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345 Brock, W.J., Vick, D.A. & Chromey, N.C. (1988) Closed-patch repeated insult dermal sensitization study (Buehler method) with INH-6573-2l in guinea pigs. Unpublished report No. HLR 34-88 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Cheng, T. (1986) Rat metabolism study of [triazole-3- 14 C] DPX-H6573. Unpublished report No. 6129-128 from Hazleton Laboratories America, Inc., VA, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Chromey, N.C., Horst, A.L., McCooey, K.T. & Sarrif, A.M. (1983) Unscheduled DNA synthesis/rat hepatocytes in vitro. Unpublished report No. HLR 209-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Cohen, S.M. (1998) Urinary bladder carcinogenesis. Toxicol. Pathol., 26, 121–127. Cook, J. (1993) Mechanisms of rat Leydig cell tumor induction by DPX-H6573-193 (flusilazole). Unpublished report No. HLR 410-93 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Cook, J.C., Klinefelter, G.R., Hardisty, J.F., Sharpe, R.M. & Foster, P.M.D. (1999) Rodent Leydig Cell tumorigenesis: a review of the physiology, pathology, mechanisms, and relevance to humans. Crit. Rev. Toxicol., 29, 169–261. Donovan, S.M. & Irr, J.D. (1982) Mutagenicity evaluation in Salmonella typhimurium. Unpublished report No. HLR 611-82 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Farrow, M.G., Cortina, T. & Padilla-Nash, H. (1983) In vivo bone marrow chromosome study in rats - H # 14,728. Unpublished report No. 201-636 from Hazleton Laboratories America, Inc., VA, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Finlay, C. (1998) Flusilazole technical: primary eye irritation study in rabbits. Unpublished report No. DuPont- 1300 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Finlay, C. (2000) Flusilazole technical: acute oral toxicity study in male and female rats. Unpublished report No. DuPont-3749 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Foster, M.D. (2007) Induction of Leydig cell tumors by xenobiotics. In: Hardy, M. & Payne, A. (eds), The Leydig cell in health and disease. Humana Press, Totuwa, NJ, USA. Chapter 27, pp 383–392. Gargus, J.L. & Sutherland, J.D. (1983) Acute skin absorption LD 50 test on rabbits. Unpublished report No. 288-83 from Hazelton Laboratories America Inc., VA, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE. USA. Hall, J.A., Dashiell, O.L. & Kennedy, G.L. (1984) Eye irritation test in rabbits. Unpublished report No. HLR 582-82 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE. USA. Keller, D.A. (1990) Subchronic oral toxicity: 90-day study with DPX-H6573-193 feeding study in mice. Unpublished report No. HLR 60-90 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Keller, D.A. (1992a) Mechanism of toxicity: 90-day feeding study in rats with DPX-H6573-194 (flusilazole). Unpublished report No. HLR 628-92 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Keller, D.A. (1992b) Oncogenicity study with DPX-H6573-193 (flusilazole): 18-month feeding study in mice. Unpublished report No. HLR 35-92 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. FLUSILAZOLE 317–347 JMPR 2007
346 Keller, D.A. (1992c) Oncogenicity study with DPX-H6573-194 (flusilazole): 2-year feeding study in rats. Unpublished report No. HLR 527-92 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Lamontia, C.L., Staples, R.E. & Alvarez, L. (1984a) Embryo-fetal toxicity and teratogenicity study of INH- 6573-39 by gavage in the rat. Unpublished report No. HLR 444-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Lamontia, C.L., Staples, R.E. & Alvarez, L. (1984b) Embryo-fetal toxicity and teratogenicity study of INH-6573-39 by gavage in the rat. Unpublished report No. HLR 142-84 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. McCooey, K.T., Chromey, N.C., Sarrif, A.M. & Hemingway, R.E. (1983) CHO/HGPRT assay for gene mutation. Unpublished report No. HLR 449-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Mertens, J.J.W.M. (1999) DPX-H6573 technical: a 28-day mechanistic feeding study with 28 days of recovery in dogs. Unpublished report No. DuPont-1623 from WIL Research Laboratories Inc, OH, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Mullin, L.S. (1990) Reproductive and fertility effects with flusilazole: multigeneration reproduction study in rats. Unpublished