Registration Dossier
Registration Dossier
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EC number: 292-932-1 | CAS number: 91031-31-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence Assessment
The substances of the glycol esters category are readily biodegradable. All available screening studies, investigating the ready biodegradability of the substances, demonstrated degradation rates ≥ 60% after 28 days. Thus, the test substances of the glycol esters category do not meet the screening criterion for persistency and are not considered to be P or vP.
Bioaccumulation Assessment
Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) has a log Kow > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the Glycol Esters category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free glycol alcohol (e. g. ethylene glycol). From literature it is well known, that these hydrolysis products will be metabolized and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by low calculated BCF values of 0.893 - 89.4 L/kg (Arnot-Gobas including biotransformation estimate, upper trophic; BCFBAF v3.00). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the Glycol Esters Category members. Thus, taking all information into account, the test substance is not considered to be B or vB.
For a detailed reference list please refer to the CSR.
Toxicity Assessment
Long-term toxicity testing with Daphnia magna resulted in a NOELR of ≥ 0.02 mg/L for the read-across substance butylene glycol dicaprylate/dicaprate (CAS 853947-59-8) (OECD 211). Moreover, Fatty acids, C16-18, esters with ethylene glycol is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, 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.
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