Registration Dossier
Registration Dossier
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EC number: 285-533-9 | CAS number: 85116-81-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fatty acids, C14 -18 and C16 -18 -unsaturated, esters with neopentyl glycol (CAS No. 85116 -81 -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
Fatty acids, C14 -18 and C16 -18 -unsaturated esters with neopentyl glycol is readily biodegradable based on one study according to OECD 301 B (95.6% (CO2 evolution) after 28 d) with the read-across substance 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation
Due to the low water solubility, rapid environmental biodegradation and metabolism via enzymatic hydrolysis of the Neopentyl glycol esters, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and neopentyl glycol. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by the low calculated BCF values 0.9 - 35.6 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the NPG esters. Thus, the test substance does not meet the criterion for bioaccumulative and it is not considered to be B or vB.
Toxicity
No effects occurred in the long-term toxicity tests with Daphnia magna (OECD 211) with the read-across substances Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS No. 68855-18-5) and 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) up to the highest tested concentrations 0.0019 mg/L (meas. TWA) and 1 mg/L (loading rate), respectively. No effects were observed in the study with algae (NOELR (72h) ≥ 100 mg/L). Fatty acids, C14 -18 and C16 -18 unsaturated, esters with neopentyl glycol is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 for environmental or human health hazards. Thus, based on the current data, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and Fatty acids, C14 -18 and C16 -18 -unsaturated, esters with neopentyl glycol does not fulfil the T criterion.
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