Toelatingsnummer 11754 N

SAFARI  

 

11754 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VEREENVOUDIGDE UITBREIDING

 

Gelet op de aanvraag d.d. 7 juni 2011 (20110552 VUG) van

 

Du Pont de Nemours (Nederland) B.V.

Baanhoekweg 22

3313 LA  DORDRECHT

 

 

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

 

SAFARI

 

gelet op artikel 31, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

1.                  Het gebruiksgebied van het middel SAFARI wordt met ingang van datum dezes uitgebreid met de toepassing in witlof en cichorei. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.                  Het middel wordt toegelaten tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie.

 

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: Water dispergeerbaar granulaat

 

werkzame stof:

gehalte:

triflusulfuron-methyl

50 %

 

 

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

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.

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

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

 

 

Specifieke vermeldingen:

 

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

 

  1. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

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

 

 

    1. bij het toelatingsnummer een cirkel met daarin de aanduiding W.5.

 

De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel SAFARI
(11754 N), een middel op basis van de werkzame stof triflusulfuron-methyl. Het middel is reeds toegelaten als onkruidbestrijdingsmiddel in de teelt van bieten. Het middel is bij dit besluit toegelaten tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie. Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel voor de teelt van witlof en cichorei gevraagd.

 

Ten aanzien van de volgende aspecten is verzocht de vereenvoudigde uitbreidingsprocedure  te volgen:

 

- Fysische en chemische eigenschappen

- Analysemethoden

- Werkzaamheid

 

2.2 Informatie met betrekking tot de stof

Het betreft een middel dat de werkzame stof triflusulfuron-methyl bevat die per 1 januari 2010 geplaatst is op Annex I van richtlijn 91/414 (Richtlijn 2009/77/EG, 1 juli 2009) en is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst als stof 289 in de bijlage.

 

 

2.3 Karakterisering van het middel

SAFARI bevat de werkzame stof triflusulfuron-methyl. Triflusulfuron-methyl is een herbicide dat behoort tot de sulfonylureum verbindingen. Het middel werkt door verstoring van de aminozuursynthese.

 

2.4 Voorgeschiedenis

De aanvraag is op 10 juni 2011 ontvangen; op 8 juni 2011 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 23 juli 2012 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

De beoordeling van deze aanvraag is conform Rgb d.d. 13 juni 2011 en Evaluation Manual 1.1.

 

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 SAFARI op basis van de werkzame stof triflusulfuron-methyl 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, 5 april 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. 5 april 2013 tot vereenvoudigde uitbreiding van de toelating van het middel SAFARI, toelatingnummer 11754 N

 

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Wettelijk Gebruiksvoorschrift

Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel door middel van een na opkomst toepassing in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden

 

Toepassingsgebied

Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per teeltcyclus

Maximaal aantal kg middel per ha per teeltcyclus

Minimum interval tussen toepassingen in dagen

Bieten

breedbladige onkruiden

30 g/ha*

4

0,12

7

* in LDS-systeem in combinatie met toegelaten middelen

 

 

Het gebruik in de teelt van witlof en cichorei is beoordeeld conform de “vereenvoudigde uitbreidingsprocedure”. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in dit/deze toepassingsgebied(en), komt voor risico en verantwoordelijkheid van de gebruiker.

 

Toepassings-

gebied

Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Maximaal aantal kg middel per ha per 12 maanden

Minimum interval tussen toepassingen in dagen

Witlof
(pennenteelt en zaadteelt)

breedbladige onkruiden

10-30 g/ha*

4

0,06

14

Cichorei

breedbladige onkruiden

10-30 g/ha*

4

0,06

14

* in LDS-systeem in combinatie met toegelaten middelen

 

Toepassingsvoorwaarden

 

Het middel dient te worden toegepast in 150-400 liter water per ha.

 

Het loof van behandelde gewassen mag niet aan vee worden vervoederd.

 

Niet meer dan 120 g product/ha per 3 jaar toepassen op hetzelfde perceel in de teelt van suikerbiet en voederbiet.

 

Volg- en vervanggewassen

Gezien de aard van het middel kan niet uitgesloten worden dat er negatieve effecten op bepaalde volg- en vervanggewassen op kunnen treden

Na  toepassing in bieten kunnen onder stresscondities enkele dagen na toepassing gele vlekjes op het blad verschijnen welke echter weer snel verdwijnen.

 

Om niet tot de doelsoorten behorende planten te beschermen is toepassing in de teelt van witlof en cichorei uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal 50% driftreducerende spuitdoppen.

 

Het middel kan in de teelt van witlof en cichorei chlorose en een (tijdelijke) groeiremming veroorzaken.

 

Resistentiemanagement

Dit middel bevat de werkzame stof triflusulfuron-methyl. Triflusulfuron-methyl behoort tot de sulfonylureumverbindingen. De HRAC code is B. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen op te volgen.


 

 

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 5 april 2013 tot vereenvoudigde uitbreiding van de toelating van het middel SAFARI, toelatingnummer 11754 N

 

Contents

 

 

                                                                                                                                              Page

1.     Identity of the plant protection product 4

2.     Physical and chemical properties. 4

3.     Methods of analysis. 5

4.     Mammalian toxicology. 5

5.     Residues. 11

Calculation of the ADI 15

6.     Environmental fate and behaviour 16

7.     Ecotoxicology. 44

8.     Efficacy. 64

9.     Conclusion. 64

10.       Classification and labelling. 64

Appendix 1  Table of authorised uses. 1

Appendix 2  Reference list 2

 


1. Identity of the plant protection product

 

1.1       Applicant

Du Pont de Nemours (Nedeland) B.V.

Crop Protection Products- St 18M

Baanhoekweg 22, 3313 AC Dordrecht

 

1.2       Identity of the active substance

 

ISO name

Triflusulfuron-methyl

Name in Dutch

Triflusulfuron-methyl

Chemical name

Methyl 2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid [IUPAC]

CAS no

126535-15-7

EEC no

Not allocated

 

The active substance was included in Annex I of Directive 91/414/EEC on 1 January 2010.

From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC.

 

1.3       Identity of the plant protection product

 

Name

SAFARI

Formulation type

WG

Content active substance

500 g/kg pure active substance

 

1.4       Function

Herbicide

 

1.5       Uses applied for

See GAP (Appendix I).

 

1.6       Background to the application

The application concerns a simplified extension request.

 

1.7       Packaging details

Packaging details do not change.

 

 

2. Physical and chemical properties

 

The physical and chemical properties of the plant protection product remain unchanged.

 

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?

-

Tactile warning of danger obligatory?

-

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 

3. Methods of analysis

 

Residue analytical methods

 

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

HPLC-MS/MS LOQ: 0.01 mg/kg (sugar beet, beet).

ILV available

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

Not required, crops will not be fed

 

Based on the proposed use of the plant production product, the analytical methods for determination of residues in food/feed of plant origin are required to be validated for watery and special matrices (chicory and wild chicory).

 

Definition of the residue and proposed MRLs for triflusulfuron-methyl

Matrix

definition of the residue for monitoring

MRL

Food/feed of plant origin

triflusulfuron-methyl

0.02 mg/kg

Food/feed of animal origin

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

 

The residue analytical methods, included in the abovementioned table, are suitable for monitoring of the MRLs. For wild chicory a specific method would be required. No residues are expected in wild chicory however and therefore no analytical method is required.

