Toelatingsnummer 12452 N

Calypso  

 

12452 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

Dit besluit is een rectificatie van het besluit van 14 december 2012. Het besluit van
14 december 2012 komt te vervallen.

Het wettelijk gebruiksvoorschrift en gebruiksaanwijzing is op enkele punten verbeterd. Het verschil tussen de bedekte en onbedekte teelt van bessen, braam en framboos stond niet juist vermeld. Dit is gecorrigeerd en duidelijker weergegeven. Tevens is er een dubbele vermelding van gewassen in de veiligheidstermijnen verwijderd.

 

1 UITBREIDING TOELATING

 

Gelet op de aanvraag d.d. 27 maart 2009 (20090304 UG) van

 

Bayer CropScience SA-N.V.

Energieweg 1

3641 RT  MIJDRECHT

 

tot uitbreiding van de gebruiksdoeleinden van de toelating als bedoeld inartikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het gewasbeschermingsmiddel, op basis van de werkzame stof thiacloprid

 

Calypso

 

gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

1.      Het gebruiksgebied van het middel Calypso wordt met ingang van datum dezes  uitgebreid met de toepassing in diverse gewassen. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit.

 

2.      De toelating geldt tot 31 december 2014.

 

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 onder A bij dit besluit is voorgeschreven.

 

1.4 Classificatie en etikettering

Gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto 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: Suspensie concentraat

 

werkzame stof:

gehalte:

thiacloprid

480 g/l

 

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

Xn

Schadelijk

N

Milieugevaarlijk

 

Waarschuwingszinnen: 

 

R20/22            -Schadelijk bij inademing en opname door de mond.

R40                 -Carcinogene effecten zijn niet uitgesloten.

R43                 -Kan overgevoeligheid veroorzaken bij contact met de huid.

R50/53            -Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

 

S21                 -Niet roken tijdens gebruik.

S23                 -(Gas/rook/damp/spuitnevel) niet inademen.

S36/37            -Draag geschikte handschoenen en beschermende kleding.

S46                 -In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.

S60                 -Deze stof en de verpakking als gevaarlijk afval 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.)

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

SPo 2              -Was alle beschermende kleding na gebruik.

 

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:

 

    1. letterlijk en zonder enige aanvulling:
      het wettelijk gebruiksvoorschrift
      De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

    1. 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.3.

 

1.5. Aflever- en opgebruiktermijn (respijtperiode)

De nieuwe restrictiezinnen dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden afgeleverd tot 1 mei 2013 en worden opgebruikt tot 1 januari 2014.

 

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Calypso (12452 N), een middel op basis van de werkzame stof thiacloprid. Het middel is reeds toegelaten als insectenbestrijdingsmiddel in diverse gewassen. Het middel is toegelaten tot 31 december 2014. Met onderliggende aanvraag wordt uitbreiding gevraagd voor de toepassingen in ‘potatoes (seed, starch, ware), fodder and sugar beet, cereals, pulses, peas, beans, oilseed rape, hemp, berries (red, white, black currant, gooseberry, blueberry, blackberry, raspberry, loganberry, tayberry, cranberry, elderberry, mulberry, hip, strawberry, fruiting vegetables (indoor), flower bulbs/bulb flowers, floriculture, public gardens, head cabbage, cauliflower, broccoli, Brussels sprouts, Chinese cabbage, kohlrabi, Swede, turnip, red beet, beetroot, parsnip, radish, carrots, black salsify, Jerusalem artichoke, celeriac, root parsley, witloof (root production), chicory (root production) and asparagus (not in production)’.

 

2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis van de werkzame stoffen thiacloprid toegelaten.

De stof is per 1 januari 2005 geplaatst op Annex I van Richtlijn 91/414 (Richtlijn 2004/58/EG, 23 april 2004), en vervolgens goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011).

 

2.3 Karakterisering van het middel

Calypso is een breedwerkend insecticide dat behoort tot de chemische groep van de

chloronicotinylen. Calypso is geformuleerd als een suspensie concentraat met een gehalte

van 480 g thiacloprid per liter.

Calypso is een systemisch insecticide. Het wordt door het blad van de plant opgenomen en

via acropetaal en translaminair transport verdeeld over het blad. Ook insecten op moeilijk bereikbare plaatsen, zoals de onderzijde van het blad, worden bestreden. Vanuit het blad vindt geen transport plaats naar andere bladeren. Insecten die aan het blad zuigen of die in contact komen met Calypso aanwezig op het blad (contactwerking) zullen sterven.

Het werkingsmechanisme berust op de blokkering van de overdracht van zenuwprikkels in

het insect. Thiacloprid bindt zich daartoe aan de acetylcholine receptor in de zenuwcellen

van het insect. Daardoor vindt geen zenuwprikkeloverdracht plaats in de zenuwcellen van

het insect waardoor het insect spoedig dood gaat. Het werkingsmechanisme van de

chloronicotinylen onderscheidt zich van andere chemische groepen zoals de pyrethroiden,

organische fosforesters en carbamaten. Deze chemische groepen hebben ook een effect op

de overdracht van prikkels via de zenuwen, maar grijpen op een andere plaats aan in het

zenuwstelsel van het insect.

 

2.4 Voorgeschiedenis

De aanvraag is op 8 april 2009 ontvangen; op 9 april 2009 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 2 november 2009 is de aanvraag in behandeling genomen.

 

 

3  RISICOBEOORDELINGEN

De toetsing is uitgevoerd conform RGB en de Evaluation Manual 1..

 

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 gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van het middel Calypso op basis van de werkzame stof thiacloprid voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 28, eerste lid, 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, 15 februari 2013

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





ir. J.F. de Leeuw

voorzitter




HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

Dit middel is uitsluitend bestemd voor professioneel gebruik

 

BIJLAGE I bij het besluit d.d. 15 februari 2013 tot uitbreiding van de toelating van het middel Calypso, toelatingnummer 12452 N

 

A.

Wettelijk gebruiksvoorschrift

 

Toegestaan is uitsluitend het gebruik als insectenbestrijdingsmiddel als

I :Gewasbehandeling:

a.      in de teelt van aardappel

b.      in de teelt van suikerbiet en voederbiet met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

c.      in de teelt van granen

d.      in de onbedekte teelt van peulvruchten (inclusief landbouwerwten, landbouwstambonen, veldbonen) met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

e.      in de teelt van koolzaad, blauwmaanzaad, vezelvlas en mosterdzaad

f.        in de teelt van hennep met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

g.      in de teelt van appels, peren, pruimen en kersen (onbedekt) (zie onderaan voor restricties)

h.      in de teelt van rode bes, witte bes, zwarte bes, kruisbes en blauwe bes,

i.         in de bedekte teelt van cranberry, vlierbes, bosbes (inclusief vossebes en veenbes), azarole, duindoorn, meidoorn, jochelbes, jostabes, en peerlijsterbes

j.         in de teelt van braam en framboos

k.       in de onbedekte teelt van loganbes en taybes

l.         in de teelt van aardbei met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

m.    in de bedekte teelt van rozenbottel

n.      in bedekte teelt van aubergine, augurk, courgette, komkommer, paprika, pattison, Spaanse peper en tomaat

o.      in onbedekte teelt van sluitkool, spruitkool, bloemkool, broccoli, Chinese kool en Oosterse bladkolen

p.      in de teelt van koolrabi

q.      in de teelt van koolraap, knolraap, pastinaak, radijs, rammenas, rettich en daikon

r.        in de teelt van bos-, was- en winterpeen en Parijse wortel

s.      in de teelt van schorseneer

t.        in de teelt van rode biet

u.      in de teelt van knolselderij en wortelpeterselie

v.       in de teelt van witlof- en cichoreipennen met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

w.     in de teelt van asperges met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

x.       in de onbedekte teelt van bleekselderij en knolvenkel

y.       in de onbedekte teelt van bloembol-, bloemknol- en bolbloemgewassen met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

z.      in de bedekte teelt van bloembol-, bloemknol- en bolbloemgewassen met dien verstande dat maximaal 3 bespuitingen per seizoen zijn toegestaan

aa.  in de bedekte teelt van bloemisterijgewassen

bb.  in de onbedekte teelt van bloemisterijgewassen  met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

cc.  in de teelt van boomkwekerijgewassen

                                                               i.      in spillen met dien verstande dat langs oppervlaktewater maximaal 3 bespuitingen zijn toegestaan

                                                             ii.      in opzetters met dien verstande dat langs oppervlaktewater maximaal 980 liter spuitvloeistof per hectare mag worden verspoten

                                                            iii.      in overige boomkwekerijgewassen met dien verstande dat langs oppervlaktewater maximaal 3 bespuitingen met maximaal 1100 liter spuitvloeistof zijn toegestaan

dd.  in de teelt van vaste planten met dien verstande dat langs oppervlaktewater maximaal 3 bespuitingen zijn toegestaan

ee.  in particuliere tuinen met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

ff.      in openbaar groen met dien verstande dat maximaal 2 bespuitingen per seizoen zijn toegestaan

gg.  de veredeling en zaadteelt van overige akkerbouw-, groenten- en bloemisterijgewassen

 

II Aangietbehandeling

            hh.  in de containerteelt van boomkwekerijgewassen

 

III Druppelbehandeling, mits toegepast na 1 maart:

ii. in de teelt op substraat van aubergine, paprika, Spaanse peper en tomaat.

 

Restricties:

 

Om in het water levende organismen  te beschermen is toepassing in de onbedekte teelten van appels, peren, pruimen en kersen op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien:
voor 1 mei:

§         gespoten wordt met tunnelspuit en een maximale hoeveelheid spuitvloeistof van 1100 liter per hectare of

§         in de eerste 20 meter grenzend aan het oppervlaktewater gebruik wordt gemaakt van een venturi-dop in combinatie met een éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel en een maximale hoeveelheid spuitvloeistof van 1100 L.

vanaf 1 mei

§         tussen het oppervlaktewater en de buitenste bomenrij een windscherm en een rijpad zijn geplaatst en het windscherm niet bespoten wordt, of

§         gespoten wordt met een tunnelspuit, of

§         een teeltvrije zone van 6 meter aanwezig is en maximaal 1000 liter spuitvloeistof wordt toegepast, of

§         sensor gestuurd gespoten wordt met maximaal 1000 (appel, pruim, kers) of 800 (peer) liter spuitvloeistof per hectare, of

§         een emissiescherm (2,5 m) tussen boomgaard en oppervlaktewater aanwezig is en maximaal 950 liter spuitvloeistof per hectare wordt verspoten, of

§         het middel verspoten wordt met een dwarsstroomspuit met reflectiescherm en maximaal 850 liter spuitvloeistof per hectare of

§         in de eerste 20 meter grenzend aan het oppervlaktewater gebruik wordt gemaakt van een venturi-dop in combinatie met een éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel en een maximale hoeveelheid spuitvloeistof van 1000 L.

 

 

 

Om in het water levende organismen te beschermen is toepassing op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal 75% driftreducerende spuitdoppen in de volgende gewassen:

 

§         aardappel, suiker- en voederbiet, peulvruchten, koolzaad, blauwmaanzaad, vezelvlas en mosterdzaad, hennep, sluitkool, spruitkool, bloemkool, broccoli, Chinese kool, Oosterse bladkolen, koolrabi, koolraap, knolraap, pastinaak, radijs, rammenas, rettich en daikon, bos-, was- en winterpeen en Parijse wortel, schorseneer, aardpeer,  rode biet, knolselderij en wortelpeterselie. witlof- en cichoreipennen, asperges, bleekselderij, knolvenkel, bloembol-, bloemknol- en bolbloemgewassen, bloemisterijgewassen, openbaar groen, de veredeling en zaadteelt van overige akkerbouw-, groenten- en bloemisterijgewassen

 

 

Om niet tot de doelsoorten behorende geleedpotigen te beschermen is toepassing op percelen die niet grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt minimaal 50% driftredurende spuitdoppen in de volgende gewassen:

 

§         aardappels, peulvruchten, hennep, bessen (alle), aardbeien, bloembol-, bloemknol- en bolbloemgewassen, bloemisterijgewassen, openbaar groen, witlof, chichorei, asperge, blauwmaanzaad, mosterdzaad, vezelvlas, oosterse bladkolen, rettich, daikon, bleekselderij, knolvenkel, particuliere tuinen, de veredeling en zaadteelt van overige akkerbouw-, groenten- en bloemisterijgewassen

 

In de teelt van bessen, braam- en framboosachtigen is een spuitvolume van maximaal 1000 L water/ha toegestaan.

