOQ) Not required.
Body fluids and tissues (principle of
method and LOQ)
Not required. Didecyldimethyl ammonium chloride is not
classified as toxic or highly toxic
Based on the intended use analytical methods to determine residues of didecyldimethyl-ammonium
chloride in food/feed of animal and plant origin are not required.
Since the product is applied as spray, an HPLC-ELSD method to determine residues in air with an loq
of 40 µg/m3 has been provided. The method was validated and is acceptable.
4.3.3 Glutaraldehyde
Soil (principle of method and LOQ) Waived, Persistence or accumulation of
glutaraldehyde or its metabolites in soil is not
expected (BASF)
LC-MS/MS, 0.05 mg/kg (Dow)
The method is not required since the DT50 < 3 days
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Air (principle of method and LOQ) [HPLC/UV, 18 µg/m3 (BASF)
HPLC/UV, 55.0 ng/sample (STS: 0.44 ppb or 1.8
µg/m3; LTS: 0.027 ppb or 0.11 µg/m3 ) (Dow) ]
It has been agreed that a new method will be
submitted before product authorisation
Water (principle of method and LOQ) GC-MS, LOQ = 0.05 µg/l (for drinking water and
surface water) (BASF)
LC-MS-MS, 0.1 µg/l (for drinking water and surface
water) (Dow)
Body fluids and tissues (principle of method
and LOQ)
Rat blood: GC-MS, 20 ng/g (Dow)
Body tissues: waived (BASF, Dow) It is technically
impossible at this time to analyse glutaraldehyde in
animal tissues as the glutaraldehyde will react with
the biological material, followed by rapid
metabolisation and elimination.
Food/feed of plant origin (principle of method
and LOQ for methods for monitoring
purposes)
Waived (BASF, Dow) The product is not intended to
be added to food and feedstuffs or be used in
facilities during food processing. Only by accident
may trace amounts of glutaraldehyde be on the
surface of food and feedstuffs. Due to evaporation,
photodegradation and rapid reactions with
proteins, only trace amounts would be expected
even in the case of accident.
Food/feed of animal origin (principle of
method and LOQ for methods for monitoring
purposes)
Waived (BASF, Dow). It is technically impossible at
this time to analyse glutaraldehyde in animal
tissues as the glutaraldehyde will react with the
biological material, followed by rapid
metabolisation and elimination.
Based on the intended use analytical methods to determine residues of glutaraldehyde in food/feed
of animal and plant origin are not required.
Since the product is applied as spray, an HPLC-UV method to determine residues in air with an loq of
1 µg/m3 has been provided. The method was validated and is acceptable.
4.4 Overall conclusions methods of analysis
The submitted analytical methods meet the requirements.
Data requirements
None.
5 Efficacy
5.1 Function
Virocid F is a disinfectant based on 5% w/w Alkyl (C12-16) dimethylbenzylammoniumchloride, 5%
w/w didecyldimethylammoniumchloride and 24% w/w glutaraldehyde.
5.2 Field of use envisaged
The proposed field of use of Virocid F is the control of:
• Bacteria (excluding mycobacteria and bacterial spores), yeasts and viruses in animal housings and
related places for animals, including animal transport vehicles, by spraying;
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• Bacteria (excluding mycobacteria and bacterial spores) and yeasts in animal housings and related
places for animals, by fogging.
These uses are included in PT03.
The product is intended for professional use.
5.3 Effects on target organisms and efficacy
5.3.1 Efficacy data submitted and evaluation of data
Thirteen studies were provided and used in this assessment. These are summarised in Table 1.
Table 1. Summary of studies assessed
Test (version) Phase, step
Test organism Test parameters Results*
Bacteria (excluding mycobacteria and bacterial spores)
EN 1656 (2009) 2, 1
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris
Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C
log R>5.23: 0.25 %; Clean; 30 min; 10°C
EN 1656 (2009) 2, 1
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris
Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 5 min Test temperature: 10°C
log R>5.03: 0.5 %; Clean; 5 min; 10°C
EN 14349 (2007) 2, 2
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris
Concentration (%): 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C
log R>4.0: 0.25 %; Clean; 30 min; 10°C
EN 14349 (2012) 2, 2
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris
Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 5 min Test temperature: 10°C
log R>4.00: 0.25 %; Clean; 5 min; 10°C
NFT 72-281 (2014) Simulated-use
Orientation of the
surfaces: Vertically, at
a height of 1m (+/-
10%), and a distance
from the fogger of
2,6m (+/- 10%),
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Escherichia coli
Concentration (%): 10% (2.4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 20°C Relative humidity (%):
log R>5.09: 10 %; Clean; 1 hour; 20°C
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Test (version) Phase, step
Test organism Test parameters Results*
inoculum oriented at
the opposite of the
fogger.
40 – 80 Room volume: 33 m3
Fogging device: Nebulo Type Europa 700W
NFT 72-281 (2014) Simulated-use
Orientation of the
surfaces: Vertically, at
a height of 1m (+/-
10%), and a distance
from the fogger of
2,6m (+/- 10%),
inoculum oriented at
the opposite of the
fogger.
Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris
Concentration (%): 10% (2,4 ml Virocid F /m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 19 – 21.5 to 27°C (final) Relative humidity (%): 62 – 74 to 90 (final) Room volume: 33 m3
Fogging device:
Nebulo Type Europa 700W
log R>5.09: 10 %; Clean; 1 hour; 20°C
Yeasts
EN 1657 (2005) 2, 1
Candida albicans Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C
log R>4.07: 0.25 %; Clean; 30 min; 10°C
EN 1657 (2005) 2, 1
Candida albicans Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 5 min Test temperature: 10°C
log R>4.18: 0.5 %; Clean; 5 min; 10°C
EN 16438 (2014) 2, 2
Candida albicans Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C
log R>3.87: 0.25 %; Clean; 30 min; 10°C
NFT 72-281 (2014) Simulated-use
Orientation of the
surfaces: Vertically, at
a height of 1m (+/-
10%), and a distance
from the fogger of
2,6m (+/- 10%),
inoculum oriented at
the opposite of the
fogger.
Candida albicans Concentration (%): 10% (2.4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 20°C Relative humidity (%): 40 – 80 Room volume: 33 m3
log R>5.99: 10 %; Clean; 1 hour; 20°C
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Test (version) Phase, step
Test organism Test parameters Results*
Fogging device:
Nebulo Type Europa 700W
NFT 72-281 (2014) Simulated-use Orientation of the
surfaces: Vertically, at
a height of 1m (+/-
10%), and a distance
from the fogger of
2,6m (+/- 10%),
inoculum oriented at
the opposite of the
fogger.
Candida albicans Concentration (%): 10% (2,4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 19 – 21.5 to 27°C (final) Relative humidity (%): 62 – 74 to 90 (final) Room volume: 33 m3
Fogging device:
Nebulo Type Europa 700W
log R>5.99: 10 %; Clean; 1 hour; 20°C
Viruses / Bacteriophages
EN 14675 (2006) 2, 1
Bovine enterovirus Concentration (%): 0.1, 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C
log R>4.0: 0.25 %; Clean; 30 min; 10°C
EN 14675 (2006) 2, 1
Bovine enterovirus Concentration (%): 0.1, 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 5 min Test temperature: 10°C
log R>4.1: 0.5 %; Clean; 5 min; 10°C
The available information was sufficient to evaluate the efficacy of Virocid F for control of bacteria
(excluding mycobacteria and bacterial spores), yeasts and viruses, considering evaluation is done
under article 121 of the WGB. For spray application the studies show that Virocid F complies with the
criteria for lg reduction for PT03 disinfectants for the key species of the target organisms, when used
in accordance with the instructions described on the WG/GA. For fogging application additional
information was required. The fogging application is withdrawn at the applicant’s request.
5.3.2 Evaluation of the label (WG/GA)
The applicant has provided a WG/GA in Dutch. This has been adapted to our standards.
Regarding the dose instruction for fogging (diffusion time, contact time, monitoring of the
concentration of active ingredients) there are still some issues that need clarification.
For the claimed spray applications it was added to the WGGA that surfaces have to stay wet with
spray solution during the entire contact time.
5.4 Mode of action
ADBAC
C12-16-ADBAC is a cationic surfactant type active substance. Since it is surface active, it has fair
wetting properties and reacts strongly with cell walls of microorganisms. Its mode of action,
therefore, is to destroy the cell walls by sticking on the exterior structures and by entering and
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disintegrating the inner phospholipid-bilayer-based membrane structures. Due to its interaction with
phospholipid-bilayer-based structures, it severely alters the cell wall permeability, disturbs
membrane-bound iontranslocation mechanisms and may facilitate the uptake of other biocides.
DDAC
DDAC has properties similar to the benzyl QUATS but with organic soil and hard water tolerance.
DDAC is a cationic surfactant type active substance. Due to its interaction with phospholipid-bilayer
structures, it severely alters the cell wall permeability, disturbs membrane-bound ion-translocation
mechanisms, and may facilitate the uptake of other biocides.
Glutaraldehyde
The activity of glutaraldehyde is reported to be due to its reaction with nucleophilic cell components,
where it forms irreversible cross-links with enzymes and other proteins, ultimately resulting in cell
death.
5.5 Limitations on efficacy including resistance
5.5.1 General limitations
The following limitations are mentioned:
- for all application methods, the surfaces have to be cleaned prior to disinfection;
- for fogging application a minimum temperature of 20oC is required.
- for fogging application the volume of the animal housing should not exceed 150 m3.
5.5.2 Resistance
Virocid F is a combination of three active ingredients (glutaraldehyde and two quaternary
ammonium compounds) with different disinfecting mechanisms which extends the efficacy of the
product and thereby reduces the risk of development of resistance. Therefore no resistant
management strategies are required.
5.6 Overall conclusions of efficacy
Based on the data submitted and considering that the evaluation is done under article 121 of the
WGB, it can be concluded that Virocid F, when used in accordance with the proposed label (WG/GA),
is effective in controlling:
• Bacteria (excluding mycobacteria and bacterial spores), yeasts and viruses in animal housings and
related places for animals, including animal transport vehicles, by spraying.
The fogging application is withdrawn from the claim at the applicant’s request.
6 Human toxicology
ADBAC (benzyl-C8-18-alkyldimethyl ammonium chloride)
The List of Endpoints below is taken from the combined LOEPs on ADBAC-BKC (BPC-11 June 2015)
Where relevant, some additional remarks/information are given in italics.
List of endpoints
Absorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption: US ISC
Based on data on urine excretion (5-8%) and tissue
residues (<1%), and on the highly ionic nature of
the a.s., it is expected that the oral absorption is
around 10% at non-corrosive concentrations.
EQC
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Due to its ionic nature, C12-16-BKC is expected not
to easily pass biological membranes. Indeed, the
fraction of the oral dose absorbed was about 10%,
based on the urinary mean value 3-4% (with a
single peak value = 8.3%) and biliary excretion
values (3.7-4.6%), as well as on the absence of
residues in the carcass.
The oral absorption value of 10 % at non-corrosive
concentrations.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
The oral absorption can be considered
approximately 10%, based on the administered
dose eliminated via urine, bile and tissue residues,
in two independent studies from the two
applicants.
The oral absorption value of 10 % at non-corrosive
concentrations.
(US ISC; EQC)
Rate and extent of dermal absorption*: US ISC
Based on data from an in vitro study on human
skin, the % absorbable was almost identical for 2
different dilutions (0.03% and 0.3%). Summing up
the radioactivity present in the receptor fluid, in
the skin at the application site (after stratum
corneum removal) and in the tape strips 6-20 the
value for dermal absorption of the a.s. is 8.3% at
non-corrosive concentrations.
EQC
Based on the level of radioactivity at the skin
application site after removal of the stratum
corneum layers (6.5-8.7% of the dose), and
considering the ionic nature of C12-16-BKC, it can
be expected that the dermal absorption is not
different from the oral one (10%).
The dermal absorption value has to be considered
of 10 % at non-corrosive concentrations.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Summing up the radioactivity present in the
receptor fluid, in the skin at the application site
(after stratum corneum removal) and in the tape
strips 6-20 the value for dermal absorption of the
a.s. is 8.3% at both tested concentrations (i.e., at
non-corrosive concentrations)
(US ISC; EQC)
Distribution: US ISC
Most radioactivity was confined to the intestines.
Levels in central organs (liver and kidney) were low
and decreased rapidly over time
EQC
The plasma, blood and organ radioactivity levels
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were essentially non-quantifiable. At the high oral
dose-level only, quantifiable levels of radioactivity
were found in some central organs (highest levels
in the liver and kidney) at 8 hours post-dosing;
otherwise, most radioactivity was confined to the
intestines. Levels decreased rapidly over time
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Most radioactivity was confined to the intestines.
Levels in central organs (liver and kidney) were low
and decreased rapidly over time (US ISC; EQC)
Potential for accumulation: US ISC
None noted
EQC
None. No residues were measured in the carcass
after 168h.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
None relevant (US ISC; EQC)
Rate and extent of excretion: US ISC
Following oral administration in rats: 87 –99%
excreted in faeces as unabsorbed material, 5 – 8%
excreted in urine
EQC
Following oral administration in rats: 87 –99%
excreted in faeces as unabsorbed material, 5 – 8%
excreted in urine
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Excretion was rapid (within a 48 to 72-hour
period). The vast majority of the oral dose was
excreted in the faeces (80-90%) as unabsorbed
material; 5 – 8% excreted in urine. About 4% of the
oral dose was eliminated in the bile in a 24-hour
period
(US ISC; EQC)
Toxicologically significant metabolite US ISC
None. Four major metabolites of C12-16-ADBAC
were identified, as the product of alkyl chain
hydroxylation. It can be hypothesized that C12-16-
ADBAC metabolism is carried out by gut microflora.
