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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Data for the definitive conclusion on the PBT or vPvB properties of Fatty Acid Methyl Esters are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2008) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence (P) Assessment:

One of the screening criterions for persistence is the ready biodegradability of a substance. As Fatty Acid Methyl Esters are readily biodegradable, it can not be expected that the substances are P or vP.

Bioaccumulation (B) Assessment:

In contrast to a log KOW of > 3 forFatty acids, C8-10, Me esters (CAS 85566-26-3), a FattyAcid Methyl Esters with carbon chain length C8 - C10, no bioaccumulation potential is expected.

Due to the low water solubility and the ready biodegradability of Fatty acids, C8-10, Me esters (CAS 85566-26-3) the bioavailability is very low and an uptake isnot expected. Should the substance be taken up by fish, Fatty Acid Methyl Ester will be extensively metabolized by carboxylesterase (CaEs) enzymes, which are ubiquitous across species and have a broad specificity.Aliphatic esters, like Fatty Acid Methyl Esters, are biotransformed into fatty acids that are very similar to endogenous compounds and are rapidly used as carbon and energy sources. In addition, existing experimental fish bioconcentration data (42-day laboratory study, OECD 305) for aliphatic esters with log Kow between 3 and 6 show BCF values below 100, which is indicating no bioaccumulation potential. More detailed information can be found attached in the bioaccumulation assessment in IUCLID 5.2 under chapter 13.

In conclusion, Fatty Acid Methyl Esters are not B or VB.

Toxicity (T) Asessment:

The long-term no-observed effect concentrations (NOEC values) calculated for algal toxicity of C8 and C10 components are higher than 0.01 mg/L, and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Regulation (EC) No. 1272/2008 (CLP), Regulation (EU) No. 286/2011 (2ndATP) and Directive 67/548/EEC. Therefore, Fatty acids, C8-10 (even numbered), Me esters (CAS No. 85566-26-3) does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

 

In conclusion, Fatty acids, C8-10 (even numbered), Me esters (CAS No. 85566-26-3) is considered not to be PBT or vPvB.