Registration Dossier
Registration Dossier
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EC number: 204-558-8 | CAS number: 122-62-3
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
LC50 (14d) = 865 mg/kg soil dw for Eisenia fetida (read across to Bis(ethylhexyl) adipate CAS 103-23-1)
Key value for chemical safety assessment
Additional information
No data are available for the acute or chronic toxicity to earthworm for Bis(2-ethylhexyl) sebacate (CAS 122-62-3). Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related category member Bis(2-ethylhexyl)adipate (DEHA, CAS 103-23-1) was conducted. Further justification is given within the endpoint summary 6.1 and within the category justification section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance within this category was used. In this study earthworms were exposed to DEHA amended quartz sand and soil (method 88 / 302 EWG). LC50s of >1000 mg/kg and 865 mg/kg were reported after 7 and 14 day exposures, respectively (Huls, 1996). Due to the structural and property similarities with the tested category member Bis(2-ethylhexyl)adipate (CAS 103-23-1) this result is also applicable to read across to Bis(2-ethylhexyl) sebacate (CAS 122-62-3).
According to ECHAs Guidance R.7c, the absence of chronic or long-term effects in aquatic organisms up to the substance solubility limit can be used as part of a Weight of Evidence argument to modify/waive the data requirements of Annex IX and X. For the category PFAE linear, there are three chronic tests on aquatic invertebrates available for insoluble category members (i.e. CAS 103-23-1 Bis(ethylhexyl)adipate; CAS 33703-08-1 Diisononyl adipate and CAS 103-24-2 Bis(2 -ethylhexyl) azelate). These substances exhibit log Kow values > 5 and a water solubility < 0.05 mg/L. In none of these tests effects on Daphnia were observed in nominal concentrations well above the limit of water solubility. Therefore, it is assumed that chronic tests on terrestrial organisms will not result in a different outcome. This is underlined by the absence of acute effects to earthworm established for other members of the PFAE linear category (i.e. Bis(tridecyl) adipate CAS 16958-92-2 and Dibutyl adipate CAS 105-99-7). Therefore no chronic tests for terrestrial organisms are either provided, or deemed as necessary for the chemical safety assessment.
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