Pesticide residues in food â 2007: Toxicological ... - ipcs inchem

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TOXICOLOGICAL MONOGRAPHS AND MONOGRAPH ADDENDA
Page 2 and 3: Pesticide residues in food — 2007
Page 4: TABLE OF CONTENTS Page List of part
Page 7 and 8: Dr Vicki L. Dellarco, Office of Pes
Page 10 and 11: Abbreviations used 3-MC ACTH ADI ai
Page 12 and 13: MRL MS MS/MS MTD NMR NOAEC NOAEL NO
Page 14: Introduction The toxicological mono
Page 19 and 20: 4 Aminopyralid has not been evaluat
Page 21 and 22: 6 Table 3. Tissue distribution of r
Page 23 and 24: 8 The test material was 94.5% chemi
Page 25 and 26: 10 One male rat died on test day 3,
Page 27 and 28: 12 had slight irritation of the iri
Page 29 and 30: 14 not dose-dependant. Sodium was a
Page 31 and 32: 16 In a 13-week feeding study, grou
Page 33 and 34: 18 Rat In a 24-month study of toxic
Page 35 and 36: 20 2.4 Genotoxicity Aminopyralid (b
Page 37 and 38: 22 change was considered to be a ph
Page 39 and 40: 24 in one rabbit in the group at th
Page 41 and 42: 26 respectively (Table 16). Gross p
Page 43 and 44: 28 then radiolabelled aminopyralid
Page 45 and 46: 30 moribund condition on day 17 of
Page 47 and 48: 32 Critical end-points for setting
Page 49 and 50: 34 Dryzga, M.D. & Stebbins, K.E. (2
Page 51 and 52: 36 Wilson, C.W. (2001) Aminopyralid
Page 53 and 54: 38 Appendix 1 Application of the IP
Page 55 and 56: 40 urine, 24-28% in faeces, and 2-3
Page 57 and 58: 42 24 h. Clearance of radioactivity
Page 59 and 60: 44 and DACT (G 28273) using a gas c
Page 61 and 62: 46 Figure 1. Proposed metabolic pat
Page 63 and 64: 48 Figure 3. Primary metabolic path
Page 65 and 66:
50 Table 3. Dermal irritation and s
Page 67 and 68:
52 Table 4. Results of studies of c
Page 69 and 70:
54 cholesterol of females at the hi
Page 71 and 72:
56 No treatment-related effect on s
Page 73 and 74:
58 From the rats in the supplementa
Page 75 and 76:
60 There were no effects on clinica
Page 77 and 78:
62 Body-weight gain was retarded by
Page 79 and 80:
64 2.4 Genotoxicity Atrazine was te
Page 81 and 82:
66 End-point Test system Concentrat
Page 83 and 84:
68 Litter parameters, including lit
Page 85 and 86:
70 Table 13. Relevant findings of a
Page 87 and 88:
72 Dealkylation reactions at the 4
Page 89 and 90:
74 In a test for DNA repair in vitr
Page 91 and 92:
76 The NOAEL was 50 ppm, equal to 4
Page 93 and 94:
78 (iii) Diaminochlorotriazine, DAC
Page 95 and 96:
80 on control diet for a 39-week re
Page 97 and 98:
82 Table 18. Relevant findings in a
Page 99 and 100:
84 basophilia, minimal subacute int
Page 101 and 102:
86 Hydroxyatrazine was not carcinog
Page 103 and 104:
88 DEA and DIA significantly increa
Page 105 and 106:
90 analysed for LH. Rats were necro
Page 107 and 108:
92 gavage for 4 weeks; a group of 4
Page 109 and 110:
94 a dose of 6.25 mg/kg bw (i.e. 12
Page 111 and 112:
96 In a study on the effects of atr
Page 113 and 114:
98 those in the control group that
Page 115 and 116:
100 (h) Studies on estrogenic and a
Page 117 and 118:
102 Although it has been reported t
Page 119 and 120:
104 Immunological effects in B6C3F
Page 121 and 122:
106 independent reviews (Neuberger,
Page 123 and 124:
108 selected by random digit-dialle
Page 125 and 126:
110 supported by a number of short-
