Safety evaluation of certain food additives - ipcs inchem

MISCELLANEOUS NITROGEN-CONTAINING SUBSTANCES (addendum) 561
12 mg/kg bw per day in 2-year studies in rats and mice, which provides a margin of
safety of 480 in relation to the estimated level of intake. The overall evaluation of
the data indicates that combined intake would not raise safety concerns.
1.6 Consideration of secondary components
No flavouring agents in this group have minimum assay values of less
than 95%.
1.7 Conclusion
In the previous evaluation of substances in this group, studies of acute
toxicity, short-term and long-term studies of toxicity and studies of genotoxicity were
available. None raised safety concerns. The toxicity data available for this
evaluation supported those from the previous evaluation.
The Committee concluded that these 14 flavouring agents, which are
additions to the group of miscellaneous nitrogen-containing substances evaluated
previously, do not give rise to safety concerns at the current estimated levels of
intake.
2. RELEVANT BACKGROUND INFORMATION
2.1 Explanation
This monograph summarizes the additional key data relevant to the
safety evaluation of the group of 14 miscellaneous nitrogen-containing substances
that includes 11 alkyl isothiocyanates (Nos 1884–1891 and 1893–1895) and 3
mercapto-isothiocyanates (Nos 1892, 1896 and 1897).
2.2 Additional considerations on intake
There is no additional information on intake.
2.3 Biological data
2.3.1 Biochemical data: absorption, distribution, metabolism and excretion
(a) Oxazoles, oxazolines, pyrimidines and pyrazoles
There has been no additional information on the absorption, distribution,
metabolism or excretion of these flavouring agents since the preparation of the
original monograph (Annex 1, reference 177).
(b) Isothiocyanates
(i) Absorption, distribution and excretion
Data on the absorption, distribution and excretion of isothiocyanates indicate
that these flavouring agents are rapidly absorbed, metabolized and excreted in