EQC
None.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
None
(US ISC; EQC)
* the dermal absorption value is applicable for the active substance and might not be usable in
product authorization
Acute toxicity
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Rat LD50 oral US ISC
344 mg/kg bw
EQC
358 mg (obtained with C8-18-BKC/kg bw)
Although the test item is different, this result can
be considered valid for C12-16-BKC, based on the
similar mechanism for oral toxicity shown by
QUATS with this alkyl chain length.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
350 mg/kg bw
(US ISC; EQC)
Rabbit LD50 dermal US ISC
2848 mg/kg bw
EQC
Testing not allowed, active substance is corrosive
to skin
Literature LD50 values = 800-1400 mg/kg
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
<2000 mg/kg bw (Literature data provided by
EQC)
Rat LC50 inhalation US ISC
Study not conducted
EQC
Study not conducted - not relevant
C12-16-BKC is not volatile (calculated vp < 1x10-2 Pa
at 20°C) and is corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Study not conducted - not relevant
The a.s. is not volatile and is corrosive
(US ISC; EQC)
Skin corrosion/irritation US ISC
Corrosive
NOAEC = 0.3% in water at 2.0 mL/kg body weight
per day (2 week-treatment)
EQC
Corrosive
The maximum concentration reported in the
literature that does not produce irritating effect on
intact skin is established at 0.1% a.s.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Corrosive
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NOAEC = 0.3% in water at 2.0 mL/kg body weight
per day (2 week-treatment/rat)
The maximum concentration reported in the
literature that does not produce irritating effect on
intact skin is established at 0.1% a.s. (US ISC; EQC)
Eye irritation US ISC
Corrosive
EQC
Testing not allowed, active substance is corrosive
to skin
The maximum concentration reported in the
literature without irritating effect in the eyes =
0.02% a.s
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Corrosive.
The maximum concentration reported in the
literature without irritating effect in the eyes =
0.02% a.s
(US ISC; EQC)
Respiratory tract irritation US ISC
No study available, but expected to be corrosive
EQC
No study available, but expected to be corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available, but expected to be corrosive
(US ISC; EQC)
Skin sensitisation (test method used and
result)
US ISC
None (Buehler Test on guinea pig)
EQC
None (modified Draize test, guinea pig)
Result confirmed by a published study with GPMT
test
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
None.
(US ISC; EQC)
Respiratory sensitisation (test method used
and result)
US ISC
No study available, but expected to be not a
sensitiser
EQC
No study available, but expected to be not a
sensitiser
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
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PRODUCT AUTHORIZATION:
No study available, but expected to be not a
sensitiser
Repeated dose toxicity
Short term
Species/ target / critical effect US ISC
No short-term study available
EQC
Rat/dog, no specific toxic effects/ critical effects:
body weight and body weight gain reduction
associated to lower food intake
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Dog: no specific toxic effects/ critical effects: body
weight and body weight gain reduction associated
to lower food intake
(EQC)
Lowest relevant oral NOAEL US ISC
No short-term study available
EQC
LOAEL: 43-53 mg/kg/day (28-day dog- Supporting
study)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
LOAEL: 43-53 mg/kg/day (28-day dog- Supporting
study) (EQC)
Lowest relevant dermal NOAEL US ISC
No short-term study available
EQC
Study not conducted – not relevant
Effects are characterised by local corrosive effects
related to concentration rather than systemic
toxicity due to dermal uptake
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Study not conducted – not relevant
Effects are characterised by local corrosive effects
related to concentration rather than systemic
toxicity due to dermal uptake
(US ISC; EQC)
Lowest relevant inhalation NOAEL US ISC
No study available. Expected to be
irritant/corrosive.
EQC
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No study available. Expected to be
irritant/corrosive.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Expected to be
irritant/corrosive.(US ISC; EQC)
Subchronic
Species/ target / critical effect US ISC
Local effects (irritation/corrosivity) at the site of
contact in all species tested. Non specific systemic
effects (e.g. reduced body weight and body weight
gain), secondary to local effects.
EQC
Rat/dog, no specific toxic effects/ critical effects:
body weight and body weight gain reduction
associated to lower food intake
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat/dog: Local effects (irritation/corrosivity) at the
site of contact in all species tested. Non specific
systemic effects (e.g. reduced body weight and
body weight gain), secondary to local effects.
(US ISC; EQC)
Lowest relevant oral NOAEL US ISC
13.1 mg/kg/day (1 year, Dog)
EQC
1250 ppm = 45 mg a.s./kg bw/day (90-day, Dog)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
13.1 mg/kg/day (1 year, Dog)
(US ISC)
Lowest relevant dermal NOAEL US ISC
20 mg/kg bw/day (highest dose tested)
EQC
Study not conducted – not relevant
Effects are characterised by local corrosive effects
related to concentration rather than systemic
toxicity due to dermal uptake
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
20 mg/kg bw/day (highest dose tested)
(US ISC)
Lowest relevant inhalation NOAEL US ISC
No study available. Expected to be
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irritant/corrosive.
EQC
No study available. Expected to be
irritant/corrosive.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Expected to be
irritant/corrosive. (US ISC; EQC)
Long term
Species/ target / critical effect US ISC
Rat/mouse: Local effects (irritation/corrosivity) at
the site of contact in all species tested. Non
specific systemic effects (e.g. reduced body weight
and body weight gain), secondary to local effects.
EQC
Rat/mouse: Local effects (irritation/corrosivity) at
the site of contact in all species tested. Non
specific systemic effects (e.g. reduced body weight
and body weight gain), secondary to local effects.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat/mouse: Local effects (irritation/corrosivity) at
the site of contact in all species tested. Non
specific systemic effects (e.g. reduced body weight
and body weight gain), secondary to local effects.
(US ISC; EQC)
Lowest relevant oral NOAEL US ISC
44 mg/kg/day (2-years rats)
EQC
47 mg/kg/day (2-years rats)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
44-47 mg/kg/day (2-years rats)
(US ISC; EQC)
Lowest relevant dermal NOAEL US ISC
Study not conducted
EQC
Study not conducted – not relevant
Effects are characterised by local corrosive effects
related to concentration rather than systemic
toxicity due to dermal uptake
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Study not conducted – not relevant
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(US ISC; EQC)
Lowest relevant inhalation NOAEL US ISC
Study not conducted
EQC
Study not conducted – not relevant
Active substance is not volatile and corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Study not conducted – not relevant
(US ISC; EQC)
Genotoxicity
In-vitro:
In-vivo:
US ISC
In vitro:
Ames test – negative (with and without metabolic
activity)
Chromosomal aberration test – negative (with and
without metabolic activity)
Mammalian cell gene mutation assay – negative
(with and without metabolic activity)
In vivo:
Micronucleus assay - negative
EQC
In vitro:
Not genotoxic in vitro gene mutation study in
bacteria and in vitro cytogeneticity and gene
mutation assays in mammalian cells
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
The substance can be considered not genotoxic
based on:
in vitro (Ames test, Chromosomal aberration test,
Mammalian cell gene mutation assay) and in vivo
test (Chromosomal aberration test in rat bone
marrow) (US ISC)
Carcinogenicity
Species/type of tumour US ISC
Rat/none, Mouse/none
EQC
C12-16-ADBAC is not carcinogenic
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No neoplastic lesions were found that were
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considered treatment related.
Rat study (US ISC; EQC)
Mouse study (US ISC)
Relevant NOAEL/LOAEL US ISC
The NOELs related to non neoplastic effects in
chronic oral toxicity studies were 44 mg/kg/day for
rats and 73 mg/kg/day for mice.
EQC
In rats the NOAEL for non neoplastic effects was 47
mg a.s./kg/day.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No carcinogenic effects were observed.
Rat study (US ISC; EQC)
Mouse study (US ISC)
Reproductive toxicity
Developmental toxicity
Species/ Developmental target / critical effect US ISC
Rabbit/maternal toxicity
EQC
Rat /maternal toxicity
Rabbit / maternal toxicity
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for developmental toxicity (US
ISC; EQC)
Relevant maternal NOAEL US ISC
Rabbit: 4 mg/kg bw
EQC
Rat: 10 mg/kg bw/day
Rabbit: 3 mg/kg bw/day
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific concern for developmental toxicity.
Maternal NOAELs consistently lower than
developmental NOAELs. Maternal effects mostly
due to gastrointestinal distress, not relevant to
systemic toxicity (US ISC; EQC)
Relevant developmental NOAEL US ISC
Rabbit: 12 mg/kg bw
EQC
Rat: > 100 mg/kg bw/day
Rabbit: > 9 mg/kg bw/day
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CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for developmental toxicity (US
ISC; EQC)
Fertility
Species/ critical effect US ISC
Rat/ cortical adrenal hypertrophy in F0 females,
lower weight gain and higher spleen weights in F1
EQC
Rat/reduced weight gain and food consumption in
parental and F1 animals
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for reproductive toxicity (US
ISC; EQC)
Relevant parental NOAEL US ISC
608 mg/kg food (≥ 30 mg/kg bw/day)
EQC
1000 mg/kg food (> 50 mg/kg bw/day)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific concern for reproductive toxicity.
Parental NOAELs related to general toxicity
(US ISC; EQC)
Relevant offspring NOAEL US ISC
608 mg/kg food (≥ 30 mg/kg bw/day)
EQC
1000 mg/kg food (> 50 mg/kg bw/day)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific concern for reproductive toxicity.
NOAELs in F1 related to general toxicity and equal
to the parental ones (US ISC; EQC)
Relevant fertility NOAEL US ISC
1620 mg/kg food (≥ 52 mg/kg bw/day)
EQC
> 2000 mg/kg food (> 100 mg/kg bw/day)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for reproductive toxicity (US
ISC; EQC)
Neurotoxicity
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Species/ target/critical effect US ISC
Study not conducted/ not relevant
EQC
Study not conducted – not relevant
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific concern for neurotoxicity (US ISC; EQC)
Developmental Neurotoxicity
Species/ target/critical effect US ISC
No indication from available studies
EQC
No indication from available studies
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for developmental
neurotoxicity (US ISC; EQC)
Immunotoxicity
Species/ target/critical effect US ISC
Study not conducted. No indication of such an
effect in the available toxicity studies
EQC
Study not conducted. No indication of such an
effect in the available toxicity studies.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific concern for immunotoxicity. (US ISC;
EQC)
Developmental immunotoxicity
Species/ target/critical effect US ISC
No indication from available studies
EQC
No indication from available studies
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for developmental
immunotoxicity (US ISC; EQC)
Other toxicological studies
US ISC
No further study conducted/ not relevant
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EQC
No further study conducted/ not relevant
CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION
No further study conducted/ not relevant
(US ISC; EQC)
Medical data
US ISC
No substance-specific effects have been noted. No specific observations or sensitivity/allergenicity
have been reported.
EQC
Skin reactions observed after dermal exposure to C12-16-BKC can be regarded as an irritant reaction
rather than a true sensitisation reaction. This is supported by the results from animal tests, which do
not indicate a sensitising potential
CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION
Skin reactions observed after dermal exposure to C12-16-BKC can be regarded as an irritant reaction
rather than a true sensitisation reaction. This is supported by the results from animal tests, which do
not indicate a sensitising potential (EQC)
Summary for Local effects
Value Study
Dermal NOAEC 0.3% 2-week skin irritation study with
rats (US ISC)
Oral NOAEC Not data available
Summary for systemic effects
Value Study Safety
factor
AELlong-term Not relevant
AELmedium-term Not relevant
AELshort-term Not relevant
ADI* Not applicable
ARfD Not applicable
* If residues in food or feed.
MRLs
Relevant commodities Not applicable
Reference value for groundwater
According to BPR Annex VI, point 68 US ISC
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0.1 µg/L
EQC
0.1 µg/L
Dermal absorption
Study (in vitro/vivo), species tested US ISC
In vitro study (human skin samples)
EQC
2 in vivo study available on rats, none of them
allowing a quantitative determination (oral
exposure not prevented; radioactivity in the
stratum corneum included)
Formulation (formulation type and including
concentration(s) tested, vehicle)
US ISC
C12-16-ADBAC aqueous solution (0.03% and 0.3%
w/w)
EQC
1: 1.5 and 15 mg a.s. /kg bw, as 6-hour exposure
over 10% of the body surface
2: 0.4 mL of a 0.77% w/w aqueous solution of C8-18-
BKC
Dermal absorption values used in risk
assessment
US ISC
The sum of the absorbed dose, the exposed skin
(2.18%-2.13) and the % of radioactivity present in
tape strips 6-20 gave rise to a value of 8.3%.
EQC
Estimated similar to the oral absorption (10%).
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
The sum of the absorbed dose, the exposed skin
(2.18%-2.13) and the % of radioactivity present in
tape strips 6-20 gave rise to a value of 8.3%.
