Safety evaluation of certain food additives - ipcs inchem

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ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS 307 et al. [2007]). The consumption of (E,Z)-geranic acid (No. 1825) is derived predominantly from its presence in traditional foods (i.e. it has a consumption ratio 1; Table 2), whereas the consumption of prenyl acetate (No. 1827) and (E,Z)-3,7,11-trimethyldodeca-2,6,10-trienyl acetate (No. 1831) is derived predominantly from their use as flavouring agents (i.e. they have consumption ratios
308 ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS (ii) Methyl 2-methyl-2-propenoate (No. 1834) In male Wistar rats administered a single dose of methyl 2-methyl- 2-propenoate at 8 mmol/kg bw via gavage, serum concentrations of methacrylic acid reached 0.5 mmol/l within 5 min after administration and peaked at about 0.8 mmol/l between 10 and 15 min after administration. In vitro studies with rat and human serum confirmed the rapid hydrolysis of methyl 2-methyl- 2-propenoate to methacrylic acid. The hydrolysis was catalysed by non-specific carboxylesterases, and steady-state kinetic parameters indicated that hydrolysis was more efficient in rat serum than in human serum (Bereznowski, 1995). In a series of experiments, the retention and excretion of methyl 2-methyl- 2-propenoate in rats were studied. Adult male Wistar rats (three per group) were administered methyl [1,3- 14 C]methacrylate at 5.7 mg/kg bw via gavage or via intravenous injection. Two additional groups of male Wistar rats were administered methyl [2- 14 C]methacrylate at a dose of 6.8 mg/kg bw via intravenous injection (three rats) or 120 mg/kg bw via gavage (two rats). All groups of rats were housed in glass metabolism cages, and their exhaled carbon dioxide, urine and faeces were monitored for 10 days post-dosing. Regardless of the route of administration, the dose or the place of the radiolabel, 76–88% of the radiolabel was eliminated as exhaled 14 CO2, approximately 65% of which within the first 2 h after administration. Only minor amounts of radiolabel were eliminated in the urine (4.7–7.2%) and faeces (1.7–3.0%) (Bratt & Hathway, 1977). Albino rabbits housed in metabolism cages were orally administered methyl 2-methyl-2-propenoate at 3.5 ml/kg bw (equivalent to approximately 3.3 g/kg bw). In urine collected for 3 days following administration, conjugates of glucuronic acid and organic sulfates were present (Deichmann & Thomas, 1943). Blood samples from 10 individuals were incubated with 10 μg methyl 2-methyl-2-propenoate at 37 °C for 90 min. Disappearance of methyl 2-methyl- 2-propenoate from human blood followed pseudo first-order kinetics. Half-lives varied from 18 to 40 min (Corkill et al., 1976). (b) Metabolism Upon hydrolysis, the 14 esters in this group produce short-chain acids (C1–C6; saturated, branched and unbranched; and unsaturated, branched) and alcohols (mostly C1–C8, but also one C12 and one C16; saturated, branched and unbranched; and unsaturated, branched). The group further consists of branchedchain saturated and unsaturated alcohols (C12 and C16), aldehydes (C5) and acids (C5 and C8). The Committee previously reviewed data on the metabolism of linear and branched-chain saturated and unsaturated aliphatic acyclic alcohols, aldehydes, acids and related esters (Annex 1, references 132 and 138) and on some related terpenoids (Annex 1, reference 167). General aspects of their metabolism have been described (Annex 1, references 131, 137 and 166). Additional data are available on two substances in the present group of flavouring agents: (E,Z)-phytol (No. 1832) and methyl 2-methyl-2-propenoate (No. 1834).
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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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Page 263 and 264: 256 SULFITES: ASSESSMENT OF DIETARY
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Page 271 and 272: 264 INTRODUCTION Figure 1. Procedur
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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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