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129 Heneweer, M., van den Berg, M. & Sanderson, J.T. (2004) A comparison of human H295R and rat R2C cell lines as in vitro screening tools for effects on aromatase. Toxicol. Lett., 146, 183–194. Hertner, Th. (1988a) G 34048 - autoradiographic DNA repair test on rat hepatocytes. Unpublished report No. 871374 dated 22 January 1988 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hertner, Th. (1988b) G 28273 - autoradiographic DNA repair test on rat hepatocytes. Unpublished report No. 871370 dated 10 March 1988 from Ciba-Geigy Ltd, Basle, Switzerland.. Submitted to WHO by Syngenta Crop Protection AG. Hertner, Th. (1992) G 30027 - autoradiographic DNA repair test on rat hepatocytes. Unpublished report No. 911246 dated 14 April 1992 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hertner, Th. (1993) G 30027 - dominant lethal test, mouse, 8-weeks. Unpublished report No. 911247 dated 7 January 1993 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hessel, P.A., Kalmes, R., Smith, T.J., Lau, E., Mink, P.J. & Mandel, J. (2004) A nested case–control study of prostate cancer and atrazine exposure. J. Occup. Environ. Med., 46, 379–385. Holbert, M. S. (1991) G 30027 - Acute inhalation toxicity study in rats. Unpublished report No. 8079‐91 dated 18 July 1991 from Stillmeadow, Inc., Houston, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Hooghe, R.J., Devos, S. & Hooghe-Peters, E.L. (2000) Effects of selected herbicides on cytokine production in vitro. Life Sci., 66, 2519–2525. Hool, G. (1981a) G 30027 - nucleus anomaly test in somatic interphase nuclei of Chinese hamster. Unpublished report No. 783027 dated 20 January 1981 (supplemented 6 October 1986) from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hool, G. (1981b) G 30027 - chromosome studies in male germinal epithelium in mouse (test for mutagenic effects on spermatogonia). Unpublished report No. 800209 dated 25 January 1981 (supplemented 6 October 1986) from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hool, G. (1981c) G 30027 - chromosome studies in male germinal epithelium in mouse (test for mutagenic effects on spermatocytes). Unpublished report No. 800210 dated 28 January 1981 (supplemented 6 October 1986) from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Hool, G., (1981d) G 30027 – dominant lethal test in mouse. Unpublished report No. 801380 dated 8 August 1981 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Huber, K.R., Batastini, G., & Arthur, A.T. (1989) G 30027 - 21-day dermal toxicity study in the rabbit. Unpublished report No. 882035 dated 1 December 1989 from Ciba-Geigy Corp., Research Department, Pharmaceuticals Division, Summit, New Jersey, USA. Submitted to WHO by Syngenta Crop Protection AG. Hui, X., Wester, R., Maibach, H.I., Gilman, S.D., Gee, S.J., Hammock, B.D., Simoneaux, B., Breckenridge, C. & Kahr, R. (1996a) Disposition of atrazine in Rhesus monkey following intravenous administration. Unpublished report of Study Nos UCSF 95SU04 (UCSF), BDH-081-1 (UC Davis), ABR 96066, 96073 dated 3 September 1996 from Ciba Crop Protection. Submitted to WHO by Syngenta Crop Protection AG. Hui, X., Wester, R., Maibach, H.I., Simoneaux, B. & Breckenridge, C. (1996b) Disposition of atrazine in Rhesus monkey following oral administration. Unpublished report of study Nos UCSF 96SU01 (UCSF) ABR-96094; Ciba Study Number 306-96, dated 30 October 1996, from Ciba Crop Protection. Submitted to WHO by Syngenta Crop Protection AG. Hummel, H., Youreneff, M., Giknis, M. & Yau, E.T. (1989) G 28273 - a teratology (segment II) study in rats. Unpublished report No. 872177 dated 15 August 1989 from Ciba-Geigy Corp., Research Department, Pharmaceuticals Division, Summit, New Jersey, USA. Submitted to WHO by Syngenta Crop Protection AG. ATRAZINE 37–138 JMPR 2007
