List of Annex II studies which were considered as relied ...search.fytoweb.be/NL/doc/DimethoateEssential.pdf · Owner: CHE JIIA, 4.1/16 Knold, L. 2002 Validation of analytical method

Dimethoate

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 2 – Final (16 October 2007) 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/ Reference number

Author (s) Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished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, 1.11 Pedersen, S.N. Hald, M.

2002 Identification and determination of active ingredient dimethoate (CAS No. 60-51-5) and impurities in five samples of dimethoate technical, batch nos.: 10812-00, 10903-00, 10927-00, 11014-00 and 11030-00. DTF Doc No. 132-034 GLP Unpublished Owner: CHE

IIA, 2.1/01 Young, S. 29.01.01 Dimethoate (pure) - melting point Company Report No. SCI 063/004779 DTF Doc No. 113-001 GLP Unpublished Owner: DTF

IIA, 2.1/05 Comb, A.L. 2005 Dimethoate (pure grade) - Melting temperature Company Report No. SCI 063/004779 DTF Doc. No. 113-002 GLP Unpublished Owner: DTF

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.

1




IIA, 2.1/06 Comb, A.L. 2005 Dimethoate (pure grade) - Boiling temperature Huntingdon Life Science Company Report No. SCI110/052209 DTF Doc. No. 113-003 GLP Unpublished Owner: DTF

IIA, 2.2/01 Young, S. 29.01.01 Dimethoate (99,1 %) pure) - relative density Company Report No. SCI 067/004784 DTF Doc No. 112-001 GLP Unpublished Owner: DTF

IIA, 2.3/02 Lystbaek, K. 30.10.96 The Henry's law constant of Dimethoate (calculated) Company Report No. DTF Doc No. 115-003 Not GLP Unpublished Owner: CHE

IIA, 2.4/01 Jorgensen, S.F. 28.02.02 Appearance of Dimethoate technical Company Report No. KLy/lon DTF Doc No. 111-004 Not GLP Unpublished Owner: CHE

IIA, 2.4/02 Sorensen, E.V. 13.08.99 !! CONFIDENTIAL !! - Batch analytical certificate of Dimethoate Batch No.: 291-BSe-75B Company Report No. Not indicated DTF Doc No. 132-030 Not GLP Unpublished Owner: CHE

2




IIA, 2.5/02 Brielbeck, B., Matyas, A.

12.03.02 Tabular presentation of spectra for the purified active substance Dimethoate Company Report No. 104-032 DTF Doc No. 133-067 Not GLP Unpublished Owner: DTF

IIA, 2.5/03 Alsted, A.L. 23.10.91 Determination of the molar extinction coefficient of analytical grade Dimethoate Company Report No. 60-51-5 DTF Doc No. 117-004 Not GLP Unpublished Owner: DTF

IIA, 2.5/04 Hald, M. Sandberg, B.

13.05.98 Characterization of Omethoate PESTANAL (CAS No. 1113-02-6), Batch No. 32090, product 45600 Company Report No. REF 042-02 DTF Doc No. 133-035 GLP Unpublished Owner: CHE

IIA, 2.6/02 Robson, M. 14.10.91 Determination of the solubility of Dimethoate in buffered aqueous solutions at pH 5, 7 and 9 (study no. 460/57) Company Report No. 460/57 DTF Doc No. 114-002 Not GLP Unpublished Owner: DTF

IIA, 2.6/03 Meinerling, M. Herrmann, S.

27.11.00 Determination of the water solubility of O-desmethyl dimethoate (free acid) Company Report No. 9421185 DTF Doc No. 114-010 GLP Unpublished Owner: DTF

3




IIA, 2.7/01 Madsen, S. 12.12.94 Solubility of Dimethoate in organic solvents (Excluding raw data) Company Report No. 42040 DTF Doc No. 114-008 GLP Unpublished Owner: CHE

IIA, 2.8/02 Meinerling, M. Herrmann, S.

27.11.00 Determination of the partition coefficient (n-Octanol/Water) of O-desmethyl dimethoate (free acid) by high performance liquid chromatography (HPLC) Company Report No. 9422186 DTF Doc No. 114-011 GLP Unpublished Owner: DTF

IIA, 2.9/04 Meinerling, M. 16.10.01 Determination of the Dissociation constant of O-desmethyl dimethoate (free-acid) in water Company Report No. 9423194 DTF Doc No. 115-005 GLP Unpublished Owner: DTF

IIA, 2.10/01 Förster, B. 15.06.99 Estimation of the atmospheric residence time of Dimethoate using the Atkinson method Company Report No. Not indicated DTF Doc No. 192-006 Not GLP Unpublished Owner: DTF

