Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

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 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:

Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was considered non-irritant in both assays. These assays have limitations for use with coloured substances. Neither test has been validated. Investigations in rabbit eyes which were not in accordance with current standards indicated that even the repeated application of a 10 % aqueous solution is not irritant to mucous membranes. 

 

On the Similar Substance two experimental results are available:

Skin Irritation: Not irritant

Eye Irritation: Not irritant

 

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 Skin and Eye irritation.

Justification for classification or non-classification