Page 127 and 128:
112 DEA, DIA and DACT did not show
Page 129 and 130:
114 Special 6-month study a Special
Page 131 and 132:
116 Group ARfD for atrazine, deethy
Page 133 and 134:
118 Appendix 1 Application of the I
Page 135 and 136:
120 greater, and in a 26-week study
Page 137 and 138:
122 1. Comparison of the reproducti
Page 139 and 140:
124 III. Can human relevance of the
Page 141 and 142:
126 Cummings, A.M., Rhodes, B.E. &
Page 143 and 144:
128 implications for endocrine disr
Page 145 and 146:
130 IARC (1999) Atrazine. In: Some
Page 147 and 148:
132 Meek, M.E., Bucher, J.R., Cohen
Page 149 and 150:
134 Pino, A., Maura, A. & Grillo, P
Page 151 and 152:
136 No. 2214-01 dated 4 March 2002
Page 153 and 154:
138 Wise, P.M., Kashon, M.L., Krajn
Page 155 and 156:
140 for c onsideration by the prese
Page 157 and 158:
142 Figure 1. Proposed metabolic pa
Page 159 and 160:
144 Benzazimide (azinphos-methyl me
Page 161 and 162:
146 Table 3. Cholinesterase activit
Page 163 and 164:
148 Table 5. Cholinesterase activit
Page 165 and 166:
150 Table 7. Results of studies of
Page 167 and 168:
152 Table 9. Pup parameters in rats
Page 169 and 170:
154 Table 12. Inhibition of plasma,
Page 171 and 172:
156 Deaths occurred in all groups,
Page 173 and 174:
158 Treatment-related functional ob
Page 175 and 176:
160 in males at 120 ppm and in fema
Page 177 and 178:
162 on the day after cessation of t
Page 179 and 180:
164 The main toxicological findings
Page 181 and 182:
166 Levels relevant for risk assess
Page 183 and 184:
168 Summary Value Study Safety fact
Page 185 and 186:
170 Herbold, B.A. (1995) E1582 - Mi
Page 187 and 188:
172 United States Environment Prote
Page 189 and 190:
174 At its meeting in 2000, the Joi
Page 191 and 192:
176 With cyclopropyl-labelled cyhal
Page 193 and 194:
178 The patterns of metabolites der
Page 195 and 196:
180 2. Toxicological studies 2.1 Ac
Page 197 and 198:
182 months of treatment. At the sam
Page 199 and 200:
184 of the dosing period and a redu
Page 201 and 202:
186 (up to 26%) and triglycerides (
Page 203 and 204:
188 weight or fetal crown/rump leng
Page 205 and 206:
190 treatment with lambda-cyhalothr
Page 207 and 208:
192 No other data on human observat
Page 209 and 210:
194 In a 2-year dietary study with
Page 211 and 212:
196 15 mg/kg bw per day 30 mg/kg bw
Page 213 and 214:
198 Summary for cyhalothrin and lam
Page 215 and 216:
200 Milburn, G.M. (2004) Lambda-cyh
Page 217 and 218:
202 beet and several vegetable and
Page 219 and 220:
204 Table 1. Key parameters of bloo
Page 221 and 222:
206 differences in the percentage a
Page 223 and 224:
208 2. Toxicological studies 2.1 Ac
Page 225 and 226:
210 Signs of irritation were observ
Page 227 and 228:
212 and 0, 4.6, 45.2 and 639 mg/kg
Page 229 and 230:
214 ratios in males at all doses an
Page 231 and 232:
216 The stability of difenoconazole
Page 233 and 234:
218 Table 4. Treatment-related hist
Page 235 and 236:
220 3000 ppm and 6000 ppm, but thes
Page 237 and 238:
222 conducted on all mice during th
Page 239 and 240:
224 Absolute liver weights and live
Page 241 and 242:
226 Hepatocellular Early 0 2 0 2 0
Page 243 and 244:
228 Blood chemistry measurements sh
Page 245 and 246:
230 (a) Discussion of a possible mo
Page 247 and 248:
232 toxic for this compound, partic
