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PIRIMICARB List of Annex II studies which were considered as relied upon for the evaluation with a view to Annex I inclusion and for which the main submitter has claimed data protection Version 1 Rapporteur Member State: UK November 2005 SANCO/10073/2006

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PIRIMICARB

List of Annex II studies which were conas relied upon for the evaluation with a

Annex I inclusion and for which the main submitter has c

data protection

Version 1

Rapporteur Member State: UK

November 2005

SANCO/10073/2006

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

PIRIMICARB

List of Annex II studies which were considered as relied upon for the evaluation with a view to Annex I inclusion

and for which the main submitter has claimed data protection

Version 1 – November 2005 B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further information, B.4 Proposals for classification and labelling, B.5 Methods of analysis

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports1 on previous use in granting national authorizations

IIA, 2.14/01

Evans AJ, Mullee DM

2001 Pirimicarb Technical Grade Active Ingredient – Determination of Surface Tension. SafePharm Laboratories SPL Report No. 1292/014 GLP, Unpublished

IIA, 2.9.2/01

Hamlet JM 1997 Pirimicarb: Aqueous Photolysis at pH5 and pH7 at 25 degrees C. Jealott's Hill Research Station Zeneca Report No. RJ2298B GLP, Unpublished

IIA, 2.9.1/01

Huynh TT, Mathis SMG

1996 Pirimicarb: Aqueous Hydrolysis in pH5, 7 and 9 Solutions at 25 Degrees C. Jealott’s Hill Research Station Zeneca Report No. RJ2051B GLP, Unpublished

IIA, 2.15/02

Jackson WA 2002 Oxidising Properties – Pirimicarb Syngenta Technology and Projects Process Hazards Section PHS Ref : HT02/186 Non-GLP, Unpublished

1 Entries are based on information received from the main data submitter and in certain cases Member States. Neither the Commission nor the Member States are responsible for the completeness or validity of this information received.

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports1 on previous use in granting national authorizations

IIA, 2.9.2/02

Moffatt F 1994 Pirimicarb: Quantum Yield and Environmental Half-Life for Direct Phototransformation in Aqueous Solution. Jealott’s Hill Research Station Zeneca Report No. RJ1542B GLP, Unpublished

IIA, 2.13/02

Tremain SP 2001 Pirimicarb Technical Grade Active Ingredient – Determination of Explosive Properties. SafePharm Laboratories SPL Report No. 1292/011 GLP, Unpublished

IIA, 2.1.1/01

Wollerton C, Husband R

1994 Pirimicarb: Physico-chemical Study on Pure Active Ingredient. Jealott's Hill Research Station Zeneca Report No. RJ1612B GLP, Unpublished

IIA, 2.1.1/02

Wollerton C, Husband R

1994 Pirimicarb: Physico-Chemical Study on Technical Grade Active Ingredient. Jealott's Hill Research Station Zeneca Report No. RJ1613B GLP, Unpublished

IIA, 2.9.4/01

Wollerton C, Husband R

1994 Pirimicarb: Dissociation Constants of Pirimicarb and its Metabolites R34836, R31805 and R34865. Jealott's Hill Research Station Zeneca Report No. RJ1548B GLP, Unpublished

IIA, 4.2.2.2/01

Bolton A 1997 Independent Validation of Standard Operating Procedure RAM 274/02. CEMAS, Berkshire Report No. CEMR-660 GLP, Unpublished

IIA, 4.1/01 Clarke PM, Massey PR, Tandy MJ

1994 The Determination of Pirimicarb and Associated Impurities in Technical Material By Capillary Gas Chromatography. Zeneca Agrochemicals, Jealott's Hill Research Station Report No. PAM 832/1 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports1 on previous use in granting national authorizations

IIA, 4.2.1.2/01

Coombe NB 1996 Independent Laboratory Validation of Standard Operating Procedure RAM 265/02. CEMAS Report No. CEMR-622 GLP, Unpublished

IIA, 4.2.4.1/01

Crooks S J 2001 Pirimicarb: Validation of a Residue Analytical Method for the Determination of Residues in Air Samples. Jealott’s Hill Research Station Report No. TMJ4572B Non GLP, Unpublished

IIA, 4.2.1.1/03

Croucher A 2000 Pirimicarb: Validation of an Analytical Method for the Determination of Pirimicarb and Metabolite Residues in Tobacco, Stone Fruit and Citrus Fruit. Covance Laboratories Ltd. Report No. 38/256-D2140 GLP, Unpublished

IIA, 4.2.1.1/04

Cullen GM 1993 Pirimicarb: Determination of Pirimicarb and its Carbamate Metabolites in Crops - Analytical Method Validation. Jealott’s Hill Research Station Report No. RJ1056B GLP, Unpublished

IIA, 4.2.1.2/02

Doran AM, McGuire GM

2001 Pirimicarb and Metabolites: Independent Laboratory Validation in Tomatoes and Oil Seed Rape Grain. Inveresk Research Group Report No. 20265 GLP, Unpublished

