Registration Dossier
Registration Dossier
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EC number: 285-203-4 | CAS number: 85049-34-9
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Related composition:
- Boundary composition
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for the test substance 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
The test substance is determined to be readily biodegradablein. This was shown in one study according to OECD 310 (79.9% after 28 d) with the read-across substance propylene glycol diisostearate (CAS 68958-54-3). The read-across is justified in detail in the read-across justification in section 13. Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation Assessment
The test substance has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis, 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 a low calculated BCF value of 0.893 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Thus, taking all information into account, the test substance is not considered to be B or vB.
Toxicity Assessment
Long-term toxicity testing with Daphnia magna resulted in a NOEC of ≥ 0.02 mg/L for the read-across substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) (OECD 211). The read-across is justified in detail in the read-across justification in section 13. Moreover, the test substance is not classified 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 test substance is not considered to meet the T criterion.
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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