Toelatingsnummer 14450 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 TOELATING
Gelet op de aanvraag d.d. 30 januari 2013 (20130255 TB) van
Twinoxide International
De Tongelreep 17
5684 PZ BEST
tot verkrijging van een toelating als bedoeld in artikel 49, eerste lid, Wet
gewasbeschermingsmiddelen en biociden voor de biocide, op basis van natriumchloriet en
natriumbisulfaat ten behoeve van de in-situ vorming van chloordioxide.
TwinOxide 0.3% oplossing
gelet op artikel 121, eerste lid, jo. artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en
biociden,
BESLUIT HET COLLEGE als volgt:
1.1 Toelating
1. Het middel TwinOxide 0.3% oplossing is toegelaten voor de in bijlage I genoemde
toepassingen onder nummer 14450 N met ingang van datum dezes. Voor de gronden
van dit besluit wordt verwezen naar bijlage II bij dit besluit.
2. De toelating geldt tot 1 mei 2024.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit
besluit is voorgeschreven.
TwinOxide 0.3% oplossing
14450 N
1.4 Classificatie en etikettering
(Hieronder wordt de totale classifcatie van de twee precursors weergegeven. Voor de
specifieke classificatie en etikettering voor precursor A en precursor B zie bijlage 2,
hoofdstuk 8)
Gelet op artikel 50 Wet gewasbeschermingsmiddelen en biociden worden voorschriften
gegeven.
Dit leidt tot de volgende voorschriften:
De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt:
aard van het preparaat: Diversen
gehalte:
51,4 %
99 %
werkzame stof:
Natriumchloriet*
Natriumbisulfaat*
*Ten behoeve van de in-situ vorming van chloordioxide
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
PICTOGRAM(MEN)
pictogram:
GHS03-Licht ontvlambaar
GHS05-corrosief
GHS06-giftig
GHS09-milieu
SIGNAALWOORD
Gevaar
Gevarenaanduidingen
H272
H302
H311
H314
H318
H331
H400
Voorzorgsmaatregelen
P210
Kan brand bevorderen; oxiderend.
Schadelijk bij inslikken.
Giftig bij contact met de huid.
Veroorzaakt ernstige brandwonden en oogletsel.
Veroorzaakt ernstig oogletsel
Giftig bij inademing.
Zeer giftig voor in het water levende organismen.
Verwijderd houden van warmte/vonken/open vuur/hete
oppervlakken. — Niet roken.
P221
Vermenging met brandbare stoffen? absoluut vermijden.
P280
Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P284
Adembescherming dragen.
P303 + P361 + P353 + P310 BIJ CONTACT MET DE HUID (of het haar):
verontreinigde kleding onmiddellijk uittrekken – huid met water
afspoelen/afdouchen. Onmiddellijk een ANTIGIFCENTRUM of
een arts raadplegen.
P305 + P351 + P338 + P310 BIJ CONTACT MET DE OGEN: voorzichtig
afspoelen met water gedurende een aantal minuten;
contactlenzen verwijderen, indien mogelijk. Blijven spoelen.
Onmiddellijk een ANTIGIFCENTRUM of een arts raadplegen.
Aanvullende etiketelementen
EUH032
Vormt zeer giftig gas in contact met zuren.
Behalve de voorgeschreven aanduidingen en vermeldingen moeten op de verpakking
voorkomen:
a. letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.
b. hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
De vervaldatum (24 maanden na de productiedatum voor zowel Component A als Component
B) dient op het etiket te worden vermeld. De Twinoxide 0,3% oplossing (gebruiksoplossing) is
twee weken houdbaar.
2 DETAILS VAN DE AANVRAAG
Het betreft een aanvraag tot verkrijging van een toelating van het middel TwinOxide 0.3%
oplossing (14450 N), een middel op basis van de stof(fen) natriumchloriet en natriumbisulfaat,
ten behoeve van de in-situ vorming van chloordioxide.
De aanvrager heeft een adequaat aanvraagdossier ingediend. Het Ctgb is in de beoordeling
uitgegaan van de wetenschappelijk gezien beste eindpunten.
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
TwinOxide 0.3% oplossing op basis van de stof(fen) natriumchloriet en natriumbisulfaat ten
behoeve van de in-situ vorming van chloordioxide. voldoende werkzaam en heeft het geen
schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 49, Wet
gewasbeschermingsmiddelen en biociden).
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 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid
van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 11 april 2014
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE I bij het besluit d.d. 11 april 2014 tot toelating van het middel TwinOxide 0.3%
oplossing, toelatingnummer 14450 N
Opmerking: er zijn drie 3 WGGA’s opgesteld voor de verschillende componenten van
TwinOxide oplossing 0,3%.
Eén WGGA voor het middel TwinOxide 0.3% oplossing (te bevestigen op de
aanmaaktank). Daarnaast hebben beide precursors een eigen WGGA (TwinOxide
Component A en TwinOxide Component B).
1. WG/GA voor TwinOxide 0.3% oplossing (aan te brengen op de aanmaaktank)
Chloordioxide
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als middel ter bestrijding van bacteriën (excl.
bacteriesporen en mycobacteriën) en gisten:
a. op oppervlakken, voorwerpen en materialen die in contact kunnen komen met eet- en
drinkwaren en diervoeding, en de grondstoffen hiervoor in de levensmiddelen- en
diervoederindustrie;
b. op membraanfilters voor proceswater en koelwater;
c. in tanks en leidingsystemen voor de bereiding, opslag en vervoer van water, exclusief
humane drinkwatersystemen.
De actieve stof (chloordioxide) dient te worden bereid door uit te gaan van de twee precursors
TwinOxide Component A (natriumchloriet) en TwinOxide Component B (natriumbisulfaat), en
deze met elkaar een gecontroleerde reactie te laten aangaan in een hiervoor geschikte
aanmaaktank.
De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.
Vanwege gezondheidsrisico’s niet meer dan 14,5 kilogram TwinOxide Component A
(natriumchloriet) per persoon per dag gebruiken.
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Algemeen
TwinOxide 0,3% oplossing bestaat uit twee precursors, TwinOxide component A
(natriumchloriet) en TwinOxide component B (natriumbisulfaat), die uitsluitend in combinatie
met elkaar gebruikt mogen worden.
Het middel bestrijdt op oppervlakken en in leidingsystemen aanwezige bacteriën en gisten door
oxidatie.
Technische hulpmiddelen
Om de TwinOxide componenten A en B voor de bereiding van de TwinOxide 0,3% oplossing
zo veilig mogelijk in de aanmaaktank te deponeren dient de gebruiker de bijgeleverde trechters
op de verpakkingen te schroeven nadat de verzegeling en het deksel voorzichtig zijn
verwijderd.
De gebruiksoplossing (TwinOxide 0,3% oplossing) wordt toegepast in een dompelbad, door
middel van een doseersysteem, of door middel van spuitapparatuur (handspraypomp;
spuitflacon; lage druk apparatuur met grove druppelgrootte).
Voor het homogeniseren van de gebruiksoplossing bij aanmaaktanks groter dan 100 liter dient
gebruik te worden gemaakt van een elektro-mechanisch roerapparaat, gedurende 2 minuten bij
28 omwentelingen per minuut.
Aanmaakprocedure en verwijdering
Instructies voor het maken van TwinOxide 0,3% oplossing:
1. Lees altijd de gebruiksaanwijzing (bevindt zich op de aanmaaktank en op de
verpakkingen van TwinOxide Component A en B) en volg de veiligheidsinstructies
(MSDS).
2. Schrijf de productiedatum op het etiket van de aanmaaktank.
3. Gebruik alleen hele verpakkingen.
Dosering:
voor het maken van de gebruiksoplossing: zie onderstaande tabel.
TwinOxide Component B (g)
Water (L)
TwinOxide Component A (g)
20
20
1
40
40
2
100
100
5
200
200
10
500
500
25
1000
1000
50
2000
2000
100
10.000
10.000
500
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet)
per persoon per dag.
Aanmaken gebruiksoplossing:
4. Vul de aanmaaktank met schoon water - zorg voor een watertemperatuur van minimaal
20 graden Celsius. Gebruik zoveel water als nodig is voor het verkrijgen van de juiste
dosering.
5. Schud de beide verpakkingen met TwinOxide Component A en TwinOxide Component
B voor gebruik.
6. Verwijder de verzegeling en de deksels van de verpakkingen en schroef de bijpassende
trechters erop.
7. Deponeer eerst TwinOxide Component A in de aanmaaktank met water.
8. Deponeer vervolgens TwinOxide Component B in de aanmaaktank met water.
9. Sluit de aanmaaktank.
10. Niet schudden of mengen.
11. Wacht ten minste 3 uur.
12. Bij aanmaaktanks groter dan 100 liter: Homogeniseer de gebruiksoplossing met een
elektro-mechanisch roerapparaat - Pas op voor afgassen van chloordioxide!
13. TwinOxide 0,3% oplossing is klaar voor gebruik en wordt onverdund gebruikt.
14. De gebruiksoplossing dient binnen 14 dagen gebruikt te worden.
15. Bewaar de gebruiksoplossing in een donkere, koele en droge ruimte.
Instructies voor verwijdering van de gebruiksoplossing
De gebruiksoplossing kan geneutraliseerd worden door per liter 15 gram natriumsulfiet toe te
voegen. Tien minuten na toevoeging van het natriumsulfiet kan de gebruiksoplossing volgens
lokale voorschriften verwijderd worden.
Verpakkingen schoon maken en als gewoon afval verwijderen.
Dosering
Dosering voor het maken van de gebruiksoplossing met een concentratie van 0,3%
chloordioxide (3.000 ppm of 3 gram chloordioxide per liter): zie tabel onder
‘aanmaakprocedure’.
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet) per
persoon per dag.
a. Desinfectie van oppervlakken, voorwerpen en materialen in de levensmiddelen- en
diervoerderindustrie.
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten voorwerpen, uitrusting en materialen gedurende minimaal 15 minuten
onderdompelen in een desinfectiebad met gebruiksoplossing.
De dompelbadvloeistof kan maximaal 2 weken gebruikt worden bij gemiddeld gebruik. De
concentratie kan worden gecontroleerd met beschikbare teststrips of testkit voor
chloordioxide.
