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EC number: 214-071-2 | CAS number: 1077-28-7
None of the low- and intermediate-dosed female animals died prematurely.
One high-dosed female died prematurely on the 21st day of gestation following a rupture of the cardiac artrium. All circumstance connected with the exitus indicate that this death was spontaneous.
No substance-related effects were observed on behaviour, external appearance and faeces ind teh dams of the low and intermediate testes dose levels. 7 of 21 pregnant high-dosed animals showed a slightly reduced motility during the first 3 days of treatment.
No substance-related difference in b.w. between treated and control female animals was noted at the low- and intermediate-dose level.
The high dose caused a very marginal - though still detectable - decrease in b.w. during the gestation period (between 2 % and 4 % compared to the controls, significant at p <= 0.01 on gestation days 10, 13, 15, 16) and during the lactation period (between 7 % and 8 % compared to the controls, significant at p <= 0.01 on gestation days 7, 14).
The relative food consumption was not influenced at the low dose level.
A mild transient decrease in the relative food consumption was noted in the intermediate dose between the 18th and 21st gestation day. The difference fron the controls was minus 10 % to minus 14 % (not significant at p <= 0.01).
A mild decrease in the relative food consumption was also noted at the high dose (on 10th and between 13th and 21st gestation day, minus 7 % to minus 15 %, significant at p <= 0.01 on the 13th, 14th and 19th gestation day).
The low, intermediate and high dose did not influence the reproduction parameters of the rats. The duration of pregnancy was within the normal range, the parturition not inflienced.
Birth index, live birth index, viability index, lactation and overall survival index were similar to those of the control group at the low and the intermediate dose. However, the lactation index was marginally and significantly (at p <= 0.05) decreased at the high dose.
The number of pups born was not affecte, the pups developed normally. B.w. of pups at birth did not differ between the control and substance-treated groups.
1 stillbirth was observed at the low dose (control: 2 stillbirths). This finding is within the normal range of background data and was not attributed to the administration of the test compound.
One of the pups from a high dosed dam was malformed, it showed haematoms in the head region. This malformation was considered as spontaneous and not substance related.
Macroscopic post mortem findings:
Macroscopic inspection revealed no systemic changes connected with the treatment. the number of implants according to SALEWSKI was similar in the control and substance treated groups. A spontaneous rupture of the atrium was noted in the heart of 1 prematurely deceased high-dosed dam (the one where prematurely death was reported).
F1 -generation (until weaning)
Sex distribution: not influenced
B.w. during pre and post weaning: All values are within normal range at the low. intermediate and high dose.
External examination: Except for 1 malformation (see above) no abnormalities were observed.
Morphological landmarks, functional tests, open-field test:
The time-points for pinna detachment, upper incisor eruption, ear and eye opening, cleavage of the balanopreputilal gland and vagianl opening of the pups fren the low-, intermediate- and high-dosed dams were not influenced.
All functional tests and the open-field test revealed no subtance-related influence for the animals of low, the intermediate and the high dose.
Macroscopic post mortem findings: No substance related pathological changes were observed.
F1-dams and male F1-partners
Mortality: None of the rats died prematurely.
Clinical Signs: None of the F1-parent animals showed any changes of behaviour, external appearance and faeces.
B.w.: All values of the groups 2, 3, 4 were within the normal range
All reproduction parameters were within the range of the controls. Duration of pregnancy and the parturition were not delayed. Birth index, live birth indedex, viability index, lactation and overall survival index were similar in all groups. No influence was noted on the number of pups born, their birth weight and their development.
One malformed pup in group 4 (a tailless pup) is considered as spontaneous.
Macroscopic post mortem findings: No changes were observed.
F2-generation (until weaning)
Sex distruibution: The sex distribution was not infuenced.
Body weight during pre- and post weaning: All values were within the normal range.
External examination: abnormalities were observed.
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