IIA, 2.11/01 Young, S. 29.01.01 Dimethoate technical - flammability (solids) Company Report No. SCI 064/004780 DTF Doc No. 142-002 GLP Unpublished Owner: DTF

4




IIA, 2.11/02 Young, S. 30.01.01 Dimethoate technical - autoignition temperature Company Report No. SCI 065/004782 DTF Doc No. 142-001 GLP Unpublished Owner: DTF

IIA, 2.11/03 Comb, A.L. 2005 Dimethoate (Technical) - Flammability (Solids) - (Batch: 611/A) Company Report No. SCI109/052215 DTF Doc. No. 142-005 GLP Unpublished Owner: DTF

IIA, 2.11/04 Comb, A.L. 2005 Dimethoate (Technical) – Auto-ignition temperature (Liquids and gases) Company Report No. SCI108/052211 DTF Doc. No. 142-004 GLP Unpublished Owner: DTF

IIA, 2.13/01 Young, S. 29.01.01 Dimethoate technical - explosive properties Company, Report No. SCI 066/004783 DTF Doc No. 141-002 GLP Unpublished Owner: DTF

IIA, 2.13/02 Comb, A.L. 2005 Dimethoate (technical) - Explosive properties Company Report No. SCI107/052210 DTF Doc. No. 141-005 GLP Unpublished Owner: DTF

5




IIA, 2.14/02 Comb, A.L. 2005 Dimethoate (technical) surface tension Company Report No. SCI106/052207 DTF Doc. No. 116-002 GLP Unpublished Owner: DTF

JIIA, 4.1/09

Sorensen, E.V.

2001 Analytical method AM 443.2: Determination of Omethoate (CAS No. 1113-02-6) and Isodimethoate (CAS No. 3344-11-4) in Dimethoate technical, Dimethoate concentrates and EC formulations Company Report No. AM 443.2, Version 3 DTF Doc No. 131-035 Not GLP Unpublished Owner: CHE

JIIA, 4.1/16

Knold, L.

2002 Validation of analytical method VAM 022-02 for determination of water in technical pesticide or its formulations Company Report No. VAL 022-02 DTF Doc No. 131-042 GLP Unpublished Owner: CHE

IIA, 4.2/01 Harper, H. 05.09.01Validation of methodology for thedetermination of residues in apples, artichokes, celery, cherries, lettuce, tomatoes, wheat (grain, green plant and straw), sugar beets (top and roots), asparagus and melons (peel and pulp) Company Report No. SCI 050/004288 DTF Doc No. 522-028 GLP Unpublished Owner: DTF

6




IIA, 4.2/02 Harper, H. 26.11.01 Dimethoate and Omethoate; validation of methodology for the determination of residues in bran, bread, flour, wheatgerm and wheat (grain) Company Report No. SCI/083 DTF Doc No. 522-031 GLP Unpublished Owner: DTF

IIA, 4.2/05 Todd, M. 17.07.01 Dimethoate and Omethoate - Validation of methodology for the determination of residues ofDimethoate and Omethoate in olives (RAC) Company Report No. SCI 026/004068 DTF Doc No. 522-036 GLP Unpublished Owner: DTF

IIA, 4.2/06 Harrison 10.02.98 Study to determine the magnitude of residue of dimethoate and omethoate in protected lettuce following a single glasshouse application ofDANADIM DIMETHOATE 40 in the United Kingdom Company Report No. AK/3375/CN DTF Doc No. 533-4225 GLP Unpublished Owner: DTF

IIA, 4.2/07 Jalali, K., Hiler, R.L.

20.05.98 Validation and radiovalidation of the analytical residue methodfor the determination of Dimethoate and Omethoate in goat and hen tissues, milk and eggs Company Report No. 631W-1 DTF Doc No. 523-005 GLP Unpublished Owner: CHE

7




IIA, 4.2/13 Jacobsen, B., Williams, B.B.

27.09.97Dissipation of Dimethoate in soil under field conditions when applied to bare ground in New York (Final Report #40971) Company Report No. 40971 DTF Doc No. 922-005 GLP Unpublished Owner: CHE

IIA, 4.2/15 Mihalik, R., Bussard, J.B.

01.07.93Method validation for the analysis of Dimethoate in aquatictest water Company Report No. 40863 DTF Doc No. 525-003 GLP Unpublished Owner: CHE

IIA, 4.2/16 Grote, C. 21.12.00Validation on analytical method No. 480/0 - GS/MS determinationof Dimethoate and Omethoate intap water and surface water Company Report No. 2000/1018561 DTF Doc No. 525-005 GLP Unpublished Owner: DTF

IIA 4.2/21 Jones, A.

