Registration Dossier
Registration Dossier
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EC number: 232-391-0 | CAS number: 8013-07-8
Endpoint summary
Administrative data
Description of key information
A combined repeated dose toxicity with the reproduction/developmental toxicity screening test was carried out on rats according to OECD test guideline 422. A combined chronic toxicity/carcinogenicity study was carried out according to OECD test guideline 453.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
In parent animals:
No mortalities were observed. No test-item related effects were seen. Neither food consumption nor body weight development were affected at any dosage. There were no treatment-related effects on reproductive endpoints. The assessment of clinical chemistry and haematology parameters indicated no differences between animals treated with the test item and vehicle controls. During necropsy no test item-treated findings were noted. For males treated at 300 and 1000 mg/kg/day, mean absolute and relative liver weights were dose-dependently increased. At necropsy liver- minimal hepatocellular hypertrophy in animals treated at 1000 mg/kg/day. This change was considered to represent an adaptive reaction most likely induced by an increased biotransformation of the test item. Therefore, it was not assessed as an adverse effect. Thyroid- Increased incidence of minimal follicular cell hypertrophy in animals treated at 1000 mg/kg/day. No test item- related histopathological findings were noted in the reproductive organs of either sex. In particular, the assessment of the integrity of the spermatogenetic cycle did not reveal any evidence of impaired spermatogenesis.
Litter Data:
No test item-related abnormal findings were noted for pups at first litter check or during the first 4 days post partum. Sex ratios at first litter check and on day 4 post partum were unaffected by treatment with the test item.
Mean pup weights on day 0 and day 1 post partum were unaffected by treatment with the test item. Mean pup weight development during the first 4 days post partum was unaffected by treatment with the test item. No test item-related macroscopic findings were noted during necropsy of F1 pups.
Justification for classification or non-classification
According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.
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