Registration Dossier
Registration Dossier
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EC number: 951-397-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
- Skin Corrosion/ irritation : irritating based on the rules of the CLP Regulation for classification of mixtures
- Serious eye damage/ eye irritant: Eye damage category 2, 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:
- 2 (reliable with restrictions)
- 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 / corrosion parameter:
- other: classification
- Remarks on result:
- other: skin irritant category 2
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance is to be classified as Skin irritant Category 2
- 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 constituents classified as Skin Irritant Category 2 present at more than 10% and more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008
Constituent
CAS
Classification
Source
beta-thujone
471 -15 -8
H315
ECHA C&L inventory–self classification & REACH disseminated dossier
alpha-pinene
80 -56 -8
H315
ECHA C&L inventory–self classification & REACH disseminated dossier
beta-pinene 127 -91 -3 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
limonene 138 -86 -3 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
para-cymene 99 -87 -6 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
beta-myrcene 123 -35 -3 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
terpineol-4 562 -74 -3 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
alpha-terpineol 98 -55 -5 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
delta-3 carene 13466 -78 -9 H315
ECHA C&L inventory–self classification
linalol 78 -70 -6 H315
ECHA C&L inventory–self classification & REACH disseminated dossier
Source: ECHA disseminated dossiersor 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:
- 2 (reliable with restrictions)
- 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: Eyeb damage category 2
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance is to be classified as Eye irritant category 2
- 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 more than 10% of its constituents classified as eye irritant Category 2
and should be classified as a Eye damage category 2 without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Constituent
CAS
Classification
Source
beta-thujone
471 -15 -8
H319
ECHA C&L inventory–self classification & REACH disseminated dossier
camphene
79 -92 -5
H319
ECHA C&L inventory–self classification & REACH disseminated dossier
para-cymene 99 -87 -6 H319
ECHA C&L inventory–self classification & REACH disseminated dossier
beta-myrcene 123 -35 -3 H319
ECHA C&L inventory–self classification & REACH disseminated dossier
terpineol-4 562 -74 -3 H319
ECHA C&L inventory–self classification & REACH disseminated dossier
alpha-terpineol 98 -55 -5 H319
ECHA C&L inventory–self classification & REACH disseminated dossier
linalol 78 -70 -6 H319
ECHA C&L inventory–self classification & REACH disseminated dossier
p-metha-1,3 -diene 99 -86 -5 H319 ECHA C&L inventory–self classification & REACH disseminated dossier
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 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 and skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant and eye corrosive was based on existing data on constituents (additivity principles)the registered substance has constituent present at more than 10% classified as Skin irritant Category 2 and classified as Eye damage Category 2 and should be classified as a skin irritant and eye damage without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008
Constituent
|
CAS |
Classification |
Source |
beta-thujone |
471 -15 -8 |
H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
alpha-pinene |
80 -56 -8 |
H315 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| beta-pinene | 127 -91 -3 | H315 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| limonene | 138 -86 -3 | H315 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| para-cymene | 99 -87 -6 | H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| beta-myrcene | 123 -35 -3 | H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| terpineol-4 | 562 -74 -3 | H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| alpha-terpineol | 98 -55 -5 | H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| delta-3 carene | 13466 -78 -9 | H315 |
ECHA C&L inventory–self classification |
| linalol | 78 -70 -6 | H315/ H319 |
ECHA C&L inventory–self classification & REACH disseminated dossier |
| camphene | 79 -92 -5 | H319 | ECHA C&L inventory–self classification & REACH disseminated |
| p-mentha-1,3 -diene | 99 -86 -5 | H319 | ECHA C&L inventory–self classification & REACH disseminated |
Source: ECHA disseminated dossiersor self classification
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: Skin Irritant Category 2 (H315: Causes skin irritation) and Eye irritant category 2 (H319) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).
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.
