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397 Harada, T. (1983) A review on medical examinations of factory workers possibly exposed to procymidone technical materials. Unpublished report No BG-31-0019 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Hoberman, A. (1992a) Dose-range developmental toxicity (embryo-fetal toxicity and teratogenic potential) study of procymidone administered orally via gavage to Crl:CD®BR VAF/Plus® presumed pregnant rats. Unpublished report No BT-21-0160 from Argus Research Laboratories, Inc., Horsham, Pennsylvania, USA. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Hoberman, A. (1992b) Developmental toxicity (embryo-fetal toxicity and teratogenic potential including a postnatal evaluation) study of procymidone administered orally via gavage to Crl:CD®BR VAF/Plus® presumed pregnant rats. Unpublished report No BT-21-0161 from Argus Research Laboratories, Inc., Horsham, Pennsylvania, USA. Submitted to WHO by Sumitomo Chemical C., Ltd, Osaka, Japan. Hoberman, A. (1992c) Dose-range developmental toxicity (embryo-fetal toxicity and teratogenic potential including a postnatal evaluation) study of procymidone administered orally via gavage to Crl:CD®BR VAF/Plus® presumed pregnant rats (amendment). Unpublished report No BT-21-0164 from Argus Research Laboratories, Inc., Horsham, Pennsylvania, USA. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Hodge, M., Williams, M., Hollis, K., Moreland, S., Greenwood, M., MacLean Head, L. & Foster, P. (1991) Procymidone: one-generation study in the rat. Unpublished report No. BT-11-0144 from Imperial Chemical Industries, Macclesfield, Cheshire, England. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Hosokawa, S. (1984) Toxicity of S-7131 technical material to rats in prolonged dietary administration over 9 months (BT-60-0003). addendum to final report. Unpublished report No. BT-40-0095 from Takarazuka Research Centre, Takarazuka, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd., Osaka, Japan. Inawaka, K. (2003) Study for effects of procymidone on development of fetal external genitalia in rabbits. Unpublished report No. BT-0211 from Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd Inawaka, K. (2005) Study for determination of minimum toxic dose of the effects on male external genitalia in rats with procymidone. Unpublished report No. BT-0217 from Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Izumi, H. (2005) Teratogenicity study of hydroxylated procymidone in rats by oral administration (observations in male offspring). Unpublished report No. BT-0222 from Panapharm Laboratories Co., Ltd, Kumamoto, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Kadota K, Kohda H &Miyamoto J (1976a) Acute toxicity studies with S-7131 technical material in mice and rats; oral, subcutaneous, intraperitoneal, dermal. Unpublished report No. BT-60-0002 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Kadota, K. & Miyamoto, J. (1976) Eye and skin irritation study with S-7131 technical material in albino rats. Unpublished report No. BT-60-0004 from the Institute for Biological Sciences, Hyogo, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Keller, J. & Cardy, R. H. (1986) Oral chronic toxicity and oncogenicity study in rats TB0100 Sumisclex. Unpublished report No. BT-61-0112 from Litton Bionetics Inc., Rockville, Maryland, USA. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Kimura, K., Shiba, K. & Iba, K. (1988) Comparative metabolism of procymidone in rats and mice. Unpublished report No. BM-80-0019 from Takarazuka Research Center, Sumitomo Chemical Co. Ltd., Takarazuka, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Kinsey, D, Banham, P., Godley, M., Ishmael, J. & Blackburn, D. (1985) Procymidone: six-month feeding study in mice. Unpublished report No BT-51-0102 from Imperial Chemical Industries plc., Macclesfield, England. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. PROCYMIDONE 349–401 JMPR 2007
398 Kogiso, S. (1991) Reverse mutation test of Sumilex in bacterial system. Unpublished report No. BT-10-0138 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Kogiso, S., Kasaoka, Y., Kato, H. & Nakatsuka, I. (1992) Reverse mutation test of CCA in bacterial systems. Unpublished report No. BT-20-0148 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Kohda, H., Nakamura, M. & Kadota, T. (1980) Acute oral and subcutaneous toxicity of three metabolites of procymidone. Unpublished report No. BT-00-0037 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Kumagai, H. (2007). Statement on medical examinations at Sumitomo Osaka Works, dated 29 August, 2007. Submitted to WHO by Sumitomo Chemical Co., Ltd, Osaka, Japan. Kurihara, T. (2001) A review on medical examination of factory workers possibly exposed to procymidone technical materials. Unpublished report No. BT-0197 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Matsui, M, (2005a) In