(US ISC)
Data requirements
No additional data requirements are identified.
Local respiratory effects and determination of local Acceptable Exposure Level (AEClocal inhalation)
AEClocal inhalation
Recent data on acute inhalation exposure to ADBAC indicate an LC50 value of 53 mg/m3 in rats (4h
nose only exposure)1. In addition, a NOAEC of 0.049 mg/m3 was derived in an experiment where
mice were exposed head only during 45 minutes. Effects included a concentration dependent
decrease in tidal volume (>15%) and decreased respiratory rate at 0.23 mg/m3 as well as an increase
of inflammatory cells (neutrophils and alveolar macrophages in bronchial lavage fluid) at 19 mg/m3)2.
In the EPA RED document of ADBAC, an LC50 of > 54 mg/m3 and < 510 mg/m3 was reported.
Furthermore, the EPA RED concluded that an inhalation AEC might be derived based on the NOAEL of
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2.4 mg/kg bw/day based on hyperactivity and laboured breathing at 7.3 mg/kg bw/day in an oral
developmental toxicity study in rabbits (also included in the endpoint list of ADBAC). However, local
effects are not considered in this study, and therefore, this route-to-route extrapolation seems not
appropriate.
Based on the available LC50 values and applying a safety factor of 100 based on the limited
information available (only LC50) with in addition a factor of 3 to account for extrapolation from lethal
to non-lethal affects, the calculated AEC would be 0.18 mg/m3. Taking the NOAEC of 0.049 mg/m3
without an additional safety factor, the AEC for local effects after inhalation is set at 0.049 mg/m3.
In view of the above considerations the AEClocal inhalation is set at 0.049 mg/m3 in a worst case approach.
DDAC (Didecyldimethylammonium chloride)
The List of Endpoints below is taken from the combined LOEPs on DDAC (BPC-11 June 2015). Where
relevant, some additional remarks/information are given in italics.
List of Endpoints
Absorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption: US ISC
Based on data on urine excretion (≈3%) and tissue
residues (<1%), and on the 90% recovery of
radioactivity in faeces as unabsorbed material
DDAC oral absorption is limited to 10% at non-
corrosive concentrations.
EQC
Based on the urinary excretion (3-4%), biliary
excretion values (2.6%), the absence of residues in
the carcass, and 85-90% recovery of radioactivity in
faeces as unabsorbed material the actual absorbed
fraction is approximately10% of the orally
administered dose, at non-corrosive
concentrations.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
A value of 10% oral absorption is taken forward to
risk characterization at non-corrosive
concentrations. (US ISC; EQC)
Rate and extent of dermal absorption*: US ISC
About 0.1% of a DDAC dose delivered as aqueous
solution fully penetrated human skin in vitro in 24
h; including the radioactivity present in the dermis
and epidermis at the dose site mean total
absorbable DDAC was 9.41% (rounded to 10%) at
non-corrosive concentrations.
EQC
No possible to quantify DDAC in the available
study; indication of similarity between oral and the
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dermal bioavailability. It is estimated as a worst
case that DDAC dermal absorption is limited to
≈10%.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
A value of 10% dermal absorption is taken forward
to risk characterization at non-corrosive
concentrations. (US ISC)
Distribution: US ISC
Mainly in the g.i. tract, tissue residues (<1%).
EQC
Radioactivity mainly detected in the g.i. tract, and
at a much lower level in the liver and in the kidney.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Mainly detected in the g.i. tract, and at a much
lower level in the liver and in the kidney. No
detectable residues at 168 h (US ISC; EQC)
Potential for accumulation: US ISC
None. Tissue residues (<1%)
EQC
None. No residues in the carcass
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
None (US ISC; EQC)
Rate and extent of excretion: US ISC
The majority (>90%) of orally administered DDAC is
excreted, very likely unabsorbed, via the faeces.
Urine excretion ≈3% in 24-48 hours
EQC
The vast majority (86-96%) of the oral dose was
excreted in the faeces as unabsorbed material.
Urinary excretion was 3-4% and biliary excretion
2.6%, in a 24-hour period.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Around 90% of the oral dose was excreted in the
faeces as unabsorbed material. Urinary excretion
was 3-4% and biliary excretion 2.6% within 24
hours (US ISC; EQC)
Toxicologically significant metabolite US ISC
None. The majority of DDAC metabolism is
expected to be carried out by intestinal flora giving
rise to hydroxylation products in the alkyl chain,
none of them exceeding 10%
EQC
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None. Conjugated metabolites were detected in
the urine
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
None. The majority of DDAC metabolism is
expected to be carried out by intestinal flora
forming hydroxylation products in the alkyl chain,
none of them exceeding 10%. In addition
conjugated metabolites were excreted in urines
(US ISC; EQC)
* the dermal absorption value is applicable for the active substance and might not be usable in
product authorization
Acute toxicity
Rat LD50 oral US ISC
238 mg/kg
EQC
264 mg/kg bw
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
The lowest value is 238 mg/kg (US ISC)
Rabbit LD50 dermal US ISC
3342 mg/kg
EQC
No test available. Literature data : >2000 mg/kg
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
>2000 mg/kg (US ISC; EQC)
Rat LC50 inhalation US ISC
No test available. Not allowed since DDAC is
corrosive
EQC
No test available. Not necessary since the active
substance is not volatile, (vapour pressure < 1 x 10-
2 Pa at 20°C) and only spraying with big, not
inhaled, droplets with MMAD > 40 µm is
recommended.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Test unnecessary: DDAC is not volatile, (vapour
pressure < 1 x 10-2 Pa at 20°C and 2.3x10-4 Pa at
50ºC); only spraying with big, not inhaled, droplets
with MMAD > 40 µm is recommended; testing is
not allowed with corrosive chemicals (US ISC; EQC)
Skin corrosion/irritation US ISC
Corrosive
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EQC
Corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Corrosive (US ISC; EQC)
Eye irritation US ISC
Corrosive
EQC
Corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Corrosive (US ISC; EQC)
Respiratory tract irritation US ISC
No data available. Expected to be irritant/corrosive
EQC
No data available. Expected to be irritant/corrosive
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No data available. Expected to be irritant/corrosive
Skin sensitisation (test method used and
result)
US ISC
Not a skin sensitiser (Magnusson and Kligman
procedure - OECD Guideline 406)
EQC
Not a skin sensitiser (Magnusson and Kligman
procedure - OECD Guideline 406)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Not a skin sensitiser (Magnusson and Kligman
procedure - OECD Guideline 406) (US ISC; EQC)
Respiratory sensitisation (test method used
and result)
US ISC
No data available. Expected to be not a respiratory
sensitizer.
EQC
No data available. Expected to be not a respiratory
sensitizer.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No data available. Expected to be not a respiratory
sensitizer
Repeated dose toxicity
Short term
Species/ target / critical effect US ISC
No study available
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EQC
Rat/gi tract/ irritation corrosivity leading to body
weight reduction.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat/gi tract/ irritation corrosivity leading to body
weight reduction. (EQC)
Lowest relevant oral NOAEL US ISC
None
EQC
None. The only availbale study is by gavage in rat
/28-day/ NOAEL = 2.5 mg/kg/day: not relevant
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Data available only via gavage, which is not an
appropriate route of exposure for NOAEL
derivation.
Lowest relevant dermal NOAEL US ISC
Local effects NOAEC=0.6% DDAC in water at 2
mL/kg bw per day (5 day application)
Local effects NOAEC =0.3% DDAC in water at 2
mL/kg bw per day (2-week application).
EQC
No study available.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Local effects NOAEC =0.6% DDAC in water at 2
mL/kg bw per day (5 day application) (US ISC)
Local effects NOAEC =0.3% DDAC in water at 2
mL/kg bw per day (2-week application).
(US ISC)
Lowest relevant inhalation NOAEL US ISC
No study available. Not necessary.
EQC
No study available. Not necessary.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Not necessary.
Subchronic
Species/ target / critical effect US ISC
Rat and dog/gi tract/ irritation corrosivity leading
to body weight reduction.
EQC
Rat and dog/gi tract/ irritation corrosivity leading
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to body weight reduction.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat and dog/gi tract/ irritation corrosivity leading
to body weight reduction (US ISC; EQC)
Lowest relevant oral NOAEL US ISC
1 year dog:
NOAEL for local effects: 3 mg/kg/d
NOAEL for systemic effects: 10 mg/kg/d
EQC
90 days dog:
NOAEL for systemic effects: 15 mg/kg/d
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
NOAEL for local effects: 3 mg/kg/d (US ISC)
NOAEL for systemic effects: 10 mg/kg/d (US ISC)
Lowest relevant dermal NOAEL US ISC
90-day rat
Systemic NOAEL = 12 mg/kg /d (highest dose
tested)
Local effects NOAEL = 2 mg/kg/d.
EQC
None
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Systemic NOAEL = 12 mg/kg /d (highest dose
tested) (US ISC)
Local effects NOAEL = 2 mg/kg/d. (US ISC)
Lowest relevant inhalation NOAEL US ISC
No study available. Expected to be
irritant/corrosive.
EQC
No study available. Expected to be
irritant/corrosive.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Expected to be
irritant/corrosive.
Long term
Species/ target / critical effect US ISC
Rat/mice /gi tract/ irritation corrosivity leading to
body weight reduction.
EQC
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Rat/mice /gi tract/ irritation corrosivity leading to
body weight reduction.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat and mice/gi tract/ irritation corrosivity leading
to body weight reduction (US ISC; EQC)
Lowest relevant oral NOAEL US ISC
2 year Rat:
Non neoplastic effects lowest NOAEL: 32
mg/kg/day
EQC
2 year Rat:
Non neoplastic effects lowest NOAEL: 27
mg/kg/day
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Non neoplastic effects NOAEL: 27 mg/kg/day (EQC)
Lowest relevant dermal NOAEL US ISC
No study available. Not necessary.
EQC
No study available. Not necessary.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Not necessary.
Lowest relevant inhalation NOAEL US ISC
No study available. Expected to be
irritant/corrosive.
EQC
No study available. Expected to be
irritant/corrosive.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Expected to be
irritant/corrosive.
Genotoxicity
In-vitro:
In-vivo:
US ISC
In vitro:
Ames test – negative (with and without metabolic
activation)
Chromosomal aberration test – negative (with and
without metabolic activation)
Mammalian cell gene mutation assay – negative
(with and without metabolic activation).
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In vivo:
Chromosomal aberration test in rat bone marrow –
negative.
EQC
Not genotoxic in vitro gene mutation study in
bacteria and in vitro cytogeneticity and gene
mutation assays in mammalian cells.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
DDAC can be considered not genotoxic based on:
In vitro Ames test with and without metabolic
activation (US ISC)
In vitro chromosomal aberration test with and
without metabolic activation with OECD 473 (EQC)
In vitro mammalian cell gene mutation assay with
and without metabolic activation with OECD 476
(EQC)
In vivo chromosomal aberration test in rat bone
marrow (US ISC)
Carcinogenicity
Species/type of tumour US ISC
Rat/none
Mouse/none
EQC
Rat/none
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
DDAC was not found to be carcinogenic (US ISC;
EQC)
Relevant NOAEL/LOAEL US ISC
None
EQC
None
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Rat study (US ISC; EQC)
Mouse study (US ISC)
Reproductive toxicity
Developmental toxicity
Species/ Developmental target / critical effect US ISC
1) Rat / NOAEL / maternal toxicity
2) Rabbit / NOAEL /maternal toxicity
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EQC
Rabbit/ maternal toxicity (cases of discoloured
urine, splayed legs) / severe toxicity with abortion
at top dose level (32 mg/kg)
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No specific concern for developmental toxicity;
prenatal effects only seen as unspecific
consequence of maternal distress (US ISC or EQC)
Relevant maternal NOAEL US ISC
1) 0.8 mg/kg bw/day
2) 1.0 mg/kg bw/day
EQC
4 mg/kg bw
Relevant developmental NOAEL US ISC
1)≥ 16.2 mg/kg bw/day
2) ≥ 3 mg/kg bw/day
EQC
12 mg/kg bw
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Prenatal toxicity only seen in rabbits, clearly
secondary to maternal effects: NOAEL 12 mg/kg
bw (EQC)
Lowest NOAEL for maternal toxicity (local effects)
in rats, not considered relevant for systemic
toxicity: 0.8 mg/kg bw (US ISC)
Fertility
Species/ critical effect US ISC
Rat /NOEL/reduced body weight and food
consumption in parental and F1-F2 animals
EQC
Rat/ two-generation/ systemic toxicity
Cortical adrenal hypertrophy in F0 females; lower
weight gain and increased spleen weight in F1
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
Available studies do not indicate any specific
potential for reproductive toxicity. Observed
effects concern solely general toxicity
(US ISC; EQC)
Relevant parental NOAEL US ISC
750 mg/kg food (> 31 mg/kg bw/day)
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EQC
608 mg/kg food, corresponding to
≥ 30 mg/kg bw
Relevant offspring NOAEL US ISC
750 mg/kg food (> 31 mg/kg bw/day)
EQC
608 mg/kg food, corresponding to
≥ 30 mg/kg bw
Relevant fertility NOAEL US ISC
> 750 mg/kg food (> 31 mg/kg bw/day)
EQC
> 608 mg/kg food, corresponding to
≥ 30 mg/kg bw
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION
No specific potential for reproductive toxicity,
overall NOAEL (parental effects) at least 31
mg/kgbw/d (608mg/kg feed) (EQC)
Neurotoxicity
Species/ target/critical effect US ISC
No study available. Not necessary.
