Toelatingsnummer 12409 N

Vydate 10G  

 

12409 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

Dit besluit is een rectificatie van het besluit van 5 maart 2010. Het besluit van

5 maart 2010 komt te vervallen. Het volgende is gerectificeerd: Er is een aflever- en opgebruiktermijn toegevoegd.

 

1 HERREGISTRATIE TOELATING

 

Gelet op de aanvraag d.d. 9 september 2008 (20080779 THG) van

 

DUPONT DE NEMOURS (NEDERLAND) B.V. CPP ST. 18M

Baanhoekweg 22

3313 LA  DORDRECHT

 

 

tot herregistratie van de toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het gewasbeschermingsmiddel, op basis van de werkzame stof oxamyl

 

Vydate 10G

 

gelet op artikel 39, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Herregistratie toelating

1.      De toelating van het gewasbeschermingsmiddel Vydate 10G, welke expireert op
30 juli 2010 wordt voor de in bijlage I genoemde toepassingen verlengd onder nummer 12409. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.      De toelating geldt tot 1 april 2020.

 

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

De toelating geldt uitsluitend voor van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

1.4 Classificatie en etikettering

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: granulaat of korrel

 

werkzame stof:

gehalte:

oxamyl

10 %

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

gevaarsymbool:

aanduiding:

T

Vergiftig

N

Milieugevaarlijk

 

Waarschuwingszinnen: 

 

R25                 -Vergiftig bij opname door de mond.

R51/53            -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

 

S35                 -Deze stof en de verpakking op veilige wijze afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

S37d-NL         -Draag geschikte handschoenen tijdens het mengen en laden.

S45                 -Bij een ongeval of indien men zich onwel voelt onmiddellijk een arts raadplegen (indien mogelijk hem dit etiket tonen).

S61                 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

Specifieke vermeldingen:

 

DPD01            -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

1)    Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten 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
.

 

c.       bij het toelatingsnummer een cirkel met daarin de aanduiding W.6.

 

 

1.5 Aflever- en opgebruiktermijn

Op grond van artikel 41, vijfde lid, Wet gewasbeschermingsmiddelen en biociden en het Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007, mag het middel Vydate  10G voor niet meer toegelaten toepassingen:

1.      voor de periode van 5 maart 2010  tot 5 september 2011 nog worden gebruikt en in voorraad of voorhanden worden gehouden;

2.      voor de periode van 5 maart 2010  tot 5 maart 2011 nog op de markt worden gebracht.

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

De toelating van het gewasbeschermingsmiddel Vydate 10G is laatstelijk verlengd tot
30 juli 2010. Het betreft een aanvraag tot herregistratie van de toelating van het middel
Vydate 10G (
12409 N), een middel op basis van de werkzame stof oxamyl. De herregistratie wordt aangevraagd voor de toelating als grondbehandelingsmiddel (nematicide/insecticide):

  1. in de teelt van aardappelen, mits toegepast kort voor of tijdens het poten op zodanige wijze dat het middel in een arbeidsgang wordt gestrooid en ingewerkt;
  2. in de teelt van bieten, mits toegepast als rijenbehandeling in een arbeidsgang met het zaaien;
  3. op vermeerderingsvelden van aardbeien met dien verstande dat het middel direct na de toepassing moet worden ingewerkt;
  4. in de teelt van spruitkool, met dien verstande dat het middel in één arbeidsgang wordt toegepast en ingewerkt;
  5. in de teelt van bospeen, waspeen en winterwortel, mits toegepast als rijenbehandeling in een arbeidsgang met het zaaien óf mits toegepast kort voor of tijdens het zaaien op zodanige wijze dat het middel in een arbeidsgang wordt gestrooid en ingewerkt;
  6. in de teelt van lelies, met dien verstande dat het middel in één arbeidsgang wordt toegepast  en ingewerkt;
  7. in de grondgebonden teelten van bloemisterijgewassen, mits toegepast voor of tijdens het uitplanten en met dien verstande dat het middel direct na toepassing moet worden ingewerkt;
  8. bij potplanten, mits toegepast voor het oppotten;
  9. in de teelt van boomkwekerijgewassen, met dien verstande dat het middel direct na toepassing moet worden ingewerkt;
  10. in de bloemenzaadteelt met dien verstande dat het middel direct na toepassing moet worden ingewerkt.

 

 

2.2 Informatie met betrekking tot de stof

De werkzame stof oxamyl is bij Richtlijn 2006/16/EG van de Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 91/414/EEG.

 

2.3 Karakterisering van het middel

Vydate 10G is gebaseerd op oxamyl en is geformuleerd als een granulaat. Het product heeft een nematicide en insecticide werking en wordt in Europa reeds meer dan 30 jaar gebruikt in meerdere gewassen. Vydate 10G wordt toegepast door middel van een grondbehandeling, volvelds of in rijen, tijdens, vóór of na het planten en wordt gebruikt ter bestrijding van meerdere nematoden soorten, waaronder cyste-vormende en vrijlevende aaltjes. Naast nematoden worden ook verschillende (bodem) insecten bestreden. Oxamyl is zeer selectief voor planten en heeft minimaal 30 dagen effect, afhankelijk van de gewassen.

De werking van oxamyl tegen nematoden berust op remming van het enzym acetylcholinesterase. De stof heeft na contact of opname direct een effect op het zenuwstelsel van het plaagorganisme. Oxamyl behoort tot de groep van de carbamaten. Carbamaten en organofosfaten hebben hetzelfde werkingsmechanisme. Beide remmen de werking van het enzym acetylcholinesterase, waardoor de zenuwen continu elektrisch ontladen. Deze continuë signalen leiden tot vermoeide, niet-functionerende zenuwen, ongecoördineerde beweging en uiteindelijk de dood. Oxamyl remt ook de ontwikkeling van eieren of cysten van vele soorten nematoden.

De snelheid en het effect van de nematicide werking is afhankelijk van de dosis. De inwerking treding is normaliter snel - binnen 2 uur - en wordt sneller als hogere concentraties worden toegepast. De contactwerking van oxamyl wordt bereikt door de toepassing in de grond en verspreiding in de bodem en door systemische verplaatsing binnen de plant naar weefsels die door de nematoden worden aangetast. Omdat oxamyl niet vluchtig is, is het van belang om het middel in de grond te werken daar waar bescherming nodig is van de ontwikkeling van de wortel. Dit is belangrijk tijdens de kieming, de vroege ontwikkeling van het gewas en perioden van wortelgroei. Zodra endoparasitaire wortelaaltjes in de plant zijn binnengedrongen, zijn ze moeilijk of soms zelfs onmogelijk te bestrijden.

 

2.4 Voorgeschiedenis

De aanvraag is op 16 september 2008 ontvangen; op 8 juli 2008 zijn de verschuldigde aanvraagkosten ontvangen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de RGB aangeduide (delen van de) toepasselijke versie van de HTB ( in dit geval versie 1.0)

 

3.1  Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in 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 (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van het middel en de stof staat beschreven in Hoofdstuk 2, Physical and Chemical Properties, in Bijlage II bij dit besluit.

 

3.2  Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van de analysemethoden staat beschreven in Hoofdstuk 3, Methods of Analysis, in Bijlage II bij dit besluit.

 

3.3  Risico voor de mens

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar (artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en biociden).
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij dit besluit.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in Bijlage II bij dit besluit.

 

3.6  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
Vydate 10G op basis van de werkzame stof oxamyl voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).


 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden 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, 26 maart 2010

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





dr. D. K. J. Tommel

voorzitter

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 26 maart 2010 tot herregistratie van de toelating van het middel Vydate 10G, toelatingnummer 12409 N

 


 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als grondbehandelingsmiddel:

  1. in de teelt van aardappelen, mits toegepast kort voor of tijdens het poten op zodanige wijze dat het middel in een arbeidsgang wordt gestrooid en ingewerkt;
  2. in de teelt van bieten, mits toegepast als rijenbehandeling in een arbeidsgang met het zaaien;
  3. op vermeerderingsvelden van aardbeien met dien verstande dat het middel direct na de toepassing moet worden ingewerkt;
  4. in de teelt van spruitkool, met dien verstande dat het middel in één arbeidsgang wordt toegepast en ingewerkt;
  5. in de teelt van bospeen, waspeen en winterwortel, mits toegepast als rijenbehandeling in een arbeidsgang met het zaaien óf mits toegepast kort voor of tijdens het zaaien op zodanige wijze dat het middel in een arbeidsgang wordt gestrooid en ingewerkt;
  6. in de teelt van lelies, met dien verstande dat het middel in één arbeidsgang wordt toegepast  en ingewerkt;
  7. in de grondgebonden teelten van bloemisterijgewassen, mits toegepast voor of tijdens het uitplanten en met dien verstande dat het middel direct na toepassing moet worden ingewerkt;
  8. bij potplanten, mits toegepast voor het oppotten;
  9. in de teelt van boomkwekerijgewassen, met dien verstande dat het middel direct na toepassing moet worden ingewerkt;
  10. in de bloemenzaadteelt met dien verstande dat het middel direct na toepassing moet worden ingewerkt.

