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483 Grosshans, F. (2003) Pyrimethanil: review of the dossier - answer to questions from the Rapporteur Member State. Unpublished report No. 2003/1023037 from BASF AG, Agrarzentrum Limburgerhof, L imburgerhof, Germany. Submitted to WHO by BASF, France. Harvey, P.W. (1991a) Technical SN 100 309: 28 day dietary and gavage repeated dose study in rats Unpublished report No. A81779 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Harvey, P.W. (1991b) Technical SN 100 309: Mouse 28-day dietary repeat dose study. Unpublished report No. A81781 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Harvey, P.W. (1991c) Technical SN 100309: dog 90-day oral (gavage) repeat dose study. Unpublished report No. A81790 from Schering Agrochemicals Ltd, Saffron Walden, Essex UK. Submitted to WHO by BASF, France. Harvey, P.W. (1992a) Technical SN 100309: dog oral maximum tolerated dose - 13 day range-finding study. Unpublished report No. A81763 from Schering Agrochemicals Ltd, Saffron Walden, Essex , UK. S ubmitted to WHO by BASF, France. Harvey, P.W. (1992b) Technical SN 100309: rat 10-day oral range finding study. Unpublished report No. A81776 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Harvey, P.W. (1992c) Addendum No. 1: technical SN 100 309: rat 10-day oral range finding study. Unpublished report No. A81777 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Harvey, P.W. (1994) 2nd amendment to report No. TOX90/223-25 - SN 100309: 13 weeks oral (dietary) toxicity study in the rat followed by a 4 week reversibility period. Unpublished report No. A81785 from Toxicol Laboratories Ltd, Ledbury Herefordshire, UK. Submitted to WHO by BASF, France. Harvey, P.W. & Davies, M. (1990) Technical SN 100 309: 28-day repeat dose study in dogs. Unpublished report No. A81764 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Harvey, P.W. & Rees, S.J. (1991) SN 100309 (CR 19325/3): mouse 90-day dietary repeat dose study. Unpublished report No. A81792 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Healing, G. (1992a) Technical SN 100 309: rat 7-day dietary thyroid function test using perchlorate discharge as a diagnostic test. Unpublished report No. A81829 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Healing, G. (1992b) Technical SN 100 309: rat 14-day dietary study to investigate the mechanism of thyroid response. Unpublished report No. A81828 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Healing, G. (1994) 1st addendum to report No. TOX/92/223-62: technical SN 100309: 104 week rat combined chronic toxicity and oncogenicity study - report of individual pathology findings. Unpublished report No. A81808 from AgrEvo UK Ltd, Chesterford Park, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Healing, G. (1995c) 2nd amendment to report No. TOX/92/223-68: technical SN 100309: 80 week oral (dietary administration) carcinogenicity study in the mouse. Unpublished report No. A89479 from Hazleton UK, Harrogate, North Yorkshire, UK. Submitted to WHO by BASF, France. Healing, G. (1996a) 1st amendment to report TOX/94/223-82: technical SN 100309 - guinea-pig skin sensitization study (Magnusson & Kligman maximisation assay). Unpublished report No. A89294 from Centre International de Toxicologie, Evreux, France. Submitted to WHO by BASF, France. Healing, G. (1996b) 2nd amendment to report TOX/94/223-82: technical SN 100309 - guinea-pig skin sensitization study (Magnusson & Kligman maximisation assay). Unpublished report No. A89340 from Centre International de Toxicologie, Evreux, France. Submitted to WHO by BASF, France. PYRIMETHANIL 445–486 JMPR 2007
484 Hemmings, P.A. (1991a) Residue levels in rat tissues following repeated daily oral dosing with ( 14 C) SN 100 309 at 10 mg/kg bodyweight. Unpublished report No. A81622 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Hemmings, P.A. (1991b) The distribution and excretion of radiolabelled residues in the mouse following oral dosing with [ 14 C] SN 100309 at 10 mg/kg bodyweight. Unpublished report No. A81624 from Schering Agrochemicals Ltd, Saffron Walden, Essex , UK. Submitted to WHO by BASF, France. Hemmings, P.A. (1993) SN 100 309: excretion and tissue residues of a radiolabelled oral dose in rats following pre-dosing for 14 days with unlabelled SN 100 309. Unpublished report