"VIABILITY: Viability (morbidity and mortality) checks were made twice daily

DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: detailed physical examinations were performed immediately prior to dosing [within approximately 30 minutes] and approximately 2 hours after dosing.

BODY WEIGHT: Yes - Time schedule for examinations: GD4, and once daily from GD6-20

FOOD CONSUMPTION: Yes - Time schedule for examinations: GD4-20 (2- or 3-days consumptions)

POST-MORTEM EXAMINATIONS: Yes - Sacrifice on gestation day 20 - Organs examined: A macroscopic post-mortem evaluation was performed on GD 20, during which corpora lutea, implantation data and uterine weights were recorded. In addition, liver and kidney weights were determined.

The ovaries and uteri were examined to determine: - Number of corpora lutea; - Weight of intact gravid uterus; - Location and number of implantation sites, resorptions, fetal death, dead fetuses; - Gross evaluation and weight of placentas.

The fetuses were removed, weighed (live and recently dead fetuses), sexed and examined externally for defects. Approximately half of the fetuses were examined for soft tissue abnormalities. The other half was processed for staining with Alizarin Red S and examined for skeletal abnormalities and ossication state.

Statistical analyses were performed using the individual animal (or litter) as the basic experimental unit. For litter/fetal findings, the litter was the treated experimental unit and the basis for statistical analysis and biological signicance was assessed with relevance to the severity of the anomaly and the incidence of the finding within the background control population. The following statistical methods have been used for the analysis of the results: Williams' test, Dunnett's test, Shirley's test, Steel's test, Kruskal-Wallis test, Wilcoxon rank sum tests.

Indices: Sex ratio, Pre implantation loss, Post implantation loss, Gravid uterine adjusted body weights, Mean litter placental and fetal weights"

F1 Male/Female Sprague Dawley Rat