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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:

Biodegradation in water was determined in a Modified Storm Test (CO2 Evolution Test) according to the EU method C4 and OECD 301 B. 83% degradation was observed within a period of 28 days. As >60% biodegradability was observed within the 10d-window the test item can be assessed as readily biodegradable. Since this result was obtained with a test on ready biodegradability, the substance can be regarded as not P and not vP.

The bioaccumulation potential of the substance was investigated experimentally in Cyprinus carpius (CITI 1992) and calculated with EPIWIN. The experimentally derived bioconcentration factors at two concentration levels were 0.8 - 1.2 (0.5 mg/l) and <2.6 (0.05 mg/l) respectively. The calculated BCF was 35.35 (BCFWIN v2.14). Furthermore the octanol-water partitioning coefficient is below 4.5. The criteria for bioaccumulation (PBT and vPvB) are thus not fulfilled.

In 3 fish early-life-stage tests with Pimephales promelas NOEC-values of 4.2 mg/l (32 d), 15.6 mg/l (32 d) and 11 mg/l (35 d) were obtained for the endpoint growth (measured as weight). The geometric mean of these 3 NOEC values is 8.9 mg/l. The criterion for toxicity is not fulfilled since the NOEC values in 3 long-term studies are above 0.01 mg/L.

Furthermore the substance is not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC and is not carcinogenic, mutagenic or toxic for reproduction.