Registration Dossier
Registration Dossier
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EC number: 951-766-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- Absolute of Dipteryx odorata (Fabaceae) obtained from beans by organic solvents treatment and subsequent ethanol extraction
- EC Number:
- 951-766-6
- Molecular formula:
- Not relevant, UVCB substance
- IUPAC Name:
- Absolute of Dipteryx odorata (Fabaceae) obtained from beans by organic solvents treatment and subsequent ethanol extraction
- Test material form:
- other: Crystal
- Details on test material:
- - Physical state: Crystal
- Storage condition of test material: room temperature (20 ± 5 °C)
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Remarks on result:
- other: not applicable
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.
No skin sensitisation study was available on the registered substance. Moreover, some of its constituents are classified as skin sensitisers Cat.1 or Cat.1B (Coumarin) and are 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 because sub-categories does not exist for the classification of the sensibilisation hazard of mixtures.
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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