IIA, 4.2.1.1/05

Edwards MJ, Dick JP

1978 Residue Analytical Method No. 38 Determination of Residues of Pirimicarb and its Two Carbamate Metabolites in Milk, Eggs and Animal Tissues. Jealott’s Hill Research Station Report No. PPRAM38 Non-GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports1 on previous use in granting national authorizations

IIA, 4.2.5.1/01

Hall MG 2000 Pirimicarb: Determination in Human and Animal Plasma by LC-UV and LC-MS. Central Toxicology Laboratory Zeneca Report No. CTL/R/1441 GLP, Unpublished

IIA, 4.2.3.2/01

Hargreaves SL 1999 Analytical Method for the Determination of Residues of Pirimicarb, Prosulfocarb, Picoxystrobin and Flutriafol in Water. Jealott’s Hill Research Station Syngenta technical letters 49045/01 and 46932/01 Non GLP, Unpublished

IIA, 4.2.1.1/01

Harradine KJ 1995 Pirimicarb: Validation of a Method for the Determination of Pirimicarb and its Carbamate Metabolites in Brassica, Cereal Grain and Straw, Pome Fruit, Fruiting Vegetables (Edible Peel), Leafy Vegetables, Root and Tuber Vegetables. Jealott’s Hill Research Station Report No. RJ1806B GLP, Unpublished

IIA, 4.2.3.1/01

Harradine KJ 1996 Pirimicarb: Validation of a Method for the Determination of Pirimicarb and its Carbamate Metabolite (Desmethyl Pirimicarb) in Water. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2027B GLP, Unpublished

IIA, 4.2.2.1/01

Kwiatkowski AS, Robinson NJ

1996 Pirimicarb and Desmethyl Pirimicarb: Analytical Method and Validation of a Method for the Determination of Residues in Soil. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ1983B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports1 on previous use in granting national authorizations

IIA, 4.2.1.2/03

Tillkes M 1995 Validation of DFG Method S19 (Modified Extraction) for the Determination of the Residues of Pirimicarb and Desmethyl-Pirimicarb in Milk, Muscle, Kidney, Liver and Egg. Dr. Specht and Partner Report No. ZEN-9503V GLP, Unpublished

IIA. 4.2.1.1/02

Wright DR 1998 Transfer of Standard Operating Procedure RAM 265/03 to Covance Laboratories in Four Crop Matrices. Covance Laboratories Ltd Report No. 38/229-D2140 GLP, Unpublished

B.6 Toxicology and metabolism

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.1.1/01

Brown A 1997a

Pirimicarb: Whole Body Autoradiography in the Rat. Central Toxicology Laboratory Report No. CTL/P/5383 GLP, Unpublished

IIA, 5.1.1/02

Brown A 1997b

Pirimicarb: Excretion and Tissue Distribution of a Single Oral Dose (1 mg/kg) in the Rat. Central Toxicology Laboratory Report No. CTL/P/5329 GLP, Unpublished

IIA, 5.1.1/03

Brown A 1997c

Pirimicarb: Excretion and Tissue Distribution of a Single Oral Dose (50 mg/kg) in the Rat. Central Toxicology Laboratory Report No. CTL/P/5381 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.1.1/04

Brown A 1997d

Pirimicarb: Excretion and Tissue Distribution of a Single Oral Dose (1 mg/kg) in the Rat Following Repeat Dosing. Central Toxicology Laboratory Report No. CTL/P/5382 GLP, Unpublished

IIA, 5.4.1/01

Callander RD 1995 Pirimicarb: An Evaluation of the Mutagenic Potential Using S. typhimurium and E. coli. Central Toxicology Laboratory Report No. CTL/P/4798 GLP, Unpublished

IIA, 5.8.1.2/03

Callander RD 2000a

Pirimicarb Metabolite 062/06 (R031805): Bacterial Mutation Assay in S.typhimurium and E.coli. Central Toxicology Laboratory Zeneca Report No. CTL/YV4619/REG/REPT GLP, Unpublished

IIA, 5.8.1.2/04

Callander RD 2000b

Pirimicarb Metabolite 062/07 (R034865): Bacterial Mutation Assay in S.typhimurium and E.coli. Central Toxicology Laboratory Zeneca Report No. CTL/YV4620/REG/REPT GLP, Unpublished

IIA, 5.4.1/04

Clay P 1996 Pirimicarb: L5178Y TK+/- Mouse Lymphoma Mutation Assay. Central Toxicology Laboratory Report No: CTL/P/5080 GLP, Unpublished

IIA, 5.8.1.2/06

Clay P 2001a

Pirimicarb Metabolite 062/06 (R031805): L5178Y TK+/- mouse lymphoma mutation assay. Central Toxicology Laboratory Syngenta Report No. CTL/VV0225/REGULATORY/REPORT GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.8.1.2/07

Clay P 2001b

Pirimicarb Metabolite 062/07 (R034865): L5178Y TK+/- mouse lymphoma mutation assay. Central Toxicology Laboratory Syngenta Report No. CTL/VV0226/REGULATORY/REPORT GLP, Unpublished

