version 1search.fytoweb.be/nl/doc/pirimicarbessential.pdf · 2006-07-17 · cemas, berkshire report...
TRANSCRIPT
sidered view to
laimed
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Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished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 SafePharm Laboratories SPL Report No. 1292/014 GLP, Unpublished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Aqueous Photolysis at pH5 and pH7 at 25 degrees C. Jealott's Hill Research Station Zeneca Report No. RJ2298B GLP, Unpublished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Hydrolysis in pH5, 7 and 9 Solutions at 25 Degrees C. Jealott’s Hill Research Station Zeneca Report No. RJ2051B GLP, Unpublished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Oxidising Properties – Pirimicarb Syngenta Technology and Projects Process Hazards Section PHS Ref : HT02/186 Non-GLP, Unpublished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Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished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