Registration Dossier
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EC number: 939-682-8 | CAS number: -
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (21 d) and NOEC (56 d) = 1000 mg test item/kg soil dw (nominal, for mortality, growth, reproduction and feeding activity of Eisenia andrei, OECD 222)
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 1 000 mg/kg soil dw
Additional information
As no study is available for assessing the toxicity of the substance to soil macroorganisms, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related Alkyl Dimethyl Betaine (EC 931-700-2) was applied. The read across is justified due to the structural similarity of the analogue substances and similar physico-chemical properties resulting in a similar environmental fate and ecotoxicity profile. Further justification is given in the analogue justification attached to section 13 in IUCLID.
One key GLP study (IBACON, 2013) is available in which the effect of the test item on the mortality, growth (biomass), reproduction (number of offspring) and feeding activity of the earthworm Eisenia andrei after 28 d/56 d exposure was assessed according to the OECD guideline 222 (2004). In controlled test conditions with a 16 h photoperiod adult worms were exposed to five test concentrations ranging from 10 to 1000 mg/kg soil dw in artificial soil with a reduced content of peat (5%), adjusted to and maintained at a water content of approximately 18 - 22 %. At the end of the test, the endpoints were compared to the negative control. No mortality (28 d), behavioural abnormalities (28 d) or significant differences in the reproduction rates (56 d), body weight changes (28 d) or feeding activity were found, even at the highest test concentration. The 28 d/56 d NOEC for mortality, growth, reproduction and feeding activity was determined to be 1000 mg test item/kg soil, i.e. the highest tested nominal concentration.
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