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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:

Cumene can be classified as readily biodegradable under aerobic conditions. A degradation rate of > 60 % was determined within 10 days based on BOD measurement. The calculation of the bioconcentration factor yielded a BCF of 94.69 L/kg wet wt taking into account the measured log Kow of 3.5. Based on the result, a low potential for bioconcentration is to be expected, which is confirmed by an experimental BCF of 35.5 found in a poorly documented bioconcentration study with fish (C. auratus). These data indicate that cumene is not to be regarded as a substance being persistent (P/vP) and/or bioaccumulative (B/vB) according to the criteria of REACH Directive, Article 14.3 (d) and the Technical Guidance Document (TGD) R.11 of the European Chemicals Agency.

Based on the results on short- and long-term toxicity of cumene to aquatic organisms, the lowest (L(E)C50 was determined to be > 1 mg/L in short-term toxicity testing and the NOEC >0.01 mg/L in long-term toxicity testing. Based on the results on mammalian toxicity data of cumene, the substance does not meet the criteria for classification as 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. Based on the results on mammalian toxicity data of cumene, there is no evidence of chronic toxicity that would meet the criteria for classification: STOT RE 1, or STOT RE 2 according to Regulation EC No 1272/2008.

Taken as a whole, these data indicate that cumene is not to be regarded as a substance exhibiting PBT or vPvB properties according to the criteria of REACH Directive, Article 14.3 (d) and the Technical Guidance Document (TGD) R.11 of the European Chemicals Agency.