Registration Dossier
Registration Dossier
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EC number: 285-206-0 | CAS number: 85049-36-1
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, 2012).
Persistence (P) Assessment:
The substance Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) is readily biodegradable. Therefore, the substance is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation (B) Assessment:
Due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. This is supported by the low BCF and BAF values calculated for the substance of 25.17 L/kg and a BAF value of 691.9 L/kg respectively (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Based on the available information, the substance does not meet the B or vB criteria.
Toxicity (T) Assessment:
Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 202, part II, determining a NOEL (21 d) > 1 mg/L. The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. The criteria for “T” based on mammalian effects are therefore not met.
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