 

Om de vogels en zoogdieren te beschermen moet u gemorst product verwijderen.

 

Om de vogels en de zoogdieren te beschermen moet het product volledig in de bodem worden ondergewerkt; zorg ervoor dat het product ook aan het voorend is ondergewerkt.

 

  

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

Vydate 10G is een systemisch werkend middel in granulaatvorm dat insecten- en aaltjesdodende eigenschappen bezit. Het wordt in de grond gebracht en van daaruit door de plantwortels opgenomen en in de plant verspreid.

 

Toepassingen

Aardappelen, tegen aaltjes
Volveldsbehandeling
Ter voorkoming van schade door aaltjes dient het middel vlak voor of tijdens het pootklaar maken van de grond volvelds te worden gestrooid.

Het middel zo gelijkmatig mogelijk over het oppervlak verdelen met daarvoor geschikte strooiapparatuur, en direct inwerken tot een diepte van 10 à 15 cm. Het meest geschikt voor het inwerken is een frees, maar ook andere werktuigen waarmee een gelijkmatige menging wordt bereikt, zijn bruikbaar.
Dosering: 40 kg per ha

Toplaagbehandeling
Op percelen waar na de najaarsontsmetting met vloeibare middelen de grond niet kerend is bewerkt kan voorafgaande aan een eventuele grondbewerking in het voorjaar
Vydate 10G volvelds worden gestrooid en ingewerkt in de toplaag (5 cm) van de grond.

De toplaag wordt bij de najaarsontsmetting namelijk het slechtst ontsmet en verkrijgt zo een extra behandeling. Deze toepassing dient zo kort mogelijk voor het poten te geschieden.
Dosering: 20 kg per ha

 

Rijenbehandeling tijdens het poten

Bij tegen Globodera pallida (het witte aardappelcystenaaltje) partieel resistente rassen kan het middel tijdens het poten, met behulp van op de pootmachine opgebouwde apparatuur worden uitgestrooid in de aardappelrug op een strook met een breedte van 25-30 cm.
Hierdoor wordt de beginontwikkeling van het gewas bevorderd, waardoor later tijdens het groeiseizoen de resistente eigenschappen beter tot hun recht komen.

Schade, zowel opbrengst- als kwaliteitsverlies, door aaltjes van met name wortellesie- en wortelknobbelaaltjes, wordt grotendeels voorkomen door deze behandeling.
Dosering
: 10 kg per ha.

 

Bieten, tegen bietenkevertjes, springstaarten of aaltjes.
Ter voorkoming van schade door het bietenkevertje, springstaarten of aaltjes het middel tijdens het zaaien in de zaaivoor aanbrengen door middel van een aan de zaaimachine gekoppelde deugdelijke granulaatstrooier of opbouwset.

Met name schade veroorzaakt door aaltjes in de beginontwikkeling van het gewas wordt voorkomen.

Dosering:

  • bietencystenaaltjes: 25 kg per ha
  • wortelknobbelaaltjes: 15 kg per ha
  • vrijlevende aaltjes: 10 kg per ha
  • bietenkevertje en springstaarten: 7,5 kg per ha

 

Aardbeien (vermeerderingsvelden), tegen aaltjes.

Vlak voor het planten het middel gelijkmatig volvelds strooien en ongeveer 10 à 15 cm diep inwerken, bij voorkeur met een frees.

Dosering: 40 kg per ha.

 

Spruitkool, tegen aaltjes

Vydate 10G kan ingezet worden tegen bietencystenaaltjes.

Ter beperking van schade door bietencystenaaltjes het middel kort voor het uitplanten strooien en direct inwerken met een frees of een ander werktuig waarmee een gelijkmatige menging wordt bereikt.

Dosering: 40 kg per ha.


 

Bospeen, waspeen en winterwortel, tegen aaltjes

Vydate 10G kan als rijenbehandeling tijdens het zaaien of als volveldstoepassing kort voor of tijdens het zaaien worden ingezet tegen vrijlevende aaltjes, wortellesieaaltjes en wortelknobbelaaltjes.

Rijentoepassing 

Het middel tijdens het zaaien in de zaaivoor aanbrengen door middel van een aan de zaaimachine gekoppelde daartoe geëigende granulaatstrooier of apparaat.

Dosering: 10 kg per ha, gebaseerd op een rugafstand van minimaal 50 cm breed.

 

Volveldstoepassing

Het middel dient vlak voor of tijdens het plantklaar maken van de grond volvelds te worden gestrooid. Het middel zo gelijkmatig mogelijk over het oppervlak verdelen met daarvoor geschikte strooiapparatuur en direct inwerken tot een diepte van 10 à 15 cm.

Dosering: 40 kg per ha.

 

Lelies, tegen aaltjes

Vydate 10G kan voor of na het planten ingezet worden tegen wortellesieaaltjes

Voor planten:

Het middel dient vlak voor of tijdens het plantklaar maken van de grond volvelds te worden gestrooid. Het middel zo gelijkmatig mogelijk over het oppervlak verdelen met daarvoor geschikte strooiapparatuur en direct inwerken tot een diepte van 10 à 15 cm.

Na het planten:

Direct na het planten (in ieder geval voor opkomst van het gewas) een éénmalige rijenbehandeling boven de geplante bollen uitvoeren met daarvoor in aanmerking komende apparatuur waarmee het middel in de grond wordt gebracht en direct wordt toegedekt.

Dosering: 40 kg per ha

 

Grondgebonden teelten van bloemisterijgewassen, tegen aaltjes.

Het middel vóór het uitplanten gelijkmatig volvelds uitstrooien en direct daarna inwerken tot een diepte van 10 à 15 cm.
Dosering: 400 gram per are.

 

Potplanten, tegen aaltjes.

Ter voorkoming van schade door onder andere wortelknobbelaaltjes de potgrond direkt voor het oppotten behandelen.

Dosering: 40 gram per m3 grond.

 

Boomkwekerijgewassen, tegen aaltjes.

Ter voorkoming van schade door aaltjes wordt het middel kort voor het zaaien of planten gelijkmatig volvelds gestrooid en direct daarna ingewerkt. Met deze behandeling wordt meestal geen afname van de aaltjesbesmetting bereikt, maar wordt groeiremming door aaltjes voorkomen.

Dosering: 40 kg per ha.

 

Bloemenzaadteelt, tegen aaltjes.
Het middel vóór het zaaien gelijkmatig volvelds uitstrooien en daarna direct inwerken of tijdens het zaaien met aangepaste zaaiapparatuur een rijenbehandeling uitvoeren in de zaaivoor.

Dosering:        volvelds: 400 gram per are

rijenbehandeling: 0.5 gram per strekkende meter bij een rijafstand van 50 cm.

 

 


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 26 maart 2010 tot herregistratie van de toelating van het middel Vydate 10G, toelatingnummer 12409 N

 

 

RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         7

 

4.   Mammalian toxicology                                      10

 

5.   Residues                                                            18

 

6.   Environmental fate and behaviour                22

 

7.   Ecotoxicology                                                    46

 

8.   Efficacy                                                               69

 

9.   Conclusion                                                        72

 

10. Classification and labelling                             72

 


1.         Identity of the plant protection product

 

1.1       Applicant

Du Pont de Nemours (Nederland) B.V.

Baanhoekweg 22

3313 LA Dordrecht

 

1.2       Identity of the active substance

Common name

Oxamyl

Name in Dutch

Oxamyl

Chemical name

(EZ)-N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio)acetamide [IUPAC]

CAS no

23135-22-0

EC no

245-445-3

 

The active substance was included on August 1st, 2006 in Annex I of Directive 91/414/EEC.

 

1.3       Identity of the plant protection product

Name

Vydate 10G

Formulation type

GR

Content active substance

10%m/m pure oxamyl

 

The formulation is identical to that assessed for the inclusion of the active substance in Annex I of Directive 91/414/EEC.

 

1.4       Function

Nematicide/insecticide.

 

1.5       Uses applied for

See GAP (Appendix 1).

 

1.6       Background to the application

It concerns a re-registration.

 

1.7       Packaging details

 

1.7.1    Packaging description

Material:

Container: polypropylene

Bag: Paper/LDPE/Alu/Paper

Capacity:

15 or 20kg (pp container)

5 or 10kg (bag)

Type of closure and size of opening:

Container: closed transfer system

Bag: adhesive tapped and/or glued.

Other information

ADR/UN compliant.

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS (no particular recommendations)

 


 

2.                  Physical and chemical properties

 

2.1              Active substance: oxamyl

 

Identity

Data on the identity is taken from the List of Endpoints included in the Review Report, SANCO/10212/05 final of March 2006. Amendments are depicted in italic print.

