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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 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:


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 is non mutagenic in these assays; 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.


 


Moreover, an Ames test is available also in the similar substance, Acid Blue 090, EC: 228-058-4 (Huntsman, 2014).


In this assay, strains TA98, TA100, TA1535, TA1537 and TA102 of S. typhimurium were exposed to test item at concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate (experiment I and II), in the presence and absence of mammalian metabolic activation according to the plate incorporation method (experiment I) and the pre-incubation method (experiment II). Test item was tested up to the limit concentration of 5000 µg/plate in all tester strains used.


The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of increased induced mutant colonies over background with any of the test substance concentrations. Based on the findings of the study, it was clear that the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used


 


On the Similar Substances experimental data are available:


Not Mutagenic in Ames test


 


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 Germ cell mutagenicity.

Justification for classification or non-classification