Registration Dossier
Registration Dossier
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EC number: 250-528-2 | CAS number: 31242-17-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Administration of the test item by once daily oral gavage to Crl:CD(SD) Sprague Dawley rats (males for 4 weeks starting from 2 weeks prior to mating, and females from 2 weeks prior to mating continuing until at least Day 13 of lactation) was well tolerated at dose levels up to 450 mg/kg/day. Dose level-related slightly higher levels of liver enzymes were noted at up to 450 mg/kg/day, and cholesterol was slightly lower for females at 450 mg/kg/day. There were no effects on reproduction and development that were considered to be related to administration of the test item.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Read-across study is reliable without restriction.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Quality of whole database:
- Read-across study is reliable without restriction.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There were no effects on reproduction and development that were considered to be related to the source substance. Therefore in accordance to Regulation (EC) No. 1272/2008 no classification and labelling is required for reproductive and develomental toxicity.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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