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131 Lindsay, L.A., Wimbert, K.V., Giknis, M.L.A. & Yau, E.T. (1989) Hydroxyatrazine (G 34048) - a teratology (segment II) study in rats. Unpublished report No. 872202 dated 14 February 1989 (supplemented 2 November 1990 and 14 May 1993) from Ciba-Geigy Corp., Research Department, Pharmaceuticals Division, Summit, New Jersey, USA. Submitted to WHO by Syngenta Crop Protection AG. Lioi, M.B., Scarfi, M.R., Santoro, A., Barbieri, R., Zeni, O., Salvemini, F., Di Berardino, D. & Ursini, M.V. (1998) Cytogenetic damage and induction of pro-oxidant state in human lymphocytes exposed in vitro to glyphosate, vinclozolin, atrazine, and DPX-E9636. Environ. Mol. Mutagen., 32, 39–46. Liu, C.Y. & Thakur, A.K. (1999) Statistical report for survival and mammary tumor analyses from the Fischer 344/Lati rat study (Pinter, 1990). Unpublished report No. 6117-998 dated 2 September 1999 from Covance Laboratories Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. Luebke, R.W., Chen, D.H., Dietert, R., Yang, Y., King, M. & Luster, M.I. (2006) The comparative immunotoxicity of five selected compounds following developmental or adult exposure. J. Toxicol. Environ. Health B Crit. Rev., 9, 1–26. Lynch, S.M., Rusiecki, J.A., Blair, A., Dosemeci, M., Lubin, J., Sandler, D., Hoppin, J.A., Lynch, C.F. & Alavanja, M.C.R. (2006) Cancer incidence among pesticide applicators exposed to cyanazine in the Agricultural Health Study. Environ. Health Perspect., 114, 1248–1252. MacLennan, P.A., Delzell, E., Sathiakumar, N., Myers, S.L., Cheng, H., Grizzle, W., Chen, V.W. & Wu, X.C. (2002) Cancer incidence among triazine herbicide manufacturing workers. J. Occup. Environ. Med., 44, 1048–1058. MacLennan, P.A., Delzell, E., Sathiakumar, N. & Myers, S.L. (2003) Mortality among triazine herbicide manufacturing workers. J. Toxicol. Environ. Health A., 66, 501–517. Mainiero, J., Youreneff, M. & Giknis, M. (1987) Two-generation reproduction study in rats: atrazine technical. Final report. Unpublished report No. MIN 852063 dated 2 September 1987 from Safety Evaluation Facility. Summit, New Jersey, USA. Submitted to WHO by Syngenta Crop Protection AG. Marty, J.H. (1992a) G 28279 - developmental toxicity (teratogenicity) study in rats (oral administration). Unpublished report No. 901262 dated 1 June 1992 from Ciba-Geigy Ltd, Stein, Switzerland. Submitted to WHO by Ciba-Geigy Ltd. Marty, J.H. (1992b) Developmental toxicity (teratogenicity) study in rats with G 30033 technical (oral administration). Unpublished report No. 901265 dated 1 June 1992 from Ciba-Geigy Ltd, Stein, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Maurer, Th. (1983) G 30027 - skin sensitization effects in guinea pigs (optimization test). Unpublished report No. 830644 dated 29 November 1983 from Ciba-Geigy Ltd, Basle, Switzerland.. Submitted to WHO by Syngenta Crop Protection AG. Mayhew, D.A. (1986) Two-year chronic feeding/oncogenicity study in rats administered atrazine. Unpublished report No. 410-1102 dated 29 April 1986 from American Biogenics Corporation, Decatur, IL, USA. Submitted to WHO by Syngenta Crop Protection AG. McConnell, R.F. (1989) Comparative aspects of contraceptive steroids: effects observed in rats. Toxicol. Pathol., 17, 385–388. McConnell, R.F. (1995) A histomorphologic reevaluation of the ovaries, uterus, vagina, mammary gland, and pituitary gland from Sprague-Dawley and Fischer 344 female rats treated with atrazine. Unpublished report Nos 483-278 & 483-279 dated 10 March 1995 from Hazleton Laboratories, Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. McElroy, J.A., Gangnon, R.E., Newcomb, P.A., Kanarek, M.S., Anderson, H.A., Vanden Brook, J., Trentham- Dietz, A.M. & Remington, P.L. (2007) Risk of breast cancer for women living in rural areas from adult exposure to atrazine from well water in Wisconsin. J. Expo. Sci. Environ. Epidemiol., 17, 207–214. McMullin, T.S., Andersen, M.E., Nagahara, A., Lund, T.D., Pak, T., Handa, R.J. & Hanneman, W.H. (2004) Evidence that atrazine and diaminochlorotriazine inhibit the estrogen/progesterone induced surge of luteinizing hormone in female Sprague-Dawley rats without changing estrogen receptor action. Toxicol. Sci., 79, 278–286. ATRAZINE 37–138 JMPR 2007
132 Meek, M.E., Bucher, J.R., Cohen, S.M., Dellarco, V., Hill, R.N., Lehman-McKeeman, L.D., Longfellow, D.G., Pastoor, T., Seed, J. & Patton, D.E. (2003) A framework for human relevance analysis of information on carcinogenic modes of action. Crit. Rev. Toxicol., 33, 591–653. Meisner, L.F., Belluck, D.A. & Roloff, B.D. (1992) Cytogenetic effects of alachlor and/or atrazine in vivo and in vitro. Environ. Mol. Mutagen., 19, 77–82. Mencoboni, M., Lerza, R., Bogliolo, G., Flego, G. & Pannacciulli, I. (1992) Effect of atrazine on hemopoietic system. In Vivo., 6, 41–44. Mehta, C.S. (1980a) 2,4-Diamino-6-chloro-s-triazine (DACT, G 28273) FL‐781538 ARS 1857 - rat acute oral toxicity. Unpublished report No. 1290A-79 dated 6 August 1980 from Stillmeadow Inc., Houston, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Mehta, C. S. (1980b) 