Toepassing door middel van spuiten:
Oppervlakken behandelen met spuitapparatuur. Zorg dat de te behandelen oppervlakken
gedurende de gehele inwerktijd bevochtigd zijn met gebruiksoplossing. Tijdens het spuiten
geschikte adembescherming (filter B) dragen.
b. Desinfectie van membraanfilters voor proceswater en koelwater.
Dosering:Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten filters gedurende minimaal 15 minuten onderdompelen in een dompelbad
met onverdunde gebruiksoplossing. Controleer de uitputtingsgraad van het bad met behulp
van de beschikbare teststrips of testkits. Tijdens het dompelen geschikte adembescherming
(filter B) dragen.
c. Desinfectie van tanks en leidingsystemen voor de bereiding, opslag en vervoer van water,
exclusief humane drinkwatersystemen
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Zorg dat de te behandelen oppervlakken gedurende de gehele inwerktijd bevochtigd zijn
met gebruiksoplossing. Ruim naspoelen met drinkwater en de concentratie chloordioxide
controleren met behulp van de beschikbare teststrips of testkits. De chloordioxide
concentratie in het laatste spoelwater moet onder de norm van 0.2 ppm liggen. De
gebruiksoplossing kan hergebruikt worden.
Gebruik aanmaaktanks die van LDPE vervaardigd zijn en controleer deze regelmatig op
integriteit.
2. WG/GA voor Precursor TwinOxide Component A
natriumchloriet
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Het gebruik van Precursor TwinOxide Component A is uitsluitend toegestaan voor de productie
van chloordioxide voor het gebruik als middel ter bestrijding van bacteriën (excl. bacteriesporen
en mycobacteriën en mycobacteriën) en gisten:
a. op oppervlakken, voorwerpen en materialen die in contact kunnen komen met eet- en
drinkwaren en diervoeding, en de grondstoffen hiervoor in de levensmiddelen- en
diervoederindustrie;
b. op membraanfilters voor proceswater en koelwater;
c. in tanks en leidingsystemen voor de bereiding, opslag en vervoer van water, exclusief
humane drinkwatersystemen.
De actieve stof (chloordioxide) dient te worden bereid door uit te gaan van de twee precursors
TwinOxide Component A (natriumchloriet) en TwinOxide Component B (natriumbisulfaat), en
deze met elkaar een gecontroleerde reactie te laten aangaan in een hiervoor geschikte
aanmaaktank. De toepasser dient de gebruiksaanwijzingen voor de doseerinstallatie van de
leverancier te volgen.
De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.
Vanwege gezondheidsrisico’s niet meer dan 14,5 kilogram TwinOxide Component A
(natriumchloriet) per persoon per dag gebruiken.
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Algemeen
TwinOxide 0,3% oplossing bestaat uit twee precursors, TwinOxide component A
(natriumchloriet) en TwinOxide component B (natriumbisulfaat), die uitsluitend in combinatie
met elkaar gebruikt mogen worden.
Het middel bestrijdt op oppervlakken en in leidingsystemen aanwezige bacteriën en gisten door
oxidatie.
Technische hulpmiddelen
Om de TwinOxide componenten A en B voor de bereiding van de TwinOxide 0,3% oplossing
zo veilig mogelijk in de aanmaaktank te deponeren dient de gebruiker de bijgeleverde trechters
op de verpakkingen te schroeven nadat de verzegeling en het deksel voorzichtig zijn
verwijderd.
De gebruiksoplossing (TwinOxide 0,3% oplossing) wordt toegepast in een dompelbad, door
middel van een doseersysteem, of door middel van spuitapparatuur (handspraypomp;
spuitflacon; lage druk apparatuur met grove druppelgrootte).
Voor het homogeniseren van de gebruiksoplossing bij aanmaaktanks groter dan 100 liter dient
gebruik te worden gemaakt van een elektro-mechanisch roerapparaat, gedurende 2 minuten bij
28 omwentelingen per minuut.
Aanmaakprocedure en verwijdering
Instructies voor het maken van TwinOxide 0,3% oplossing:
1. Lees altijd de gebruiksaanwijzing (bevindt zich op de aanmaaktank en op de
verpakkingen van TwinOxide Component A en B) en volg de veiligheidsinstructies
(MSDS).
2. Schrijf de productiedatum op het etiket van de aanmaaktank.
3. Gebruik alleen hele verpakkingen.
Dosering:
voor het maken van de gebruiksoplossing: zie onderstaande tabel.
TwinOxide Component A (g)
20
40
100
200
500
1000
2000
10.000
TwinOxide Component B (g)
20
40
100
200
500
1000
2000
10.000
Water (L)
1
2
5
10
25
50
100
500
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet)
per persoon per dag.
Aanmaken gebruiksoplossing:
4. Vul de aanmaaktank met schoon water - zorg voor een watertemperatuur van minimaal
20 graden Celsius. Gebruik zoveel water als nodig is voor het verkrijgen van de juiste
dosering.
5. Schud de beide verpakkingen met TwinOxide Component A en TwinOxide Component
B voor gebruik.
6. Verwijder de verzegeling en de deksels van de verpakkingen en schroef de bijpassende
trechters erop.
7. Deponeer eerst TwinOxide Component A in de aanmaaktank met water.
8. Deponeer vervolgens TwinOxide Component B in de aanmaaktank met water.
9. Sluit de aanmaaktank.
10. Niet schudden of mengen.
11. Wacht ten minste 3 uur.
12. Bij aanmaaktanks groter dan 100 liter: Homogeniseer de gebruiksoplossing met een
elektro-mechanisch roerapparaat - Pas op voor afgassen van chloordioxide!
13. TwinOxide 0,3% oplossing is klaar voor gebruik en wordt onverdund gebruikt.
14. De gebruiksoplossing dient binnen 14 dagen gebruikt te worden.
15. Bewaar de gebruiksoplossing in een donkere, koele en droge ruimte.
Instructies voor verwijdering van de gebruiksoplossing:
De gebruiksoplossing kan geneutraliseerd worden door per liter 15 gram natriumsulfiet toe te
voegen. Tien minuten na toevoeging van het natriumsulfiet kan de gebruiksoplossing volgens
lokale voorschriften verwijderd worden. Verpakkingen schoon maken en als gewoon afval
verwijderen.
Dosering
Dosering voor het maken van de gebruiksoplossing met een concentratie van 0,3%
chloordioxide (3.000 ppm of 3 gram chloordioxide per liter): zie tabel onder
‘aanmaakprocedure’.
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet) per
persoon per dag.
a. Desinfectie van oppervlakken, voorwerpen en materialen in de levensmiddelen- en
diervoerderindustrie.
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten voorwerpen, uitrusting en materialen gedurende minimaal 15 minuten
onderdompelen in een desinfectiebad met gebruiksoplossing.
De dompelbadvloeistof kan maximaal 2 weken gebruikt worden bij gemiddeld gebruik.
De concentratie kan worden gecontroleerd met beschikbare teststrips of testkit voor
chloordioxide.
Toepassing door middel van spuiten:
Oppervlakken behandelen met spuitapparatuur. Zorg dat de te behandelen
oppervlakken gedurende de gehele inwerktijd bevochtigd zijn met gebruiksoplossing.
Tijdens het spuiten geschikte adembescherming (filter B) dragen.
b. Desinfectie van membraanfilters voor proceswater en koelwater.
Dosering:Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten filters gedurende minimaal 15 minuten onderdompelen in een
dompelbad met onverdunde gebruiksoplossing. Controleer de uitputtingsgraad van het
bad met behulp van de beschikbare teststrips of testkits. Tijdens het dompelen
geschikte adembescherming (filter B) dragen.
c. Desinfectie van tanks en leidingsystemen voor de bereiding, opslag en vervoer van
water, exclusief humane drinkwatersystemen
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Zorg dat de te behandelen oppervlakken gedurende de gehele inwerktijd bevochtigd zijn
met gebruiksoplossing. Ruim naspoelen met drinkwater en de concentratie chloordioxide
controleren met behulp van de beschikbare teststrips of testkits. De chloordioxide
concentratie in het laatste spoelwater moet onder de norm van 0.2 ppm liggen. De
gebruiksoplossing kan hergebruikt worden.
Gebruik aanmaaktanks die van LDPE vervaardigd zijn en controleer deze regelmatig op
integriteit.
3. WG/GA voor Precursor TwinOxide Component B
natriumwaterstofsulfaat
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Het gebruik van Precursor TwinOxide Component B is uitsluitend toegestaan voor de productie
van chloordioxide voor het gebruik als middel ter bestrijding van bacteriën (excl. bacteriesporen
en mycobacteriën en mycobacteriën) en gisten:
a. op oppervlakken, voorwerpen en materialen die in contact kunnen komen met eet- en
drinkwaren en diervoeding, en de grondstoffen hiervoor in de levensmiddelen- en
diervoederindustrie;
b. op membraanfilters voor proceswater en koelwater;
c. in tanks en leidingsystemen voor de bereiding, opslag en vervoer van water, exclusief
humane drinkwatersystemen.
De actieve stof (chloordioxide) dient te worden bereid door uit te gaan van de twee precursors
TwinOxide Component A (natriumchloriet) en TwinOxide Component B (natriumbisulfaat), en
deze met elkaar een gecontroleerde reactie te laten aangaan in een hiervoor geschikte
aanmaaktank. De toepasser dient de gebruiksaanwijzingen voor de doseerinstallatie van de
leverancier te volgen.
De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.
Vanwege gezondheidsrisico’s niet meer dan 14,5 kilogram TwinOxide Component A
(natriumchloriet) per persoon per dag gebruiken.
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Algemeen
TwinOxide 0,3% oplossing bestaat uit twee precursors, TwinOxide component A
(natriumchloriet) en TwinOxide component B (natriumbisulfaat), die uitsluitend in combinatie
met elkaar gebruikt mogen worden.
Het middel bestrijdt op oppervlakken en in leidingsystemen aanwezige bacteriën en gisten door
oxidatie.
Technische hulpmiddelen
Om de TwinOxide componenten A en B voor de bereiding van de TwinOxide 0,3% oplossing
zo veilig mogelijk in de aanmaaktank te deponeren dient de gebruiker de bijgeleverde trechters
op de verpakkingen te schroeven nadat de verzegeling en het deksel voorzichtig zijn
verwijderd.
De gebruiksoplossing (TwinOxide 0,3% oplossing) wordt toegepast in een dompelbad, door
middel van een doseersysteem, of door middel van spuitapparatuur (handspraypomp;
spuitflacon; lage druk apparatuur met grove druppelgrootte).