 

Active substance (ISO Common Name)

Oxamyl

Chemical name (IUPAC)

N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide

Chemical name (CA)

Methyl 2-(dimethylamino)-N-methylamino)carbonyl]oxy]-2-oxoethanimidothioate

CIPAC No

342

CAS No

23135-22-0

EEC No (EINECS or ELINCS)

245-445-3

FAO Specification (including year of                                publication)

Data not available

Minimum purity of the active substance as manufactured (g/kg)

970 g/kg

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

None identified.

Molecular formula

 C7H13O3N3S

Molecular mass

 219.3 g/mol

Structural formula

 

 

In EFSA Scientific Report the following outstanding data requirements are stated:

1.      identity of impurities (submission date proposed by the notifier: unknown; data requirement was identified during the EPCO 6 meeting; a statement regarding the specificity has been submitted to the RMS, which addresses the annex point only partially; refer to point 1)

 

In 2005, a new production site was evaluated and accepted for which the abovementioned data requirement was satisfied.

 

Physical-chemical properties

Data on the identity and the physical and chemical properties is taken from the List of Endpoints included in the EFSA Scientific Report of January 2005. Amendments are depicted in italic print.

 

Melting point (state purity)

 98.5°C- 100°C (99.9%)

Boiling point (state purity)

Decomposition occurs before a boiling point is reached

Temperature of decomposition

160 oC (DSC analysis)

Appearance (state purity)

White crystalline solid (purity not stated)

Pale yellow/green liquid (43.3% technical concentrate)

Relative density (state purity)

1.313 g/cm3 (density) at 20°C (100%)

Surface tension

73.1 mN/m at 20°C.

Vapour pressure (in Pa, state temperature)

5.12 x 10-5 Pa at 25°C.

Henry’s law constant (in Pa·m3·mol-1)

4.89 x 10-8 x Pa x m3 x mol-1 at 25°C.

Solubility in water (in g/l or mg/l, state                                   temperature)

148.1g/l at 20°C at pH 5.0 (for stability reasons)

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

Solvent

n-heptane

10.5 mg/l

dichloromethane

> 250

Methanol.

> 250

acetone

> 250

ethyl acetate

3.14

 Xylene

41.3 [all in g/L]

Partition co-efficient (log Pow) (state pH and temperature)

The Log Po/w at 25°C and Ph 5 = - 0.44.

Hydrolytic stability (DT50) (state pH and temperature)

The half life of Oxamyl was determined to be

> 31 days at pH 5 and 25° C.

     8 days at pH 7 and 25° C.

     3 hours at pH 9 and 25° C.

Dissociation constant

pKa estimated to be = -2.11.

UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength)

At 25° C the e at 290nm was determined to be

At pH 2 = 61.6 

At pH 7 = 80.1

At pH>10 = 1154

Photostability (DT50) (aqueous, sunlight,  state pH)

t1/2 was determined to be = 7 days at pH 5 and at 25°C.

Quantum yield of direct photo-

transformation in water at λ > 290 nm

0.0187

Photochemical oxidative degradation in air

Half-life is 5.7 hours (Atkinson calculation, based on a 12 hour day; 1.5x106 OH radicals).

Flammability

Flashpoint: 57.4 oC (42% TK)

Auto-flammability

303 oC (43.3% TK)

Oxidising properties

Not oxidising (statement)

Explosive properties

Oxamyl does not classify as explosive (43.3% TK).

 

In EFSA Scientific Report the following outstanding data requirements are stated:

1.      boiling point or temperature of decomposition ( the study has been submitted to the RMS but has not been evaluated; refer to point 1)

2.      auto-flammability of the dry technical material (the study has been submitted to the RMS but has not been evaluated; refer to point 1)

 

The auto-flammability of the dry technical material is not considered required, because oxamyl is processed as a 42% technical concentrate. A study is available on the technical concentrate. Results are added to the List of Endpoints.

 

Acceptable data regarding the boiling point and temperature of decomposition of the purified active ingredient were provided by the applicant.

 

2.2              Plant protection product: Vydate 10G

Vydate 10G is a granule for direct application and is not dispersed in water prior to application as soil treatment product.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

Visual

Granule (solid)

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

Visual

Blue-green

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

Olfactory

Slight solvent

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP

EC A14

Not explosive

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

Not oxidising based on the structure of the individual componetns of Vydate 10G.

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

GLP

EC A10

Not highly flammable

Acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

EC A16

400 oC

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

 

Not applicable

 

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

Not applicable

 

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC MT75

1%: 6.8

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

 

Not applicable

 

B.2.2.12 (IIIA 2.5)

Viscosity

 

Not applicable

 

B.2.2.13 (IIIA 2.6)

Relative density

 

Not applicable

 

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

GLP

CIPAC MT159

Pour: 0.72 g/ml

Tapped: 0.81 g/mL

Acceptable

B.2.2.15 (IIIA 2.7)

Storage stability

GLP

CIPAC MT46

Stable for 2 weeks at 54 oC in glass.

 

Properties evaluated before and after storage: a.s. content (4.9% decrease), pH, attrition resistance, dust content, dry sieve analysis.

Acceptable

B.2.2.16 (IIIA 2.7)

Shelf life

GLP

GIFAP monograph no. 17

Stable for 2 years in foil/PE/paper 10kg packaging at 20 oC.

 

Properties determined before and after storage: appearance, packaging stability, pH (1%), dust content, attrition resistance, dry sieve analysis.

 

According to the summary, a.s. content dropped by 7.7%. Main breakdown product is formed by hydrolysis (metabolite A2213). Only one additional peak was observed in the sample. The product complies with the specification after storage.

 

 

Acceptable.

 

No reference is made in the report to the analytical method used for the determination of the a.i. in the formulation. The applicant has provided a statement that method D1410.220.01.ES was used.

 

It is reasonable to assume the packaging tested is comparable to the packaging proposed for the Dutch market, although the foil is not specified.

B.2.2.17

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.18 (IIIA 2.8)

Persistent foaming

 

Not applicable

 

B.2.2.19

(IIIA 2.8)

Suspensibility

 

Not applicable

 

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

 

Not applicable

 

B.2.2.21

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

 

Not applicable

 

B.2.2.24

(IIIA 2.8)

Particle size distribution

GLP

CIPAC MT58.2

850 – 250 µm             97.3%

250 – 150 µm             0.7%

< 150 µm (+loss)       2.1%

Total < 250µm            2.7%

Acceptable

B.2.2.25

(IIIA 2.8)

Content of dust/fines

GLP

CIPAC MT171

3.2 mg (0.01%)

Acceptable

B.2.2.26

(IIIA 2.8)

Attrition and friability

GLP

CIPAC MT178

Attrition resistance: 100%

Acceptable

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable

 

B.2.2.29

(IIIA 2.8)

Flowability

GLP

CIPAC MT172

Sample drops through the sieve spontaneously

Acceptable

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

 

Not applicable

 

B.2.2.31

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.32

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

 

Not applicable

 

2.9.2

Chemical compatibility with other products

 

Not applicable

 

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions.

 

2.3       Data requirements

None.

 

 

3.                  Methods of analysis

 

Description and data on the analytical methods is taken from the List of Endpoints included in the EFSA Scientific Report of January 2005. Amendments are depicted in italics.

 

3.1.            Analytical methods in technical material and plant protection product

Technical as (principle of method)

Technical Oxamyl, with acetanilide as internal standard, is diluted in aqueous phosphoric acid (pH= 2.7). Sample is analysed by HPLC with uv detection at 240nm.

Impurities in technical as (principle of method)

 Impurities coded 13703, A2213, D2256, E2321, D2293, U1746, L2020 and 31144 are treated in the same manner as technical Oxamyl. The analysis is carried out using HPLC with uv detection at 205nm. Quantitation is by comparison with known standards.

Impurities methanol, cylclohexanone and triethyl amine are analysed by GC with an FID detector following the dissolution of the sample in NN-dimethylformamide.

Preparation (principle of method)

Method D1410.220.02.ES, using HPLC, for the determination of oxamyl in Vydate 10G

 

Conclusion

The analytical methods regarding the technical active ingredient have been assessed in the DAR and are considered to be acceptable. For the formulation, the applicant provided a fully validated method.

 

3.2       Residue analytical methods

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

Food samples are extracted with acetone, cleaned up by SPE (aminopropyl-bonded silica cartridges). The sample is then analysed using RP HPLC coupled to a post column hydrolyser which releases the methyl amine and which is in turn derivatised with o-phthaldehyde. The residue is quantified using a fluorescence detector. 

LOQ was validated for selected crops at 0.01 to 0.1 mg/kg. Recovery levels were higher at the 0.01mg/kg as opposed to the 0.05 and 0.1mg/kg spiking levels indicating that the analysis of Oxamyl using this analytical method may be difficult.

