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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 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:

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 study 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 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 Acute Toxicity.

Justification for classification or non-classification