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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 ready biodegradation of alphamethylstyrene was investigated in studies conducted according to OECD Guideline 301 D and EU Method C.4-E and OECD Guideline 301C, respectively. Although alpha-methylstyrene would have to be assessed as not readily biodegradable under the test conditions employed (56% biodegradation after 21 d) when strictly applying the OECD 301 criteria, an in-depth evaluation of the 301D study revealed that the substance has to be regarded as being rapidly biodegradable. In a study conducted according to OECD Guideline 305 C, BCF (fish) values of 12 -113 (0.03 mg/L) and 15 -140 (0.3 mg/L) were determined. These results indicate a low potential for bioaccumulation of alpha-methylstyrene in fish. Based on the results on short- (data from 3 trophic levels) and long-term toxicity (data from 2 trophic levels including the results of Daphnia magna which proved to be the most sensitive organism in acute toxicity testing) of alpha-methylstyrene to aquatic organisms, the lowest L(E)C50 were determined to be >1 mg/L in short-term toxicity testing and NOEC >0.01 mg/L in long-term toxicity testing. These data indicate that alpha-methylstyrene 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. Based on the results on mammalian toxicity data of alpha-methylstyrene, 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. Therefore, the substance 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. Based on the results on mammalian toxicity data of alpha-methylstyrene, 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. Therefore, the substance is not to be regarded as a substance exhibiting T 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.

Taken as a whole, these data indicate that alpha-methylstyrene 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.