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

Not required; no residues are expected.

Soil (principle of method and LOQ)

Soil is extracted using formic acid:methanol: acetonitrile (5:39:156). The extract is centrifuged and the supernatant is evaporated to dryness prior to being dissolved in methanol/0.1% formic acid in 10mM ammonium acetate (10:90). Analysis was carried out using HPLC/MS/MS using the parent ion 236.9 m/z to daughter ion 71.8 m/z for Oxamyl and the parent ion 162.6 m/z to daughter ion 72.1 m/z for the oxime.

LOQ: The method was validated at 0.0055 mg/kg for both the Oxamyl and the Oxime.

Water (principle of method and LOQ)

Water was cleaned by eluting through an SPE SAX  cartridge in sequence with an SPE Oasis HLB cartridge. The sample was then analysed using HPLC/MS/MS using the parent ion 236.9 m/z to daughter ions 72 m/z and 90 m/z.

LOQ: The method was validated for 0.1mg/l in ground, drinking and surface waters.

Air (principle of method and LOQ)

Air was sucked through an Supelpak 20E XAD-2 porous polymer. This adsorbent was extracted using acetonitrile and the extract was analysed using HPLC/MS. The method was validated at a spiking level equivalent to 0.24 mg/m3.

Body fluids and tissues (principle of method and LOQ)

A method of analysis was presented for the determination of Oxamyl in urine and in blood serum. The sample was extracted with ethyl acetate, cleaned up using GPC and analysed using GC/MS or GC/FPD. The method was validated in the range 0.01 to 0.1 mg/kg.

 

Based on the proposed use of the plant protection product analytical methods for determination of residues in food/feed of plant origin are required for matrices with a high water content (e.g. strawberry, carrot).

 

Definition of the residue and MRL’s for oxamyl

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

Oxamyl

0.01 mg/kg or higher

Food/feed of animal origin

No definition of the residue is proposed. No relevant residues are expected to occur in food/feed of animal origin.

 

Required LOQ

Soil

Oxamyl

0.05 mg/kg (default)

Drinking water

Oxamyl

0.1 µg/L (drinking water guideline)

Surface water

Oxamyl

0.1 µg/L

Air

Oxamyl

0.3 µg/m3 (derived from the AOEL (0.001 mg/kg bw/day) according to SANCO/825/00)

Body fluids and tissues

Oxamyl

0.05 mg/l (blood)

0.1 mg/kg (tissues; meat or liver)

 

The residue analytical methods, included in the abovementioned List of Endpoints, are suitable for monitoring of the MRL’s.

 

The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable and suitable for monitoring of residues in the environment.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRL’s and for monitoring of residues in the environment.

 

3.3       Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

Proposal for the classification of oxamyl (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

-

-

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

Supported shelf life of the formulation: 2 years.

 

In the GAP/instructions for use the following has to be stated:

Not applicable.

 

 

4.                  Mammalian toxicology

 

Oxamyl is an existing active substance, included in Annex I of Directive 91/414/EEC. The final List of Endpoints presented below is taken from the EFSA Scientific Report on oxamyl (2005) 26; 1-78 (d.d. 14 January 2005), also taking into account the final review report on oxamyl (SANCO/10212/05 – final, d.d. 6 March 2006). Where relevant, some additional remarks/information are given in italics.

 

List of Endpoints




Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)

Rate and extent of absorption:

Rapid: 80% within 24 hours at 1 mg/kg bw

Distribution:

Widely distributed after 7 days: highest concentrations in whole blood (0.1 mg equivalents/g) and in heart, liver, kidney, lungs, spleen and the gastro-intestinal tract (0.04 to 0.09 mg equivalents/g)

Potential for accumulation:

No evidence of accumulation

Rate and extent of excretion:

Initially rapid: 80.5% within 24 hours (80% in urine): 93% after 7 days (91% in urine): no sex-related differences in the excretion pattern

Metabolism in animals

Extensive: 0-11% unchanged oxamyl excreted by 24 hours: oxamyl hydrolysis to IN-A2213 followed by glucuronide conjugation: other metabolites include IN-N0079, IN-L2953, IN-D2708, and IN-KP532: extensive incorporation of tissue radioactivity into amino acids

Toxicologically significant compounds
(animals, plants and environment)

Parent compound; the main metabolites, IN-A2213 and IN-D2708, are generated in vivo and are considered to be adequately tested in studies involving DPX-D1410 based on the available data.

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

3.1 mg/kg bw  (male rat); R28

2.5 mg/kg bw  (female rat)

Rat LD50 dermal

5027 mg/kg bw (male rabbit)

>2000 mg/kg bw (female rabbit)

Rat LC50 inhalation

0.056 mg/l air, nose only; R26

Skin irritation

Non-irritant (rabbit)

Eye irritation

Transient irritant (rabbit)

Skin sensitisation (test method used and result)

42% oxamyl technical in cyclohexanone and water: non-sensitizing (Buehler)

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Clinical signs of cholinergic perturbation

Lowest relevant oral NOAEL / NOEL

0.93 mg/kg bw/day (equal to 35 ppm; 1-year dog) based on clinical signs of cholinesterase inhibition at 1.46 mg/kg bw/day

Lowest relevant dermal NOAEL / NOEL

50 mg/kg bw/day (21-day rabbit, female) based on decreases in plasma and erythrocyte cholinesterase activity

Lowest relevant inhalation NOAEL / NOEL

No data, not required

 

Genotoxicity (Annex IIA, point 5.4)

Genotoxicity

No genotoxic potential1

1 In vitro: bacterial gene mutation test , mammalian cell gene mutation test (CHO/HGPRT), chromosome aberration test; in vivo: mouse micronucleus test. All tests negative.

 

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect

Decreased plasma cholinesterase activity (rat)

Lowest relevant NOAEL / NOEL

1.97 mg/kg bw/day (male rat) based on reduced plasma cholinesterase activity in rat

Carcinogenicity

No evidence of carcinogenic potential

 

Reproductive toxicity (Annex IIA, point 5.6)

Reproduction target / critical effect

Reduced pup survival and reduced litter size at the parentally toxic dose of 150 ppm (rat)

Lowest relevant reproductive NOAEL /

25 ppm (1.43 mg/kg bw/day)

Developmental target / critical effect

Decreased foetal body weight (rat)

Lowest relevant developmental NOAEL / NOEL

0.5 mg/kg bw/day for maternal and developmental toxicity

 

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)

Target / critical effects

No evidence for delayed neurotoxicity

Erythrocyte cholinesterase inhibition and clinical signs of cholinergic perturbation

Acute Neurotoxicity NOAEL

0.1 mg/kg bw/day (rat gavage) based on decreased body weight gain & food consumption; inhibition of plasma, erythrocyte and brain cholinesterase and clinical signs;  FOB and motor activity effects

Subchronic neurotoxicity NOAEL

1.69 mg/kg bw/day (equivalent to 30 ppm; rat 90-day dietary) based on decreased body weight & food consumption; inhibition of plasma, erythrocyte and brain cholinesterase and clinical signs;  FOB and motor activity effects

 

Other toxicological studies (Annex IIA, point 5.8)

Acute lethal dose INA-2213

11,000 mg/kg (male rat)

10-dose subacute INA-2213

No NOAEL; histopathological changes, clinical signs and body weight loss at 1000 mg/kg bw/day (male rat)

Oral LD50 INN-79

LD50  = 6675 mg/kg (6370-6990 mg/kg) (male rat)

Acute lethal dose INN-79

450 mg/kg (male rat)

10-dose subacute INN-79

No NOAEL; body weight, organ weight and liver effects at 90 mg/kg bw/day (male rat)

90-day oral INN-79

NOELparental = 50 ppm (4.0 (male) and 4.2 (female) mg/kg bw/day) based on reduced body weight and altered clinical chemistry parameters in both sexes

NOELfertility = 450 ppm (34.3 (male) and 35.7 (female) mg/kg bw/day)

NOELdevelopmental = 150 ppm (11.4 (male) and 12.6 (female) mg/kg bw/day) based on decreased body weight in F1 pups during lactation

Ames test INN-79

Not mutagenic

Oral LD50 IND-2708

LD50  = 3540 mg/kg (male rat)

Neurotoxicity DPX-D1410 NOAEL / NOEL

0.06 mg/kg (Acute human gavage)

 

 

Medical data (Annex IIA, point 5.9)

 

No incidents or accidents during the manufacturing process.  No data relating to exposure of the general public to oxamyl or epidemiological studies.

 

Summary (Annex IIA, point 5.10)

 

Value

Study

Safety factor

ADI

0.001 mg/kg bw/day

Acute neurotoxicity study (rat)

100

AOEL

0.001 mg/kg bw/day

Acute neurotoxicity study (rat)

100

ARfD (Acute Reference Dose)

0.001 mg/kg bw/day

Acute neurotoxicity study (rat)

100

 

Dermal absorption (Annex IIIA, point 7.3)

 

Dermal absorption of Oxamyl 10GR (Vydate ®) based on in vivo data and correction made with in vitro results is:

0.04%.

