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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:

TCD-emulsifier is predicted to be readily biodegradable by the (Q)SAR models in BIOWIN v4.10. TCD-emulsifier is not considered to fulfil the P or vP criterion. Although a log Kow = 5.83 was predicted for TCD-emulsifier (QSAR calculation using EpiSuite 4.1/KOWWIN v.1.68), the QSAR estimated BCF is ≤ 2000 (EpiSuite 4.1/BCFBAFv3.01), thus the B or vB criterion is not fulfilled. Acute aquatic toxicity test results of TCD-emulsifier were used in the risk assessment since chronic data are not available. Three trophic levels are covered by the acute toxicity data set. Adverse effects were neither observed in fish nor in daphnia at the maximum water solubility of 0.3 mg/L. No inhibition of algal growth was observed at the limit concentration of 100 mg/L (obtained with the Na salt, which is soluble at least to 100 mg/L). Therefore, TCD-emulsifier did not elicit any adverse effects in aquatic toxicity tests up to maximum water solubility of the unionised molecule. TCD-emulsifier is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. There is no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.