Safety evaluation of certain food additives - ipcs inchem

More documents

Recommendations

Info

ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS 323 Table 5 (contd) CHO, Chinese hamster ovary; S9, 9000 × g supernatant from rat liver. a With and without metabolic activation. b Calculated using a density of 0.936 g/ml for methyl 2-methyl-2-propenoate. c Without metabolic activation; negative with metabolic activation. d Calculated using a relative molecular mass of 100.13 for methyl 2-methyl-2-propenoate. e Without metabolic activation, at cytotoxic concentration; negative with metabolic activation. f With and without metabolic activation, (mainly) at cytotoxic concentrations. g The article is in Japanese, and only summary tables are available in English. h Only with metabolic activation, at cytotoxic concentrations. i With metabolic activation (no data on cytotoxicity). j Without metabolic activation, at cytotoxic concentrations. k At cytotoxic concentration(s). l According to authors, 10 6 –10 3 (v/v) is equivalent to approximately 0.001–1 μg/ml. m Without metabolic activation (no data on cytotoxicity). n With and without metabolic activation (no data on cytotoxicity). o Exposure duration not reported.
324 ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS Bensink, 1984; National Toxicology Program, 1986; Zeiger et al., 1987; Zeiger, 1990; Schweikl et al., 1994; Kajiura, 1997b). Methyl 2-methyl-2-propenoate in (cytotoxic) concentrations ranging from 10 to 100 mmol/l showed weak positive results in a similar assay utilizing S. typhimurium strain TM677 in the presence, but not in the absence, of metabolic activation (Poss et al., 1979; Haskell Laboratory, 1989) and was negative in a similar assay in concentrations up to 2000 μg/plate in S. typhimurium strain YG7108pin3ERb5 (Emmert et al., 2006). Assays in mammalian cell lines have been performed with methyl 2methyl-2-propenoate (No. 1834) only. In several mouse lymphoma mutation assays in L5178Y cells, methyl 2-methyl-2-propenoate showed positive results in the presence of metabolic activation (Rohm & Haas Co., 1985; Amtower et al., 1986; National Toxicology Program, 1986; Myhr et al., 1990; Dearfield et al., 1991). In the absence of metabolic activation, one assay revealed negative results (Rohm & Haas Co., 1985), one revealed ambiguous results (National Toxicology Program, 1986) and four revealed positive (or weakly positive) results (Moore et al., 1988; Doerr et al., 1989; Myhr et al., 1990; Dearfield et al., 1991). The positive results were mainly observed at cytotoxic concentrations. In the HPRT assay using V79B Chinese hamster lung fibroblast cells, methyl 2-methyl-2-propenoate at concentrations of 10 or 20 mmol/l showed a very weak mutagenic response after direct exposure for 24 h. The authors indicated that testing this flavouring agent was difficult owing to severe cytotoxicity at concentrations above 20 mmol/l (Schweikl et al., 1998). Micronucleus assays with V79 Chinese hamster lung fibroblasts (Schweikl et al., 2001) and mouse lymphoma L5178Y cells (Doerr et al., 1989) showed very weak positive results at concentrations that were cytotoxic. In a cell transformation assay with BHK21/C13 cells, methyl 2-methyl-2propenoate tested negative at concentrations of 1 × 10 6 to 1 × 10 2 mol/l (Anderson et al., 1979). Methyl 2-methyl-2-propenoate was also tested using Chinese hamster ovary (CHO) cells for colony-forming efficiency in a DNA synthesis inhibition assay and in two cytogenetic assays (i.e. chromosomal aberration and sister chromatid exchange) (Yang et al., 2003). Clonogenic survival showed a statistically significant dose- and time-dependent decrease in colony counts when exposed for 2, 6, 12 and 24 h to concentrations ranging from 10 6 to 10 3 (v/v) (equivalent to