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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 criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are used as information to decide whether tetradecyl stearate (CAS 17661-50-6) may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

Based on the available data, tetradecyl stearate (CAS 17661-50-6) is considered to be readily biodegradable based on experimental data. Thus, the substance does not meet the screening criterion for persistence and is not considered to be P or vP.

 

Bioaccumulation Assessment

The bioaccumulation potential of tetradecyl stearate (CAS 17661-50-6) is expected to be low. This assumption is based on a low bioavailability due to its ready biodegradability, high adsorption potential and low water solubility. Furthermore, the substance is rapidly metabolised and excreted by organisms and thus significant accumulation is not expected. This is supported by calculated low BCF/BAF values of 0.89 - 0.90 (BCF: Arnot-Gobas estimate, upper trophic) and 2.67 - 8.08 L/kg (BAF: Arnot-Gobas estimate, upper trophic), respectively. Please refer to IUCLID section 5.3.1 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the target substance is not considered to be B or vB.

 

Toxicity Assessment

Aquatic toxicity data for the assessment of the target substance were taken from the structurally similar source substances. Long-term toxicity testing withScenedesmus subspicatus and Daphnia magnaresulted in no effects up to the limit of water solubility. All available short-term toxicity data did not result in any toxicity up to the water solubility limit as well. Moreover, the substance is not classified according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP) considering Regulation (EU) No 605/2014 (5th ATP). Thus, given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are not met and the target substance as well as the source substances are not considered to meet the T criterion.