Registration Dossier
Registration Dossier
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PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Fatty acids, C16-18 (even numbered), esters with glycerol oligomers 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
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; read-across) confirmed with QSAR calculations for representative constituents (VEGA (1.1.4); Ready Biodegradability Model (v1.0.9)).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 (even numbered), esters with glycerol oligomers is characterized by poor water solubility (91.9 µg/L) and a high log Kow (-8.05 to 20.38, EPI Suite v4.11, Kowwin v1.68, calculated for representative constituents). Based on the physico/chemical properties such as poor water solubility and high potential for adsorption a reduced availability in water is expected. In addition, the available literature data showed that soil microorganisms are capable to break-up ester bonds and degrade fatty acids in significant amounts. Moreover, the data indicated the non-toxic properties of fatty acids since they can be used as energy source. It can be concluded that the bioaccumulation potential of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is negligible. This is supported by a low calculated BCF value ranged from 0.94 - 18.58L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). With VEGA 1.1.3 BCF values of 0.74 - 2 L/kg were determined (Caesar v2.1.14) for the main components of the substance.
Thus, the substance is not considered to be B or vB.Thus, the test substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity
All acute effect concentrations available for Fatty acids, C16-18 (even numbered), esters with glycerol oligomers are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the available chronic effect concentration (daphnia, algae) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008.Therefore, test substance is not considered to meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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