vitro plasma protein binding of procymidone and PCM-CH 2 OH in human, rat, rabbit and monkey. Unpublished report No. BM-0109 from Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Matsui, M. (2005b) In vitro metabolism of procymidone and PCM-CH 2 OH in S9 fraction of human, rat, rabbit and monkey female livers. Unpublished report No. BM-0118 from Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Mikami, N. & Yamamoto, H. (1976) Metabolism of N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2- dicarboximide in rats. Unpublished report No BM-60-0002 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. Milburn, G. & Moreland, S. (1991) Procymidone: multigeneration reproduction study in the rat (first supplement – additional histopathology). Unpublished report No. BT-11-0140 from Imperial Chemical Industries, Macclesfield, England. Submitted to WHO by Sumitomo Chemical Co., Ltd., Osaka, Japan. Mogi, M. (2005a) Pharmacokinetics and excretion of [phenyl- 14 C]procymidone after single oral administration to cynomolgus monkeys. Unpublished report No. BM-0103 from Shin Nippon Biomedical Laboratories, Wakayama, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Mogi, M. (2005b) Pharmacokinetics and excretion of [phenyl- 14 C]procymidone during and after repeated oral administration to cynomolgus monkeys. Unpublished report No. BM-0104 from Shin Nippon Biomedical Laboratories, Wakayama, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Mogi, M. (2005c) Biliary excretion after single oral administration of [carbonyl- 14 C]procymidone to monkey. Unpublished report No. BM-0106 from Shin Nippon Biomedical Laboratories, Wakayama, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Mogi, M. (2005d) Biliary excretion after single oral administration of [carbonyl- 14 C] procymidone to rabbit. Unpublished report No. BM-0107 from Shin Nippon Biomedical Laboratories, Wakayama, Japan. Submitted to WHO by Sumitomo Chemical Co, Ltd. Mogi, M. (2005e) Tissue distribution of pregnant monkey and fetus after single oral administration of [phenyl- 14 C]procymidone to pregnant monkey. Unpublished report No. BM-0125 from Shin Nippon Biomedical Laboratories, Wakayama, Japan. Submitted to WHO by Sumitomo Chemical Co. Ltd. Moore, M.R. (1993) Two-year oral toxicity and carcinogenicity study in mice: supplement A to the final report. Unpublished report No. BT-31-0172 from Hazleton Laboratories America Inc., Rockville, Maryland, USA. Submitted to WHO by Sumitomo Chemical Co. Ltd. Moriya, M, & Katom K, (1977) Mutagenicity of S-7131 in bacterial test systems. Unpublished report No. BT-71-0021 from Sumitomo Chemical Co., Ltd, Osaka, Japan. Submitted to WHO by Sumitomo Chemical Co., Ltd. PROCYMIDONE 349–401 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
Page 14:
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
Page 148 and 149:
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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Page 272 and 273:
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
Page 361 and 362: 346 Keller, D.A. (1992c) Oncogenici
Page 364 and 365: PROCYMIDONE First draft prepared by
Page 366 and 367: 351 Rats Groups of five male and fe
Page 368 and 369: 353 Table 1. Pharmacokinetic parame
Page 370 and 371: 355 Seven doses C max (µg equivale
Page 372 and 373: 357 Three groups of five male and f
Page 374 and 375: 359 The excretion of radioactivity
Page 376 and 377: 361 Figure 1. Proposed metabolic pa
Page 378 and 379: 363 water consumption were determin
Page 380 and 381: 365 finding. Histopathology reveale
Page 382 and 383: 367 The NOAEL was 500 ppm, equivale
Page 384 and 385: 369 The NOAEL was 100 mg/kg bw per
Page 386 and 387: 371 at 2000 ppm. Histopathology rev
Page 388 and 389: 373 b Each test was conducted in tr
Page 390 and 391: 375 experimental period. Rats were
Page 392 and 393: 377 hypospadias, testicular atrophy
Page 394 and 395: 379 a single dose, which produced o
Page 396 and 397: 381 The anti-androgenic activities
Page 398 and 399: 383 but only at 6000 ppm after 13 w
Page 400 and 401: 385 The results are summarized in T
Page 402 and 403: 387 males (all litters) in the grou
Page 404 and 405: 389 procymidone (18-27% of the admi
Page 406 and 407: 391 Procymidone induced liver tumou
Page 408 and 409: 393 The Meeting concluded that the
Page 410 and 411: 395 Toxicologically significant com
Page 414 and 415: 399 Murakami, M., Yoshitake, A. & H
Page 416: 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
Page 425 and 426: 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
Page 431 and 432: 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
Page 439 and 440: 424 body‐weight gains (3-10% decr
Page 441 and 442: 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 498 and 499:
483 Grosshans, F. (2003) Pyrimethan
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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