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Pesticide residues in food — 2006: Toxicological ... - ipcs inchem

Pesticide residues in food — 2006: Toxicological ... - ipcs inchem

Pesticide residues in food — 2006: Toxicological ... - ipcs

  • Page 2 and 3: Pesticide residues in food — 2006
  • Page 4: TABLE OF CONTENTS Page List of part
  • Page 7 and 8: Dr Helen Hakansson, Institute of En
  • Page 10 and 11: Abbreviations used ADI ALT APDM ARf
  • Page 12: Introduction The toxicological mono
  • Page 16 and 17: BIFENAZATE First draft prepared by
  • Page 18 and 19: 5 In a series of experiments, group
  • Page 20 and 21: 7 In a study of the time-course of
  • Page 22 and 23: 9 the administered dose in males an
  • Page 24 and 25: 11 limited absorption of parent com
  • Page 26 and 27: 13 NAME/No. STRUCTURE D1989 OCH 3 D
  • Page 28 and 29: 15 2.1 Acute toxicity Results of st
  • Page 30 and 31: 17 (f) Sensitization In a study of
  • Page 32 and 33: 19 Table 9. Clinical chemistry effe
  • Page 34 and 35: 21 The degree of this finding was m
  • Page 36 and 37: 23 On histopathological examination
  • Page 38 and 39: 25 (equal to 0, 0.9, 10.4 or 25 mg/
  • Page 40 and 41: 27 Haemoglobin (g/dl): Before treat
  • Page 42 and 43: 29 weekly. Blood and urine samples
  • Page 44 and 45: 31 (females) (equal to 0, 1.0, 3.9,
  • Page 46 and 47: 33 Cytogenetic test Chinese hamster
  • Page 48 and 49: 35 groups of 30 males and 30 female
  • Page 50 and 51: 37 and placed in 10% ammonium sulfi
  • Page 52 and 53:

    39 was > 5000 mg/kg bw. The LC 50 i

  • Page 54 and 55:

    41 Multigeneration study of reprodu

  • Page 56 and 57:

    43 Medical data No significant adve

  • Page 58:

    45 Trutter, J.A. (1997a) 28-Day die

  • Page 61 and 62:

    48 Evaluation for acceptable daily

  • Page 63 and 64:

    50 Table 2. Radioactivity in blood

  • Page 65 and 66:

    52 10 10 0.42 0.0462 0.63 0.0080 8.

  • Page 67 and 68:

    54 Figure 2. Transfer of radioactiv

  • Page 69 and 70:

    56 Skin 33.07 61.59 0.5 17.94 17.29

  • Page 71 and 72:

    58 Table 10. Summary of metabolites

  • Page 73 and 74:

    60 Table 14. Summary of identified

  • Page 75 and 76:

    62 Table 18. Summary of metabolites

  • Page 77 and 78:

    64 Table 19. Structures of identifi

  • Page 79 and 80:

    66 Metabolite Structure O M510F14 N

  • Page 81 and 82:

    68 Metabolite Structure M510F39 N O

  • Page 83 and 84:

    70 2. Toxicological studies 2.1 Acu

  • Page 85 and 86:

    72 1% Tylose CB 30.000. The injecti

  • Page 87 and 88:

    74 the end of dosing. Blood samples

  • Page 89 and 90:

    76 examinations were carried out 8

  • Page 91 and 92:

    78 concentrations were increased at

  • Page 93 and 94:

    80 times were slightly, but signifi

  • Page 95 and 96:

    82 in males and females rats at 250

  • Page 97 and 98:

    84 End-point Test object Dose a (LE

  • Page 99 and 100:

    86 parental rats was not markedly a

  • Page 101 and 102:

    88 groups in conception frequencies

  • Page 103 and 104:

    90 0.7 ± 3.5%, 1.8 ± 4.2%, 2.9 ±

  • Page 105 and 106:

    92 In this study of developmental n

  • Page 107 and 108:

    94 3. Observations in humans In the

  • Page 109 and 110:

    96 was 100 ppm, equal to 10 mg/kg b

  • Page 111 and 112:

    98 Acute toxicity Rat, LD 50 , oral

  • Page 113 and 114:

    100 Mellert, W., Kaufmann, W. & Hil

  • Page 116 and 117:

    CYFLUTHRIN AND BETA-CYFLUTHRIN Firs

  • Page 118 and 119:

    105 Table 1. Diastereoisomer pairs

  • Page 120 and 121:

    107 (i) In vivo Rats Four groups of

  • Page 122 and 123:

    109 2. Toxicological studies 2.1 Ac

  • Page 124 and 125:

    111 Species Strain Sex Route Formul

  • Page 126 and 127:

    113 Rat Groups of 20 male and 20 fe

  • Page 128 and 129:

    115 group and in the groups at the

  • Page 130 and 131:

    117 cyfluthrin (purity, 95.5-95.9%)

  • Page 132 and 133:

    119 In a short-term study of exposu

  • Page 134 and 135:

    121 and dissection. At termination,

  • Page 136 and 137:

    123 2.5 Reproductive toxicity (a) M

  • Page 138 and 139:

    125 gestation. The vehicle was 1% C

  • Page 140 and 141:

    127 females was exposed during days

  • Page 142 and 143:

    129 were not seen in rats in the co

  • Page 144 and 145:

    131 men was exposed for 1 h to actu

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    133 40 g/l, in a flowable concentra

  • Page 148 and 149:

    135 were removed from five males an

  • Page 150 and 151:

    137 weights and food consumption we

  • Page 152 and 153:

    139 In females at the highest dose,

  • Page 154 and 155:

    141 The dermal toxicity of cyfluthr

  • Page 156 and 157:

    143 The Meeting concluded that the

  • Page 158 and 159:

    145 Estimate of acute reference dos

  • Page 160 and 161:

    147 Cage, S. (2004) [ 14 C]-beta-cy

  • Page 162 and 163:

    149 Heimann, K.G. (1984c) FCR 4545

  • Page 164 and 165:

    151 Jones, R.D. & Hastings, T.F. (1

  • Page 166 and 167:

    153 Pauluhn, J. & Mohr, U. (1984).

  • Page 168:

    155 Von Keutz, E. (1987) FCR 4545 -

  • Page 171 and 172:

    158 Zeta-cypermethrin .............

  • Page 173 and 174:

    160 Evaluation for acceptable daily

  • Page 175 and 176:

    162 polar metabolites, which are fu

  • Page 177 and 178:

    164 for up to 70 days. Signs typica

  • Page 179 and 180:

    166 rapidly metabolized by cleavage

  • Page 181 and 182:

    168 2. Toxicological studies 2.1 Ac

  • Page 183 and 184:

    170 Table 2. Effect of cis : trans

  • Page 185 and 186:

    172 Table 3. Significant haematolog

  • Page 187 and 188:

    174 Rabbits Occluded dermal applica

  • Page 189 and 190:

    176 1100 ppm in weeks 1-6, with inc

  • Page 191 and 192:

    178 Wistar-derived (Alderley Park)

  • Page 193 and 194:

    180 At 1500 ppm, liver APDM activit

  • Page 195 and 196:

    182 for premature deaths, 10 male a

  • Page 197 and 198:

    184 by gavage for days 7 to 19 of g

  • Page 199 and 200:

    186 observed at the intermediate an

  • Page 201 and 202:

    188 The females recovered from this

  • Page 203 and 204:

    190 tibial nerve (SPTN), trigeminal

  • Page 205 and 206:

    192 4. Toxicological studies 4.1 Ac

  • Page 207 and 208:

    194 for 5 weeks. Observations inclu

  • Page 209 and 210:

    196 caused obvious irritation and r

  • Page 211 and 212:

    198 days 6-15 of gestation. After m

  • Page 213 and 214:

    200 was observed in two males at 72

  • Page 215 and 216:

    202 control and other treated group

  • Page 217 and 218:

    204 Table 14. Results of studies of

  • Page 219 and 220:

    206 (b) Developmental toxicity Rats

  • Page 221 and 222:

    208 mild and temporary paraesthesia

  • Page 223 and 224:

    210 range appeared to exist for the

  • Page 225 and 226:

    212 for which the LD 50 was > 2000

  • Page 227 and 228:

    214 substances. Since conventional

  • Page 229 and 230:

    216 Critical end-points relevant fo

  • Page 231 and 232:

    218 Butterworth, S.T.G. & Clark, D.

  • Page 233 and 234:

    220 East Millstone, New Jersey, USA

  • Page 235 and 236:

    222 Jersey, USA. Submitted to WHO b

  • Page 237 and 238:

    224 Toxicology Laboratory (Tunstall

  • Page 239 and 240:

    226 Ullrich, B. (2003) Report on a

  • Page 241 and 242:

    228 Cyromazine was first evaluated

  • Page 243 and 244:

    230 were taken for the measurement

  • Page 245 and 246:

    232 highest dose, rather than indic

  • Page 247 and 248:

    234 Tissue residues: Tissues a < 0.

  • Page 249 and 250:

    236 Because of the low total recove

  • Page 251 and 252:

    238 Name Description Compound found

  • Page 253 and 254:

    240 After each dose of [U- 14 C tri

  • Page 255 and 256:

    242 In male and female monkeys give

  • Page 257 and 258:

    244 stress and discomfort during th

  • Page 259 and 260:

    246 Table 18. Dermal absorption of

  • Page 261 and 262:

    248 rate under steady-state conditi

  • Page 263 and 264:

    250 2. Toxicological studies 2.1 Ac

  • Page 265 and 266:

    252 the test substance. The method

  • Page 267 and 268:

    254 taken for haematological and bi

  • Page 269 and 270:

    256 not differ appreciably from pre

  • Page 271 and 272:

    258 Analysis of the diets showed th

  • Page 273 and 274:

    260 considered to be biologically s

  • Page 275 and 276:

    262 observed incidence probably rel

  • Page 277 and 278:

    264 c Cyromazine was assayed twice

  • Page 279 and 280:

    266 2.5 Reproductive toxicity (a) M

  • Page 281 and 282:

    268 either sporadic or as a consequ

  • Page 283 and 284:

    270 fetuses were removed, weighed a

  • Page 285 and 286:

    272 The NOAEL for maternal toxicity

  • Page 287 and 288:

    274 In New Zealand White rabbits, c

  • Page 289 and 290:

    276 and litters with malformations.

  • Page 291 and 292:

    278 of melamine powder into the rab

  • Page 293 and 294:

    280 reduction in the survival of ma

  • Page 295 and 296:

    282 There is significantly less ris

  • Page 297 and 298:

    284 Toxicological data Cyromazine h

  • Page 299 and 300:

    286 Toxicological evaluation The Me

  • Page 301 and 302:

    288 Other toxicological studies Tox

  • Page 303 and 304:

    290 IARC (1999a) Some chemicals tha

  • Page 305 and 306:

    292 Simoneaux, B. & Marco, G. (1984

  • Page 307 and 308:

    294 Declaration of Helsinki (Cristi

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    296 lowered arousal level at doses

  • Page 311 and 312:

    298 Cerebellum 3 1 51** 76** 80** 7

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    300 Table 4. Maximum inhibition of

  • Page 315 and 316:

    302 auditory/physical examination w

  • Page 317 and 318:

    304 • • • • • Home-cage o

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    306 Dogs Groups of four male and fo

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    308 capsules. Some volunteers recei

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    310 Blood was taken for measurement

  • Page 325 and 326:

    312 Human a Dietary administration

  • Page 327 and 328:

    314 Piccirillo, V.J. (1978) Acute o

  • Page 329 and 330:

    316 Haloxyfop (racemic), its sodium

  • Page 331 and 332:

    318 Recovery of radioactivity in ur

  • Page 333 and 334:

    320 skin of nine male and nine fema

  • Page 335 and 336:

    322 1.2 Biotransformation Mice In a

  • Page 337 and 338:

    324 2. Toxicological studies 2.1 Ac

  • Page 339 and 340:

    326 96%) at a concentration designe

  • Page 341 and 342:

    328 was centrilobular hepatocellula

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    330 The treatment had no effect on

  • Page 345 and 346:

    332 All dogs were killed for autops

  • Page 347 and 348:

    334 with that of controls (but no s

  • Page 349 and 350:

    336 Table 4. Results of studies of

  • Page 351 and 352:

    338 doses of up to 1.0 mg/kg bw per

  • Page 353 and 354:

    340 delayed ossification in the hyo

  • Page 355 and 356:

    342 Mice In a GLP-compliant study,

  • Page 357 and 358:

    344 and in females at the highest d

  • Page 359 and 360:

    346 Between January 1999 and Januar

  • Page 361 and 362:

    348 The Meeting concluded that halo

  • Page 363 and 364:

    350 Critical end-points for setting

  • Page 365 and 366:

    352 Elcombe, B.M. (2002a) Effects o

  • Page 367 and 368:

    354 Scortichini, B.H., Bohl, R.W. &

  • Page 369 and 370:

    356 Economic Co-operation and Devel

  • Page 371 and 372:

    358 There were no treatment-related

  • Page 373 and 374:

    360 comparable to control levels. A

  • Page 375 and 376:

    362 Groups of 17 male and 17 female

  • Page 377 and 378:

    364 No compound-related effects wer

  • Page 379 and 380:

    366 Berry, D. & Gore, C.W. (1975) P

  • Page 381 and 382:

    368 Quinoxyfen has not been evaluat

  • Page 383 and 384:

    370 In the main study, which compli

  • Page 385 and 386:

    372 Concentrations of total radioac

  • Page 387 and 388:

    374 several hydroxy-quinoxyfen meta

  • Page 389 and 390:

    376 There were no mortalities or ad

  • Page 391 and 392:

    378 at doses of ≥ 100 mg/kg bw pe

  • Page 393 and 394:

    380 In a GLP-compliant study to det

  • Page 395 and 396:

    382 control group. This was observe

  • Page 397 and 398:

    384 The homogeneity and stability o

  • Page 399 and 400:

    386 Testes weight (g) at 24 months

  • Page 401 and 402:

    388 slight (3 out of 30) hepatocell

  • Page 403 and 404:

    390 marked inanition, decreased fae

  • Page 405 and 406:

    392 Females Relative liver weightt

  • Page 407 and 408:

    394 were patch-tested specifically

  • Page 409 and 410:

    396 In studies of developmental tox

  • Page 411 and 412:

    398 Rat, LC 50 , inhalation Rabbit,

  • Page 413 and 414:

    400 Gollapudi, B.B. & Lick, S.J. (1

  • Page 416 and 417:

    TEMEPHOS First draft prepared by De

  • Page 418 and 419:

    405 by thin-layer chromatography (T

  • Page 420 and 421:

    407 In a special study to investiga

  • Page 422 and 423:

    409 concluded that temephos was of

  • Page 424 and 425:

    411 Table 3. Effects on mean erythr

  • Page 426 and 427:

    413 Females 0 1.091 1.224 1.324 1.3

  • Page 428 and 429:

    415 of up to 18 ppm. In the group a

  • Page 430 and 431:

    417 Chromosomal aberration DNA repa

  • Page 432 and 433:

    419 of the birds treated with temep

  • Page 434 and 435:

    421 concentration of 1 ppm. Only on

  • Page 436 and 437:

    423 being appreciably less than thi

  • Page 438 and 439:

    425 Lowest relevant developmental N

  • Page 440:

    427 WHO (1991) Safe use of pesticid

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    430 All new studies with thiabendaz

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    432 use of this dose form was consi

  • Page 447 and 448:

    434 At 1000 mg/kg bw, qualitative e

  • Page 449 and 450:

    436 At 100 mg/kg bw, slightly decre

  • Page 451 and 452:

    438 There were no treatment-related

  • Page 453 and 454:

    440 Table 6. Incidence of malformat

  • Page 455 and 456:

    442 Dose (mg/kg bw) (grouped by exp

  • Page 457 and 458:

    444 1157 12/21 (57.1)*** 27.2 ± 33

  • Page 459 and 460:

    446 versus placebo): increased appe

  • Page 461 and 462:

    448 activity, tiptoe gait, landing

  • Page 463 and 464:

    450 Noakes, J.P. (2005a) Thianendaz

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    452 tests normally performed and th

  • Page 467 and 468:

    454 Radiolabel was excreted primari

  • Page 469 and 470:

    456 the excretory organs, was the r

  • Page 471 and 472:

    458 Table 6. Excretion of radioacti

  • Page 473 and 474:

    460 of unchanged parent compound we

  • Page 475 and 476:

    462 M10 (KNO 1891) + M11 (KNO 1893)

  • Page 477 and 478:

    464 on body weights. Exposure at 15

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    466 The no-observed-adverse-effect

  • Page 481 and 482:

    468 Hepatocytes, hypertrophy 0 2 6

  • Page 483 and 484:

    470 they may also be related to var

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    472 weights of males were approxima

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    474 Thyroid weight (mg): Week 12 6

  • Page 489 and 490:

    476 Table 17. Relevant findings in

  • Page 491 and 492:

    478 Dogs In a dose range-finding st

  • Page 493 and 494:

    480 Prostate / uterine weight (g) 2

  • Page 495 and 496:

    482 the treatment groups receiving

  • Page 497 and 498:

    484 No gross findings were observed

  • Page 499 and 500:

    486 received a macroscopic examinat

  • Page 501 and 502:

    488 Although decreased concentratio

  • Page 503 and 504:

    490 Sciatic nerve; No. examined 50

  • Page 505 and 506:

    492 are caused by the higher incide

  • Page 507 and 508:

    494 2.5 Reproductive toxicity (a) M

  • Page 509 and 510:

    496 In a two-generation study of re

  • Page 511 and 512:

    498 In dams that died or were sacri

  • Page 513 and 514:

    500 No clinical signs or increased

  • Page 515 and 516:

    502 Table 33. Selected variations a

  • Page 517 and 518:

    504 Days 16-21 73.3 78.7 62.5 44.3*

  • Page 519 and 520:

    506 Thiacloprid was not teratogenic

  • Page 521 and 522:

    508 Table 37. Motor and locomotor a

  • Page 523 and 524:

    510 Day 91 19.78 20.00 19.58 18.22*

  • Page 525 and 526:

    512 Table 40. Selected findings in

  • Page 527 and 528:

    514 plate incorporation procedure,

  • Page 529 and 530:

    516 (iv) Comparative study on liver

  • Page 531 and 532:

    518 and relative liver weight in an

  • Page 533 and 534:

    520 at 2500 ppm. The administration

  • Page 535 and 536:

    522 No macroscopic changes were det

  • Page 537 and 538:

    524 The following procedures were p

  • Page 539 and 540:

    526 litter for the group at 1000 pp

  • Page 541 and 542:

    528 Hepatic enzyme activities in th

  • Page 543 and 544:

    530 subtypes 1A1, 2B1, 2D1 and othe

  • Page 545 and 546:

    532 Long-term studies of toxicity a

  • Page 547 and 548:

    534 The Meeting concluded that ther

  • Page 549 and 550:

    536 Estimate of acceptable daily in

  • Page 551 and 552:

    538 dated 27 July, from Bayer AG, W

  • Page 553 and 554:

    540 Kroetlinger, F. (1995a) YRC 289

  • Page 555 and 556:

    542 Wetzig, H. & Geiss, V. (1998b)

  • Page 557 and 558:

    544 Table A1. NOAELs and LOAELs for

  • Page 559 and 560:

    546 2.2 Postulated mode of action (

  • Page 561 and 562:

    548 • • • Chromosomal aberrat

  • Page 563 and 564:

    550 Table A3. NOAELs and LOAELs for

  • Page 565 and 566:

    552 Appendix 2 Table B1. List of an

  • Page 567 and 568:

    554 Metabolite Structure / trivial

  • Page 569 and 570:

    556 Metabolite Structure / trivial

  • Page 571 and 572:

    558 Evaluation for acute reference

  • Page 573 and 574:

    560 increased thyroid weights in th

  • Page 575 and 576:

    562 Table 4. Results of bone-marrow

  • Page 577 and 578:

    564 malformations between the contr

  • Page 579 and 580:

    566 In a study of prenatal developm

  • Page 581 and 582:

    568 combination of heparin and an a

  • Page 583 and 584:

    570 Table 10. Selected findings fro

  • Page 585 and 586:

    572 In a short-term study of neurot

  • Page 588 and 589:

    ANNEX 1 Reports and other documents

  • Page 590 and 591:

    577 31. Pesticide residues in food:

  • Page 592 and 593:

    579 66. Pesticide residues in food

  • Page 594:

    581 100. Pesticide residues in food

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