Voor het homogeniseren van de gebruiksoplossing bij aanmaaktanks groter dan 100 liter dient
gebruik te worden gemaakt van een elektro-mechanisch roerapparaat, gedurende 2 minuten bij
28 omwentelingen per minuut.
Aanmaakprocedure en verwijdering
Instructies voor het maken van TwinOxide 0,3% oplossing:
1. Lees altijd de gebruiksaanwijzing (bevindt zich op de aanmaaktank en op de
verpakkingen van TwinOxide Component A en B) en volg de veiligheidsinstructies
(MSDS).
2. Schrijf de productiedatum op het etiket van de aanmaaktank.
3. Gebruik alleen hele verpakkingen.
Dosering:
voor het maken van de gebruiksoplossing: zie onderstaande tabel.
TwinOxide Component A (g)
20
40
100
200
500
1000
2000
10.000
TwinOxide Component B (g)
20
40
100
200
500
1000
2000
10.000
Water (L)
1
2
5
10
25
50
100
500
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet)
per persoon per dag.
Aanmaken gebruiksoplossing:
4. Vul de aanmaaktank met schoon water - zorg voor een watertemperatuur van minimaal
20 graden Celsius. Gebruik zoveel water als nodig is voor het verkrijgen van de juiste
dosering.
5. Schud de beide verpakkingen met TwinOxide Component A en TwinOxide Component
B voor gebruik.
6. Verwijder de verzegeling en de deksels van de verpakkingen en schroef de bijpassende
trechters erop.
7. Deponeer eerst TwinOxide Component A in de aanmaaktank met water.
8. Deponeer vervolgens TwinOxide Component B in de aanmaaktank met water.
9. Sluit de aanmaaktank.
10. Niet schudden of mengen.
11. Wacht ten minste 3 uur.
12. Bij aanmaaktanks groter dan 100 liter: Homogeniseer de gebruiksoplossing met een
elektro-mechanisch roerapparaat - Pas op voor afgassen van chloordioxide!
13. TwinOxide 0,3% oplossing is klaar voor gebruik en wordt onverdund gebruikt.
14. De gebruiksoplossing dient binnen 14 dagen gebruikt te worden.
15. Bewaar de gebruiksoplossing in een donkere, koele en droge ruimte.
Instructies voor verwijdering van de gebruiksoplossing:
De gebruiksoplossing kan geneutraliseerd worden door per liter 15 gram natriumsulfiet toe te
voegen. Tien minuten na toevoeging van het natriumsulfiet kan de gebruiksoplossing volgens
lokale voorschriften verwijderd worden. Verpakkingen schoon maken en als gewoon afval
verwijderen.
Dosering
Dosering voor het maken van de gebruiksoplossing met een concentratie van 0,3%
chloordioxide (3.000 ppm of 3 gram chloordioxide per liter): zie tabel onder
‘aanmaakprocedure’.
De gebruiksoplossing niet verder verdunnen voor gebruik.
Let op: Gebruik niet meer dan 14,5 kilogram TwinOxide Component A (natriumchloriet) per
persoon per dag.
a. Desinfectie van oppervlakken, voorwerpen en materialen in de levensmiddelen- en
diervoerderindustrie.
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten voorwerpen, uitrusting en materialen gedurende minimaal 15 minuten
onderdompelen in een desinfectiebad met gebruiksoplossing.
De dompelbadvloeistof kan maximaal 2 weken gebruikt worden bij gemiddeld gebruik.
De concentratie kan worden gecontroleerd met beschikbare teststrips of testkit voor
chloordioxide.
Toepassing door middel van spuiten:
Oppervlakken behandelen met spuitapparatuur. Zorg dat de te behandelen
oppervlakken gedurende de gehele inwerktijd bevochtigd zijn met gebruiksoplossing.
Tijdens het spuiten geschikte adembescherming (filter B) dragen.
b. Desinfectie van membraanfilters voor proceswater en koelwater.
Dosering:Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Toepassing door middel van dompelen:
De te ontsmetten filters gedurende minimaal 15 minuten onderdompelen in een
dompelbad met onverdunde gebruiksoplossing. Controleer de uitputtingsgraad van het
bad met behulp van de beschikbare teststrips of testkits. Tijdens het dompelen
geschikte adembescherming (filter B) dragen.
c. Desinfectie van tanks en leidingsystemen voor de bereiding, opslag en vervoer van
water, exclusief humane drinkwatersystemen
Dosering: Gebruik de onverdunde gebruiksoplossing.
Minimale inwerktijd: 15 minuten.
Zorg dat de te behandelen oppervlakken gedurende de gehele inwerktijd bevochtigd zijn
met gebruiksoplossing. Ruim naspoelen met drinkwater en de concentratie chloordioxide
controleren met behulp van de beschikbare teststrips of testkits. De chloordioxide
concentratie in het laatste spoelwater moet onder de norm van 0.2 ppm liggen. De
gebruiksoplossing kan hergebruikt worden.
Gebruik aanmaaktanks die van LDPE vervaardigd zijn en controleer deze regelmatig op
integriteit.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d. 11 april 2014 tot toelating van het middel TwinOxide 0.3%
oplossing, toelatingnummer 14450 N
RISKMANAGEMENT
Contents
Page
1. Introduction .................................................................................................................. 11
2. Identity ......................................................................................................................... 11
3. Physical and chemical properties ................................................................................. 14
4. Efficacy ........................................................................................................................ 15
5. Human toxicology......................................................................................................... 17
6. Environment ................................................................................................................. 26
7
Conclusion ................................................................................................................... 29
8
Classification and labelling ........................................................................................... 30
9
References................................................................................................................... 31
pag. 10
1. Introduction
TwinOxide 0,3% oplossing
This assessment concerns the biocidal product based on the active substance chlorine
dioxide. Originally, this application has been submitted under the differentiated
enforcement policy of biocides.
The assessment includes the following product<s>:
Product
Applicant
PT
Application number
TwinOxide 0,3%
oplossing
TwinOxide
International B.V.
PT4 en PT 11
20130255 TB
(voorheen 20120610 TBO)
The active substance chlorine dioxide has been notified for product types PT2, 3, 4, 5, 11,
and 12. has not yet been included in the Union list of approved substances of EU
Regulation 528/2012.
2. Identity
TwinOxide 0.3% oplossing is a disinfectant ( PT4 and PT11) based on chlorine dioxide
(0.3% w/w) in situ generated in a tank by mixing two precursors namely sodium chlorite
(TwinOxide Component A) and sodium hydrogensulphate (TwinOxide Component B).
All three substances are described below.
2.1
Identity of Chlorine dioxide
General
Active substance (ISO Common Name)
Name in Dutch
Chlorine dioxide (non-ISO)
Chloordioxide
Identity
Chemical name (IUPAC)
Chemical name (CA)
CAS No
EC No
Other substance No.
Molecular formula
Molecular mass
Structural formula
Chlorine dioxide
Chlorine dioxide
10049-04-4
EINECS: 233-162-8
Not applicable
ClO2
67.45
O=Cl=O
The active substance has not yet been included in the Union list of approved substances
of EU Regulation 528/2012. A CAR of the active substance is not available.
Physical and chemical properties relevant to the risk assessment
Appearance
Surface tension
Vapour pressure (Pa)
3
-1
Henry’s law constant (Pa m mol )
Solubility in water (g/L or mg/L)
Yellow to reddish-yellow gas
Not applicable
Range of calculated values including:
o
9.33 hPa at -67 C
o
653.3 hPa at 0 C
o
975.9 hPa at 10 C
383.459 at 10°C, calculated on the basis of the solubility
in water and vapour pressure at 10°C
o
7.5 g/l at 20 C
o
11.5 g/l at 10 C
Partial pressure 100mbar
pag. 11
pH of 8 g/L solution in water = 2-3
Partition coefficient (log POW)
Dissociation constant
UV/VIS absorption (max.) (if absorption > 290 nm
state ε at wavelength)
Not applicable
(highly reactive gas; will not bio-accumulate)
Not applicable
Concentrated solutions (>10%) are easily detonated by
sunlight
Hazard identification for classification and labelling
Flammability
Oxidising properties
Explosive properties
Flashpoint: not applicable
Flammability: not flammable
Auto-flammability: not self-igniting
Oxidising (O, R8)
Not explosive
At high concentrations (>10% v/v) chlorine dioxide may
decompose to chlorine and oxygen by explosion
Analytical methods for the technical active substance
Adequate analytical methodology is available to determine the content of active
substance and significant and/or relevant impurities in the technical active substance.
Conclusions active substance Chlorine dioxide
The identity, physical and chemical properties and analytical methods of the active
substance are sufficiently described.
2.2
Identity of Sodium chlorite
General
Active substance (ISO Common Name)
Name in Dutch
Sodium chlorite (non-ISO)
Natriumchloriet
Identity
Chemical name (IUPAC)
Chemical name (CA)
CAS No
EC No
Other substance No.
Molecular formula
Sodium chlorite
Sodium chlorite
7758-19-2
231-836-6
Not available
Molecular mass
90.44157 g/mol (anhydrous)
Structural formula
Na.ClO2
Na.ClO2
The active substance has not yet been included in the Union list of approved substances
of EU Regulation 528/2012. A CAR of the active substance is not available.
Physical and chemical properties relevant to the risk assessment
Appearance
Surface tension
Vapour pressure (Pa)
3
-1
Henry’s law constant (Pa m mol )
Solubility in water (g/L or mg/L)
Partition coefficient (log POW)
Dissociation constant
UV/VIS absorption (max.) (if absorption > 290 nm
state ε at wavelength)
Odourless solid, commercially available solutions (25-31)
are light yellow liquids with odour of chlorine.
N/A
-7
1.1 x 10 Pa at 25°C
Ca. 0 since the vapour pressure of sodium chlorite is very
low and water solubility is very high.
pH5:
501 g/L at 3°C
572 g/L at 20°C
643 g/L at 30.1°C
-2.7 at 21 °C
pKa = 2.15
No absorption expected > 290 nm
pag. 12
Hazard identification for classification and labelling
Flammability
Flashpoint: 25%TK >60 °C
Flammability: N/A
Auto-flammability: Not self-igniting
Oxidising properties
25%TK: Not oxidising
Explosive properties
25%TK: Not explosive
Analytical methods for the technical active substance
Adequate analytical methodology is available to determine the content of active
substance and significant and/or relevant impurities in the technical active substance.
