Registration Dossier
Registration Dossier
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EC number: 208-655-6 | CAS number: 537-01-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The test item, Cerium carbonate, was administered daily by oral gavage to male and female Sprague-Dawley rats, for 2 weeks before mating, during mating, gestation and until day 5post-partum, at dose-levels of 150, 450 or 1000 mg/kg/day.
There were no adverse effects of treatment at any dose-level on mortality, clinical signs, body weight or food consumption. Animals treated at 1000 mg/kg/day had lower white blood cell counts and females in this group had lower chloride concentration and higher glucose, potassium, inorganic phosphorus and urea levels.
There were no effects in any group on mating, fertility or delivery and no treatment-related effects on the mean numbers ofcorpora lutea, implantations or pups. There were no effects on mean pup body weight, survival or sex. There were no treatment-related organ weights and macroscopic changes in rats treated at 1000 mg/kg/day. At 450 or 150 mg/kg/day, there were no treatment-related organ weights and macroscopic changes.
There were microscopic treatment related findings in the stomach that consisted of increased incidence and/or severity of submucosal eosinophil infiltration and pyloric gland hyperplasia in rats from both sexes treated at 1000 mg/kg/day and males at 450 mg/kg/kg. However, the microscopic findings in the stomach were likely to be related to portal-of-entry irritating effects, due to the high concentrations of the substance given as a bolus by gavage.
No microscopic treatment related changes were observed in the testes and ovaries.
Based on the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 450 mg/kg/day in female and male rats based on systemic effect. The NOEL for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day.
Short description of key information:
NOAEL for reproductive performance (mating and fertility): 1000 mg/kg/day
Effects on developmental toxicity
Description of key information
NOAEL on progeny: 1000 mg/kg/day
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
see above
Justification for classification or non-classification
As no adverse effects on fertility and on progeny were observed for concentrations up to 1000 mg/kg bw, no classification is required according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
Additional information
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