 

 

Om de bijen en andere bestuivende insecten te beschermen is de toepassing in onbedekte containerteelt van boomkwekerijgewassen (aangietbehandeling) niet toegestaan in soorten die in bloei kunnen komen. Gebruik in de kas is wel toegestaan in soorten die in bloei kunnen komen, mits er tijdens de bloei geen bijen of hommels in de kas actief naar voedsel zoeken.

 

 

Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.

 

Om de bodemorganismen te beschermen mag u dit product in de toepassing in grootfruit (met uitzondering van jong gewas), klein fruit (met uitzondering van de onbedekte teelt van aardbei), de bedekte teelt van vruchtgroenten (met uitzondering van substraatteelt) en in onbedekte bloemisterijgewassen ten hoogste twee maal gebruiken en in toepassingen in bedekte bloemisterijgewassen en boomkwekerijgewassen  ten hoogste driemaal gebruiken.

 

Hennep mag niet vervoederd worden.


 

Veiligheidstermijn:

De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:

1 dag:         voor bedekte teelt van aardbei, druppelbehandeling van aubergine, paprika, Spaanse peper en tomaat, voor gewasbehandeling augurk, courgette, komkommer, pattison,

3 dagen:     voor gewasbehandeling van aubergine, paprika, Spaanse peper, tomaat, onbedekte teelt van aardbei, rode bes, witte bes, zwarte bes, kruisbes, blauwe bes, loganbes, taybes, braam en framboos.

7 dagen:     voor peulvruchten, landbouwerwten, landbouwstambonen, veldbonen, bedekte teelt van rode bes, witte bes, zwarte bes, kruisbes, blauwe bes, cranberry, vlierbes, bosbes (inclusief vossebes en veenbes), azarole, duindoorn, meidoorn, jochelbes, jostabes, peerlijsterbes, braam, framboos en rozenbottel, onbedekte teelt van sluitkool, spruitkool, bloemkool, broccoli, Chinese kool, Oosterse bladkolen, koolrabi, pastinaak, radijs, rammenas, rettich, daikon, bos-, was- en winterpeen, Parijse wortel, schorseneer, cichoreipennen, knolselderij en wortelpeterselie

14 dagen:   voor aardappel, appel, peer, pruim, kers, bleekselderij en knolvenkel.

21 dagen:   voor granen

45 dagen:   voor koolzaad, blauwmaanzaad, vezelvlas en mosterdzaad

35 dagen:   voor biet, koolraap, knolraap, rode biet

 

Dit middel is uitsluitend bestemd voor professioneel gebruik.

 

B.

Gebruiksaanwijzing

 

Algemeen

De werking van Calypso komt met name via contactwerking tot stand.

 

Het gebruik in de teelt van blauwmaanzaad, vezelvlas en mosterdzaad, de bedekte teelt van rode bes, witte bes, zwarte bes, kruisbes, blauwe bes, cranberry en vlierbes, de teelt van bosbes (inclusief vossebes en veenbes), azarole, duindoorn, meidoorn, jochelbes, jostabes, en peerlijsterbes, de bedekte teelt van braam en framboos, de bedekte teelt van rozenbottel, de teelt van rettich en daikon, de onbedekte teelt van Oosterse bladkolen, in de teelt van rettich en daikon, de onbedekte teelt van bleekselderij en knolvenkel, de containerteelt van Sempervivum, Astible, Rhodondendron, Azalea, Taxus, Thuja, Hedera, Euonymus, Osmanthus, Photinia, Pieris, Acer, Viburnum, Hydrangea en Fagus, in particuliere tuinen en de veredeling en zaadteelt van overige akkerbouw-, groenten- en bloemisterijgewassen is op basis van een “vereenvoudigde uitbreiding”. Er is voor deze uitbreiding geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd.

 

Resistentiemanagement

Om de kans op verminderde gevoeligheid te beperken, is het aan te bevelen om af te wisselen met insecticiden met een ander werkingsmechanisme, die voor de betreffende toepassing een toelating hebben.

 

Gewasveiligheid

Als er nog geen ervaring is opgedaan met het middel dient een proefbespuiting uitgevoerd te worden om de verdraagzaamheid van het gewas te testen.

 


Toepassingen gewasbehandelingen

 

Aardappel, waaronder zetmeel-, consumptie- en pootaardappel, ter bestrijding van bladluizen zoals groene perzikluis, aardappeltopluis, wegedoornluis en vuilboomluis ter voorkoming van zuigschade

Een behandeling uitvoeren wanneer gemiddeld meer dan 50 bladluizen per samengesteld blad voorkomen. Voor vuilboomluis is nog geen schadedrempel vastgesteld. Voor deze bladluis geldt dat een behandeling uitgevoerd dient te worden zodra aantasting wordt waargenomen. De dosering is afhankelijk van de bezetting van het gewas. Bij zeer zware bezetting, ook onderin het gewas, verdient de hogere dosering de voorkeur.

Dosering: 0,15-0,25 l middel per hectare

 

Aardappel, waaronder zetmeel-, consumptie- en pootaardappel, ter bestrijding van de Coloradokever (Leptinotarsa decemlineata).

Een behandeling uitvoeren zodra larven of kevers worden aangetroffen.

Dosering: 0,15 l middel per hectare

 

Suikerbiet en voederbiet, ter voorkoming van zuigschade door o.a. de groene perzikluis.

Zodra aantasting wordt waargenomen een bespuiting uitvoeren. Maximaal 2 maal toepassen per seizoen.

Dosering: 0,25 l middel per hectare

 

Granen, ter bestrijding van het graanhaantje (Lema cyanella).

Een behandeling uitvoeren als per halm tenminste 1 larve wordt aangetroffen.

Dosering: 0,15 l middel per hectare

 

Peulvruchten (onbedekte teelt) (inclusief landbouwerwten, landbouwstambonen, veldbonen), ter bestrijding van bladluizen.
Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 l middel per hectare

 

Koolzaad, ter bestrijding van de koolzaadglanskever (Meligethes aeneus).

Een behandeling uitvoeren zodra vóór de bloei van het gewas per plant gemiddeld 3-5 glanskevers aanwezig zijn. Zodra het gewas bloeit is een behandeling niet meer zinvol.

Dosering: 0,15 l middel per hectare

 

Koolzaad, ter bestrijding van de koolzaadsnuitkeversoorten (Ceutorhynchus assimilis, C. napi, C. pleurostigma, C. quadrigens) en de koolzaadgalmug (Dasyneura brassicae).

Een behandeling uitvoeren zodra per plant 1 of meer snuitkevers aanwezig zijn. Zodra alle hauwen zijn gevormd is een behandeling niet meer zinvol. Met toepassing tegen de koolzaadsnuitkever C.assimilis wordt ook beschadiging door de koolzaadgalmug tegengegaan.

Dosering: 0,15 l middel per hectare

 

Blauwmaanzaad, vezelvlas en mosterdzaad, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,15 l middel per hectare

 

Hennep, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren. De bespuiting na één week herhalen.

Dosering:        0,025% (25 ml middel per 100 liter water) onder glas of

                        0,25 l middel per hectare in de vollegrond

 


Hennep, ter bestrijding van groene perzikluis

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering:        0,025% (25 ml middel per 100 liter water) onder glas of

                        0,25 l middel per hectare in de vollegrond

 

Appel, ter bestrijding van bladluizen

Bij aanwezigheid van de stammoeders van de roze appelluis of zodra aantasting van één van de overige bladluizen wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,025% ( 25 ml middel per 100 liter water)

 

Appel, ter bestrijding van appelzaagwesp

Als prikken van de zaagwespen worden waargenomen (onder de kelkslippen) een bespuiting uitvoeren.

Dosering: 0,025% (25 ml middel per 100 liter water)

 

Appel, ter bestrijding van groene appelwants

Zodra larven van de groene appelwants worden waargenomen een bespuiting uitvoeren.

Dosering: 0,025% (25 ml middel per 100 liter water)

 

Peer, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Peer, ter bestrijding van groene appelwants

Zodra larven van de groene appelwants worden waargenomen een bespuiting uitvoeren.

Dosering: 0,025% (25 ml middel per 100 liter water)

 

Pruim en kers, ter bestrijding van groene appelwants

Zodra larven van de groene appelwants worden waargenomen een bespuiting uitvoeren.

Dosering: 0,025% (25 ml middel per 100 liter water)

 

Pruim en kers, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Rode bes, witte bes, zwarte bes, kruisbes en blauwe bes, ter bestrijding van bladluizen en groene appelwants

Zodra de larven van de groene appelwants of bladluizen worden waargenomen een bespuiting uitvoeren.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken

 

Bedekte teelt van:bosbes (incusief vossebes en veenbes), azarole, duindoorn, meidoorn, jochelbes, jostabes en peerlijsterbes, ter bestrijding van groene appelwants

Zodra de larven van de groene appelwants worden waargenomen een bespuiting uitvoeren.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken.

 

Bedekte teelt van: cranberry en vlierbes, bosbes (incusief vossebes en veenbes), azarole, duindoorn, meidoorn, jochelbes, jostabes en peerlijsterbes ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken.

 

Braam en framboos, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken.

 

Onbedekte teelt van loganbes en taybes, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken.

 

Aardbei, ter bestrijding van bladluizen, o.a. Fimbriaphis fimbriata

Een behandeling uitvoeren zodra bladluizen worden aangetroffen. Maximaal 2 maal toepassen per seizoen.

Dosering:   0,025 % (25 ml middel per 100 liter water) met maximaal 0,25 liter middel per ha of 0,25 l middel per hectare (vollegrond)

 

Aardbei, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren.

De bespuiting na één week herhalen. Maximaal 2 maal toepassen per seizoen.

Dosering:   0,025 % (25 ml middel per 100 liter water) met maximaal 0,25 liter middel per ha of 0,25 l middel per hectare (vollegrond)

 

Bedekte teelt van rozenbottel, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water), maximaal 1000 L water/ha gebruiken.

 

Bedekte teelt van aubergine, augurk, courgette, komkommer, paprika, pattison, Spaanse peper en tomaat, ter bestrijding van bladluizen

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Bedekte teelt van aubergine, augurk, courgette, komkommer, paprika, pattison, Spaanse peper en tomaat, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren.

De bespuiting na één week herhalen.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Onbedekte teelt van sluitkool, spruitkool, bloemkool, broccoli, Chinese kool en Oosterse bladkolen, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Koolrabi, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Onbedekte teelt van koolraap, knolraap, pastinaak, radijs, rammenas, rettich en daikon, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Bos-, was- en winterpeen en Parijse wortel, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Schorseneer, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Rode biet, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Knolselderij en wortelpeterselie, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Witlof- en cichoreipennen, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 l middel per hectare

 

Asperges, ter bestrijding van bladluizen.

Een behandeling uitvoeren zodra bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Asperges, ter bestrijding van aspergekever.

Een behandeling uitvoeren zodra aspergekevers worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Bleekselderij en knolvenkel, ter bestrijding van wantsen en bladluizen.

Een behandeling uitvoeren zodra wantsen of bladluizen worden aangetroffen.

Dosering: 0,25 liter middel per hectare

 

Bedekte teelt van bloembol-, bloemknol- en bolbloemgewassen ter bestrijding van bladluizen.

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Onbedekte teelt van bloembol-, bloemknol- en bolbloemgewassen, ter bestrijding van bladluizen.

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,25 l middel per hectare

 

Gladiool, ter bestrijding van gladiolentrips

Bij het verschijnen van het derde blad starten met de bestrijding. De behandelingen daarna nog één keer herhalen met een interval van 7 tot 10 dagen.

Dosering:   0,025 % (25 ml middel per 100 liter water) bedekte teelt of

                   0,25 l middel per hectare in de vollegrond

 

Bedekte teelt van bloemisterijgewassen, ter bestrijding van bladluizen

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Onbedekte teelt van bloemisterijgewassen, ter bestrijding van bladluizen

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,25 l middel per hectare

 

Bedekte en onbedekte teelt van bloemisterijgewassen, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren. De bespuiting na één week herhalen.