 

Local effects

Oxamyl produces mild local effects in an acute dermal toxicity study (mild erythema and oedema at 2000 mg/kg bw), without local effects in a dermal irritation study. However, these mild local effects are covered in the risk assessment/management by means of assignment of R- and S-phrases. Oxamyl does not produce local effects after repeated exposure.

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Vydate 10G needs to be classified as R25 ‘Toxic if swallowed’ based on the acute oral toxicity (LD50 rat 34 mg/kg bw).  

The formulation Vydate 10G does not need to be classified on the basis of its acute dermal toxicity (LD50 rat 5000 mg/kg bw).

The formulation Vydate 10G when tested in milled form has a LC50 of 0.68 mg/L. In principle this should lead to classification as R23 ‘Toxic by inhalation’. R23 is not asigned since the formulation is a granulate with a respirable fraction less than 1% and therefore does not present a risk at inhalation.

 

The formulation Vydate does not need to be classified for dermal irritation, eye irritation or skin sensitisation (Buehler test).

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

See List of Endpoints. The in vivo test was done with a liquid (SL) formulation and the in vitro tests with Vydate 10G. It can be assumed that dermal absorption from a liquid formulation is higher than for a granular formulation. The value of 0.04% dermal absorption is therefore considered worst case. Vydate 10G is directly applied in granular form. Therefore, a value for a spray dilution is not necessary.

 

4.3       Available toxicological data relating to non-active substances (IIIA 7.4)

The available toxicological data relating to non-active substances will be taken into account in the classification and labelling of Vydate 10G.

 

4.4       Exposure/risk assessments

An application has been submitted for the re-registration of the plant protection product Vydate 10G, used in soil treatment based on the active substance oxamyl.

 

Vydate 10G is a GR formulation and contains 100 g/kg oxamyl.

 

The intended uses are listed under 1.5 / Appendix 1 (GAP).

 

4.4.1    Operator exposure/risk

According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:

Tier 1: Risk assessment using the EU-AOEL with the use of PPE*

Tier 2: Risk assessment using the NL-AOEL with the use of PPE*

Tier 3: Refinement of the risk assessment using new dermal absorption data

Tier 4: Prescription of PPE

 

* In general Tier 1 and 2 is done without the use of PPE. However, no appropriate exposure model is available. Therefore exposure data from a field study are used. In this study operators used PPE (gloves during loading).

 

 Tier 1

 

Calculation of the EU-AOEL / Tolerable Limit Value (TLV)

For oxamyl no TLV has been set. The AOEL will be used for the risk assessment.

 

Since the formulation is applied once during the period January - December, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.

 

Since oxamyl is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.001 mg/kg bw/day (= 0.07 mg/day for a 70-kg operator), based on the acute neurotoxicity study in the rat is applied (see List of Endpoints).

 

Exposure/risk

Exposure to oxamyl during mixing and loading and application is usually estimated with models. For soil incorporation of granular formulations like Vydate 10G no EU-accepted models are available. In previous assessments of Vydate 10G, the operator exposure was based on a field study with Vydate 10G in potatoes in The Netherlands. This study is also used for operator risk assessment in the DAR for oxamyl. In the DAR an estimation for operator exposure based on the US-PHED (Pesticide Handlers Exposure Database) is also included. Only the results with the operator exposure study are given as these data are the most representative for the working practice in The Netherlands.

 

The study involved 10 operators. With this number of operators the highest exposure measured is used for risk assessment. This highest actual exposure with use of PPE (gloves during loading) was 2.35 mg/kg oxamyl for inhalation and 21.21 mg/kg for dermal exposure, based on  5 ha treated per working day. Exposure assessment models use a default value of 10 ha/day. For the current soil incorporation applications the highest dose is 40 kg Vydate 10G/ha, equivalent to 4 kg oxamyl/ha. The dose in potplants is 40 g Vydate 10G/m3 soil, equivalent to 4 g oxamyl/m3 soil. The estimated respiratory exposure is: 2.35 mg/kg x 10 (area of 10 ha/day instead of 5 ha/day) x 4 (kg active substance/ha) x 1000 (conversion mg to mg) = 0.092 mg/day. The estimated dermal exposure is: 21.21 mg/kg x 10 x 4 x 1000 x 0.04% (dermal absorption) = 0.00034.

In the Table below the estimated internal exposure is compared with the systemic AOEL.

 

Table T.1 Internal operator exposure to oxamyl and risk assessment for the use of Vydate 10G

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Soil incorporation in potato, sugar beet and fodder beet, strawberries (regeneration only), Brussels sprout, carrot, Lilium and floriculture for seed production (all uncovered) and on floriculture for flower production and tree nurseries (covered and uncovered).

Loading/application

Respiratory

0.092

0.07

1.31

Dermal

0.00034

0.07

< 0.01

Total

0.092

0.07

1.31c

a       External exposure was estimated a field study. Internal exposure was calculated with:

·       biological availability via the dermal route: 0.04% (see 4.2)

·       biological availability via the respiratory route: 100% (worst case)

b       The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

c       PPE: gloves during loading

 

The intended use in potplants is mixing of Vydate 10G with soil. This is a highly automated process. The total amount of Vydate 10G used on a working day is much lower than the amount used in field applications. Therefore, exposure of the applicator (loading only) will be much lower than in field applications.

 

Since the EU-AOEL is exceeded with the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

 

Tier 2

 

The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NL-AOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

 

The calculation of the systemic AOEL for semi-chronic is based on the NOAEL of 0.1 mg/kg bw/day in the acute neurotoxicity study with the rat. Calculations from other studies result in higher AOELs.

Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

 


Used factors are:

·       extrapolation rat ® human on basis of caloric demand                                     4

·       other interspecies differences:                                                                            3

·       intraspecies differences: (professional use)                                                       3

·       biological availability via oral route:                                                                      80%*

·       weight of professional operator/worker:                                                              70 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

 

AOELsystemic: 0.1 x 1 x 70 / (4 x 3 x 3) = 0.194 mg/day

 

Table T.2 Internal operator exposure to oxamyl and risk assessment for the use of Vydate 10G

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AOEL

(mg/day)

Risk-index b

Soil incorporation in potato, sugar beet and fodder beet, strawberries (regeneration only), Brussels sprout, carrot, Lilium and floriculture for seed production (all uncovered) and on floriculture for flower production and tree nurseries (covered and uncovered).

Loading/application

Respiratory

0.092

0.194

0.47

Dermal

0.00034

0.194

< 0.01

Total

0.092

0.194

0.47c

a       External exposure was estimated a field study. Internal exposure was calculated with:

·       biological availability via the dermal route: 0.04% (see 4.2)

·       biological availability via the respiratory route: 100% (worst case)

b       The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

c       PPE: gloves during loading                   

 

Since the NL-AOEL is not exceeded with the use of PPE, a higher tier assessment is not required.

 

4.4.2    Bystander exposure/risk

As Vydate 10G is a low dust granular formulation that is applied by broadcast or in furrow, no drift will occur. Therefore, bystander exposure will be negligible.

 

4.4.3    Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the operator using gloves at loading after dermal and respiratory exposure to oxamyl as a result of the application of Vydate 10G in potato, sugar beet and fodder beet, strawberries (regeneration only), Brussels sprout, carrot, Lilium, floriculture for seed production, floriculture for flower production and tree nurseries.

 


Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander after dermal and respiratory exposure to oxamyl as a result of the application of Vydate 10G in potato, sugar beet and fodder beet, strawberries (regeneration only), Brussels sprout, carrot, Lilium, floriculture for seed production, floriculture for flower production and tree nurseries.

 

Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure to oxamyl as a result of the application of Vydate 10G in potato, sugar beet and fodder beet, strawberries (regeneration only), Brussels sprout, carrot, Lilium, floriculture for seed production, floriculture for flower production and tree nurseries.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

None.

 

4.7       Combination toxicology

Vydate 10G contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8       Mammalian toxicology classification and labelling

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)

 

Symbol:

T+

Indication of danger: Very toxic

 

Risk phrases

R26/28

 

Very toxic by inhalation and if swallowed.

 

Proposal for the classification and labelling of the formulation concerning health

 

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labelling of the preparation is proposed:

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

T

Indication of danger:

Toxic

R phrases

25

Toxic if swallowed.

S phrases

35

This material and its container must be disposed of in a safe way.

 

37d-NL

Wear suitable gloves during mixing and loading.

 

45

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

Explanation:

Hazard symbol:

-

Risk phrases:

R23 is not assigned since the formulation contains <1% particle <50 µm.