approximately 1–1000 μg/ml): plating efficiency was reduced between 20% and 40% after 2 h and between 40% and 90% after 6–24 h. Results of the DNA synthesis inhibition assay showed that methyl 2-methyl-2-propenoate exposure reduced the rate of [methyl- 3 H]thymidine incorporation in a statistically significant, dose-dependent manner. Chromosomal aberrations and the frequency of sister chromatid exchanges were also increased (Yang et al., 2003). Other experiments also showed induction of chromosomal aberrations in CHO cells (Anderson et al., 1990) and mouse lymphoma L5178Y cells (Moore et al., 1988; Doerr et al., 1989) and of sister chromatid exchanges in CHO cells (Anderson et al., 1990) following treatment with methyl 2-methyl-2-propenoate. Sister chromatid exchange experiments conducted with human lymphocytes were negative (Cannas et al., 1987).
Page 2 and 3:
WHO FOOD ADDITIVES SERIES: 60 Safet
Page 4 and 5:
CONTENTS Preface ..................
Page 6:
PREFACE The monographs contained in
Page 10 and 11:
ASPARAGINASE FROM ASPERGILLUS NIGER
Page 12 and 13:
Page 14 and 15:
Page 16 and 17:
Page 18 and 19:
Page 20:
Page 23 and 24:
16 CALCIUM LIGNOSULFONATE (40-65) 1
Page 25 and 26:
18 CALCIUM LIGNOSULFONATE (40-65) ~
Page 27 and 28:
20 CALCIUM LIGNOSULFONATE (40-65) A
Page 29 and 30:
22 CALCIUM LIGNOSULFONATE (40-65) c
Page 31 and 32:
24 CALCIUM LIGNOSULFONATE (40-65) T
Page 33 and 34:
Page 35 and 36:
28 CALCIUM LIGNOSULFONATE (40-65) i
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 46 and 47:
ETHYL LAUROYL ARGINATE First draft
Page 48 and 49:
ETHYL LAUROYL ARGINATE 41 and Devel
Page 50 and 51:
ETHYL LAUROYL ARGINATE 43 lauroyl a
Page 52 and 53:
ETHYL LAUROYL ARGINATE 45 arginine.
Page 54 and 55:
ETHYL LAUROYL ARGINATE 47 resulting
Page 56 and 57:
ETHYL LAUROYL ARGINATE 49 Table 4.
Page 58 and 59:
ETHYL LAUROYL ARGINATE 51 weight ch
Page 60 and 61:
ETHYL LAUROYL ARGINATE 53 stomach l
Page 62 and 63:
ETHYL LAUROYL ARGINATE 55 fibrosis
Page 64 and 65:
ETHYL LAUROYL ARGINATE 57 Table 5 (
Page 66 and 67:
ETHYL LAUROYL ARGINATE 59 first 4 d
Page 68 and 69:
ETHYL LAUROYL ARGINATE 61 The gener
Page 70 and 71:
ETHYL LAUROYL ARGINATE 63 treatment
Page 72 and 73:
ETHYL LAUROYL ARGINATE 65 gestation
Page 74 and 75:
ETHYL LAUROYL ARGINATE 67 Body weig
Page 76 and 77:
ETHYL LAUROYL ARGINATE 69 Table 6.
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
ETHYL LAUROYL ARGINATE 77 About 99%
Page 86 and 87:
ETHYL LAUROYL ARGINATE 79 concentra
Page 88 and 89:
ETHYL LAUROYL ARGINATE 81 theoretic
Page 90 and 91:
ETHYL LAUROYL ARGINATE 83 Huntingdo
Page 92 and 93:
PAPRIKA EXTRACT First draft prepare
Page 94 and 95:
PAPRIKA EXTRACT 87 of capsanthin ra
Page 96 and 97:
PAPRIKA EXTRACT 89 biochemical para
Page 98 and 99:
PAPRIKA EXTRACT 91 Table 1. Sales o
Page 100 and 101:
PAPRIKA EXTRACT 93 Table 2. Estimat
Page 102 and 103:
PAPRIKA EXTRACT 95 The European Sci
Page 104 and 105:
PAPRIKA EXTRACT 97 The potential di
Page 106 and 107:
PAPRIKA EXTRACT 99 Hornero-Mendez,
Page 108 and 109:
PAPRIKA EXTRACT 101 Appendix 1. Res
Page 110 and 111:
PAPRIKA EXTRACT 103 Appendix 1. (co
Page 112:
PAPRIKA EXTRACT 105 Appendix 1. (co
Page 115 and 116:
108 PHOSPHOLIPASE C EXPRESSED IN PI
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 124 and 125:
PHYTOSTEROLS, PHYTOSTANOLS AND THEI
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170:
Page 173 and 174:
166 POLYDIMETHYLSILOXANE (addendum)
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 190 and 191:
STEVIOL GLYCOSIDES (addendum) First
Page 192 and 193:
STEVIOL GLYCOSIDES (addendum) 185 r
Page 194 and 195:
STEVIOL GLYCOSIDES (addendum) 187 c
Page 196 and 197:
STEVIOL GLYCOSIDES (addendum) 189 a
Page 198 and 199:
STEVIOL GLYCOSIDES (addendum) 191 N
Page 200 and 201:
STEVIOL GLYCOSIDES (addendum) 193 2
Page 202 and 203:
STEVIOL GLYCOSIDES (addendum) 195 T
Page 204 and 205:
STEVIOL GLYCOSIDES (addendum) 197 a
Page 206 and 207:
STEVIOL GLYCOSIDES (addendum) 199 r
Page 208 and 209:
STEVIOL GLYCOSIDES (addendum) 201 l
Page 210 and 211:
STEVIOL GLYCOSIDES (addendum) 203 g
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
STEVIOL GLYCOSIDES (addendum) 209 t
Page 218 and 219:
STEVIOL GLYCOSIDES (addendum) 211 t
Page 220 and 221:
STEVIOL GLYCOSIDES (addendum) 213 s
Page 222 and 223:
STEVIOL GLYCOSIDES (addendum) 215 C
Page 224 and 225:
STEVIOL GLYCOSIDES (addendum) 217 L
Page 226:
STEVIOL GLYCOSIDES (addendum) 219 W
Page 229 and 230:
222 SULFITES: ASSESSMENT OF DIETARY
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Page 245 and 246:
Page 247 and 248:
Page 249 and 250:
Page 251 and 252:
Page 253 and 254:
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261 and 262:
Page 263 and 264:
Page 265 and 266:
Page 268:
SAFETY EVALUATIONS OF GROUPS OF REL
Page 271 and 272:
264 INTRODUCTION Figure 1. Procedur
Page 274 and 275:
DIETARY EXPOSURE ASSESSMENT OF FLAV
Page 276 and 277:
Page 278 and 279:
Page 280 and 281: DIETARY EXPOSURE ASSESSMENT OF FLAV
Page 296: DIETARY EXPOSURE ASSESSMENT OF FLAV
Page 299 and 300: 292 ALIPHATIC BRANCHED-CHAIN SATURA
Page 329: 322 ALIPHATIC BRANCHED-CHAIN SATURA
Page 339 and 340: 332 ALIPHATIC LINEAR ,-UNSATURATED
Page 358 and 359: ALKOXY-SUBSTITUTED ALLYLBENZENES PR
Page 360 and 361: ALKOXY-SUBSTITUTED ALLYLBENZENES 35
Page 380 and 381:
ALKOXY-SUBSTITUTED ALLYLBENZENES 37
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
FURAN-SUBSTITUTED ALIPHATIC HYDROCA
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
Page 496 and 497:
Page 498 and 499:
Page 500 and 501:
Page 502 and 503:
Page 504 and 505:
Page 506 and 507:
Page 508 and 509:
Page 510 and 511:
Page 512 and 513:
Page 514 and 515:
Page 516 and 517:
Page 518 and 519:
Page 520 and 521:
Page 522 and 523:
Page 524 and 525:
Page 526 and 527:
Page 528 and 529:
Page 530 and 531:
Page 532 and 533:
Page 534 and 535:
Page 536 and 537:
Page 538 and 539:
Page 540 and 541:
HYDROXY- AND ALKOXY-SUBSTITUTED BEN
Page 542 and 543:
Page 544 and 545:
Page 546 and 547:
Page 548 and 549:
Page 550 and 551:
Page 552 and 553:
Page 554 and 555:
Page 556 and 557:
MISCELLANEOUS NITROGEN-CONTAINING S
Page 558 and 559:
Page 560 and 561:
Page 562 and 563:
Page 564 and 565:
Page 566 and 567:
Page 568 and 569:
Page 570 and 571:
Page 572 and 573:
Page 574 and 575:
Page 576 and 577:
Page 578 and 579:
Page 580 and 581:
Page 582 and 583:
Page 584:
Page 587 and 588:
580 SUBSTANCES STRUCTURALLY RELATED
Page 589 and 590:
Page 591 and 592:
Page 593 and 594:
Page 595 and 596:
Page 597 and 598:
Page 599 and 600:
Page 602:
ANNEXES
Page 605 and 606:
598 ANNEX 1 10. Specifications for
Page 607 and 608:
600 ANNEX 1 No. 54, 1974; WHO Techn
Page 609 and 610:
602 ANNEX 1 70. Evaluation of certa
Page 611 and 612:
604 ANNEX 1 108. Toxicological eval
Page 613 and 614:
606 ANNEX 1 148. Residues of some v
Page 615 and 616:
608 ANNEX 1 188. Safety evaluation
Page 617 and 618:
610 ANNEX 2 ECG electrocardiogram E
Page 619 and 620:
612 ANNEX 2 SI stimulation index SU
Page 621 and 622:
614 ANNEX 3 Ms J. Baines, Food Stan
Page 624 and 625:
ANNEX 4 ACCEPTABLE DAILY INTAKES, O
Page 626 and 627:
ANNEX 4 619 Food additive Specifica
Page 628 and 629:
ANNEX 4 621 3. FLAVOURING AGENTS 3.
Page 630 and 631:
ANNEX 4 623 Flavouring agent No. Sp
Page 632 and 633:
ANNEX 4 625 Flavouring agent JECFA
Page 634 and 635:
ANNEX 4 627 Actual production volum
Page 636 and 637:
ANNEX 4 629 Flavouring agent No. Sp
Page 638 and 639:
ANNEX 5 SUMMARY OF THE SAFETY EVALU
Page 640 and 641:
ANNEX 5 633 Secondary components Co
show all

Safety evaluation of certain food additives - ipcs inchem

Create successful ePaper yourself

Delete template?

Save as template?