Fatty acids, C16-18, esters with diethylene glycol

Endpoint summary

Description of key information

The hazard assessment is based on the data currently available. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

The dataset investigating the aquatic toxicity of Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) is not complete. Thus, in order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

The available information on the source substance is used to predict the same endpoints for Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8). The target substance is characterized as an ester of ethylene glycol esterified (mono/di) with linear and saturated C16-C18 fatty acids. A structurally very similar substance was selected as source substance. Ethylene distearate (CAS 627-83-8) is a mono-constituent substance described as a diester of ethylene glycol with C16-C18 linear and saturated fatty acids.

All available experimental data on the target and source substance performed according to internationally accepted guidelines indicate no evidence of acute and chronic toxicity to aquatic organisms. Data for all three trophic levels are available. No toxicity was observed up to the limit of water solubility in all available experimental studies. The water solubility of the target substance was determined to be < 1 µg/L at 20 °C, pH=6.3 (OECD 105).

The short-term toxicity to fish was determined in a standard OECD guideline study with freshwater fish (from the source substance Ethylene distearate (CAS 627-83-8)). No mortality was observed after 96 h up to the limit of water solubility. The same was recorded for the short-term toxicity to aquatic invertebrates and to aquatic algae. No immobilization of Daphnia magna and no inhibition of growth of aquatic algae were observed in experimental studies according to OECD guidelines up to the limit of water solubility for the target substance itself.

Long-term toxicity testing to fish was not considered to be necessary since there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. No toxicity to fish was observed in the available acute test. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.

The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. The toxicity control from the biodegradation study indicated that the target substance is not inhibitory to activated sludge microorganisms.

Based on the available results for the target substance itself and from one structurally related read-across substance for one endpoint (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. All reliable data from the suitable source substance support the read-across by showing a consistent pattern of results.