Registration Dossier

Administrative data

Description of key information

Skin sensitisation: skin sensitiser, based on the rules of the CLP Regulation for classification of mixtures

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Key result
Parameter:
other: classification
Remarks on result:
other: skin sensitiser category 1
Interpretation of results:
Category 1 (skin sensitising) 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 (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 or 1 (limonene, linalool, alpha-pinene, geraniol, 1,8 -cineole, alpha-thujene) and potentially present above the CLP generic concentration limit of 1% for category 1 that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
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 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 or 1 (limonene, linalool, alpha-pinene, geraniol, 1,8 -cineole, alpha-thujene) and potentially present above the CLP generic concentration limit of 1% for category 1 that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 boundary composition, the registered substance is classified as skin sensitiser: Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.