Registration Dossier
Registration Dossier
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EC number: 943-242-0 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers 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
Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers is readily biodegradable in one study according to OECD 301B (95.6% (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 Assessment
Due to the low water solubility, rapid environmental biodegradation and metabolism via enzymatic hydrolysis of Reaction products from the esterification of neopentylglycol with fatty acids, C16 -18 (even numbered) and C18 -unsatd. and fatty acids, C18 -unsaturated, dimers, 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 value 0.893 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer torefer to IUCLID section 5.3.1 for a detailed overview on bioaccumulation.
Toxicity Assessment
No effects occurred in the long-term toxicity tests with Daphnia magna (OECD 211) and Pseudokirchneriella subcapitata up to the limit of water solubility. No effects were observed in all studies. Moreover, Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers is not classified according to Regulation (EC) No. 1272/2008 for environmental and human health hazards. Thus, based on the available data, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance does not fulfil the T criterion.
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