Registration Dossier

Administrative data

Description of key information

Skin sensitisation: skin sensitiser, based on classified constituents.

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 1B
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 (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 (limonene) 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. 1B 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 1B (limonene) 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. 1B without further testing according to the Regulation (EC) No 1272/2008.

Constituent

 

EC number

Classification according to Regulation 1272/2008

Source

alpha-pinene

201-291-9

Skin Sens 1

Notified classification and labelling

beta-pinene  242-060-2

  Skin Sens 1B

Notified classification and labelling

 cineole  207-431-5

  Skin Sens 1B

Notified classification and labelling

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

No information was available regarding respiratory sensitisation.