Safety evaluation of certain food additives - ipcs inchem

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MISCELLANEOUS NITROGEN-CONTAINING SUBSTANCES (addendum) 565 Table 3. Results of short-term toxicity studies with miscellaneous nitrogencontaining substances used as flavouring agents No. Flavouring agent 1561 Butyl isothiocyanate 1562 Benzyl isothiocyanate 1562 Benzyl isothiocyanate 1562 Benzyl isothiocyanate 1563 Phenethyl isothiocyanate 1563 Phenethyl isothiocyanate 1563 Phenethyl isothiocyanate 1563 Phenethyl isothiocyanate 1563 Phenethyl isothiocyanate 1885 Ethyl isothiocyanate Species; sex No. of test groups a / no. per group b Route Duration (days) NOAEL (mg/kg bw per day) c References Rat; M 8/5 Diet 14
566 MISCELLANEOUS NITROGEN-CONTAINING SUBSTANCES (addendum) kidneys and liver were removed at necropsy. The thickness of the urinary bladder epithelium increased with treatment in both sexes of each group and was more prominent in males than in females. In general, bladder inflammation peaked on day 2 or 3 and consisted of neutrophil infiltration, cytoplasmic vacuolation, necrosis and haemorrhage. On day 7, slight bladder epithelial hyperplasia was reported. There were no noteworthy changes in the ureter, kidney or liver (Akagi et al., 2003). In another series of experiments, 12 groups of male rats were fed benzyl isothiocyanate, phenethyl isothiocyanate or 10 other structurally related substances at levels calculated to provide an estimated daily intake of 80 mg/kg bw in each group for 14 days. Urine samples were collected on days 0 (controls only), 1 and 14. At necropsy on day 14, urinary bladders, ureters, kidneys and liver were examined. Urinary analysis for all treated groups except the ethyl isothiocyanate (No. 1885) group resulted in pH and electrolyte changes as reported in the previous experiment. Treatment with phenethyl isothiocyanate produced epithelial hyperplasia and an increased incidence of papillary or nodular hyperplasia, whereas phenyl isothiocyanate and butyl isothiocyanate (No. 1561) produced hyperplasia at a much greater incidence (>80%). There were no noteworthy changes in the other organs examined (Akagi et al., 2003). As part of a study to evaluate the tumour-promoting activity of isothiocyanates in rats pretreated with diethylnitrosamine and N-butyl-N- (4-hydroxybutyl)nitrosamine, groups of male rats (six per group) were maintained on 0.1% diets (equivalent to 100 mg/kg bw per day) of benzyl isothiocyanate or phenethyl isothiocyanate for 32 weeks. Weekly measurement of body weight and food consumption revealed no significant differences between test and control groups. At necropsy, liver, kidneys and urinary bladder were excised, and liver and kidney weights were recorded. Relative liver weight was significantly (P < 0.001) increased for both test substances, and relative kidney weight was increased (P < 0.01) for the phenethyl isothiocyanate group. Histopathological evaluation of the urinary bladder revealed epithelial hyperplasia in all animals in the benzyl isothiocyanate and phenethyl isothiocyanate groups. One animal in both the benzyl isothiocyanate and phenethyl isothiocyanate groups was reported to exhibit papillomas, and two animals in the phenethyl isothiocyanate group exhibited carcinomas. These results are consistent with those reported for rats exposed to high concentrations of other irritant isothiocyanates, such as allyl isothiocyanate (Annex 1, reference 177). There was no increase in the incidence of foci (>0.5 mm), adenomas or carcinomas in the livers of benzyl isothiocyanate– or phenethyl isothiocyanate–treated rats (Hirose et al., 1998). In a subsequent study at the same laboratory, groups of male F344 rats were maintained on a basal diet or diets containing 0.1% (100 mg/kg bw per day) of phenethyl isothiocyanate for either 32 or 48 weeks. The 32-week group was then maintained on a basal diet for an additional 1, 3 or 7 days or 16 weeks prior to sacrifice. All animals were given an intraperitoneal injection of a 100 mg/kg bw dose of 5-bromo-2-deoxyuridine 1 h before sacrifice. Biweekly measurement of body weight and food consumption revealed decreased weight gain (6–8%) after 32 weeks, which slightly recovered in rats returning to a basal diet. At necropsy, liver, kidneys and urinary bladder were removed and weighed. Relative bladder weights
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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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16 CALCIUM LIGNOSULFONATE (40-65) 1
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18 CALCIUM LIGNOSULFONATE (40-65) ~
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20 CALCIUM LIGNOSULFONATE (40-65) A
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22 CALCIUM LIGNOSULFONATE (40-65) c
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24 CALCIUM LIGNOSULFONATE (40-65) T
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28 CALCIUM LIGNOSULFONATE (40-65) i
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ETHYL LAUROYL ARGINATE First draft
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ETHYL LAUROYL ARGINATE 41 and Devel
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ETHYL LAUROYL ARGINATE 43 lauroyl a
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ETHYL LAUROYL ARGINATE 45 arginine.
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ETHYL LAUROYL ARGINATE 47 resulting
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ETHYL LAUROYL ARGINATE 49 Table 4.
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ETHYL LAUROYL ARGINATE 51 weight ch
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ETHYL LAUROYL ARGINATE 53 stomach l
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ETHYL LAUROYL ARGINATE 55 fibrosis
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ETHYL LAUROYL ARGINATE 57 Table 5 (
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ETHYL LAUROYL ARGINATE 59 first 4 d
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ETHYL LAUROYL ARGINATE 61 The gener
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ETHYL LAUROYL ARGINATE 63 treatment
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ETHYL LAUROYL ARGINATE 65 gestation
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ETHYL LAUROYL ARGINATE 67 Body weig
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ETHYL LAUROYL ARGINATE 69 Table 6.
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ETHYL LAUROYL ARGINATE 77 About 99%
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ETHYL LAUROYL ARGINATE 79 concentra
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ETHYL LAUROYL ARGINATE 81 theoretic
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ETHYL LAUROYL ARGINATE 83 Huntingdo
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PAPRIKA EXTRACT First draft prepare
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PAPRIKA EXTRACT 87 of capsanthin ra
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PAPRIKA EXTRACT 89 biochemical para
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PAPRIKA EXTRACT 91 Table 1. Sales o
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PAPRIKA EXTRACT 93 Table 2. Estimat
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PAPRIKA EXTRACT 95 The European Sci
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PAPRIKA EXTRACT 97 The potential di
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PAPRIKA EXTRACT 99 Hornero-Mendez,
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PAPRIKA EXTRACT 101 Appendix 1. Res
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PAPRIKA EXTRACT 103 Appendix 1. (co
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PAPRIKA EXTRACT 105 Appendix 1. (co
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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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Page 522 and 523: FURAN-SUBSTITUTED ALIPHATIC HYDROCA
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Page 587 and 588: 580 SUBSTANCES STRUCTURALLY RELATED
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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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