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

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Dr D. Kanungo, Additional DG, Directorate General of Health Services, Ministry of Health and Family Welfare, West, Block No. 1, RK Puram, New Delhi, India (WHO Temporary Adviser) Dr Jeronimas Maskeliunas, Food Standards Officer, Joint FAO/WHO Food Standards Programme, Nutrition and Consumer Protection Division, Food and Agriculture Organization of the United Nations, Viale delle terme di Caracalla, 00153 Rome, Italy (FAO Staff Member) Dr Heidi Mattock, 21bis rue du Mont Ouest, 38230 Tignieu-Jameyzieu, France (WHO Editor) Dr Douglas B. McGregor, Toxicity Evaluation Consultants, 38 Shore Road, Aberdour KY3 0TU, Scotland (WHO Temporary Adviser) Dr Utz Mueller, Principal Toxicologist, Risk Assessment – Chemical Safety, Food Standards Australia New Zealand, PO Box 7186, Canberra, BC ACT 2610, Australia (WHO Temporary Adviser) Dr Rudolf Pfeil, Pesticides and Biocides Division, Federal Institute for Risk Assessment, Thielallee 88-92, D-14195 Berlin, Germany (WHO Temporary Adviser) Dr Prakashchandra V. Shah, United States Environmental Protection Agency, Mail Stop: 7509P, 1200 Pennsylvania Avenue NW, Washington DC 20460, USA (WHO Temporary Adviser) Mr Christian Sieke, Federal Institute for Risk Assessment, Thielallee 88-92, D-14195 Berlin, Germany (FAO Temporary Adviser) Dr Atsuya Takagi, Division of Cellular and Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan (WHO Temporary Adviser) Dr Angelika Tritscher, WHO Joint Secretary, International Programme on Chemical Safety, World Health Organization, 1211 Geneva 27, Switzerland (WHO Joint Secretary) Dr Qiang Wang; Institute of Quality and Standard for Agricultural Products, Zhenjiang Academy of Agricultural Sciences, 198 Shiqiao Road, Hangzhou 310021, China (FAO Temporary Adviser) Dr Gerrit Wolterink, Centre for Substances & Integrated Risk Assessment, National Institute of Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, PO Box 1, 3720 BA Bilthoven, Netherlands (WHO Temporary Adviser) Dr Yong Zhen Yang, FAO Joint Secretary, FAO Plant Protection Service (AGPP), Viale delle Terme di Caracalla, 00153 Rome, Italy (FAO Joint Secretary) Dr Jürg Zarn, Swiss Federal Office of Public Health, Food Toxicology Section, Stauffacherstrasse 101, CH-8004 Zurich, Switzerland (WHO Temporary Adviser) vii
Page 2 and 3: Pesticide residues in food — 2007
Page 4: TABLE OF CONTENTS Page List of part
Page 7: Dr Vicki L. Dellarco, Office of Pes
Page 11 and 12: FAO Food and Agricultural Organizat
Page 13 and 14: xii
Page 16: TOXICOLOGICAL MONOGRAPHS AND MONOGR
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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