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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:

The substance under evaluation does not fulfill any of the criteria for PBT or vPvB.

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.

The bioaccumulation potential of Dodecane-12-lactam 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).

These low BCF values indicate that the bioaccumulation potential of Dodecane-12-lactam is low and below the PBT criteria.

The screening criteria for toxicity are acute toxicity data for the aquatic environment. If these values are below 0.1 mg/l the substance can be regarded as potentially toxic. The lowest valid acute test results derived from aquatic toxicity testing with fish, invertebrates and algae are as follows: Cyprinus carpio (fish): 96 h-LC50 = 63 mg/l Daphnia magna: 48 h-EC50 = 59 mg/l Scenedesmus subspicatus: 72 h-ErC50 = 172 mg/l. Since the acute test data show that the LC50 and EC50, respectively are well above 0.1 mg/l, the screening criterion for toxicity is not fulfilled.

Furthermore the substance 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 the DSD) 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 (or CLP Regulation). 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.