 

The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorization of triflusulfuron-methyl. This simplified extension does not give rise to re-assess these residue analytical methods.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs.

 

 

4. Mammalian toxicology

 

List of Endpoints

Triflusulfuron-methyl is an existing active substance, included in Annex I of Directive 91/414/EEC. The final List of Endpoints presented below is taken from the EFSA Scientific Report on triflusulfuron (2008) 195; 1-115 (d.d. 30 September 2008).

 



Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 6.1)

Rate and extent of oral absorption

Rapid, 65% in rats at low dose, based on urine and carcass

Distribution

Well distributed

Potential for accumulation

No potential for accumulation in organs

Rate and extent of excretion

Almost complete in 72 hours via the urine and faeces

Metabolism in animals

Extensively metabolised by hydroxylation/demethylation on the triazine ring and cleavage of the sulphonylurea bridge

Toxicologically relevant compounds
(animals and plants)

Parent compound and metabolites

Toxicologically relevant compounds
(environment)

Parent compound and metabolites

 

Acute toxicity (Annex IIA, point 6.2)

Rat LD50 oral

> 5000 mg/kg bw

Rat LD50 dermal

> 2000 mg/kg bw

Rat LC50 inhalation

> 5.1 mg/L (4 hours, nose only)

Skin irritation

Non irritant

Eye irritation

Non irritant

Skin sensitisation

Non sensitising (M&K)

 

Short term toxicity (Annex IIA, point 6.3)

Target / critical effect

Body weight, food intake/decrease; liver: increased weight/elevated blood enzymes/;hypertrophy; erythrocytes:regenerative anaemia

Relevant oral NOAEL

6.6 mg/kg bw (90 days rat)

Relevant dermal NOAEL

1000 mg/kg bw (21 days in rabbit)

Relevant inhalation NOAEL

No data not required

 

Genotoxicity (Annex IIA, point 6.4)

 

No genotoxic potential

 

Long term toxicity and carcinogenicity (Annex IIA, point 6.5)

Target/critical effect

Decreased body weight, food consumption and RBC (rat); decreased body weight and increased liver weight (mice)

Relevant NOAEL

4.06 mg/kg/d, 2 year feeding study in male rat

20.9 mg/kg bw/day (male) in 18 month study in mice

Carcinogenicity

Testis/increased incidence of Leydig cell hyperplasia and adenoma in male rat.

Liver slight increased adenomas in male mice

R40

 

Reproductive toxicity (Annex IIA, point 6.6)

Reproduction toxicity

Reproduction target / critical effect

Decreased bw in pups, no reproductive effects

 

Relevant parental NOAEL

5.8 mg/kg bw

 

Relevant reproductive NOAEL

≥ 89.5 mg/kg bw

 

Relevant offspring NOAEL

5.8 mg/kg bw

 

 

Developmental toxicity

Developmental target / critical effect

No teratogenic potential in rabbit

Developmental effects in rat at maternotoxic doses.

 

Relevant maternal NOAEL

120 mg/kg bw in rat

15 mg/kg bw in rabbit

 

Relevant developmental NOAEL

≥ 800 mg/kg bw in rabbit

120 mg/kg bw in rat

 

 

Neurotoxicity/Delayed neurotoxicity (Annex IIA, point 6.7)

Acute neurotoxicity

NOAEL (acute): 2000 mg/kg bw (for neurotoxicity)

NOAEL (90 day): 186.2 mg/kg bw/day

 

Repeated neurotoxicity

 

Delayed neurotoxicity

No data, not required

 

 

Other toxicological studies (Annex IIA, point 6.8)

IN-D8526

No mutagenic potential (Ames), ALD 670 mg/kg bw, no aromatase inhibition

IN-E7710

No mutagenic potential (Ames), ALD 670 mg/kg bw, no aromatase inhibition

IN-M7222

No mutagenic potential (Ames, CHO/HPRT, chromosome aberration in vitro), ALD 450 mg/kg bw, no aromatase inhibition.

IN-W6725

No mutagenic potential (Ames, CHO/HPRT, micronucleus), no aromatase inhibition

Other impurities

Toxicological studies provided for impurities IN-JH152, IN-KE010, IN-KH237, and IN-JK541: ALD > 5000 mg/kg bw; negative in vitro mutagenicity studies for IN-KE010, IN-KH237, and IN-JK531

 

Medical data (Annex IIA, point 5.9)

 

No adverse effects related to triflusulfuron

 

Summary (Annex IIA, point 5.10)

Value

Study

Safety factor

ADI

0.04 mg/kg/d

2 year study in rat

100

AOEL

0.04 mg/kg/d

90 day study in rat

100, corrected for 65% oral absorption

ARfD

1.2 mg/kg bw

Rat developmental study

100

                                                                                              

Dermal absorption (Annex IIIA, point 7.3)

In vitro dermal absorption in human skin (Triflusulfuron 50 WG, DEBUT, SAFARI)

50% (concentration and dilution)

 

Local effects

Triflusulfuron-methyl does not produce local effects, neither after a single nor repeated exposure.

 

Data requirements active substance

In PRAPeR meeting 48 it was concluded that for the metabolites IN-M7222 and IN-E7710 no specific reference values could be set as the toxicological database was to limited. Therefore, it was stated in the EFSA conclusion that it is not possible to perform a consumer risk assessment. To fill this data gap additional information was provided by the applicant, which was included in an addendum to the DAR (post annex 1 inclusion) by the RMS (France). The addendum has been commented on by EFSA and by the member states and was subsequently revised by the RMS.

 

A 90-day oral toxicity study was submitted for the metabolites IN-M7222. In the study a NOAEL of 3 mg/kg bw/day was set based on decreased body weight and food consumption. This leads to an ADI of 0.003 mg/kg bw/day with a safety factor of 1000 (additional 10 for extrapolating from subchronic to chronic).

For IN-E7710 no 90-day toxicity study is available. It was concluded that the ADI of IN-M7222 can be used based on the close structural similarity and the available toxicological information for IN-E7710 (IN-E7710 was of lower acute oral toxicity compared to IN-M7222). The use of the ADI of IN-M7222 for IN-E7710 was agreed upon by EFSA and the member states during the commenting phase.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation SAFARI does not need to be classified on the basis of its acute oral (LD50 rat > 5000 mg/kg bw), dermal (LD50 rat >2000 mg/kg bw), and inhalation toxicology (LC50 rat > 6.1 mg/L).

 

The formulation SAFARI is not classifiable as a skin or eye irritant.

 

The formulation SAFARI does not have sensitising properties in a Maximisation test.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

See List of Endpoints. The in vitro dermal absorption study was performed with the formulation SAFARI.

 

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

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

 

4.4       Exposure/risk assessments

 

Overview of the intended uses

An application has been submitted for the extension of the plant protection product , a herbicide based on the active substance triflusulfuron-methyl.

 

is a WG formulation and contains 500 g/kg triflusulfuron-methyl.

 

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 triflusulfuron-methyl no TLV has been set. The AOEL will be used for the risk assessment.

 

Since the formulation is applied 1-4 times during the period April - June, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.

 

Since triflusulfuron-methyl is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.04 mg/kg bw/day (= 2.8 mg/day for a 70-kg operator), based on the 90-day study in rat is used for the risk assessment (see List of Endpoints).

