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EC number: 701-116-0
CAS number: 2156592-45-7
effects on rats of both sexes after repeated dosing with2-Butenoic
acid, 4-oxo-4-(tridecylamino)-, (Z)-, branched,
as well as any effects of the test item on male and female reproductive
performance, such as gonadal function, conception, parturition and early
lactation of the offspring were investigated.
used were 0 (control), 40, 125 and 400 mg/kg/day.
male and one high dose females died during the study, the deaths being
One control female and one mid-dose
femalewere found not pregnant at necropsy.
one high dose female was sacrificed for total litter loss on Day 2 post
of females with live pups on Day 4 post partum was: 9 in each of
the control and mid-dose groups, 10 in the low dose group and 8 in the
high dose group.
muscle tone was observed in males and females of the high dose group.This
finding was considered not to be toxicologically relevant, since no
effects were seen in the functional observation battery tests,
especially in the grip strength and foot splay tests.Males
of the high dose showed a slight body weight loss during the first week
of the study, and body weights remained slightly decreased compared to
the other groups throughout the study. However, these changes were
mainly attributable to one male, which was probably mis-dosed. No
findings of toxicological significance were noted during the in-vivo phase,
both in male and female animals.
toxicologically relevant differences were found in terms of mating
performance and reproductive parameters.
significant differences were found on litter data parameters and sex
toxicologically significant changes were observed in clinical
treatment-related changes were observed both in male and female animals
at post mortem macroscopica
nd microscopic examinations and organ weight analysis.
basis of the results obtained in the study, the NOAEL (No Observed
Adverse Effect Level) for both systemic toxicity and
reproduction/developmental toxicity was considered to be 400
mg/kg/day for males and females.
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