Safety evaluation of certain food additives - ipcs inchem

ETHYL LAUROYL ARGINATE 67
Body weight gain of animals receiving 1000 mg/kg bw per day was
significantly lower than that of the controls throughout treatment (45% of that of
controls). Food consumption in this treatment group was significantly lower in the
2nd week of treatment (days 13–19 of gestation, 79% of that of controls). These
effects were considered by the authors to be treatment related. Body weight gains
and food consumption of animals receiving 100 and 300 mg/kg bw per day were
similar to those of controls. There were no treatment-related effects upon the dam
or litter survival or on fetal or placental weight. There was a low incidence of fetal
anomalies in all groups, which were not related to treatment. The authors concluded
that 300 mg ethyl lauroyl arginate/kg bw per day (equal to 207 mg ethyl-N -lauroyl-
L-arginate HCl/kg bw per day) was the NOAEL for the dam, based on effects on
maternal body weight gain and food intake. The NOAEL for the fetus was concluded
to be 1000 mg ethyl lauroyl arginate/kg bw per day (equal to 691 mg ethyl-N -lauroyl-
L-arginate HCl/kg bw per day), based on no adverse effects upon survival and
development up to the maximum dose tested (Huntingdon Life Sciences Ltd, 1998f).
2.3 Observations in humans
Three adverse events were reported by two of six subjects in a
pharmacokinetic study reported in section 2.1.1. One subject at 2.5 mg/kg bw
reported headache, and one subject at 1.5 mg/kg bw reported diarrhoea and
flatulence. Both events were considered to be mild in nature, and the authors
concluded that these events were unlikely to be related to treatment. There were
no clinically significant changes in the clinical parameters assessed (CentraLabS
Clinical Research Ltd, 2005b).
3. DIETARY EXPOSURE
3.1 Introduction
The Committee has not previously evaluated the dietary exposure to ethyl
lauroyl arginate. Ethyl lauroyl arginate is used as a preservative to protect food
against microbial contamination and spoilage. The active ingredient responsible for
the preservative action is ethyl-N-lauroyl-L-arginate HCl, which is present in the
article of commerce at a level in the range 85–95%. The Committee noted that use
levels based on the active ingredient are approximately 15% lower than those based
on the article of commerce (i.e. the use level for the article of commerce is “up to
225 mg/kg” compared with “up to 200 mg/kg” for the active ingredient).
3.2 Use in foods
Ethyl lauroyl arginate is used in the food categories listed in Table 6, at the
levels indicated therein.