Registration Dossier
Registration Dossier
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EC number: 274-764-0 | CAS number: 70693-32-2
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Decanoic acid, mixed esters with neopentyl glycol and octanoic acid (CAS No. 70693-32-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).
Persistence
Decanoic acid, mixed esters with neopentyl glycol and octanoic acid (CAS No. 70693-32-2) is readily biodegradable in studies with the read-across substances 2,2-dimethyl-1,3-propanediyl dioctanoate (CAS No. 31335-74-7) and Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol (CAS No. 85186-86-3) according to OECD 301 B (93.1% (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
Due to the low water solubility, rapid environmental biodegradation and metabolism via enzymatic hydrolysis of the Neopentyl glycol esters group members, 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 value1.39 - 12.55 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. The substance is thus 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. With Pseudokirchneriella subcapitata no effects occurred up to the limit of water solubility. Decanoic acid, mixed esters with neopentyl glycol and octanoic acid 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 Decanoic acid, mixed esters with neopentyl glycol and octanoic acid does not fulfil the T criterion.
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