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313 Gardner, J.R. (1989) CME 151 technical material: Acute dermal toxicity, skin and eye irritancy. Unpublished report No. DK-412-002 from Sittingbourne Research Centre, Kent, England. Submitted to WHO by BASF, Ecully Cedex, France. Glaza, S.M. (1997) Dermal sensitization study of AC 336379 in guinea pigs - maximization test (EC Guidelines). Unpublished report No. DK-416-003 from Corning Hazleton Inc, Vienna, USA. Submitted to WHO by BASF, Ecully Cedex, France. Greenough, R.J. & Goburdhun, R. (1986a) CME 151 - dietary maximum tolerated dose study in dogs. Unpublished report No. DK-420-001 from Inveresk Research International, Musselburgh EH21 7UB, England. Submitted to WHO by BASF, Ecully Cedex, France. Greenough, R.J. & Goburdhun, R. (1986b) CME 151: 13 Week dietary toxicity study in dogs. Unpublished report No. DK-425-002 from Inveresk Research International Ltd, Tranent, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Greenough, R.J. & Goburdhun, R. (1988) SAG 151 52-week dietary toxicity study in dogs. Unpublished report No. DK-427-003 from Inveresk Research International Ltd, Musselburg, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Heidemann, A. & Miltenburger, H.G. (1986) Chromosome aberrations in cells of Chinese hamster cell line V79. Unpublished report No. DK-435-004 from Laboratorium fur Mutagenitatsprufung, TH Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Heidemann, A. & Miltenburger, H.G. (1987) Chromosome aberrations in cells of Chinese hamster cell line V79. Unpublished report No. DK-435-006 from Laboratorium fur Mutagenitatsprufung, TH Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Heusener, A. & Eberstein, M. (1985) Acute toxicity study in rats after epicutaneous administration. Unpublished report No. DK-412-001 from E. Merck, 64271 Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Heusener, A. & Jacobs, M. (1987a) Acute toxicity study in rats after oral administration. Unpublished report No. DK-411-008 from E. Merck, 64271 Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Heusener, A. & Jacobs, M. (1987b) Acute toxicity study in rats after oral administration. Unpublished report No. DK-411-009 from E. Merck, 64271 Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Jackson, G.C. & Hardy, C.J. (1986) ZTH 236 Z50 Acute inhalation toxicity study in rats 4-hour exposure. Unpublished report No. DK-413-001 from Huntingdon Research Centre, Huntingdon, England. Submitted to WHO by BASF, Ecully Cedex, France. Kynoch, S.R. (1985) Acute oral toxicity to rats of ZTH 236 Z50 and Report Amendment No. 1. Unpublished report No. DK-411-004 from Huntingdon Research Centre, Huntingdon, England. Submitted to WHO by BASF, Ecully Cedex, France. Milanez, A. (1999) Health surveillance for dimethomorph at the Cyanamid Resende Plant, Resende, Brazil. Unpublished report No. DK-445-006 from Cyanamid Quimica Brazil. Submitted to WHO by BASF, Ecully Cedex, France. Milanez, A., Almeida, J.M. & Nass, W. (2000) Dimethomorph: medical data information - status February 2000. Unpublished report No. 2000/1022687 from Cyanamid Agrar, Resende, Brazil. Submitted to WHO by BASF, Ecully Cedex, France. Müller, W. (1987a) CME 151 - preliminary oral (gavage) embryotoxicity study in the rabbit. Unpublished report No. DK-432-003 from Hazleton Laboratories Deutschland GmbH, Kesselfeld 29, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Müller, W. (1987b) Treatment of pregnant Sprague-Dawley rats with CME 151 - Letter report. Unpublished report No. DK-432-006 from Hazleton Laboratories Deutschland GmbH, Kesselfeld 29, Germany. Submitted to WHO by BASF, Ecully Cedex, France. DIMETHOMORPH 273–315 JMPR 2007
314 Müller, W. (1989a) SAG 151 Oral (gavage) teratogenicity study in the rabbit. Includes Amendment No. 1 to Final Report. Unpublished report No. DK-432-004 from Hazleton Laboratories, Münster, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Müller, W. (1989b) SAG 151 Oral (gavage) teratogenicity study in the rat. Unpublished report No. DK-432-002 from Hazleton Laboratories, Münster, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Osterburg, I. (1986) ZTH 236Z50 - preliminary oral (gavage) embryotoxicity study in the rat. Unpublished report No. DK-432-001 from Hazleton Laboratories Deutschland GmbH, Kesselfeld 29, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Osterburg, I. (1990) SAG 151 Two generation oral (dietary administration) reproduction toxicity study in the rat (two litters in the F1 generation). Unpublished report No. DK-430-001 from Hazleton Laboratories, Münster, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Perry, C.J. (1986) CME 151 – 6-week dietary dose range finding study in mice. Unpublished report No. DK-420-003 from Inveresk Research International, Musselburgh, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Perry, C.J. (1987) CME 151 - histopathological examination of ileum sections taken from the rat (IRI project No. 435025) and mouse (IRI project No. 435067) dose range finding studies. Unpublished report No. DK-420-004 from Inveresk Research International, Musselburgh, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Poth, A. & Miltenburger, H.G. (1986) Cell transformation assay with Syrian hamster embryo (SHE) cells. Unpublished report No. DK-435-005 from Laboratorium fur Mutagenitaetspruefung, TH Darmstadt, Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Ruckman, S.A. (1987) CME 151 toxicity to rats by dietary admixture for 13 weeks with a 4-week withdrawal period (final report). Unpublished report No. DK-425-001 