130 IARC (1999) Atrazine. In: Some chemicals that cause tumours of the kidney or urinary bladder in rodents and some other substances. Vol. 73, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. IARCPress, Lyon. Infurna, R.N. (1984) Atrazine technical, a teratology study (segment II) in rats. Unpublished report No. 832109 dated 18 September 1984 from Ciba-Geigy Corp., Research Department, Pharmaceuticals Division, Summit, New Jersey, USA. Submitted to WHO by Syngenta Crop Protection AG. Innes, J.R.M., Ulland, B.M., Valerio, M.G., Pertrucelli, L., Fishbein, L., Hart, E.R., Pallota, A.J., Bates, R.R., Falk, H.L., Gart, J.J., Klein, M., Mitchell, I. & Peters, J. (1969) Bioassay of pesticides and industrial chemicals for tumorogenicity in mice: a preliminary note. J. Natl. Cancer Inst., 42, 1101–1114. Kahrs, R. & Thede, B. (1987) Study of 14 C-atrazine dose/response relationship in the rat. Unpublished report No. ABR-87087 dated 23 October 1987 form Ciba-Geigy Corp., Greensboro, North Carolina, USA. Submitted to WHO by Syngenta Crop Protection AG. Karrow, N.A., McCay, J.A., Brown, R.D., Musgrove, D.L., Guo, T.L., Germolec, D.R. & White, K.L., Jr. (2005) Oral exposure to atrazine modulates cell-mediated immune function and decreases host resistance to the B16F10 tumor model in female B6C3F1 mice. Toxicol., 209, 15–28. Kligerman, A.D., Doerr, C.L., Tennant, A.H. & Peng, B. (2000a) Cytogenetic studies of three triazine herbicides. In vivo micronucleus studies in mouse bone marrow. Mutat. Res., 471, 107–112. Kligerman, A.D., Doerr, C.L., Tennant, A.H. & Zucker, R.M. (2000b) Cytogenetic studies of three triazine herbicides. In vitro studies. Mutat. Res., 465, 53–59. Knobil, E. (1974) On the control of gonadotropin secretion in the Rhesus monkey. Recent Prog. Hormone Res., 30, 1–36. Kuhn, J.O. (1988) G 30027 - acute oral toxicity study (mouse). Unpublished report No. 5421-88 dated 27 July 1988 from Stillmeadow Inc., Houston, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Kuhn, J.O. (1991a) G 30027 - acute oral toxicity study in rats. Unpublished report No. 7800‐91 dated 18 March 1991 from Stillmeadow Inc., Sugar Land, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Kuhn, J.O. (1991b) DACT (G 28273) - technical ground FL-871776 - acute oral toxicitity study in rats. Unpublished report No. 7801-91 dated 21 March 1991 from Stillmeadow Inc., Sugar Land, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Kuhn, J.O. (1991c) G 30033 - acute oral toxicity study in rats. Unpublished report No. 7802-91 dated 22 March 1991 from Stillmeadow Inc., Sugar Land, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Kuhn, J.O. (1991d) Deisopropyl-atrazine (G 28279) - acute oral toxicity study in rats. Unpublished report No. 7803-91 dated 25 March 1991 from Stillmeadow Inc., Sugar Land, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Kuhn, J.O. (1991e) Hydroxyatrazine (G 34048) - technical FL-870869 - acute oral toxicity study in rats. Unpublished report No. 7938-91 dated 3 April 1991 from Stillmeadow Inc., Sugar Land, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Laws, S.C., Ferrell, J.M., Stoker, T.E., Schmid, J. & Cooper, R.L. (2000) The effects of atrazine on female Wistar rats: an evaluation of the protocol for assessing pubertal development and thyroid function. Toxicol. Sci., 58, 366–376. Laws, S.C., Ferrell, J.M., Stoker, T.E. & Cooper, R.L. (2003) Pubertal development in female Wistar rats following exposure to propazine and atrazine biotransformation by-products, diamino-S-chlorotriazine and hydroxyatrazine. Toxicol. Sci., 76, 190–200. Laws, S.C., Ferrell, J., Best, D., Buckalew, A., Murr, A. & Cooper, R.L. (2006) Atrazine stimulates the release of serum ACTH and adrenal steroids in male Wistar rats. Unpublished report (abstract) from Reprod. Tox. Division, NHEERL, ORD, U.S. EPA, Research Triangle Park, NC, USA. ATRAZINE 37–138 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
Page 94 and 95: 79 250 and 500 ppm. Body-weight gai
Page 96 and 97: 81 In an assay for reverse mutation
Page 98 and 99: 83 on pubertal development in femal
Page 100 and 101: 85 parameters (decreased pH, specif
Page 102 and 103: 87 Table 20. Relevant findings in a
Page 104 and 105: 89 0, 75, 150 or 300 mg/kg bw per d
Page 106 and 107: 91 The NOAEL was 25 ppm, equal to 1
Page 108 and 109: 93 In a study on the effect of atra
Page 110 and 111: 95 Delayed parturition was seen at
Page 112 and 113: 97 observed in the pair-fed group.
