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EC number: 204-679-6 | CAS number: 124-09-4
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
Results of the reliable Earthworm reproduction test (according to OECD 222, compliant to GLP; RL 1; 2017):
NOEC (28 d, adult mortality) = 250 mg test item/kg soil (dw)
LOEC (28d, adult mortality) = 500 mg test item/kg soil (dw).
NOEC (28 d, biomass) ≥ 1000 mg test item/kg soil (dw) (the highest concentration tested).
LOEC (28 d, biomass) > 1000 mg test item/kg soil (dw).
NOEC (56 d, reproduction) = 125 mg test item/kg soil (dw)
LOEC (56 d, reproduction) = 250 mg test item/kg soil (dw).
EC10 (56 d, reproduction) = 176.1 mg test item/kg soil (dw) (95% Confidence limits (CL) = 151.0 – 202.3 mg test item/kg soil (dw)).
EC50 (56 d, reproduction) = 441.9 mg test item/kg soil (dw) (95% CL = 414.3 – 475.3 mg test item/kg soil (dw)).
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 176.1 mg/kg soil dw
Additional information
Terrestrial toxicity of the submission substance was analyzed with regard to earthworm reproduction according to OECD 222 and ISO 11268-2 (Part 2), compliant with GLP (RL 1). The earthworm Eisenia fetida (Lumbricidae) was chosen as a representative of the soil fauna. Boric acid was used as a reference substance to confirm sensitivity of test organisms.
The test consisted of 5 treatment groups (62.5, 125, 250, 500 and 1000 mg test item/kg soil dry weight (dw)) plus control and was conducted using artificial soil. The test was performed with 4 replicates per treatment and 8 replicates for the control (10 worms per replicate).
Adult mortality and biomass were analyzed after 28 days. Reproduction was monitored after 56 days. All validity criteria of the guideline were met:
Mortality of the adults in the control = 7.5% (required: ≤ 10%);
Mean number of juveniles in the control = 274.1 (required: ≥ 30);
Coefficient of variation for the number of juveniles in the control = 23.0 (required: ≤ 30%).
The exposure period was from January 19, 2017 – March 16, 2017.
The following results were obtained:
7.5% mortality was observed in the control. In the five tested concentrations of the test item the mortality ranged from 10 to 47.5%. Fisher’s Exact Test (1-sided, p ≤ 0.05) showed a significant difference concerning mortality between the control and the concentrations of 500 and 1000 mg test item/kg soil (dw). Therefore, NOECMortality was determined as 250 mg test item/kg soil (dw). Accordingly, the LOECMortality was determined as 500 mg test item/kg soil (dw).
Statistical analysis showed no significant difference (Welch t-test, 2-sided; p ≤ 0.05) concerning biomass development of individual adults over 28 days between the control and all concentrations of the test item. Therefore, the NOECBiomass was considered to be ≥ 1000 mg test item/kg soil (dw) (the highest concentration tested). The LOECBiomass could not be determined and was regarded as > 1000 mg test item/kg soil (dw).
Statistical analysis (Williams t-test; 1-sided, p ≤ 0.05) showed a significant difference concerning the number of juveniles between the control and the concentrations of 250, 500 and 1000 mg test item/kg soil (dw). All other concentrations tested did not differ statistically significantly from the control.
Therefore, the NOECReproduction was determined to be 125 mg test item/kg soil (dw) and accordingly, the LOECReproduction as 250 mg test item/kg soil (dw)
The EC10 and EC50 values were calculated with the nonlinear regression using the 3-parameter normal CDF.
The EC10 was calculated as 176.1 mg test item/kg soil (dw) (95% Confidence limits (CL) = 151.0 – 202.3 mg test item/kg soil (dw)).
The EC50 was calculated as 441.9 mg test item/kg soil (dw) (95% CL = 414.3 – 475.3 mg test item/kg soil (dw)).
The EC50 value for boric acid tested as the toxic reference in a separate study (ECT study number IRR1602) was calculated by Probit analysis using linear max. likelihood regression as 325.4 mg boric acid/kg artificial soil (dw) (95% confidence limits: 314.6 – 349.7 mg boric acid/kg artificial soil (dw)). The estimated EC50 value is slightly lower than recommended by the guideline. However, since the calculated EC50 is a factor of 1.2 lower than the recommended value of 400 mg Boric acid/ kg soil (dw) acceptable sensitivity of the test system is assumed.
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