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EC number: 923-908-7 | CAS number: 1187204-08-5
Number of females paired
Number of females mated
Number of females,which were not pregnant (A)
Number of females which reared their pups until day 4 post partum
(A) Female nos. 67 and 73 were not pregnant
The purpose of this study was to generate preliminary information concerning the effects of LCE08129 on the possible health hazards likely to arise from repeated exposure over a relatively limited period of time. In addition it provides information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition.
LCE08129 was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.
The following dose levels were applied:
Group 1: 0 mg/kg body weight/day (control group)
Group 2: 100 mg/kg body weight/day
Group 3: 300 mg/kg body weight/day
Group 4: 1000 mg/kg body weight/day
A standard dose volume of 5 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (olive oil).
The following results were obtained:
All animals survived until the scheduled necropsy.
In group 3 and 4, all animals pushed their head through the bedding material and showed salivation after application during the whole treatment period. These findings were considered to be a sign of discomfort but not a toxic effect.
In group 4 males, mean food consumption and mean body weight gain were slightly reduced after treatment start. Mean body weights were similar to the control group. This transient reduction was considered to be test item-related but not adverse.
In group 2 and 3 males, mean food consumption, mean body weight gain and mean body weights were not affected by treatment with the test item.
In females, mean food consumption, mean body weight gain and mean body weights were not affected by treatment with the test item.
None of the parameters under investigation during the functional observational battery (appearance, behavior in the open field, grip strength, landing food splay, body temperature) and the locomotor activity measurements gave an indication of a test item-related effect.
No test item-related effects were noted from the clinical laboratory investigations.
All pairs mated. No effects were noted in the reproduction and breeding data.
No test item-related findings were noted on organ weights or organ weight ratios in any group.
No test item-related macroscopical or histopathological findings were observed.
The mean number of pups at first litter check was not affected by the treatment with the test item. No abnormal pup was noted at any dose level during external examinations.
Pup weights were not affected by treatment with the test item.
No abnormal findings were noted during macroscopical examination of the pups.
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