EQC
No study available. Not necessary.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
No study available. Not necessary.
(No structural similarity to known neurotoxin; no
alert for neurotoxic effects; no sign of
neurotoxicity found in sub-chronic/chronic study)
Developmental Neurotoxicity
Species/ target/critical effect US ISC
n.a.
EQC
n.a.
Immunotoxicity
Species/ target/critical effect US ISC
No study available. Not necessary.
EQC
No study available. Not necessary.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
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PRODUCT AUTHORIZATION:
No study available. Not necessary.
Developmental immunotoxicity
Species/ target/critical effect US ISC
n.a.
EQC
n.a.
Other toxicological studies
US ISC
No other study available.
EQC
No other study available.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION:
No study available. Not necessary.
Medical data
US ISC
No medical reports on the manufacturing personnel have been submitted.
EQC
No study available. Statements from medical doctors from different production locations indicate
that during production no problems are found which can be related to exposure to DDAC.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION:
No specific observations or sensitivity/allergenicity or any medical information have been reported
(US ISC; EQC)
Summary for Local effects
Value Study
Dermal NOAEC 0.3% 2-week skin irritation study with
rats (US ISC)
Oral NOAEC 0.03% 52-week oral gavage study in
dogs (US ISC)
Summary for systemic effects
Value Study Safety
factor
AELlong-term Not relevant
AELmedium-term Not relevant
AELshort-term Not relevant
ADI* Not applicable
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ARfD Not applicable
* If residues in food or feed.
MRLs
Relevant commodities Not applicable
Reference value for groundwater
According to BPR Annex VI, point 68 US ISC
0.1 µg/L
EQC
0.1 µg/L
Dermal absorption
Study (in vitro/vivo), species tested US ISC
In vitro study on Human dermatomed skin
membranes
EQC
In vivo study on rats (some cross-contamination
due to grooming and possible concomitant oral
exposure-quantification not possible)
Formulation (formulation type and including
concentration(s) tested, vehicle)
US ISC
1. 1.85% (w/v) DDAC in water
2. NP-1 formulation 1.85% (w/v) DDAC plus
components other than water (not specified)
EQC
1.5 and 15 mg/kg (40% DDAC in water)
Dermal absorption values used in risk
assessment
US ISC
1. 10% (for water dilutions only)
2. 17.8% (for non water dilutions formulations)
EQC
10% (as for the oral route) is taken as worst case
approach.
CONCLUSION TO BE TAKEN INTO ACCOUNT AT
PRODUCT AUTHORIZATION:
10% for simple aqueous formulations (US ISC)
To be checked at MS levels at the moment of
authorization of single product with other co-
formulants.
Data requirements active substance
No additional data requirements are identified.
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Glutaraldehyde
For the active substance glutaraldehyde a AR is available for PT2, 3, 4, 6, 11 and 12 (October 2014).
The List of Endpoints below is taken from this AR. Where relevant, some additional
remarks/information are given in italics.
List of endpoints
Absorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption: Approx. 37 to 51 % for both sexes depending on
dose level and method of calculation (measured as
radioactivity of 14C labelled GA). (Dow, BASF)
Oral absorption of 40 % is proposed for estimating
the systemic dose.
Rate and extent of dermal absorption for the
active substance:
10 % is proposed based on weight of evidence.
Rate and extent of dermal absorption for the
representative product(s)1:
Distribution: All organs and tissues (radioactive label)
Potential for accumulation: No potential for accumulation
Rate and extent of excretion: Rapid and almost complete, independent of the
sex
Toxicologically significant metabolite(s) Metabolites are poorly known, but none expected
to be toxicologically significant
Acute toxicity
Rat LD50 oral 77 mg/kg bw (for pure GA); R25 (Dow)
Rat LD50 dermal > 1000 mg/kg bw (for pure GA; highly dependent
on concentration) (BASF)
Rat LC50 inhalation 0.28 mg/L in male rats and 0.35 mg/L in female
rats; R23 (BASF, Dow)
Skin irritation Corrosive, R34 (Dow, BASF)
Eye irritation Corrosive, R41 (Dow, BASF)
Skin sensitization (test method used and
result)
Sensitising; Guinea pig maximisation test R43
(Dow, BASF)
Repeated dose toxicity
Species/ target / critical effect Rat / kidney / increased kidney weight coupled
with a slight increase in urea nitrogen in females
(Dow, BASF)
Mouse / kidney / increased kidney weight (Dow)
Dog / GI tract / increased incidence of vomiting
(Dow)
Lowest relevant oral NOAEL / LOAEL NOAEL 2.9 mg/kg bw/day (2.9 and 3.6 mg/kg
bw/day for males and females, respectively), rat
(Dow, BASF)
Lowest relevant dermal NOAEL / LOAEL NOAEL/LOAEL not established: skin irritation but
no systemic effects
Lowest relevant inhalation NOAEL / LOAEL LOAEC 0.26 µg GA/L, mice (local irritant effects; no
indications of systemic toxicity other than
secondary to irritation) (Dow)
1 Please consider Q5 on Derivation of dermal absorption values of section 4.1.1 of the Manual of Technical
Agreements (MOTA) version 5.
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Genotoxicity In vitro: Positive results in Ames test (Dow, BASF),
sister chromatid exchange assay (BASF), in vitro
chromosomal aberration assay (BASF), Forward
mutation assay (Dow, BASF).
In vivo: Slightly positive in an intraperitoneal in vivo
micronucleus test and equivocal in all oral studies
presumed due to test substance not reaching the
target organ. (BASF)
Carcinogenicity
Species/type of tumour Large Granular Lymphocytic Leukaemia in female
rats (Dow)
Testis Leydig cell adenomas in male rats (BASF)
lowest dose with tumours LGLL: 5.5 mg/kg bw/day (2-year oral study; not
treatment related) (Dow)
Leydig cells: 3.5 mg/kg bw/day (2-year oral study)
(BASF)
Reproductive toxicity
Species/ Reproduction target / critical effect 1. Increased resorption rate, increased post-
implantation losses, reduction in mean
placental weights (Teratogenicity study in
rabbits; Dow, BASF)
2. Testes Leydig cell hyperplasia, cystic
degeneration (2-year oral study in Wistar
rats; BASF)
3. Testes consistency changes (2-year oral
study in Fischer 344 rats; Dow)
4. Diffuse degeneration of the testes (1-year
oral study in Wistar rats; BASF)
Due to the nature and incidence of the findings
there is no ground for classification for
teratogenicity. Glutaraldehyde had little effect on
any reproduction parameters even at maternally
toxic doses and there is no ground for classification
for fertility effects.
Lowest relevant reproductive NOAEL / LOAEL 1. NOAEL 15 mg/kg bw/day
2. LOAEL 3.5 mg/kg bw/day
3. NOAEL 3.6 mg/kg bw/day
4. NOAEL 3.2 mg/kg bw/day
(The numbers refer to the studies as indicated
above)
Species/Developmental target / critical effect None in rabbits or rats (Dow, BASF)
Developmental toxicity
Lowest relevant developmental NOAEL /
LOAEL
Not relevant
Neurotoxicity / Delayed neurotoxicity
Species/ target/critical effect None
Lowest relevant developmental NOAEL / Not relevant
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LOAEL.
Other toxicological studies
Respiratory irritation Moderately potent peripheral sensory irritant;
Peripheral sensory irritation test, in mice (BASF)
Respiratory sensitisation Potential respiratory sensitizer; Mouse IgE test
(Dow)
Medical data
Cohort studies and case studies have identified
respiratory and skin sensitization as the main
effects on human health. Glutaraldehyde is among
the most common causes of occupational asthma
among health care workers.
Other health risks are due to the corrosive
properties of glutaraldehyde.
Summary Value Study Safety factor
Non-professional user
ADI (acceptable daily intake, external long-
term reference dose)
Not relevant - -
AELmedium-term 0.014 mg/kg
bw/day*
Rat 90-day oral
study
100
AELlong-term 0.014 mg/kg
bw/day*
Rat 90-day oral
study
100
AECinhalation 10.6 µg/m3
(2.6 ppb)
2-year
inhalation study
in the mouse
24***
AECacute inhalation 0.5 mg/m3
(120 ppb)
Human study on
odour detection
and
chemesthetic
detection
3.2
AECdermal not
established*
Drinking water limit 0.1 µg/L As set by EU
Drinking Water
Directive
(98/83/EC)
Not relevant
ARfD (acute reference dose) 0.60 mg/kg
bw/day
Rabbit
teratogenicity
study
25
Professional user
Reference value for inhalation (proposed OEL) - - -
Reference value for dermal absorption
concerning the active substance:
10% estimated
value
- -
Reference value for dermal absorption
concerning the representative product(s)4:
10% estimated
value
- -
* AELmedium-term/ long-term is based on the NOAEL of 3.5 mg/kg bw/day of a rat carcinogenicity study
(instead of the stated 90-day oral study in rats) and corrected for 40% oral absorption.
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** From the human volunteer- and occupational studies an NOEL of 0.2% glutaraldehyde was
derived. For the risk assessment an NOEClocal dermal of 0.2% (without additional assessment factors) will
be used.
*** AECinhalation = 0.255 mg/m3 / (2.5interspecies × 3.2intraspecies × 3LOAEC-to-NOAEC) = 0.0106
mg/m3
Data requirements
No additional data requirements are identified.
6.1 Human exposure assessment active substance
6.1.1 General aspects
Virocid F is a suspension concentrate and contains Alkyl (C12-16) dimethylbenzylammoniumchloride
(ADBAC) (5%), Didecyldimethylammoniumchloride (DDAC) (5%), and glutaraldehyde (24%) as active
substances. The proposed field of use of Virocid F is surface disinfection of animal housings and
equipment, and means of animal transport (PT3).
Virocid F is applied to the surfaces by spraying or by fogging. The application dosage is 0.5% Virocid F
in water when it is applied by spraying to disinfect of means for transport of animals, corresponding
to 0.025% ADBAC, 0.025% DDAC and 0.12% glutaraldehyde in the in-use solution. The application
dosage to disinfect animal housings is 0.25% (0.0125% ADBAC, 0.0125% DDAC and 0.06%
glutaraldehyde in the in-use solution). For application by fogging, the application dosage is 10%,
corresponding to 0.5% ADBAC, 0.5% DDAC and 2.4% glutaraldehyde.
The formulation Virocid F is for professional use.
6.1.2 Identification of main paths of professional exposure towards active substance from its use
in biocidal product
The professional user can be dermally and respiratory exposed to active substances ADBAC, DDAC
and glutaraldehyde during mixing and loading, and spraying using Virocid F. During application by
fogging no exposure of the professional user is expected because fogging is performed using a fully
automated system (IGEBA Nebulo Europe 700W) , and no person or animal may be present in the
room until the concentration of glutaraldehyde drops below 0.1 ppm, as described in the WG/GA.
The very low vapour pressure and Henry’s law constant of ADBAC and DDAC ( vapour pressure 6.03 x
10-4 Pa at 20 ºC for ADBAC and 5.9x10-6 Pa at 20oC voor DDAC, Henry’s law constant 5.03 x 10-7 Pa x
m3/mol at 20 ºC for ADBAC and 4.27x10-9 Pa m3/mol at 20 ºC for DDAC), indicates poor partitioning
of these compounds from aqueous solution. Therefore inhalation exposure to ADBAC and DDAC is
considered negligible. Local exposure of upper airway to ADBAC and DDAC is possible during
spraying.
For glutaraldehyde respiratory exposures is possible due to high vapour pressure.
As Virocid F is intended for professional use only, oral exposure is considered negligible.
6.1.3 Identification of main paths of non-professional exposure towards active substance from its
use in biocidal product
The formulation Virocid F is intended for professional use only.
6.1.4 Indirect exposure as a result of use of the active substance in biocidal product
During application of Virocid F by spraying secondary respiratory bystander exposure to the active
substances may occur. However, this exposure is expected to be lower than direct exposure of a
professional user applying the formulation by spraying. The applicant has indicated that the treated
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surfaces does need to be washed. Therefore, secondary dermal exposure of the general public
including children visiting a farm by touching treated surfaces, and secondary exposure of animal by
licking or touching treated surfaces cannot be excluded.
6.2 Human health effects assessment product
6.2.1 Toxicity of the formulated product
No studies with Virocid F have been submitted and the classification and labelling of the formulation
has been prepared based on the calculation method described in Annex I of Regulation
1272/2008/EC.
6.2.2 Data requirements formulated product
No additional data requirements are identified.
6.3 Risk characterisation for human health
6.3.1 Professional users
Exposure by mixing/loading and application by coarse spraying
To estimate systemic and local respiratory exposure to glutaraldehyde during the application Virocid
F by spraying, Spraying Model 2 (User Guidance v.1, 2002, p.30) is considered to be applicable. Using
Spraying Model 2 is in accordance with draft final CAR for glutaraldehyde for scenario “Disinfection
of a Poultry Farm by spraying” and is also included in the HEAd hoc recommendation 6. This model
also includes mixing and loading step; therefore no separate assessment of mixing and loading is
performed. The concentration glutaraldehyde in the in-use solution is 0.12%. The indicative exposure
values are 273 mg/min for hand exposure without protective gloves, 7.8 mg/min for hand exposure
inside protective gloves, 222 mg/min for body exposure and 76 mg/m3 for respiratory exposure. The
exposure duration for professional users is considered to be 3 hours/day. The results of exposure
estimates are presented in table below.
