Registration Dossier
Registration Dossier
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EC number: 203-757-7 | CAS number: 110-33-8
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
LC50 (14d) > 800 mg/kg for Eisenia fetida (read across to Dibutyl adipate CAS 105-99-7 and Bis(2-ethylhexyl) adipate CAS 103-23-1)
Key value for chemical safety assessment
Additional information
No study on the toxicity of Dihexyl adipate (CAS 110 -33 -8) to earthworm is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related category members Dibutyl adipate (CAS 105-99-7) and Bis(2-ethylhexyl) adipate (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.
The study conducted with Dibutyl adipate (CAS 105-99-7) was performed as a limit test according to OECD guideline 207 and GLP (Moser, 2013). The test organism Eisenia fetida was exposed to the test substance in artificial soil for 14 days, at the nominal test concentration 1000 mg/kg. No mortality occurred during the test period. Hence, the 14d LC50 was assessed as > 1000 mg/kg soil dw.
The study conducted with Bis(2-ethylhexyl) adipate (CAS 103-23-1) was performed according to EU method C.8 and GLP (Huels, 1996). The test organism Eisenia fetida was exposed to the test substance in artificial soil for 14 days, at nominal test concentrations of 171, 301, 550, 1000 mg/kg dw. The 14d LC50 was determined to be 865 mg/kg soil dw.
Due to the structural and property similarities with the tested category members Dibutyl adipate (CAS 105-99-7) and Bis(2-ethylhexyl) adipate (CAS 103-23-1) this result is also applicable to read across to Dihexyl adipate (CAS 110-33-8).
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 Nonanedioic acid, bis(2-ethylhexyl) ester). 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.
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