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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
42 mg/kg bw/day
Additional information

 Endpoint  Generation  Sex  Effect level
 NOAEL  F1a  male  39 mg/kg bw(day actual dose recived)
 NOAEL  F1a  female   46 mg/kg bw(day actual dose recive

Short description of key information:
GUIDELINE FOLLOWED (U.S.F.D.A Guidelines (1966))
F0 group consisted of 10 males and 20 females cohabited for 14 days. F1a group was discarded and the F0 group remated. Twenty to 24 apparently normal offspring (F1b) of each sex were randomly selected in approx. equal numbers from each group and mated 1 / 1 with rats from the same group.The same procedure was followed with the F2 group. The F3b group was sacrificed after weaning and the overt physical and reproductive parameters called for in the FDA Guideline were evaluated. The results are shown in the tables on the pages 4 and5. As usual, rats in each cage were examined daily.

Effects on developmental toxicity

Description of key information
Sexually mature virgin females were mated with experienced young adult male rats. The dams' F1c litter was used for this study. The dams were placed on test or control diets for gestation days 6-15, incl., and were sacrificed (CO2 inhalation) on gestation day 20.
Effect on developmental toxicity: via oral route
Dose descriptor:
6.4 mg/kg bw/day
Additional information

The weights of the high-dose females at termination and their weight changes (excluding the uterus and contents) were significantly less than those of the control group and less than those of the two groups tested at lower doses, as indicated in the summary table above. In addition, their liver weights were significantly increased relative to their corrected body weight and increased relative to those of the two lower dose test groups. Diaphragmatic hernias occurred only in the high dose group and were believed, by the investigators, to be due to the test material. Their incidence was not significant (two-sample rank test), but they occurred in 4 / 19 of the high dose litters from this study. The incidences of unossified and incompletely ossified hyoid bones also were significantly increased compared to the controls and were increased compared to the two lower dose test groups. However, sternabrae, centra, and skull bones were not similarly affected.

Justification for classification or non-classification

Additional information