2003 Validation Of Analytical Methodology For The Determination Of Dimethoate And Omethoate In Olives, OliveOil, Oranges, Lettuce And Wheat Grain Company Report No.: PGD-104DTF Doc No. 522-032 GLP status : yes Unpublished Owner: DTF

8




IIA 4.2/22 Kang, J.

2003 Independent Laboratory Validation of a Method for the Determination of Residues of Dimethoate and Omethoate in Olives Company Report No. -2061 DTF Doc No. 522-043 GLP Unpublished Owner: DTF

IIA 4.2/23 Kang, J.

2003 Independent Laboratory Validation of a Method for the Determination of Residues of Dimethoate and Omethoate in Olive Oil Company Report No. -2060 DTF Doc No. 522-042 GLP Unpublished Owner: DTF

IIA 4.2/24 Kang, J.

2003 Independent Laboratory Validation of a Method for the Determination of Residues of Dimethoate and Omethoate in Oranges, Lettuce and Wheat Grain Company Report No. -2062 DTF Doc No. 522-044 GLP Unpublished Owner: DTF

IIA, 4.2/20 Harper, H. 2001 Dimethoate and its metabolites - Validation of methodology for the determination of residues in human plasma and urine Company Report No. SCI/068 DTF Doc No. 520-014 GLP Unpublished Owner: DTF

9




IIA, 4.2/25 Harper, H. 2003 Dimethoate and its metabolites - Validation of methodology for the determination of residues in human plasma and urine Company Report No. SCI/ 068/032513 DTF Doc No. 523-010 GLP Unpublished Owner: DTF

10

B.6 Toxicology and metabolism Annex Point / Reference number


Reports on previous use in granting national authorizations

IIA, 5.1/02 Leibold, E., Hoffmann, H.D.

03.04.01 Study on the dermal penetration of 14C-Dimethoate in rats Company Report No. 01B0418/006016 DTF Doc No. 654-002 GLP Unpublished Owner: DTF

IIA, 5.1/03 Davies, D.J. 07.12.99 Dimethoate: in vitro absorption from a 400 g/l EC formulation through human and rat epidermis Company Report No. JV1591/REG/REPT DTF Doc No. 460-003 GLP Unpublished Owner: DTF

IIA, 5.1/04 Heylings, J.R. (part of Davies, 1999)

22.11.00 Statement regarding project no.: 104-065 contract CO9027 - JV1591 Dimethoate: In vitro absorption from a 400 g/l EC formulation through human and rat epidermis Company Report No. CO9027-JV1591 DTF Doc No. 481-036 Not GLP Unpublished Owner: DTF

IIA, 5.3/10 Chambers, P.R. 12.11.99 Dimethoate 400 g/l EC: toxicity study by dermal administration to han wistar rats for 4 weeks Company Report No. SCI 018/993964 DTF Doc No. 432-005 GLP Unpublished Owner: DTF

IIA, 5.3/12 Hilaski, R. 27.04.99 A 5-day dermal toxicity study of Dimethoate 4 E (neat formulation) in rats Company Report No. 827-002 DTF Doc No. 431-001 GLP Unpublished Owner: CHE

IIA, 5.3/13 Leibold, E. 04.12.00 Dimethoate 400 g/l EC -

11

Annex Point / Reference number



Hoffmann, H.D. spreading on the skin after dermal administration to rats Company Report No. 10B0734/006031 DTF Doc No. 432-008 Not GLP Unpublished Owner: DTF

IIA, 5.4/05 Fautz, R. 1990 Unscheduled DNA synthesis in primary hepatocytes of male rats in vitro Company Report No. 160007 DTF Doc No. 457-007 GLP Unpublished Owner: DTF

IIA, 5.4/06 Fautz, R. 1990 Unscheduled DNA synthesis in primary hepatocytes of male rats in vitro with Dimethoate technical Company Report No. 171000 DTF Doc. No. 457-008 GLP Unpublished Owner: DTF

IIA 5.6/12 Mellert, W. et al 2003 Dimethoate – Two Generation Reproduction toxicity study in Wistar rats; Administration in the diet Company Report No. 70R0466/99118 DTF Doc No. 453-007 GLP Unpublished Owner: DTF

IIA, 5.8/05 Albrecht, A. 21.11.00 Acute oral toxicity Up-and-down method with O-Desmethyl Dimethoate (free acid) Company Report No. 0001595 DTF Doc No. 421-019 GLP Unpublished Owner: DTF

IIA, 5.8/06 Brennan, C. 07.06.01 Dimethoate, Omethoate, 4 metabolites - comparison of toxicity and cholinesterase inhibition potential following a single oral gavage administration to male CD rats Company Report No.

