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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

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, 2017).


Persistence (P) Assessment:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. Octanoic acid, monoester with glycerol is readily biodegradable (85.3% after 28 d, OECD 301 F). 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:

The substance has a log Kow value of 1.71 (KOWWIN v1.68), which is below the trigger value of 4.5 for aquatic organisms and below 2 for air-breathing organisms. Furthermore, the substance does not ionize under environmental conditions and therefore a non-lipophilic bioaccumulation is not expected.


Furthermore, due to the rapid environmental biodegradation and metabolization via enzymatic hydrolysis of the Glycerides category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and glycerol. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Tocher, 2003). This is supported by calculated BCF values ranging from 0.89-57.1 L/kg within the category (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Experimental data on glycerol tristearate (CAS No. 555-43-1, category member) showed a BCF value in fish < 10 (Freitag, 1985).


Based on the available information, the substance does not meet the B or vB criteria.


Toxicity (T) Assessment:

The available data on short-term and long-term toxicity indicate that the Glycerides category members are not chronically toxic. All reported no-observed effect concentrations (NOEC values) are higher than 0.01 mg/L. Furthermore, Octanoic acid, monoester with glycerol 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). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is not considered to be T.


In conclusion, Octanoic acid, monoester with glycerol (CAS 26402-26-6) is not PBT or vPvB.