No. A81631 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Higham, A.T. (1990) SN 100 309: 13-week oral (dietary) toxicity study in the rat followed by a 4-week regression period. Unpublished report No. A81783 from Toxicol Laboratories Ltd, Ledbury, Herefordshire, UK. Submitted to WHO by BASF, France. Husband, R.F. (1992) Amendment 1 - conforming amendment number one Schering Agrochemicals Limited - SN 100309 - 13 week oral (dietary) toxicity study in the rat followed by a 4 week reversibility period. Unpublished report No. A81784 from Toxicol Laboratories Ltd, Ledbury, Herefordshire, UK. Submitted to WHO by BASF, France. Irvine, L.F. (1991) Technical SN 100 309: oral (gavage) development toxicity (teratogenicity) study in the New Zealand White rabbit. Unpublished report No. A81798 from Toxicol Laboratories Ltd, Ledbury, H erefordshire, UK. Submitted to WHO by BASF, France. Jackson, C.M. & Bennett, L.K. (1991) Technical SN 100309: rat oral developmental toxicity (teratogenicity) study. Unpublished report No. A81800 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Jackson, C.M., Everett, D.J. (1994) 1st amendment to report No. TOX/92/223-57 - technical SN 100309: in vitro Chinese hamster ovary/HPRT locus gene mutation assay. Unpublished report No. A89515 from Huntingdon Research Centre, Huntingdon, UK. Submitted to WHO by BASF, France. Jackson, G.C., Hardy, C.J. (1992) Technical SN 100309: rat acute (4-hour exposure) inhalation toxicity study. Unpublished report No. A81820 from Huntingdon Research Centre, Huntingdon, UK. Submitted to WHO by BASF, France. Jardinet, F. (2006) Pyrimethanil (BAS 605 F) JMPR evaluation. Toxicology monograph. Unpublished report No. 2006/1039449 from BASF Agro SAS, France. Submitted to WHO by BASF, France. Jones, E. & Gant, R.A. (1990) Technical SN 100309: bacterial mutation assay. Unpublished report No. A81788 from Huntingdon Research Centre, Huntingdon, UK. Submitted to WHO by BASF, France. Jones, E. & Gant, R.A. (1991) Technical SN 100309: bacterial mutation assay with Escherichia coli. Unpublished report No. A81805 from Huntingdon Research Centre, Huntingdon, UK. Submitted to WHO by BASF, France. Kitching, J. (1998) AE F132593 (soil metabolite of pyrimethanil) - code: AE F132593 00 ID99 0001 - bacterial reverse mutation assay. Unpublished report No. C000864 from Huntingdon Life Sciences Ltd, H untingdon, Cambridgeshire, UK. Submitted to WHO by BASF, France. Malarkey, P. (1990) Mouse acute oral study. Unpublished report No. A81775 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Markham, L.P. (1989a) Technical SN 100 309: rat acute oral toxicity study. Unpublished report No. A81766 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Markham, L.P. (1989b) Technical SN 100 309: rat acute dermal toxicity study. Unpublished report No. A81769 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. Markham, L.P. (1989c) Technical SN 100 309: rabbit skin irritancy study. Unpublished report No. A81771 from Schering Agrochemicals Ltd, Saffron Walden, Essex, UK. Submitted to WHO by BASF, France. PYRIMETHANIL 445–486 JMPR 2007
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Pesticide residues in food — 2007
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TABLE OF CONTENTS Page List of part
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Dr Vicki L. Dellarco, Office of Pes
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Abbreviations used 3-MC ACTH ADI ai
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MRL MS MS/MS MTD NMR NOAEC NOAEL NO
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Introduction The toxicological mono
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AMINOPYRALID First draft prepared b
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5 higher renal excretion in the gro
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7 Table 4. Recovery of radioactivit
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9 Table 7. Pharmacokinetic paramete
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11 (c) Exposure by inhalation Five
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13 Table 9. Acute toxicity of amino
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15 The data from urine analysis rev
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17 18, monthly for palpable masses.
