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Classification & Labelling & PBT assessment

PBT assessment

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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:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. The substance Fatty acids, soya, 2-ethylhexyl esters (CAS 93572-14-6) is considered to be readily biodegradable. Therefore, it 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 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. 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 BCF and BAF values calculated for the substance of 131.9 and 261 L/kg ww 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, soya, 2-ethylhexyl esters (CAS 93572-14-6) 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 NOEC (21 d) >= 1 mg/L. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. The criteria for “T” based on mammalian effects are therefore not met.