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EC number: - | CAS number: -
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across: supporting information
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 871 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: adult mortality
- Remarks on result:
- other: 95% confidence interval 783 to 978 mg/kg dry soil
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 560 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: adult mortality
- Duration:
- 42 d
- Dose descriptor:
- EC50
- Effect conc.:
- 278.4 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: number of juveniles
- Remarks on result:
- other: 95 % confidence limits 164.9 to 470.0 mg/kg dry soil
- Duration:
- 42 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: number of juveniles
- Details on results:
- RANGE-FINDER
- Data from the range-finding study is shown in Table 1 (attached).
- Adult mortality was reported as 0 % (0.1 mg/kg dry soil), 0 % (1 mg/kg dry soil), 0 % (10 mg/kg dry soil), 0 % (100 mg/kg dry soil) and 33.3 % (1000 mg/kg dry soil).
- Adult mortality was 10 % in the solvent and water control groups.
CHEMICAL ANALYSIS
- The formulation analysis report is presented in Annex 2 (attached).
- Mean concentration of substance in test formulations prepared for application in the definitive test were within the applied limits ± 20 %, which confirmed accurate formulation.
HEALTH AND MORTALITY
- Adult mortality is shown in Table 2 and Appendix 1 (attached).
- The LC50 value is shown in Table 3 (attached).
- Adult mortality was found to be 0 % (20 mg/kg dry soil), 0 % (35 mg/kg dry soil), 0 % (60 mg/kg dry soil), 0 % (100 mg/kg dry soil), 0 % (175 mg/kg dry soil), 0 % (315 mg/kg dry soil), 10 % (560 mg/kg dry soil) and 67.5 % (1000 mg/kg dry soil).
- Adult mortality was 2.5 % in the solvent and water control groups.
- At 1000 mg/kg dry soil, the adult worms appeared small and inactive.
JUVENILE WORMS
- The numbers of juvenile worms counted at termination are shown in Table 4 and Appendix 2 (attached).
- The EC50 value is given in Table 5 (attached).
- Control group productivity was acceptable (mean of 136.0 juveniles per replicate in the solvent control and 153.4 in the water control).
- The coefficient of variation of the number of juveniles in the solvent control group was 6.76 %.
- The mean number of juveniles produced was 144.0 (20 mg/kg dry soil), 121.8 (35 mg/kg dry soil), 99.8 (60 mg/kg dry soil), 92.3 (100 mg/kg dry soil), 86.5 (175 mg/kg dry soil), 80.3 (315 mg/kg dry soil), 43.5 (560 mg/kg dry soil) and 25.0 (1000 mg/kg dry soil).
- Mean number of juveniles produced was 136.0 in the solvent control and 153.4 in the water control.
- A reduction in the number of juveniles was calculated as 0 % (20 mg/kg dry soil), 10.4 % (35 mg/kg dry soil), 26.6 % (60 mg/kg dry soil), 32.1 % (100 mg/kg dry soil), 36.4 % (175 mg/kg dry soil), 41.0 % (315 mg/kg dry soil), 68.0 % (560 mg/kg dry soil) and 81.6 % (1000 mg/kg dry soil). - Results with reference substance (positive control):
- - Adult mortality was 23.8% in the positive control group.
- Mean number of juveniles produced in the positive control group was 3.8. - Reported statistics and error estimates:
- - Statistical analysis was carried out using SAS 9.1 (SAS Institute 2002).
- The statistical report is presented in Annex 3 (attached).
- Statistically significant reduction in number of adults was observed at 1000 mg/kg dry soil (p < 0.001***).
- Statistically significant reductions in number of juveniles was observed at 175 and 315 mg/kg dry soil (0.004**) and 560 and 1000 mg/kg dry soil (p < 0.001***).
