Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
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
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- OECD Guideline, GLP study
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 an OECD 422, 28-day and 1-generation oral gavage screening study in rats there were no test substance-related effects on reproductive performance or effects on offspring at any concentration tested. Under the conditions of this study, the test substance was not a selective reproductive toxicant. The NOAEL for reproductive toxicity and effects on offspring was 200 mg/kg/day, the highest concentration tested.
Short description of key information:
Oral: OECD 407 and OECD 422; 28-day and 1-Gen Screen gavage, rats.
NOAEL (reproductive effects) = 200 mg/kg (highest dose tested).
Reliability = 1
Justification for selection of Effect on fertility via oral route:
OECD Guideline, GLP study
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
The test substance did not adversely affect reproductive function. The substance does not need to be classified for reproductive toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 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.
