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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:

In general, for the classification and PBT assessment of Benzene, C15-16-alkyl derivs., in cases where no data were available on the target substance, data were read-across from structurally related materials. A read-across source substance for Benzene, C15-16 -alkyl derivs. was found to be readily biodegradable in the OECD manometric respirometry test, with 64% biodegradability in 28 days. Therefore, Benzene, C15-16-alkyl derivs. is not considered to be persistent.

A key study using method ASTM E-35.31 was conducted on a read-across source substance for Benzene, C15-16-alkyl derivs. to assess the bioaccumulation potential in fish. Results indicate a half-life of 15.3 days and a BCF of 35. Therefore, Benzene, C15-16 -alkyl derivs. is not considered bioaccumulative.

Studies show that Benzene, C15 -16 -alkyl derivs. is not toxic to aquatic organisms at the limits of water solubility. Therefore, Benzene, C15-16-alkyl derivs. does not meet the PBT criteria for chronic aquatic toxicity. Benzene, C15-16-alkyl derivs. is not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3), and no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Based on the data collected and the discussion above, Benzene, C15-16-alkyl derivs. does not meet the criteria for either PBT or VPvB. Benzene, C15-16-alkyl derivs. does not show chronic aquatic toxicity; is readily biodegraded in the environment; has a very low bioaccumulation potential; and is not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.