Page 114 and 115: 99 examined, offspring in the atraz
Page 116 and 117: 101 antagonize E2-induced luciferas
Page 118 and 119: 103 increase in steroidogenesis is
Page 120 and 121: 105 The immune system of adult mice
Page 122 and 123: 107 In a later review of cancer epi
Page 124 and 125: 109 In a 25-day study in rabbits tr
Page 126 and 127: 111 developmental toxicity were 10
Page 128 and 129: 113 regulation in male offspring in
Page 130 and 131: 115 (d) Diaminochlorotriazine (DACT
Page 132 and 133: 117 Developmental target/critical e
Page 134 and 135: 119 • The failure to ovulate resu
Page 136 and 137: 121 The relationship between increa
Page 138 and 139: 123 Table A2. Comparison of paramet
Page 140 and 141: 125 Ballantine, L., Murphy, T. G. &
Page 142 and 143: 127 Dunkelberg, H., Fuchs, J., Heng
Page 146 and 147: 131 Lindsay, L.A., Wimbert, K.V., G
Page 148 and 149: 133 Morseth, S.L. (1996d) Chronic (
Page 150 and 151: 135 Rudzki, M.W., Batastina, G., &
Page 152 and 153: 137 Tennant, A.H., Peng, B. & Klige
Page 154 and 155: AZINPHOS-METHYL First draft prepare
Page 156 and 157: 141 methylation and oxidation of me
Page 158 and 159: 143 Table 1. Acute oral toxicity of
Page 160 and 161: 145 Table 2. Cholinesterase activit
Page 162 and 163: 147 at the highest dose. In both sp
Page 164 and 165: 149 Table 6. Cholinesterase activit
Page 166 and 167: 151 Table 8. Fertility of F 0 and F
Page 168 and 169: 153 Table 10. Fertility parameters
Page 170 and 171: 155 Groups of 22 mated Sprague-Dawl
Page 172 and 173: 157 after completion of the feeding
Page 174 and 175: 159 reduced motor activity in males
Page 176 and 177: 161 sensitivity with that of labora
Page 178 and 179: 163 measures to prevent worker expo
Page 180 and 181: 165 when brain cholinesterase activ
Page 182 and 183: 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
Page 188 and 189: LAMBDA-CYHALOTHRIN First draft prep
Page 190 and 191: 175 Figure 1. Chemical structures o
Page 192 and 193: 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
Page 252 and 253:
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 270 and 271:
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
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
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279 and the E : Z isomer ratio was
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281 Table 10. Tissue distribution o
Page 298 and 299:
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
Page 326 and 327:
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
Page 339 and 340:
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
Page 347 and 348:
332 No treatment-related signs of m
Page 349 and 350:
334 Table 6. Incidence of selected
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336 or teratogenic potential at the
Page 353 and 354:
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
Page 359 and 360:
344 Lowest relevant reproductive NO
Page 361 and 362:
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
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
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
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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
Page 412 and 413:
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
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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
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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
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
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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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