Registration Dossier
Registration Dossier
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EC number: 944-405-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the absence of adverse effects on male and female rats, the NOAEL was determined to be 15000 mg/kg diet corresponding to an intake of at least 894 mg/kg body weight per day in females and at least 870 mg/kg body weight per day in males.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In a GLP compliant study performed according to OECD guideline 422, the possible effects of the test substance on general toxicity were examined in groups of 12 male and 12 female Wistar rats. The test substance was administered at constant concentrations in the diet at levels of 0 (control), 1500, 5000 and 15000 mg/kg diet during a premating period of 2 weeks and during mating, gestation until day 4 of lactation. These dietary levels provided an overall mean intake of at least 104, 333 and 894 mg/kg body weight per day in females of the low-, mid- and high-dose group and at least 85, 280 and 870 mg/kg body weight per day in males of the low-, mid- and high-dose group.
The content and homogeneity of the test substance in the carrier were analysed and accepted. Stability testing showed a decrease in concentration after storage of the test substance in the carrier in the freezer for more than 5 weeks and slightly lower concentrations in the mid dose group after 4 days in the animal room. There was no treatment-related mortality. Daily clinical observations did not reveal any treatment-related clinical signs. Neurobehavioral observations and motor activity assessment did not indicate any neurotoxic potential of the test substance. There were no relevant differences in body weights or food consumption during the premating period, during the post-mating period in males, or in dams during the gestation period and the lactation period.
Justification for classification or non-classification
Based on the results of the combined oral repeated dose toxicity study and reproduction/developmental toxicity screening test, the test substance does not have to be classified for repeated dose toxicity in accordance with Regulation (EC) No. 1272/2008.
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