Registration Dossier

Administrative data

Description of key information

No study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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:

LD50 rat: > 2.000 mg/kg/bw. (orig.: Lu, F.C. & Lavallée, A. [1964] Can. Pharm. J. 97, 30)

LD50 mouse s.c. 4.600 mg/kg/bw. (orig.: Gross, E. [1961] Z. Krebsforschg. 64, 287)

 

Moreover on the Similar Substance one studt is available on rats:

Acute toxicity: Oral

LD50 > 2500 mg/l (a.i)

 

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 Acute Toxicity.

Justification for classification or non-classification