Page 249 and 250:
234 after an exposure period of at
Page 251 and 252:
236 male pups at 250 ppm were signi
Page 253 and 254:
238 There were also no treatment-re
Page 255 and 256:
240 Table 14. Incidence of skeletal
Page 257 and 258:
242 Analyses of the sites of fetal
Page 259 and 260:
244 weekly throughout the study. At
Page 261 and 262:
246 Table 15. Scores for hindlimb g
Page 263 and 264:
Page 265 and 266:
250 Table 18. Studies of toxicity a
Page 267 and 268:
252 1,2,4-Triazole does not modulat
Page 269 and 270:
Page 271 and 272:
256 recovery period. The microsomal
Page 273 and 274:
258 Microscopic examinations reveal
Page 275 and 276:
260 powder. The remaining one third
Page 277 and 278:
262 16 deaths among females at 3000
Page 279 and 280:
264 of allergic reaction to a formu
Page 281 and 282:
266 Lowest relevant developmental N
Page 283 and 284:
268 Gerspach, R. (2000) CGA 169374
Page 285 and 286:
270 Melly, J. & Lohse, K. (1982) Mi
Page 287 and 288:
272 Thomas, H. (1992) The effect of
Page 289 and 290:
274 Explanation Dimethomorph is a c
Page 291 and 292:
276 Profiles for urinary and faecal
Page 293 and 294:
278 Table 7. Excretion pattern in r
Page 295 and 296:
280 Table 9. Tissue distribution of
Page 297 and 298:
282 In an additional study on possi
Page 299 and 300:
284 2.2 Short-term studies of toxic
Page 301 and 302:
286 To investigate the contribution
Page 303 and 304:
288 groups at the highest dose, fem
Page 305 and 306:
290 The ileums from all mice in the
Page 307 and 308:
292 the control group were terminat
Page 309 and 310:
294 the groups at weeks 11 (only ha
Page 311 and 312:
296 in females). This study was con
Page 313 and 314:
298 without metabolic activation (8
Page 315 and 316:
300 Clinical observations, feed con
Page 317 and 318:
302 weights measured and they were
Page 319 and 320:
304 of them with signs of improper
Page 321 and 322:
306 (j) Cardiovascular, respiratory
Page 323 and 324:
308 that the increased incidence in
Page 325 and 326:
310 Toxicological evaluation The Me
Page 327 and 328:
312 Ainsworth, G.A. & Wright, A. (1
Page 329 and 330:
314 Müller, W. (1989a) SAG 151 Ora
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:
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:
Page 379 and 380:
364 for males and females at 2500 o
Page 381 and 382:
366 daily for signs of toxicity; bo
Page 383 and 384:
368 Groups of four male and four fe
Page 385 and 386:
370 Table 17. Hepatic findings in a
Page 387 and 388:
Page 389 and 390:
374 Table 20. Findings in offspring
Page 391 and 392:
376 (b) Developmental toxicity Rats
Page 393 and 394:
378 The study did not identify a NO
Page 395 and 396:
380 Table 25. Blood plasma kinetic
Page 397 and 398:
382 Table 27. Dosing schedule and t
Page 399 and 400:
384 Table 28. Ejaculate mass and te
Page 401 and 402:
386 3. Studies on metabolites (a) 3
Page 403 and 404:
388 Table 31. Metabolite concentrat
Page 405 and 406:
390 females. The histopathological
Page 407 and 408:
392 was a significant increase in t
Page 409 and 410:
394 Levels relevant to risk assessm
Page 411 and 412:
396 Summary Value Study Safety fact
Page 413 and 414:
398 Kogiso, S. (1991) Reverse mutat
Page 415 and 416:
400 Savides, M.C. (2002) The in viv
Page 418 and 419:
PROFENOFOS First draft prepared by