IIA, 5.8.1.2/09

Clay P 2001c

Pirimicarb Metabolite 062/06 (R031805): In Vivo Rat Liver Unscheduled DNA Synthesis Assay. Central Toxicology Laboratory Syngenta Report No. CTL/SR1104/REGULATORY/REPORT GLP, Unpublished

IIA, 5.8.1.2/10

Clay P 2001d

Pirimicarb Metabolite 062/06 (R031805): Mouse Bone Marrow Micronucleus Test. Central Toxicology Laboratory Syngenta Report No. CTL/ SM1105/REGULATORY/REPORT GLP, Unpublished

IIA, 5.8.1.1/05

Fletcher K 1971a

Pirimicarb (PP062): Subacute oral toxicity of the plant metabolite, desmethylpirimicarb. Industrial Hygiene Research Laboratories (now known as Central Toxicology Laboratory) Report No. HO/IH/T/842 Non GLP, Unpublished

IIA, 5.8.1.1/06

Fletcher K 1971b

Pirimicarb (PP062): Subacute oral toxicity of the plant metabolite, desmethylformamidopirimicarb. Industrial Hygiene Research Laboratories (now known as Central Toxicology Laboratory) Report no. HO/IH/T/843 Non GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.8.1.2/05

Fox V 2001a

Pirimicarb Metabolite 062/06 (R031805): In Vitro Cytogenetic Assay In Human Lymphocytes. Central Toxicology Laboratory Syngenta Report No. CTL/SV1030/REG/REPT GLP, Unpublished

IIA, 5.8.1.2/08

Fox V 2001b

Pirimicarb Metabolite 062/07 (R34865): In Vitro Cytogenetic Assay In Human Lymphocytes. Central Toxicology Laboratory Syngenta Report No. CTL/SV1031/REG/REPT GLP, Unpublished

IIA,5.3.3/07

Garner R, Phillips CE, Slack P

1995 First Revision to Pirimicarb (PP062): Pirimicarb Anaemia (A Chemically-Induced Autoimmune Haemolytic Anaemia). Central Toxicology Laboratory Report No. CTL/P/61 Non GLP, Unpublished

IIA, 5.1.2/01

Gledhill AJ 1998 Pirimicarb: Biotransformation in the Rat. Central Toxicology Laboratory Report No. CTL/P/5530 GLP, Unpublished

IIA, 5.3.2/03

Griffiths D, Conning DM

1995 First Revision to Ninety-Day Oral Toxicity of PP062 - Albino Rats. Central Toxicology Laboratory Report No. CTL/R/237 Non GLP, Unpublished

IIA, 5.3.2/04

Griffiths D, Conning DM

1995 First Revision to Ninety-Day Oral Toxicity of PP062 - Albino Rats. Individual Animal Data Central Toxicology Laboratory Report No. CTL/R/237 Non GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.3.3/01

Hodge MCE 1995a

Subchronic Studies with Pirimicarb (PP062) in the Beagle Dog: Ninety-day Oral Toxicity of PP062 - Beagle Dogs (Part 1) and Oral Toxicity of PP062 - Beagle Dogs (Part 2). Central Toxicology Laboratory (formerly known as Industrial Hygiene Research Laboratories) Report No. CTL/P/4593 Incorporating CTL/R/241 and CTL/R/248 (Previously IHR/241 and IHR/248) Non GLP, Unpublished

IIA, 5.3.3/02

Hodge MCE 1995a

Subchronic Studies with Pirimicarb (PP062) in the Beagle Dog: Ninety-day Oral Toxicity of PP062 - Beagle Dogs (Part 1) and Oral Toxicity of PP062 - Beagle Dogs (Part 2). Individual Animal Data Central Toxicology Laboratory (formerly known as Industrial Hygiene Research Laboratories) Report No. CTL/P/4593 Incorporating CTL/R/241 and CTL/R/248 (Previously IHR/241 and IHR/248) Non GLP, Unpublished

IIA, 5.3.3/06

Hodge MCE 1995b

First Revision to Pirimicarb (PP062): 2-Year Feeding Study in Beagle Dogs. Central Toxicology Laboratory Report No. CTL/R/337 Non GLP, Unpublished

IIA, 5.3.3/04

Horner SA 1998 Pirimicarb: 1 Year Oral Toxicity Study in Dogs. Central Toxicology Laboratory Report No. CTL/P/5690 GLP, Unpublished

IIA, 5.3.3/05

Horner SA 1998 Pirimicarb: 1 Year Oral Toxicity Study in Dogs. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/5690 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.8.2.1/01

Horner SA 1996a

Pirimicarb: Acute Neurotoxicity Study in Rats. Central Toxicology Laboratory Report No. CTL/P/5232 GLP, Unpublished

IIA, 5.8.2.1/02

Horner SA 1996a

Pirimicarb: Acute Neurotoxicity Study in Rats. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/5232 GLP, Unpublished

