Registration Dossier
Registration Dossier
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EC number: 271-347-5 | CAS number: 68541-50-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) is considered as readily biodegradable. This assumption is based on a study conducted according to OECD 301B (91% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.Bioaccumulation
The bioaccumulation potential of2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) is expected to be low. This assumption is based on a low bioavailability of the substance due to its ready biodegradability and low water solubility. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values (0.89 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.Toxicity
2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) is considered to be not toxic. The assessment is based on a read across to the structurally similar TMP group member Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8). In a study on the long-term toxicity of Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to Daphnia magna a NOELR (21d) ≥ 0.11 g/L (nominal; WAF) was recorded. Furthermore 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) 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 substance is considered to be not T.Conclusion
In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data
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