Registration Dossier
Registration Dossier
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EC number: 939-525-3 | CAS number: 1471313-03-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study performed in compliance with GLP and OECD guideline 421 with minor deviations (Klimisch score 2).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a reproduction/developmental toxicity screening test, no impact of the substance was identified on fertility of rats exposed by gavage up to 1000 mg/kg bw/day. Therefore the NOAEL was 1000 mg/kg bw/day for reproductive toxicity.
Justification for selection of Effect on fertility via oral route:
Only one study available.
Effects on developmental toxicity
Description of key information
In a reproduction/developmental toxicity screening test, no signs of toxicity that could be attributable to the substance were identified on offspring of female rats exposed by gavage up to 1000 mg/kg bw/day from 2 weeks before mating until day 4 of lactation. Therefore the NOAEL was 1000 mg/kg bw/day for developmental toxicity.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study performed in compliance with GLP and OECD guideline 421 with minor deviations (Klimisch score 2).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
One reproduction / developmental screening study showing no adverse effect on development is available (section 7.8.1). A waiver is therefore submitted for this endpoint.
Justification for classification or non-classification
In a recent GLP reproduction / developmental toxicity screening test conducted according to OECD guideline 421, the NOAEL for the reproductive/developmental toxicity screening was established at 1000 mg/kg bw/day. No effects on reproduction parameters and on offspring were reported in this study. The substance is therefore not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