IIA, 5.8.2.1/03

Horner SA 1996b

Pirimicarb: Subchronic Neurotoxicity Study in Rats. Central Toxicology Laboratory Report No. CTL/P/5233 GLP, Unpublished

IIA, 5.8.2.1/04

Horner SA 1996b

Pirimicarb: Subchronic Neurotoxicity Study in Rats. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/5233 GLP, Unpublished

IIA, 5.8.1.2/01

Lees D 2001 Pirimicarb Metabolite 062/06 (R031805): 90 Day Dietary Toxicity Study In Rats. Syngenta UK Syngenta Report No. CTL/ PR1184/ REGULATORY/REPORT GLP, Unpublished

IIA, 5.8.1.2/02

Lees D 2001 Pirimicarb Metabolite 062/06 (R031805): 90 Day Dietary Toxicity Study In Rats. Individual Animal Data Syngenta UK Syngenta Report No. CTL/ PR1184/ REGULATORY/REPORT GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.2.5/01

Lees D, Doyle CE

1995 Pirimicarb: Eye Irritation to the Rabbit. Central Toxicology Laboratory Report No. CTL/P/4706 GLP, Unpublished

IIA, 5.3.4/01

Lees D, Leah AM

1995 Pirimicarb: 21-Day Dermal Toxicity to the Rat. Central Toxicology Laboratory Report No. CTL/P/4805 GLP, Unpublished

IIA, 5.3.4/02

Lees D, Leah AM

1995 Pirimicarb: 21-Day Dermal Toxicity to the Rat. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/4805 GLP, Unpublished

IIA, 5.2.1/01

Lees D, Connolly HJ

1995a

Pirimicarb: Acute Oral Toxicity to the Rat. Central Toxicology Laboratory Report No. CTL/P/4802 GLP, Unpublished

IIA, 5.2.2/01

Lees D, Connolly HJ

1995b

Pirimicarb: Acute Dermal Toxicity to the Rat. Central Toxicology Laboratory Report No. CTL/P/4855 GLP, Unpublished

IIA, 5.2.4/01

Lees D, Connolly HJ

1995c

Pirimicarb: Skin Irritation to the Rabbit. Central Toxicology Laboratory Report No. CTL/P/4858 GLP, Unpublished

IIA, 5.8.1.1/02

Lefevre VK, Parkinson GR

1974 Pirimicarb (PP062; 2-Dimethylamino-5, 6-Dimethylpyrimidin-4-yl Dimethylcarbamate): Acute Oral Toxicities of Plant and Mammalian. Metabolites. Central Toxicology Laboratory Report No. CTL/P/101B Non GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.8.1.1/01

Parkinson GR 1974 Pirimicarb Metabolites (R31680 and R35140): Acute Oral Toxicity. Central Toxicology Laboratory Report No. HO/CTL/P/144 Non GLP, Unpublished

IIA, 5.8.1.1/03

Parkinson GR 1979 Pirimicarb Metabolite R34836: Subacute Oral Toxicity to Rats. Central Toxicology Laboratory Report No. CTL/P/401 (Revised) Non GLP, Unpublished

IIA, 5.8.1.1/04

Parkinson GR 1978 Pirimicarb Metabolite R34885: Subacute Oral Toxicity To Rats. Central Toxicology Laboratory Report No. CTL/P/402 Non GLP, Unpublished

IIA, 5.8.1.3/01

Parkinson GR 1975 Oral Toxicities Of Three Guanidine Compounds. ICI Industrial Hygiene Research Laboratories (now known as Central Toxicology Laboratory) Report No. CTL/P/160 Non GLP, Unpublished

IIA, 5.2.3/01

Parr-Dobrzanski RJ

1994 Pirimicarb: 4-Hour Acute Inhalation Toxicity Study in the Rat. Central Toxicology Laboratory Report No. CTL/P/4522 GLP, Unpublished

IIA 5.3.2/01

Paul D, Richards D, Banham PB, Weight TM

1995 First Revision to Pirimicarb: Growth Study to Determine a No-Effect Level in the Female Rat. Central Toxicology Laboratory Report No. CTL/P/408 Non GLP, Unpublished

IIA, 5.5.2/01

Rattray NJ 1998 Pirimicarb: 80 Week Carcinogenicity Study in Mice. Central Toxicology Laboratory Report No. CTL/P/5839 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 5.5.2/02

Rattray NJ 1998 Pirimicarb: 80 Week Carcinogenicity Study in Mice. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/5839 GLP, Unpublished

IIA, 5.3.2/02

Richards D, Banham PB, Weight TM

1978 Pirimicarb: Paired Feeding Study in the Female Rat. Central Toxicology Laboratory Report No. CTL/P/407 Non GLP, Unpublished

IIA, 5.5.1/01

Tinston DJ 1992 Pirimicarb: Two Year Feeding Study in Rats. Central Toxicology Laboratory Report No. CTL/P/3040 GLP, Unpublished

IIA, 5.5.1/02

Tinston DJ 1992 Pirimicarb: Two Year Feeding Study in Rats. Individual Animal Data Central Toxicology Laboratory Report No. CTL/P/3040 GLP, Unpublished

