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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for Diisodecyl azelate (CAS 28472-97-1) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence

Diisodecyl azelate (CAS 28472-97-1) is readily biodegradable. 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 Diisodecyl azelate (CAS 28472-97-1) 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/BAF: 0.9/1.1 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

Diisodecyl azelate (CAS 28472-97-1) is considered as not toxic. In a chronic study with Daphnia magna a NOELR (21 d) of 4 mg/L (nominal, > water solubility) based on reproduction was recorded which is above the trigger value of 0.01 mg/L. Furthermore the substance is not classified according to Regulation (EC) No. 1272/2008 (7th ATP). 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.