Table T.1. Internal professional operator exposure to glutaraldehyde and risk assessment during
spraying
Route Estimated internal
exposurea (mg/kg
bw/day)
Systemic
AEL (mg/kg
bw/day)
Risk-indexb
Spraying, no PPEc, systemic effects
Dermal 0.1782 0.014 12.7
Respiratory 0.0057 0.014 0.41
Total 0.1839 0.014 13.1
Spraying, with PPEc, systemic effects
Dermal 0.0108 0.014 0.77
Respiratory 0.0005 0.014 0.04
Total 0.0109 0.014 0.81
Spraying, local effects
Route Estimated external
exposure (mg/m3)
Local
AEC (mg/m3)
Risk-indexb
Respiratory 0.091 0.0106 8.58
a Internal exposure was calculated using biological availability via the dermal route of 10 %
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b The risk indices are calculated by dividing the internal exposure by the systemic AEL, or, for local respiratory effects, by dividing
external exposure by external AEC
c Exposure with PPE (gloves, protective clothing, respiratory protection equipment (RPE) with protection factor 10) is calculated
using indicative exposure value inside protective gloves of 7.8 mg b.p./min according to Spraying Model 2 and considering 90%
body exposure reduction due to the use of protective clothing.
Based on the risk assessment, no adverse systemic and local respiratory effects after exposure to
glutaraldehyde are expected for the protected (gloves, protective clothing and RPE with protection
factor 10) professional user after surface disinfection by spraying for 3 hours.
Before the disinfection of animal housing can take place, thorough cleaning has to be performed.
Therefore, taken in to account this cleaning procedure and other tasks than cleaning/disinfections, 3
hours exposure is considered to be a realistic assumption for farmers. According to the WG/GA the
in-use concentration of Virocid F for disinfection animal housing is 0.25%. This is half of the
concentration used in the calculation above (0.5%), which is based on the maximum in-use
concentration used in the means of animal transport. Based on the in-use concentration of 0.25%,
the risk index by disinfection of animal housing is refined to be 0.40 after 3 hours. Therefore, the use
of Virocid F is not expected to cause adverse health effects, even when this is performed by
contractors specialised in animal house disinfection.
Local dermal exposure to ADBAC, DDAC and glutaraldehyde can occur during mixing and loading of
Virocid F and during spraying. During mixing and loading, the professional user is dermally exposed
to the concentrate (containing 5% w/w ADBAC, 5% w/w DDAC and 24% w/w glutaraldehyde), and
during the application the professional user is dermally exposed to the in-use dilution of Virocid F.
The maximum dilution is 0.5%, corresponding to 0.025% w/w ADBAC, 0.025% w/w DDAC and 0.12%
w/w glutaraldehyde.
For the exposure to the concentrated product, the NOAEL for all active substances are exceeded. The
use of PPE (gloves and protective clothing) is therefore prescribed for the professional user during
mixing and loading. The concentration of glutaraldehyde in the in-use dilution (0.12%) does not
exceed the NOEL of 0.2% for glutaraldehyde and the combined concentration of ADBAC and DDAC
(0.05%) is lower compared to the NOAEL of 0.3%. Therefore no adverse health effects are expected
due to dermal exposure to ADBAC, DDAC and glutaraldehyde during disinfection by spraying. By
spraying the upper airway of the professional user may be exposed to in-use solution of Virocid F.
However, because the concentrations of ADBAC, DDAC and glutaraldehyde in the in-use solution are
all below the NOAEL, no adverse effects are expected.
Exposure by fogging
The formulate Virocid F may be applied to surfaces by fogging. For this purpose Virocid F is diluted to
10% in water, and transferred to the fogging apparatus IGEBA Nebulo Europe 700W. Exposure during
mixing and loading is already evaluated above, therefore no separate assessment is needed. The
fogging is automated process and no person or animal is allowed to be present in the room while the
room is treated. Therefore no exposure of the professional user during disinfection by fogging is
expected. However, if the professional user needs to enter the area during treatment in emergency
situations (for example the apparatus used for the fumigation is not working properly), than the
professional user could be respiratory and dermally exposed to unknown concentration of the active
substances. Therefore, the following sentence needs to be included in the WG/GA: “If a treatment
area needs to be entered due to emergency situation, wear suitable protective personal equipment
and suitable respiratory protection equipment.”
After the treatment, the room is released for use only when glutaraldehyde drops below 0.1 ppm
(=100 mg/m3), according to the WGGA. However, this concentration of 100 mg glutaraldehyde/m3 is
far higher than the local inhalation AEC of 0.0106 mg/m3 for glutaraldehyde.
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According to the applicant the average concentration of glutaraldehyde during the fogging treatment
is 148 ppm. Assuming ventilation rate of 4 /hr (RIVM report 320005003/2006) and initial
concentration of 148 ppm (=148000 mg/m3), ConsExpo 4.1 shows that after 4.5 hours the
glutaraldehyde air concentration decreases below the inhalation AEC of 0.0106 mg/m3. Based on this
information the following sentence should be added to the WG/GA: “The room may be released for
unprotected person or animals 4.5 hours after the fogging application.”
6.3.2 Non-professional users, including the general public
The formulation Virocid F is intended for professional use only.
6.3.3 Indirect exposure as a result of use
According to the proposed WG/GA the disinfected surfaces do not need to be rinsed, meaning that
the active substances may remain on the treated surfaces. The general public (e.g. children visiting
farm) and animal may be dermally and orally exposed to ADBAC, DDAC and glutaraldehyde by
touching or licking the surfaces disinfected with Virocid F.
For local effects the sum of the concentrations of ADBAC (0.025%) and DDAC (0.025%) in Virocid F is
lower than the NOAEL (0.3%). In addition, the concentration of glutaraldehyde (0.12%) is lower than
its NOEL 0.2%. Therefore no local adverse effects are expected due to the exposure due to dermal
exposure to ADBAC, DDAC and glutaraldehyde by touching disinfected surface.
For glutaraldehyde, systemic effects need to be addressed. According to the applicant, up to 1.0-2.4
mL of Virocid F is applied per m2 from spraying and fogging, corresponding to 230-576 mg
glutaraldehyde/m2 (1-2.4 mL x 0.96 g/cm3 x 24% ). As a worse case for secondary exposure a toddler
of 10 kg was assumed to enter the treated area. The palms of both hands (115.2 cm2) becomes
contaminated by touching disinfected surface, and 10% of glutaraldehyde on hands is orally ingested
by hand-to-mouth transfer. For transfer coefficient of glutaraldehyde from treated surface to hands
18% is used, which is the worst value for transfer of dried fluid from various surface (TNsG, 2007).
Using the oral absorption rate of 40% (the draft CAR), the systemic exposure level is calculated as
following:
Amount of glutaraldehyde on hands
0.01152 m2 x 576 mg glutaraldehyde/m2 x 18% (transfer coefficient)
= 1.194 mg glutaraldehyde on hands
Systemic dermal exposure
1.194 mg x 90% x 10% (dermal absorption) = 0.107 mg
Systemic oral exposure
1.194 mg x 10% x 40% (oral absorption) = 0.048 mg
Total systemic exposure
(0.107 mg+ 0.048 mg)/10 kg bw = 0.015 mg/kg bw/day
As the calculated exposure level 0.015 mg/kg bw/day is higher than the systemic AEL of 0.014 mg/kg
bw/day (RI=1.07), adverse health effects due to secondary exposure to gultaraldehyde by using
Virocid F cannot be excluded. Therefore, the risk for the general public due to the secondary
exposure to glutaraldehyde contained in Virocid F is considered unacceptable, and the following
sentence should be included in the WG/GA : “Rinse off the surface using clean drinking water after
disinfection”. With the inclusion of the rinsing step, the dermal and oral exposure of animal to the
active substances is also considered to be acceptable.
6.3.4 Combined exposure
The formulation Virocid F is a mixture of three active substances. The combined toxicological effect
of these three active substances has not been investigated with regard to repeated dose toxicity.
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Possibly, the combined exposure to these active substances may lead to a different toxicological
profile than the profiles based on the individual substances.
For risk assessment based on local effects, the principle of addition can be applied. During mixing and
loading, the use of PPE(gloves and protective clothing) is prescribed and therefore no local dermal
effects need to be considered. During application by spraying, the total concentration of irritating
substances (i.e. 3 active substances.) in the solution is 0.17% (0.025%+0.025%+0.12%). This value is
lower than the NOAEL of 0.2% for glutaraldehyde and the NOAEL of 0.3% for ABDAC and DDAC.
Therefore it is concluded that there is no concern for combined dermal exposure to the three active
substances.
Regarding inhalation exposure, glutaraldehyde is the only substance for which such exposure is
possible. Therefore there is no concern for combined exposure for inhalation exposure.
Only for glutaraldehyde systemic effects were evaluated, therefore no addition on systemic effects
are expected.
6.3.5 Substance of Concern
This product also contains a substance of concern, for which a Community Limit value has been set.
The risk assessment for dermal and respiratory exposure to these substances was performed using
appropriate models. Based on the risk assessment, no adverse effects are expected for the
unprotected professional user from respiratory exposure to SoC Human Toxicology 1 as a result of
the application of Virocid F, when used in accordance with WG/GA.
6.4 Overall conclusions for the aspect human health
Based on this risk assessment, it was concluded that no adverse health effects are expected for the
protected professional user (gloves, protective clothing and respiratory protection equipment with
protection factor of 10) after dermal and respiratory exposure to ADBAC, DDAC and glutaraldehyde
as a result of the application of Virocid F, when used in accordance to the WG/GA. Furthermore, the
following sentences should be added to the WG/GA: The room may be released for unprotected
person or animals 4.5 hours after the fogging application.” and “If a treatment area needs to be
entered due to emergency situation, wear suitable protective personal equipment and suitable
respiratory protection equipment.”
Furthermore, when used according to the WG/GA, no adverse health effects are expected for the
general public and animal by indirect exposure to ADBAC, DDAC and glutaraldehyde as a result of the
application of Virocid F. The following sentence should be included in the WG/GA : “Rinse off the
surface using clean drinking water after disinfection”.
6.5 Additional indirect exposure risk assessment
Based on efficacy evaluation the application by fogging is not authorised. The applicant has asked if
the restriction sentence in the WGGA: “Rinse off the surface using clean drinking water after
disinfection”, which was required due to the risk identified from indirect exposure after fogging
application could be removed. Hereafter the risk assessment for secondary exposure is performed
based on the application by spraying:
According to the applicant, 400 mL of Virocid F dilution is applied per m2 by spraying. In animal
housing and mean of animal transportation, max concentrations of Virocid F are 0.5% and 0.25%
w/w, respectively. This corresponds to the application of glutaraldehyde amount of 257 mg (400 mL
x 1.07 g/cm3 x 0.25% x 24%) per m2 in animal housing, and 514 mg (400 mL x 1.07 g/cm3 x 0.5% x
24%) per m2 in means of animal transportation.
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For animal housing, a toddler of 10 kg was assumed to enter the treated area as the worst case.
Using the same approach as that taken in the evaluation, the systemic exposure level is calculated as
following:
Amount of glutaraldehyde on hands
0.01152 m2 x 257 mg glutaraldehyde/m2 x 18% (transfer coefficient)
= 0.533 mg glutaraldehyde on hands
Systemic dermal exposure
0.533 mg x 90% x 10% (dermal absorption) = 0.048 mg
Systemic oral exposure
0.533 mg x 10% x 40% (oral absorption) = 0.021 mg
Total systemic exposure
(0.048 mg+ 0.021 mg)/10 kg bw = 0.0069 mg/kg bw/day
The calculated exposure level 0.0069 mg/kg bw/day is lower than the systemic AEL of 0.014 mg/kg
bw/day (RI=0.50). Therefore no adverse effects are expected.
For means of transportation, exposure of animals transported is taken into consideration. The AEL
values of 0.014 mg/kg bw for glutaraldehyde is the limit value derived for human exposure. Therefor
for animal exposure assessment, an animalAELmedium-term will be derived. Considering the NOAEL of 3.5
mg/kg bw/day, correction for 40% oral absorption, and using an assessment factor of 5, an
animalAELmedium-term of 0.28 mg/kg bw/day can be derived. The assessment factor of 5 is chosen to be
in line with EFSA guidance on birds and mammals (2009). According to this guidance document the
same endpoint as in the human risk assessment, without the AF applied as part of the human risk
assessment, should be used for a mammalian chronic risk assessment. Subsequently, the exposure is
compared to the NOAEL and if long-term toxicity/exposure ratio is less than 5 an unacceptable risk
occurs. In other words, using this information, reflecting this by using an AF of 5, a resulting risk index
>1 would be considered unacceptable.
