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EC number: 224-809-5
CAS number: 4500-29-2
Four groups comprised of 10 adult males and 10 non pregnant nulliparous
female rats (Wistar Crl:WI) were dosed daily by oral gavage with 12, 30
and 75 mg/kg body weight per day of the test item at dose volume of 5
mL/kg body weight using sterile water as vehicle. Doses were selected
based on a dose-range finder study. Control animals were treated
identically with the vehicle alone. After 14 days of treatment to both
male and female, animals were paired (1:1) till the evidence of mating
in the form of sperm positive vaginal smears. Males and females were
sacrificed on treatment day 29 and post natal day 4 respectively and
subjected to necropsy.
No test item related clinical signs and mortalities were observed in
both males and females. Body weight development and food consumption was
not affected. Group mean litter weight, total litter weight as well as
male and female litter weight on post natal day 0 and 4 was unaffected.
No treatment related effect was observed on precoital interval and
duration of gestation. Pre and post natal data like group mean number of
corpora lutea, percent preimplantation loss and post implantation loss
remained unaffected due to treatment when compared with controls. No
treatment related effects were observed on reproductive indices like
coagulation index, delivery index, fertility index and viability index
and there were no effects on litter data like number of males and
females, sex ratio and still birth. Survival of pubs from post natal day
0 to 4 remained unaffected and treatment related gross external findings
were not observed.
With regard to organ weights, in males a statistical significant
decrease in absolute right testes weight in LD group and a decrease in
absolute epididymides (right, left and total weight) and relative total
epididymides weight in LD and HD group when compared with the controls
were revealed. However, since no dose relationship was established and
no histopathological changes were observed, no toxicological
significance is attributed to these findings. At necropsy of all male
and female animals, no macroscopic changes were observed and no
treatment-related histopathological findings of reproductive organs were
A detailed qualitative examination of the testes taking into account the
tubular stages of the spermatogenic cycle, revealed no abnormal
In conclusion, the repeated administration of the test item to male
animals for 28 days and female animals for a maximum of 54 days revealed
no significant toxicological findings and mortalities. Reproductive
toxic effects were not revealed. Based on the data, the no observed
adverse effect level (NOAEL) for maternal toxicity was equal or greater
75 mg/kg body weight per day. The no observed effect level (NOEL) for
reproductive toxicity was equal or greater 75 mg/kg body weight per day.
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