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PBT assessment

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PBT assessment: overall result

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

1.Persistence Assessment:

Based on experimental data, Reactive Blue 049 can be concluded to be not readily biodegradable and stable in the environment.

2.Bioaccumulation Assessment:

According to the screening criteria for bioaccumulation (B for bioaccumulative, vB for very bioaccumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log Kow ≤4.5. The octanol-water partition coefficient for the test item is log Pow = - 3.88. This value is much below the threshold value of log Kow ≤4.5. Considering the low water solubility and the influence of lipid solubility on the bioconcentration of hydrophobic compounds demonstrating a decrease in lipid solubility with increasing Kow values (Chessells et al. (1992)) for superhydrophobic compounds (log Kow >6), it can be assumed that it will led to reduced BCFs. In conclusion, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.

3.Toxicity Assessment:

No long-term studies for marine or freshwater organisms are available. Short term toxicity tests are available for all the three tropic levels (fish, invertebrate and aquatic plants). Aquatic acute toxicity studies did not show any effects up to 100 mg/L. Reactive Blue 049 is not classified for CMR and specific target organ toxicity on repeated exposure. Therefore, based on current knowledge, the substance does not fulfil the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.

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