 

Exposure/risk

Exposure to triflusulfuron-methyl during mixing and loading and application of 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.

 

Table T.1 Internal operator exposure to triflusulfuron-methyl and risk assessment for the use of

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on chicory (roots) and wild chicory, 0.015 kg a.s/ha (uncovered)

Mixing/

Loadingc

Respiratory

<0.01

2.8

<0.01

Dermal

0.50

2.8

0.18

Applicationd

Respiratory

<0.01

2.8

<0.01

Dermal

0.23

2.8

0.08

 

Total

0.73

2.8

0.26

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   50% (concentrate) and 50% (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 NL-model.

d    External exposure is estimated with EUROPOEM

 

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

 

4.4.2    Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

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.

The exposure is estimated for the unprotected worker. In Table T.2 the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.2  Internal worker exposure to triflusulfuron-methyl and risk assessment after application of SAFARI

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Re-entry activities in chicory and wild chicory

 

Respiratory

-

-

-

Dermal

0.34

2.8

0.12

 

Total

0.34

2.8

0.12

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

·       biological availability via the dermal route:  50% (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.

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

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

The product complies with the Uniform Principles..

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to triflusulfuron-methyl as a result of the application of SAFARI in chicory and wild chicory.

 

Bystander exposure

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no adverse health effects to bystanders are expected.

 

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 chicory and wild chicory due to exposure to triflusulfuron-methyl after application of SAFARI.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints 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

SAFARI 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 and labelling of the formulation concerning health

The current classification and labelling, 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:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

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

Child-resistant fastening obligatory?

-

Tactile warning of danger obligatory?

-

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 

5. Residues

 

List of Endpoints

The List of Endpoints presented below is obtained from the Conclusion on the peer review of triflusulfuron Issued on 30 September 2008, EFSA Scientific Report (2008) 195, 1-115. The List of Endpoints presented below is the most recent before the publishing of the review report finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 26 February 2009 in view of the inclusion of triflusulfuron in Annex I of Directive 91/414/EEC and the meeting on 9 March 2012 on which the Standing Committee has taken note of the revision of the review report after the assessment of the addendum to the DAR. Dutch comments, when relevant, are presented in italics.

 

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

Plant groups covered

root vegetables (sugar beets)

Rotational crops

Lettuce, Radish, Carrot, Sorghum and Wheat

Plant residue definition for monitoring

wheat, lettuce, sugar beet, broccoli

Metabolism in rotational crops similar to

metabolism in primary crops?

No IN-M7222 and IN-N7710* accumulate in

rotational crops.

Processed commodities

 

Residue pattern in processed commodities

similar to residue pattern in raw commodities?

-

Plant residue definition for monitoring

IN-M7222

Plant residue definition for risk assessment

IN-M7222 and IN-N7710

Conversion factor (monitoring to risk assessment)

None

* the metabolited IN-E7710 is misnamed in the List of Endpoints as IN-N7710

 IN-M7222 = N,N-bis-desmethyl triazine amine, IN-E7710 = N-desmethyl triazine amine

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

Animals covered

Goat

Time needed to reach a plateau concentration

in milk and eggs

48 h

Animal residue definition for monitoring

IN-M7222

Animal residue definition for risk assessment

IN-M7222

Conversion factor (monitoring to risk assessment)

None

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

No

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

 

Residues of triflusulfuron methyl below LOQ

IN-M7222 and IN-N7710 accumulates in barley

and broccoli. Further rotational crop studies are

required

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

 

IN-M7222 and IN-N7710 are stable for up to 18

months at < -18°C

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

Further data are required to address the level of residues in livestock.

Ruminant:

 

Poultry:

 

Pig:

 

 

Conditions of requirement of feeding studies

Expected intakes by livestock ≥ 0.1 mg/kg diet

(dry weight basis) (yes/no - If yes, specify the

level)

YES

-

-

Potential for accumulation (yes/no):

 

-

-

Metabolism studies indicate potential level of

residues ≥ 0.01 mg/kg in edible tissues (yes/no)

 

-

-

Muscle

-

-

-

Liver

-

-

-

Kidney

-

-

-

Fat

-

-

-

Milk

-

 

 

Eggs

 

-

 

 

 

 

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

Crop/processed crop

 

Number

of studies

Transfer factor

% Transference

N/A

 

 

 

 

Comments on/additions to List of Endpoints

Points that are not covered by the List of Endpoints or that need clarification are discussed below.

 

5.1       Summary of residue data

The following assessment is based on the draft assessment report (May 2007) and

the addendum to the DAR (December 2010) prepared  Rapporteur Member State France. In the addendum to the DAR additional data were assessed to support the additional representative uses on red beet and chicory. These data were not pointed out as “confirmatory data” in the part B of the Inclusion Directive. The additional data were, from RMS point of view, necessary to demonstrate additional safe use for triflusulfuron. At its meeting on 26 February 2009 the Standing Committee on the Food Chain and Animal Health decided on the inclusion of triflusulfuron in Annex I of Directive 91/414/EEC and after the assessment of the addendum to the DAR, on 9 March 2012 the Standing Committee revised the review report in support of an amendment to the conditions for approval for triflusulfuron (SANCO/4439/09 – final rev. 1).

 

5.1.1    Metabolism in plants

The metabolism of 14C-triflusulfuron-methyl in sugar beets was studied in a small-scale field plot and in a greenhouse at approximately 100 g a.s./ha, approximately twice the maximum anticipated seasonal use rate. The concentration of total radiolabel, expressed as triflusulfuron-methyl equivalents, declined rapidly in the sugar beet plants, falling from 4 to 5 mg/kg on day 0 to approximately 0.1 mg/kg 28 days after treatment. By day 14, residues of triflusulfuron-methyl had declined to <0.01 mg/kg. There were no significant residues of triflusulfuron-methyl or its transformation products (<0.01 mg/kg) in mature sugar beet roots.

The principal metabolites found in plant samples/tops of 14C-carbonyl and 14C-triazine triflusulfuron-methyl were N-desmethyl triazine amine (IN-E7710; <0.022 mg/kg), N,N-bis-desmethyl triazine amine (IN-M7222; <0.024 mg/kg), the acid sulfonamide (IN-JJ98713; <0.01 mg/kg) and its glucose conjugate (also <0.01 mg/kg). The metabolic breakdown of triflusulfuron-methyl involves cleavage of the sulfonylurea bridge that is followed by further metabolism of the initial degradation products.

 

The metabolism provided in sugar beet included roots and leaves. It contains enough information on leaves and roots to support chicory witloof use.

 

5.1.2    Metabolism in livestock

In the original DAR, the need for animal studies was not triggered as residues of triflusulfuron-methyl were low. However, as the metabolites IN-M7222 and IN-E7710 are in the residue definition and there are significant residues in rotational crops the need for animal studies is triggered. Intakes are 0.14 mg/kg DM/day for both dairy and beef cattle, which exceeds the trigger of 0.1 mg/kg DM/day.

