Registration Dossier
Registration Dossier
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EC number: 283-880-0 | CAS number: 84775-50-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Coriandrum sativum, Umbelliferae.
Endpoint summary
Administrative data
Description of key information
According to ECHA Guidance on the Application of the CLP Criteria (2015), Coriander oil can be classified as skin sensitizer based on its composition (Dipentene, Geraniol, Geranyl acetate, pinene alpha, pinene beta and terpinolene) classified as skin sensitizer Cat. 1B, above the generic concentration limit of 1%).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Key result
- Parameter:
- other: Classification
- Remarks on result:
- other: Skin sensitiser category 1B
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Coriander oil obtained from seeds of Coriandrum sativum by steam distillation shall be classified as a skin sensitizer cat.1B without further testing based on calculation rules for mixtures according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.
- 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 (2015) 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 some of its constituents are classified as skin sensitisers Cat.1B (Linalol, Dipentene, geraniol, geranyl acetate, pinene alpha, pinene beta, terpinolene) and are all potentially 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. 1B without further testing according to the Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) 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 some of its constituents are classified as skin sensitisers 1B (Linalol, Dipentene, geraniol, geranyl acetate, pinene alpha, pinene beta and terpinolene) and are all 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 1B without further testing according to the Regulation (EC) No 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 classified as skin sensitiser: Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).
No information was available regarding respiratory sensitisation.
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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