Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, 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:
2015
Bibliographic source:
ECHA-15-G-05-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
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): eucalyptus oil globulus
- Molecular formula (if other than submission substance): see confidential
- Molecular weight (if other than submission substance): see confidential
- Smiles notation (if other than submission substance): see confidential
- Structural formula attached as image file (if other than submission substance): see confidential
- Substance type: Natural Complex Substance
- Physical state: see confidential
- Analytical purity: see confidential
- Impurities (identity and concentrations): see confidential
- Composition of test material, percentage of components: see confidential
- Purity test date: see confidential
- Lot/batch No.: see confidential
- Expiration date of the lot/batch: see confidential
- Storage condition of test material: room temperature

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: classification
Remarks on result:
other: skin sensitiser category 1B

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) 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 (2015) was used to determine the skin sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers Cat.1B (cineol 1,8; dipentene, alpha pinene...) and are all potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1B without further testing according to the Regulation (EC) No 1272/2008.