12




SCI 058/004733 DTF Doc No. 463-006 GLP Unpublished Owner: DTF

IIA, 5.8/07 Brennan, C. 19.04.02 Dimethoate and Hydroxy Dimethoate: Comparison of toxicity and Cholinesterase inhibition potential following a single oral gavage administration to male CD rats Company Report No. SCI 084/014449 DTF Doc No. 463-007 GLP Unpublished Owner: DTF

IIA, 5.8/08 Lamb, I.C. 26.07.93 A range-finding acute study of Dimethoate in rats Company Report No. 206001 DTF Doc No. 421-012 GLP Unpublished Owner: CHE

IIA, 5.8/09 Lamb, I.C. 27.07.93 An acute neurotoxicity study of Dimethoate in rats Company Report No. 206002 DTF Doc No. 468-005 GLP Unpublished Owner: CHE

IIA, 5.8/10 Schaefer, G.J. 27.04.99 An acute dietary neurotoxicity study of Dimethoate technical in rats Company Report No. 827-004 DTF Doc No. 421-016 GLP Unpublished Owner: CHE

IIA, 5.8/11 Lamb, I.C. 07.02.94 A subchronic (13 week) neurotoxicity study of Dimethoate in rats Company Report No. 206003 DTF Doc No. 468-006 GLP Unpublished Owner: CHE

IIA, 5.8/12 Myers, D.P. 19.10.01 Dimethoate; Dose finding study in

13




CD rats by oral gavage administration preliminary to developmental neurotoxicity study Company Report No. CHV 068/00129 DTF Doc No. 468-009 GLP Unpublished Owner: CHE

IIA, 5.8/13 Myers, D.P. 27.09.01 Dimethoate; Effects on cholinesterase in the CD rat (adult and juvenile) by oral gavage administration Company Report No. CHV 070/012226 12226 DTF Doc No. 468-007 GLP Unpublished Owner: CHE

IIA, 5.8/14 Myers, D.P. 19.10.01 Dimethoate; Developmental neurotoxicity study in the CD rat by oral gavage administration Company Report No. CHV 069/03881 003881 DTF Doc No. 468-008 GLP Unpublished Owner: CHE

IIA, 5.8/16 Dreher, D.M: 1998 CHA 3620-Fresh: Acute oral toxicity test in the rat Company Report No. 545/111 DTF Doc No. 421-014 GLP Unpublished Owner: CHE

IIA, 5.8/18 Dreher D.M. 2001 Iso-Dimethoate - Acute oral toxicity in the rat - acute toxic class method Company Report No. 545/137 DTF Doc No. 463-004 GLP Unpublished Owner: DTF

IIA, 5.8/19 Brennan, C. 08.06.01 Isodimethoate - toxicity and cholinesterase inhibition potential following a single oral gavage administration to male CD rats

14




Company Report No. SCI 059/004730 DTF Doc No. 463-005 GLP Unpublished Owner: DTF

IIA, 5.9/01 Nielsen, A.M.R. 04.08.99 Standard procedures for biological monitoring of production personnel Company Report No. Not appliable DTF Doc No. 475-003 Not GLP Unpublished Owner: CHE

IIA, 5.9/02 Nielsen, A.M.R. 02.06.94 Adverse health effects in employees associated with production of technical grade Dimethoate and Dimethoate formulations Company Report No. Not applicable DTF Doc No. 475-004 Not GLP Unpublished Owner: CHE

IIA, 5.9/03 Nielsen, A.M.R. 24.06.99 Occupied Health Services Company Report No. Not applicable DTF Doc No. 475-005 Not GLP Unpublished Owner: CHE

IIA, 5.9/04 Juel, K., Lynge, E.

01.10.95 Mortality and incidence of cancer among employes Company Report No. Not indicated DTF Doc No. 475-002 Not GLP Unpublished Owner: CHE

IIA, 5.5/01 Schladt, L. 02.03.94 E 6876 - Chronic toxicological study in Wistar rats to determine a No-Inhibition level for the cholinesterase activity (32-week administration of test substance in drinking water) Company Report No. T 2033899 DTF Doc No. 537-002

15




GLP Unpublished Owner: DTF

IIA, 5.5/02 Schladt, L. 21.02.95 E 6876 (Folimat) - Study for chronic toxicity and carcinogenity in Wistar rats following two-year administration in drinking water Company Report No. T 2030748 DTF Doc No. 537-001 GLP Unpublished Owner: DTF

IIA, 5.5/03 Schladt, L. 08.02.01 E Company Report No. DTF Doc No GLP Published 6876 - Oncogenicity study in B6C3F1 Mice (Administration in the drinking water over 24 months; T1032655) Company Report No. T1032655 DTF Doc No. 555-001 GLP Unpublished Owner: DTF

IIA, 5.6/01 Dotti, A., Biedermann, K., Luetkemeier, H.

