Registration Dossier
Registration Dossier
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EC number: 947-393-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, 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 followed
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
Test material
- Reference substance name:
- Rectified Essential Oil of Pogostemon cablin (Lamiaceae) with high content in alpha and delta guaiene obtained from leaves by distillation.
- EC Number:
- 947-393-3
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- Rectified Essential Oil of Pogostemon cablin (Lamiaceae) with high content in alpha and delta guaiene obtained from leaves by distillation.
- Test material form:
- not specified
Constituent 1
Results and discussion
In vitro
Results
- Irritation parameter:
- other:
- Remarks on result:
- other: Eye irritation Category 2
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- A component (alpha-guaiene) is present at a content superior to 10 % and is classified H319. Thereore the substance is by default classified H319.
- 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 serious eye damage/ eye irritant hazard of the registered substance. The decision of classification as eye Damage category 2 was based on existing data on constituents (additivity principles) the registered substance has a constituent classified as Eye Damage Category 2 present at more than 10% and should be classified as a Eye damage category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
The component alpha-guaiene (EC N°641 -402 -1) is present at a content superior to 10 % and is classified H319 (IFRA elbelling manual). Thereore the substance is by default classified H319.
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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