Safety evaluation of certain food additives - ipcs inchem

ETHYL LAUROYL ARGINATE 49
Table 4. Acute toxicity of ethyl lauroyl arginate and associated formulations
Formulation Species Sex Route LD50
(mg/kg bw)
Ethyl lauroyl arginate
(90.1% active
ingredient a )
Ethyl lauroyl arginate
(90.1% active
ingredient)
Rat Male and
female
Rat Male and
female
Formulation b Rat Male and
female
N -Lauroyl-Larginine
(purity
98.6%)
Rat Male and
female
Reference
Oral >2000 Huntingdon Life
Sciences Ltd (2000a)
Dermal >2000 Huntingdon Life
Sciences Ltd
(2000b)
Oral >2000 Huntingdon
Research Centre Ltd
(1995a)
Oral >2000 Cidasal (2003a)
LD50, median lethal dose.
a Active ingredient: ethyl-N -lauroyl-L-arginate HCl.
b Formulation: 19.5% ethyl-N -lauroyl-L-arginate HCl, 73% propylene glycol; LD50 based on
the weight of the formulation.
collected for weight measurement and retained for possible histopathological
examination.
There were no deaths. Body weight gain, food consumption and food
conversion efficiencies were reduced in a dose-dependent manner in all treated
animals during week 1, particularly in high-dose animals. During the remaining
period (weeks 2–4), body weight gain and food conversion efficiencies were similar
to or greater than those of the controls, although food consumption remained low
for treated animals. Haematological investigations just before necropsy revealed
marginal differences from controls in females receiving 50 000 mg/kg diet; these
changes comprised slightly higher haemoglobin concentration and mean cell
haemoglobin and volume. Blood chemistry findings indicated slight effects in the
liver, comprising lower total protein, albumin and calcium concentrations for males
receiving 37 500 and 50 000 mg/kg diet. Females receiving 50 000 mg/kg diet had
higher blood enzyme activities (alkaline phosphatase, alanine aminotransferase
and aspartate aminotransferase). Females receiving 37 500 mg/kg diet had slightly
higher aspartate aminotransferase and alanine aminotransferase activities. Liver
weights and macroscopic appearance did not differ from those of controls. Analysis
of other organ weights and macroscopic examination did not reveal any findings
related to treatment. The highest dietary concentration of 50 000 mg ethyl lauroyl
arginate/kg was considered acceptable for the subsequent 13-week study
(Huntingdon Life Sciences Ltd, 2000c).
In the 13-week study, groups of 20 male and 20 female Han Wistar rats were
administered ethyl lauroyl arginate (purity, 90.1% and 93.2% ethyl-N -lauroyl-Larginate
HCl [two batches]) in the diet at concentrations of 0, 5000, 15 000 or