Conclusions active substance Sodium chlorite
The identity, physical and chemical properties and analytical methods of the active
substance are sufficiently described.
2.3
Identity of Sodium hydrogensulphate
General
Active substance (ISO Common Name)
Name in Dutch
Sodium hydrogensulphate
Natriumwaterstofsulfaat
Identity
Chemical name (IUPAC)
Chemical name (CA)
CAS No
EC No
Other substance No.
Molecular formula
Molecular mass
Structural formula
Sodium hydrogensulphate
Sodium hydrogensulphate
7681-38-1
231-665-7
Reach Annex I index number: 016-046-00-X
HO4S.Na
120.06 (anhydrous)
The active substance is has not yet been included in the Union list of approved
substances of EU Regulation 528/2012. A CAR of the active substance is not available.
Physical and chemical properties relevant to the risk assessment
Appearance
Surface tension
Vapour pressure (Pa)
3
-1
Henry’s law constant (Pa m mol )
Solubility in water (g/L or mg/L)
White hygroscopic crystalline
n.a.
n.a.
n.a.
285 g/L at 25°C
Partition coefficient (log POW)
Dissociation constant
UV/VIS absorption (max.) (if absorption > 290 nm
state ε at wavelength)
n.a.
n.a.
No information available
Hazard identification for classification and labelling
Flammability
Oxidising properties
Explosive properties
Flashpoint: n.a.
Flammability: n.a.
Auto-flammability: n.a.
n.a.
Not explosive
Analytical methods for the technical active substance
Adequate analytical methodology is available to determine the content of active
substance and significant and/or relevant impurities in the technical active substance.
pag. 13
Conclusions active substance Sodium hydrogensulphate
The identity, physical and chemical properties and analytical methods of the active
substance are sufficiently described.
3 Physical and chemical properties
Identity of the biocidal poduct
Name
Content active substance
Formulation type
Packaging
TwinOxide 0.3% oplossing
Precursor A: 51.4%w/w sodium chlorite
Precursor B: 99%w/w sodium hydrogensulphate
XX
A: 20g, 40g PP snap secure container
100g, 200g, 500g, 1kg PP container
2kg PE container
10kg, PP bucket
B: 20g, 40g PP snap secure container
100g, 200g, 500g, 1kg PP container
2kg PE container
10kg, PP bucket
Physical and chemical properties of the biocidal product
Appearance
Explosive properties
Oxidising properties
Auto-flammability
Flashpoint or Flammability
pH 1% solution
Relative density
Storage stability/ Shelf life
Physical and chemical compatibility
Viscosity
Surface tension
Precursor A: white powder/granulate
Precursor B: off-white crystalline solid
Working solution: yellow liquid
Precursor A: not explosive
Precursor B: not explosive
Working solution: not explosive
Precursor A: strong oxidising
Precursor B: not oxidising
Working solution: not oxidising
Precursor A: not self igniting
Precursor B: not self igniting
Working solution: not self igniting
Precursor A: not flammable
Precursor B: not flammable
Working solution: not flammable
Precursor A: 10-11 (10%)
Precursor B: 1 (5%)
Working solution: 1.6
Precursor A: 0.97
Precursor B: 1.4
Working solution: 1.04
Precursor A: 24 months in PP and PE
Precursor B: 24 months in PP and PE
Working solution: 2 weeks in LDPE
Precursor A: not applicable
Precursor B: not applicable
Working solution: not applicable
Precursor A: not applicable
Precursor B: not applicable
Working solution: not applicable
Precursor A: not applicable
Precursor B: not applicable
Working solution: not applicable
Analytical methods for analysis of the biocidal product
Preparation (principle of method)
Iodometric titration
Residue analytical methods
Adequate residue analytical methodology is available to monitor residues of the biocide
taking into account all possible exposure scenarios and the toxicity of the active
substance(s).
pag. 14
Conclusions biocidal product
The identity, the physical and chemical properties and the analytical methods of the
biocidal product are sufficiently described.
4 Efficacy
Function
TwinOxide 0.3% oplossing is a disinfectant (PT2, PT4, PT5 and PT11) based on chlorine
dioxide (0.3% w/w) in situ generated in a tank by mixing two precursors, containing 51.4%
sodium chlorite (TwinOxide Component A) and 99% sodium hydrogensulphate
(TwinOxide Component B).
Field of use envisaged
The proposed field of use of TwinOxide 0.3% oplossing is the control of:
• bacteria, viruses, fungi and algae
- on food-contact surfaces, materials and equipment in industrial areas (PT04)
• bacteria, viruses, yeast, fungi and algae
- in drinking water intended for animal consumption (PT05)
- in water used for post-harvest washing of potatoes, vegetables, fruits and shrimps
(PT04)
• biofilm
- in water lines and - distribution systems (PT04)
• biofilm, bacteria, viruses, yeast, fungi, and algae
- in water distribution systems for livestock, including prevention of aftergrowth of
biofilm (PT04)
- in irrigation water and for the removal of biofilm from water irrigation systems in
horticulture and greenhouses (PT02)
• bacteria, viruses, yeast, fungi, algae, biofouling and biofilm
- on membrane filters (UF and RO) to prevent biofilm fouling of the membranes
(PT11)
- in tanks and lines for the preparation, storage transfer and dispensing of water
(including drinking water) (PT04)
• bacteria, viruses, yeast and fungi
- in water to be frozen for the production of ice
- in process water that is used for animal feed production (PT4)
Please note that:
Disinfection of water to be frozen for the production of ice to extend the shelf life of fish, is
not a biocidal claim and will therefore be removed from the label.
Drinking water disinfection for professional use, with the exception of disinfection by
drinking water production companies, is not included within the differentiated enforcement
policy. Therefore the disinfection of drinking water intended for animal consumption is
excluded and removed from the WG/GA.
All remaining uses are included in PT2, PT4 and PT11.
The product is intended for professional use only.
Effects on target organisms and efficacy
The available information was sufficient to evaluate the efficacy of TwinOxide 0.3%
oplossing considering that the authorisation is done under article 121 of the WGB.
Several studies testing efficacy were provided for TwinOxide 0.3% oplossing, some were
considered to be suitable and acceptable.
Efficacy of 0,3% chlorine dioxide solution was demonstrated in quantitative suspension
tests (phase 2, step 1) according to EN standards with the required standard organisms
pag. 15
for bacteria and yeasts, high level soiling conditions of 3 g/l bovine albumin, a contact
time of 15 minutes and a test temperature of 20 ºC. As a result, the range of use
concentrations (5 ppb – 50 ppm) on the WG/GA has been adapted to 0,3% chlorine
dioxide solution only.
4.3.1 Evaluation of the label (WG/GA)
The applicant has provided a Dutch WG/GA. This has been adapted to our standards.
Three separate WG/GA’s are drafted, one for the product TwinOxide 0.3% oplossing to
be placed on the tank and one for each precursor TwinOxide Component A and B.
• Mycobacteria will be excluded from the bacterial claim, because these are not claimed
organisms and no data on mycobactericidal efficacy have been provided;
• The temperature of water needed for the preparation of TwinOxide 0.3% oplossing is
increased from 10 ºC to minimum 20ºC since efficacy was demonstrated at this
temperature;
• Since no efficacy studies on Legionella were provided, the use in human drinking
water systems is excluded from the use in tanks and lines for the preparation, storage
and dispensing of water.
The following uses of TwinOxide 0.3% oplossing have been excluded on request of the
applicant during the assessment procedure and were removed from the label:
• the use against fungi, viruses, algae, bacterial spores and biofilm
• the use in water for post-harvest washing of potatoes, vegetables, fruits and shrimps
• the use in water lines and - distribution systems against biofilm
• in process water that is used for animal feed production
• the use in irrigation water and for the removal of biofilm from water irrigation systems
in horticulture and greenhouses
During the assessment procedure the use concentrations of the remaining uses were
increased to 0,3% chlorine dioxide since efficacy was demonstrated at this concentration.
In addition, on request of the applicant, the application method for the use on membrane
filters has been changed from the use of a flow controlled dosing pump system to the use
of dipping baths.
4.3.2 Mode of action
Chlorine Dioxide acts as an oxidizing agent and reacts with several cellular constituents,
including the cell membrane of microbes. By “stealing” electrons from them (oxidation), it
breaks their molecular bonds, resulting in the death of the organism by the break up of
the cell.
Resistance and resistance management strategies
No data was submitted on the possible occurrence of resistance of target organisms to
chlorine dioxide. Considering that the authorisation is done under article 121 of the WGB
this is acceptable.
Conclusions
Based on the data submitted and considering that the evaluation is done under article
121 of the WGB, it can be concluded that TwinOxide 0.3% oplossing, when used in
accordance with the proposed label (WG/GA), is effective in controlling bacteria
(excluding mycobacteria and bacterial spores) and yeasts
- on surfaces, materials and equipment in food- and feed industry;
- on membrane filters for proceswater and cooling water;
- in tanks and lines for the preparation, storage transfer and dispensing of water, with the
exception of drinking water systems for humans.
These uses are included in PT4 and PT11.
pag. 16
The following uses of TwinOxide 0.3% oplossing have been excluded on request of the
applicant during the assessment procedure:
• the use against fungi, viruses, algae, bacterial spores and biofilm;
• the use in water for post-harvest washing of potatoes, vegetables, fruits and shrimps;
• the use in water lines and - distribution systems against biofilm;
• in process water that is used for animal feed production;
• the use in irrigation water and for the removal of biofilm from water irrigation systems
in horticulture and greenhouses.
5 Human toxicology
Chlorine dioxide
For chlorine dioxide a OECD SIDS (2006) is available. In addition there is an EMEA
report on the use of sodium chlorite in post-milking teat dip products available (1996),
addressing the properties of chlorine dioxide.
List of Endpoints
Chlorine dioxide produces local effects after single (skin corrosion and eye irritation) and
repeated exposure. As the local effects are the primary effects of chlorine dioxide, the risk
assessment is based on local effects. Acute exposure of the skin to chlorine that
originates from the decomposition of chlorine dioxide, causes irritation and burns.
Chlorine dioxide gas can be absorbed by the skin, where it damages tissue and blood
cells. Inhalation of chlorine dioxide gas causes coughing, a sore throat, severe
headaches, lung oedema and bronchial spasms. The symptoms can begin to show long
after the exposure has taken place and can remain for a long time. Chronic exposure to
chlorine dioxide causes bronchitis.