Safety phrases:

S2, S13 and S20 are no longer invariably assigned to formulations intended for professional use only.

S37d-NL is assigned based on the operator risk assessment.

S23, 28 and SPo2 are not compulsory in combination with the assigned risk-phrases.

Other:

-

 

 

5.                  Residues

 

List of Endpoints

The List of Endpoints from the EFSA conclusion on oxamyl d.d. 14 January 2005 is used as the basis for the evaluation of Vydate 10G.

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

One acceptable metabolism study in potatoes was provided.

A number of metabolism studies from the 1970’s were presented for a range of crops. These studies were not considered to be acceptable as stand alone metabolism studies. If the GAP for oxamyl is extended then additional metabolism studies will be required.

Rotational crops

Two studies were submitted which between them studied the uptake of oxamyl into beetroot, cabbage, sorghum, barley and lettuce. These studies indicated that only in the case of soil aged for 30 days pre-planting were residues of oxamyl detected in the rotational crops. Both of these studies had applications greater than the recommended potato GAP but it is considered prudent that a label recommendation should be in place, which recommends that rotational crops should not be planted within 120 days of an oxamyl application to soil. This is required to minimize the possibility of residues being detected which will exceed the limit of detection for oxamyl which is the likely MRL.

Plant residue definition for monitoring

Parent oxamyl.

Plant residue definition for risk assessment

As for monitoring.

Conversion factor (monitoring to risk assessment)

None.

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Goat and hens

Animal residue definition for monitoring

None required

Animal residue definition for risk assessment

None required

Conversion factor (monitoring to risk assessment)

None

Metabolism in rat and ruminant similar (yes/no)

The metabolism is similar but faster

Fat soluble residue: (yes/no)

No

 

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

 

 

If crops are planted within 120 days of oxamyl application then residues of oxamyl may be detected in the roots and aerial parts of these crops

 

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

 

 

Residues of oxamyl are stable in a range of fruit and vegetables when they are stored in a freezer for up to 1 year

 

 

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock ³ 0.1 mg/kg diet/day:

Ruminant:

Poultry:

Pig:

An animal feeding study was not required on the basis of the diet of food animals. Metabolism studies in the goat and in hens indicate that the only identifiable residue possible in the goat and hen is thiocyanate. No residues of oxamyl or its oxime will be detected in these animals.

Muscle

 

 

 

Liver

 

 

 

Kidney

 

 

 

Fat

 

 

 

Milk

 

 

 

Eggs

 

 

 

 


Comments on/additions to List of Endpoints

 

5.1       Summary of residue data

 

5.1.1    Metabolism in plants

The behaviour of oxamyl was investigated in the crop group root and tuber vegetables (potato) for Annex I listing.

Furthermore, metabolism was investigated via foliage, fruit or soil application in potato, peanut, tobacco, tomato, orange and apple as was summarised by the JMPR (2002). Overall, oxamyl is rapidly metabolised into metabolites not containing an intact carbamate structure.

The studies available cover the intended uses.

 

5.1.2    Metabolism in livestock

Residues at the time of harvest are < LOQ (0.01* mg/kg) in potato, beet, carrot (animal feed). Metabolism in livestock needs not to be investigated for the current re-registration request, since the theoretical dietary intake is less than 0.1 mg/kg dry feed.

 

5.1.3    Residue definition (plant and animal)

plants

The metabolites of oxamyl found in plants do not contain an intact carbamate structure. The only toxicological relevant residue in the crops investigated is oxamyl. The residue definition for plants is oxamyl (monitoring as well as risk assessment).

 

animals

No residue definition required.

 

5.1.4    Stability of residues

Residues have been found to be stable for at least 1 year at –18°C in watery matrix, thus covering potato, beet, carrot and Brussels sprouts.

 

5.1.5    Residue data

An Evaluation Report for the re-evaluation of harmonised EU-MRLs in the framework of art. 12.2 of Regulation (EC) 396/2005 was drafted by RMS Ireland. This report is available to Ctgb on EFSA extranet.

 

Potato

(cGAP-NL: 1x 2-4 kg as/ha, pre-planting)

Eight supervised residue trials are available in the Evaluation report for Oxamyl (by RMS Ireland, May 2009). The trials are performed according to cGAP-NL. No residues above the LOQ are found at harvest.

 

Sugar beet and fodder beet

(cGAP-NL: 1x 0.75-2.5 kg as/ha, pre-planting)

Nineteen supervised residue trials on sugar beet are available in the Evaluation report for Oxamyl (by RMS Ireland, May 2009). The trials are performed according to cGAP-NL. No residues above the LOQ are found at harvest. Trials with sugar beet can be extrapolated to fodder beet.

 

Brussels sprouts

(cGAP-NL: 1x 4 kg as/ha, pre-planting)

Three supervised residue trials on Brussels sprouts are available in the Evaluation report for Oxamyl (by RMS Ireland, May 2009). The trials are performed according to cGAP-NL. No residues above the LOQ are found at harvest.

 


Carrot

(cGAP-NL: 1x 4 kg as/ha, pre-planting)

Four supervised residue trials on carrots are available in the Evaluation report for Oxamyl (by RMS Ireland, May 2009). The trials are performed according to cGAP-NL. No residues above the LOQ are found at harvest.

 

Strawberries

(cGap-NL: 1x 4 kg as/ha, pre planting)

No supervised residue trials are available for strawberries. For strawberry, application is requested only for regeneration plants, up to August. Therefore, the period between application and fruit production is > 6 months. From metabolism data and the trials in potato, beet, Brussels sprouts and carrot as well as the short half live time of oxamyl in soil, it is predicted that no residues will be present in strawberry fruits. No further residue data are required.

 

5.1.7    Residues from livestock feeding studies

Residues at the time of harvest are < LOQ (0.01* mg/kg) in potato, beets, carrot, brussels sprouts and strawberry. It is not necessary to investigate the metabolism in livestock for the current authorisation request.

 

5.1.8    Processing factors

A high temperature hydrolysis study is available in the Evaluation report for Oxamyl (by RMS Ireland, May 2009). This study demonstrated that oxamyl was stable under pasteurisation conditions, degraded (57.8% remaining) under baking/boiling conditions, and completely degraded under sterilisation conditions.  The only degradation product was IN‑A2213.

 

5.1.9    Calculation of the ADI and the ARfD

The ADI is set at 0.001 mg/kg bw/day based on the NOAEL of 0.1 mg/kg bw/day in the acute neurotoxicity study in the rat, with a safety factor of 100. (See List of Endpoints for human toxicology)

 

The ARfD is set at 0.001 mg/kg bw/day based on the NOAEL of 0.1 mg/kg bw/day in the acute neurotoxicity study in the rat, with a safety factor of 100.

 

5.2       Maximum Residue Levels

Maximum residue levels have been set in Annex II and IIIB of Regulation (EC) 396/2005. The MRLs for the intended uses are all set at 0.01* mg/kg. Notification of revised MRLs is not necessary.

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the EU-MRLs available in Annex II and IIIB of Regulation (EC) 396/2005. The maximum TMDI is 47.3 % of the ADI for the UK Toddlers. The TMDI is 14.7 % and 34.8% of the ADI for the Dutch general population and Dutch children ages 1-6, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo rev. 2.0 and the harmonised and temporary MRLs available in Annex II and IIIB of Regulation (EC) 396/2005 for the intended uses. The highest percentage of the ESTI is 153.8 % of the ARfD for potatoes for the UK infant. ESTI values for the other commodities in all other consumer diets are all lower than 100% of the ARfD.

A refinement was made for potatoes using the HR value of 0.007 mg/kg from the supervised residue trials (HR level is below LOQ of 0.01 mg/kg) available in the Evaluation report from Ireland (May 2009) and a processing factor of 0.6 for baking/boiling conditions (See 5.1.8). The ESTI shows that 65% of the ARfD is used for potatoes for the UK infant.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to oxamyl is currently expected when Vydate 10G is used according to the intended use.

The product complies with the Uniform Principles.

 

5.4       Data requirements

None.

 

 

6.                  Environmental fate and behaviour

 

The Plant Protection Products and Biocides Regulations (RGB) published in the Government Gazette (Staatscourant) 188 of 28 September 2007 came into effect on 17 Oktober 2007, while repealing the Uniform Principles Decree on Plant Protection Products (BUBG) and the Regulation elaborating the uniform principles for plant protection products (RUUBG).

 

Risk assessment is done in accordance with Chapter 2 of the RGB for products based on
- active substances which have already been included in Annex I of directive 91/414/EEC

- “new” active substances;

or

Risk assessment is done in accordance with Chapter 10 of the RGB for products based on
- active substances which have not been included in Annex I of directive 91/414/EEC.

This means that for the current application of Vydate 10G, risk assessment is done in accordance with Chapter 2 of the RGB.