Dosering:   0,025 % (25 ml middel per 100 liter water) onder glas of

                   0,25 l middel per hectare in de vollegrond

 

Bedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van bladluizen

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,025 % (25 ml middel per 100 liter water)

 

Onbedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van bladluizen

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,25 l middel per hectare

 

Bedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren. De bespuiting na één week herhalen.

Dosering:   0,025 % (25 ml middel per 100 liter water)

 

Onbedekte teelt van boomkwekerijgewassen en vaste planten met uitzondering van opzetters, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een bespuiting uitvoeren. De bespuiting na één week herhalen.

Dosering:   0,25 L middel per hectare

 

Particuliere tuinen, ter bestrijding van bladluizen  

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering:   0,25 l middel per hectare

 

Openbaar groen, ter bestrijding van bladluizen  

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren. Toepassing dient op een zorgvuldige manier uitgevoerd te worden. Blootstelling van omstanders en milieu moet voorkomen worden.

Dosering:   0,25 l middel per hectare

 

De veredeling en zaadteelt van overige akkerbouw-, groenten- en bloemisterijgewassen ter bestrijding van bladluizen

Zodra een aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,25 l middel per hectare.

 

Toepassing aangietbehandeling

Bedekte en onbedekte containerteelt van de Sempervivum, Astible, Rhodondendron en Azalea, Taxus, Thuja, Hedera, Euonymus, Osmanthus, Photinia, Pieris, Acer, Viburnum, Hydrangea en Fagus, ter bestrijding van de larven van de taxuskever. Indien larven gevonden worden de potten aangieten met  10% van het potgrondvolume

Dosering: 0.063% (63 ml middel per 100 liter voor 1 m3 potgrond)

 

 

Toepassingen druppelbehandeling

Bedekte teelt van aubergine, paprika, Spaanse peper en tomaat op kunstmatig substraat, ter bestrijding van de larven van kaswittevlieg

Bij aanwezigheid van de larven van de kaswittevlieg een druppelbehandeling uitvoeren.

De druppelbehandeling alleen na 1 maart uitvoeren.

Dosering: 20 ml middel per 1000 planten

 

Gevoeligheid gewassen

Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van bloemisterijgewassen, boomkwekerijgewassen, vaste planten en groenteteeltgewassen en de verschillen in gewasverdraagzaamheid, verdient het aanbeveling om alvorens een middel toe te passen een proefbespuiting uit te voeren.


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 15 februari 2013 tot uitbreiding van de toelating van het middel Calypso, toelatingnummer 12452 N

 

 

 

                                                                                                                                                      

Contents                                                                                                                             Page

           

1          Identity of the plant protection product                                                                 12

2          Physical and chemical properties                                                                           12

3          Methods of analysis                                                                                                              18

4          Mammalian toxicology                                                                                               20

5          Residues                                                                                                                     31

6          Environmental fate and behaviour                                                                         40

7          Ecotoxicology                                                                                                             60

8          Efficacy                                                                                                                      103

9          Conclusion                                                                                                                108

10        Classification and labelling                                                                                    109

 

Appendix 1    Table of authorised uses

Appendix 2    Reference List        

 


1.      Identity of the plant protection product

 

1.1       Applicant

Bayer CropScience B.V.

Energieweg 1

3641 RT  MIJDRECHT

The Netherlands

 

1.2       Identity of the active substance

Common name

Thiacloprid

Name in Dutch

Thiacloprid

Chemical name

(Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide

CAS no

111988-49-9)

EEC no

N/A

 

The active substance was included on January 1st, 2005 in Annex I of Directive 91/414/EEC.

 

1.3       Identity of the plant protection product

Name

Calypso

Formulation type

SC, Suspension Concentrate

Content active substance

480 g/l of pure thiacloprid

 

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

 

1.4       Function

Insecticide.

 

1.5       Uses applied for

See GAP (Appendix I). The assessments of the different aspects reported in this Appendix also includes the field uses in cranberry, elderberry, mulberry and hip. Initially these uses were also claimed, but as the assessment regarding the aspect ecotoxicology did not meet the standards for these uses, the applicant has withdrawn these uses from the label.

 

1.6       Background to the application

It concerns an extension of the authorization.

 

1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE

Capacity:

Up to 5 liter bottles/canister

Type of closure and size of opening:

Screw cap 36-50-63 mm (with HF seal or internal wad)

Other information

UN/ADR 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: thiacloprid

Data on the identity and the physical and chemical properties is taken from the List of Endpoints (the final List of Endpoints presented below is taken from the final review report on thiacloprid (SANCO/4347/2000 – final, d.d. 13 May 2004). Where relevant, some additional remarks/information are given in italics.

Identity

Active substance (ISO Common Name)

Thiacloprid

Chemical name (IUPAC)

(Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-

yliden}cyanamide

Chemical name (CA)

Cyanamide, [3-[(6-chloro-3-pyridinyl)methyl]-2-

thiazolidinylidene]-

CIPAC No

631

CAS No

111988-49-9

EEC No (EINECS or ELINCS)

not allocated

FAO Specification (including year of                                publication)

an FAO specification does not yet exist

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

975 g/kg

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

None of the impurities are of toxicological or environmental significance

Molecular formula

C10H9ClN4S

Molecular mass

252.73 g/mol

Structural formula

 

 

Physical-chemical properties

Melting point (state purity)

136 °C (99.3 %)

Boiling point (state purity)

Not determined as thermal decomposition starts at

270°C

Temperature of decomposition

thermal decomposition starts at

270°C

Appearance (state purity)

Yellowish solid

Relative density (state purity)

Density at 20 °C: 1.46 g/cm3 (99.3 %)

Surface tension

66mN/m

Vapour pressure (in Pa, state temperature)

3 x 10-10 Pa at 20°C

Henry’s law constant (in Pa·m3·mol-1)

5 x 10-10 Pa m3 mol -1

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

pH4: 186 mg/l at 20°C

pH7: 184 mg/l at 20°C

pH9: 185 mg/l at 20°C

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

n-Hexane                      <0.1g/l at 20°C

Xylene                           0.30g/l at 20°C

Dichloromethane           160g/l at 20°C

1-Octanol                        1.4g/l at 20°C

1-Propanol                      3.0g/l at 20°C

Acetone                            64g/l at 20°C

Ethyl acetate                   9.4g/l at 20°C

Polyethylene glycol          42g/l at 20°C

Acetonitrile                       52g/l at 20°C

Dimethyl sulfoxide          150g/l at 20°C

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

Log Pow = 1.26 at 20°C

Water solubility unaffected by pH, therefore range of

pHs not looked at.

Hydrolytic stability (DT50) (state pH and temperature)

Stable to hydrolysis at pH 5-9 at 25°C

Dissociation constant

Thiacloprid has no acid or basic properties in aqueous solution.

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

No UV absorption above 290nm

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

DT = 80 days at pH 7 in sterile aqueous buffered solution, continuously irradiated with a Xenon lamp for a test period of 18 days or 324 days continuous sunlight for Phoenix, Arizona.

Quantum yield of direct photo-

transformation in water at λ > 290 nm

0.00035

Photochemical oxidative degradation in air

Atmospheric t½ = <1 day

Flammability

Non-flammable

Auto-flammability

No self-ignition

Oxidising properties

No oxidising properties (statement)

Explosive properties

Non-explosive

 

2.2              Plant protection product: Calypso

Data on the plant protection product is taken from the data submitted by the applicant.

The range of the application concentration of the plant protection product is 0.021-0.167%.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

visual

suspension

 

acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

visual

lightbrown

acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

organoleptic

weak, characteristic

acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP:

EEC A.14

Not explosive

acceptabe

B.2.2.5 (IIIA 2.2)

Oxidising properties

statement

Examination of the chemical structures of the active ingredient and of the formulants establishes that all the ingredients do not contain any chemical groups typical for oxidizing agents such as peroxy or nitro groups, positive halogens (e.g. halogen bonded to nitrogen) or metals in a high oxidation step. Thus the product can be regarded as incapable of reacting exothermically with a combustible material such as powdered cellulose.

acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

na

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

EEC A.15

No self-ignition up to a temperature of 600°C

acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP

EEC A.9

No flash point up to 100 °C (boiling point)

acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

na

 

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC 75

neat formulation: 7.4

1% dilution: 6.9

acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP

OECD 115

59.1 mN/m (0.03 %, 20 °C)

acceptable

Surface tension should be determined from the neat formulation. However, content hydrocarbons in formulation is < 10 % , hence no trigger for R65 and therefore this result is acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP

OECD 114

shear rate

(s-1)

viscosity at 20°C

(mPa.s)

viscosity at 40°C

(mPa.s)

100

120.1

-

-

-

-

acceptable

Viscosity should be determined at two shear rates at 20 °C and 40 °C. However, content hydrocarbons in formulation is < 10 % , hence no trigger for R65 and therefore this result is acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP

OECD 109

D204 = 1.179

acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

na

 

B.2.2.15 (IIIA 2.7)

Storage stability

non-GLP

CIPAC

MT 46.31

 

 

The formulation was tested in HDPE for 2 weeks at 54 °C.

 

Properties tested:

a.i. content, appearance, claying, package stability, pH (1 % dilution), spontaneity of dispersion, suspensibility (0.06 % dilution), wet sieving, pourability, persistent foaming (0.06 % dilution)

acceptable

B.2.2.15 (IIIA 2.7)

Storage stability

non-GLP

CIPAC MT39.3

 

The formulation was tested after storage at 0 °C for 7 days.

Properties tested:

suspensibility (0.06 % dilution) and  wet sieving.

acceptable

B.2.2.16 (IIIA 2.7)

Shelf life

non-GLP

GIFAP monograph no. 17

The formulation was tested in HDPE at ambient temperature for 2 years.

 

Properties tested:

a.i. content, appearance, claying, package stability, pH (1 % dilution), spontaneity of dispersion, suspensibility (0.06 % dilution), wet sieving, pourability, persistent foaming (0.06 % dilution)

acceptable

B.2.2.17

(IIIA 2.8)

Wettability

 

na

 

B.2.2.18 (IIIA 2.8)

Persistent foaming

GLP

CIPAC MT47.2

after 1 min. 20 ml foam (0.167 % in CIPAC water D)

acceptable

B.2.2.19

(IIIA 2.8)

Suspensibility

GLP

CIPAC

MT 184

99 % (0.06 % in CIPAC water D)

99 % (0.167 % in CIPAC water D)

not acceptable

Test should be performed at the lowest application concentration (0.021 %) or lower.

B.2.2.19

(IIIA 2.8)

Suspensibility

GLP

CIPAC

MT 161

99 % (0.03 % in CIPAC water C)

 

acceptable

The lowest test  concentration is considered sufficiently representative for the lowest application concentration (0.021 %).

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

GLP

CIPAC

MT 160

99 % (0.03 % in CIPAC water C)

 

acceptable

Tested concentration is sufficiently representative.

B.2.2.21

(IIIA 2.8)

Dilution stability

 

na

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

na

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

GLP

CIPAC

MT 59.3

 

0 % residue > 75 µm

acceptable

B.2.2.24

(IIIA 2.8)

Particle size distribution

 

na

 

B.2.2.25

(IIIA 2.8)

Content of dust/fines

 

na

 

B.2.2.26

(IIIA 2.8)

Attrition and friability

 

na

 

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

na

 

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

 

na

 

B.2.2.29

(IIIA 2.8)

Flowability

 

na

 

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

GLP

CIPAC MT148

3.15 % residue

0.30 % rinsed residue

acceptable

B.2.2.31

(IIIA 2.8)

Dustability

 

na

 

B.2.2.32

(IIIA 2.8)

Adherence and distribution to seeds

 

na

 

2.9.1

Physical compatibility with other products

 

na

 

2.9.2

Chemical compatibility with other products

 

na

 

na = not applicable

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are not sufficiently described by the available data.

 

2.3       Data requirements

None.

 

 

3.      Methods of analysis

 

Description and data on the analytical methods are taken from the List of Endpoints of thiacloprid (DAR, February 2004). Changes and/or additions are taken up in italics.

 

3.1.            Analytical methods in technical material and plant protection product

Technical as (principle of method)

Thiacloprid was determined by HPLC-UV

Impurities in technical as (principle of method)

Impurities were determined by HPLC-UV (Butonal by GC-FID, water by Karl Fisher and TBACl and NaCl by capillary electrophoresis)

Preparation (principle of method)

Thiacloprid was determined by HPLC-UV

 

Conclusion

These analytical methods for the (impurities in) the technical as have been assessed in the DAR and are considered to be acceptable.

