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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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 TONKA ABSOLUTE.

Some ingredients of TONKA ABSOLUTE have been classified as skin sensitisers Cat.1 or 1B (Coumarin) and are all present above the generic concentration limit of 1%.

Therefore the test substance shall be classified as aSkin sensitizerCat. 1without further testing according to the Regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Reading:
1st reading
Remarks on result:
other: not applicable
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.

No skin sensitisation study was available on the registered substance. Moreover, some of its constituents are classified as skin sensitisers Cat.1 or Cat.1B (Coumarin) and are 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, without further testing according to the Regulation (EC) No 1272/2008 because sub-categories does not exist for the classification of the sensibilisation hazard of mixtures.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

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 and the GHS.

Self-classification:

Based on the typical composition provided by the Lead Registrant, the registered substance is classified as aSkin Sensitiser Cat. 1, H317 (May cause an allergic skin reaction) according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.