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19 Table 12. Body weights of rats f
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21 Table 15. Results of assays for
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23 in both groups, feed consumption
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25 neurotoxicity after 12 months. B
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27 The same five time-mated NZW rab
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29 Mortality was increased in all g
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31 Levels relevant to risk assessme
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33 References Brooks, K.J. (2001a)
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35 Consulting, The Dow Chemical Com
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ATRAZINE First draft prepared by Ru
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39 in the early 1990s; this reflect
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41 Maximum concentrations in the bl
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43 In a study on comparative metabo
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45 Table 1. Metabolism of atrazine
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47 Figure 2. Proposed metabolic pat
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49 to intact skin; and that no read
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51 the highest dose, and food consu
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53 mice (evaluated as roughly equiv
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55 Table 5. Incidence of mammary tu
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57 Table 6. Selected findings from
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59 was decreased when compared with
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61 Table 9. Selected findings of a
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63 proestrus at the expense of days
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65 Table 10. Selected studies of ge
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67 End-point Test object Concentrat
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69 Table 12. Relevant findings in a
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73 respectively) and in males at th
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77 All dams survived until the end
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79 250 and 500 ppm. Body-weight gai
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81 In an assay for reverse mutation
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83 on pubertal development in femal
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85 parameters (decreased pH, specif
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89 0, 75, 150 or 300 mg/kg bw per d
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91 The NOAEL was 25 ppm, equal to 1
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93 In a study on the effect of atra
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95 Delayed parturition was seen at
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97 observed in the pair-fed group.
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99 examined, offspring in the atraz
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101 antagonize E2-induced luciferas
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103 increase in steroidogenesis is
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105 The immune system of adult mice
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107 In a later review of cancer epi
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109 In a 25-day study in rabbits tr
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111 developmental toxicity were 10
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113 regulation in male offspring in
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115 (d) Diaminochlorotriazine (DACT
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117 Developmental target/critical e
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119 • The failure to ovulate resu
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121 The relationship between increa
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123 Table A2. Comparison of paramet
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125 Ballantine, L., Murphy, T. G. &
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127 Dunkelberg, H., Fuchs, J., Heng
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129 Heneweer, M., van den Berg, M.
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131 Lindsay, L.A., Wimbert, K.V., G
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133 Morseth, S.L. (1996d) Chronic (
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135 Rudzki, M.W., Batastina, G., &
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137 Tennant, A.H., Peng, B. & Klige
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AZINPHOS-METHYL First draft prepare
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141 methylation and oxidation of me
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143 Table 1. Acute oral toxicity of
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145 Table 2. Cholinesterase activit
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147 at the highest dose. In both sp
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149 Table 6. Cholinesterase activit
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151 Table 8. Fertility of F 0 and F
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153 Table 10. Fertility parameters
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155 Groups of 22 mated Sprague-Dawl
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157 after completion of the feeding
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159 reduced motor activity in males
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161 sensitivity with that of labora
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163 measures to prevent worker expo
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165 when brain cholinesterase activ
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167 Critical end-points for setting
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169 Eiben, R., Schmidt, W., & Loese
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171 Myhr, B.C. (1983) Evaluation of
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LAMBDA-CYHALOTHRIN First draft prep
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175 Figure 1. Chemical structures o
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177 In a comparative study, the abs
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179 Figure 2. Main pathways of biot
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181 (iv) Dermal sensitization In a
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183 observed in rats at the highest
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185 Mortality was not affected by t
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187 the group at 100 ppm, reduction
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189 and five females per group were
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191 10-12%) than those of controls
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193 Comments Biochemical aspects Or
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195 Toxicological evaluation Althou
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197 Metabolism in animals Toxicolog
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199 Harrison, M.P. (1984a) Cyhaloth
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DIFENOCONAZOLE First draft prepared
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203 a sex difference nor any marked
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205 demonstrated that the highest t
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207 Figure 3. Proposed metabolic pa
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209 of the study were unremarkable.