E 6876 (c.n. Omethoate) Range finding study to the two generation reproduction study in the rat Company Report No. 207325 DTF Doc No. O_553-001 Not GLP Unpublished Owner: DTF

IIA, 5.6/02 Dotti, A., Kinder, J., Biedermann, K., Luetkemeier, H., Wright, J.

E 6876 (c.n. Omethoate) Two generation reproduction study in the rat Company Report No. 207336 DTF Doc No. O_553-002 Not GLP Unpublished Owner: DTF

IIA, 5.7/01 Bomann, W., Sykes, A.K.

07.01.93

E 6876 (c.n. Omethoate) - Study for delayed neurotoxicity following acute oral administration to the hen Company Report No. Not indicated DTF Doc No. O_541-001 Not GLP

16




Unpublished Owner: DTF

IIA, 5.8/01 Mellert, W., Deckardt, K., Kaufman, W., van Ravenzwaay, B.

2003 Omethoate - Acute oral neurotoxicity study in Wistar rats; single administration by gavage Company Report No. 20C0709/01098 DTF Doc No. O_541-004 GLP Unpublished Owner: DTF

17

B.7 Residue data Annex Point / Reference number

Author (s)+

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


IIA, 6.0/02 Harper, H. 30.07.01 Dimethoate and Omethoate - storage stability in cherries at approximately -18 °C Company Report No. SCI 053/012268 DTF Doc No. 545-002 GLP Unpublished Owner: DTF

IIA, 6.1/01 Corden, M.T. 28.06.00 14C-Dimethoate - metabolism in potatoes Company Report No. SCI 021/002705 DTF Doc No. 641-002 GLP Unpublished Owner: DTF

IIA, 6.1/02 Corden, M.T. 11.12.01 14C-Dimethoate metabolism in potatoes investigation of components A, G and K Company Report No. SCI/054 DTF Doc No. 641-006 GLP Unpublished Owner: DTF

IIA, 6.1/03 Corden, M.T. 10.12.01 14C-Dimethoate - metabolism in wheat Company Report No. SCI/049 DTF Doc No. 641-005 GLP Unpublished Owner: DTF

IIA, 6.2/01 Jalali, K., Krautter, G.R., Cassidy, M.S., Cassidy,J.E.

23.01.95 The metabolism of Dimethoate in the lactating goat following oral administration for 3 consecutive days Company Report No. 761E/412W DTF Doc No. 652-003 GLP Unpublished Owner: CHE

IIA, 6.2/02 Jalali, K., Hiler, R.

29.04.97 Further characterization of [14C]Dimethoate residues in the 48-60 hour milk extract from the study entitled: The metabolism

18


Author (s)+



of [14C]Dimethoate in the lactating goat following oral administration for 3 consecutive days (MRID 43583301) Company Report No. 632W DTF Doc No. 652-005 GLP Unpublished Owner: CHE

IIA, 6.2/03 Jalali, K., Krautter, G.R., Cassidy, M.S., Cassidy, J.E.

23.01.95 The metabolism of [14C]Dimethoate in laying hens following oral administration for 7 consecutive days Company Report No. 760E/411W DTF Doc No. 652-002 GLP Unpublished Owner: CHE

IIA, 6.3/01 Wilson, A. 10.07.01 Dimethoate - Residue study (decline curve) with an EC formulation containing 400 g/l Dimethoate applied to wheat in Spain and Italy in 2000 Company Report No. SCI 046/004815 DTF Doc No. 534-4022 GLP Unpublished Owner: DTF

IIA, 6.3/02 Wilson, A. 18.01.02 Dimethoate, residue study (at harvest) with an EC formulation containing 400 g/l Dimethoate applied to wheat in Spain and Italy in 2001 Company Report No. SCI/070 DTF Doc No. 534-4030 GLP Unpublished Owner: DTF

IIA, 6.3/03 Wilson, A. 28.01.02 Dimethoate, residue study (decline and at harvest) with an EC formulation containing 400 g/l Dimethoate applied to wheat in United Kingdom and Germany in 2001 Company Report No. SCI 080/14431 DTF Doc No. 534-4032

19


Author (s)+



GLP Unpublished Owner: DTF

IIA, 6.3/04 Wilson, A. 05.04.02 Dimethoate, Residue decline curve study with an EC formulation containing 400 g/l Dimethoate applied to olives in Spain, Italy and Greece, 1999 Company Report No. SCI 023/003604 DTF Doc No. 532-5006 GLP Unpublished Owner: DTF

