Registration Dossier
Registration Dossier
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EC number: 201-089-0 | CAS number: 78-16-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) 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-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) is considered to be readily biodegradable. This assumption is based on a study conducted according to OECD 301B (85.3% (CO2 evolution) after 29 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 of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) 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 (1.04 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.
Toxicity
2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) is considered to be not toxic. The assessment is based on a read across to the structurally similar TMP group member Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6). In a study on the long-term toxicity of Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) to Daphnia magna a NOELR (15d) of 2570 mg/L (nominal; WAF) was recorded. Furthermore 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 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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