Registration Dossier
Registration Dossier
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EC number: 947-718-9 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is not PBT/vPvB.
The PBT Assessment for the target substanceIsooctadecanoic acid, mixed esters with oxybis[propanediol]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 Assessment
The target substance is not readily biodegradable according to the OECD criteria based on read-across from the similar substance Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3). The substance is thus expected to be not rapidly degradable by microorganisms in both the aquatic and terrestrial environments and may therefore potentially fulfil the P/vP criterion.
Bioaccumulation Assessment
The bioaccumulation potential of Isooctadecanoic acid, mixed esters with oxybis[propanediol] is expected to be low. This assumption is based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. Given a very high log Koa value of 14.55(KOAWIN v1.10), the substance will not partition to aerosols and predominantely occur in the hydrophobic compartement. The high molecular weight of the substance significantly reduces the absorption due to steric hindrance to cross biological membranes. It can be concluded that the bioaccumulation potential of Isooctadecanoic acid, mixed esters with oxybis[propanediol] is negligible. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the substance is not considered to be B or vB.
Toxicity Assessment
For the substance Isooctadecanoic acid, mixed esters with oxybis[propanediol] the available acute effect concentrations are ≥ 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (algae) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is not readily biodegradable and has low potential for bioaccumulation. Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
In conclusion the target may fulfill the P/vP criterion but not the B/vB or T criteria.
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