 

The analytical method for the preparation has been assessed and is considered to be acceptable.

 

3.2       Residue analytical methods

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

Thiacloprid was determined by HPLC-UV, with a LOQ of 0.02 mg/kg (high water content matrices)

Thiacloprid was also determined by HPLC-MS/MS, with a LOQ of 0.02 mg/kg (among others for sugarbeet)

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

Thiacloprid was determined by HPLC-UV, with an LOQ of 0.02 mg/kg (0.01 mg/kg for milk)

Soil (principle of method and LOQ)

Thiacloprid and its metabolites M02 and M30 were determined by HPLC-UV, with an LOQ of 0.01 mg/kg (HPLC-MS/MS, LOQ of 0.005 mg/kg)

Water (principle of method and LOQ)

Thiacloprid was determined by HPLC-UV, with an LOQ of 0.05 mg/l.

Air (principle of method and LOQ)

Thiacloprid was determined by HPLC-UV, with an LOQ of 0.0018 mg/m3

Body fluids and tissues (principle of method and LOQ)

No methods were required

 

Based on the proposed use of the plant protection product analytical methods for the determination of residues in food/feed of plant origin are required for watery (apples, pears, berries, potato, etc.), and fat matrices (linseed, oilseed rape etc) and a specific method for sugarbeet and hot peppers.

 

Definition of the residue and MRL’s for thiacloprid

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

Thiacloprid

0.5 mg/kg (, tomato, aubergine),

1 mg/kg (pepper)

0.3 mg/kg (apple, pear peach, apricot, cucumber, courgette)

0.2 mg/kg ((water)melon)

0.3 mg/kg (rape seed)

0.02 mg/kg (sugarbeet)

Food/feed of animal origin

Thiacloprid

0.05 mg/kg (meat, fat), 0.3 mg/kg (kidney, liver)

0.03 mg/kg (milk)

 

Required LOQ

Soil

Thiacloprid and its metabolites M02 and M30

0.05 mg/kg (default)

Drinking water

Thiacloprid

0.1 µg/L (drinking water guideline)

Surface water

Thiacloprid

0.1 µg/L

Air

Thiacloprid

0.006 mg/m3 (derived from the AOEL according to SANCO/825/00)

Body fluids and tissues

The active substance is not classified as (very) toxic thus no definition of the residue is proposed.

 

 

The residue analytical methods, included in the abovementioned List of Endpoints, are suitable for monitoring of the proposed 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 the active ingredient (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

S21

When using do not smoke

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:

-

 

The proposed labelling above is equal to the previous decision regarding the labelling of the plant protection product Calypso (dated 29 July 2005).

 

 

4.      Mammalian toxicology

 

List of Endpoints

Thiacloprid is a new active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on thiacloprid (SANCO/4347/2000 – final, d.d. 13 May 2004). Where relevant, some additional remarks/information are given in italics.

 



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

Rate and extent of absorption

Rapid absorption. Around 95% based on oral and i.v. administration at low dose levels.

Distribution

Widely distributed with the highest levels in liver and kidneys.

Potential for accumulation

No evidence of accumulation.

Rate and extent of excretion

Rapid-53-66% excreted in urine largely within 24 hours of dosing, 24-34% in faeces (i.v. administration show that faecal residues are largely due to biliary excretion).

Metabolism in animals

Extensive: oxidation, hydroxylation, opening of the thiazolidine ring and conjugation.

Toxicologically significant compounds
(animals, plants and environment)

Parent compound and metabolites.

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

Males: 621-836 mg/kg bw.

Females: 396-444 mg/kg bw.                      R22

Rat LD50 dermal

>2000 mg/kg bw.

Rat LC50 inhalation

2.535 and 1.223 mg/l in male and females, respectively (4 hour exposure/nose only).  R20

Skin irritation

Not irritant.

Eye irritation

Not irritant.

Skin sensitization (test method used and result)

Negative in a M & K test.

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Liver (enzyme induction and histopathological changes). Thyroid (hormonal effects and histopathological changes).

Lowest relevant oral NOAEL / NOEL

100 ppm: 90-day rat study (equivalent to
7.3 mg/kg bw/day in males.

Lowest relevant dermal NOAEL / NOEL

100 mg/kg bw/day (rat).

Lowest relevant inhalation NOAEL / NOEL

0.182 mg/litre of air (rat).

 

Genotoxicity (Annex IIA, point 5.4)

 

No genotoxic potential. 1

1 The genotoxic potential of thiacloprid was investigated in five in vitro studies (two Ames tests, mammalian cell gene mutation test in Chinese hamster V79 cells, mammalian cytogenetic test in Chinese hamster V79 cells, mammalian cell DNA repair test in primary rat hepatocytes) and in one in vivo study (micronucleus test in mouse bone marrow).

 

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

Target/critical effect

Liver (enzyme induction and histopathological changes). Thyroid (hormonal effects and histopathological changes).

Nervous system (degeneration).

Lowest relevant NOAEL / NOEL

25 ppm (equivalent to 1.23 mg/kg bw/day).

Carcinogenicity

Thyroid adenomas in male rats.

Uterine adenocarcinomas in rats.

Ovarian luteomas in mice.                          R40

 

Reproductive toxicity (Annex IIA, point 5.6)

Reproduction target / critical effect ‡

Dystocia, reduced pup weight and viability at maternally toxic dose levels.

Lowest relevant reproductive NOAEL / NOEL

50 ppm: 2.7 mg/kg bw/day (rat). 2

Developmental target / critical effect

Reduced foetal weight increased resorptions and increased skeletal effects at maternally toxic dose levels.

Lowest relevant developmental NOAEL / NOEL

Maternal toxicity: 2 mg/kg bw/day (rabbit).

Developmental toxicity: 10 mg/kg bw/day (rabbit).

2 Parental, offspring and reproduction NOAEL

 

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)

Delayed neurotoxicity test

Not required

Acute neurotoxicity (gavage administration)

 

Short-term neurotoxicity (dietary administration).

Reduced motor and locomotive activity.

 

 

No neurotoxic effects.

 

Other toxicological studies (Annex IIA, point 5.8)                                

Metabolite data.

 

 

 

Investigations on enzyme induction/reactions.

 

 

 

 

Investigations on the reproductive findings.

M02 & M30 are less acutely toxic than parent compound: no genotoxic potential.

 

The mechanistic data indicate that hepatic enzyme induction by thiacloprid is the primary cause of the thyroid, uterine and ovarian changes. Both M30 and M34 lack the ability to induce the relevant enzymes required for these effects.

 

The mechanistic data indicate that there are no specific effects on birth functions.

 

Medical data (Annex IIA, point 5.9)

Thiacloprid is a new active substance.

Limited data

 

Summary (Annex IIA, point 5.10)

Value

Study

Safety factor

ADI

0.01 mg/kg bw/day.

2-year rat study

100

AOEL

0.02 mg/kg bw/day.

Rabbit developmental study (maternal toxicity).

100

ARfD (acute reference dose)

 

0.03 mg/kg bw/day.

Acute neurotoxicity study (rat).

100

 

Dermal absorption (Annex IIIA, point 7.3)

Concentrate

 

 

In use dilution

1% based on in vitro data (human epidermal membranes) and supported by in vivo data (primate study).

 

10% based on in vitro data (human epidermal membranes) and supported by in vivo data (primate study).

 

Additional remarks

 

Carcinogenicity

In long term studies in rats and mice an increased incidence of several tumours was observed. This has been the subject of extensive discussions. The mechanism underlying this increase has been investigated in detail.

The main effect of thiacloprid is enzyme induction in the liver in all species tested (rats, mice, dogs). This enzyme induction in its turn results in changes in hormonal balance.

Especially the increased UDP-glucoronyl transferase activity in the liver causes accelerated metabolism and excretion of thyroid hormones, resulting in severe disruption of thyroid function. Feed back regulation causes increased blood levels of TSH stimulating thyroid function. After prolonged exposure this results in the increased incidence of thyroid adenomas in rats. This effect is therefore secondary to enzyme induction and the increase is only seen at relatively high doses, well above the NOAEL which is based on liver effects. In comparison to humans, rats are especially sensitive to this effect due to the absence of Thyriod Binding Globulin (TBG) in the rat. Therefore, increases in thyroid adenomas in rats, caused by this mechanism, are considered of no relevance for humans (RIVM-report 601516009, Factsheet FSV-007/00, 2001).

Thiacloprid also induces an increase in aromatase activity in the liver of rats and mice. This enzyme is involved in the conversion of androgens into estrogens. This hormonal disturbance is considered the cause of the increased incidence of uterine adenocarcinomas in rats and ovarian luteomas in mice. This effect is therefore also secondary to enzyme induction in the liver and will only occur at exposure levels were significant enzyme induction is found.

 

Neurotoxicity

In the 2 year rat study effects on the nervous system were seen (degeneration). No neurotoxic effects were found in any of the other repeated dose studies available, including a 13 week neurotoxicity study in the rat. This type of nervous degeneration is common in ageing rats and starts after 13-14 months of age. The small increases found in this study occurred only at relatively high doses well above the NOAEL and LOAEL. At these doses severe toxicological effects (liver and thyroid) occurred. The effects have no consequences for the risk assessment for humans since the reference values are based on other critical effects seen at lower doses.

 

Local effects

Thiacloprid produces local effects after a single exposure (mild skin and eye irritation), but these local effects are covered in the risk assessment/management by means of assignment of R- and S-phrases. Thiacloprid 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 Calypso needs to be classified as R22 ‘Harmful if swallowed’, based on the acute oral toxicity (300 mg/kg bw < LD50 rat <500  mg/kg bw).

The formulation Calypso does not need to be classified on the basis of its acute dermal (LD50 rat >4000 mg/kg bw) toxicology.

The formulation Calypso needs to be classified as R20 ‘Harmful by inhalation’, based on the acute inhalation toxicity (LC50 rat 1630 mg/m3).

The formulation Calypso is considered not irritating to skin and eyes.

The formulation Calypso is positive in a Maximisation test for skin sensitisation and needs to be classified as R43 ‘May cause sensitisation by skin contact’.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

See List of Endpoints. Dermal absorption studies are done with the SC Calypso formulation.

 

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

Other formulants: no reason for concern.

 

4.4       Exposure/risk assessments

 

Overview of the intended uses

An application has been submitted for the extension of the authorisation of the plant protection product Calypso, an insecticide based on the active substance thiacloprid.

Calypso is a SC formulation and contains 480 g/L thiacloprid.

The intended uses are listed under 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 without the use of PPE

Tier 2: Risk assessment using the NL-AOEL without the use of PPE

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

Tier 4: Prescription of PPE

 

Tier 1

 

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

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

 

Since the formulation is applied 1-3 times during the period March - September, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.

 

Since thiacloprid is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.02 mg/kg bw/day (= 1.4 mg/day for a 70-kg operator), based on the developmental study in the rabbit, is used for the risk assessment (see List of Endpoints).

 

Exposure/risk

Exposure to thiacloprid during mixing and loading and application of Calypso is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

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

Because of the large number of intended uses, the highest dose of a single crop is chosen as a worst-case scenario for each application method.

Mechanical downward spraying: application in potatoes, dose: 0.25 L/ha = 0.12 kg as/ha

Mechanical upward spraying: application in apple, dose: 0.375 L/ha = 0.18 kg as/ha

Manual upward spraying: application in apple, dose: 0.375 L/ha = 0.18 kg as/ha

Manual upward spraying appears to be a worst-case scenario for manual downward spraying and therefore manual downward spraying is not included in the risk assessment

Manual up- and downward spraying in the greenhouse: application in strawberry, dose: 0.4 L/ha = 0.192 kg as/ha.

