Registration Dossier
Registration Dossier
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EC number: 618-295-5 | CAS number: 897626-46-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Bis(2-octyldodecyl) azelate (CAS 897626-46-9) 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
Bis(2-octyldodecyl) azelate (CAS 897626-46-9) is considered to be readily biodegradable. This assumption is based on a a study conducted according to OECD 301B (81.5% (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-octyldodecyl) azelate (CAS 897626-46-9) 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
Bis(2-octyldodecyl) azelate (CAS No. 897626-46-9) is considered to be not toxic. Studies on the long-term toxicity of the substance are not available. The evaluation is therefore based on data available for the structurally related category member Bis(2-ethylhexyl) azelate (CAS No. 103-24-2). The study was conducted according to OECD guideline 211 using Daphnia magna as test organism. No toxic effects up to the limit of water solubility (< 0.004 mg/L in aqua dest) were determined. 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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