- There was a statistically significant reduction in the mean number of juveniles in the positive control group(p < 0.001***). - Validity criteria fulfilled:
- yes
- Conclusions:
- The LC50 for adult mortality on Day 21 was 871 mg/kg dry soil (95 % confidence interval 783 mg/kg dry soil to 978 mg/kg dry soil). The NOEC was 560 mg/kg dry soil. The EC50 for the number of juveniles on Day 42 was 278.4 mg/kg dry soil (95 % confidence interval 164.9 to 470.0 mg/kg dry soil). The NOEC was 100 mg/kg dry soil.
- Executive summary:
GUIDELINE
A study was performed to assess the effects of the test item on the reproductive output of the enchytraeid wom Enchytraeus albidus in an artificial soil under laboratory conditions. The method followed was that described in OECD Guideline for the testing of Chemicals (2004) No 220, Enchytraeid Reproductive Test.
METHOD
Eleven groups of worms were allocated to the study and eight groups of 40 worms were treated with test item at 20, 35, 60, 100, 175, 315, 560 and 1000 mg/kg dry soil. The three groups of 80 worms were water control, solvent control and a positive control group treated with Mascot Systemic (active ingredient carbendazim) at 1.2 mg/kg dry soil. Adult worms were removed from the soil on Day 21 and the juvenile worms were reared until Day 42.
RESULTS
Adult mortality was reported as 0 % (20, 35, 60, 100, 175 and 315 mg/kg dry soil), 10 % (560 mg/kg dry soil) and 67.5 % (1000 mg/kg dry soil) compared to 2.5 % in the solvent and water control groups and 23.8 % in the positive control group. The mean number of juveniles produced was 144.0 (20 mg/kg dry soil), 121.8 (350 mg/kg dry soil), 99.8 (60 mg/kg dry soil), 92.3 (100 mg/kg dry soil), 86.5 (175 mg/kg dry soil), 80.3 (315 mg/kg dry soil), 43.5 560 mg/kg dry soil) and 25.0 (1000 mg/kg dry soil). The mean number of juveniles produced was 136.0 in the solvent control group and 153.4 in the water control group. A mean of 3.8 juveniles was produced in the positive control group.
Reduction in the number of juveniles was calculated as 0, 10.4, 26.6, 32.1, 36.4, 41.0, 68.0 and 81.6 % at test item treatment rates of 20, 35, 60, 100, 175, 315, 560 and 1000 mg/kg dry soil compared to the solvent control. Statistically significant reductions were observed at 175 and 315 mg/kg dry soil (0.004**) and 560 and 1000 mg/kg dry soil (p < 0.001***).
The study was considered valid as there was ≤ 20 % adult mortality at Day 21 and ≥ 25 juveniles had been produced in each control replicate by the end of the test with the coefficient of variation of reproduction ≤ 50 %. In addition, application of the toxic reference (carbendazim applied at 1.2 mg/kg dry soil) resulted in substantial and unequivocal toxic effects.
CONCLUSION
The LC50 for adult mortality on Day 21 was 871 mg/kg dry soil (95 % confidence interval 783 mg/kg dry soil to 978 mg/kg dry soil). The NOEC was 560 mg/kg dry soil. The EC50 for the number of juveniles on Day 42 was 278.4 mg/kg dry soil (95 % confidence interval 164.9 to 470.0 mg/kg dry soil). The NOEC was 100 mg/kg dry soil.
