Registration Dossier
Registration Dossier
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EC number: 211-014-3 | CAS number: 627-83-8
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
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-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. Thus, the strategy for 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.
The current hazard assessment is based on the presently available data.
Key value for chemical safety assessment
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-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. Thus, the strategy for 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.
The current hazard assessment is based on the presently available data.
Since no studies investigating the toxicity to soil macroorganisms 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 two 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) was conducted. 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.
The first study with butylene glycol dicaprylate / dicaprate was performed according to OECD 207 under GLP conditions (Lührs, 2001). Eisenia fetida was exposed to 5 different test substance concentrations up to 1000 mg/kg dw in artificial soil for 14 d. Mortality and body weight were recorded at the end of the study. No mortality was observed resulting in a LC50 of > 1000 mg/kg dw. The body weight increased significantly at a test concentration of 1000 mg/kg dw. Therefore, a NOEC of 500 mg/kg dw was determined.
Eisenia foetida foetida was used in the second study according to EU Method C.8 (GLP) to evaluate the toxicity of decanoic acid, mixed diesters with octanoic acid and propylene glycol to soil macroorganisms (Scholz, 1996). A limit test with a concentration of 1000 mg/kg dw did not result in mortality after 14 d of exposure. Therefore, a LC50 > 1000 mg/kg dw was determined.
Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by an equal ecotoxicological profile, it can be concluded that ethylene distearate will not exhibit effects on soil macroorganisms.
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