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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

Constituent 1
Reference substance name:
Essential oil of Tanacetum annuum
IUPAC Name:
Essential oil of Tanacetum annuum
Test material form:
liquid

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: classification
Remarks on result:
other: Skin sensitization category 1 - H317

Applicant's summary and conclusion

Interpretation of results:
other: Skin sensitization category 1 - H317
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
Blue Tansy oil contains constituents that are classified as skin sensitisers Cat.1 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. 1
Executive summary:

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 Blue Tansy oil.

Blue Tansy oil has not been tested itself in vitro/in chemico or in vivo, but some individual constituents of this UVCB are suspected or have been classified as skin sensitizers (see table) and are all present or potentially present above the generic concentration limit of 1 %. Therefore the substance shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 127212008.

Source: ECHA disseminated dossiers

Skin sensitization category 1 - H317 classified constituents:

Beta pinene (typ. 4%)

Alpha pinene (typ. 2%)

Myrcene (typ. 2.5%)

Caryophyllene (typ. 1.6%)

Limonene (typ. 1.5%)