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Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Based on the data collected and the discussion in the dossier, Benzenesulfonic Acid, 4-sec-C15-16-alkyl derivs-., compd. with 1 -aminopropane-2 -ol does not meet the criteria for either PBT or VPvB as it is biodegraded in the environment, has a low bioaccumulation potential, low chronic aquatic toxicity and is not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.

Persistence Assessment:

The obtained results and observations from the aerobic biodegradation screening tests in water show that Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs-., compd. with 1 -aminopropane-2 -ol. does induce inhibition to the inoculum, but can be considered inherently biodegradable as shown in an extended (42 days) OECD 301F study resulting in biodegradation >60%. Therefore, Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs-., compd. with 1 -aminopropane-2 –ol is not persistent.

Bioaccumulation Assessment:

A flow-through fish test (OECD 305E) was conducted to assess the bioaccumulation potential of four different mixtures of Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts (read across). Results indicate BCF values ranging from 2 to 1000. Therefore, on the basis of read-across data, Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol is concluded not bioaccumulative.

Toxicity Assessment:

None of the acute EC50 values for marine or freshwater organisms are 0.1 mg /L, and none of the QSAR estimates for long-term NOECs (EPISuite 2012) are 0.01 mg/L. In addition the read across substance Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts is not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3). There is no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC. Therefore Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol does not meet the PBT criteria for toxicity.

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