Registration Dossier
Registration Dossier
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EC number: 946-638-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Not mutagenic based on classified constituents
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro, other
- Remarks:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Key result
- Species / strain:
- other: not relevant
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not relevant
- Executive summary:
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the mutagenic potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as mutagenic Cat. 2 (methyl eugenol) and strictly present below the CLP generic concentration limit of 1% that triggers classification of the mixture. As none of the other constituents of the registered substance are classified for mutagenicity, the registered substance is not classified for mutagenicity, without further testing according to the Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the mutagenic potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as mutagenic Cat. 2 (methyl eugenol) and strictly present below the CLP generic concentration limit of 1% that triggers classification of the mixture. As none of the other constituents of the registered substance are classified for mutagenicity, the registered substance is not classified for mutagenicity, without further testing according to the Regulation (EC) No 1272/2008.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, the registered substance is not classified for mutagenicity according to the Regulation (EC) No. 1272/2008 (CLP).
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.