Page 420 and 421:
405 Similar results were obtained i
Page 422 and 423:
407 1.3 Effects on enzymes and othe
Page 424 and 425:
409 bw by gavage. An additional fiv
Page 426 and 427:
411 within 12 days. No other detail
Page 428 and 429:
413 treatment. Corneal opacity was
Page 430 and 431:
415 All rats of the group at the hi
Page 432 and 433:
417 The treatment produced no signi
Page 434 and 435:
419 In another study, groups of fou
Page 436 and 437:
421 p resence of nodules or masses
Page 438 and 439:
423 intervals at 0.3 ppm, but never
Page 440 and 441:
425 The study was not conducted in
Page 442 and 443:
427 activity was inhibited by 21% a
Page 444 and 445:
429 day during gestation and 0, 0.7
Page 446 and 447:
431 muscularly 60 min before the se
Page 448 and 449:
433 Comments Biochemical aspects [P
Page 450 and 451:
435 Studies of developmental toxici
Page 452 and 453:
437 Estimate of acceptable daily in
Page 454 and 455:
439 Cannelongo, B.F. (1982b) CGA 15
Page 456 and 457:
441 Loosli, R. (1989) Cholinesteras
Page 458:
443 Williams, S.C., Marco, G.J., Si
Page 461 and 462:
446 Evaluation for acceptable daily
Page 463 and 464:
448 Table 2. Calculated pharmacokin
Page 465 and 466:
450 time, while the concentration i
Page 467 and 468:
452 Sum 91.5 — — — — —
Page 469 and 470:
454 Mice In a study of absorption,
Page 471 and 472:
456 findings were observed on necro
Page 473 and 474:
458 was observed (relative to contr
Page 475 and 476:
460 The deaths were considered to b
Page 477 and 478:
462 The LOAEL was 8000 ppm (529.1 a
Page 479 and 480:
464 e xamination was performed befo
Page 481 and 482:
466 43%, 71% and 59% (control, lowe
Page 483 and 484:
468 At interim kill, no significant
Page 485 and 486:
470 2.5 Reproductive toxicity (a) M
Page 487 and 488:
472 necropsy. The uterus and ovarie
Page 489 and 490:
474 (b) Short-term studies of neuro
Page 491 and 492:
476 were noted at day 4. Liver weig
Page 493 and 494:
478 In a 90-day dietary study of to
Page 495 and 496:
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
Page 501 and 502:
486 Simpson, E. (2003) Historical c
Page 503 and 504:
488 All the pivotal studies met the
Page 505 and 506:
490 or distribution of [ 14 C]zoxam
Page 507 and 508:
492 indicated that zoxamide is very
Page 509 and 510:
494 Metabolite RH141,452 (3,5-dichl
Page 511 and 512:
496 2.2 Short-term studies of toxic
Page 513 and 514:
498 The only findings of note were
Page 515 and 516:
500 canine juvenile polyarteritis s
Page 517 and 518:
502 Table 10. Organ weight and hist
Page 519 and 520:
504 Week 52 3 167 2 795 2 538 2 052
Page 521 and 522:
506 weights were increased in a dos
Page 523 and 524:
508 The zoxamide metabolites, RH 14
Page 525 and 526:
510 Table 15 Pup body weights durin
Page 527 and 528:
512 consumption were monitored thro
Page 529 and 530:
514 anti-tubulin compounds at 37 °
Page 531 and 532:
516 were higher than those of the c
Page 533 and 534:
518 Acute neurotoxicity b 2000 mg/k
Page 535 and 536:
520 Ferguson, J.S., Morrison, R.D.
Page 537 and 538:
522 Snyder, P.W., Kazacos, E.A., Sc
Page 539 and 540:
524 14. Pesticide residues in food.
Page 541 and 542:
526 50. Pesticide residues in food
Page 543 and 544:
528 84. Pesticide residues in food
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