 

Table T.1 Internal operator exposure to thiacloprid and risk assessment for the use of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on potatoes (uncovered)

Mixing/

Loadingc

Respiratory

0.01

1.40

 0.01

Dermal

0.24

1.40

0.17

Applicationc

Respiratory

0.01

1.40

0.01

Dermal

0.36

1.40

0.26

 

Total

0.62

1.40

0.4

Mechanical upward spraying on apple (uncovered)

Mixing/

Loadingc

Respiratory

0.01

1.40

0.01

Dermal

0.22

1.40

0.15

Applicationc

Respiratory

0.03

1.40

0.02

Dermal

8.21

1.40

5.86

 

Total

8.46

1.40

6.0

Manual upward spraying on apple (uncovered)

Mixing/

Loading

Respiratoryd

< 0.01

1.40

< 0.01

Dermalc

0.23

1.40

0.17

Applicatione

Respiratory

0.22

1.40

0.16

Dermal

10.0

1.40

7.14

 

Total

10.5

1.40

7.5

Manual up- and downward spraying on strawberry (covered)

Mixing/

Loading and applicationf

Respiratory

0.19

1.40

0.14

Dermal

3.84

1.40

2.74

 

Total

4.03

1.40

2.9

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (concentrate) and 10% (spray dilution) (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    External exposure is estimated with  EUROPOEM

d    External exposure is estimated with  NL-model

e    External exposure is estimated with  German model (90th percentile)

f     External exposure is estimated with  Dutch greenhouse model.

 

Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

 

Tier 2

 

Calculation of the NL-AOEL

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 exposure is based on the NOAEL of 2.7 mg/kg bw/day in the 2 generation reproduction 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:                                                                      95%*

·       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: 2.7 x 1 x 70 / (4 x 3 x 3) = 5.30 mg/day

 

Exposure/risk

 

Table T.2 Internal operator exposure to thiacloprid and risk assessment for the use of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AOEL

(mg/day)

Risk-index b

Mechanical upward spraying on apple (uncovered)

Mixing/

Loadingc

Respiratory

0.01

5.30

< 0.01

Dermal

0.22

5.30

0.04

Applicationc

Respiratory

0.03

5.30

0.01

Dermal

8.21

5.30

1.55

 

Total

8.46

5.30

1.6

Manual upward spraying on apple (uncovered)

Mixing/

Loading

Respiratoryd

< 0.01

5.30

< 0.01

Dermalc

0.23

5.30

0.04

Applicatione

Respiratory

0.22

5.30

0.04

Dermal

10.0

5.30

1.89

 

Total

10.5

5.30

2.0

Manual up- and downward spraying on strawberry (covered)

Mixing/

Loading and applicationf

Respiratory

0.19

5.30

0.04

Dermal

3.84

5.30

0.72

 

Total

4.03

5.30

0.8

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (concentrate) and 10% (spray dilution) (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    External exposure is estimated with  EUROPOEM

d    External exposure is estimated with  NL-model

e    External exposure is estimated with  German model (90th percentile)

f     External exposure is estimated with  Dutch greenhouse model.

 

Since the NL-AOEL is exceeded without the use of PPE, a tier 3 assessment has to be performed.

 

Tier 3

Since the results of acceptable dermal absorption studies were already used in tier 1 and 2, a further refinement with additional dermal absorption data is not considered relevant and a tier 4 assessment will be performed.

 

Tier 4

The NL-AOEL is exceeded without the use of PPE and dermal absorption data have already been taken into account in the risk assessment. Therefore, in Tier 4 a risk assessment is performed with and without the use of PPE.

 

Table T.3 Internal operator exposure to thiacloprid and risk assessment for the use of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AOEL

(mg/day)

Risk-index b

without

PPE

with

PPE

without

PPE

with

PPE

Mechanical upward spraying on apple (uncovered)

Mixing/

Loadingc

Respiratory

0.01

(0.01)

5.30

< 0.01

(< 0.01)

Dermal

0.22

(0.22)

5.30

0.04

(0.04)

Applicationc

Respiratory

0.03

(0.03)

5.30

0.01

(0.01)

Dermal

8.21

0.82

5.30

1.55

0.15

 

Total

8.46

1.08

5.30

1.6

0.2f

Manual upward spraying on apple (uncovered)

Mixing/

Loading

Respiratoryd

< 0.01

(< 0.01)

5.30

< 0.01

(< 0.01)

Dermalc

0.23

(0.23)

5.30

0.04

(0.04)

Applicatione

Respiratory

0.22

(0.22)

5.30

0.04

(0.04)

Dermal

10.0

3.11

5.30

1.89

0.59

 

Total

10.5

3.56

5.30

2.0

0.7g

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (concentrate) and 10% (spray dilution) (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    External exposure is estimated with  EUROPOEM

d    External exposure is estimated with  NL-model

e    External exposure is estimated with  German model (90th percentile)

f     PPE: gloves and coverall during application

g    PPE: coverall during application

 

4.4.2    Bystander exposure/risk

During spraying operations there should be no bystanders present in the greenhouse. No exposure to bystanders is therefore expected.

 

The exposure is estimated for the unprotected bystander during mechanical and manual upward spraying in the field. In Table T. 4 the estimated internal exposure is compared with the systemic EU-AOEL. The application in apple appears to be a worst-case scenario (0.18 kg as/ha and 1500 L/ha).

 

Table T.4  Internal bystander exposure to thiacloprid and risk assessment after

application of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Bystander exposure during mechanical and manual upward application.

 

Respiratory

0.01

1.40

0.01

Dermal

0.18

1.40

0.13

 

Total

0.19

1.40

0.1

a       External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:

·       biological availability via the dermal route: 10% (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.

 

4.4.3    Worker exposure/risk

 

Tier 1

Shortly after application it is possible to perform re-entry activities during which intensive contact with the treated crop will occur. Therefore, worker exposure is calculated. With the Dutch greenhouse/EUROPOEM II model, re-entry activities in the greenhouse with tomatoes (0.18 kg as/ha and a transfer coefficient of 0.45) are considered to be a worst-case scenario for all the intended uses applied for. The exposure is estimated for the unprotected worker. In the Table T.5 the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.5 Internal worker exposure to thiacloprid and risk assessment after application

of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index c

Re-entry activities in tomato (covered)

 

Respiratory

0.06

1.40

0.04

Dermal

1.46

1.40

1.04

 

Total

1.52

1.40

1.1

a       External exposure was estimated with Dutch greenhouse model/ EUROPOEM II. Internal exposure was calculated with:

·       biological availability via the dermal route: 10% (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.

 

Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

 

Tier 2

The exposure is estimated for the unprotected worker. In Table T.6 the estimated internal exposure is compared with the systemic NL-AOEL.

 

Table T.6 Internal worker exposure to thiacloprid and risk assessment after application

of Calypso

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL0.01-AOEL

(mg/day)

Risk-index c

Re-entry activities in tomato (covered)

 

Respiratory

0.06

5.30

0.01

Dermal

1.46

5.30

0.28

 

Total

1.52

5.30

0.3

a       External exposure was estimated with Dutch greenhouse model/ EUROPOEM II. Internal exposure was calculated with:

·       biological availability via the dermal route: 10% (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.

 

Since the NL-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

4.4.4    Re-entry

Re-entry exposure (not work related) is possible after application in public gardens against aphids. The largest part of the residue will be located on leaves. Thus, individuals (adults and children) can be exposed when walking/running through the gardens. However, no appropriate model is available to estimate this exposure. Worker activities (in apple) can be seen as a worst-case scenario for re-entry in public gardens: duration of exposure is longer for the worker and the application rate is higher (0.18 vs 0.12 kg as/ha). The transfer coefficient for dermal exposure is 0.45 after application on apple and the same number (or less) might be applicable for dermal exposure in public gardens. Although children have a lower body weight than adult workers, resulting in a lower AOEL, worker activities in apple are still a worst-case scenario compared to re-entry activities in public gardens.

 

As the worker exposure in apples is acceptable without the use of PPE, the risk after exposure to Calypso in public gardens is acceptable.

 

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 unprotected operator after dermal and respiratory exposure to thiacloprid as a result of the uncovered application of Calypso in several intended uses applied for.

 

For the unprotected operator, adverse health effects after dermal exposure to thiacloprid as a result of the application of Calypso in other intended uses cannot be excluded. Correct use of personal protective equipment (gloves and coverall during spraying) will reduce the dermal exposure and results in a sufficient reduction of the exposure to thiacloprid for the application of Calypso in these crops.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to thiacloprid during application of Calypso according to the intended uses applied for.

 

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 during re-entry activities in the intended uses applied for, due to exposure to thiacloprid after application of Calypso.

 

Re-entry exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected individual due to exposure to thiacloprid after application of Calypso on public gardens.

 

4.5       Appropriate mammalian toxicology and operator exposure end-points relating to the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

Based on this evaluation, no additional data requirements are identified.

 

4.7       Combination toxicology

Calypso 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:

Xn

Indication of danger: Harmful

 

Risk phrases

R20/22

Harmful by inhalation and if swallowed

 

R40

Limited evidence of a carcinogenic effect

 

Proposal for the classification and labelling of the formulation concerning health

The current classification and labelling (Xn, R20/22, R40, R43, S23, S36/37, S46, SPo2) which is prepared in conformity with Directive 1999/45/EC, can be maintained.

 

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:

Xn

Indication of danger:

Harmful

R phrases

20/22

Harmful by inhalation and if swallowed

 

40

Limited evidence of a carcinogenic effect.

 

43

May cause sensitisation by skin contact.

S phrases

23

Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).

 

36/37

Wear suitable protective clothing and gloves.

 

46

If swallowed, seek medical advice immediately and show this container or label.

Special provisions:
DPD-phrases

SPo2

Wash all protective clothing after use.

 

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?

not applicable

Tactile warning of danger obligatory?

not applicable

 

 

5.      Residues

 

Thiacloprid

Thiacloprid is a new active substance, included in Annex I of 91/414/EEC. The List of Endpoints presented below is the most recent (Feb 2004) before the publishing of the final review report.

 

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

Plant groups covered

Apples, tomatoes, cotton

Rotational crops

Lettuce, turnip and wheat

Plant residue definition for monitoring

Thiacloprid

Plant residue definition for risk assessment

Thiacloprid

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

Goats and hens

Animal residue definition for monitoring

Thiacloprid

Animal residue definition for risk assessment

Thiacloprid

Conversion factor (monitoring to risk assessment)

None

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

No (based on log pow)

 

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

 

 

No data were submitted or required, due to residues of parent and individual metabolites in rotational crops being less than 0.1 mg/kg, with the exception of metabolites M30, M37, M02 and M34 in the wheat study. However these metabolites were not considered to be of toxicological concern.

 

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

 

Residues of thiacloprid in apple, tomato and melon peel were stable for up to 18 months, when stored at <-18°C.

 

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

Intakes by ruminants were ³ 0.1 mg/kg diet/day:

Ruminant:

yes

Poultry:

no

Pig:

no

Muscle

<0.01

 

 

Liver

0.04

 

 

Kidney

0.01

 

 

Fat

<0.01

 

 

Milk

<0.01

 

 

Eggs

-

 

 

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Cop/processed crop

Number of studies

Transfer factor

Apple

Juice

Wet pomace

Dry pomace

Sauce

Washed fruit

Dried fruit

2

 

0.3

3.3

6.5

0.7

0.8

0.5

Peach

Washed fruit

Preserves

3

 

0.7

<0.2

Tomato

Washed fruit

Peeled fruit

Paste

Juice

Preserves

2

 

0.7

0.3

2.6

0.6

0.5

Melons and watermelons

Pulp

Peel

8

 

<0.3

4

* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies

 

Comments on/additions to List of Endpoints

No comments.

 

5.1       Summary of residue data

 

5.1.1    Metabolism in plants

In the Draft Assessment Report (DAR) the metabolism is reported in 2 crop groups: fruit (apple, tomato) and pulses & oilseeds (cotton). For the registration of Calypso, the applicant submitted a metabolism study in wheat (evaluated in RIVM report 09865A00, d.d. 22-04-2005), which is part of the crop group cereals. For the current extension of authorisation the applicant submitted a metabolism study on seed treated sunflower seeds (evaluated in NOTOX report 492946, d.d 10-02-2010), however since the intended use does not include seed treatment this study was not taken into account. There is no study available for the crop group root and tubers, relevant for potato and sugar- and fodder beet.

 

Metabolism studies in the DAR were performed with the radiolabel in the 3-methyl C-atom from the pyridylmethyl group. In the metabolism study in wheat the same label position was used. After spray application of thiacloprid, >80% of the residue in hay, straw and grain was parent thiacloprid and <4% were residues in which the methylene-bond was broken.

