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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

1.Persistence Assessment:

Based on the data of Inherent biodegradability test– Modified MITI test (OECD TG 302 C), BOD5/COD and hydrolysis study (OECD 111), the test substance FAT 93450 can be concluded to be not readily biodegradable and stable in the environment. Hence, the substance can be considered to fulfil the persistence criteria.

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 Kow = 3.38. This value is below the threshold value of log Kow ≤4.5. Hence, the substance can be considered to not fulfil the bioaccumulation (neither B nor vB) criteria.

3. Toxicity assessment:

No long-term studies for marine or freshwater organisms are available. According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfil the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. The lowest short-term toxicity value from conducted studies with the substance was 2.97 mg ai /L in Lemna growth inhibition test-(7d EC50) whilst the other values were: Fish - 96 h LC50 = 650 mg ai/L; Invertebrates - 48 h EC50 = 96 mg ai /L. The substance is neither classified as carcinogenic, mutagenic or toxic for reproduction. There is no evidence of chronic toxicity from the available 28-day repeated dose mammalian toxicity test. No sub-chronic or chronic repeated dose toxicity studies are available. 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. Solvent Yellow 163 does not fulfil the bioaccumulation and toxicity criteria, hence it is not to be regarded as PBT or vPvB.