A considerable amount of data has been reviewed by various authorities regulating water
quality, including WHO and US EPA, and regulatory limits have been proposed of 0.21 to
0.5 mg/L for chlorine dioxide. The WHO1 indicates that if chlorine dioxide is used as a last
step in drinking water disinfection, the concentration of chlorite should be below 0.2 mg/L.
In the Netherlands the limit value of 0.2 ppm (0.2 mg/L) is used for chlorine dioxide by the
surveillant of Water Supply companies.
A Occupational Exposure Limit (OEL) of 0.3 mg/m3 was established in 1996 for chlorine
dioxide, as 15 minute TWA. In other countries (Germany, Denmark, Finland) the same
level was set for a 8-hour TWA.
This OEL has expired upon the introduction of the modified OEL system on 1 January
2007 and now falls within the private domain. In the lack of reliable data on repeated
inhalation exposure to chlorine dioxide, this value will be used as an AEC for inhalation
exposure.
Chlorine dioxide is classified as corrosive (Skin Corr. 1B, H314) on Annex VI of
Regulation 1272/2008/EC. Based on the specific concentration limits for chlorine dioxide,
concentrations ≥1% are classified as irritating to skin. Based on this, the concentration of
1% is considered to be the AEC for local dermal effects.
Data requirements active substance
No additional data requirements are identified.
Sodium hydrogensulphate
The List of Endpoints is based on the IUCLID file prepared for the registration of the
substance under the REACH Regulation.
1
Guidelines for Drinking Water Quality, 3rd Edition, vol. 1, Recommendations WHO,
Geneva, 2004
pag. 17
List of Endpoints
Sodium hydrogensulphate is completely and rapidly absorbed from gastrointestinal tract.
No data on dermal absorption are available, but considering the ionic structure of the
compound it is likely to be low. Based on the EFSA guidance on dermal absorption2, the
default values of 25% dermal absorption are stipulated for solutions containing > 5%
sodium hydrogensulphate and 75% for solutions containing ≤ 5% sodium sulphate.
Sodium hydrogensulphate has low acute toxicity by oral and inhalation route (oral LD50 =
2140 mg/kg bw, inhalation LC50 > 2.4 mg/L). The substance is not irritating to skin, but
causes serious damage to eyes. Sodium hydrogensulphate is not a skin sensitizer.
No repeated dose toxicity studies with sodium hydrogensulphate are available, but readacross with its analogue sodium sulphate is considered to be acceptable. In the oral
(gavage) 28-day combined repeated dose and reproduction/developmental toxicity
screening with sodium sulphate in rats, the highest dose level of 1000 mg/kg bw/day was
considered to be a NOAEL. In a non-standard, non-GLP study, rats were fed a diet
containing around 2% sodium sulphate for 4 weeks. No adverse effects were noted,
resulting in a NOAEL of 2000 mg/kg bw/day. In the 90-day repeated dose toxicity study,
sodium sulphate solution was used as a positive control. Daily administration of 16%
sodium sulphate solution (dose level of 2 mL/kg bw/day) to male and female New
Zealand White rabbits resulted in a subacute dermatitis at the test site. This concentration
was considered to be a LOAEL.
Sodium hydrogensulphate gave negative result in the in vitro chromosome aberration test
in human lymphocytes at dose levels up to 5 mM (non-guideline and non-GLP study). No
further data are available. Its structural analogue sodium sulphate gave negative results
in the in vitro gene mutation tests in bacteria and in mammalian cells and in chromosome
aberration test in CHO lung fibroblasts (V79), with and without metabolic activation.
Based on this, sodium hydrogensulphate is considered to be not genotoxic.
No reliable long-term studies on sodium hydrogensulphate are available.
No adverse effects on reproduction and fertility were noted in the combined repeated
dose and reproduction/developmental toxicity screening with the structural analogue
sodium sulphate in rats up to the highest dose level of 1000 mg/kg bw/day.
AEL/AEC derivation
Although only limited number of toxicological studies are available on sodium
hydrogensulphate, it can be concluded that the toxicity of the substance is minimal. In the
well-performed combined repeated dose and reproduction/developmental toxicity
screening with the structural analogue sodium sulphate in rats, no adverse effects were
seen at the dose level of 1000 mg/kg bw/day. Applying the assessment factor 100, this
results in the AEL of 10 mg/kg bw/day. No correction for exposure duration is considered
to be necessary in this case, as no adverse effects were noted in the study, indicating the
very low toxicity of the substance. Thus it is not expected that prolonged administration of
the substance will lead to the exacerbation of toxicological effects.
In the 90-day dermal toxicity study with rabbits, application of 16% sodium sulphate to
rabbit skin resulted in subacute dermatitis. Applying a factor 3 for the conversion from
LOAEL to NOAEL results in the AEC of 5.3% for local effects. No additional assessment
factor is considered to be necessary.
Data requirements active substance
No additional data requirements are identified.
Sodium chlorite
The List of Endpoints (LoE) is based on an EPA evaluation, including data from a EPA
evaluation (2006) and a OECD SIDS (2006).
2
EFSA Guidance on dermal absorption. EFSA Journal 2012; 10(4): 2665.
pag. 18
List of Endpoints
Sodium chlorite is rapidly absorbed from the gastrointestinal tract, when administered
orally (rate constant 0.198 h-1, absorption half-life 3.5 hours), with 75% of the recovered
dose excreted in urine and 25% in faeces. In the in vitro dermal absorption study with
3.5% and 30.8% solution of sodium chlorite, using human and rat skin, at the high dose
level thinning of the epidermis was observed at 2 hours post-dose. At 24 hours post-dose
at the high dose level all human cells had areas of disrupted epidermis and the stratum
corneum of each cell was very thin and dry in appearance. All rat cells at the high dose
level showed extensive damage to the stratum corneum. The mean recovery was only
53.12% and 75.71% for human and rat skin, respectively, for 30.8% sodium chlorite and
18.7% and 20.23% for human and rat skin, respectively, for 3.5% sodium chlorite.
Considering the amount of the compound in the receptor fluid, receptor chamber, in the
skin and stratum corneum as potentially absorbed, the absorption was 9.93% for human
skin and 68.06% for rat skin for 30.8% sodium chlorite, and 7.65% for human skin and
18.88% for rat skin for 3.5% sodium chlorite.
However, although there is an in vitro dermal absorption study, this study is not
considered acceptable due to the low recovery (between 18-53%). Therefore, the EFSA
Guidance on Dermal Absorption (2012)3 in which the default value of 25% for products
containing >5% a.s is proposed, will be used. Based on this guidance the value of 25%
for dermal absorption will be used in the risk assessment.
The acute oral LD50 of NaClO2 is 284 mg/kg bw, the acute dermal LD50 is 100 mg/kg bw
and the acute inhalation LC50 is 0.29 mg/L.
A 34.5% solution of sodium chlorite was not irritating to rabbit skin, while 31% solution
was severely irritating to eyes. A 31% solution of sodium chlorite gave negative results in
Magnusson-Kligman maximization test.
A subchronic oral (gavage) toxicity study with rats showed salivation, effects in blood
(reduced erythrocyte counts (both sexes), reduced haematocrit and haemoglobin levels
(males only)), increased spleen and adrenal weights (both sexes) and local effects in the
stomach (chronic inflammation, ulceration, oedema). The NOAEL was set at 7.5 mg/kg
bw/day. No repeated dose dermal and inhalation toxicity studies are available.
The substance was not genotoxic in in vitro and in vivo genotoxicity assays, including in
vivo micronucleus test and chromosomal aberration test, and a sperm-head abnormality
test in mice. The 85 weeks drinking water study with rats and mice did not indicate
increased tumour incidence up to and including the highest dose level of 600 mg/L.
However, in another carcinogenicity study with rats and mice administered sodium
chlorite in drinking water at dose levels of 250 and 500 mg/L (ca. 36 and 71 mg/kg
bw/day actual ingested) for 78 weeks higher incidences of liver and lung tumour were
observed in male rats. The LOAEL was 36 mg/kg bw/day (the lowest dose tested).
A two-generation reproductive toxicity and developmental neurotoxicity study with rats
administered sodium chlorite at 35, 70 and 300 mg/L in drinking water is available for
sodium chlorite. The study was evaluated by the World Health Organisation (Backgound
document for development of WHO Guidelines for Drinking Water Quality: Chlorite and
chlorate in Drinking Water, 2005), who noted the following: “There were reductions in
water consumption, food consumption and body weight gain in both sexes in all
generations at various times throughout the experiment, primarily in the 70 and 300 mg/L
groups; these were attributed to lack of palatability of the water. At 300 mg/L, reduced
pup survival, reduced body weight at birth and throughout lactation in F1 and F2, lower
thymus and spleen weights in both generations, lowered incidence of pups exhibiting a
normal righting reflex, delays in sexual development in males and females in F1 and F2
and lower blood cell parameters in F1 were noted. Significant reductions in absolute and
3
EFSA Guidance on dermal absorption. EFSA Journal 2012; 10(4); 2665.
pag. 19
relative liver weights in F0 females and F1 males and females, reduced absolute brain
weights in F1 and F2 and a decrease in the maximum response to auditory startle
stimulus on postnatal day (PND) 24 but not at PND 60 were noted in the 300 and 70 mg/L
groups. Minor changes in red blood cell parameters in the F1 generation were seen at 35
and 70 mg/, but these appeared to be within normal ranges based on historical data. The
NOAEL in this study was 35 mg/L (2.9 mg chlorite/kg/day, or 4 mg sodium chlorite/kg
bw/day), based on lower auditory startles amplitude, decreased absolute brain weight in
the F1 and F2 generations and altered liver weights in two generations. “
In a developmental toxicity study with rabbits mean lower foetal weight and slightly higher
incidence of foetuses with retardation of ossification of some bones was observed at dose
levels producing maternal toxicity (reduced food consumption, transient reductions in
body weight gain, reduced water consumption). The NOAEL for both maternal and
developmental toxicity was set at 12 mg/kg bw/day.
Local effects
No data on skin and eye irritation properties of pure sodium chlorite are available. The
34.5% solution of sodium chlorite was not irritating to skin, while serious damage to eyes
was observed in the eye irritation study with the 31% solution of sodium chlorite. A 31%
solution was not sensitizing in the Magnusson-Kligman maximization test.
