Safety evaluation of certain food additives - ipcs inchem

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ETHYL LAUROYL ARGINATE 57 Table 5 (contd) Formulation Test system Test subject Concentration Results Reference In vivo Micronucleus formation d Mouse bone marrow 2000 mg/kg bw, orally Negative Cidasal (2003c) N-Lauroyl-L-arginine (purity 98.6%) a Active ingredient: ethyl-N -lauroyl-L-arginate HCl. b Formulation: 19.5% ethyl-N -lauroyl-L-arginate HCl, 73% propylene glycol. c In the presence and absence of Aroclor 1254–induced rat liver microsomal fraction (S9 mix). d Killed at 24 and 48 h.
58 ETHYL LAUROYL ARGINATE the results of the 13-week dietary study described above (Huntingdon Life Sciences Ltd, 2001c) in which a NOAEL of 5000 mg ethyl lauroyl arginate/kg diet (equal to 384 mg ethyl lauroyl arginate/kg bw per day) was identified. Groups of eight male and eight female rats were allowed free access to the diets for 4 weeks prior to pairing for mating. Treatment was then continued throughout mating and until termination after weaning of the litters. The animals selected to form the F1 generation were continuously treated with diets at concentrations of 0, 1500, 5000 or 15 000 mg/kg (equal to 0, 173, 589 and 1750 mg/kg bw per day for males; and 0, 169, 586 and 1734 mg/kg bw per day for females) from the time of weaning until termination at 8 weeks of age. All animals were checked at least twice daily for clinical signs; once a week, animals were subjected to a thorough physical examination. Body weight and food consumption were recorded at regular intervals for both the F0 and F1 animals. After the initial 4 weeks of treatment, F0 females were paired on a one-to-one basis with males from the same treatment group. Mating was ascertained by vaginal smears and ejected copulation plugs, and the day on which mating was detected was designated day 0 of gestation. Once mating had occurred, the males and females were separated. All F0 females were allowed to deliver their young naturally and rear their own offspring until day 21 of lactation. All litters were examined at day 1 of age for numbers of live and dead pups, body weights, sex ratio and general clinical observations; and subsequently examined daily for clinical signs and dam/ litter interaction until day 21 of age. Following weaning, offspring were selected for the F1 generation based on a random numbers table (12 males and 12 females per treatment group). Sexual maturation was assessed for the selected F1 males and females, and body weights were recorded twice weekly. F0 males were culled after successful littering by females, and F0 females were culled after their litters were weaned. All F0 animals were subjected to a detailed macroscopic examination, and samples of any abnormal tissues were taken. The number of implantation sites was recorded for F0 females. All F1 animals were subjected to a detailed macroscopic examination. The general condition of treated F0 and F1 animals was similar to that of controls, and no deaths occurred. Body weight and body weight gain of F0 males and females were not adversely affected by treatment. Body weight of F1 males and females and body weight gain to 8 weeks of age were unaffected by treatment. Food consumption was similar in all groups of F0 animals, both before mating and, for females, during gestation and lactation. Food consumption of F1 animals was similar to that of controls, and there were no clear effects on food conversion efficiency in F0 animals in the pre-pairing period or in the F1 animals up to 8 weeks of age. In the F0 females, the intakes of ethyl lauroyl arginate increased during lactation in response to the physiological demands of the litter, reaching a level of approximately twice the premating intake during the 2nd week of lactation. F1 animals had higher intakes of ethyl lauroyl arginate than did their F0 parents, as expected based on the higher food consumption of young animals. Mating performance, fertility, gestation length, gestation index, numbers of implantations and litter sizes were similar in all groups and were considered to be unaffected by treatment up to 15 000 mg/kg diet. At 15 000 mg/kg diet, the litters of two of the eight females lost body weight in the
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WHO FOOD ADDITIVES SERIES: 60 Safet
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CONTENTS Preface ..................