2,4-Diamino-6-chloro-s-triazine (DACT, G 28273) FL‐781538 ARS 1857 - rat acute oral toxicity. Unpublished report No. 1290B-79 dated 7 August 1980 from Stillmeadow Inc., Houston, Texas, USA. Submitted to WHO by Syngenta Crop Protection AG. Submitted by: Syngenta Crop Protection AG. Meyer, A. (1987) G 28273 - autoradiographic DNA repair test on human fibroblasts. Unpublished report No. 871371 dated 20 November 1987 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Meyer, A. (1988) G 34048 - autoradiographic DNA repair test on human fibroblasts. Unpublished report No. 871375 dated 11 January 1988 from Ciba-Geigy Ltd, Basle, Switzerland. Submitted to WHO by Syngenta Crop Protection AG. Mills, P.K. (1998). Correlation analysis of pesticide use data and cancer incidence rates in California counties. Arch. Environ. Health., 53, 410–413. Mills, P.K. & Yang, R. (2003) Prostate cancer risk in California farm workers. J. Occup. Environ. Med., 45, 249–258. Mills, P.K. & Yang, R. (2006) Regression analysis of pesticide use and breast cancer incidence in California Latinas. J. Environ. Health., 68, 15–22. Minnema, D. (2001) Comparison of the LH surge in female rats administered atrazine, simazine or DACT via oral gavage for one month. Final report. Unpublished report No. 1198-98 dated 21 March 2001 from Covance Laboratories Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. Minnema, D. (2002) 52-Week toxicity study of simazine, atrazine, and DACT administered in the diet to female rats. Unpublished report No. 2214-01 dated 21 February 2002 from Covance Laboratories Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. Modic, W., Ferrell, J., Wood, C., Laskey, J., Cooper, R., & Laws, S. (2004) Atrazine alters steroidogenesis in male Wistar rats. The Toxicologist. Abstract. 568. Society of Toxicologists Annual Meeting 2004. Modic, W.M. (2004) The role of testicular aromatase in the atrazine mediated changes of estrone and estradiol the male Wistar rat. Thesis submitted to Department of Molecular & Structural Biochemistry, North Carolina State University, Raleigh, NC, USA. pp. 1–61. Moon, H.J, Han, S.Y., Shin, J.H., Kang, I.H., Kim, T.S., Hong, J.H., Kim, S.H .& Fenton, S.E. (2007) Gestational exposure to nonylphenol causes precocious mammary gland development in female rat offspring. J. Reprod. Dev., 53, 333–344. Morseth, S.L. (1996a) Evaluation of the luteinizing hormone (LH) in female Sprague-Dawley rats - pilot study: final report. Unpublished report No. 2386-109:6791 dated 18 January 1996 from Corning Hazleton, Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. Morseth, S.L. (1996b) Evaluation of the luteinizing hormone (LH) surge in female Sprague-Dawley ratsmethod validation: final report. Unpublished report No. 2386-110 dated 18 January 1996 from Corning Hazleton, Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. Morseth, S.L. (1996c) Evaluation of the luteinizing hormone (LH) surge in atrazine-exposed female Sprague- Dawley rats: 6-month report. Unpublished report No. 2386-111 dated 25 October 1996 from Corning Hazleton, Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection AG. 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
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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 144 and 145: 129 Heneweer, M., van den Berg, M.
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
Page 194 and 195: 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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Page 264 and 265:
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
Page 292 and 293:
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
Page 314 and 315:
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
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
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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
Page 341 and 342:
326 respectively; range for histori
Page 343 and 344:
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
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
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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
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
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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
Page 421 and 422:
406 The metabolism of ring-labelled
Page 423 and 424:
408 2. Toxicological studies 2.1 Ac
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410 Rabbits Groups of two male and
Page 427 and 428:
412 Groups of five male and five fe
Page 429 and 430:
414 control group and in the test g
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416 of the rabbits at the highest d
Page 433 and 434:
418 The NOAEL for brain acetylcholi
Page 435 and 436:
420 Table 2. Histopathological find
Page 437 and 438:
422 1 out of 70; lowest dose, 3 out
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
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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