IIA, 5.4.1/02

Wildgoose J, Howard CA, Richardson CR, Randall V

1987 Pirimicarb: A cytogenetic study in human lymphocytes in vitro. Central Toxicology Laboratory Report No. CTL/P/1655 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

B.7 Residue data Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 6.2.1/01

Akhavan M, Murray S, Johnson J

1997 Pirimicarb: The Nature Of The Residues Of Orally Administered (2-14C-RING)-Pirimicarb In Tissues And Eggs Of Laying Hens (WRC-97-021) (WINO 8348). Western Research Centre Report No. RR 97-008B GLP, Unpublished

IIA, 6.3.2/06

Benwell L, Brereton R

2000 Pirimicarb: Residue Levels in Wheat from Trials carried out in Southern France and Italy during 1999. Covance Laboratories Ltd Report No: 38/252-D2143 GLP, Unpublished

IIA, 6.3.2/01

Benwell L, Cowley P

1999 Pirimicarb: Residue Levels in Winter Wheat from Trials carried out in Northern Europe during 1998. Covance Laboratories Ltd Report No: 38/227-D2143 GLP, Unpublished

IIA, 6.3.2/05

Benwell L, Cowley P

1999 Pirimicarb: Residue Levels in Winter Wheat from Trials carried out in Southern Europe during 1998. Covance Laboratories Ltd Report No: 38/212-D2143 GLP, Unpublished

IIA, 6.1.4/01

Jessop KM 1998 Pirimicarb : Metabolism in Wheat. Jealott’s Hill Research Station Report No. RJ2413B GLP, Unpublished

IIA, 6.3.2/04

Mills H, Bailey A

2001 Pirimicarb: Residue Levels in Winter Wheat from Trials conducted in the UK during 2001. Covance Laboratories Ltd Report No: 1983/21-D2160 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 6.3.2/02

Mills H, Picard JM

2001 Pirimicarb: Residue Levels in Winter Wheat from Trials carried out in Northern France during 2000. Covance Laboratories Ltd Report No: 38/273-D2143 GLP, Unpublished

IIA, 6.1.4/02

Muir G 1998 Pirimicarb: Further Investigation of Residues in Wheat Straw and Radiovalidation of Enforcement Methods for Analysis of Wheat Grain and Straw. Jealott’s Hill Research Station Report No. RJ2550B GLP, Unpublished

IIA, 6.2.2/01

Murray S, Akhavan M, Johnson J

1998 Pirimicarb: The nature of the residues of orally administered [2-14C-ring]-pirimicarb in tissues and milk of lactating goat (WRC-98-097) (WINO 8348). Western Research Center Report No. RR-98-049B GLP, Unpublished

IIA, 6/01 Patel A 1997 Pirimicarb and its Carbamate Metabolites : Storage Stability of Residues in Wheat (Straw and Grain) Stored Deep Frozen at <-18°C. Jealott's Hill Research Station Report No. RJ2194B GLP, Unpublished

IIA, 6.3.2/03

Patel A, Codd MS

1995 Pirimicarb and Metabolites: Residue Levels in Winter Wheat From Trials Carried out in the UK During 1994. Jealott’s Hill Research Station Report No. RJ1981B GLP, Unpublished

IIA 6.3 Spillner C 2000 Pirimicarb: Residue levels of parent and metabolites on foliages and in soil after treatment to potatoes in North Carolina during 1998 and 1999. Zeneca Ag Products, Inc Report No. RR 99-065B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 6.6.1/01

Vispetto T, Tovshteyn M, Kaya K, Johnson J

1998 2-14C-Ring Pirimicarb Confined Accumulation Studies on Rotational Crops, (WRC-96-141) (WINO 15721). Western Research Center Report No RR 96-087B GLP, Unpublished

B.8 Environmental fate and behaviour Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 7.1.1.1.2\2/01 Also IIA 7.1.1.2.1\1/02

Earl VL 1997 Pirimicarb: Soil Surface Photolysis Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2255B GLP, Unpublished

IIA, 7.2.1.2/02

Giese G, Müller J

1992 Photolysis of Pirimicarb in Water including Quantum Yield. Fraunhofer-Institut für Umweltchemie und Ökotoikologie,Grafschaft, 5948 Schmallenberg. Report No. ICI-002/7-21 GLP, Unpublished

IIA, 7.2.1.2/01, see IIA, 2.9.2/01

Hamlet JM 1997 Pirimicarb: Aqueous Photolysis at pH5 and pH7 at 25 degrees C. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2298B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 7.1.1.2.1\2.1/01

Harradine KJ, Patel A

1996 Desmethyl Pirimicarb: Residue Levels in Soil from a Laboratory Soil Degradation Study Carried out in the UK during 1995-1996. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2111B GLP, Unpublished

IIA, 7.2.2.1/01

Heath J, Ahmed A

1992 Flurochloridone, Pirimicarb, Lambda-Cyhalothrin, Prosulfocarb, Fluazifop-P-Butyl: Volatility from French Bean Leaves and Speyer 2.1 Soil. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ1046B GLP, Unpublished

