Registration Dossier
Registration Dossier
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EC number: 289-621-8 | CAS number: 89957-99-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Boswellia papyrifera, Burseraceae.
Endpoint summary
Administrative data
Description of key information
- Skin irritation/corrosion: irritating, based on the rules of the CLP Regulation for classification of mixtures
- Eye irritation: irritating, based on the rules of the CLP Regulation for classification of mixtures
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- 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
- Irritation parameter:
- other: classification
- Remarks on result:
- other: skin irritant category 2
- Interpretation of results:
- Category 2 (irritant) 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 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 its constituents classified as Skin irritant Category 2 (alpha-pinene, limonene, beta-ocimene, linalool and geraniol) and no constituent is classified as skin corrosive 1; therefore, it should be classified as a skin irritant according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Irritation parameter:
- other: classification
- Remarks on result:
- other: eye iritant category 2
- Interpretation of results:
- Category 2 (irritating to eyes) 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 eye irritation hazard of the registered substance. The decision of classification as eye irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as eye irritant Category 2 (n-octanol, beta-ocimene, linalool and camphene) and one constituent classified as severe eye irritant category 1 (H318) (geraniol) potentially up to 1.5 %; therefore, it should be classified for eye irritation Category 2 (H319) according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
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 its constituents classified as Skin irritant Category 2 (alpha-pinene, limonene, beta-ocimene, linalool and geraniol) and no constituent is classified as skin corrosive 1; therefore, it should be classified as a skin irritant according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Eye irritation:
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 eye irritation hazard of the registered substance. The decision of classification as eye irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as eye irritant Category 2 (n-octanol, beta-ocimene, linalool and camphene) and one constituent classified as severe eye irritant category 1 (H318) (geraniol) potentially up to 1.5 %; therefore, it should be classified for eye irritation Category 2 (H319) according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
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 available information and typical composition provided by the Lead Registrant, the registered substance is classified as Skin Irritant Category 2 (H315: Causes skin irritation) and Eye irritant Category 2 (H319: Causes serious eye irritation) according to the rules for classification of mixtures of Regulation (EC) No. 1272/2008 (CLP).
No information was available regarding respiratory irritation.
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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