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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
Justification:

The PBT Assessment for Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) 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

Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) is readily biodegradable based on one study similar to ISO 10708 (94% after 28 d; O2 consumption). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).

 

Bioaccumulation

Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) indicates a low bioaccumulation potential in organisms. The biochemical process metabolizing aliphatic esters is ubiquitous in the animal kingdom. Based on the enzymatic hydrolysis of aliphatic esters and the subsequent metabolism of the corresponding carboxylic acid and alcohol, it can be concluded that the high log Kow, which indicates a potential for bioaccumulation, overestimates the true bioaccumulation potential of Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] since it does not reflect the metabolism of substances in living organisms. BCF/BAF values estimated with the BCFBAF v3.01 program also indicate that Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] will not be bioaccumulative (all well below 2000 L/kg). Taking all these information into account, it can be concluded that the bioaccumulation potential of Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] is low. Thus, the test substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

Short-term toxicity data available for all three trophic levels (fish, aquatic invertebrates, algae) for Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5), are all above the trigger value of 0.1 mg/L. Thus, the screening criteria set out in Chapter R.11: PBT Assessment” (ECHA, 2012) are not met and the test substance is not considered to meet the T criterion.