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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Basic Yellow 28 acetate is considered to be not readily biodegradable based on the design of textile dyes, a QSAR evaluation, and the BOD/COD ratio of a test with the methyl sulfate salt, which showed a biological degradation of 26.3 %. It is hence considered to be persistent.

Basic Yellow 28 acetate is considered not to be bioaccumulative based on its low log Kow of < -1.1.

Basic Yellow 28 acetate does not meet the criteria of Annex XIII for aquatic toxicity based on the EC10/NOEC of 0.03 mg/L for algal growth inhibition as the most sensitive aquatic species - without taking into account inhibition of growth due to the UV absorption by the dyestuff. The test substance was negative in in-vitro and in-vivo genotoxicity tests performed. Basic Yellow 28 in various salt forms, is used since decades for coloration of various materials without causing any suspicion of carcinogenic properties.

No data for repeated dose tests in mammals is available as the toxicity of this substance is triggered by the amount of acetic acid contained to stabilise the substance in the solution and its irritating effect. The 25 % acetic acid contained in the test substance relates to a 40 % acetic acid. As this solution is skin and eye irritating, exposure to the substance should be avoided. Due to animal welfare reasons, no repeated dose studies with this test substance have hence be conducted.