Registration Dossier
Registration Dossier
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EC number: 290-163-6 | CAS number: 90082-72-7
Endpoint summary
Administrative data
Description of key information
- Skin irritation/corrosion: irritating, based on additivity principles.
- Eye irritation: irritating, based on additivity principles.
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 compound 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 and should be classified as a skin irritant cat.2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Constituent
Cas
Classification according to the Regulation (EC) No. 1272/2008 (CLP)
Source
Pinene alpha
80-56-8
Skin Irrit. 2 - H315
ECHA C&L inventory–self classification
Pinene Beta
127-91-3
Skin Irrit. 2 - H315
ECHA C&L inventory–self classification
Carene delta-3
13466-78-9
Skin Irrit. 2 - H315
ECHA C&L inventory–self classification
Phellandren beta
555-10-2
NC
ECHA C&L inventory–self classification
Limonene
138-86-3
Skin Irrit. 2 - H315
ECHA C&L inventory–self classification
Source: ECHA disseminated dossiers or self classification
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 irritation category 2
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Executive summary:
The mixture 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 irritant to the eyes 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 and should be classified as a Eye irritant Category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Constituent
Cas
Classification according to the Regulation (EC) No. 1272/2008 (CLP)
Source
Pinene alpha
80-56-8
NC
ECHA C&L inventory–self classification
Pinene Beta
127-91-3
NC
ECHA C&L inventory–self classification
Carene delta-3
13466-78-9
NC
ECHA C&L inventory–self classification
Myrcene beta
123-35-3
Eye Irrit. 2 – H319
ECHA C&L inventory–self classification
Camphene
79-92-5
Eye Irrit. 2 – H319
ECHA C&L inventory–self classification
Limonene
138-86-3
NC
ECHA C&L inventory–self classification
Source: ECHA disseminated dossiersor self classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test material 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 and eye irritation hazard of Pine dwarf oil.
Skin irritation/corrosion:
Pine dwarf oil has not been tested itself, but there are sufficient data on its individual ingredients to adequately characterize the hazard of the mixture. Additivity principles were therefore applied:
- all Pine dwarf oils having equal or more than 10% of their constituents classified as Skin irritant Category 2 should be classified as skin irritant without further testing according to the Regulation (EC) No 1272/2008.
Eye irritation:
Pine dwarf oil has not been tested itself, but there are sufficient data on its individual ingredients to adequately characterize the hazard of the mixture. Additivity principles were therefore applied:
- all Pine dwarf oils having equal or more than 10% of their constituents classified as Eye irritant Category 2 should be classified as eye irritant without further testing according to the Regulation (EC) No 1272/2008.
Constituent |
Cas |
Skin irritation /Classification according to the Regulation (EC) No. 1272/2008 (CLP) |
Eye irritation/Classification according to the Regulation (EC) No. 1272/2008 (CLP) |
Source |
Pinene alpha |
80-56-8 |
Skin Irrit. 2 - H315 |
NC |
ECHA C&L inventory–self classification |
Pinene Beta |
127-91-3 |
Skin Irrit. 2 - H315 |
NC |
ECHA C&L inventory–self classification |
Carene delta-3 |
13466-78-9 |
Skin Irrit. 2 - H315 |
NC |
ECHA C&L inventory–self classification |
Myrcene beta |
123-35-3 |
Skin Irrit. 2 - H315 |
Eye Irrit. 2 – H319 |
ECHA C&L inventory–self classification |
Camphene |
79-92-5 |
NC |
Eye Irrit. 2 – H319 |
ECHA C&L inventory–self classification |
Limonene |
138-86-3 |
Skin Irrit. 2 - H315 |
NC |
ECHA C&L inventory–self classification |
Justification for classification or non-classification
Harmonized classification:
Pine dwarf oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Pine dwarf oil is classified as skin irritant:
- Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Based on the typical composition provided by the Lead Registrant, Pine dwarf oil is also classified as eye irrit. cat. 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- 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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