IIA, 6.3/05 Wilson, A. 18.09.01 Dimethoate; Residue study (decline curve and at harvest) with an EC formulation containing 400 g/l Dimethoate applied to olives in Spain, Italy and Greece in 2000 Company Report No. DTF Doc No. 532-5004 GLP Unpublished Owner: DTF

IIA, 6.3/06 6.5/02

Wilson, A. 14.03.02 Dimethoate, Residue study (at harvest and processing) with an EC formulation containing 400 g/l Dimethoate applied to olives in Greece in 2000 Company Report No. SCI 051/013403 DTF Doc No. 532-5005 GLP Unpublished Owner: DTF

IIA, 6.3/07 Wilson, A. 12.09.01 Dimethoate - Residue decline curve study with an EC formulation containing 400 g/l Dimethoate applied to sugar beet in Italy and Spain in 2000 Company Report No. SCI/045 DTF Doc No. 533-0001 GLP Unpublished Owner: DTF

IIA, 6.3/08 Wilson, A. 18.01.02 Dimethoate, residue study (decline curve and at harvest) with an EC formulation 400 g/l

20


Author (s)+



Dimethoate applied to sugar beet in Spain and Italy in 2001 Company Report No. SCI 069/014457 DTF Doc No. 534-5010 GLP Unpublished Owner: DTF

IIA, 6.3/11 Wilson, A. 01.03.02 Dimethoate, Residue study (at harvest) with an EC formulation containing 400 g/l Dimethoate applied to sugar beet in the United Kingdom and Germany in 2001 Company Report No. SCI 082/022134 DTF Doc No. 534-4033 GLP Unpublished Owner: DTF

IIA, 6.3/12 Wilson, A. 30.04.01 Dimethoate - Residue study (decline curve) with an EC formulation containing 400 g/l Dimethoate applied to tomatoes in Spain and Italy in 2000 Company Report No. SCI 040/004726 DTF Doc No. 533-2019 GLP Unpublished Owner: DTF

IIA, 6.3/13 Wilson, A. 04.01.02 Dimethoate, Residue study (at harvest) with an EC formulation containing 400 g/l Dimethoate applied to tomatoes in Spain and Italy in 2001 Company Report No. SCI 074/014407 DTF Doc No. 533-2020 GLP Unpublished Owner: DTF

IIA, 6.3/14

Harrison 10.02.98 Study to determine the magnitude of residue of dimethoate and omethoate in protected lettuce following a single glasshouse application of DANADIM DIMETHOATE 40 in

21


Author (s)+



the United Kingdom Company Report No. AK/3375/CN DTF Doc No. 533-4225 GLP Unpublished Owner: CHE

IIA, 6.3/15 Harrison, C 13.07.99 Study to determine the magnitude of residue of Dimethoate and Omethoate in protected lettuce following single glasshouse applications of Danadim Dimethoate 40 in the United Kingdom Company Report No. AK/4088/CN DTF Doc No. 533-4227 GLP Unpublished Owner: CHE

IIA 6.3/16 Wilson, A. 2002 Dimethoate Residue Study (Decline And At Harvest) With An Ec Formulation Containing 400 G/L Dimethoate Applied To Wheat In The United Kingdom And Germany In 2002 Company Report No. SCI 086/024290 DTF Doc No. 534-4034 GLP Unpublished Owner: DTF

IIA, 6.5/01 Aikens, P.J. 14.12.99 Dimethoate and Omethoate - Hydrolysis under simulated processing conditions Company Report No. CHV 061/994085 DTF Doc No. 911-003 GLP Unpublished Owner: DTF

22


Author (s)+



IIA 6.5/03 Wilson, A.

2003 Dimethoate Residue Study (Processed Commodity) With An Ec Formulation Containing 400 G/L Dimethoate Applied To Wheat In The United Kingdom And Germany In 2001 Company Report No. SCI 079/014476 DTF Doc No. 538-011 GLP Unpublished Owner: DTF

IIA 6.5/04 Wilson, A.

2003 Dimethoate Residue Study (At Harvest And Processing) With An Ec Formulation Containing 400 G/L Dimethoate Applied To Olives In Greece And Spain In 2001 Company Report No. SCI 072/024286 DTF Doc No. 532-5007 GLP Unpublished Owner: DTF

IIA, 6.6/01 Adair, T.H., Sprinkle, R.B., Toia, R.F.

21.06.95 A confined rotational crop study with 14C-Dimethoate using lettuce, turnips and wheat Company Report No. 413W DTF Doc No. 537-014 GLP Unpublished Owner: CHE

23

B.8 Environmental fate and behaviour Annex Point / Reference number



IIA, 7.1/11 Hofer, M. Schmitz, A. Peter, S. Gross, R.