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211 Table 3. Results of studies of
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213 The no-observed-adverse-effect
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215 lower than those of rats in the
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217 hepatocellular enlargement. In
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219 i.e. males lost 15.4% and femal
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221 and 357. This reduced food cons
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223 There was very high mortality a
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225 Table 6. Treatment-related hist
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227 Rats Groups of 80 CRL:CD(SD)®
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229 Table 7. Histopathology finding
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231 D. Temporal association. The fe
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233 2.5 Reproductive toxicity (a) M
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235 t estes weights in the males at
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237 continued to be lower than thos
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239 Corpora lutea in each ovary wer
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241 S1 + S2, not ossified — —
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243 in the control group and in the
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245 physically examined for changes
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249 can occur in untreated mice, in
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251 Study of reproductive toxicity
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257 of the test article on microsom
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259 Ophthalmoscopic examinations pe
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261 the radioactivity was re-elimin
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263 In a single-dose study of neuro
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265 Estimate of acceptable daily in
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267 Clapp, M.J.L., Killick, M.E., H
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269 Herbold, B. (1983c) THS 2212 tr
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271 Pinto, P. (2006b) Difenoconazol
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DIMETHOMORPH First draft prepared b
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275 Five different treatment groups
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277 To investigate the significance
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279 and the E : Z isomer ratio was
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281 Table 10. Tissue distribution o
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283 (e) Dermal sensitization The de
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285 females at the highest dose, to
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287 The NOAEL was 10 mg/kg bw per d
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289 concentrations in females were
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291 health, moribundity and mortali
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293 0-9%, mean, 3.5%; only one out
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Table 26. Organ weights adjusted to
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297 cell hyperplasia. The testes tu
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299 unscheduled DNA synthesis, the
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301 Figure 3. Cumulative percentage
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303 Rabbits In a dose-range finding
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305 (b) Potentiation of hexobarbito
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307 0.2% or less of the administere
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309 eye-opening, pinna unfolding or
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311 Lowest relevant inhalation NOAE
Page 328 and 329:
313 Gardner, J.R. (1989) CME 151 te
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315 van de Waart, E.J. (1991b) Eval
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318 Committee on Pesticide residues
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320 (a) Ocular irritation Rabbits T
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322 weights were decreased in males
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324 toxicity was 5 mg/kg bw per day
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326 respectively; range for histori
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328 Table 4. Incidence of Leydig-ce
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330 and/or bilateral) was noted in
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332 No treatment-related signs of m
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334 Table 6. Incidence of selected
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336 or teratogenic potential at the
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338 and progesterone. The concentra
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340 the doses used in the 1-year st
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342 No neurotoxic effects were seen
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344 Lowest relevant reproductive NO
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346 Keller, D.A. (1992c) Oncogenici
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PROCYMIDONE First draft prepared by
