Registration Dossier
Registration Dossier
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EC number: 203-091-7 | CAS number: 103-24-2
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Bis(2 -ethylhexyl) azelate (CAS 103-24-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012d).
Persistence
Bis(2 -ethylhexyl) azelate (CAS 103-24-2) is readily biodegradable in one study according to OECD 301B (81.3% (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 of Bis(2 -ethylhexyl) azelate (CAS 103-24-2) 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 (BCF:1.31 L/kg; BAF: 1.89 L/kg; Arnot-Gobas estimate, upper trophic). Thus, the substance does not meet the screening criterion for bioaccumulation and is not considered to be B or vB.
Toxicity
Bis(2 -ethylhexyl) azelate (CAS 103-24-2) is considered as not toxic.
In a study on the long-term toxicity of the substance to Daphnia magna a NOEC of > 0.0637 mg/L based on the measured substance concentration was recorded. Thus a toxic effect was not determined within the limit of water solubility of the substance. 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.
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