Registration Dossier
Registration Dossier
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EC number: 268-638-4 | CAS number: 68132-46-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Under the conditions of the study, the NOAEL for reproductive toxicity was determined to be 9000 mg/kg/day for females and 8000 mg/kg/day for males.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 8 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The reproductive toxicity of the test material was investigated in a 2-generation reproductive toxicity study with Sprague-Dawley rats. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
During the study fifteen male and thirty female rats per group at 80 days of age were placed on diet at test material concentrations of 5 and 10%, alongside a negative control plain diet and a negative control of oleic acid at 5 and 10%. All animals were mated within each group at 100 days of age (F0 generation). The offspring were weaned onto the corresponding diet. Twenty male and 20 female rats from each group (with the members of each sex coming from a different dam) were selected shortly after weaning and were carried to sexual maturity. The F0 parents and all remaining offspring were subsequently destroyed. At 100 days of age the F1 animals were mated and parameters were recorded.
The test material doses received via the 5 % diet were calculated to be 4500 (female) and 4000 (male) mg/kg/day (5% equates to 50,000 mg/kg diet, multiplied by 0.09 for females and 0.08 for males using the EFSA guidance to give a dose of 4,500 or 4000 mg/kg/day, respectively) and at 10% diet were 9000 (female) and 8000 (male) mg/kg/day.
There were no test material related findings observed in any of the measured parameters or indices determined in the study.
Under the conditions of the study, the NOAEL for reproductive toxicity was determined to be 9000 mg/kg/day for females and 8000 mg/kg/day for males.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to reproductive toxicity.
Additional information
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