Registration Dossier

Administrative data

Key value for chemical safety assessment

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 Acid Blue 083. 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:

Several published papers reporting positive and negative mutagenic/genotoxic effects of the test item could not be evaluated, due to the lack of information for considering the adequacy of the studies, as stated also in the safety dossier.

The studies performed with a known sample of the test item and following OECD guidelines are the bacterial reverse mutation test (2 studies),(2) the in vitro mammalian cell gene mutation test (1study), and the in vivo UDS test (1 study).

The studies on bacteria indicated that the test item in non mutagenic in this assay; however in both tests induced rat liver homogenate S 9 was used. Data from the literature indicate that the test item is mutagenic in the presence of a reduced metabolic activation system (hamster liver homogenate).

The in vitro mammalian cell gene mutation test has made use of induced rat liver homogenate. The negative results may have been influenced by such metabolic condition. The in vivo UDS gave negative results.

 

On the Similar Substance one experimental data is available:

Not Mutagenic in Ames test

 

Based on the information received no concern were found, therefore the following endpoint were 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 Germ cell mutagenicity.


Endpoint Conclusion: No study available

Justification for classification or non-classification