15.10.03 Reply to questions raised by the RMS (UK) in the letters received 13 August and 23 September 2003 - Request for further information regarding the fate and behaviour evaluation for Dimethoate - Revision 1 Company Report No. 269-002 DTF Doc No. 784-037 Not GLP Unpublished Owner: DTF

IIA, 7.1/03 Skinner, W., Shepler, K.

08.06.94 Photodegradation on [14C] Dimethoate in/on soil by natural sunlight Company Report No. 414W DTF Doc No. 925-002 GLP Unpublished Owner: CHE


(1994a)02.09.94

Dissipation of Dimethoate in soil under field conditions with grain sorghum in Texas (Final Report #40972) Company Report No. 40972 DTF Doc No. 922-004 GLP Unpublished Owner: CHE


(1994b)

27.09.94

Dissipation of Dimethoate in soil under field conditions when applied to bare ground in New York (Final Report #40971) Company Report No. 40971 DTF Doc No. 922-005 GLP Unpublished Owner: CHE

IIA, 7.2/03 Hertl, J. 10.07.00 Ready biodegradability of Dimethoate in a closed bottle test Company Report No. 8522160 DTF Doc N.o 924-005 GLP Unpublished Owner: DTF

IIA, 7.2/07 Förster, B. 15.06.99 Estimation of the atmospheric residence time of Dimethoate

24




using the Atkinson method Company Report No. Not indicated DTF Doc No. 192-006 Not GLP Unpublished Owner: DTF

25

B.9 Ecotoxicology Annex Point / Reference number



IIA, 8.1/01 Zok, S. 30.10.01 Dimethoate - acute toxicity in the ring-necked pheasant (Phasianus colchicus) after single oral administration (LD50) Company Report No. 12W0466/99126 DTF Doc No. 441-007 GLP Unpublished Owner: DTF

IIA, 8.1/02 Zok, S. 30.10.01 Dimethoate - acute toxicity in the northern bobwhite quail (Colinus virginianus) after single oral administration (LD50) Company Report No. 11W0466/99128 DTF Doc No. 441-008 GLP Unpublished Owner: DTF

IIA, 8.1/07 Zok, S. 31.10.01 Dimethoate - avian dietary LC50 test in chicks of the bobwhite quail (Colinus virginianus) Company Report No. 31W0466/99127 DTF Doc No. 445-010 GLP Unpublished Owner: DTF

IIA, 8.1/08 Zok, S. 31.10.01 Dimethoate - avian dietary LC50 test in chicks of the ring-necked pheasant (Phasianus colchicus) Company Report No. 36W0466/99130 DTF Doc No. 445-009 GLP Unpublished Owner: DTF

IIA, 8.1/09 Gallagher, S.P., Foster, J., Beavers, J.B., Jaber, M.

05.06.96 Dimethoate: a reproduction study with the northern bobwhite (Colinus virginianus) Company Report No. 232-115 DTF Doc No. 445-006 GLP Unpublished Owner: CHE

IIA, 8.1/11 Gallagher, S.P., Foster, J.W.,

26.03.96 Dimethoate: a reproduction study with the mallard (Anas

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Beavers, J.B., Jaber, M.

platyrhynchos) Company Report No. 232-116 DTF Doc No. 445-005 GLP Unpublished Owner: CHE

IIA 8.1/14 Gallagher, S.P. Grimes, J. Beavers, J.B.

2003 Omethoate: An Acute Oral Toxicity Study With The Ring-Necked Pheasant Company Report No. 542-102 DTF Doc No. 0_811-001 GLP Unpublished Owner: DTF

IIA 8.1/15 Gallagher, S.P. Grimes, J. Beavers, J.B.

2003 Omethoate: An Acute Oral Toxicity Study With The Northern Bobwhite Company Report No. 542-101 DTF Doc No. 0_811-002 GLP Unpublished Owner: DTF

IIA, 8.2/03 Hertl, J. 01.03.01 Acute toxicity of O-Desmethyl Dimethoate, Potassium salt to rainbow trout (Oncorhynchus mykiss) in a 96-hour static test (Final report revision No.1) Company Report No. 8553230 DTF Doc No. 442-010 GLP Unpublished Owner: DTF

IIA, 8.2/04 Hertl, J. 05.02.02 Acute toxicity of Dimethylthiophosphoric acid, Na-salt to rainbow trout (Oncorhynchus mykiss) in a 96-hour static test (Final report) Company Report No. 10561230/ 10561230A/ 10561230 DTF Doc No. 442-011 GLP Unpublished Owner: DTF

IIA, 8.2/05 Hertl, J. 26.03.02 Acute toxicity of Dimethyl phosphoric acid, Na-salt to rainbow trout (Oncorhynchus mykiss) in a 96-hour static test Company Report No. 10582230A /10582230/

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10582230 DTF Doc No. 442-012 GLP Unpublished Owner: DTF

IIA, 8.2/07 Strawn, T.L., Muckermann, M.

25.01.94 Early life-stage toxicity of Dimethoate to the rainbow trout (Oncorhynchus mykiss) under flow-through conditions Company Report No. 40864 DTF Doc No. 444-004 GLP Unpublished Owner: CHE

IIA, 8.2/09 Hertl, J. 03.01.02 Analytical report and Study protocol, Acute toxicity of Dimethoate to daphnia magna in a 48-hour immobilization test (Final report) Company Report No. 10591220/ 10591220A/ 10591220 DTF Doc No. 443-011 GLP Unpublished Owner: DTF

IIA, 8.2/10 Hertl, J. 01.03.01 Toxicity of O-Desmethyl Dimethoate, Potassium salt to daphnia magna in a 48-hour immobilization test (Final report revision No.1) Company Report No. 8552220 DTF Doc No. 443-010 GLP Unpublished Owner: DTF

IIA, 8.2/11 Hertl, J. 05.02.02 Final Report, Acute toxicity of Dimethylthiophosphoric acid, Na-salt to daphnia magna in a 48-hour immobilization test Company Report No. 10562220/ 10562220A/ 10562220 DTF Doc No. 443-012 GLP Unpublished Owner: DTF

IIA, 8.2/12 Hertl, J., Meinerling, M. Herrmann, S.

04.03.02 Acute toxicity of Dimethyl phosphoric acid, Na-salt to Daphnia magna in a 48-hour immobilization test

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Company Report No. 10581220/ 10581220A/ 10581220 DTF Doc No. 443-013 GLP Unpublished Owner: DTF

IIA, 8.2/16 Hertl, J. 26.02.01 Toxicity of O-Desmethyl Dimethoate, Potassium salt to scenedesmus subspicatus in an algal growth inhibition test (Final report revision No.1) Company Report No. 8551210 DTF Doc No. 443-009 GLP Unpublished Owner: DTF

IIA, 8.2/17 Heintze, A. 22.03.02 Assessment of side effects of Dimethoate on the larvae of the midge, Chironomus riparius with the laboratory test method Company Report No. 20011123/01-ASCr DTF Doc No. 446-003 GLP Unpublished Owner: DTF

IIA, 8.4/01 Stäbler, D. 26.11.01 Acute toxicity of Dimethoate on earthworms, Eisenia foetida using an artificial soil test Company Report No. 20011123/01-NLEf DTF Doc No. 449-009 GLP Unpublished Owner: DTF

IIA, 8.4/02 Stäbler, D. 26.11.01 Acute toxicity of Dimethylphosphoric acid, Na salt on earthworms, Eisenia foetida using an artificial soil test Company Report No. 20011122/01-NLEf DTF Doc No. 449-008 GLP Unpublished Owner: DTF

IIA, 8.4/03 Stäbler, D. 26.11.01 Acute toxicity of Dimethylthiophosphoric acid, Na salt on Earthworms, Eisenia foetida using an artificial soil test

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Company Report No. 20011121/01-NLEf DTF Doc No. 449-007 GLP Unpublished Owner: DTF

IIA, 8.4/04 Stäbler, D. 22.03.02 Final Report, Dimethoate, Assessments of effects on reproduction and growth on Eisenia foetida in Artificial soil Company Report No. 20011123/01-NREf DTF Doc No. 449-018 GLP Unpublished Owner: DTF

IIA, 8.5/03 Kölzer, U. 20.11.01 Assessment of the side effects of Dimethyl phosphoric acid, Na salt on the activity of the soil microflora Company Report No. 20011122/01-ABMF DTF Doc No. 449-006 GLP Unpublished Owner: DTF

IIA, 8.5/04 Kölzer, U. 20.11.01 Assessment of the side effects of Dimethylthiophosphoric acid, Na salt on the activity of the soil microflora Company Report No. 20011121/01-ABMF DTF Doc No. 449-005 GLP Unpublished Owner: DTF

IIA, 8.7/01 Hertl, J. 10.07.00 Toxicity of Dimethoate to activated sludge in a respiration inhibition test Company Report No. 8521171 DTF Doc No. 924-006 GLP Unpublished Owner: DTF

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Documents

List of Annex II studies which were considered as relied ...search.fytoweb.be/NL/doc/DimethoateEssential.pdf · Owner: CHE JIIA, 4.1/16 Knold, L. 2002 Validation of analytical method