IIA, 7.1/01 Hill SE, Jones SD

1997 Pirimicarb and Desmethyl Pirimicarb: Storage Stability of Residues and Desmethyl Pirimicarb in Sandy Loam and Clay Soil. Zeneca Agrochemicals, Jealott's Hill Research Station Report No. RJ2272B GLP, Unpublished

IIA, 7.1.1.2.2/01

Huynh T, Mullar K, Spurgeon C

1996 Pirimicarb: Field Soil Dissipation Study Using 14 C Material (WRC-96-102) (Wino21887). Western Research Center Report No. RR 96-072B GLP, Unpublished

IIA, 7.2.1.1/01, see IIA, 2.9.1/01

Huynh TT, Mathis SMG

1996 Pirimicarb: Aqueous Hydrolysis in pH5, 7 and 9 Solutions at 25 Degrees C. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2051B GLP, Unpublished

IIA, 7.2.1.3.2/01

Kirkpatrick D, Kellett DN

1992 14C-Pirimicarb: The Degradation in Water/Sediment Systems. Huntingdon Research Centre Ltd Report No. HRC/ISN 282/921039 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 7.1.1.2.1\2.3/01

Mellor SJ 2001a

Pirimicarb: Aerobic Rate of Degradation of R031805, A Soil Degradate, in Three Soils. Huntingdon Life Sciences Ltd Report No. ZCA 050/004572 GLP, Unpublished

IIA, 7.1.1.2.1\2.4/01

Mellor SJ 2001b

Pirimicarb: Aerobic Rate of Degradation of R034865, A Soil Degradate, in Three Soils. Huntingdon Life Sciences Ltd Report No. ZCA 049/004564 GLP, Unpublished

IIA, 7.1.1.1.1/01 Also IIA, 7.1.1.1.2\1/01 and IIA, 7.1.1.2.1\1/01

Miles PD, Hamlet J

1998 Pirimicarb: Metabolism in Aerobic and Anaerobic Soils under Laboratory Conditions. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ2682B GLP, Unpublished

IIA, 7.1.2.2.1/01

Millais AJ, Kaur AK

2000a

Pirimicarb: Adsorption and Desorption Properties of R034836, a Soil Degradate, in Six Soils. Huntingdon Life Sciences Ltd Report No. ZCA 046/003356 GLP, Unpublished

IIA, 7.1.2.2.2/01

Millais AJ, Kaur AK

2000b

Pirimicarb: Adsorption and Desorption Properties of R034885, a Soil Degradate, in Six Soils. Huntingdon Life Sciences Ltd Report No. ZCA 045/003144 GLP, Unpublished

IIA, 7.2.1.2/03, see IIA, 2.9.2/02

Moffatt F 1994 Pirimicarb: Quantum Yield and Environmental Half-Life for Direct Phototransformation in Aqueous Solution. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ1542B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point/ reference number

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 7.1.2.2.4/01

O’Hara CD 2000 Pirimicarb: Adsorption and Desorption Properties of R34865, a Soil Degradate, in Six Soils. Huntingdon Life Sciences Ltd Report No. ZCA 047/002954 GLP, Unpublished

IIA, 7.1.2.2.3/01

Vaughan PC, Lane MCG

1994 Pirimicarb: Adsorption and Desorption Properties in Soil of R31805, a Major Soil Metabolite. Zeneca Agrochemicals, Jealott’s Hill Research Station Report No. RJ1587B GLP, Unpublished

B.9 Ecotoxicology Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.3.2.1/02

Adelberger I 2000 Pirimicarb: a Tier II laboratory study to evaluate the effects of a WG formulation on the predatory mite, Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae). GAB Biotechnologie GmbH Report No: 20001093/01 - NETP GLP, Unpublished

IIA, 8.3.2.3.1/05

Ambriz J P 1973 Preliminary assessment of the efficiency of the insecticide ‘Pirimor’ as a chemical weapon against the alfalfa aphid. ICI report No. ME0223B Non-GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.3.1.1/02

Collins IGC, Jackson D, Lewis GB

1994 Pirimicarb: acute contact toxicity to honey bees (Apis mellifera) of pirimicarb and a pirimicarb/maneb mixture. Jealott’s Hill Research Centre Report No: RJ1532B GLP, Unpublished

IIA, 8.2.6.2/02

Daniel M, Shillabeer N

2000 Pirimicarb : Toxicity of the metabolite R31805 to the green alga Selenastrum capricornutum. Brixham Environmental Laboratory Report No: BL6912/B GLP, Unpublished

IIA, 8.2.1.2/01

Daniel M, Magor SE, Shillabeer N

2001a

R034865: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss). Brixham Environmental Laboratory Syngenta Report No: 47536 (BL6900/B) GLP, Unpublished

IIA, 8.2.4.2/05

Daniel M, Magor SE, Shillabeer N

2001b

R034865: Acute Toxicity to Daphnia magna. Brixham Environmental Laboratory Report No. 47537 (BL6901/B) GLP, Unpublished

