Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation: non-skin sensitiser, based on non-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: not classified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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. 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.

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 not classified as skin sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and GHS.

No information was available regarding respiratory sensitisation.