Registration Dossier
Registration Dossier
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EC number: 231-869-6 | CAS number: 7773-01-5
Toxicity to soil macroorganisms except arthropods
Administrative data
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted to a guideline with plenty of detail. A reliability higher than 2 is not appropriate due to validity of the test not being met for cocoon numbers apart from the lowest dose.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- See the read-across report attached in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- See the read-across report attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 111 mg/kg soil dw
- Nominal / measured:
- not specified
- Conc. based on:
- other: Mn
- Basis for effect:
- reproduction
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
- Deviations:
- yes
- Remarks:
- natural soil used rather than artificial soil
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Manganese sulphate monohydrate
- IUPAC Name:
- Manganese sulphate monohydrate
- Details on test material:
- - Name of test material (as cited in study report): Manganese sulphate mono hydrate
- Lot/batch No.: Stock # 33341 Lot #I18129
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test substrate
- Details on preparation and application of test substrate:
- The test substrate is a natural soil containing 1.2% organic matter.
Test organisms
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
Study design
- Study type:
- laboratory study
- Substrate type:
- natural soil
- Limit test:
- no
- Total exposure duration:
- 21 d
Results and discussion
Effect concentrations
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 111 mg/kg soil dw
- Conc. based on:
- other: Mn
- Basis for effect:
- reproduction
Any other information on results incl. tables
Range-finding tests for manganese (Mn) were performed using Mn sulphate (MnSO4·H2O). Nominal concentrations of Mn (w/w) in soil were 0, 100, 500, 1000, 5000, and 10000 mg/kg. Results showed cocoon production was 69% of control at 500 mg/kg and 4% of control at 1000 mg/kg. No cocoons were produced in soil containing mg more than 1000 mg/kg.
ANOVA results of definitive cocoon production tests using actual measured concentrations of Mn produced a bounded NOEC of 1111 mg/kg and a bounded LOEC of 1236 mg/kg at P=0.05. Cocoon production was analyzed by nonlinear regression. The Gompertz nonlinear model produced best fit. The EC50 derived from this model for toxicity of Mn to E.fetida cocoon production was 629 mg/kg. The EC50 was 927 mg/kg. Results of the definitive adult survival tests using actual measured concentrations of Mn, showed a bounded NOEC of 1444 mg/kg and a bounded LOEC of 2222 mg/kg. Adult EC20 and EC50 values were 1718 mg/kg and 1920 mg/kg, respectively.
Endpoint |
Cocoon production |
Adult |
NOEC mg/kg |
1111 |
1444 |
LOEC mg/kg |
1236 |
2222 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- no
- Remarks:
- Only in the lowest concentration group (100 mg/kg) had a coefficient of variation less than 30%. Mean mortality was less than 10% in the definitive study, apart from top dose, and in rangefinder for concentrations up to 500 mg/kg.
- Conclusions:
- The 21 day NOEC based on reproduction is 1111 mg Mn/kg soil
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