 

The metabolism of thiacloprid in wheat is comparable to that in tomato and apple and (to a certain extent) to that in cotton. To extrapolate to all crop groups it is required to study the metabolism in 3 different crop groups; this requirement has been fulfilled. However, the requirement to label the molecule in all relevant groups has not been fulfilled. In this case the molecule should be labeled in both ring systems to monitor all degradation products. Because the thiazolidine ring was not labeled, there is no information about the form and behaviour of metabolites containing only the thiazolidine ring.

However, the sum of all metabolites not containing the thiazolidine moiety was 3.3% TRR in tomatoes, 0.0 % in apples, 3.3 % in wheat hay, 3.6 % in wheat straw, 1.7 % in wheat grain, 6.9 % in cotton leaves and 75.8 % in cotton seed. These results show that (with the exception of cotton seed) only a very minor part of the residues did not contain the thiazolidine moiety of the active substance. Therefore it was considered that metabolism studies with a second label are not necessary.

 

The presence of 6-chloronicotinic acid (a metabolite without the thiazolidine moiety which is present at 75.8 % of the TRR free and conjugated) in cotton seeds is due to the accumulation of this acid in the seed. It is suggested that phloem acts as a sink for weak acids when the 6-chloronicotinic acid being secreted from the apoplasm into the phloem. It is very likely that the 6-chloronicotinic acid in the seed originated from leaf metabolism where it was identified as one of the metabolites. EFSA suggests (See Reasoned opinion: Modification of the existing MRL for thiacloprid in strawberries, 2010; 8(1):1498) to further investigate the presence of 6-chloronicotinic acid in oilseeds and pulses during the Article 12.1 evaluation of Regulation (EC) 396/2005. It should be noted that 6-chloronicotinic acid and its precursor 6-chloropicolyl alcohol are metabolites containing 6-chlorpyridinyl moiety, which are characteristic not only for thiacloprid but also for imidacloprid and acetamiprid.

 

Conclusion

The four available studies show sufficiently that the metabolic pathway is similar in all crops investigated. The parent compound is the major component after foliar treatment. Since the metabolism is investigated in three different crop groups the metabolic pathway can be extrapolated to all crop groups.

 

5.1.2    Metabolism in livestock

In the monograph the metabolism is reported in goat and hen. No further data required

 

5.1.3    Residue definition (plant and animal)

See List of Endpoints.

 

5.1.4    Stability of residues

In the monograph the stability during frozen storage is reported in apple, tomato and melon peel. These crops belong to the crop group commodities with high water content. Potato and fodder beet also belong to this crop group and are therefore sufficiently covered.

Cereals fall in the crop group non-fatty dry crops. The notifier submitted additional data on storage stability data in wheat (forage, hay, grain and straw), showing stability for a period of 28 months.

Sugar beet cannot be classified in any crop group and is considered a special case. The notifier has stated that this classification is mainly due to analytical method and not to storage life of the residues: sugar beet is a matrix with high water and sugar content and can be compared to other water-sugar matrices like apple. Since thiacloprid has been proven stable in melon and in a number of other water matrices, it is also expected to be stable in sugar beet.

 

5.1.5    Supervised residue trials

 

Potatoes

(cGAP-NL: 2x0.12 kg as/ha or 3x0.072 kg as/ha, interval 7-10d, PHI: 14d)

Eight studies with potato are available in the RIVM report 09865A00 (d.d. 22 April 2005). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1.The current EU-MRL of 0.02* mg/kg for potato is sufficient for the intended use.

 

Root and tuber vegetables (Swede, turnip, parsnip, radish, carrot, black salsify, Jerusalem artichoke, beetroot, celeriac, root parsley, chicory and witloof roots)

(cGAP-NL: 2x, 0.12 kg as/ha, interval 14d, PHI, 7d)

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI:- for chicory and witloof roots)

Trials with potato, sugarbeet and carrot can be extrapolated to the whole group of root and tuber vegetables. Eight studies with potato and eight studies with sugarbeet are available in the RIVM report 09865A00 (d.d. 22 April 2005). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage. In some studies the number of applications was 3 and the application interval was longer (maximal 21 days). In these trials the number of applications and the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest.

In total 11 trials in carrots are available in NOTOX document 21313-res (d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications, application interval and growth stage, except for six trials which were performed with application intervals ranging from 7-9 days. The residue levels selected for MRL setting and risk assessment are presented in table R1.The current EU-MRLs of 0.02* mg/kg for radishes, Jerusalem artichokes, Swedes, turnips, chicory and witloof roots, of 0.05 mg/kg for beetroot, carrots, horseradish, parsnips, parsley root and salsify, and of 0.1 mg/kg for celeriac are sufficient for the intended uses.

 

Oilseed rape

(cGAP-NL: 2x, 0.072 kg as/ha, interval 14d, PHI, 45d)

Eight trials with rapeseed are available in the EFSA Reasoned opinion: Modification of the existing MRLs for thiacloprid in table olives, olives oil production, poppyseeds and various root vegetables, d.d. 2 December 2009. The trials are performed with a single application of 0.096-0.12 kg as/ha and a PHI of 30 days. This GAP is considered worst-case compared to cGAP-NL and is acceptable. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.3 mg/kg for oilseed rape seed is sufficient for the intended use.

 

Cherries

(cGAP-NL: 2x, 0.012 kg as/hL (0.18 kg as/ha), interval 60d, PHI, 14d)

Eight supervised residue trials are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials are not performed according to cGAP-NL, but can be considered worst-case (interval 7d instead of 60d). The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.3 mg/kg for cherry is sufficient for the intended use.

 

Plum

(cGAP-NL: 2x, 0.012 kg as/hL (0.18 kg as/ha), interval 60d, PHI, 14d)

Eight supervised residue trials are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials are not performed according to cGAP-NL, but can be considered worst-case (interval 7d instead of 60d). The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.1 mg/kg for plum is sufficient for the intended use.

 

Unprotected other small fruit & berries (Currants, gooseberry, blueberry, cranberry, elderberry, mulberry, rose hips)

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI: 3d)

Eight supervised residue trials on currants are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, application interval and growth stage. The number of applications was 3 instead of two. In these trials the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest (PHI of 3 days). The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 1 mg/kg for other small fruit & berries is sufficient for the intended uses.

 

Unprotected canefruit (blackberries, raspberries, loganberry and tayberry)

(cGAP-NL: 2x, 0.12kg as/ha, interval 7-10d, PHI: 3d)

Eight supervised residue trials on raspberries are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, application interval and growth stage. The number of applications was 3 instead of two. In these trials the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest (PHI of 3 days). The residue levels selected for MRL setting and risk assessment are presented in table R1. Trials with raspberries can be extrapolated to blackberries, loganberries and tayberries. The current EU-MRL of 3 mg/kg for blackberries and raspberries is sufficient for the intended uses. The current EU-MRL of 1 mg/kg for loganberries and tayberries is sufficient for the intended uses.

 

Protected Strawberries

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI: 1d)

Eight supervised residue trials on strawberries are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, application interval and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 1 mg/kg for strawberries is sufficient for the intended uses.

 

Unprotected Strawberries

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI: 3d)

Eight supervised residue trials on strawberries are available in the RIVM report 09865A00 (d.d. 22 April 2005). The trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, and growth stage. The application interval was 14 days (cGAP 7 days). In these trials the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 1 mg/kg for strawberries is sufficient for the intended uses.

 

Apple and pear

(cGAP-NL: 2x, 0.012 kg as/hL (0.18 kg as/ha), interval 60d, PHI, 14d)

Trials with apple can be extrapolated to pear. Eight supervised residue trials on apple are available in the DAR. The trials are performed with 2x 0.0096-0.036 kg as/hL (0.144-0.180 kg as/ha) with and interval of 7 days and a PHI of 13-14 days. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.3 mg/kg for both apple and pear is sufficient for the intended uses.

 

Chinese cabbage

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI, 7d)

In total 1 trial in Chinese cabbage and 7 trials in curly kale are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage.  The application interval for trials in two reports was 10 days (cGAP 7 days). In these trials the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest (PHI of 7 days). The residue levels selected for MRL setting and risk assessment are presented in table R1. Trails with curly kale and Chinese cabbage can be extrapolated to the whole group op leaf cabbages. The current EU-MRL of 1 mg/kg for leaf cabbages is sufficient for the intended uses.

 

Kohlrabi

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI, 7d)

In total 4 trials in kohlrabi are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage.  The application interval was 10 days (cGAP 7 days). In these trials the longer application interval is considered acceptable because of an assumed (based on decline data) negligible contribution of the first application to the residue at harvest (PHI of 7 days). The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.05 mg/kg for kohlrabi is sufficient for the intended use.

 

Brussels sprouts

(cGAP-NL: 2x, 0.12 kg as/ha, interval 10d, PHI, 7d)

In total 8 trials in Brussels sprouts are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.05 mg/kg for Brussels sprouts is sufficient for the intended use.

 

Head cabbages

(cGAP-NL: 2x, 0.12 kg as/ha, interval 10d, PHI, 7d)

In total 8 trials in head cabbages are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.2 mg/kg for head cabbage is sufficient for the intended use.

 

Cauliflower and broccoli

(cGAP-NL: 2x, 0.12 kg as/ha, interval 10d, PHI, 7d)

In total 4 trials in broccoli and 4 trials in cauliflower are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.1 mg/kg for flowering brassicaceae is sufficient for the intended use.

 

Cereals

(cGAP-NL: 1x, 0.072 kg as/ha,BBCH 39-89 PHI, 21d)

In total 8 trials in wheat are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), number of applications, timing of application and growth stage.  In some trials the samples at harvest (PHI 21 days) consist of wheat ear, which is not the right commodity to represent the harvestable part of the crop. Residues in wheat ear are considered worst-case compared to wheat grain. The trials are therefore acceptable. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 0.1 mg/kg for wheat, triticale and spelt is sufficient for the intended use.

In total 8 trials in barley are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), number of applications, timing of application and growth stage.  In some trials the samples at harvest (PHI 21 days) consist of wheat ear, which is not the right commodity to represent the harvestable part of the crop. Residues in wheat ear are considered worst-case compared to wheat grain. The trials are therefore acceptable. The residue levels selected for MRL setting and risk assessment are presented in table R1. The current EU-MRL of 1 mg/kg for barley and oats is sufficient for the intended use.

 

Pulses

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI, 7d)

In total 8 trials for pea (pulses) are available in NOTOX document 21313-res, d.d. 10-02-2010). All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, application interval and growth stage, but not with respect to number of applications (3 instead of 2 applications, which can be considered worst-case).  In 4 trials (Billian, 2007) the application interval between the first and second application was 14 days (cGAP 7 days). Deviation of the PHI for the first application is within 25% (PHI first application 28 instead of 21 days). The residue levels selected for MRL setting and risk assessment are presented in table R1. Trials with peas (pulses) can be extrapolated to the whole group of pulses. The current EU-MRL of 0.1 mg/kg for pulses is sufficient for the intended use.

 

Asparagus

(cGAP-NL: 2x, 0.12 kg as/ha, interval 7-10d, PHI:-)

Trials with asparagus are not available and are not considered necessary since the applications are not in the production phase.

 

Tomato and eggplant

(cGAP-NL: 3x, 0.18 kg as/ha, interval 7-10d, PHI, 3d)

In total 9 trials for tomatoes are available in the DAR. All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications, application interval and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. Trials with tomato can be extrapolated to the eggplant. The current EU-MRL of 0.5 mg/kg for tomatoes and aubergines is sufficient for the intended use.

 

Pepper and chilli pepper

(cGAP-NL: 3x, 0.18 kg as/ha, interval 7-10d, PHI, 3d)

In total 5 trials for peppers are available in the DAR. All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications, application interval and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. Trials with peppers can be extrapolated to the chilli pepper. The current EU-MRL of 1 mg/kg for peppers is sufficient for the intended use.

 

Cucumber, courgette, gherkin and patisson

(cGAP-NL: 3x, 0.18 kg as/ha, interval 7-10d, PHI, 1d)

In total 8 trials for cucumbers are available in the DAR. All trials were performed according to the cGAP with respect to dose rate (or within 25% deviation of the dose rate), timing of application, number of applications, application interval and growth stage. The residue levels selected for MRL setting and risk assessment are presented in table R1. Trials with cucumbers can be extrapolated to the whole group of cucurbits with edible peel. The current EU-MRL of 0.3 mg/kg for cucurbits with edible peel is sufficient for the intended use.

