Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

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 Pow 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 ErC10 (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.

Categories Display