Registration Dossier
Registration Dossier
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EC number: 210-826-5 | CAS number: 624-03-3
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-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.
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-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.
Since no studies investigating the toxicity to soil macroorganisms of ethane-1,2-diyl palmitate (CAS 624-03-3) 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. Nevertheless, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.
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 structurally related read-across substances (in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5) which are characterized by an equal ecotoxicological profile, it can be concluded that ethane-1,2-diyl palmitate will not exhibit toxic effects to soil macroorganisms.
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