In the 90-day oral (gavage) toxicity study local effects in the stomach were observed at
the highest dose level (80 mg/kg bw/day), including chronic inflammation, ulceration and
oedema.
AEL/AEC derivation
Based on the lowest NOAEL of 4 mg/kg bw/day in the two-generation reproductive
toxicity study with rats and applying the assessment factor 100, the AELsystemic long-term of
0.04 mg/kg bw/day can be derived for sodium chlorite.
Based on the NOAEL of 7.5 mg/kg bw/day in the 90-day repeated oral toxicity study with
rats and applying the assessment factor 100, the AELsystemic medium-term of 0.075 mg/kg
bw/day can be derived for sodium chlorite.
Finally, based on the NOAEL of 12 mg/kg bw/day in the developmental toxicity study with
rabbits and applying the assessment factor 100, the AELsystemic short-term of 0.12 mg/kg
bw/day can be derived for sodium chlorite.
As no skin effects were seen in the skin irritation study with 34.5% solution of sodium
chlorite, this concentration shall be considered as an AEClocal dermal for skin irritation
effects.
Data requirements active substance
No additional data requirements are identified.
5.1
Human exposure assessment active substance
5.1.1 General aspects
TwinOxide 0.3% oplossing consists of two components A and B, both white, almost
odorless powders which need to be mixed together in water to generate 0.3% chlorine
dioxide solution. The component A contains 51.4% sodium chlorite; the component B
contains 99% sodium hydrogensulphate. The proposed fields of use of TwinOxide 0.3%
oplossing are disinfection of food-contact surfaces, materials and equipment in industrial
areas, the prevention of biofilm fouling of the membrane filters for the process water and
disinfection of tanks and lines for the preparation, storage, transfer and dispensing of
water (PT2, 4 and 11). TwinOxide 0.3% oplossing (the stock solution) is applied
undiluted.
The formulation TwinOxide 0.3% oplossing is intended for professional use only.
pag. 20
5.1.2
Identification of main paths of professional exposure towards active substance
from its use in biocidal product
For the disinfection of food-contact surfaces the biocidal product will be applied by coarse
spraying or by dipping. In case of membrane filters the disinfection occurs by dipping
them into the disinfection baths with a maximal volume of 100 L. For tanks and lines
disinfection the solution of TwinOxide 0.3% oplossing is injected into the flush water using
a dosing pump.
The professional user can be dermally and respiratory exposed to the precursors sodium
hydrogensulphate and sodium chlorite during the preparation of the stock TwinOxide
0.3% oplossing solution. Furthermore, the professional user can be respiratory and
dermally exposed to the active substance chlorine dioxide formed during the stock
solution preparation, during the surface disinfection by coarse spraying or dipping,
membrane filter disinfection by dipping and during the dosing (coupling/decoupling of
transfer lines) of the stock solution into the flush water.
As TwinOxide 0.3% oplossing is used by professional users, oral exposure to the solution
of chlorine dioxide is considered negligible.
5.1.3
Identification of main paths of non-professional exposure towards active
substance from its use in biocidal product
The formulation TwinOxide 0.3% oplossing is intended for professional use only.
5.1.4 Indirect exposure as a result of use of the active substance in biocidal product
The secondary exposure to chlorine dioxide on surfaces is expected to be negligible, as
chlorine dioxide is a highly volatile and reactive substance, which is expected to degrade
quickly at the site of the first contact with organic matter. Exposure of bystanders to the
generated chlorine dioxide may be possible if they will be present in the close proximity
during the preparation of the dosing solution and by surface disinfection by coarse
spraying or dipping due to volatility of chlorine dioxide. However, this exposure is
expected to be significantly lower than the exposure of professional users who will be
involved in the preparation of the dosing solutions.
In case of disinfection of tanks and lines for the preparation, storage, transfer and
dispensing of water, the applicant indicates that the systems should be flushed with
drinking water until the concentration of chlorine dioxide is below the limit value of 0.2
ppm (0.2 mg/L). In order to check whether the concentration is below the limit value the
test strips will be used (included in the WG/GA). Based on this no concern for secondary
exposure exists.
5.2
Human health effects assessment product
5.2.1 Toxicity of the formulated product
No studies with TwinOxide 0.3% oplossing 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.
5.2.2 Data requirements formulated product
No additional data requirements are identified.
5.3
Risk characterisation for human health
5.3.1 Professional users
During the preparation of the stock solution of TwinOxide 0.3% oplossing professional
user can be dermally and respiratory exposed to the precursors sodium
hydrogensulphate and sodium chlorite. Inhalation exposure to the active substance
chlorine dioxide, generated in situ, can occur during the preparation of the solution.
pag. 21
Sodium hydrogensulphate
The exposure to sodium hydrogensulphate has been estimated by using Mixing and
Loading model 5, as recommended by the HEEG opinion 2008 (endorsed at the TM I
2008) for simple loading (e.g. 1 bag per day). The indicative dermal exposure is 10.2 mg
active substance per each transferred kilogram active substance. The indicative
inhalation exposure is 0.66 mg/kg a.s. The dermal absorption of sodium
hydrogensulphate is considered to be 25% in accordance with the EFSA Guidance on
dermal absorption (2012); inhalation absorption is considered to be 100% by default.
The applicant has indicated that the precursors will be submitted in packs of 0.02-20 kg.
Therefore the highest amount of precursor B transferred per day is considered to be 20
kg. Considering the concentration of sodium hydrogensulphate of 99% in the precursor B,
per day a maximum of 19.8 kg sodium hydrogensulphate is considered to be transferred.
Respectively, the total dermal exposure is (19.8 x 10.2 =) 201.96 mg sodium
hydrogensulphate on hands. The total inhalation exposure is (19.8 x 0.66 =) 13.07 mg
sodium hydrogensulphate inhaled. Considering the dermal absorption of 25% and
inhalation absorption of 100%, internal dermal exposure is (201.96 x 25% =) 50.49 mg;
internal inhalation exposure is (13.07 x 100% =) 13.07 mg. Considering the body weight
of professional user of 60 kg, the resulting internal exposure is (50.49 + 13.07)/60 = 1.06
mg/kg bw/day
Based on this, the following exposure estimates are derived:
Table T.1 Internal professional operator exposure to sodium hydrogensulphate and risk
assessment for the use of precursor B during mixing and loading
Estimated internal
exposurea (mg/kg
bw/day)
Systemic
AELlong-term
(mg/kg
bw/day)
Risk-indexb
0.84
10
0.08
Respiratory
0.22
10
0.02
Total
1.06
10
0.10
Route
Mixing and loading, no PPE
Dermal
a
b
Internal exposure was calculated with:
biological availability via the dermal route: 25 %
biological availability via the respiratory route: 100%
The risk-index is calculated by dividing the internal exposure by the systemic AELlong-term
Based on this, no adverse effects from exposure to sodium hydrogensulphate during
mixing and loading of precursor B are expected for unprotected professional users.
However, as the concentration of sodium hydrogensulphate in the precursor B (99%) is
above the AEC of 5.3% for local effects, the use of personal protective equipment
(gloves, coverall) is prescribed for professional users.
Sodium chlorite
The exposure to sodium chlorite has been estimated by using Mixing and Loading model
5, as recommended by the HEEG opinion 2008 (endorsed at the TM I 2008) for simple
loading (e.g. 1 bag per day). The indicative dermal exposure is 10.2 mg active substance
per each transferred kilogram active substance. The indicative inhalation exposure is 0.66
mg/kg a.s. The dermal absorption of sodium chlorite is considered to be 25% in
accordance with the EFSA Guidance on dermal absorption (2012); inhalation absorption
is considered to be 100% by default.
The applicant has indicated that the precursors will be submitted in packs of 0.02-20 kg.
Therefore the highest amount of precursor A transferred per day is considered to be 20
pag. 22
kg. Considering the concentration of sodium chlorite of 51.4% in the precursor A, per day
a maximum of (20 x 51.4% =) 10.28 kg sodium chlorite is considered to be transferred.
Respectively, the total dermal exposure is (10.28 x 10.2 =) 104.86 mg sodium chlorite on
hands. The total inhalation exposure is (10.28 x 0.66 =) 6.78 mg sodium chlorite inhaled.
Considering the dermal absorption of 25% and inhalation absorption of 100%, internal
dermal exposure is (104.86 x 25% =) 26.22 mg; internal inhalation exposure is (6.78 x
100% =) 6.78 mg. Considering the body weight of professional user of 60 kg, the resulting
internal exposure is (26.22 + 6.78)/60 = 0.55 mg/kg bw/day.
If the use of personal protective equipments (gloves, respiratory protective equipment) is
considered, resulting in 90% reduction of dermal and respiratory exposure, the resulting
internal exposure is (0.55/10 = ) 0.06 mg/kg bw/day.
Based on this, the following exposure estimates are derived:
Table T.2 Internal professional operator exposure to sodium chlorite and risk assessment
for the use of precursor A during mixing and loading
Estimated internal
exposurea (mg/kg
bw/day)
Systemic
AELlong-term
(mg/kg
bw/day)
Risk-indexb
0.44
0.04
11.00
Respiratory
0.11
0.04
2.75
Total
0.55
0.04
13.75
0.04
0.04
1.10
Respiratory
0.01
0.04
0.28
Total
0.06
0.04
1.38
Route
Mixing and loading, no PPE
Dermal
Mixing and loading, PPE + RPE
Dermal
a
b
Internal exposure was calculated with:
biological availability via the dermal route: 25 %
biological availability via the respiratory route: 100%
The risk-index is calculated by dividing the internal exposure by the systemic AELlong-term
Based on this, adverse effects from exposure to sodium chlorite during mixing and
loading of precursor A cannot be excluded even for protected (gloves, respiratory
protective equipment) professional user.
In order to calculate the maximal amount of the substance which can be loaded on one
day, the reverse reference calculation is performed by the Ctgb, considering the internal
systemic exposure of 0.04 mg/kg bw/day (AELlong-term systemic). Considering the risk index of
1.38 with the use of gloves and respiratory protective equipment for the transfer of 20 kg
precursor A, the maximal amount of precursor A which can be transferred on 1 day is
(20/1.38 = )14.49 kg. The applicant indicated that the whole pack of the substance needs
to be used to prepare the stock solution. Based on the packaging size proposed by the
applicant (0.02 kg, 0.04 kg, 0.1 kg, 0.2 kg, 0.5 kg, 1 kg, 2 kg, 10 kg and 20 kg) the
maximal packaging size should be limited to 10 kg.
