Registration Dossier
Registration Dossier
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EC number: 238-925-9 | CAS number: 14858-73-2
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No experimental data available. The existing data indicates no need to investigate further the effects on aquatic organisms. The calculated chronic NOEC for fish exceeds the water solubility limit of the substance by a factor of 3.7.
Key value for chemical safety assessment
Additional information
According to REACH Regulation (Annex IX, 9.1, column II) long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The test substance is highly insoluble in water, readily biodegradable and evaporates quickly from water (Henry's Law). Hence, availability of the substance in the aquatic ecosystem can be expected to be low. Experimental data on aquatic bioaccumulation is lacking. However, from reliable in vitro data on percutanous absorption via human skin, it can be assumed that the test substance has a low potential to cross biological membranes. Thus, a very low biological availability of the test substance can be expected for aquatic species as well. Bis(2-ethylhexyl) carbonate did not cause any effects up to its water solubility limit in the acute aquatic toxicity tests covering three trophic levels. Missing aquatic toxicity is also likely in consideration of QSAR modelled ecotoxicity reference values (ERV). Calculated with ECOSAR (v1.11), the ERV for acute toxicity to fish is 2.274 mg/L, and the ERV for chronic toxicity to fish is 0.110 mg/L. The predicted chronic ERV exceeds the water solubility limit of the substance by a factor of 3.7. Thus, long-term toxic effects to aquatic organisms are unlikely to occur. As based on toxicity assessment as well as on availability likelihood, a long-term toxicity hazard is not ascertainable, the conduct of long-term toxicity studies is not justified in accordance with REACH Regulation (Annex IX, 9.1, column II).
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