report No. HLR 424-90 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Munley, S.M. (2000) Flusilazole technical: developmental toxicity study in rats. Unpublished report No. Dupont- 2287 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. O’Neal, F.O., Rickard, R.W., Kaplan, A.M. & Gibson, J.R. (1985) One-year feeding study in dogs with INH-6573. Unpublished report No. HLR 461-85 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Pastoor, T.P., Wood, C.K., Krahn, D.F. & Gibson, J.R. (1983) Ninety-day feeding and one-generation reproduction study in rats with Silane [bis(4-fluorophenyl)](methyl) (1H-1,2,4-triazol-1-ylmethyl) (INH-6573). Unpublished report No. HLR 483-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Pastoor, T.P., Wood, C.K., Drahn, D.F. & Aftosmis, J.G. (1984) Four-week range finding and ninety-day feeding study in mice with Silane [bis(4-fluorophenyl)](methyl) (1H-1,2,4-triazol-1-ylmethyl) (INH-6573). Revised unpublished report No. HLR 341-83 1-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Pastoor, T.P., Rickard, R.W., Sykes, G.P., Kaplan, A.M. & Gibson, J.R. (1986) Long-term feeding (combined chronic toxicity/oncogenicity study) and two-generation, four-litter reproduction study in rats with INH-6573. Unpublished report No. HLR 32-86 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO bv E.I. du Pont de Nemours & Co., Inc., DE, USA. Reynolds, V. (1991) Mutagenicity testing of DPX-H6573-194 in the Salmonella typhimurium plate incorporation assay. Unpublished report No. HLR 33-91 by Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Rickard, R.W., Wood, C.K., Krahn, D.F. & Aftosmis, J.G. (1983) Three-month feeding study in dogs with Silane [bis(4-fluorophenyl)](methyl) (1H-1,2,4-triazol-1-ylmethyl) (INH-6573). Unpublished report No. HLR 461-83 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. Sarver, J.W., Vick, D.A., Valentine, R., Chromey, N.C. & Kaplan, A.M. (1986) Twenty-one dose dermal toxicity study with INH-6573-82 in rabbits. Unpublished report No. HLR 744-86 from Haskell Laboratory for Toxicology and Industrial Medicine, DE, USA. Submitted to WHO by E.I. du Pont de Nemours & Co., Inc., DE, USA. FLUSILAZOLE 317–347 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
Page 10 and 11:
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
Page 18 and 19:
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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Page 92 and 93:
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
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
Page 158 and 159:
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
Page 184 and 185:
169 Eiben, R., Schmidt, W., & Loese
Page 186 and 187:
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
Page 210 and 211:
195 Toxicological evaluation Althou
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197 Metabolism in animals Toxicolog
Page 214 and 215:
199 Harrison, M.P. (1984a) Cyhaloth
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DIFENOCONAZOLE First draft prepared
Page 218 and 219:
203 a sex difference nor any marked
Page 220 and 221:
205 demonstrated that the highest t
Page 222 and 223:
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
Page 228 and 229:
213 The no-observed-adverse-effect
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215 lower than those of rats in the
Page 232 and 233:
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)®
Page 244 and 245:
229 Table 7. Histopathology finding
Page 246 and 247:
231 D. Temporal association. The fe
Page 248 and 249:
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
Page 282 and 283:
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
Page 294 and 295:
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
Page 302 and 303:
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
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 328 and 329: 313 Gardner, J.R. (1989) CME 151 te
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: 344 Lowest relevant reproductive NO
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
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395 Toxicologically significant com
Page 412 and 413:
397 Harada, T. (1983) A review on m
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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