Safety evaluation of certain food additives - ipcs inchem

60 ETHYL LAUROYL ARGINATE
animals were similarly necropsied at weaning for macroscopic investigation and
organ weight analysis.
The general condition of F0 and F1 animals receiving diets containing ethyl
lauroyl arginate was similar to that of controls. Mortality occurred in three F0 and
three F1 animals: in the F0 generation, one male at 2500 mg/kg diet and one female
at 15 000 mg/kg diet were killed for animal welfare reasons; and one male at
15 000 mg/kg diet was found dead (histopathological examination revealed a
malignant nephroblastoma). In the F1 generation, one male receiving 15 000 mg/kg
diet was killed for humane reasons; and two females, one from each of the 2500
and 15 000 mg/kg diet groups, were killed for reasons of animal welfare after their
offspring were weaned. All of these deaths were considered by the authors not to
be related to treatment. Overall, body weight and body weight gain of the F0 males
were not affected by treatment. Body weight gain for F0 treated females was
significantly greater during gestation (by between 9% and 19%) than that of the
concurrent control; however, body weight gain during lactation returned to a level
similar to that of controls. At 15 000 mg/kg diet, body weight gain of F1 animals was
reduced from day 14 of age as animals established independent feeding. Overall,
body weight change of F1 males up to termination was not affected by treatment;
however, body weight gain of F1 females remained lower than that of controls until
lactation, when the difference was reversed and treated animals gained more body
weight than controls. Food consumption and food conversion efficiency were
unaffected by treatment in both F0 and F1 animals.
There were no effects of treatment in either the F0 or F1 generation on
premating estrous cycles, mating performance, fertility or gestation length. Sexual
maturation of the F1 generation was unaffected by treatment in males; in females,
vaginal opening was significantly delayed by 4 days in the group receiving ethyl
lauroyl arginate at 15 000 mg/kg in the diet. This finding was considered by the
authors to be related to treatment; there was no effect on vaginal opening of females
in the 6000 or 2500 mg/kg diet groups. F1 litter size, survival and sex ratio were
unaffected by ethyl lauroyl arginate treatment. The physical development of F1 litters
was comparable in all groups and not affected by treatment.
Terminal investigations of F0 and F1 adult animals showed no effects on pretermination
estrous cycles or on sperm assessment. Macroscopic examination of
F0 and F1 adults did not reveal any changes attributable to treatment, nor were there
any microscopic findings. Organ weights for F0 males were unaffected by treatment;
however, F0 females showed significantly reduced relative weights for the spleen
(15 000 mg/kg diet) and ovaries (2500 and 15 000 mg/kg diet) when compared with
controls. This was considered by the authors not to be toxicologically significant, as
there was no dose-dependent trend, and the relative weight differences were small
(within 10% of control). Reduced organ weights were observed in F1 offspring
(weanlings) at 15 000 mg/kg diet (absolute and relative spleen and thymus weights)
and at 6000 mg/kg diet (relative thymus weight). However, there were no conclusive
effects of treatment on organ weights of F1 adults. Necropsy of F1 offspring showed
no treatment-related changes.