 

Two metabolism studies in lactating goat were submitted. In the first study the goats were dosed at a rate of 15 mg/kg DM/day, which is circa 100 N, with either triazine or carbonyl labelled triflusulfuron-methyl. No significant metabolites were found from the carbonyl label. From the triazine label several metabolites were identified: IN-M7222 was present at 0.013 mg/kg in milk; at 0.009 mg/kg in liver and 0.014 mg/kg in kidney. The metabolite IN-E7710 was present at 0.007 mg/kg in milk and 0.007 mg/kg in liver but was not analysed for in kidney. The metabolite IN-D8526 was present at 0.015 mg/kg in milk; 0.027 mg/kg in liver and 0.016 mg/kg in kidney. IN-6603614 was present at 0.002 mg/kg in milk, 0.005 mg/kg in liver and 0.012 mg/kg in kidney. Triflusulfuron-methyl was also present but is not of interest since livestock intakes would be of metabolites and not of triflusulfuron-methyl. In the second study, goats were dosed with the same material as the first study but at circa 1N. The metabolites identified were the same as in the first study.

 

The main issue with these studies is that animals had been dosed with triflusulfuron-methyl whereas livestock would not be exposed to this compound but would be exposed to the metabolites IN-M7222 and IN-E7710. Although not found during the goat metabolism the meeting of experts concluded that metabolite IN-M7222 and IN-E7710  that have the same molecular structure as  IN-D8526 are highly likely to be formed from the parent molecule.

 

5.1.3    Residue definition (plant and animal)

From the metabolism data it is clear that triflusulfuron-methyl will not be present at harvest as it is rapidly metabolised therefore it is not in the residue definition. The only compounds that might be present are IN-M7222 and IN-E7710. These two metabolites are more toxic than the triflusulfuron-methyl. On the basis of this information the residue definition for risk assessment is set as IN-M7222 and IN-E7710. The monitoring residue definition is IN-M7222 since this is a good marker compound.

 

The meeting of experts concluded that the animal residue definition for monitoring and risk assessment should be IN-M7222. Since very limited field trial data are available to accurately quantify the metabolites IN-M7222 and IN-E7710 a conversion factor (monitoring to risk assessment) could not be determined.

 

5.1.4    Stability of residues

The stability of IN-M7222 and IN-E7710 in a freezer storage stability study was investigated. The study demonstrated that these metabolites are stable for at least 12 months at -20 ºC.

 

5.1.5        Supervised residue trials

Chicory root, root crop intended for witloof production or wild chicory roots as sugar plant

(cGAP-NL: cGAP-NL:4x0.015 kg as/ha, interval 14d, (BBCH 10-39) PHI n.a.)

In the addendum to the DAR (December 2010) two residue trials in chicory roots are evaluated. The submitted study provides information about two trials carried out at two sites in northern France over one season.  Chicory was treated with four application of triflusulfuron methyl at 15 mg/ha between BBCH 12 and BBCH16 the critical GAP. The application stage is significantly earlier than the critical GAP (BBCH39), however, decline studies show that no residues are expected in any part of the plant 14 days after the last application and it is reasonable to  assume submitted trials cover the intended GAP.

 

No data was provided on witloof, the chicory roots were not forced to produced witloof because residue level were below the level of detection in all samples. It is however very unlikely that residue concentrate in witloof leaves above the LOQ, if no residues were detected in the root.

 

5.1.6    Residues in succeeding crops

A confined rotational crop study was conducted, which showed that the only significant residues were the same as those seen in primary crops and this was confirmed by a radio labelled field study. It was considered by the meeting of experts that the cold rotational crop study was not sufficient to fully quantify residues in rotational crops and a data gap was identified. A new crop rotation study is underway following the EU peer review conclusions. However, for the time being, the consumer risk assessment was performed using a worst case scenario for all input parameters. The safety margin that resulted from this calculation shows that the use of triflusulfuron methyl chicory, does not bring to light any unacceptable risk for the European consumer.

 

5.1.7    Residues from livestock feeding studies

The dietary burden to livestock from ingestion of triazine metabolites (IN-E7710, IN-M7222) from primary or rotational crops is very low. Considering the facts of low levels metabolite in dietary burden and further metabolism of triazine amines and rapid excretion, there is no reasonable anticipation of occurrence of either IN-M7222 or IN-E7710 above the limit of quantification (<0.01 mg/kg) in animal edible tissues. Although not found during the goat metabolism, metabolite IN-M7222 and IN-E7710  that have the same molecular structure as  IN-D8526 are highly likely to be formed from the parent molecule at levels significantly higher than worst case 1x levels predicted form the dietary burden calculation. Hence it can be concluded that a livestock feeding study is not necessary anymore to perform risk assessment. A feeding restriction for triflusulfuron-methyl treated crops is not required.

 

5.1.8    Processing factors

Processing studies are not required as residues are low.

 

5.1.9    Calculation of the ADI and the ARfD

Calculation of the ADI

An ADI of 0,003 mg/kg was set for metabolite IN-M7222 based on a 90 day rat dietary study on which a NOAEL of 3 mg/kg was determined and a safety factor of 1000.  The standard safety factor 100-fold for inter- and intra-species variations is used and an extra10-fold for extrapolating from a subchronic to chronic study duration and for setting the ADI on a LOAEL instead of a NOAEL.This ADI is also applicable to IN-E7710 so it covers the new residue definition for risk assessment.

 

Calculation of the ARfD

Neither IN-M7222 nor IN-E7710 is acutely toxic and no ARfD was deemed necessary.

 

5.2       Maximum Residue Levels

In Annex IIIA of Regulation (EC) 396/2005 EU-MRLs of 0.02* mg/kg (=LOQ) are present for triflusulfuron in witloof and chicory root. The product complies with the MRL Regulation. Considering the new definition of residue for triflusulfuron methyl, MRL for plants should be expressed as IN-M7222  which LOQ  is 0,01 mg/kg.

 

5.3       Consumer risk assessment

Initial consumer risk assessment could not be finalized because no toxicological reference values were available to support the new residue definition that was set during the European peer reviewed evaluation (N,N-bis-desmethyl triazine amine (IN-M7222) and N-desmethyl triazine amine (IN-E7710)). A toxicological assessment of these two metabolites being available nowadays, a new consumer risk assessment was performed including the uses in chicory witloof.

 

Risk assessment for chronic exposure through diet

An ADI of 0,003 mg/kg was set for metabolite IN-M7222, which is also applicable to IN-E7710 hence it covers the new residue definition for risk assessment.

 

European consumer exposure was evaluated for the intended uses with the EFSA PRIMo 2 model using the following values:

For risk assessment, the definition of residue is the sum of IN-M7222 and IN-E7710. For these metabolites, both LOQs were set at 0.01 mg/kg. Hence the MRL value used for consumer risk assessment is the sum of the LOQ, i.e. 0.02* mg/kg.

 

For sugar beet foliage, 10 trials are available in the DAR, the results for metabolites of IN-M7222 and IN-E7710 were:

- IN‑E7710 is observed in 3 locations only and below the LOQ (<0.010 mg/kg)

- IN‑M7222 is detected in 3 locations at very low levels, < 0.010, 0.010 and 0.019 mg/kg respectively.

The value used for risk assessment is the sum of median value for IN-M7222 and the LOQ for IN-E7710, i.e. 0.02 mg/kg.

 

Results of chronic risk assessment show that worst case TMDI account for 15.3% of the ADI for UK toddler, the main contributor being sugar beet root. All other TMDI calculated for European consumers account for less than 10% of the ADI.

 

Risk assessment for acute exposure through diet

No ARfD was proposed for this compound, short term dietary exposure was not relevant.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to triflusulfuron-methyl is currently expected, when SAFARI is authorised for the intended uses.