IIA, 8.3.2.1/05

Deprez C, Farrelly LC

1994a

Pirimicarb: investigation into the toxicity of a 50% WG formulation to the cereal aphid parasitoid, Aphidius rhopalosiphi. Jealott’s Hill Research Station Report No: RJ1560B GLP, Unpublished

IIA, 8.3.2.1/07

Deprez C, Farrelly LC

1994b

Pirimicarb : investigation into the toxicity of a 50% WG formulation to the larvae of the hoverfly Episyrphus balteatus. Jealott’s Hill Research Station Report No: RJ1723B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.3.2.1/06

Farrelly LC 1994 Pirimicarb : investigation into the toxicity of a 50% WG Formulation to predatory Lycosid spiders (Lycosidae, Araneae) and the Carabid beetle Pterostichus melanarius. Jealott’s Hill Research Station Report No: TMJ3356B GLP, Unpublished

IIA, 8.6.1/01

Fleming TM, Everett CJ, Cole JFH

1996a

Pirimicarb: a Tier 1 glasshouse study to assess the effects on the seedling emergence of a variety of species. Jealott's Hill Research Station Report No: RJ2242B GLP, Unpublished

IIA, 8.6.1/02

Fleming TM, Everett CJ, Cole JFH

1996b

Pirimicarb : A Tier 1 glasshouse study to assess the effects on the vegetative vigour of a variety of species. Jealott’s Hill Research Station Report No: RJ2243B GLP, Unpublished

IIA, 8.2.4.1/03

Hamer MJ

1995 Pirimicarb : toxicity of the technical material to aquatic invertebrates. Jealott’s Hill Research Station Report No. TMJ 3423B Not GLP, Unpublished

IIA, 8.2.4.1/07

Hamer MJ 1997 Pirimicarb : acute toxicity to first instar Chironomus riparius in water alone. Jealott’s Hill Research Station Syngenta Crop protection AG Report No: TMJ3756B Not GLP, Unpublished

IIA, 8.2.4.2/01

Hamer MJ

1998a

R35140: acute toxicity of the pirimicarb degradate 062/03 to Daphnia magna. Jealott’s Hill Research Station Report No. TMJ 3977B Not GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.2.4.2/04

Hamer MJ

1998b

R31805: acute toxicity of the pirimicarb degradate 062/06 to Daphnia magna. Jealott’s Hill Research Station Report No. TMJ 3976B Not GLP, Unpublished

IIA, 8.2.4.2/06

Hamer MJ

1998c

R16210: acute toxicity of the pirimicarb degradate 062/10 to Daphnia magna. Jealott’s Hill Research Station Report No. TMJ 3978B Not GLP, Unpublished

IIA, 8.2.5/02

Hamer MJ, Goggin UM

1997 Pirimicarb: effects on Daphnia survival and reproduction in sediment-water systems. Jealott’s Hill Research Station Report No. RJ2320B GLP, Unpublished

IIA, 8.3.2.1./04

Hargreaves NJ, Travis A

2001 Pirimicarb : a Tier II study to evaluate the effect of a WG Formulation on the Hoverfly Episyrphus balteatus (Diptera : Syrphidae). Jealott’s Hill Research Station Report No: RJ3188B GLP, Unpublished

IIA, 8.3.1.1/03

Hiemer M, Winkler J, Kleiner R

1992 Testing toxicity to honey bees - Apis Mellifera L. (laboratory) according to BBA Guideline VI, 23-1. Biochem Gmbh Karlsruhe Report No: 92 10 48 039 GLP, Unpublished

IIA, 8.1.2/01

Johnson AJ, Dawe IS

1997a

Pirimicarb dietary LC50 to the bobwhite quail. Huntingdon Life Sciences Ltd Report No. ISN 397/ 963859 GLP, Unpublished

IIA, 8.1.2/02

Johnson AJ, Dawe IS

1997b

Pirimicarb dietary LC50 to the mallard duck. Huntingdon Life Sciences Report No. ISN 396/963795 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.3.2.1/03

Kemmeter F 2000 Pirimicarb: a Tier II laboratory study to evaluate the effects of a WG formulation on the green lacewing, Chrysoperla carnea Steph. (Neuroptera, Chrysopidae). GAB Biotechnologie GmbH Report No: 20001093/01 - NECC GLP, Unpublished

IIA, 8.2.1.1/01

Kent SJ, Magor SE, Shillabeer N

1998 Pirimicarb : acute toxicity to rainbow trout (Oncorhynchus mykiss). Brixham Environmental Laboratory Report No. 15272 (BL6403/B) GLP, Unpublished

IIA, 8.2.1.1/02

Kent SJ, Magor SE, Shillabeer N

1998 Addendum to Pirimicarb : acute toxicity to rainbow trout (Oncorhynchus mykiss). Brixham Environmental Laboratory Report No. 15272 (BL6403/B) GLP, Unpublished

IIA, 8.2.2.2/01

Kent SJ, Morris DS, Shillabeer N

1996 Pirimicarb : chronic toxicity to fathead minnow (Pimephales promelas) embryos and larvae. Brixham Environmental Laboratory Report No. 15280 (BL5676/B) GLP, Unpublished

