Registration Dossier
Registration Dossier
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EC number: 283-291-9 | CAS number: 84604-14-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Rosmarinus officinalis, Labiatae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, 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:
- 2 (reliable with restrictions)
- 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:
- Rosemary, ext.
- EC Number:
- 283-291-9
- EC Name:
- Rosemary, ext.
- Cas Number:
- 84604-14-8
- Molecular formula:
- Not applicable for UVCB substance
- IUPAC Name:
- Essential oil of Rosmarinus officinalis L. (Lamiaceae) obtained from leaves, flowers and twigs by steam distillation
- Test material form:
- liquid
1
Results and discussion
In vivo
Results
- Irritation parameter:
- other: classification
- Remarks on result:
- other: skin irritant category 2
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irrit. 2, H315
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- The substance has more than 10% of constituents classified as Skin irritant Category 2 and should be classified as a skin irritant.
- 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 irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of 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.
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.
