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Toxicity to aquatic algae and cyanobacteria

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The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated 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.

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Additional information

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated 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.

Since no studies investigating the toxicity to aquatic algae and cyanobacteria of ethylene distearate (CAS 627-83-8) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was conducted. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment.

The first study with butylene glycol dicaprylate / dicaprate was performed as a limit test according to EU Method C.3 using the freshwater algae Scenedesmus subspicatus (Scholz, 1997). A test substance concentration of 1000 mg/L (nominal) and 3 mg/L (measured, based on TOC content) respectively, did not result in any effects on the growth rate and biomass after 72 h resulting in an EL10/50 > 3 mg/L (measured, initial). The recovery rate in the stability test was > 80% and the concentration after 48 and 72 h did not differ more than 20%. Therefore, the test substance was bioavailable throughout the test.

The second study with the read-across substance fatty acids, C16-18, esters with ethylene glycol was performed according to the DIN 38412-9 under GLP conditions (Stelter, 1994). The green algae Scenedesmus subspicatus was exposed to nominal concentrations of 10 and 100 mg/L without a further filtration step. No inhibition of growth of S. subspicatus up to the limit of water solubility was observed resulting in an EC50 > 100 mg/L. An EC10 of 34 mg/L was determined since growth stimulation was observed in both concentrations used in this study.

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that ethylene distearate will not exhibit chronic effects to aquatic algae up to the limit of water solubility.