The product complies with the MRLS in Annex IIIa to Regulation (EC) 396/2005 for chicory witloof and chicory root.

 

5.4              Data requirements

No data requirements were identified.

 

 

6. Environmental fate and behaviour

 

Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011).

 

Triflusulfuron-methyl is an existing active substance and is included in Annex I since 01/01/2010 (directive 2009/77/EC d.d. 01/07/2009). In the inclusion directive Part b, confirmatory data has been set relating to the relevance of metabolites IN-M7222, IN-D8526 and IN-E7710 if Triflusulfuron is classified as carcinogenic category 3. The Notifier submitted the required data, which has been evaluated in Addendum to Volume 3 – Annex B.2, B.5, B.6, B.7, B.8 and B.9 (rev. December 2010). In addition the Notifier also submitted data to support the additional representative uses on red beet and chicory. At last the notifier also submitted additional data in order to amend the restriction in the inclusion  directive Part A: “Use only every third year on the same field”. All additional data were evaluated in the Addendum and led to the following conclusions:

-          the proposed GAP on sugar and fodder beet (with applications every year) can be considered acceptable for operator, bystander, worker, consumer and environment. Therefore, it can be concluded that the restriction “Use only every third year on the same field” can be modified as follow: “Only uses as a herbicide at max 60 g/ha per year may be authorized”.

-          at the predicted environmental concentrations in groundwater obtained for applications every year the metabolites IN-M7222 (N,N-bis-desmethyl triazine amine), IN-D8526 (triazine amine) and IN-E7710 (N-desmethyl triazine amine) are not relevant according to the guidance document on the assessment of relevant metabolites in groundwater (Sanco/221/2000, rev.10, 25/02/2003).

-          it can be proposed to include the GAP on red beet and chicory in annex I of Directive 91/414/EEC and to revise the Review Report accordingly.

 

The underlying risk assessment is based on the revised List of Endpoints from the EFSA Conclusion as presented in the Addendum. Data and revisions described in the Addendum, are indicated with grey shading. The most recent version of the Addendum (revised December 2010) has not yet amended to the comments of the latest reporting table dated February 2011. However for the section Fate & Behaviour in the Environment, only textual comments have been made by EFSA which have no consequences for the LoEP presented in the Addendum (rev. December 2011).

 

List of Endpoints Fate/behaviour  (revised LoEP, Addendum December 2010)

 

 

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

Anaerobic degradation ‡ (aerobic 5d/anaerobic 62 d)

Mineralization after 100 days

 

<0.1 % after 62 d, [14C- ester carbonyl ]-label (n=1)

<0.8 % after 62 d, [14C- triazine]-label (n=1)

Non-extractable residues after 100 days

 

9.6-10.5 % after 62 d, [14C- ester carbonyl ]-label (n=1)

29.9 % after 62 d, [14C- triazine]-label (n=1)

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

IN-W6725 - 57.7 % (5 d) / 71.7-77.4 % (62 d), [14C- ester carbonyl ]-label (n=1)

IN-D8526 : 47.4 % (5 d) / 57.2 % (62 d), [14C- triazine]-label (n=1)

Soil photolysis ‡

 

Continuous artificial light (Xenon) during 15 days (equivalent to 75 d natural summer sunlight at latitude 52° N)

The information obtained from the aerobic laboratory studies clearly indicate that microbial degradation is significantly faster than photolysis at 52°N. Despite the fact that the estimated photolytic DT50 will probably be shorter at latitude of 30-40°N, it is not expected to lead to a significant competitive process in field for the intended use.

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

- dark conditions:

IN-W6725 : max. 62.4 % after 15 d, [14C- ester carbonyl ]-label (n=1)

IN-D8526 : max. 47.5 % after 15 d, [14C- triazine]-label (n=1)

- continuous artificial light:

IN-W6725 : max. 11.7 % after 15 d, [14C- ester carbonyl ]-label (n=1)

IN-66036 : max. 12.2 % after 2 d, [14C- ester carbonyl ]-label (n=1)

IN-D8526 : max. 11.8 % after 15 d, [14C- triazine]-label (n=1)

IN-JM000 : 13.5 % after 15 d, [14C- triazine]-label (n=1)

IN-JL000: non-transient minor, max 7.1% after 2 days, [14C- triazine]-label (n=1)

 

 

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

Laboratory studies ‡

Triflusulfuron-methyl

Aerobic conditions – Persistence and modelling endpoints

Soil type

X[1]

pH

t. oC / % MWHC

DT50 /DT90 (d)

DT50 (d)

20 °C pF2/10kPa

St.

2)

Method of calculation

Sandy loam (Somersham)

 

7.8

25 / 75% of pF2.5

5.7/19

ü        6

9

SFO

Loamy sand (Speyer 2.2)

 

6.1

20 / 42% MWHC

6.2/21

9

SFO

Sandy loam (Alstedgard)

 

8.1

20 / 42% MWHC

5.3/18

6

SFO

Loamy sand (Duelman)

 

5.2

20 / 42% MWHC

15/48

6

SFO

Silt (Soest)

 

7.3

20 / 42% MWHC

6.4/21

7

SFO

Silt (Soest)

 

7.3

20 / 42% MWHC (low dose rate: 5g/ha)

8.8/29

7*

5

SFO

Silt (Soest)

 

7.3

20 / 21% MWHC

7.3/24

3*

4

SFO

Silt (Soest)

 

7.3

10 / 42% MWHC

21/69

8*

16

SFO

Geometric mean/median DT50

 

8.4/6.9

6.5/6.0

-

SFO

* The four values for Soest soil were averaged before calculating the mean and median for all soils (then, there is only one value for Soest soil, not 4).

 

IN-W6725

Aerobic conditions – Persistence & modelling endpoints

Soil type

 

X1

pH

t. oC / % MWHC

DT50/ DT90
(d)

 f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

2)

Method of calculation

Silt loam (Mattapex)

 

5.9

20 / 50% MWHC

107/354

-

ü             87

5

SFO

Sandy loam (Handorf)

 

5.8

20 / 50% MWHC

403/1340

-

2

SFO

Clay (San Pietro)

 

7.9

20 / 50% MWHC

124/413

-

2

SFO

Sandy clay loam (Hidalgo)

 

7.8

20 / 50% MWHC

372/1237

-

1

SFO

Clay loam (Lleida)

 

7.5

20 / 50% MWHC

101/337

-

3

SFO

Loamy sand (Mattapex)

 

6.6

20 / 50% MWHC

31/103

-

3

SFO

Clay loam (Pesaro)

 

7.6

20 / 50% MWHC

88/293

-

3

SFO

Loamy sand (Speyer)

 

5.7

20 / 50% MWHC

13/43

-

2

SFO

Geometric mean/median

-

-

-

79/89

-

SFO

 

IN-D8526

Aerobic conditions –Persistence & modelling endpoints

Soil type

 

X1

pH

t. oC / % MWHC

DT50/ DT90
(d)

 f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

2)

Method of calculation

Sandy loam (Handorf)

 

5.8

20 / 50% MWHC

167/556

-

152

5

SFO

Silt loam (Mattapex)

 

5.9

20 / 50% MWHC

369/23731

-

303

586

5

DFOP2

DT90DFOP/3.32

Loamy sand* (Speyer 2.2)

 

6.1

20 / 42% MWHC

108/359

0.64

108

14

SFO

Clay (San Pietro)

 

7.9

20 / 50% MWHC

74/246

-

62

4

SFO

Sandy loam* (Somersham)

 

7.8

25 / 75% of pF2.5

40/134

0.8

**

20

SFO

Loamy sand (Duelman)

 

5.2

20 / 42% MWHC

664/2207

1

552

15

SFO

Geometric mean for acidic soils (pH<7)

Worst-case for alkaline soils (pH>7)

-

-

284

62

-

SFO

* study conducted on parent substance

** not reliable for modelling

1 Persistence endpoint. Kinetic parameters: m0=103.4% AR, k1=0.086 day-1, k2=0.001 day-1, g=0.335

2 If the model allows the use of a DFOP kinetics. Otherwise, use DT90/3.32. The DT90/3.32 value is used in the calculation of the geometric mean.