 

Table R1: Selected residue levels from trials with thiacloprid

Crop

Residue levels selected for MRL setting (mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Potato

8x <0.02

0.02

0.02

Sugarbeet[1]

8x <0.02

0.02

0.02

Carrot

7x <0.01, 0.01, 3x 0.02

0.01

0.02

Rape seed

<0.02, 0.05 (3x), 0.07 (2x), 0.08, 0.16

0.06

0.16

Apple

0.04, 0.05, 0.07 (2x), 0.12, 0.11 (2x), 0.16

0.10

0.16

Cherries

<0.02, 0.02, 0.03, 0.04, 0.06, 0.10, 0.11, 0.15

0.05

0.15

Plum

<0.02 (3x), 0.02 (2x), 0.03 (2x), 0.05

0.02

0.05

Currants unprotected

0.08, 0.16, 0.21 (2x), 0.28, 0.35, 0.37, 0.59

0.25

0.59

Raspberries[2]

0.1, 0.15 (2x), 0.27, 0.31, 0.34 (2x), 0.62

0.29

0.62

Strawberries, protected

0.04, 0.05, 0.13, 0.22, 0.31 (3x), 0.33

0.27

0.33

Strawberries unprotected

0.02, 0.03, 0.04, 0.07 (2x), 0.08 (2x), 0.09

0.07

0.09

Leaf cabbage[3]

0.06, 0.07, 0.11, 0.12, 0.20, 0.23, 0.43, 0.66

0.16

0.66

Kohlrabi

<0.01, 0.01, 0.02 (2x)

0.02

0.02

Brussels sprouts

<0.01 (3x), 0.02 (4x), 0.04

0.02

0.04

Head cabbage

<0.01 (3x), 0.01, 0.02 (2x), 0.04, 0.14

0.02

0.14

Cauliflower and broccoli

<0.01, 0.02 (2x), 0.03 (3x), 0.06, 0.07

0.03

0.07

Wheat

<0.02 (6x), 0.02, 0.07

0.02

0.07

Barley

<0.02 (4x), 0.05, 0.12, 0.21, 0.60

0.04

0.60

Pulses

<0.01 (3x), 0.19, 0.02, 0.03 (2x), 0.05

0.02

0.05

Tomatoes

0.07 (2x), 0.12(2x), 0.14, 0.15, 0.18, 0.24, 0.25

0.14

0.25

Peppers

0.07, 0.08, 0.33, 0.36, 0.37

0.33

0.37

Cucumbers

0.04, 0.07, 0.08 (2x), 0.12, 0.15 (2x), 0.18

0.1

0.18

 

5.1.6    Residues in succeeding crops

See List of Endpoints.

 

5.1.7    Residues from livestock feeding studies

A calculation of the total dietary burden is performed including the already authorised uses and the intended uses in authorisation request 20090304 UG.

 

Crop

STMR

HR

Turnips

0.01

0.02

Swedes

0.01

0.02

Potato

0.02

0.02

Sugarbeet / fodderbeet

0.02

0.02

Sugarbeet leaves / fodderbeet leaves

0.02

0.02

Pulses

0.02

0.05

Apple pomace

0.1

-

Cabbage

0.02

0.14

Cereal grains

0.02

0.6

Cereal straws

0.06

1.23

Rape seed

0.06

0.16

 

This leads to the following theoretical intake for dairy cattle, beef cattle, poultry, and pigs:

 

Animal

Maximum dietary burden (mg/kg bw/d)

Maximum dietary burden (mg/kg dry weight)

Median dietary burden (mg/kg bw/d)

Median dietary burden (mg/kg dry weight)

Dairy Ruminants

0.03

0.707

0.01

0.104

Meat Ruminants

0.05

1.095

0.01

0.197

Poultry

0.01

0.112

0.01

0.049

Pigs

0.01

0.285

0.01

0.097

 

The monograph evaluates a livestock feeding study in dairy cattle with 2 mg/kg dry feed as lowest dose level. This results in residue levels of 0.02, 0.02, 0.04, and 0.11 mg/kg for muscle, fat, kidney, and liver, respectively. Residues in milk were 0.02 mg/kg at plateau (after 5 days).

A livestock feeding study in pig is not available. The results for meat, fat, and offals from cattle are extrapolated to pig, as the metabolism in rat and ruminant was found to be similar.

 

The residue levels are in compliance with the provisional EU-MRLs established in Regulation (EC) 396/2005.

 

A livestock feeding study in poultry is not available. Based on the metabolism study available in the DAR with an exaggerated dose of 10 mg/kg bw the following MRLs are determined for poultry in Regulation (EC) 396/2005: 0.05 mg/kg for both meat and fat, 0.3 mg/kg for liver and kidney. 

 

5.1.8    Processing factors

A hydrolysis study is available in the DAR. It can be concluded that thiacloprid did not degrade abiotically under conditions representative of industrial or domestic food processing.

 


5.1.9    Calculation of the ADI and the ARfD

Calculation of the ADI

The ADI is based on the NOAEL of 1 mg/kg bw/d in the 2-year rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.01 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

Calculation of the ARfD

The ARfD is based on the NOAEL of 3 mg/kg bw/d in the acute neurotoxicity rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of 0.03 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

5.2       Maximum Residue Levels

MRLs are available in Annex II and IIIB of Regulation (EC) 396/2005. The product complies with the MRL Regulation.

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out in the most recent published EFSA Reasoned opinion: Modification of the existing MRL for thiacloprid in peas (d.d. 9 December 2010) using EFSA PRIMo rev. 2.0, containing all available Member State diets. The maximum TMDI is 81.5 % of the ADI for the DE children. The TMDI is 32.2 % and 80.6 % 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 STMRs and HRs of the intended uses. The highest percentage of the ESTI is 81.7 % of the ARfD for Chinese cabbage for the Dutch children. ESTI values for the other commodities in all other consumer diets are all lower.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to thiacloprid is currently expected. The product complies with the Uniform Principles.

 

5.4       Data requirements

No data requirements are identified.

 

 

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 Calypso, risk assessment is done in accordance with Chapter 2 of the RGB.

 

Thiacloprid is a new active substance placed on Annex I on 1 january 2005. Remarks made at the decision for inclusion are: “MS should pay particular attention to the protection of non-target arthropods, to the protection of aquatic organisms and to the potential of groundwater contamination, when the active substanceis applied in regions with vulnerable soil and/or climatic conditions”

Endpoints were taken form the LoEP of February 2004. Supplements to the LoEP are added in italics.

 

List of Endpoints Fate/behaviour 

In the List of Endpoints the following codes are used for the active substance and metabolites:  

thiacloprid = YRC 2894

thiacloprid amide = M02 = KKO 2254

thiacloprid sulfonic acid = M30 = WAK6999

thiacloprid sulfonic acid amide = M34

 

Fate and Behaviour in the Environment

 


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

Mineralisation after 100 days ‡

 

6.5-34 % after 100 days (n=4)

Non-extractable residues after 100 days ‡

 

22-30 % after 100 days (n=4)

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

 

Major metabolites (>10%AR)

M02 60-74% after 3-30 days (n=4)

M30 4.5-20% after 14-100 days (n=4)

 

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

Anaerobic degradation

 

No data provided, not required for the currently requested uses (summer applications).

Soil photolysis

 

Negligible (dissipation rate in irradiated sample comparable to dark controls)

 


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

Method of calculation

Parent: first order

M02 Lab ACSL optimise non linear fitting of first order degradation of parent®M02 and M02®CO2, field first order

M30, M34 lab first order, field insufficient data

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20°C, aerobic): ‡ means are geometric &

                                               normalised to field capacity

parent 0.7-5.0 days (n=4, r2=0.97-0.99)  mean 1.3 days

M02 32-142 days (n=4)                         mean 41.7 days

M30 16-79 days (n=3, r2=0.98-0.99)     mean 23.4 days

M34 8-52 days (n=3, r2=0.99-1.0)         mean 15.1 days

 

DT90lab (20°C, aerobic): ‡

parent 2.3-15.5 days (n=4)

M02 106-473 days (n=4)

M30 54-262 days (n=3, r2=0.98-0.99)

M34 26-175 days (n=3, r2=0.99-1.0)

 

DT50calc (10°C, aerobic): ‡ From 20°C aerobic values above as 1.2-10.3 days using Q10 of 2.2.

 

DT50lab (20°C, anaerobic): ‡

not submitted, not required for intended uses

 

degradation in the saturated zone: ‡

not submitted, not required

 

Field studies (state location, range or median with

n value)

DT50f: ‡

         Northern Europe     Southern Europe

parent 9-27 days (n=6)     10-16 days (n=2)r2=0.82-0.98

M02 46-314 days (n=6)  68-107 days (n=2)r2=0.9-0.99

 

DT90f: ‡

          Northern Europe                   Southern Europe

parent 31-91 days (n=6)                  35-53 days (n=2)

M02 153-1047 days (n=4)               226-357 days (n=4)

Soil accumulation and plateau concentration

Metabolite M02 could accumulate in Northern Europe.  Plateau concentration calculated at 0.14mg/kg assuming a DT50 of 314 days, 50% crop interception and 260g a.s/ha is applied a year.

M02 (Z)-[3-[(6-chloro-3-pyridinyl)methyl]-2-thiazolidinylidene]urea)

M30 2[1-(6-chloropyridine-3-ylmethyl)-3-carbamoyl-ureido]-ethane sulfonic acid sodium salt

M34 2-{(aminocarbonyl)[(6-chloro-3-pyridinyl)methyl]amino} ethanesulfonic acid, sodium salt

 

Er is een studie geleverd waarin concentraties aan thiacloprid in de bodem in de 0-

10 cm laag na 10 jaar gebruik met 150 g w.s./ha/jaar zijn bepaald op basis van de beschikbare veldgegevens. Deze studie is ook opgenomen in Addendum I (d.d.nov. 2002). Er is daarbij gebruik gemaakt van twee-compartimenten kinetische modellering: dit wordt niet geaccepteerd voor Nederlandse beoordelingen, aangezien dit geen bruikbare invoergegevens voor PEARL oplevert. Op grond van het bovenstaande worden de uit de genoemde studie afkomstige concentraties aan thiacloprid in de bodem niet gebruikt voor de risicobeoordeling.

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc (ml/g)

Kd

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

dependence)

Kf oc parent 393-870 (mean 615,1/n=0.83-0.94, n=6)

M02 166-438 (mean 288,1/n=0.76-0.91, n=5)

M30 11.9-26.2 (mean 19.8,1/n=0.91-0.98, n=5)

Kd oc M34 2.94-6.27 (mean 5.02, n=4)

No evidence that changes in soil pH influences the sorption of parent or metabolites.

Two extra soil adsorption/desorption studies have been submitted to the CTB for the application of Calypso (12452N). They were summarized by RIVM. Results are:

M02 (KKO254) Kom 184 L/kg, sandy loam soil

M30 (WAK6999) Kom 12,9 L/kg, sandy loam soil.

 

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

Column leaching

 

No data submitted, not required as satisfactory batch sorption data are available

Aged residues leaching

Guideline: BBA

Aged for (days): 30 and 60

Precipitation (ml): 393

Leachate: 14.5% AR (day 30) and 19.4% AR (day 60)

Leachate 30day incubations (% AR):

parent undetected, M02 0.1, M30 11.6, unknowns 2

Leachate 60day incubations (% AR):

parent undetected, M02 undetected, M30 18.5, unknowns 1

73% AR retained in top 10cm (30 day incubations).

 

Lysimeter/ field leaching studies

 

Location: Germany, Monheim

Study type: lysimeter planted with grass

No. of applications: 2 years, 2 applications/year

Application rate (kg a.s./ha/year):

0.4 (1st year) and 0.365 (2nd year) to sparse grass

Average annual precipitation (mm): 869

Average annual leachate volume (mm): 372

% AR in leachate: 3%

Peak annual average concentrations (mg/l):

Total radioactivity 2.31mg a.s. equivalents /l

Parent and M02 not detected

M30 2.4 mg/l

M34 0.27 mg/l

Z5 0.16 mg/l

Z5 4-[(6-chloro-3-pyridyl)methyl]-1,2,4-thiadiazaperhydroine-1,1,3-trione

 

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH 5______:Stable to hydrolysis

 

pH 7______: Stable to hydrolysis

 

pH 9______: Stable to hydrolysis

Photolytic degradation of active substance and

relevant metabolites

Artificial irradiation equated to summer days, Phoenix Arizona; DT50 324 days. Stable to Photolysis no major (>10%AR) metabolites formed.