 

The underlying risk assessment is based on the final List of Endpoints for oxamyl, taken from the EFSA-conclusion (finalised 14 January 2005), on the previous risk assessment for Vydate10G as laid down in C-190.3.10 (CTB decision 02/2008) and (if relevant for the risk assessment) data submitted for this national authorisations (added to the list of endpoints in italic).

 

List of Endpoints Fate/behaviour 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralisation after 100 days

 

CO2 maximum levels = 25.6-108.5% (at final sampling timepoints, 31-179 days) (n = 6 incubations; 5 soils tested – 3 soils incubated at 20 °C, 1 soil incubated at 10 °C and 20 °C, 1 soil incubated at 25 °C)

Non-extractable residues after 100 days

 

NER maximum levels = 17.7-26.4% (time of maximum occurrence = 21-179 days) (n = 6 incubations; 5 soils tested – 3 soils incubated at 20 °C, 1 soil incubated at 10 °C and 20 °C, 1 soil incubated at 25 °C)

Relevant metabolites - name and/or code, % of applied (range and maximum)

 

IN-A2213 and IN-D2708 were major degradation products in soil;

IN-A2213 maximum levels = 7.6-51.0% (time of maximum occurrence = 1-60 days) (n = 6 incubations; 5 soils tested – 3 soils incubated at 20 °C, 1 soil incubated at 10 °C and 20 °C, 1 soil incubated at 25 °C);

IN-D2708 maximum levels = 20.3-39.5% (time of maximum occurrence = 10-90 days) (n = 5 incubations; 4 soils tested – 2 soils incubated at 20 °C, 1 soil incubated at 10 °C and 20 °C, 1 soil incubated at 25 °C)

[In a fifth soil (Drummer #6), which may have had a stressed microbial population due to its strongly acidic nature, IN-D2708 was not detected]

 

 

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation

 

n = 1 soil (11 days aerobic incubation followed by 60 days anaerobic incubation)

Mineralisation: CO2 = 12.0% after 60 days

Non-extractable residues: 18.4% after 60 days

 

Metabolites (soil and flood water extraction):

IN-A2213 maximum = 69.5% at day 20

IN-D2708 maximum = 23.1% at day 32

Soil photolysis

 

n = 2 soils

Mineralisation: CO2 = 7.9-27.4% after 20 days (irradiated samples), CO2 = 37.5-42.9% after 20 days (non-irradiated samples)

Non-extractable residues: 45.4-62.1% after 20 days (irradiated samples), 5.3-7.9% after 20 days (non-irradiated samples)

 

Metabolites:

IN-A2213 – maximum = 12.2-13.4%, at 7-12 days (irradiated samples), maximum = 11.3-18.1%, at 7-20 days (non-irradiated samples)

IN-N0079 – maximum = 3.8-25.0%, at day 7 (irradiated samples), maximum = 0.9-18.3%, at 7-20 days (non-irradiated samples) [Not considered to be a photolysis metabolite. Produced by Fe II catalysis]

Uncharacterised polar fraction – maximum = 21.1-23.8%, at 12-20 days (irradiated samples), maximum = 6.5-11.0% at 7-20 days (non-irradiated samples)

[The oxamyl content of the radiolabelled starting material was only 78%.  Other components were IN-A2213 (9.0%) and a polar fraction (10.9%).]

 

 

 

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

Laboratory:

Aerobic studies on parent – non-linear simple first order regression of parent and metabolite(s) in series, simultaneous fit (ModelManager®, version 1.1)

Aerobic studies on metabolites – linear simple first order regression

Anaerobic study – linear simple first order regression

Soil photolysis study – simple first order kinetics, accounting for the effect of non-photolytic degradation

Saturated zone degradation studies – linear simple first order regression

 

Field studies:

Non-linear simple first order regression of parent and two metabolites in series, simultaneous fit (ModelManager®, version 1.1)

Laboratory studies (range or median, with n value, with r2 value)

Aerobic studies:

Oxamyl DT50lab (20-25 °C, aerobic): 3.0, 4.1, 7.9, 11.5 days (r2 = 0.973-0.988), mean = 6.6 days

IN-A2213 DT50lab (20-25 °C, aerobic): 1.7, 1.8, 5.9, 6.4 days (derived from studies on oxamyl – r2 = 0.973-0.988), mean = 4 days

[In one additional soil (Drummer #6), which was strongly acidic (pH of 4.8) and may have had a stressed microbial population, DT50lab values (20 °C, aerobic) were 112 days for oxamyl and 17.5 days for IN-A2213 (r2 = 0.998).]

IN-D2708 DT50lab (20-25 °C, aerobic – derived values): 3.4, 3.6, 5.0, 7.6 days (r2 = 0.973-0.988), mean = 4.9 days; (20 °C, aerobic – direct experimental values): 3.9, 4.8, 6.1 days (r2 = 0.828-0.887), mean = 4.9 days

[Overall mean = 4.9 days (n = 7)]

IN-N0079 DT50lab (23 °C, aerobic – direct experimental values): 4, 25, 41 minutes (r2 = 0.976-0.998), mean = 23 minutes

Degradation data under acidic soils is required.

 

Oxamyl DT90lab (20-25 °C, aerobic): 9.9-38.2 days (n = 4 soils, r2 = 0.973-0.988), mean = 22.0 days

IN-A2213 DT90lab (20-25 °C, aerobic): 5.7-21.3 days (derived from studies on oxamyl – n = 4 soils, r2 = 0.973-0.988), mean = 13.2 days

[In one additional soil (Drummer #6), which was strongly acidic (pH of 4.8) and may have had a stressed microbial population, and was not representative of a conventional European agricultural soil, DT90lab values (20 °C, aerobic) were 373 days for oxamyl and 58.2 days for IN-A2213 (r2 = 0.998).]

IN-D2708 DT90lab (20-25 °C, aerobic – derived values): 11.2-25.4 days (n = 4 soils, r2 = 0.973-0.988), mean = 16.3 days; (20 °C, aerobic – direct experimental values): 12.8-20.2 days (n = 3 soils, r2 = 0.828-0.887), mean = 16.3 days

[Overall mean = 16.3 days (n = 7)]

IN-N0079 DT90lab (23 °C, aerobic – direct experimental values): 13-135 minutes (n = 3 soils, r2 = 0.976‑0.998), mean = 77 minutes

 

(10 °C, aerobic): laboratory values

Oxamyl DT50lab (10 °C, aerobic): 16.4 days (n = 1 soil, r2 = 0.992)

IN-A2213 DT50lab (10 °C, aerobic): 21.5 days (n = 1 soil, r2 = 0.992)

IN-D2708 DT50lab (10 °C, aerobic): 65.9 days (n 1 soil, r2 = 0.992)

Oxamyl DT90lab (10 °C, aerobic): 54.4 days (n = 1 soil, r2 = 0.992)

IN-A2213 DT90lab (10 °C, aerobic): 71.3 days (n = 1 soil, r2 = 0.992)

IN-D2708 DT90lab (10 °C, aerobic): 219 days (n = 1 soil, r2 = 0.992)

 

Arrhenius analysis of nine additional data points from two studies published in the scientific literature gives Q10 (10-20 °C) values for oxamyl of 1.99, 2.66 and 3.17 (refer to ‘Environmental Fate and Behaviour’ addendum of June 2004).  This suggests that a Q10 (10-20 °C) value in the approximate range of 2 to 3 may be more representative for oxamyl than the Q10 (10-20 °C) value of 5.5 reported in the original monograph (which was only based on two data points).

 

Anaerobic soil:

Oxamyl DT50lab (25 °C, anaerobic): 6 days (n = 1 soil, r2 = 0.945)

IN-A2213 DT50lab (25 °C, anaerobic): 24 days (n = 1 soil, r2 = 0.968)

IN-D2708 DT50lab (25 °C, anaerobic): 20 days in 1 soil, r2 = 0.741)

 

Oxamyl DT90lab (25 °C, anaerobic): 19 days (n = 1 soil, r2 = 0.945)

IN-A2213 DT90lab (25 °C, anaerobic): 81 days (n = 1 soil, r2 = 0.968)

IN-D2708 DT90lab (25 °C, anaerobic): 68 days (n = 1 soil, r2 = 0.741)

 

[Rates are whole-system values (soil and flood water combined).]