 

IN-E7710

Aerobic conditions – Persistence & modelling endpoints

Soil type

 

X1

pH

t. oC / % MWHC

DT50/ DT90
(d)

 f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

2)

Method of calculation

Silt loam (Mattapex)

 

5.9

20 / 45% MWHC

226/12251

143/4743

-

2

5

DFOP

SFO

Sandy loam (Handorf)

 

5.8

20 / 45% MWHC

393/>100002

159/5273

-

2

5

FOMC

SFO

Clay (San Pietro)

 

7.9

20 / 45% MWHC

273/906

-

5

SFO

Sandy clay loam (Hidalgo)

 

7.8

20 / 50% MWHC

241/801

-

3

SFO

Clay loam (Lleida)

 

7.5

20 / 50% MWHC

76/251

-

4

SFO

Loamy sand (Mattapex)

 

6.6

20 / 50% MWHC

30/100

-

5

SFO

Clay loam (Pesaro)

 

7.6

20 / 50% MWHC

87/290

-

2

SFO

Loamy sand (Speyer)

 

5.7

20 / 50% MWHC

42/4894

67/2223

-

1

9

DFOP

SFO

Sandy loam* (Somersham)

 

7.8

25 / 75% of pF2.5

183/608

0.73

209

17

SFO

Geometric mean/median

-

-

-

97/109

-

SFO

* study conducted on parent substance

1 Persistence endpoint. Kinetic parameters: m0=100.72% AR, k1=0.057 day-1, k2=0.002 day-1, g=0.277

2 Persistence endpoint. Kinetic parameters: m0=103.5% AR, α=0.185, β=9.455

3 SFO for modelling endpoint

4 Persistence endpoint. Kinetic parameters: m0=94.5% AR, k1=0.055 day-1, k2=0.003 day-1, g=0.482

 

IN-M7222

Aerobic conditions – Persistance & modelling endpoints

Soil type

 

X1

pH

t. oC / % MWHC

DT50/ DT90
(d)

 f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

2)

Method of calculation

Silt loam (Mattapex)

 

5.9

20 / 45% MWHC

182/603

-

ü             138

4

SFO

Sandy loam (Handorf)

 

5.8

20 / 45% MWHC

166/550

-

3

SFO

Clay (San Pietro)

 

7.9

20 / 45% MWHC

292/970

-

228

4

SFO

Sandy clay loam (Hidalgo)

 

7.8

20 / 50% MWHC

486/1614

-

312

3

SFO

Clay loam (Lleida)

 

7.5

20 / 50% MWHC

242/802

-

219

4

SFO

Loamy sand (Mattapex)

 

6.6

20 / 50% MWHC

80/266

-

61

5

SFO

Clay loam (Pesaro)

 

7.6

20 / 50% MWHC

334/1108

-

268

3

SFO

Loamy sand (Speyer)

 

5.7

20 / 50% MWHC

165/547

-

165

6

SFO

Geometric mean/median for acidic soils (pH<7)

Geometric mean/median for alkaline soils (pH>7)

-

118/140

254/248

 

SFO

 

 

Field studies ‡

Parent

Aerobic conditions

Soil type (indicate if bare or cropped soil was used).

Location (country or USA state).

X1

pH (CaCl2)

 

Depth (cm)

DT50 (d)

actual

DT90(d)

actual

St.

2)

DT50 (d)

Norm.

Method of calculation

Silt (0-30cm)

Silt loam (30-90cm)

Bare soil

Northern Germany

 

7.03-7.63

90

5

16.5

6

2

2=6)

SFO

Silt loam (0-30cm)

Silty clay loam (30-70cm)

Silt loam (70-90cm)

Southern Germany

 

6.9-7.6

90

5

16.5

5

3

2=6)

SFO

 

 

IN-D8526

Aerobic conditions

Soil type

Location

 

pH

Depth (cm)

DT50 (d) actual

DT90 (d) actual

St.

(χ 2)

DT50 (d) Norm.

Method of calculation

Silt (0-30cm)

Silt loam (30-90cm)

Bare soil

Northern Germany

 

7.03-7.63

90

85

282

19

33 (χ2=20)

SFO

 

IN-E7710

Aerobic conditions

Soil type

Location

 

pH

Depth (cm)

DT50 (d) actual

DT90 (d) actual

St.

(χ 2)

DT50 (d) Norm.

Method of calculation

Silt (0-30cm)

Silt loam (30-90cm)

Bare soil

Northern Germany

 

7.03-7.63

90

319

1059

26

101 (χ2=28)

SFO

Silt loam (0-30cm)

Silty clay loam (30-70cm)

Silt loam (70-90cm)

Southern Germany

 

6.9-7.6

90

146

485

20

51 (χ2=19)

SFO

 

IN-M7222

Aerobic conditions

Soil type

Location

 

pH

Depth (cm)

DT50 (d) actual

DT90 (d) actual

St.

(χ 2)

DT50 (d) Norm.

Method of calculation

Silt (0-30cm)

Silt loam (30-90cm)

Bare soil

Northern Germany

 

7.03-7.63

90

>300

-

39

>300

2=38)

SFO

Silt loam (0-30cm)

Silty clay loam (30-70cm)

Silt loam (70-90cm)

Southern Germany

 

6.9-7.6

90

63

210

28

31 (χ2=30)

SFO

 

 

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

Yes for IN-D8526 and IN-M7222

Soil accumulation and plateau concentration ‡

 

-

 

Laboratory studies ‡

Parent

Anaerobic conditions

Soil type

X[2]

pH

t. oC / % MWHC

DT50 / DT90 (d)

DT50 (d)

20 °C pF2/10kPa

St.

(r2)

Method of calculation

Sandy loam (Somersham)

 

7.8

25°C, 75% FC for 5 days, then fllooded for up to 62 days

21/-

-

 

Linear first-order

Geometric mean/median

-

-

-

-

-

 

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Triflusulfuron-methyl 

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Sandy loam (Somersham)

1.45

7.3

-

-

0.36

25

0.90

Sandy loam (Hanford)

0.38

6.2

-

-

0.50*

132*

0.94*

Silty clay (Fargo-Ryan)

2.70

7.4

-

-

1.28

47

0.92

Silt loam (Portneuf)

0.79

8.2

-

-

0.41

52

0.94

Loamy sand (Speyer 2.2)

1.93

5.9

-

-

0.67

35

0.92

Arithmetic mean/median

0.68/0.54

40/41

0.92/0.92

pH dependence, Yes or No

No

* Values from this soil are not included in the mean and median. The soil is considered not representative of agricultural soils due to its low organic carbon content.

