Registration Dossier

Diss Factsheets

Administrative data

skin sensitisation, other
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Reference Type:
other: Guidance

Materials and methods

Test guideline
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Results and discussion

In vitro / in chemico

Key result
other: classification
Remarks on result:
other: not classified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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. The Cocoa extract contains proteins, lipids, theobromine, sugars, organic acids, caffeine, fiber, starch, water and ethanol. None of its constituents are classified as skin sensitisers that could trigger classification of the mixture. Therefore, the registered substance is not classified as a skin sensitiser without further testing according to the Regulation (EC) No 1272/2008.