Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No information is available on the substance in itself nevertheless Similar Substances were considered in order to evaluate the possibility of classification.

Acid Blue 009/Food Blue 002 (EC n. 223 -339 -8) was considered as the most representative Read Across for the substance. The substance was evaluated by SSCNFP in the OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40 adopted by the SCCNFP on 23 April 2004.

In this report it is stated that Acid Blue 009 is listed as CI 42090 in Annex IV, part 1 – list of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products; field of application 1: colouring agents allowed in all cosmetic products.


In the COLIPA document were reported:

A Local Lymph Node Assay which was in accordance with current standards revealed that Acid Blue 009 is not sensitising after dermal contact. These results were confirmed by observations in humans (study of limited value). No potential for photosenitisation was detected in the same study.

On the Similar Substance one experimental data is available:

Not Sensitizer


Based on the information received no concern were found, therefore the following endpoints have not been completed according to the Article 12 of the REACH Regulation (EC n. 1907/2006) and the substance is considered as not classified for Skin Sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification