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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:
2 (reliable with restrictions)
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:
2017
Bibliographic source:
ECHA-17-G-21-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

1
Reference substance name:
Rosemary, ext.
EC Number:
283-291-9
EC Name:
Rosemary, ext.
Cas Number:
84604-14-8
Molecular formula:
Not applicable for UVCB substance
IUPAC Name:
Essential oil of Rosmarinus officinalis L. (Lamiaceae) obtained from leaves, flowers and twigs by steam distillation
Test material form:
liquid

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: classification
Remarks on result:
other: Skin sensitizer category 1B

Applicant's summary and conclusion

Interpretation of results:
other: Skin sensitiser Category 1B
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
Rosemary oil contains constituents that are classified as skin sensitisers Cat.1B 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.
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 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 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.