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315 van de Waart, E.J. (1991b) Evaluation of the mutagenic activity of dimethomorph in an in vitro mammalian gene mutation test with V79 Chinese hamster cells (with independent repeat). Unpublished report No. DK-435-014 from RCC Notox B.V., Hertogenbosch, Netherlands. Submitted to WHO by BASF, Ecully Cedex, France. van de Waart, E.J. (1991c) Micronucleus test in bone marrow cells of the mouse with dimethomorph. Unpublished report No. DK-435-012 from RCC Notox B.V., Hertogenbosch, Netherlands. Submitted to WHO by BASF, Ecully Cedex, France. Van Dijk, A. (1990) 14 C-Dimethomorph (CME 151): absorption, distribution, metabolism and excretion after bile cannulation and single oral administration to the rat. Unpublished report No. DK-440-002 from RCC Umweltchemie AG, Itingen, Switzerland. Submitted to WHO by BASF, Ecully Cedex, France. Warren, S. (1985) ZTH 236 Z50 Preliminary assessment of toxicity to rats by dietary admixture for 4 weeks. Unpublished report No. DK-420-005 from Huntingdon Research Centre, Huntingdon, England. 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
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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 328 and 329: 313 Gardner, J.R. (1989) CME 151 te
Page 332 and 333: FLUSILAZOLE First draft prepared by
Page 334 and 335: 319 very low. Total residues exclud
Page 336 and 337: 321 irritation, flusilazole (purity
Page 338 and 339: 323 Dogs Groups of four male and fo
Page 340 and 341: 325 Table 2. Incidence of liver tum
Page 342 and 343: 327 deaths that occurred before ter
Page 344 and 345: 329 Table 5. Results of studies of
Page 346 and 347: 331 included: higher mortality (2 o
Page 348 and 349: 333 98-99% in the control group and
Page 350 and 351: 335 delivered by caesarean section
Page 352 and 353: 337 Table 7. Incidence of hydroceph
Page 354 and 355: 339 CYP3A and CYP4A isozymes). This
Page 356 and 357: 341 Overall, the data suggested tha
Page 358 and 359: 343 d Greater than the maximum tole
Page 360 and 361: 345 Brock, W.J., Vick, D.A. & Chrom
Page 362: 347 Schardein, J. (1998). A dermal
Page 365 and 366: 350 Explanation Procymidone is the
Page 367 and 368: 352 Comparative kinetics between sp
Page 369 and 370: 354 Radioactivity in urine (%) —
Page 371 and 372: 356 the applied dose in receptor fl
Page 373 and 374: 358 qualitative autoradiography of
Page 375 and 376: 360 Binding to plasma proteins The
Page 377 and 378: 362 Table 9. Results of studies of
Page 379 and 380: 364 for males and females at 2500 o
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366 daily for signs of toxicity; bo
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368 Groups of four male and four fe
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370 Table 17. Hepatic findings in a
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374 Table 20. Findings in offspring
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376 (b) Developmental toxicity Rats
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378 The study did not identify a NO
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380 Table 25. Blood plasma kinetic
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382 Table 27. Dosing schedule and t
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384 Table 28. Ejaculate mass and te
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386 3. Studies on metabolites (a) 3
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388 Table 31. Metabolite concentrat
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390 females. The histopathological
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392 was a significant increase in t
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394 Levels relevant to risk assessm
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396 Summary Value Study Safety fact
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398 Kogiso, S. (1991) Reverse mutat
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400 Savides, M.C. (2002) The in viv
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PROFENOFOS First draft prepared by
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405 Similar results were obtained i
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407 1.3 Effects on enzymes and othe
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409 bw by gavage. An additional fiv
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411 within 12 days. No other detail
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413 treatment. Corneal opacity was
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415 All rats of the group at the hi
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417 The treatment produced no signi
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419 In another study, groups of fou
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421 p resence of nodules or masses
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423 intervals at 0.3 ppm, but never
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425 The study was not conducted in
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427 activity was inhibited by 21% a
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429 day during gestation and 0, 0.7
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431 muscularly 60 min before the se
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433 Comments Biochemical aspects [P
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435 Studies of developmental toxici
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437 Estimate of acceptable daily in
Page 454 and 455:
439 Cannelongo, B.F. (1982b) CGA 15
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441 Loosli, R. (1989) Cholinesteras
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443 Williams, S.C., Marco, G.J., Si
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446 Evaluation for acceptable daily
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448 Table 2. Calculated pharmacokin
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450 time, while the concentration i
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452 Sum 91.5 — — — — —
Page 469 and 470:
454 Mice In a study of absorption,
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456 findings were observed on necro
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458 was observed (relative to contr
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460 The deaths were considered to b
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462 The LOAEL was 8000 ppm (529.1 a
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464 e xamination was performed befo
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466 43%, 71% and 59% (control, lowe
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468 At interim kill, no significant
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470 2.5 Reproductive toxicity (a) M
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472 necropsy. The uterus and ovarie
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474 (b) Short-term studies of neuro
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476 were noted at day 4. Liver weig
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478 In a 90-day dietary study of to
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480 Levels relevant to risk assessm
Page 497 and 498:
482 Beyrouty, P. (2001b) A time of
Page 499 and 500:
484 Hemmings, P.A. (1991a) Residue
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486 Simpson, E. (2003) Historical c
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488 All the pivotal studies met the
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490 or distribution of [ 14 C]zoxam
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492 indicated that zoxamide is very
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494 Metabolite RH141,452 (3,5-dichl
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496 2.2 Short-term studies of toxic
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498 The only findings of note were
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500 canine juvenile polyarteritis s
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502 Table 10. Organ weight and hist
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504 Week 52 3 167 2 795 2 538 2 052
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506 weights were increased in a dos
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508 The zoxamide metabolites, RH 14
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510 Table 15 Pup body weights durin
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512 consumption were monitored thro
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514 anti-tubulin compounds at 37 °
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516 were higher than those of the c
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518 Acute neurotoxicity b 2000 mg/k
Page 535 and 536:
520 Ferguson, J.S., Morrison, R.D.
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522 Snyder, P.W., Kazacos, E.A., Sc
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524 14. Pesticide residues in food.
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526 50. Pesticide residues in food
Page 543 and 544:
528 84. Pesticide residues in food
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