Readily biodegradable (yes/no)

No data submitted, therefore not readily biodegradeable

Laboratory studies

 

Degradation in    - DT50 water

water/sediment    - DT90 water

 

                            - DT50 whole system

                            - DT90 whole system

6-11 days

21-35 days (1st order, r2=0.98-0.98, n=2)

 

11-27 days

35-92 days (1st order, r2=0.97-0.99, n=2)

Mineralisation

4% AR (at 100 days, n=2)

Non-extractable residues

17-22% AR (at 100 days, n=2)

Distribution in water / sediment systems (active substance)

Maximum of 10-50%AR in sediment after 1-3 days.

Distribution in water / sediment systems (metabolites)

Water:

M02 max of 17-62%AR after 35 days

M30 represented 5.3-9.5% AR at the end of the study (100 days) with no evidence that concentrations had peaked.

Sediment:

M02 max of 7-36%AR after 35-62 days

 

Microcosm studies (Germany) 9 replicated systems

 

Degradation in    - DT50 water

water/sediment    - DT90 water

 

26-46 days, mean 31 days

87-153 days mean 103 days (1st order, r2=0.82-1.0)

 

Distribution in water / sediment systems (active substance)

Maximum of 141 % of the nominal initial water concentration (sum of 2 applications) in sediment 28 days after the second application.  DT50 in sediment 62 days (1st order, r2=0.82, n=1)

Distribution in water / sediment systems (metabolites)

Water:

No analyses for metabolites carried out.

Sediment:

Only M02 analysed for,M02 represented max of 62-89 % of the nominal initial water concentration (sum of 2 applications) in sediment 98 days after the second application (study end)

 

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)

Direct photolysis in air

 

Not submitted

Quantum yield of direct phototransformation

 

0.00035

Photochemical oxidative degradation in air

Half life in upper atmosphere in the presence of hydroxyl radicals 1.5 hours (Calculation using the methods of Atkinson)

Volatilisation

 

from plant surfaces: ‡

15% AR lost over 24 hours (volatiles not trapped)

 

 

from soil: ‡

12% AR over 24 hours (volatiles not trapped)

 

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

 

 

Residue definition including major (>10% AR) metabolites or those > 0.1mg/l in soil water at 1.1m depth:

Soil and surface water thiacloprid, M02, M30.

Soil water at 1.1m depth (groundwater) M30, M34 and Z5.

sediment thiacloprid, M02

 

Relevant residue definition:

soil, surface water, sediment and groundwater: thiacloprid

 

 

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study)

 

New substance.  Not available, not required.

Surface water (indicate location and type of study)

 

New substance.  Not available, not required

Ground water (indicate location and type of study)

 

New substance.  Not available, not required

Air (indicate location and type of study)

    

New substance.  Not available, not required

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data

 

Candidate for R53 and S60/61

 

Appendix 1: Metabolite names, codes and other relevant information of the pesticide Calypso with a.s. thiacloprid.

 

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of thiacloprid. The parent compound structure of thiacloprid (YRC 2894) is shown first in this list and followed by degradate or related compounds.

 

Compound name

Code number(s)

IUPAC name

Structural formula

Structure

Molecular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

thiacloprid

YRC 2894

(Z)-N-{3-[(6-chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide

C10H9ClN4S

252.73

parent

thiacloprid amide

 

M02

KKO 2254

(Z)-[3-[(6-chloro-3-pyridinyl)methyl]-2-thiazolidinylidene]urea

C10H11ClN4OS

270.7

Soil: 74% (deg route)

Water: 62%

Sediment: 36% (wat/sed study)

 

thiacloprid sulfonic acid

 

M30 WAK6999

2[1-(6-chloropyridine-3-ylmethyl)-3-carbamoyl-ureido]-ethane sulfonic acid sodium salt

 

 

336.8

Soil: 20% (deg route)

Water: 9.5% (water/sed study)

Leachate 2.4 µg/L(lysimeter)

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS[4] method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM[5]-report 601782001/2007[6].

 

For the current application this means the following:

 

Thiacloprid

The following laboratory DT50 values (20°C, pF2) are available for the active substance thiacloprid: 0.7-5.0 days (n=4, r2=0.97-0.99, geometric mean 1.3 days). The mean DT50-value of the a.s. can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

 

There are field studies available (although not required), from which only the Northern European studies are considered representative for The Netherlands (DT50 of 9-27 days, n=6). In this way, the standards for persistence as laid down in the RGB are met for thiacloprid.

 

The following metabolites are formed in amounts > 10 %: M02 in amounts of 60-74% after 3-30 days (n=4) and M30 in amounts of 4.5-20% after 14-100 days (n=4).

 

M02

For the metabolite M02 the following DT50-values (20°C, pF2, lab) are available: 32-142 days (n=4, geomean 41.7 days). Although the threshold value of 60 days for the mean DT50 (lab) was not exceeded, the available field dissipation studies for M02 show DT50 values of > 90 days. Only the Northern EU studies are considered representative for the Dutch conditions: 46-314 days (n=6, non-normalised). No mean value is given in the LoEP. The field DT90 is 153-1047 days (n=4). From the DAR the following individual SFO field dissipation half-lives are derived: 46, 314, 154, 47, 206, 172. The mean DT50 thus amounts to 156.5 days (geomean 124.4 days). Individual DT90 values are not given but the mean is assumed to be > 1 year.

 

M30

For the metabolite M30 the following DT50-values (20°C, pF2, lab) are available: 16-79 days (n=3, r2=0.98-0.99, geomean 23.4 days). Available Northern-European field studies gave two dissipation DT50 values (based on three data points each) of 138 and 141 days ((geo)mean 139.5 days) (taken from DAR, not included in the LoEP).

 

Based on the above, the proposed application(s) of the pesticide Calypso do not meet the standards for persistence as laid down in the RGB. Because for the metabolites M02 and M30  the field DT50 is > 90 days, it has to be demonstrated that application of the pesticide does not lead to accumulation of the metabolites M02 and M30 to the extent that it will have an unacceptable effect on non-target-organisms. In order to prevent this, the concentration in which the metabolites M02 and M30 is present 2 years after the last application after 10 years of annual application in the upper 20 cm of the soil where the pesticide has been applied (Gp,10) (see Table M.1 and M.2), should not exceed the MPC-INS value for soil organisms.

 

MPCsoil M02

In RIVM report 12437A00 the MPC (maximum permissable concentration, Dutch: MTR) for soil is derived for the metabolite M02.

Data sources

The derivation of the MPC for thiacloprid amide is based on the data available in the EU-dossier. Data from the Draft Assessment Report were re-assessed for their reliability. In addition, an on-line literature search was performed via SCOPUS, available via http://www.scopus.com/. This search did not result in any references from which an endpoint could be derived. In addition studies summarized in the RIVM advise reports 11010A01, 09828A00, 09215A00 and 12431A00 were also considered for this report.

 

Data for human toxicology and secondary poisoning:

If no suitable data are available, according to the INS-method no MPC is derived for these two routes, without further consequences for the final MPC.

Bioconcentration and biomagnification

Since the log Kow is < 3, the trigger for bioconcentration and biomagnification is not exceeded and a risk for bioconcentration does not occur. Derivation of the MPCsp, soil for secondary poisoning is not deemed necessary.

Human toxicological threshold limits and carcinogenicity

In the DAR is stated that the results of the toxicological studies show that thiacloprid amide has a lower acute oral toxicity  (LD50 > 2000 mg/kg bw) than the parent compound thiacloprid (lowest LD50 = 396 mg/kg bw) and that it does do not exhibit mutagenic activity in Ames tests. Therefore, thiacloprid-amide is unlikely to give rise to toxicological concerns and derivation of an MPChuman, soil is not considered relevant. No ADI is derived in the DAR and considering the fact that derivation of an MPChuman, soil is not considered relevant, derivation of an ADI on the basis of toxicity studies in the DAR is not performed.

 

Ecotoxicological effect data

Laboratory data

The available chronic ecotoxicity data for soil organisms and/or processes are summarised in Table M.1.

 

Table M.1 Ecotoxicity data for soil organisms

Taxonomic group

and processes

NOEC

test soil

[mg/kg dwt soil]

NOEC

standard soil 10% OM

[mg/kg dwt soil]

Bacteria

 

 

C-mineralisation

15.7

63.6

Macrophyta

 

 

6 plants

1.25

6.13

Fungi

 

 

5 fungi

30

250

Annelida

 

 

Eisenia fetida

> 1000 a

> 1000 a

Arachnida

 

 

Hypoaspis aculeifer

≥ 1.25

≥ 12.5

Insecta

 

 

Folsomia candida

10

10

a LC50

Field data

Field data are not available for thiacloprid amide.

 

Derivation of the MPCsoil

 

MPCeco,soil – ecotoxicity data

In Table M.1 ecotoxicity data for soil organisms are given. Several of these tests are limit tests that can not lead to fixed NOEC or EC50 values but only to unbound values. Nevertheless they can indicate that there is no high sensitivity for the tested compound. For plants the tested concentrations are close to but below the lowest NOEC. However, the lowest NOEC is for a sensitive insect and terrestrial plants are not expected to be particular sensitive to this substance. For earthworms, a limit test was performed as well that showed that acute effects were above 1000 mg/kg dwt soil. Some unreliable chronic effects were observed at this concentration which could indicate that there is some toxicity at this level but the tested concentration is 100 times higher than the lowest NOEC. In only one of the studies the test concentration range was suitable to determine the NOEC. This endpoint has the same order of magnitude as the lowest unbound values and the dataset covers a wide range of organisms, therefore, an assessment factor of 10 is considered suitable to derive the MPCsoil. The derived MPCeco, soil is 10 / 10 = 1 mg/kgdwt for Dutch standard soil.

 

Considering the large number of valid terrestrial data, derivation of an MPCeco, soil through equilibrium partitioning on aquatic ecotoxicity data is not considered necessary.

 

MPCsp,soil – secondary poisoning

Since the log Kow is < 3, the MPCsoil via secondary poisoning is not derived.

 

Conclusion

The dataset used does contain a large amount of unbound endpoints. The data available does however not give concern that the derived MPCeco, soil would not be protecting for the most sensitive species. Therefore the MPCeco, soil is selected as the MPCsoil: 1 mg/kgdwt for Dutch standard soil.

 

MPCsoil M30

PNECsoil for soil organisms

To enable the calculation of a PNEC value for soil organisms the following data are required:

- Effects on the growth/development of terrestrial plants

- A reproduction study with insects, at least including Folsomia candida (Collembola, according to ISO 11267) Since the a.s. is an insecticide, a second insect species is required.

- A study with soil fungi at least including one genus from an order.

 

Following the TGD approach, a literature search has been performed by the INS working group. No additional data has emerged from this search, therefore, the PNEC for soil organisms is set on the basis of the available data in the dossier.

 

Data present in the List of Endpoints are used for the assessment. Endpoints are not corrected to 3.4 % OM, since the logPow of thiacloprid is below 2 and assumed to be also lower for its metabolites. The PNEC value is derived using the following data as presented in Table M.2.

 

Table M.2 Toxicity data for soil organisms for M30.

Species

Endpoint

Value

[mg/kg]

 

Earthworms

Eisenia fetida

 

NOEC

LC50

 

-

>1000

Terrestrial plants

No data

 

 

Fungi (soil/agar)

No data

 

 

Insects

Folsomia candida

 

NOECreproduction

 

>1000

 

Only one long-term NOEC value is available. Therefore the PNEC is based on an assessment factor on this NOEC of 100. This leads to a PNEC of > 10 mg/kg.

 

PNECsoil for soil processes

No separate tests with M30 have been conducted. The PNEC for soil processes is therefore derived from studies with thiacloprid (NOEC 2.57 mg a.s./kg) assuming a NOEC of 10 % of the NOEC for the parent (worst-case since maximum formation is 4.5-20 %, but only at levels > 10 % the metabolite needs to be assessed). This leads to endpoints (NOEC values) of 0.26 mg/kg for mineralisation and 0.26 mg/kg for nitrogen transformation.

With a total of 2 NOEC values available, a safety factor of 50 must be applied, resulting in a PNEC value for soil processes of 0.0052 mg/kg.