 

IN-D8526 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Sandy loam (Somersham)

1.45

7.3

-

-

1.05

72

0.91

Sandy loam (Hanford)

0.38

6.2

-

-

5.24*

1379*

0.87*

Silty clay (Fargo-Ryan)

2.70

7.4

-

-

10.1

374

0.88

Silt loam (Portneuf)

0.79

8.2

-

-

1.35

171

0.89

Loamy sand (Speyer 2.2)

1.93

5.9

-

-

1.35

70

0.91

Arithmetic mean/median

3.46/1.35

172/122

0.90/0.90

pH dependence (yes or no)

No

* Values from this soil are not included in the mean and median. The soil is considered not representative of agricultural soils due to its very organic carbon content.

 

IN-E7710 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Sandy loam (Somersham)

1.45

7.3

-

-

0.59

41

0.90

Sandy loam (Hanford)

0.38

6.2

-

-

0.72*

189*

0.89*

Silty clay (Fargo-Ryan)

2.70

7.4

-

-

4.88

181

0.87

Silt loam (Portneuf)

0.79

8.2

-

-

0.87

110

0.85

Loamy sand (Speyer 2.2)

1.93

5.9

-

-

2.43

126

0.80

Arithmetic mean/median

2.19/1.65

115/118

0.86/0.86

pH dependence (yes or no)

No

* Values from this soil are not included in the mean and median. The soil is considered not representative of agricultural soils due to its low organic carbon content.

 

IN-M7222 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Sandy loam (Somersham)

1.45

7.3

-

-

0.61

42

0.95

Sandy loam (Hanford)

0.38

6.2

-

-

0.69*

182*

0.93*

Silty clay (Fargo-Ryan)

2.70

7.4

-

-

3.42

127

0.94

Silt loam (Portneuf)

0.79

8.2

-

-

0.37

47

1.05

Loamy sand (Speyer 2.2)

1.93

5.9

-

-

0.59

31

0.99

Arithmetic mean/median

1.25/0.60

62/45

0.98/0.97

pH dependence (yes or no)

No

* Values from this soil are not included in the mean and median. The soil is considered not representative of agricultural soils due to its low organic carbon content.

 

IN-W6725 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Sandy loam (Somersham)

1.45

7.3

-

-

0.08

6

0.95

Sandy loam (Hanford)

0.38

6.2

-

-

0.16*

42*

1.03*

Silty clay (Fargo-Ryan)

2.70

7.4

-

-

0.59

22

0.95

Arithmetic mean/median

0.34/0.34

14/14

0.95/0.95

pH dependence (yes or no)

No

* Values from this soil are not included in the mean and median. The soil is considered not representative of agricultural soils due to its low organic carbon content.

 

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

Column leaching ‡

 

No data provided. Not required.

Aged residues leaching ‡

No data provided. Not required.

 

Lysimeter/ field leaching studies ‡

 

No data provided. Not required.

 

PEC (soil) (Annex IIIA, point 9.1.3)

Parent

Method of calculation

DT50 (d): 15 days, maximal laboratory value

Kinetics: SFO

Application data

Crop: sugar beet

Depth of soil layer: 5cm

Soil bulk density: 1.5g/cm3

No crop interception

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

 

IN-W6725

Method of calculation

Molecular weight relative to the parent: 0.4

DT50 (d): 403 days

Kinetics: SFO

worst case from lab studies.

Application data

Application rate assumed: 10.044 g as/ha (assumed IN-W6725 is formed at a maximum of 83.7 % of the applied dose)

 

IN-D8526

Method of calculation

Molecular weight relative to the parent: 0.48

DT50 (d): 369 days

Kinetics: DFOP

worst case from lab studies.

Application data

Application rate assumed: 13.29 g as/ha (assumed IN-D8526 is formed at a maximum of 92.3% of the applied dose)

 

IN-E7710

Method of calculation

Molecular weight relative to the parent: 0.45

DT50 (d): 393 days

Kinetics: FOMC

worst case from lab studies.

Application data

Application rate assumed: 4.6035 g as/ha (assumed IN-E7710 is formed at a maximum of 34.1 % of the applied dose)

*Plateau concentration was calculated with the maximal SFO DT50 value of 273 days as it was not reached with the FOMC value.

 

IN-M7222

Method of calculation

Molecular weight relative to the parent: 0.425

DT50 (d): 485 days

Kinetics: SFO

worst case from lab studies.

Application data

Application rate assumed: 1.3898 g as/ha (assumed IN-M7222 is formed at a maximum of 10.9 % of the applied dose)

 

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

Hydrolytic degradation of the active substance and metabolites > 10 % ‡

pH 5: 3.7d at 25 °C (linear 1st order)

IN-W6725: 99.4 % AR ( 30 d), [14C- ester carbonyl ]-label

IN-D8526: 98.4 % AR ( 30 d), [14C- triazine ]-label

 

pH 7: 32 d at 25 °C (linear 1st order)

IN-W6725: 46.4 % AR ( 30 d), [14C- ester carbonyl ]-label

IN-D8526: 47.4 % AR ( 30 d), [14C- triazine ]-label

 

pH 9: 36 d at 25 °C (linear 1st order)

IN-W6725: 44.1 % AR ( 30 d), [14C- ester carbonyl ]-label

IN-D8526: 43.0 % AR ( 30 d), [14C- triazine ]-label

Photolytic degradation of active substance and metabolites above 10 % ‡

 

Artificial light (Xenon) for 15 days at 25°C

 

Considering the DT50 obtained for photolysis, hydrolysis and for dissipation from the water phase in water sediment systems, hydrolysis and dissipation from the water phase are expected to be the major route of degradation of triflusulfuron-methyl in environmental conditions. Photolysis is not expected to be significant.

pH 5: 3.8 d (1st order)

IN-W6725: 71.2% (15 d), [14C- triazine ]-label

IN-D8526: 46.8% (7 d), [14C- ester carbonyl ]-label

IN-E0Q47: 20.1% (15 d) , [14C- ester carbonyl ]-label

Unknown T9: 24% (15 d) , [14C- ester carbonyl ]-label

pH 7: 13.9 d (1st order)

IN-W6725: 18.1% (15 d), [14C- triazine ]-label

IN-66036: 14.7% (15 d), [14C- triazine ]-label

IN-D8526: 18.2% (15 d), [14C- ester carbonyl ]-label

Unknown T9: 13.5% (7 d) , [14C- ester carbonyl ]-label

pH 9: 24.6 d (1st order)

IN-W6725: 18.9% (15 d), [14C- triazine ]-label

IN-66036: 9.1-9.5% (15 d), [14C- triazine ]-label & [14C- ester carbonyl ]-label

IN-D8526: 12.1% (15 d), [14C- ester carbonyl ]-label

Unknown T9: 16.2% (15 d) , [14C- ester carbonyl ]-label

Quantum yield of direct phototransformation in water at S > 290 nm

Parent: 6.85 10-5 mol · Einstein –1 at pH 7 (estimated GSSOLAR)

IN-D8526: stable at pH 7

IN-W6725: stable at pH 7

Readily biodegradable ‡
(yes/no)

No

 

 

Degradation in water / sediment

Triflusulfuron-methyl

Distribution (eg max in water 94.9- 90.8after 0-0.25 d. Max. sed 22.5-13.3 % after 7-14 d)

Water / sediment system

pH

water phase 

pH sed

t. oC

DT50-DT90 whole sys.