Based on the risk assessment, no adverse effects are expected for protected (gloves,
respiratory protective equipment) professional user from exposure to sodium hypochlorite
as a result of mixing and loading of precursor A, if the maximal transferred amount per
day remains below 14.49 kg.
pag. 23
Application by spraying
The exposure to chlorine dioxide during the surface disinfection by spraying was
estimated using Spraying Model 1 (User Guidance v.1, 2002, p.30). The indicative
exposure value is 104 mg biocidal product per 1 m3 for inhalation exposure. Considering
the chlorine dioxide concentration of 0.3% in the formulation, the resulting air
concentration of chlorine dioxide is (104 x 0.3% = )0.312 mg/m3. As this value is above
the AEC of 0.3 mg/m3, the use of respiratory protective equipment is prescribed for
professional user. As chlorine dioxide causes primarily local effects by respiratory
exposure, the use of respiratory protective equipment is expected to prevent such effects
from occurring.
For dermal exposure, the concentration of chlorine dioxide in the solution is below the
AEClocal dermal of 1%. Therefore no adverse dermal effects are expected for unprotected
professional user from the dermal exposure to the solution fo chlorine dioxide due to the
application of TwinOxide 0.3% oplossing by coarse spraying.
In summary no adverse effects are expected from the dermal and respiratory exposure to
chlorine dioxide for a protected (respiratory protective equipment) professional user as a
result of the application of TwinOxide 0.3% oplossing by coarse spraying.
Disinfection by dipping
The disinfection by dipping occurs in dipping baths of a maximal size of 100 L, as
indicated by the applicant. An object to be disinfected needs to be submerged into the
disinfection solution for at least 15 minutes. Several object scan be disinfected on a day.
Based on the TNsG database on human exposure, total exposure duration is considered
to be 1 hour/day.
The exposure estimation was conducted using a evaporation model of ConsExpo 4.1. As
no information is available on the room size, ventilation rate and release area, the default
values for hoof disinfection baths were used. The size of hoof disinfection baths is
considered to be comparable to the dipping baths, as large volumes of the product are
being used in both cases (at least 100 L), and the dipping using 100 L baths must occur
in large industrial areas with sufficient ventilation, similarly to the large areas in which the
hoof disinfection occurs. In the first draft CAR of formaldehyde the following defaults are
used for hoof disinfection baths: room volume of 9630 m3, ventilation rate of 9.4/hour and
release area of 3 m2. The same defaults have been used for the dipping baths in the
present case. The molecular matrix weight is considered to be 18 g/mol (considering
aqueous 0.3% solution of chlorine dioxide, the matrix is considered to be water). Based
on this the following exposure estimates are derived:
Inhalation (point estimates)
inhalation mean event concentration :
3,24
mg/m3
As can be seen, this value exceeds the AEClocal inhalation of 0.3 mg/m3, therefore the use of
respiratory protective equipment is prescribed for professional user. As chlorine dioxide
causes primarily local effects by respiratory exposure, the use of respiratory protective
equipment is expected to prevent such effects from occurring.
For dermal exposure, the concentration of chlorine dioxide in the solution is below the
AEClocal dermal of 1%. Therefore no adverse dermal effects are expected for unprotected
professional user from dermal exposure to the solution fo chlorine dioxide due to the
application of TwinOxide 0.3% oplossing by dipping.
In summary no adverse effects are expected from the dermal and respiratory exposure to
chlorine dioxide for a protected (respiratory protective equipment) professional user as a
result of the application of TwinOxide 0.3% oplossing by dipping.
pag. 24
Disinfection of tanks and lines for the preparation, storage, transfer and dispensing of
water
The disinfection of tanks and Lines will be performed by using a flow controlled dosing
pump to inject a solution of TwinOxide 0.3% oplossing in the flush water. Afterwards,
tanks and piping systems will be flushed with clean water. Based on this respiratory and
dermal exposure of professional user is expected to be negligible.
5.3.2 Non-professional users, including the general public
The formulation TwinOxide 0.3% oplossing is intended for the professional use only.
5.3.3 Indirect exposure as a result of use
The secondary exposure to chlorine dioxide on surfaces is expected to be negligible, as
chlorine dioxide is a highly volatile and reactive substance, which is expected to degrade
quickly at the site of the first contact with organic matter. Exposure of bystanders to the
generated chlorine dioxide may be possible if they will be present in the close proximity
during the preparation of the dosing solution and by surface disinfection by coarse
spraying or dipping due to volatility of chlorine dioxide. However, this exposure is
expected to be significantly lower than the exposure of professional users who will be
involved in the preparation of the dosing solutions.
In case of disinfection of tanks and lines for the preparation, storage, transfer and
dispensing of water, the applicant indicates that the systems should be flushed with
drinking water until the concentration of chlorine dioxide is below the limit value of 0.2
ppm (0.2 mg/L), which will be checked with testing strips. Based on this no concern for
secondary exposure exists.
5.3.4 Combined exposure
TwinOxide 0.3% oplossing contains only one active substance and it is not described
that it should be used in combination with other formulations.
5.3.5 Substance of concern
The formulation TwinOxide 0.3% oplossing and the precursors A and B contain several
co-formulants that can be considered as potential substances of concern. However, as
these substances are classified for only local effects, their presence is covered in the risk
assessment by means of assigning the respective H- and P-statements.
5.1
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 (gloves, respiratory protective equipment) professional user
after dermal and respiratory exposure to the precursors sodium hydrogensulphate and
sodium chlorite as a result of the preparation of the stock solution of TwinOxide 0.3%
oplossing, if the maximal amount of the transferred sodium chlorite does not exceed
14.49 kg per day. Based on the proposed packaging size provided by the applicant and
the fact that the whole pack needs to be sued to prepare the stock solution, the
packaging size may not exceed 10 kg. The following restriction should be included in the
WG/GA: “Due to health risks do not use more than 14.5 kg TwinOxide 0.3% oplossing
precursor A (sodium chlorite) per day”.
Based on the risk assessment, no adverse effects are expected from the dermal and
respiratory exposure to chlorine dioxide for a protected (respiratory protective equipment)
professional user as a result of the application of TwinOxide 0.3% oplossing, when used
according to WG/GA.
Furthermore, when used according to the WG/GA, no adverse health effects are
expected for the general public by indirect exposure to chlorine as a result of the
application of TwinOxide 0.3% oplossing. In case of disinfection of tanks and pipes for the
preparation, storage, transfer and dispensing of water, the following restriction should be
included in the WG/GA: “The systems should be flushed with drinking water until the
pag. 25
concentration of chlorine dioxide is below the limit value of 0.2 ppm (0.2 mg/L). This
should be checked using testing strips. “
6 Environment
6.1 Introduction
Authorisation is requested for the product TwinOxide 0.3% oplossing containing chlorine
dioxide (ClO2) as the active substance. TwinOxide 0.3% oplossing is in-situ generated
from the precursors sodium chlorite (NaClO2) and sodium hydrogensulphate (NaHSO4).
The intended use is described in table E.1. The product is used by professionals and
indoors.
Table E.1.
Intended uses
Area of use envisaged
Control of bacteria and yeasts on materials which can come into contact with
food, beverages and animal feed and in (pipelines for) cooling- and process
water (PT2, 4 and 11)
Use concentration
a.s. (% w/w)
0.3
6.2. Product related studies
Product related studies
The exposure assessment is based on data for the active substance. There are no fate or
ecotoxicity data available for the product.
6.3
Environmental exposure assessment product
6.3.1 Chemistry and/or metabolism
The product contains sodium chlorite and sodium hydrogensulphate, which are mixed to
form the active substance chlorine dioxide. Chlorine dioxide is produced in a separate
tank from which the active substance is dosed. The precursors sodium chlorite and
sodium hydrogensulphate will react to chlorine dioxide and sodium sulphate. The
precursors will therefore not be released to the environment when applied according to
the directions of use. No environmental risk assessment was therefore made for the two
precursors and sodium sulphate.
Chlorine dioxide dissociates into chlorite (ClO2-), chlorate (ClO3-) and chloride (Cl-) ions in
aqueous media. The environmental risks have been therefore assessed for chlorine
dioxide, chlorite and chlorate ions. No risks were assessed for chloride ions and sodium
sulphate as they occur naturally in the environment and do not have biocidal properties.
Additionally,the intended uses will not significantly increase natural background
concentrations. The risk assessment was therefore focussed on the active substance
chlorine dioxide.
Chlorine dioxide, chlorite and chlorate are strong oxidants and therefore chemically
instable and will thus exist in the environment for only short periods of time. The
compounds react immediately with organic carbon when they come into contact with
excess of organic matter or react immediately with other reducing substances. As
residual product of the oxidation process free available chlorine can be build in organic
matter forming chlorinated organic micro pollutants. These chlorinated organic micro
pollutants are not addressed in the environmental risk assessment, considering that these
residuals are formed in small quantities (<10% of the applied chlorine). Furthermore
possible pH effects on the environment were not considered, because the receiving
compartments are expected to have sufficient buffering.
pag. 26
6.3.2 Distribution in the environment
Emission routes
Releases into the environment can take place at any stage of the life cycle of a product.
The major routes of entry into the environment during the application, in-service, and
waste phase for the active substance and/or its metabolites are listed in Table E.2.
Table E.2.
of
Use scenario
Potentially exposed environmental compartments based on the basis
the use envisaged
Environmental compartments and groups of organisms
exposed
1
2,3
STP Freshwater Saltwater* Soil
Air Birds and
mammals
Control of bacteria and yeasts on
++
+
+
(+)/materials which can come into
contact with food, beverages and
animal feed and in (pipelines for)
cooling- and process water (PT2,
4 and 11)
++ Compartment directly exposed, + Compartment indirectly exposed, (+) Compartment potentially exposed
(but unlikely significant concern due to a.s. hazard data and scale of exposure), - Compartment not exposed,
1
2
(Q) Qualitative assessment, depending on application, Including sediment, Including groundwater, and soil
3
invertebrates and arthropods, In the Netherlands, surplus sludge of public STPs is not applied for
fertilization and soil improvement of agricultural soil. Therefore, exposure of soil and groundwater via STP
surplus sludge application is not part of the risk assessment.