from Huntingdon Research Centre, Huntingdon, England. Submitted to WHO by BASF, Ecully Cedex, France. Schluter, H. (1990) The biokinetics and metabolism of 14 C-dimethomorph in the rat. Unpublished report No. DK-440-001 from Shell Forschung GmbH, Schwabenheim, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Schluter, H. (1991) 14 C-Dimethomorph (CME 151): investigation on the nature of metabolites occurring in rats. Unpublished report No. DK-440-006 from Shell Forschung GmbH, Schwabenheim, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Schluter, H. (1993) 14 C-Dimethomorph (CME 151): investigation of the metabolite profiles in the rat following treatment with two different labels. Unpublished report No. DK-440-011 from Shell Forschung GmbH, Schwabenheim, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Schluter, H. & Grahl, U. (1994) 14 C-Dimethomorph: additional investigation on the nature of metabolites occurring in rats. Unpublished report No. DK-440-010 from Cyanamid Forschung GmbH, Schwabenheim, Germany. Submitted to WHO by BASF, Ecully Cedex, France. Scott, K. (1986) CME 151 4-week dietary dose range finding study in rats. Unpublished report No. DK-420- 002 from Inveresk Research International Ltd, Tranent, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Smith, A. (1991) SAG 151 104-week dietary carcinogenicity study in mice. Unpublished report No. DK-428- 004 from Inveresk Research International Ltd, Scotland. Submitted to WHO by BASF, Ecully Cedex, France. Timm, A. & Miltenburger, H.G. (1986) Unscheduled DNA synthesis in hepatocytes of male rats in vitro (UDS test). Unpublished report No. DK-435-002 from Laboratorium fur Mutagenitatsprufung, TH Darmstadt, Germany. Submitted to WHO by BASF, Ecully Cedex, France. van de Waart, E.J. (1991a) Evaluation of the ability of dimethomorph to induce chromosome aberrations in cultured peripheral human lymphocytes. Unpublished report No. DK-435-013 from RCC Notox B.V., Hertogenbosch, Netherlands. Submitted to WHO by BASF, Ecully Cedex, France. DIMETHOMORPH 273–315 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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Page 104 and 105:
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
Page 278 and 279: 263 In a single-dose study of neuro
Page 280 and 281: 265 Estimate of acceptable daily in
Page 282 and 283: 267 Clapp, M.J.L., Killick, M.E., H
Page 284 and 285: 269 Herbold, B. (1983c) THS 2212 tr
Page 286 and 287: 271 Pinto, P. (2006b) Difenoconazol
Page 288 and 289: DIMETHOMORPH First draft prepared b
Page 290 and 291: 275 Five different treatment groups
Page 292 and 293: 277 To investigate the significance
Page 294 and 295: 279 and the E : Z isomer ratio was
Page 296 and 297: 281 Table 10. Tissue distribution o
Page 298 and 299: 283 (e) Dermal sensitization The de
Page 300 and 301: 285 females at the highest dose, to
Page 302 and 303: 287 The NOAEL was 10 mg/kg bw per d
Page 304 and 305: 289 concentrations in females were
Page 306 and 307: 291 health, moribundity and mortali
Page 308 and 309: 293 0-9%, mean, 3.5%; only one out
Page 310 and 311: Table 26. Organ weights adjusted to
Page 312 and 313: 297 cell hyperplasia. The testes tu
Page 314 and 315: 299 unscheduled DNA synthesis, the
Page 316 and 317: 301 Figure 3. Cumulative percentage
Page 318 and 319: 303 Rabbits In a dose-range finding
Page 320 and 321: 305 (b) Potentiation of hexobarbito
Page 322 and 323: 307 0.2% or less of the administere
Page 324 and 325: 309 eye-opening, pinna unfolding or
Page 326 and 327: 311 Lowest relevant inhalation NOAE
Page 330: 315 van de Waart, E.J. (1991b) Eval
Page 333 and 334: 318 Committee on Pesticide residues
Page 335 and 336: 320 (a) Ocular irritation Rabbits T
Page 337 and 338: 322 weights were decreased in males
Page 339 and 340: 324 toxicity was 5 mg/kg bw per day
Page 341 and 342: 326 respectively; range for histori
Page 343 and 344: 328 Table 4. Incidence of Leydig-ce
Page 345 and 346: 330 and/or bilateral) was noted in
Page 347 and 348: 332 No treatment-related signs of m
Page 349 and 350: 334 Table 6. Incidence of selected
Page 351 and 352: 336 or teratogenic potential at the
Page 353 and 354: 338 and progesterone. The concentra
Page 355 and 356: 340 the doses used in the 1-year st
Page 357 and 358: 342 No neurotoxic effects were seen
Page 359 and 360: 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
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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
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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
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404 Explanation Profenofos is the I
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406 The metabolism of ring-labelled
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408 2. Toxicological studies 2.1 Ac
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410 Rabbits Groups of two male and
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412 Groups of five male and five fe
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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
Page 439 and 440:
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
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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
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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
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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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