Ethane-1,2-diyl palmitate

Toxicity to terrestrial arthropods

Description of key information

The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available. 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 assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available. 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.

In accordance with Regulation (EC) No. 1907/2006, Annex IX, column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need. No experimental data on toxicity to terrestrial arthropods are available ethane-1,2-diyl palmitate (CAS 624-03-3). The test substance is characterised by a high log Koc indication a considerable potential for adsorption to the soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of ethane-1,2-diyl palmitate. Read-across in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 from structurally related category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) did not show any mortality to earthworms in acute tests according to OECD 207 and EU Method C.8, respectively (LC50 > 1000 mg/kg soil dw). A plant study with butylene glycol dicaprylate / dicaprate according to OECD 208 with three species from different taxonomic groups resulted in an EC50 of > 100 mg/kg soil for all tested species. Moreover, the read-across substance butylene glycol dicaprylate / dicaprate did not show any chronic effects up to the limit of water solubility on the water flea Daphnia magna in a study according to OECD 211. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Since the substance is readily biodegradable, a chronic exposure of terrestrial organisms is not likely. Thus, acute tests with terrestrial organisms from different taxonomic groups in combination with chronic aquatic data indicating no effects up to the limit of water solubility are sufficient to assess the toxicity to terrestrial organisms.