Page 366 and 367:
351 Rats Groups of five male and fe
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353 Table 1. Pharmacokinetic parame
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355 Seven doses C max (µg equivale
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357 Three groups of five male and f
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359 The excretion of radioactivity
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361 Figure 1. Proposed metabolic pa
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363 water consumption were determin
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365 finding. Histopathology reveale
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367 The NOAEL was 500 ppm, equivale
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369 The NOAEL was 100 mg/kg bw per
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371 at 2000 ppm. Histopathology rev
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373 b Each test was conducted in tr
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375 experimental period. Rats were
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377 hypospadias, testicular atrophy
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379 a single dose, which produced o
Page 396 and 397:
381 The anti-androgenic activities
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383 but only at 6000 ppm after 13 w
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385 The results are summarized in T
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387 males (all litters) in the grou
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389 procymidone (18-27% of the admi
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391 Procymidone induced liver tumou
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393 The Meeting concluded that the
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395 Toxicologically significant com
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397 Harada, T. (1983) A review on m
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399 Murakami, M., Yoshitake, A. & H
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401 Tarui, H. (2005b) In vitro meta
Page 419 and 420:
404 Explanation Profenofos is the I
Page 421 and 422:
406 The metabolism of ring-labelled
Page 423 and 424:
408 2. Toxicological studies 2.1 Ac
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410 Rabbits Groups of two male and
Page 427 and 428:
412 Groups of five male and five fe
Page 429 and 430:
414 control group and in the test g
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416 of the rabbits at the highest d
Page 433 and 434:
418 The NOAEL for brain acetylcholi
Page 435 and 436:
420 Table 2. Histopathological find
Page 437 and 438:
422 1 out of 70; lowest dose, 3 out
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424 body‐weight gains (3-10% decr
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426 treated groups for body-weight
Page 443 and 444:
428 (b) Short-term studies of neuro
Page 445 and 446:
430 represented as equally as possi
Page 447 and 448: 432 pound and the equitoxic mixture
Page 449 and 450: 434 Inhibition of brain acetylcholi
Page 451 and 452: 436 Toxicological evaluation Erythr
Page 453 and 454: 438 Neurotoxicity/delayed neurotoxi
Page 455 and 456: 440 Harris, S.B. (1982) A teratolog
Page 457 and 458: 442 Puri, E. (1982a) Autoradiograph
Page 460 and 461: PYRIMETHANIL First draft prepared b
Page 462 and 463: 447 Table 1. Excretion profile in r
Page 464 and 465: 449 Table 3. Half-life of pyrimetha
Page 466 and 467: 451 Table 4. Identification of meta
Page 468 and 469: 453 SN 614 277. The presence of the
Page 470 and 471: 455 2. Toxicological studies 2.1 Ac
Page 472 and 473: 457 treated rabbits showed slight e
Page 474 and 475: 459 still evident in the liver; how
Page 476 and 477: 461 In a 90-day feeding study, grou
Page 478 and 479: 463 per day or 800 mg/kg bw per day
Page 480 and 481: 465 The dosing solutions were prepa
Page 482 and 483: 467 mortality and morbidity. Change
Page 484 and 485: 469 2.4 Genotoxicity Pyrimethanil w
Page 486 and 487: 471 mean body‐weight gains. After
Page 488 and 489: 473 Analysis of dosing solutions in
Page 490 and 491: 475 In a 7-day feeding study, group
Page 492 and 493: 477 at 200 mg/kg bw. These clinical
Page 494 and 495: 479 s ystemic toxicity was 400 ppm
Page 496 and 497: 481 Acute toxicity Rat, LD 50 , ora
Page 500 and 501: 485 Markham, L.P. (1989d) Technical
Page 502 and 503: ZOXAMIDE First draft prepared by I.
Page 504 and 505: 489 The excretion of radioactivity
Page 506 and 507: 491 Table 3. Mean concentration of
Page 508 and 509: 493 Table 4. Distribution of metabo
Page 510 and 511: 495 were also found in the urine, a
Page 512 and 513: 497 owing to the absence of a dose-
Page 514 and 515: 499 The NOAEL was 30 000 ppm, equiv
Page 516 and 517: 501 Table 9. Haematological finding
Page 518 and 519: 503 Table 11. Body weight, food con
Page 520 and 521: 505 daily for signs of moribundity,
Page 522 and 523: 507 Table 14 Results of studies of
Page 524 and 525: 509 phase. The study was certified
Page 526 and 527: 511 Table 16. Spleen weights and hi
Page 528 and 529: 513 FOB/motor activity assessment,
Page 530 and 531: 515 Excretion was primarily in the
Page 532 and 533: 517 days 14 to 21. Increased relati
Page 534 and 535: 519 Lowest relevant inhalation NOAE
Page 536 and 537: 521 Morrison, R.D. & Gillette, D.M.
Page 538 and 539: ANNEX 1 Reports and other documents
Page 540 and 541: 525 31. Pesticide residues in food:
Page 542 and 543: 527 67. Pesticide residues in food
Page 544: 529 101. Pesticide residues in food
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