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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:

Data for the definitive conclusion on the PBT or vPvB properties of triglycerides, mixed decanoyl and octanoyl (CAS 73398-61-5) are not available. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment’ (ECHA, 2008) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

The screening criterion for persistence is the potential of a substance for ready biodegradation. As triglycerides, mixed decanoyl and octanoyl (CAS 73398-61-5) is readily biodegradable, the substance is not considered to be persistent (P) or very persistent (vP) and does not meet the “P” or “vP” criterion.

Bioaccumulation Assessment

Due to the properties of the category members Fatty Acid Glycerides, their bioaccumulation in aquatic organisms is assumed to be low.As Fatty Acid Glycerides are readily biodegradable and have very low water solubility (< 1 mg/L), only low concentrations in the aquatic environment and thus a low exposure of aquatic organisms can be expected.Furthermore Fatty Acid Glycerides (mono-, di-, and tri-esters of fatty acids with glycerol) have in mammals a common metabolic fate that involves stepwise hydrolysis to the fatty acids and glycerol. Fatty acids and glycerol feed into physiological pathways like the citric acid cycle, sugar synthesis, and lipid synthesis. Furthermore mono- and diglycerides have an amphiphilic character and can be part of biological membranes or act as emulsifier and thus, are naturally present in all living organism. Fatty Acid Glycerides are stored deliberately in the fatty tissue as energy source and will be metabolized if needed. Hence, in case bioaccumulation occurs, bioaccumulation in animal tissue is non-hazardous due to the metabolic fate of the Fatty Acid Glycerides (use as energy source).Therefore, the substance does not meet the“B” and “vB” criterion.

Toxicity Assessment

The screening criterion for toxicity is based on short-term aquatic toxicity studies. Aquatic organisms (algae, daphnia, fish) did not show any toxicity up to the limit of the water solubility (< 1 mg/L). As the LC50 or EL50 was determined as > water solubility and no effects were observed in aquatic studies, the short-term aquatic toxicity of triglycerides, mixed decanoyl and octanoyl (CAS 73398-61-5) is clearly beyond the ecologically relevant EC50 or LC50 triggers of less than 0.1 mg/L. The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, triglycerides, mixed decanoyl and octanoyl (CAS 73398-61-5) does not meet the“T”criterion.