St.

(r2)

DissT50-DissT90

water

St.

(r2)

DT50- DT90

sed

St.

(r2)

Method of calculation

Brown Carrick Hill

7.5

7.2

20

40-133

0.99

31-103

0.99

-

-

SFO

Hinchingbrooke

7.5

7.7

20

22-73

0.99

18-60

0.99

-

-

SFO

Geometric mean/median DT50

-

30/31

 

24/25

 

-

 

SFO

 

Mineralization and non extractable residues

Water / sediment system

pH water

phase

pH sed

Mineralization

x % after n d. (end of the study).

Non-extractable residues in sed. max x % after n d

Non-extractable residues in sed. max x % after n d (end of the study)

Brown Carrick Hill

7.5

7.2

1.0-2.8 after 100 d

5.5-16.1 after 100 days

5.5-16.1 after 100 days

Hinchingbrooke

7.5

7.7

1.5-2.1 after 100 d

5.6-9.0 after 100 days

5.6-9.0 after 100 days

 

IN-W6725

Distribution (eg max in water 38.4  after 100 d. Max. sed 12 % after 100 d)

 

IN-D8526

Distribution (eg max in water 23.2  after 61 d. Max. sed 18.9 % after 61 d)

 

IN-E7710

Distribution (eg max in water 10.7  after 61 d. Max. sed <5.3 %)

 

IN-JK555

Distribution (eg max in water 28.6%  after 100 d. Max. sed 19.7 % after 61 days)

 

 

PEC (surface water) and PEC sediment (Annex IIIA, point 9.2.3)

Parent

Parameters used in FOCUSsw step 1 and 2

Version control no. of FOCUS calculator: 1.1

Molecular weight (g/mol): 492.4

Water solubility (mg/L): 260

KOC (L/kg): 40

DT50 soil (d): 6.5 days (geomean, Lab, SFO)

DT50 water/sediment system (d): 40 (representative worst case from sediment water studies)

DT50 water (d): 1000

DT50 sediment (d): 40

Crop interception (%): Minimal crop cover

Parameters used in FOCUSsw step 3 (if performed)

Version control no.’s of FOCUS software: 1.1

Vapour pressure: 6 10-10 Pa

Koc: 40

1/n: 0.92

Application rate

Crop: Sugar beets

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

Application window:

D3: 11 April to 11 May

D4: 20 April to 20 May

R1: 2 April to 2 May

R3: 6 March to 5 April

 

IN-W6725

Parameters used in FOCUSsw step 1 and 2

Molecular weight: 197.2

Water solubility (mg/L): 260

Soil or water metabolite: soil and water

Koc (L/kg): 6

DT50 soil (d): 89 days (Lab, median, SFO)

DT50 water/sediment system (d): 1000

DT50 water (d): 1000

DT50 sediment (d): 1000

Crop interception (%): Minimal crop cover

Maximum occurrence observed:

Total system: 49.8%

Soil: 83.7%

Application rate

Crop: sugar beets

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

Application window: March-May & June-September

 

IN-D8526

Parameters used in FOCUSsw step 1 and 2

Molecular weight: 237.2

Water solubility (mg/L): 260

Soil or water metabolite: soil and water

Koc (L/kg): 172

DT50 soil (d): 152 days* (Lab, max for acidic soils, SFO)

DT50 water/sediment system (d): 1000

DT50 water (d): 1000

DT50 sediment (d): 1000

Crop interception (%): Minimal crop cover

Maximum occurrence observed:

Total system: 42.1%

Soil: 92.3%

Application rate

Crop: sugar beets

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

Application window: March-May & June-September

* This value was the worst-case before the Peer Review. It was agreed PECgw do not need to be recalculated to finalise EU risk assessment.

 

IN-E7710

Parameters used in FOCUSsw step 1 and 2

Molecular weight: 223.2

Water solubility (mg/L): 260

Soil or water metabolite: soil and water

Koc (L/kg): 115

DT50 soil (d): 109 days (Lab, median, SFO)

DT50 water/sediment system (d): 1000

DT50 water (d): 1000

DT50 sediment (d): 1000

Crop interception (%): Minimal crop cover

Maximum occurrence observed:

Total system: 15.6%

Soil: 34.1%

Application rate

Crop: sugar beets

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

Application window: March-May & June-September

 

IN-JK555

Parameters used in FOCUSsw step 1 and 2

Molecular weight: 487.4

Water solubility (mg/L): 260

Soil or water metabolite: water

Koc (L/kg): 20 for PECsw, 10000 for PECsed

DT50 soil (d): 1 10-10 days

DT50 water/sediment system (d): 1000

DT50 water (d): 1000

DT50 sediment (d): 1000

Crop interception (%): Minimal crop cover

Maximum occurrence observed:

Total system: 45.4%

Soil: 1 10-10 %

Application rate

Crop: sugar beets

Number of applications: 2

Interval (d): 7

Application rate(s): 30 g as/ha

Application window: March-May & June-September

 

PEC (ground water) (Annex IIIA, point 9.2.1)

Method of calculation and type of study (e.g. modelling, field leaching, lysimeter )

Modelling using FOCUS model(s), with appropriate FOCUSgw scenarios, according to FOCUS guidance.

Model(s) used: PELMO 3.3.2 and PEARL 3.3.3

Scenarios (list of names): All 9 scenarios are representative for sugar beets

Crop: Sugar beets

Geometric mean DT50lab: 6.5 d (normalisation to 10kPa or pF2, 20 °C with Q10 of 2.2).

KFOC: arithmetic mean 40 L/kg,

KFOM: arithmetic mean 23.1 L/kg,

1/n= 0.92.

Molecular weight: 492.4 g/mol

Solubility: 260 mg/l

Vapour pressure: 1.01 10-5 Pa

Plant uptake: 0

 

Kinetic pathway:

Triflusulfuron à IN-W6725 à sink

And

Triflusulfuron à IN-D8526 à IN-E7710 à IN-M7222 à sink

 

IN-W6725

Median DT50lab: 89 d (normalisation to 10kPa or pF2, 20 °C with Q10 of 2.2).

KFOC: worst-case: 6 L/kg,

KFOM: worst-case: 3.48 L/kg

1/n= 0.95.

Molecular weight: 197.2 g/mol

Solubility: 1000 mg/L (considered worst-case)

Vapour pressure: 10-10 Pa (considered worst-case)

Plant uptake: 0

Formation fraction: 1 from triflusulfuron

 

IN-D8526

Worst-case DT50lab: 284 d for acidic soils (normalisation to 10kPa or pF2, 20 °C with Q10 of 2.2).

Worst-case DT50lab: 62 d for alkaline soils (normalisation to 10kPa or pF2, 20 °C with Q10 of 2.2).

KFOC: arithmetic mean 172 L/kg,

KFOM: arithmetic mean: 99.6 L/kg

1/n= 0.89.

Molecular weight: 237.2 g/mol

Solubility: 1000 mg/L (considered worst-case)

Vapour pressure: 10-10 Pa (considered worst-case)

Plant uptake: 0

Formation fraction: 1 from triflusulfuron