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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 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is considered as 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:

2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) 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 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. 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; Sand et al., 1973). This is supported by low calculated BCF and BAF values of 0.895 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:

2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining a NOEL (21 d) > 135 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.

 

In conclusion, 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is considered not to be PBT or vPvB.