Assuming the application rate of 400 mL/m2 , glutaraldehyde residue is calculated to be 514 mg per
m2 . Using the oral absorption rate of 40% (the CAR), and assuming 100% transfer from the
disinfected surface to mouth as the worst case, the area to be licked to reach systemic AEL for a lamb
of 40 kg is calculated as following:
(0.28 mg/kg bw/day x 40 kg bw) ÷ 40% ÷ 514 mg glutaraldehyde/m2 = 0.0545 m2 =545 cm2
It is unlikely scenario to occur that a lamb licks off a disinfected surface of 545 cm2 (e.g. a square with
c.a. 23 cm side). In addition, the AEL is based on animal studies with repeated exposure (90 days or 2
year rat studies), while the exposure of animals to Virocid F is considered to be a couple of times in
their life-span. Also, the worst case 100% of glutaraldehyde is assumed to remains on disinfected
surface if the surface is left to dry, while glutaraldehyde is considered to decompose quickly.
Altogether, the risk for the animals due to the secondary exposure to glutaraldehyde contained in
Virocid F is considered acceptable.
The restriction sentence in the WG/GA : “Rinse off the surface using clean drinking water after
disinfection” is not required.
7 Environment
7.1 Introduction
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Authorisation is requested for Virocid F containing alkyl dimethyl benzyl ammonium chloride
(ADBAC), didecyldimethyl-ammonium chloride (DDAC) and glutaraldehyde as active substances. The
biocidal product concerns a veterinary hygiene disinfectant (PT03) and is for professional use only.
The intended uses are described in Table E.1.
Table E.1. Intended uses, dose, and use concentrations of the active substances.
Area of use envisaged Concentration
active substance
in product (g/kg)
Dose (g
product/L)
Use
concentration
active
substances in
diluted solution
(g/kg)
Application rate
Disinfection of animal
housing by spraying
ADBAC: 50
DDAC: 50
GA1: 240
2.5
ADBAC : 0.125
DDAC : 0.125
GA. : 0.6
not specified
Disinfection of animal
housing by fumigation 100
ADBAC : 5
DDAC : 5
GA. : 24
2.4 ml/m³
Disinfection of veterinary
transport vehicles by
fogging
5.0
ADBAC : 0.25
DDAC : 0.25
GA. : 1.2
not specified
1 Glutaraldehyde
7.2 Product related studies
The exposure assessment is based on data for the active substances. There are no fate or ecotoxicity
data available for the product. The data for the active substances applied in the current risk
assessment are presented in appendix I.
7.3 Environmental exposure assessment
7.3.1 Chemistry and/or metabolism
ADBAC and DDAC are cationic surfactants which are characterized by near irreversible binding or
interaction with organic matter. Both active substances are classified as readily biodegradable.
Metabolites are not formed > 10% in all environmental compartments. A monitoring study (Clara et
al, 2007) conducted in nine Austrian sewage treatment plants (STPs) demonstrated that quaternary
ammonium compounds are effectively removed from waste water (98.5% removal). Metabolites of
ADBAC are not formed > 10% in all environmental compartments.
Glutaraldehyde is highly hydrophilic, non-ionisable and fully soluble in water. Although
glutaraldehyde is volatile, it does not easily evaporate from water due to its high water solubility and
corresponding low Henry constant. The active substance is hydrolytically and photolytically stable
under environmental relevant conditions. Glutaraldehyde is subject to rapid photochemical
degradation in air with a half-life of 8.2 h, and classified as readily biodegradable.
Glutaraldehyde is considered to be moderately mobile in soil and sediment based on the average
organic carbon-water partitioning coefficient (Koc) of 326 L/kg. The adsorption is considered to be
irreversible as no desorption could be observed in the test.
The active substance’s physical-chemical properties applied for the exposure assessment are
summarised in appendix I.
7.3.2 Distribution in the environment
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Various phases in the life cycle of a product may cause emissions and environmental exposure.
Significant release to the environment will therefore occur during the application of products holding
the biocide. Table E.2 summarises the receiving environmental compartments that have been
identified as potentially exposed during the use of the product for the different applications.
Emissions from active substance production and product formulation are not part of the risk
assessment. The routes of entry into the environment are explained in more detail in the next
sections.
Table E.2. Foreseeable routes of entry into the environment on the basis of the intended use.
Main scenario Environmental compartments exposed
STP1 Freshwater2 Saltwater2 Soil3 Air
Disinfection of stables ++ + - + ++
Disinfection of veterinary
transport vehicles ++ + - - ++
++ Compartment directly exposed, + Compartment indirectly exposed, - Compartment not exposed, 1 Sewage Treatment Plant, 2 Including sediment, 3 Including groundwater.
7.3.2.1 Disinfection of stables
Disinfection of animal housing including cages, floors, walls, conveyor belts, and machinery is
common practice in stables and usually takes place at the beginning or ending of a breeding period.
Release of waste water holding residues of the product to the sewer and subsequently to the sewage
treatment plant is possible, but considering that most farms are not connected to the municipal
sewer, disposal to the manure depot is more likely. Alternatively, waste water may be collected and
transported by tankers and disposed to the sewer. If present, residues may be released to individual
sewage treatment plants (In Dutch: IBA) as well when equipment is for instance rinsed above sinks.
Residues that are released to the sewer can enter the aquatic environment via an STP or an IBA,
although some IBAs infiltrate their effluent in soils. When released to the manure, residues are mixed
with the top soil layer when manure is applied as a soil fertiliser. The active substances may be
subsequently emitted to groundwater due to leaching or transported to adjacent surface water due
to runoff or drainage systems. Application of sewage sludge as a soil fertiliser is highly unlikely in The
Netherlands as its chemical composition does not fulfil the environmental standards regarding
organic pollutants and heavy metals. In order to avoid unnecessary contamination of the receiving
soils, sewage sludge is treated as hazardous waste instead. Because animal houses are ventilated
after disinfection by fumigation, release to the air compartment and subsequent deposition on
surface water and soils is likely.
7.3.2.2 Disinfection of veterinary transport vehicles
Considering that professional use of biocides for the disinfection of veterinary transport vehicles is
regulated (Ontwerpbesluit milieubeheer – agrarisch, Wet bodembescherming), direct exposure of
soils and surface water is prevented as vehicles have to be disinfected above liquid-tight floors at
farms and slaughterhouses. Applications at farms will result in emission to the manure and
eventually to soils when manure is applied as a fertilizer, or to the sewer when present. Disinfection
of transport vehicles is however not common practice and is usually limited to isolate pathogenic
micro-organisms in case of epidemics. Most transport vehicles are disinfected on the premises of
slaughterhouses after been unloaded. Here, waste water is discharged to an on-site waste water
treatment plant and subsequently to the municipal sewer. Pre-treatment of waste water is
mandatory for slaughterhouses in order to fulfil the standards set by local water authorities
regarding e.g. suspended solids, lipids contents, and biological oxygen demands (Besluit algemene
regels voor inrichtingen milieubeheer).
7.3.3 Predicted environment concentration calculations
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7.3.3.1 General
Predicted Environmental Concentrations (PECs) were calculated according to relevant exposure
scenario documents (ESDs, release to the environment), the guidance on biocide legislation, Part B,
volume IV (distribution in the environment), and the model SimpleTreat (concentrations for micro-
organisms in a STP and the STP’s effluent) by using the default values for parameters, unless
otherwise noted. Release of active substances during the waste phase of the end-products is not
assessed, because it is assumed that end-products to which the active substances are added are
disposed as solid waste and usually incinerated. Possible pH effects on the environment were not
considered, because the STP and receiving compartments are expected to have sufficient buffering.
The applied methods are explained below. The risk assessment is based on the active substance’s
physical-chemical properties as listed in appendix I and the concentrations as listed in Table E.1.
Monitoring data demonstrated that STPs effectively remove ADBAC and other quaternary
ammonium compounds from waste water (Clara et al., 2007). Concentrations in surface water of
ADBAC and DDAC were therefore based on monitoring data (98.5% removal) instead of the
distribution over sewage sludge, air, and water by SimpleTreat.
Because sewage sludge is not applied as a soil fertiliser in The Netherlands, emission to soils is
negligible when vehicles are disinfected on the slaughterhouses’ premises. No PECs were therefore
calculated for soils and groundwater for this type of use.
7.3.3.2 Disinfection of stables
Emission to the environment was calculated according to the stable disinfection scenario taken from
the ESD for PT03 An application rate of 0.4 L sanitising solution/m² was applied as a worst-case for
surface disinfection. For disinfection by spraying or fumigation emission was based on the stable
volumes taken from the ESD for insecticides in stables (PT18). Although these volumes are higher
than the advised maximum room volume per fogging device (150 m³), application of multiple devices
and/or disinfection of various small sized stables is realistic.
As the amount of disinfections per year and the sizes of the surfaces to be disinfected strongly
depend on the type of animal housed, emission to soils due to disinfection of stables varies among
the different farm industries. The ESD distinguishes 18 types of farms, which were in this risk
assessment grouped in dairy cattle, beef cattle, pig farming, and poultry. Only the highest PECs and
PEC/PNEC ratios for each category are presented in the current risk assessment report. Because duck
farming is worst-case considering the number of annual applications (13 vs. 1-7 ), assessments were
made for poultry with and without ducks for comparison. Note that battery cages are not allowed in
Europe anymore (Regulation No 1999/74/EC of the European Parliament). This type of farming was
therefore excluded from the poultry group.
7.3.3.3 Disinfection of veterinary transport vehicles
Emission to the STP resulting from the disinfection of veterinary transport vehicles was only
calculated for mammals being the worst case. Considering that large scale disinfection of veterinary
transport vehicles is done on the premises of slaughterhouses where waste water is pre-treated by
grease and sediment separation tanks, it was assumed that 90% is eliminated during wastewater pre-
treatment. This assumption is justifiable as glutaraldehyde is readily biodegradable and quaternary
ammonium compounds are extreme lipophilic. Emission was based on an application rate of 0.4
L/m².
Indirect release to soils via manure is likely when vehicles are disinfected on farms. It is, however,
assumed that the frequency of disinfection is similar to that of stables, because stables are only
disinfected when animals are transported to or from the farm. Considering that the surface of
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transport vehicles is negligible towards that of stables, the risk for soil organisms is covered by the
stable scenario.
7.3.3.4 Groundwater
FOCUS PEARL (PEARL model © RIVM/Alterra, FOCUS v. 4.4.4) was used to estimate concentrations in
shallow groundwater by using the default parameters for the Kremsmünster scenario which is
assumed representative for most Dutch agricultural conditions regarding crop, soil and climate. Grass
and winter cereals were selected as crops for grassland and arable land, respectively. The worst-case
concentrations in soil were recalculated to kg/ha in order to be entered in PEARL. Manure was
distributed on grassland 1st of February, 26th of March, 18th of May and 10th of July and on arable land
3rd of October, and applied by injection for which the depth was adjusted accordingly (10 cm). For
arable land, an incorporation depth of 20 cm was used. Uptake by crops was not considered and a
simulation period of 20 years was chosen. The dose was based on the expected soil concentration
direct after manure application. The compounds’ physical-chemical properties are listed in Appendix
I.
7.4 Environmental effect assessment
Risk assessment is based on Predicted No-Effect Concentrations (PNECs) for the different
compartments which are derived from ecotoxicity data and applying assessment factors. The
assessment factor depends on the type of test performed (acute or chronic), the toxicological
endpoint (effect concentrations (ECs), no-observed effect concentrations (NOECs), etc), and the
number of data and is determined according to the Technical Guidance document (version 2003
chapter 3). The PNECs based on the ecotoxicological data applied for the current risk assessment are
presented in Table E.3.
Table E.3. Predicted no-effect concentrations for ADBAC, DDAC and glutaraldehyde
PNEC Lowest endpoint AF PNEC Test/species
ADBAC
STP EC50: 7.75 mg/L 100 0.0775 mg/L NOEC and EC50 available
(respiration studies)
fresh water NOEC: 4.15 µg/L 10 0.415 µg/L
NOECs are available for three
species belonging to three
trophic levels (fish, Daphnia and
algae). Daphnias are most
sensitive
sediment NOEC: 520 mg/kg
dwt 100 1.13 mg/kg wwt Chironomus tentans study
soil EC10: 74 mg/kg wwt 100 0.74 mg/kg wwt
C12-16-ADBAC was tested on soil
dwelling invertebrates, micro-
organisms and plants. Soil micro-
organisms are most sensitive
DDAC
STP 3h EC50: 17.9 mg/L 100 0.14 mg/L 2 EC50s for STP micro-organisms
(respiration inhibition studies)
freshwater NOEC 0.011 mg/L 10 1,1 µg/L Acute and chronic data available.
Algae are the most sensitive.
sediment NOEC 530 mg/kg
dwt
100 1.15 mg/kg wwt
Based on a chronic study with
midge larvae (Chironomus)
soil EC10 70 mg/kg wwt 50 1.4 mg/kg wwt Two chronic endpoints for
terrestrial organisms. Micro-
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organisms are most sensitive.
