Registration Dossier
Registration Dossier
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EC number: 947-264-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, 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
Data source
Reference
- Reference Type:
- other: Guidance
- Title:
- Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
- Author:
- ECHA
- Year:
- 2 017
- Bibliographic source:
- ECHA-17-G-21-EN
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
Test material
- Reference substance name:
- Essential oil of Myroxylon balsamum var. pereirae (Fabaceae) obtained from the exudate by dry distillation
- EC Number:
- 947-264-1
- IUPAC Name:
- Essential oil of Myroxylon balsamum var. pereirae (Fabaceae) obtained from the exudate by dry distillation
- Test material form:
- liquid
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Classification
- Remarks on result:
- other: Skin sensitiser category 1
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- 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 skin sensitising 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 skin sensitiser Cat.1B (Benzyl cinnamate) and is present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.
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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