 

Soil photolysis:

Oxamyl DT50lab (irradiated samples): 1.7-3.1 days (continuous irradiation) (n = 2 soils, r2 = 0.88-0.95)

Oxamyl DT50lab (dark control samples): 17.3-17.9 days (n = 2 soils, r2 = 0.43-0.77)

Oxamyl DT50lab (corrected): 1.9-3.8 days (n = 2 soils, r2: not applicable)

 

Degradation in the saturated zone (10 °C):

Oxamyl DT50lab (aerobic): 37->120 days (n = 2 subsoils, r2 = 0.76 for one subsoil and not calculated for the other subsoil)

Oxamyl DT50lab (anaerobic): 0.9-1.7 hours (n = 2 subsoils, r2 = 0.95 for one subsoil and not calculated for the other subsoil)

 

IN-A2213 DT50lab (aerobic): 239-630 days (n = 2 subsoils, r2 = 0.78-0.83)

IN-A2213 DT50lab (anaerobic): 158-231 days (n = 2 subsoils, r2 = 0.81-0.93)

 

IN-D2708 DT50lab (aerobic): 11-859 days (n = 2 subsoils, r2 = 0.53-0.83)

IN-D2708 DT50lab (anaerobic): 1209-1355 days (n = 2 subsoils; r2 = 0.29-0.42)

 

IN-N0079 DT50lab (aerobic): 1.1-12.4 days (n = 2 subsoils, r2 = 0.72-1.00)

IN-N0079 DT50lab (anaerobic): 10.7-45.3 days (n = 4 subsoils, r2 = 0.76-0.89), mean = 29 days

 

 

Field studies (state location, range or median with n value)

DT50f:

UK, England, Lincolnshire, Spalding (bare soil):

Oxamyl DT50field: 11.0 days (n = 1, r2 = 0.969)

(DT50field normalised = 5.2 d)

 

IN-A2213 DT50field: 4.6 days (n = 1, r2 = 0.969)

IN-D2708 DT50field: 3.4 days (n = 1, r2 = 0.969)

 

The Netherlands, Limburg, Ottersum (bare soil):

Oxamyl DT50field: 9.3 days (n = 1, r2 = 0.979)

(DT50field normalised = 4.6 d)

 

IN-A2213 DT50field: 1.7 days (n = 1, r2 = 0.979)

IN-D2708 DT50field: 6.7 days (n = 1, r2 = 0.979)

 

DT90f:

UK, England, Lincolnshire, Spalding (bare soil):

Oxamyl DT90field: 36.0 days (n = 1, r2 = 0.969)

IN-A2213 DT90field: 14.9 days (n = 1, r2 = 0.969)

IN-D2708 DT90field: 11.4 days (n = 1, r2 = 0.969)

 

The Netherlands, Limburg, Ottersum (bare soil):

Oxamyl DT90field: 30.7 days (n = 1, r2 = 0.979)

IN-A2213 DT90field: 5.63 days (n = 1, r2 = 0.979)

IN-D2708 DT90field: 22.2 days (n = 1, r2 = 0.979)

Soil accumulation and plateau concentration

Not applicable

 

Additional statement provided for the re-registration

A statement with a time-step normalisation of the field degradation data was submitted (A. Gurney, 2008). In this statement the data of 12 locations from 3 field studies were normalised to reference temperature and referenc soil moisture conditions in accordance with FOCUS Kinetics using day step normalisation procedure. Next to the 2 field studies already mentioned in the LoEP (see LoEP for normalised value) 10 sites from a location in UK were considered. From the results on soil characterisitics for these sites, all 10 of them should be considered separately.

For all fields day step normalisation for temperature and moisture and SFO fitting was performed. Fitting was done with FOCUS Kinetics spreadsheet by the applicant. Some of the fits resulted in high values for c2. Ctgb checked the fitting with ModelMaker and performed statistical analyses on the results (t-test). For all fittings the fitted parameter was shown to be significantly different from zero at the p=0.05 level. Also the visual fit of the degradation curve and the distribution of the residuals is considered acceptable. Therefore, the results are considered acceptable despite of the high c2 value for some of the fits. This is most probably caused by high variability in the data which is most probably caused by field variability of the plots. For 1 (2) fields Ctgb recalculated the DT50 values. For 1 location there was a datapoint included that should be considered an outlier as no residues were found a that datpoint whereas before and after there was still oxamyl present. The fit clearly improved without this point. The DT50 was somewhat higher.

Normalised DT50 values ranged from 2.6 to 8.6 days. The geometric mean normalised DT50,field is 5.3 days. This value can be used as input for (Geo)PEARL modelling.

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf/Koc

 

Kd

 

pH dependence (yes/no) (if yes type of dependence)

Oxamyl:

Kf: 0.05-0.41 mL/g (mean = 0.18 mL/g, 4 soils)
Kfoc: 4-37 mL/g (mean = 16 mL/g, 4 soils)
1/n: 0.946-1.27 (mean = 1.07, 4 soils)
Kd: 0.09-0.44 mL/g (mean = 0.19 mL/g, 5 soils)
Koc: 8-39 mL/g (mean = 17 mL/g, 5 soils) (mean KOM = 10 mL/g)

 

[Kfoc = Kf normalized to organic carbon content, Koc = Kd normalized to organic carbon content]

 

IN-A2213:

Kf: 0.048-0.20 mL/g (mean = 0.11 mL/g, 5 soils)
Kfoc: 4-10 mL/g (mean = 7 mL/g, 5 soils)
1/n: 0.87-1.24 (mean = 1.03, 5 soils)
Kd: 0.051-0.20 mL/g (mean = 0.11 mL/g, 5 soils)
Koc: 4-11 mL/g (mean = 7 mL/g, 5 soils)

(mean KOM = 4.1 mL/g)

 

IN-D2708:

Kf: 0.05-0.39 mL/g (mean = 0.17 mL/g, 5 soils)
Kfoc: 6-14 mL/g (mean = 10 mL/g, 5 soils)
1/n: 0.532-0.762 (mean = 0.67, 5 soils)
Kd: 0.03-0.31 mL/g (mean = 0.11 mL/g, 5 soils)
Koc: 2-10 mL/g (mean = 6 mL/g, 5 soils)

(mean KOM = 3.5 mL/g)

 

IN-N0079 (unstable in the presence of soil):

Kf: not calculated
Kfoc: not calculated
1/n: not calculated
Kd: 0.03-0.31 mL/g (mean = 0.11 mL/g, 5 soils)
Koc: 2-25 mL/g (mean = 8 mL/g, 5 soils)

(mean KOM = 4.7 mL/g)

No pH dependence for oxamyl or its metabolites.

 

 

 

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching

Not required

Aged residues leaching

Not required

Lysimeter/ field leaching studies

Not required

 

Monitoring data ground water

From a study described by RIZA [Watersysteemverkenningen Carbamaten, 1993] it appears that monitoring for oxamyl in ground water was performed only sporadically. A total of 5 observations are known; no measurements were above the detection limit of 0.02 µg/L.

 

Field monitoring study (evaluated by NOTOX d.d. April 2007)

 

Reference

:

Thompson H.M., 2005 (IIIA 9.2 and IIIA 10.1.7)

 

Guideline

:

no guidelines applicable

Type of study

:

Field monitoring: field dissipation & effects on birds

 

Application rate

:

37-55 kg product/ha (3.7-5.5 kg a.s./ha)

Year of execution

:

2005

 

Number of treatments

:

1, pre-plant, broadcast incorporated.

Test substance

:

Vydate 10G, batch nr not reported, average dry granule weight 0.26-0.30 mg, 97% in size range 0.25-0.85 mm, blue-green appearance.

 

Interval

:

not applicable

A.s. content

 

10% nominal oxamyl

 

Treated area

:

0.4-14.3 ha per field

Test site

:

Potato growing fields in UK

 

Conclusions

:

see study conclusion

GLP statement

:

no

 

Acceptability

:

acceptable

 

Granule count data for the main field (number of granules on the surface/0.25 m2)

Field number

minimum count

maximum count

mean count

median count

90th percentile

95th percentile

1

0

22

5.9

6

11.3

14.4

2

0

1

0.1

0

0.1

1.0

3

0

13

2.3

1

5.2

7.3

4

0

14

1.2

0

2.1

3.6

5

0

13

3.5

2

8.2

10.2

6

0

16

6.7

5.5

14.1

15.1

7

0

4

0.9

0

2.2

4.0

13

0

11

4.7

3.5

10.1

11.0

14

0

3

0.4

0

1.0

1.1

15

0

21

1.8

1

2.1

3.9

17

0

6

1.5

1

3.1

4.1

18

0

14

5.5

4.5

12.2

14.0

19

0

20

9.5

8.5

18.1

19.1

20

0

5

1.1

0

3.2

5.0

21

0

18

5.1

4.5

10.4

14.2

22

1

15

4.8

4

9.0

9.3

23

0

4

1.5

1

3.1

4.0

24

0

5

1.3

1

3.0

3.1

25

0

2

0.2

0

1.0

1.1

27

0

34

11.4

9

22.3

25.5

28

1

24

11.6

10

21.0

21.2

30

0

11

5.1

4.5

10.0

10.1

31

1

41

18.6

13.5

38.0

38.2

33

0

34

14.8

14

23.2

25.5

34

0

4

0.9

0

3.0

3.1

35

0

18

3.3

2

6.0

6.6

36

26

140

71.0

65

98.8

107.7

39

2

14

6.4