Registration Dossier
Registration Dossier
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EC number: 292-947-3 | CAS number: 91031-45-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) 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, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) is readily biodegradable in one study according to OECD 301D (69-79% (O2 consumption) after 30 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation
Aliphatic esters like fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) are biotransformed to fatty acids and the corresponding alcohol component by the ubiquitous carboxylesterase enzymes in aquatic species. Based on the rapid metabolism it can be concluded that the high log Kow, which indicates a potential for bioaccumulation, overestimates the bioaccumulation potential of fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO). BCF/BAF values estimated with the BCFBAF v3.01 program also indicate that the substance will not be bioaccumulative (all well below 2000 L/kg). Taking all these information into account, it can be concluded that the bioaccumulation potential of fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) is low and it is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity
Long-term toxicity testing withDaphnia magnaresulted in a NOELR of ≥0.02 mg/L for the source substance Butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) (OECD 211). Moreover, the target substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or 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. Moreover there is no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the target substance is not considered to meet the T criterion.
References
ECHA (2012): Guidance on information requirements and chemical safety assessment. Chapter R.11: PBT Assessment.
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