Registration Dossier
Registration Dossier
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EC number: 807-422-1 | CAS number: 66918-01-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No information available on testing of effects to fertility.
A Screening study was considered, however, giving the low toxicity of the substance, its use as cosmetic and absence of structural alerts it was concluded that no study has to be performed.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
- Justification for type of information:
- the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) the substance is used for cosmetical products, therefore animal testing was critically considered and it was concluded to not perform testing in addition to available tests performed previously and (iii) based on the structure of the substance itself and likely metabolits (alkylic alcohol and Maleic acid and the ester thereof) no hints to reproductive toxic properties are present.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
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
Description of key information
No information available on testing of effects on developmental toxicity.
A Screening study was considered, however, giving the low toxicity of the substance, its use as cosmetic and absence of structural alerts it was concluded that no study has to be performed.
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
Mode of Action Analysis / Human Relevance Framework
no information available. Based on the absence of general toxic effects, no mode of action can be established.
Justification for classification or non-classification
No information based on testing for toxicity to reproduction available.
The available information is conclusive but not sufficient for classification.
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.
