Registration Dossier
Registration Dossier
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EC number: 271-351-7 | CAS number: 68541-71-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
1.Persistence Assessment:
Based on experimental data, Acid Blue 317 can be concluded to be not readily biodegradable and stable in the environment.
2.Bioaccumulation Assessment:
The partition coefficient n-octanol/water of Acid Blue 317 at 20 °C was calculated based on the individual solubility in water and n-octanol, and determined to be log Pow = 0.291. 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.
3.Toxicity Assessment:
No long-term studies for marine or freshwater organisms are available with Acid Blue 317, however short term toxicity tests are available for all the three tropic levels (fish, invertebrate and aquatic plants). The lowest effect concentration found in the algae study (NOEC: 0.64 mg/L) is used for toxicity evaluation. Acid Blue 317 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.
Thus, taking into account the above information, Acid Blue 317 can be considered to be no PBT/vPvB according to the Annex XIII of the REACH Regulation.
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