Registration Dossier
Registration Dossier
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EC number: 248-096-5 | CAS number: 26896-48-0
Endpoint summary
Administrative data
Description of key information
Additional information
Toxicity to soil (micro)organisms and terrestrial plants
For the submission substance, a reliable 56 -days test on Earthworm reproduction according to OECD 222 was performed (compliant with GLP). Eight concentrations ranging from 1000 to 59 mg/kg dry soil were tested.
Neither relevant mortality nor relevant deviations of fresh weight change of surviving adults were observed after 28 days.
Inhibition of reproduction in the treatments in comparison to the combined controls was observed, ranging from 9.6 % to 80 %. All treatments except the lowest showed statistically significant inhibition of reproduction. All validity criteria were met.
The following results were obtained:
NOEC (reproduction, 56 d) = 59 mg/kg soil dw (nominal)
LOEC (reproduction, 56 d) = 88 mg/kg soil dw (nominal)
EC10 (reproduction, 56 d) = 39 mg/kg soil dw (nominal), 95% CI: 14 - 107.
Further, the submission substance was assessed for a possible inhibition of nitrogen transformation of soil microorganisms according to OECD 216 and EU-method C.21. Five concentrations were applied ranging from 10 to 1000 mg/kg dry weight. At the end of the test the four lowest treatments did not show any inhibition of nitrate content (rather an increase) compared to the control, whereas the highest treatment 1000 mg/kg showed inhibition of 100 % compared to the control. The following results were obtained:
NOEC (28 d; nominal): 320 mg/kg soil dw;
EC50 (28 d; nominal): 566 mg/kg soil dw.
A test on toxicity to terrestrial plants is not available: The outcome of the CSA (implicating screening assessment based on equilibrium partitioning) indicates that available long-term toxicity tests on earthworm and soil microorganisms are appropriate to cover information requirements (waiving according to "column 2" in Annex X of REGULATION (EC) No 1907/2006, together with Guidance R.7c, chapter R.7.11.5)
Toxicity to birds:
No data are available for this endpoint. In accordance with REACH Annex X, 9.6.1, Column 2, the available mammalian dataset may be used for the risk assessment. According to ECHA Guidance on Information Requirements and CSA, R.7c, risk from secondary poisoning is unlikely for a substance which has a low potential for bioaccumulation in fish and earthworms (which is the case with the submission substance).
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