Safety evaluation of certain food additives - ipcs inchem

44 ETHYL LAUROYL ARGINATE
in the throat reported by both subjects and nausea reported by one. The authors
concluded that the burning sensation and possibly the nausea were due not to ethyl
lauroyl arginate but to the use of propylene glycol as the solvent (CentraLabS
Clinical Research Ltd, 2005a).
In the subsequent clinical study conducted to GLP and in accordance with
OECD guidelines, the plasma profile of [ 13 C]ethyl lauroyl arginate (purity, 96% ethyl-
N -lauroyl-L-arginate HCl) was determined following administration of a single oral
dose to six healthy male volunteers (aged 18–55 years, mean 33.7 years). Two
subjects received a dose of 2.5 mg/kg bw, and the other four received a dose of
1.5 mg/kg bw, after an overnight fast followed by a standard breakfast. Blood
samples were taken from a forearm vein of each subject pre-dosing and over a
24-h period following dosing. Plasma samples were analysed for [ 13 C]ethyl
lauroyl arginate, [ 13 C]N -lauroyl-L-arginine and [ 13 C]arginine using LC-MS/MS. The
following pharmacokinetic parameters were calculated using the computer program
WinNonlin Pro version 3.3: Cmax, AUCt, k and t½.
Plasma concentrations of [ 13 C]ethyl lauroyl arginate were below the limit of
quantification (