Reference
MOISTURE CONTENT OF SOIL |
|||||||||||
Time (days) |
% maximum water holding capacity |
||||||||||
Water control |
Solvent control |
Test item (mg/kg dry soil) |
Carbendazim (1.2 mg/kg dry soil) |
||||||||
20 |
35 |
60 |
100 |
175 |
315 |
560 |
1000 |
||||
0 |
55 |
56 |
54 |
54 |
55 |
55 |
55 |
55 |
55 |
56 |
56 |
42 |
55 |
56 |
55 |
54 |
55 |
55 |
57 |
55 |
55 |
55 |
56 |
TEST SOIL pH |
|||||||||||
Time (days) |
% maximum water holding capacity |
||||||||||
Water control |
Solvent control |
Test item (mg/kg dry soil) |
Carbendazim (1.2 mg/kg dry soil) |
||||||||
20 |
35 |
60 |
100 |
175 |
315 |
560 |
1000 |
||||
0 |
6.1 |
6.1 |
6.1 |
6.1 |
6.1 |
6.1 |
6.1 |
6.1 |
6.2 |
6.2 |
6.2 |
42 |
6.3 |
6.3 |
6.4 |
6.4 |
6.4 |
6.4 |
6.4 |
6.4 |
6.4 |
6.2 |
6.1 |
Pre-treatment pH = 6.2 |
|||||||||||
Description of key information
The LC50 for adult mortality on Day 21 was 871 mg/kg dry soil (95 % confidence interval 783 mg/kg dry soil to 978 mg/kg dry soil). The NOEC was 560 mg/kg dry soil. The EC50 for the number of juveniles on Day 42 was 278.4 mg/kg dry soil (95 % confidence interval 164.9 to 470.0 mg/kg dry soil). The NOEC was 100 mg/kg dry soil (OECD 220).
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 278.4 mg/kg soil dw
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 100 mg/kg soil dw
Additional information
GUIDELINE
A study was performed to assess the effects of the test item on the reproductive output of the enchytraeid wom Enchytraeus albidus in an artificial soil under laboratory conditions. The method followed was that described in OECD Guideline for the testing of Chemicals (2004) No 220, Enchytraeid Reproductive Test.
METHOD
Eleven groups of worms were allocated to the study and eight groups of 40 worms were treated with test item at 20, 35, 60, 100, 175, 315, 560 and 1000 mg/kg dry soil. The three groups of 80 worms were water control, solvent control and a positive control group treated with Mascot Systemic (active ingredient carbendazim) at 1.2 mg/kg dry soil. Adult worms were removed from the soil on Day 21 and the juvenile worms were reared until Day 42.
RESULTS
Adult mortality was reported as 0 % (20, 35, 60, 100, 175 and 315 mg/kg dry soil), 10 % (560 mg/kg dry soil) and 67.5 % (1000 mg/kg dry soil) compared to 2.5 % in the solvent and water control groups and 23.8 % in the positive control group. The mean number of juveniles produced was 144.0 (20 mg/kg dry soil), 121.8 (350 mg/kg dry soil), 99.8 (60 mg/kg dry soil), 92.3 (100 mg/kg dry soil), 86.5 (175 mg/kg dry soil), 80.3 (315 mg/kg dry soil), 43.5 560 mg/kg dry soil) and 25.0 (1000 mg/kg dry soil). The mean number of juveniles produced was 136.0 in the solvent control group and 153.4 in the water control group. A mean of 3.8 juveniles was produced in the positive control group.
Reduction in the number of juveniles was calculated as 0, 10.4, 26.6, 32.1, 36.4, 41.0, 68.0 and 81.6 % at test item treatment rates of 20, 35, 60, 100, 175, 315, 560 and 1000 mg/kg dry soil compared to the solvent control. Statistically significant reductions were observed at 175 and 315 mg/kg dry soil (0.004**) and 560 and 1000 mg/kg dry soil (p < 0.001***).
The study was considered valid as there was ≤ 20 % adult mortality at Day 21 and ≥ 25 juveniles had been produced in each control replicate by the end of the test with the coefficient of variation of reproduction ≤ 50 %. In addition, application of the toxic reference (carbendazim applied at 1.2 mg/kg dry soil) resulted in substantial and unequivocal toxic effects.
CONCLUSION
The LC50 for adult mortality on Day 21 was 871 mg/kg dry soil (95 % confidence interval 783 mg/kg dry soil to 978 mg/kg dry soil). The NOEC was 560 mg/kg dry soil. The EC50 for the number of juveniles on Day 42 was 278.4 mg/kg dry soil (95 % confidence interval 164.9 to 470.0 mg/kg dry soil). The NOEC was 100 mg/kg dry soil.
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