Glutaraldehyde
STP EC50: 51 mg/L 100 0.51 mg/L EC50 from a respiration inhibition
study
fresh water NOEC: 0.025 mg/L 10 2.5 µg/L
Three trophic levels. Based on
the lowest NOEC for algal growth
inhibition
sediment No studies available. Emission to sediment is not expected considering
glutaraldehyde’s low hydrophobicity (Log Kow is -0.33)
soil EC10: 9.2 mg/kgwwt 50 0.184 mg/kg wwt carbon transformation test
Note that data on sediment organisms is not available for glutaraldehyde and therefore have to be
derived from aquatic data by applying equilibrium partitioning. However, PECsediment is also derived by
using equilibrium partitioning from PECfreshwater and therefore the ratio PEC:PNEC for freshwater
covers that of sediment as well. Calculation of PECsediment is therefore not included in the current risk
assessment. However, adsorption to sediment is not expected as the active substance is not
hydrophobic.
7.5 Risk characterisation for the environment
For each relevant compartment, PECs are divided by PNECs. Risks are considered unacceptable when
PEC/PNEC >1.
7.5.1 Aquatic compartment (incl. sediment) and STP
7.5.1.1 Water and sediment organisms and micro-organisms in the STP
Disinfection of transport vehicles
The risk characterisation for the aquatic compartment (freshwater and sediment) indirectly exposed
via a STP are presented in Table E.4 .
Table E.4. PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater indirectly
exposed due to disinfection of veterinary transport vehicles on the slaughterhouses’’ premises.
STP Fresh water Sediment
PEC (mg/L) PEC/PNEC PEC (mg/L)1 PEC/PNEC PEC (mg/kg
ww)
PEC/PNEC
ADBAC 0.002 0.021 6.15E-06 0.015 0.36 0.315
DDAC 0.002 0.011 1.16E-05 0.011 0.28 0.241
Glutaraldehyde 0.011 0.023 1.15E-03 0.459 0.01 -
Total 0.055 0.485 0.556 1 removal of the active substance(s) by sorption onto suspended matter is included.
Assuming that veterinary transport vehicles are disinfected on the slaughterhouses’ premises and
waste water is purified on-site prior to discharge to the municipal sewer, the application of ADBAC,
DDAC, and glutaraldehyde does not result in unacceptable risks for micro-organisms in the STP and
the receiving freshwater compartment including sediments as the combined PEC:PNEC ratios are
below one. It should be however noted that in absence of data on sediment toxicity, the risk ratios
for glutaraldehyde in freshwater are valid for sediment as well, resulting in a PEC:PNEC ratio slight
above one. However, considering glutaraldehyde’s low sorption profile (see appendix I) and its
irreversible binding to organic matter, sorption onto sediments and risks for sediment living
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organisms cannot be expected. Therefore, the standards for micro-organisms in the STP and the
aquatic environment are met and no risk mitigation measures are necessary.
Disinfection of stables
The risk characterisation for the aquatic compartment (freshwater and sediment) indirectly exposed
via a STP are presented in Table E.5.
Table E.5. PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater indirectly
exposed due to disinfection of stables.
STP Fresh water Sediment
PEC (mg/L) PEC/PNEC PEC (mg/L)1 PEC/PNEC PEC (mg/kg
ww)
PEC/PNEC
Spraying
ADBAC
Dairy cattle 6.06E-04 0.008 1.21E-05 0.029 7.02E-01 0.621
Beef cattle 3.28E-04 0.004 6.58E-06 0.016 3.80E-01 0.336
Pig farming 4.13E-04 0.005 8.27E-06 0.020 4.78E-01 0.423
Poultry 9.36E-04 0.012 1.88E-05 0.045 1.08E+00 0.960
DDAC
Dairy cattle 6.06E-04 0.004 2.29E-05 0.021 5.47E-01 0.475
Beef cattle 3.28E-04 0.002 1.24E-05 0.011 2.96E-01 0.257
Pig farming 4.13E-04 0.003 1.56E-05 0.014 3.72E-01 0.324
Poultry 9.36E-04 0.007 3.53E-05 0.032 8.45E-01 0.734
Glutaraldehyde
Dairy cattle 2.27E-02 0.044 2.27E-03 0.907 1.78E-02 -
Beef cattle 1.23E-02 0.024 1.23E-03 0.491 9.67E-03 -
Pig farming 1.54E-02 0.030 1.54E-03 0.618 1.22E-02 -
Poultry 3.51E-02 0.069 3.50E-03 1.40 2.76E-02 -
Total
Dairy cattle 0.056 0.957 1.10
Beef cattle 0.03 0.518 0.593
Pig farming 0.038 0.652 0.747
Poultry 0.088 1.48 1.69
Fumigation
ADBAC
Dairy cattle 4.33E-04 0.006 8.69E-06 0.021 5.02E-01 0.444
Beef cattle 1.38E-04 0.002 2.76E-06 0.007 1.60E-01 0.141
Pig farming 1.12E-04 0.001 2.24E-06 0.005 1.29E-01 0.114
Poultry 2.25E-04 0.003 4.51E-06 0.011 2.61E-01 0.231
DDAC
Dairy cattle 4.33E-04 0.003 1.64E-05 0.015 3.91E-01 0.340
Beef cattle 1.38E-04 0.001 5.20E-06 0.005 1.24E-01 0.108
Pig farming 1.12E-04 0.001 4.21E-06 0.004 1.01E-01 0.088
Poultry 2.25E-04 0.002 8.49E-06 0.008 2.03E-01 0.177
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STP Fresh water Sediment
PEC (mg/L) PEC/PNEC PEC (mg/L)1 PEC/PNEC PEC (mg/kg
ww)
PEC/PNEC
Glutaraldehyde
Dairy cattle 1.62E-02 0.032 1.62E-03 0.649 1.28E-02 -
Beef cattle 5.16E-03 0.010 5.16E-04 0.206 4.06E-03 -
Pig farming 4.18E-03 0.008 4.18E-04 0.167 3.29E-03 -
Poultry 8.43E-03 0.017 8.42E-04 0.337 6.63E-03 -
Total
Dairy cattle 0.041 0.685 0.784
Beef cattle 0.013 0.218 0.249
Pig farming 0.01 0.176 0.202
Poultry 0.022 0.356 0.408 1 removal of the active substance(s) by sorption onto suspended matter is included.
Disinfection of stables by spraying results in concentrations that exceed the PNEC for glutaraldehyde
in water (1.48 times max) and quaternary ammonium compounds in sediment (1.69 times max2).
These outcomes must be however considered as worst-case as:
• emission is based on the worst-case dosing of 0.4 L solution/m². Moreover, applying 0.4 L/m² and
considering the surfaces and fractions emitted to the sewer as specified in the ESD results
consequently in 130 to 1000 m³ waste water discharged to the sewer, which clearly negatively
impacts the receiving STP (2000 m³/d). Also note that emission was based on the total stable
surface, while disinfection by spraying is often limited to surfaces that are in direct contact with
animals, i.e. floors and lower parts of walls where the highest infestation may be expected.
Whole stables are for various reasons often disinfected by fumigation;
• stables are disinfected 1 to 7 times per year, exceptions are duck farms which are treated 13
times annually. Therefore, release to the sewer is intermittent for the majority of the stable
types. Elevated concentrations can occur temporarily, in sewers although acute effects cannot be
disregarded as all active substances are considered acutely toxic (H400).
Taken into account the above listened arguments the expected exceeding of the PNEC due to
disinfection of stables by spraying is considered acceptable.
Disinfection by fumigation does not result in unacceptable risks, although fumigation combined with
spraying, which is recommended by specialists, still results in a slight exceeding of the PNEC.
However, the applied ESD assumed that 30 to 50% of the applied disinfectant is released to the
sewer, while the majority is expected to be released to air when stables are ventilated after
treatment.
When residues are released to an IBA, malfunctioning of the waste water treatment system may be
expected as high loads of ADBAC, DDAC, and glutaraldehyde may kill the microbial population as the
system’s volume is limited (3-6 m³) and additional degradation in the sewer is not expected as the
residence time is short and an IBA is not fully loaded with organic material. A precautionary measure
to avoid discharge to an IBA is added to the WG/GA.
Conclusively, disinfection of stables will not result in unacceptable risks for the aquatic environment.
The standards are met and no additional risk mitigation beside a warning for IBAs are necessary.
2 In absence of data on sediment toxicity, the risk ratios for glutaraldeyde in water are valid for
sediment as well and should be therefore added to the aggregated risk coefficient. However, it cannot
be expected that glutaraldehyde adsorbs to sediment.
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7.5.1.2 Aggregated risk assessment
Because the product is applied at slaughterhouses and on farms both resulting in emission to the
sewer, the environment receives the active substances from different applications and therefore a
cumulative risk assessment should be performed. However, disinfection of stables is done 1-13 times
annually, while transport vehicles are disinfected daily. Therefore, the two intended uses have no
overlap in time and therefore an aggregated risk assessment, i.e. summarising the PEC:PNEC ratios
for all intended uses, is deemed not necessary.
7.5.1.3 Monitoring data (surface water)
Dutch water boards have a well-established programme for monitoring pesticide contamination of
surface waters for which the results are publicly available on-line (www.
bestrijdingsmiddelenatlas.nl). Here, monitoring data are processed in a graphic format aiming to
provide an insight into measured pesticide contamination of Dutch surface waters against
environmental standards. The Pesticide Atlas was used to evaluate measured concentrations of
pesticides in Dutch surface water, but no data are available regarding the presence of the active
substances ADBAC, DDAC and glutaraldehyde in Dutch surface water.
7.5.1.4 Surface water intended for the abstraction of drinking water
Biocidal products with the active substances ADBAC, DDAC and glutaraldehyde have been on the
market for more than three years. The existing active substances are not included in the list of
substances of concern due to their presence in surface water at drinking water abstraction points as
established by VEWIN/Ctgb (2015). In addition, ADBAC, DDAC and glutaraldehyde are not included in
the recommended list of biocides to be monitored for drinking water from surface water (RIVM,
2010), but the RIVM recommends to include quaternary ammonium compounds in general. From the
general scientific knowledge collected by the Ctgb about the product and its active substances, the
Ctgb concludes that there are in this case no concrete indications for concern about the
consequences of this product for surface water from which drinking water is produced, when used in
compliance with the directions for use. Thus the standards for surface water destined for the
production of drinking water are met.
7.5.2 Terrestrial compartment
7.5.2.1 Soil organisms
The risk characterisation for soils resulting from stable disinfection is presented in Table E.6.
Table E.6. PEC derived from the house scenario and PEC/PNEC ratios for soils due to
disinfection of stables. Concentrations are calculated after the 40th manure application on
grassland and 10th application on arable land (ten years) based on nitrogen emissions standards.
Degradation and leaching between two manure events are considered.
Grassland Arable land
PEC (mg/kg wwt) PEC/PNEC PEC (mg/kg wwt) PEC/PNEC
Spraying
ADBAC
Dairy cattle 1.17E-03 0.002 5.83E-04 <0.001
Beef cattle 9.31E-03 0.013 4.86E-03 0.007
Pig farming 6.40E-03 0.009 4.17E-03 0.006
Poultry, including duck
farming 5.52E-03 0.007 4.95E-03 0.007
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Grassland Arable land
PEC (mg/kg wwt) PEC/PNEC PEC (mg/kg wwt) PEC/PNEC
Poultry, excluding duck
farming 3.25E-03 0.004 1.60E-03 0.002
DDAC
Dairy cattle 1.61E-03 0.001 8.06E-04 <0.001
Beef cattle 1.81E-02 0.013 6.72E-03 0.005
Pig farming 1.25E-02 0.009 5.76E-03 0.004
Poultry, including duck
farming 1.08E-02 0.008 6.85E-03 0.005
Poultry, excluding duck
farming 5.74E-03 0.004 2.22E-03 0.002
Glutaraldehyde
Dairy cattle 5.40E-03 0.029 2.70E-03 0.015
Beef cattle 2.69E-02 0.146 2.25E-02 0.122
Pig farming 1.85E-02 0.1 1.93E-02 0.105
Poultry, including duck
farming 1.59E-02 0.087 2.29E-02 0.124
Poultry, excluding duck
farming 1.03E-02 0.056 7.42E-03 0.040
Total
Dairy cattle 0.032 0.017
Beef cattle 0.172 0.134
Pig farming 0.118 0.115
Poultry, including duck
farming 0.102 0.136
Poultry, excluding duck
farming 0.064 0.044
Fumigation
ADBAC
Dairy cattle 8.34E-04 0.001 4.17E-04 <0.001
Beef cattle 2.03E-03 0.003 1.06E-03 0.001
Pig farming 1.73E-03 0.002 1.13E-03 0.002
Poultry, including duck
farming 2.04E-03 0.003 1.83E-03 0.002
Poultry, excluding duck
farming 8.94E-04 0.001 5.96E-04 <0.001
DDAC
Dairy cattle 1.15E-03 <0.001 5.77E-04 <0.001
Beef cattle 3.95E-03 0.003 1.46E-03 0.001
Pig farming 3.37E-03 0.002 1.56E-03 0.001
Poultry, including duck
farming 3.97E-03 0.003 2.53E-03 0.002
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Grassland Arable land
PEC (mg/kg wwt) PEC/PNEC PEC (mg/kg wwt) PEC/PNEC
Poultry, excluding duck
farming 1.58E-03 0.001 8.24E-04 <0.001
Glutaraldehyde
Dairy cattle 3.86E-03 0.021 1.93E-03 0.01
Beef cattle 5.86E-03 0.032 4.90E-03 0.027
Pig farming 5.00E-03 0.027 5.22E-03 0.028
Poultry, including duck
farming 5.88E-03 0.032 8.45E-03 0.046
Poultry, excluding duck
farming 2.84E-03 0.015 2.76E-03 0.015
Total
Dairy cattle 0.023 0.012
Beef cattle 0.038 0.029
Pig farming 0.031 0.031
Poultry, including duck
farming 0.038 0.050
Poultry, excluding duck
farming 0.017 0.017
Emission to grassland and arable land does not result in unacceptable risks for the terrestrial
environment after ten years of successive manure applications as the PECs are well below the PNECs.