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PREFACE The monographs contained in
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ASPARAGINASE FROM ASPERGILLUS NIGER
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ASPARAGINASE FROM ASPERGILLUS NIGER
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Page 23 and 24: 16 CALCIUM LIGNOSULFONATE (40-65) 1
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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
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Page 58 and 59: ETHYL LAUROYL ARGINATE 51 weight ch
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Page 68 and 69: ETHYL LAUROYL ARGINATE 61 The gener
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Page 76 and 77: ETHYL LAUROYL ARGINATE 69 Table 6.
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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
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Page 96 and 97: PAPRIKA EXTRACT 89 biochemical para
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Page 102 and 103: PAPRIKA EXTRACT 95 The European Sci
Page 104 and 105: PAPRIKA EXTRACT 97 The potential di
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Page 108 and 109: PAPRIKA EXTRACT 101 Appendix 1. Res
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108 PHOSPHOLIPASE C EXPRESSED IN PI
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PHYTOSTEROLS, PHYTOSTANOLS AND THEI
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166 POLYDIMETHYLSILOXANE (addendum)
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STEVIOL GLYCOSIDES (addendum) First
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STEVIOL GLYCOSIDES (addendum) 185 r
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STEVIOL GLYCOSIDES (addendum) 187 c
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STEVIOL GLYCOSIDES (addendum) 189 a
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STEVIOL GLYCOSIDES (addendum) 191 N
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STEVIOL GLYCOSIDES (addendum) 193 2
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STEVIOL GLYCOSIDES (addendum) 195 T
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STEVIOL GLYCOSIDES (addendum) 197 a
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STEVIOL GLYCOSIDES (addendum) 199 r
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STEVIOL GLYCOSIDES (addendum) 201 l
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STEVIOL GLYCOSIDES (addendum) 203 g
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STEVIOL GLYCOSIDES (addendum) 209 t
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STEVIOL GLYCOSIDES (addendum) 211 t
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STEVIOL GLYCOSIDES (addendum) 213 s
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STEVIOL GLYCOSIDES (addendum) 215 C
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STEVIOL GLYCOSIDES (addendum) 217 L
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STEVIOL GLYCOSIDES (addendum) 219 W
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222 SULFITES: ASSESSMENT OF DIETARY
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SAFETY EVALUATIONS OF GROUPS OF REL
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264 INTRODUCTION Figure 1. Procedur
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DIETARY EXPOSURE ASSESSMENT OF FLAV
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292 ALIPHATIC BRANCHED-CHAIN SATURA
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332 ALIPHATIC LINEAR ,-UNSATURATED
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ALKOXY-SUBSTITUTED ALLYLBENZENES PR
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ALKOXY-SUBSTITUTED ALLYLBENZENES 35
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FURAN-SUBSTITUTED ALIPHATIC HYDROCA
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HYDROXY- AND ALKOXY-SUBSTITUTED BEN
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MISCELLANEOUS NITROGEN-CONTAINING S
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580 SUBSTANCES STRUCTURALLY RELATED
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ANNEXES
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598 ANNEX 1 10. Specifications for
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600 ANNEX 1 No. 54, 1974; WHO Techn
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602 ANNEX 1 70. Evaluation of certa
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604 ANNEX 1 108. Toxicological eval
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606 ANNEX 1 148. Residues of some v
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608 ANNEX 1 188. Safety evaluation
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610 ANNEX 2 ECG electrocardiogram E
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612 ANNEX 2 SI stimulation index SU
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614 ANNEX 3 Ms J. Baines, Food Stan
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ANNEX 4 ACCEPTABLE DAILY INTAKES, O
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ANNEX 4 619 Food additive Specifica
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ANNEX 4 621 3. FLAVOURING AGENTS 3.
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ANNEX 4 623 Flavouring agent No. Sp
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ANNEX 4 625 Flavouring agent JECFA
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ANNEX 4 627 Actual production volum
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ANNEX 4 629 Flavouring agent No. Sp
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ANNEX 5 SUMMARY OF THE SAFETY EVALU
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ANNEX 5 633 Secondary components Co
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