For the intended uses, the active substance will be discharged to the sewer and therefore
reach the surface water via a sewage treatment plant (STP). In the Netherlands, surplus
sludge of public STPs is not applied for fertilization and soil improvement of (agricultural)
soil. Therefore, exposure of soil and groundwater via STP surplus sludge application is
not part of the risk assessment. As the active substance is a gas, chlorine dioxide is
potentially released to air for all applications.
6.4
Risk characterisation for the environment
6.4.1 Water and sediment organisms and micro-organisms in the STP
Once released to (waste) water, chlorine dioxide dissociates rapidly into chlorite, chlorate
and chloride ions. Chlorine dioxide, chlorite and chlorate are strong oxidizers which will
directly react with the excess organic matter present in the sewer pipeline system that
discharges to the STP. Concentrations in the STP’s influent will be therefore low. Chlorine
dioxide will be further deactivated in the STP, resulting in negligible concentrations in the
STP’s effluent.
The remaining part of chlorine dioxide that enters the aquatic environment appears as
chlorite, chlorate and chloride ions, and reacts rapidly with (dissolved) organic material
and inorganic compounds such as manganese, iron, and sulphide. As partition
coefficients between water and sediment are low, accumulation of chlorine dioxide in
sediments will not be significant.
Chloride ions occur naturally in the environment and the intended uses will not
significantly increase natural background concentrations and thus the risk is considered
negligible.
In view of this, a low risk for aquatic organisms, sediment organisms and microorganisms in the STP is expected. The proposed intended use, when applied in
compliance with the directions for use (WG/GA), therefore, meet the standards for aquatic
organisms, sediment organisms and micro-organisms in the STP.
6.4.2 Monitoring data (surface water)
The Pesticide Atlas on internet (www.pesticidesatlas.nl) is checked to evaluate measured
concentrations of pesticides in Dutch surface water.
There are however, no data available in the Pesticide Atlas regarding the presence of the
substance chlorine dioxide, chlorite and chlorate in surface water.
pag. 27
6.4.3 Surface water intended for the abstraction of drinking water
From the general scientific knowledge collected by the Ctgb about the product and the
active substance, 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. The existing
active substance chlorine dioxide is not included in the list of substances of concern due
to its presence in surface water at drinking water abstraction points as established by
VEWIN/Ctgb.
chlorine dioxide nor its metabolites are on the recommended list of biocides to be
monitored for drinking water from surface water (RIVM, 2010). The standards for surface
water destined for the production of drinking water are met.
6.4.4 Atmosphere
Criteria for the examination of environmental risks to air are not specified by a numerical
standard. The present assessment of potential impacts on air quality, is aimed to
minimize the risk for stratospheric ozone depletion.
A half life for the active substance was not calculated as inorganic compounds are not
included in AOPwin. A half live of 2.4 days was reported for chlorine dioxide. This half life
is slightly above the trigger of < 2 days that is used as cut off value to identify chemicals
that could be of potential concern for long range transport through the atmosphere.
Chlorine dioxide is however unstable in air and rapidly decomposes into chlorine and
oxygen when exposed to sunlight.
The active substance is not listed as controlled substance according to European
Council’s Regulation no 1005/2009 and therefore not classified as ozone depleting
compound. The proposed applications meet the standards for air.
6.4.5 Terrestrial compartment
Soil organisms and non target arthropods (including bees)
There is no exposure to the soil for the proposed uses. The active substance will
disappear through reactions with the excessive amount of organic material in the sewage
system. Exposure of soil organisms and non target arthropods can therefore be excluded.
The standards for soil organisms, non target arthropods including bees are met.
Groundwater
As the proposed uses of the product will not result in exposure of the groundwater
compartment due to the rapid degradation of chlorine dioxide, the risk for the groundwater
is therefore considered acceptable.
Persistence in soil
Chlorine dioxide is chemically instable and a highly reactive oxidant. The proposed uses
will not result in exposure of soil. Therefore standards for persistence in soil are met.
6.4.6 Non compartment specific effects relevant to the food chain
Primary and secondary poisoning of birds and mammals
For the proposed uses of the active substance, direct or indirect exposure of birds and
mammals to the active substance or contaminated aquatic and terrestrial organisms is
not expected.
As the active substance does not bioaccumulate and the concentrations in surface water
are negligible, the risk for the primary and secondary poisoning is considered low. The
proposed uses meet the standards for primary and secondary poisoning of birds and
mammals.
Bioconcentration
The risk for bioconcentration in aquatic organisms is considered low as the log Kow is < 3.
Bioconcentration and biomagnification is not expected (conform the biomagnification
pag. 28
trigger value proposed for Kow in the TGD). Hence, the standards for bioaccumulation
are met.
6.5 Measures to protect the environment (risk mitigation measures)
The applicant did not include any risk mitigation measures for the environment in the draft
WG/GA. Risk mitigation measures are not required, considering that risks to the
environment are acceptable for the intended uses.
6.6 Overall conclusion for the aspect environment
It can be concluded that the product TwinOxide 0.3% oplossing when used in accordance
with the proposed label (WG/GA), complies with the environmental standards and will not
cause unacceptable effects on the environment. No risk mitigations are required.
6.7 Data requirements
There are no additional data required.
7 Conclusion
TwinOxide 0.3% oplossing is a disinfectant based on chlorine dioxide (0.3% w/w) in situ
generated in a tank by mixing two precursors, containing sodium chlorite (TwinOxide
Component A) and sodium hydrogensulphate (TwinOxide Component B).
Some of the intended uses of TwinOxide 0.3% oplossing have been excluded from the
WGGA because the PT can not been assessed under the differentiated enforcement
programme (BZT), like PT5; no adequate studies were submitted, and other uses were
removed from the WGGA on request of the applicant during the assessment procedure.
TwinOxide 0.3% oplossing, when used in accordance with the proposed label (WG/GA),
is effective in controlling bacteria (excluding mycobacteria and bacterial spores) and
yeasts
- on surfaces, materials and equipment in food- and feed industry;
- on membrane filters for process water and cooling water;
- in tanks and lines for the preparation, storage transfer and dispensing of water, with the
exception of drinking water systems for humans.
No adverse health effects are expected for the protected professional user (gloves,
respiratory protective equipment) after exposure to the precursors sodium
hydrogensulphate and sodium chlorite as a result of the preparation of the working
solution of TwinOxide 0.3% oplossing, if the maximal amount of the transferred sodium
chlorite does not exceed 14.49 kg per day.
Based on the proposed packaging size provided by the applicant, the packaging size may
not exceed 10 kg. The following restriction should be included in the WG/GA: “Due to
health risks do not use more than 14.5 kg TwinOxide 0.5% oplossing precursor A (sodium
chlorite) per day”.
No adverse effects are expected from the exposure to chlorine dioxide for a protected
professional user (respiratory protective equipment) as a result of the application of
TwinOxide 0.3% oplossing, when used according to the WG/GA.
Furthermore, when used according to the WG/GA, no adverse health effects are
expected for the general public by indirect exposure to chlorine dioxide as a result of the
application of TwinOxide 0.3% oplossing.
TwinOxide 0,3% oplossing complies with the environmental standards and will not cause
unacceptable effects on the environment.
As result of the assessment TwinOxide 0,3% oplossing can be authorised as a
disinfectant for professional use under the conditions as mentioned in the WG/GA.
The authorised uses as mentioned on the WGGA fall within product types PT4 and PT11.
pag. 29
8 Classification and labelling
Proposed for classification and labelling for the formulation of TwinOxide 0,3%
oplossing Component A
Based on Reg. (EC) 1272/2008:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
Pictogram:
GHS03
Signal word: Danger
GHS05
GHS06
GHS09
H-statements:
P-statements:
H272
May intensify fire; oxidizer
H302
Harmful if swallowed
H311
Toxic in contact with skin
H314
Causes severe skin burns and eye damage
H331
Toxic if inhaled
H400
Very toxic to aquatic life
Keep away from heat/sparks/open
flames/hot surfaces. – No smoking.
Take any precaution to avoid mixing with
combustibles/?
Wear protective gloves/protective
clothing/eye protection/ face
protection.
P210
P221
P280
P284
Supplemental Hazard
information:
Wear respiratory protection.
P303+P361+ IF ON SKIN (or hair): Remove/Take off
immediately all contaminated clothing.
P353+P310
Rinse skin with water/shower. Immediately call a POISON
CENTER or doctor/physician.
P305+P351 IF IN EYES: Rinse cautiously with water for several
+P338+P31 minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. Immediately call a POISON CENTER or
0.
doctor/physician.
Contact with acids liberates
EUH032
very toxic gas
Child-resistant fastening obligatory?
Not applicable
Tactile warning of danger obligatory?
Not applicable
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
Remarks:
H302, H331 and H311 are assigned based on the calculation rules according to Regulation
1272/2008/EC.
Only highly recommended statements are assigned by the Ctgb. P260 is not assigned, as P284
is assigned. P301+P330+P331+P310 is not assigned as this would lead to > 6 P-statements.
Proposed for classification and labelling for the formulation of TwinOxide 0,3%
oplossing Component B
Based on Reg. (EC) 1272/2008:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
pag. 30
Pictogram:
GHS05
Signal word: Danger
H-statements:
H318
Causes serious eye damage
P-statements:
Wear protective gloves/protective
clothing/eye protection/face protection.
IF
IN EYES: Rinse cautiously with water
P305+P351+
for
several minutes. Remove contact
P338 +P310
lenses, if present and easy to do.
Continue rinsing. Immediately call a POISON Center or
doctor/physician.
Supplemental Hazard
information:
-
P280
-
Child-resistant fastening obligatory?
Not applicable
Tactile warning of danger obligatory?
Not applicable
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
Remarks:
•
-
9 References
Atlas with pesticides in surface water. Database with monitoring data from pesticides in surface
water obtained from regional waterboards. http://www.pesticidesatlas.nl
Bakker, J. Biociden in oppervlaktewater voor drinkwaterproductie, National Institute of Public Health and the
Environment, RIVM report 601712007, 2010, Bilthoven, The Netherlands.
Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on
substances that deplete the ozone layer.
Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on Risk
Assessment for new notified substances; Commission Regulation (EC) No 1488/94 on Risk Assessment for
existing substances; Directive 98/8/EC of the European Parliament and of the Council concerning the
placing of biocidal products on the market. Part II. European Commission Joint Research Centre, EUR
20418 EN/2, Ispra, Italy, 2003.
VEWIN list with potential substances of concern in surface water destined for drinking water
production, VEWIN, 2013, http://www.vewin.nl/probleemstoffen
pag. 31