The standards are met and no additional risk mitigation measures are necessary.
7.5.2.2 Non-target arthropods (including bees)
The risk assessment to arthropods is considered to be similar to soil organisms due to their direct
contact with soils. The standards for soil arthropods are therefore met. Because the active
substances are expected to have a non-systemic mode of action, secondary exposure of bees
through pollen is considered negligible. Moreover, direct exposure of bees is unlikely as the product
is applied indoors where bees are absent. Hence, the risk for bees is considered acceptable for the
active substances.
7.5.2.3 Groundwater
Assessment of the drinking water criterion defines that the concentration of the active substance
and the relevant metabolites in groundwater for the preparation of drinking water needs to be < 0.1
µg/L. For the proposed applications, exposure of soil with a potential risk for leaching to
groundwater is expected after the distribution of manure on land.
Leaching of ADBAC and DDAC to groundwater can be excluded because of the high adsorption
characteristics (Koc is >1.0·105 L/kg). However, leaching to groundwater of glutaraldehyde is expected
as this compound is highly mobile and degrades slowly. Therefore, the concentrations in
groundwater were only estimated for glutaraldehyde. The doses and concentrations are listed in
Table E.7.
Table E.7. Concentrations of glutaraldehyde in groundwater. Concentration based on the
worst-case situation (spraying)
Scenario PEC after manure
application (mg/kg wwt)
Dose per manure
application (kg/ha)
Average concentration
closest to the 80th
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percentile (µg/L)
grassland 0.168 3.28E-02 <0.001
arable land 0.061 7.79E-02 <0.001
No exceeding of the groundwater limit (0.1 µg/L) is expected when manure holding the active
substances is distributed on grassland and arable land. Therefore, the standards for groundwater are
met.
7.5.2.4 Persistence in soil
The half-lives of ADBAC and glutaraldehyde in soils (see appendix I) does not exceed the criteria for
persistence in soils (180 days). The standard for persistence in soils is therefore met.
The half live of DDAC in soils (DT50 212 days at 12°C) does exceed the criteria for persistence in soils
(180 days). Although the standard for persistence in soils is not met, the accompanied risks are
considered acceptable as the PECs are below the PNEC.
7.5.3 Non compartment specific effects relevant to the food chain
7.5.3.1 Bioconcentration
ADBAC and DDAC are surfactants and therefore a normal Kow could not be established. An
experimental BCF (whole fish) is determined at 79 L/kg for ADBAC and 81 L/kg for DDAC, indicating
that ADBAC and DDAC have a low potential for bioaccumulation. Hence the product meets the
standards for bioaccumulation.
As the log Kow of glutaraldehyde is < 3 (see appendix I) and the active substance is not highly
adsorptive (Koc <20000 L/kg in sediment and/or 50000 L/kg in soils), bioconcentration is not expected
according to the trigger values presented in the TGD. The risk for bioconcentration of the proposed
uses is therefore considered not relevant. The standards for bioconcentration are met and no further
assessment of secondary poisoning is deemed necessary.
7.5.3.2 Primary and secondary poisoning of birds and mammals
The low BCFs (see above) indicate that the risk for birds and mammals is low regarding secondary
poisoning. Hence the product meets the standards for the risk to birds and mammals. Primary
poisoning is not expected for the intended uses.
7.5.4 Atmosphere
Criteria for the examination of environmental risks to air are not specified in the form of a numerical
standard. The assessment of potential impacts on air quality is aimed to minimize the risk for
stratospheric ozone depletion. There are no indications that ADBAC, DDAC and glutaraldehyde
contribute to depletion of the ozone layer as the compounds are not listed as ‘controlled substance’
in Annex I of Regulation (EC) No 1005/2009 of the European Parliament. Moreover, AOPwin
calculates for the active substances the following half-lives in air (OH timeframe 24 hrs/day, 0.5×106
OH radicals/cm3):
• ADBAC: 8.8 hours
• DDAC: 8.3 hours
• Glutaraldehyde: 8.2 hours
The calculated half-lives are below the trigger of 2 days, which is used as cut off value to identify
chemicals that could be of potential concern for long range transport through the atmosphere. The
environmental risk to air is therefore considered acceptable.
7.6 Measures to protect the environment (risk mitigation measures)
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No risk mitigations were proposed by the applicant. Because release to an individual sewage
treatment plant may result in malfunctioning of the installation, a precautionary measure stating
that residues must be discharged to the manure deposit or municipal sewer will be added. This is
discussed in the next section.
7.7 Overall conclusion for the aspect Environment
An authorisation of a biocide in The Netherlands is only possible when the risks related to the
product application are acceptable. When used in accordance with the legal Instructions for Use
(WG/GA), Virocid F complies with the environmental standards and will not cause unacceptable
effects to the environment provided that inhibition of the functioning of the IBA is prevented. The
following risk mitigation is therefore included in the WG/GA:
NL: Om verminderd functioneren van een Individuele Behandeling Afvalwater (IBA) bij toepassing
van dit middel op de boerderij te voorkomen, dienen afvalresten die het middel bevatten geloosd te
worden op de mestopslag of op de gemeentelijke riolering.
EN: To prevent the inhibition in functioning of an on-site wastewater treatment system (IBA),
possible residues containing the product must be discharged to the slurry pit or to a municipal STP.
The fogging application is withdrawn at the applicant’s request.
8 Conclusion
The fogging application is withdrawn at the applicant’s request.
The applicant has proven that Virocid F under the proposed Legal Conditions for Use and the
Directions for Use (WG/GA), is sufficiently effective and that no unacceptable risk is expected to
human health, the person who uses the product and the environment (Art. 121 jo art. 49 first
paragraph Dutch 2007 Plant Protection Products and Biocides Act).
9 Classification and labelling
The identity of all substances in the mixture that contribute to the classification of the mixture *:
ADBAC, DDAC, gluetaraldehyde
Pictogram: GHS02 Signal word: Danger
GHS05
GHS06
GHS07
GHS08
GHS09
H-statements: H226 Flammable liquid and vapour
H301 Toxic if swallowed.
H314 Causes severe skin burns and eye damage.
H317 May cause an allergic skin reaction.
H330 Fatal if inhaled.
H334 May cause allergy or asthma symptoms or
breathing difficulties if inhaled.
H335 May cause respiratory irritation.
H410 Very toxic to aquatic life with long lasting effects.
P-statements: P210 Keep away from heat, hot surfaces,
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sparks, open flames and other ignition
sources. No smoking.
P260 Do not breathe
dust/fume/gas/mist/vapours/spray.
P264 Wash … thoroughly after handling.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing.
P301+P310 IF SWALLOWED: Immediately call a POISON
CENTER/doctor/...
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
contaminated clothing. Rinse skin with water [or
shower].
P304+P340 IF INHALED: Remove person to fresh air and keep
comfortable for breathing.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and
easy to do. Continue rinsing.
P342+P311 If experiencing respiratory symptoms: Call a
POISON CENTER/doctor/...
Supplemental Hazard
information:
EHU071 Corrosive to the respiratory tract.
Child-resistant fastening obligatory? Not applicable
Tactile warning of danger obligatory? Not applicable
Explanation:
Pictogram: GHS06 is due to H301and GHS07is due to H335.
H-statements: H301 is assigned in accordance with the calculation described
in Guidance on the application of the CLP Criteria, and based
on exposure to glutaraldehyde in vapour form. H330 and H335
are assigned because of glutaraldehyde.
P-statements: P210 is highly recommended when H226 is assigned.P260 is
proposed by the applicant. For the rest highly recommended P-
statements for the assigned hazard classifications are
proposed.
Other: EUH071 is assigned because of the combination of H314 and
H330.
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
10 References
Bakker, J. Biociden in oppervlaktewater voor drinkwaterproductie, National Institute of Public Health and the
Environment, RIVM report 601712007, 2010, Bilthoven, The Netherlands.
Clara, M., Scharf, S., Scheffknecht, C., and Gans, O. 2007. Occurrence of selected surfactants in untreated and
treated sewage. Water Research 41, 4339-4348
Database with monitoring data from pesticides in surface water obtained from regional water boards.
http://www.bestrijdingsmiddelenatlas.nl
Lijst met probleemstoffen voor de bereiding van drinkwater uit oppervlaktewater, VEWIN, 2015
http://www.vewin.nl/probleemstoffen
Emission Scenario Document for Product Type 3: Veterinary hygiene biocidal products, JRC Scientific and
Technical Reports, Report nr. EUR 25116 EN, Publications Office of the European Union, Luxembourg, 2011
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OECD Series on Emission Scenario Documents Number 14. Emission Scenario Document for insecticides for
stables and manure storage systems. OECD report ENV/JM/MONO(2006)4. Organisation for Economic Co-
operation and Development, Paris, Jan 2006.
Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on
substances that deplete the ozone layer.
Guidance on the Biocidal Product Regulation. Volume IV: Environment - Part B: Risk Assessment (Active
Substances). European Chemicals Agency, Report no. ECHA-15-G-01-EN, Helsinki, Finland, 2015.
Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens.
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Appendix I. Input parameters for modelling, environmental assessment
parameter value remarks
ADBAC
molecular weight (g/mole) 359.6 g/mol
Average value. 340.0 – 396.1 g/mol,
depending on alkyl chain length C12 -
C14 - C16
melting point (°C) 150
Compound is a solid at environmental
temperature. Start to decompose at
150°C.
vapour pressure at test temperature
(Pa) 6.03E-04
test temperature vapour pressure (°C) 20
solubility at test temperature (mg/L) 431000 pH 6.5:
test temperature solubility (°C) 20
Henry constant (Pa × m3 × mol-1) 5.03E-07 Calculated
test temperature Henry constant (°C) -
octanol-water partition coefficient
(L/kg) - deemed inaccurate (see Koc)
organic carbon-water partition
coefficient (L/kg) 2658607
The average Koc for sand, sandy loam,
clay loam, silt loam.
characterisation of biodegradability readily biodegradable
half-life for biodegradation in fresh
water at 12°C (days) 15
Default half-life for compounds that
are readily biodegradable according to
the TGD as no degradation studies are
available.
half-life for biodegradation in
sediment at 12°C(days) -
half-life for biodegradation in soil at
12°C (days) 76
half-life for leaching from soil (days)
rate constant for biodegradation in
STP (/d) not relevant
Data for ADBAC is available
demonstrating that an STP effectively
removes 98.5% of the active
ingredients from the waste water
(monitoring study for several
municipal STPs, Clara et al., Water
Research 41, 4399-4348).
half-life in air (hrs) 8.8
Estimated with AOPwin (OH
timeframe 24 hrs/day, 0.5×106 OH
radicals/cm³)
parameter Value Remarks
DDAC
molecular weight (g/mole) 362.1
melting point (°C) 98.2
Compound is a solid at environmental
temperature. Start to decompose at
98.2°C.
vapour pressure at test temperature
(Pa) 5.90E-6
test temperature vapour pressure (°C) 20
solubility at test temperature (mg/L) 500000
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test temperature solubility (°C) 20
Henry constant (Pa m³/ mol) 4.27E-9
test temperature Henry constant (°C) 20
octanol-water partition coefficient
(L/kg) -
organic carbon-water partition
coefficient (L/kg) 1.1E6
characterisation of biodegradability readily biodegradable
half-life for biodegradation in fresh
water at 12°C (days) 15
Default half-life for compounds that
are readily biodegradable according
to the TGD as no degradation studies
are available.
half-life for biodegradation in
sediment at 12°C(days) -
half-life for biodegradation in soil at
12°C (days) 212
rate constant for biodegradation in
STP (/d) not relevant
Data for DDAC is available
demonstrating that an STP effectively
removes 98.5% of the active
ingredients from the waste water
(monitoring study for several
municipal STPs, Clara et al., Water
Research 41, 4399-4348).
half-life in air (hrs) 8.3
Estimated with AOPwin (OH
timeframe 24 hrs/day, 0.5×106 OH
radicals/cm³)
parameter value remarks
Glutaraldehyde
molecular weight (g/mole) 100.11
melting point (°C) -33
Compound is a liquid at
environmental temperature.
vapour pressure at test temperature
(Pa) 44 Pure substance
test temperature vapour pressure (°C) 20
solubility at test temperature (mg/L) miscible
≥ 51.3 g/100ml
test temperature solubility (°C) 20.2+/- 0.1 °C
21 °C
Henry constant (Pa × m3 × mol-1) 0.0086 calculated
test temperature Henry constant (°C) -
octanol-water partition coefficient
(L/kg) 0.47
organic carbon-water partition
coefficient (L/kg) 326
characterisation of biodegradability readily biodegradable
half-life for biodegradation in soil at
12°C (days) 30
Default value for readily
biodegradable compounds
rate constant for biodegradation in
STP (/d) 24
Default value for readily
biodegradable compounds
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