Registration Dossier
Registration Dossier
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EC number: 942-072-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The screening criteria given in the ‘Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment’ (ECHA, 2014) are used as surrogate information to decide whether fatty acids, coco, decyl esters (CAS 93455-79-9)may potentially fulfil the PBT or vPvB criteria.
Persistence Assessment
Based on the available data, fatty acids, coco, decyl esters is considered to be readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation Assessment
The bioaccumulation potential of fatty acids, coco, decyl esters is expected to be low. This assumption is based on a low bioavailability of the substances 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 BCF/BAF values of 1.40 - 3.51 and 117.60 - 206.20 L/kg (Arnot-Gobas estimate, upper trophic), respectively.Moreover, an additional (Q)SAR using VEGA v1.0.8 resulted in a low potential for bioaccumulation as well. The BCF read-across model v1.0.2 resulted in a BCF of 10. The target substance is within the training set of the model (consisting of 860 compounds) and the prediction is reliable. Six similar compounds with similarities of 0.734 - 0.869 were taken into account for the final prediction. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the test substance is not considered to be B or vB.
Toxicity Assessment
Long-term toxicity testing with Pseudokirchneriella subcapitata/Desmodesmus subspicatus and Daphnia magna resulted 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. Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
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