IIA, 8.2.4.1/01

Kent SJ, Shillabeer N

1996 Pirimicarb : acute toxicity to Daphnia magna. Brixham Environmental Laboratory Report No. 15271 (BL5798/B) GLP, Unpublished

IIA, 8.2.4.1/02

Kent SJ, Shillabeer N

1996 Addendum to Pirimicarb : acute toxicity to Daphnia magna. Brixham Environmental Laboratory Report No. 15271 (BL5798/B) GLP, Unpublished

IIA, 8.2.4.2/02

Kent SJ, Sankey SA, Banner AJ, Magor SE

1995a

R34836: acute toxicity to Daphnia magna. Brixham Environmental Laboratory Report No. BL5317/B GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.2.4.2/03

Kent SJ, Sankey SA, Banner AJ, Magor SE

1995b

R34885: acute toxicity to Daphnia magna. Brixham Environmental Laboratory Report No. 14543 (BL5335/B) GLP, Unpublished

IIA, 8.3.2.3.1/01

Lewis GB 1992 Pirimicarb : A Review of its Effects on Arthropod Natural Enemies. ICI Agrochemicals, Jealott’s Hill Research Station Report No: TMJ2938A Non-GLP, Unpublished

IIA, 8.2.1.1/03

Magor SE, Kent SJ, Shillabeer N

1998 Pirimicarb : acute toxicity to fathead minnow (Pimephales promelas). Brixham Environmental Laboratory Report No. 20036 (BL6404/B) GLP, Unpublished

IIA, 8.2.1.1/04

Magor SE, Kent SJ, Shillabeer N

1998 Addendum to Pirimicarb : acute toxicity to fathead minnow (Pimephales promelas). Brixham Environmental Laboratory Report No. 20036 (BL6404/B) GLP, Unpublished

IIA, 8.2.6.2/01

Magor SE, Shillabeer N

2001 R034865 : Toxicity to the Green Alga Selenastrum capricornutum. Brixham Environmental Laboratory Report No: BL6902/B GLP, Unpublished

IIA, 8.5.1.2/01

McMurray A 2001 A laboratory assessment of the effects of pirimicarb metabolites 062/06 and 062/07 on soil microflora respiration and nitrogen transformation according to OECD guidelines 216 and 217. Chemex International plc Report No: ENV5417 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.4.1.2/01

Moser T, Römbke J

2001a

Pirimicarb: acute toxicity of the metabolite R031805 to the Earthworm Eisenia andrei in an artificial soil test. ECT Oekotoxikologie GmbH Report No: F14RA GLP, Unpublished

IIA, 8.4.1.2/02

Moser T, Römbke J

2001b

Pirimicarb: acute toxicity of the metabolite R034865 to the Earthworm Eisenia andrei in an artificial soil test. ECT Oekotoxikologie GmbH Report No: F12RA GLP, Unpublished

IIA, 8.3.1.1/01

Petto R 1995 Toxicity Testing of Pirimor (ICI 91010-I-0-WG ) to honey bees (Apis Mellifera L) (Hymenoptera, Apidae ) in the laboratory. RCC Umweltchemie Gmbh & Co kg. Report No. RCC289102 GLP, Unpublished

IIA, 8.3.2.2.1/01

Riedel KW, Cole JFH

1994 Pirimicarb : an investigation of the effects on non-target arthropods in barriered field plots of spring barley. Jealott’s Hill Research Station Report No: RJ1604B GLP, Unpublished

IIA, 8.1.3/02

Rodgers MH, Dawe IS, Healey GF

1997 Pirimicarb effects on reproduction in mallard duck. Huntingdon Life Sciences Report No. ISN 356/963350 GLP, Unpublished

IIA, 8.1.3/01

Rodgers MH, Martin I, Healey GF

1997 Pirimicarb effects on reproduction in bobwhite quail. Huntingdon Life Sciences Report No. ISN 357/963673 GLP, Unpublished

PIRIMICARB List of studies relied upon for which data protection has been claimed SANCO/10073/2006, rev final

30 November 2005

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Reports on previous use in granting national authorizations

IIA, 8.3.2.1/01

Schuld M 2000 Pirimicarb 500 WG: toxicity to the aphid parasitoid Aphidius rhopalosiphi (Hymenoptera, Braconidae) DeStefani-Perez using an extended laboratory test. GAB Biotechnologie GmbH Report No: 20001093/01 - NEAP GLP, Unpublished

IIA, 8.1.1/01

Van Dreumel IF, Leopold MA

1996a

Acute oral toxicity study with pirimicarb in the bobwhite quail. Notox B.V., The Netherlands Report No. Notox 175567 GLP, Unpublished

IIA, 8.1.1/02

Van Dreumel IF, Leopold MA

1996b

Acute oral toxicity study with pirimicarb in the mallard duck. Notox B.V., The Netherlands Report No. Notox 175578 GLP, Unpublished