Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Sodium isostearoyl lactylate (ISL) is readily biodegradable as predicted by QSAR. Based on this information, the substance is not considered to be P and/or vP.

The QSAR estimated log P_ow of the substance is 3.98, indicating lack of significant bioaccumulation potential.

Daphnia magna was identified as most sensitive organism in the tests for aquatic toxicity with a 48-h EC₅₀ of 0.798 mg/L. Data for chronic aquatic toxicity are not available. However, the algae growth inhibition test according to OECD 201 is a multi-generation test. The chronic effect level E_rC₁₀ (72 h) in Raphidocelis subcapitata is 8.06 mg/L, and the 72-h NOEC is 6.021 mg/L. Since the EC₅₀ and EC₁₀ are above 0.01 mg/L, the substance is not considered to fulfil the toxicity criterion T. Furthermore, the substance is neither classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A or 1B, or 2), nor is there other evidence of chronic toxicity, as identified by the classifications "STOT RE 1, or STOT RE 2" according to CLP Regulation.

In conclusion, sodium isostearoyl lactylate (ISL) is readily biodegradable, not bioaccumulating, and does not fulfil any of the T-criteria. Therefore, the substance does not qualify for classification as PBT.