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EC number: 931-597-4
CAS number: -
Mixed Ash, when administered daily by oral gavage to pregnant Hannover Wistar rats from gestation days GD6 to GD19 at 1000 mg/kg bw/day induced no maternal systemic toxicity and no effect on body weight or growth in a GLP-compliant OECD 414 Prenatal Developmental Toxicity test. No effect on the embryotoxicity and foetotoxicity was observed (number of foetuses with retarded body weight and malformations) in the study based on overall development. No mortality occurred during the study.
All test item formulations were within the range of 98-108% of nominal concentration and were found to be homogenous. No test item was detected in the vehicle control samples.
In the higher dose group, some symptoms were present. Noisy respiration was observed in 1 out of 20 and 1 out of 24 animals in the Mid and High dose group. The finding appeared from Day 12 until Day 19, the symptom occurred for a maximum of eight days.
Piloerection was present in 1 out of 24 animals in the High group. The finding appeared from Day 12 until Day 19, the symptom occurred for a maximum of eight days. Red discharge around right eye was observed in 1 out of 24 animals.
No test item related body weight effects were observed in any of the dose groups. No changes in the food consumption in any of the dose groups was observed during the treatment period. No test item related macroscopic and microscopic findings were present at necropsy in the surviving animals.
There were no statistically significant changes in the concentration of the T3, T4 and TSH level between the Control and the Dose groups. There were no statistical differences in the organ weights between the control and the Dose groups. There were no statistically significant differences in the intra-uterine parameters in the test item treated animals when compared to the controls. There was no toxicologically significant difference in the foetal weights of either sex of foetuses, sex distribution or on anogenital distance between the control and treatment groups. There were no adverse test item related effects on external, visceral or skeletal development of foetuses in the study.
Foetal malformations observed in the study were all considered to be incidental. They showed no dose dependency and thus were not regarded as a test item related effect.
The following no-observed-adverse-effect (NOAEL) levels were derived:
NOAELmaternal toxicity: 1000 mg/kg bw/day
Based on no maternal systemic effects at 1000 mg/kg bw/day.
NOAELembryotoxicity: 1000 mg/kg bw/day
Based on the lack of any test-item related intra-uterine effect in any treatment group.
NOAELfoetotoxicity: 1000 mg/kg bw/day
Based on no effect on runts at 1000 mg/kg bw/day.
NOAELteratogenecity: 1000 mg/kg bw/day
Based on the lack of treatment related malformations in any dose group.
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