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EC number: 245-740-7 | CAS number: 23564-05-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
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- Endpoint summary
- Stability
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-02-07 to 2017-06-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Version / remarks:
- July 29, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- Acetone
- Details on preparation and application of test substrate:
- The composition of this artificial soil was based on OECD Guideline No. 222 (2016) (the percentages refer to the dry weight):
- 10 % Sphagnum peat (no visible plant remains; finely ground and air-dried)
- 20 % Kaolin-Clay (kaolinite content > 30 %)
- 69 – 70 % Quartz sand (fine sand content with particles between 50 and 200 microns higher than 50 %)
- 0.3 - 1 % Calcium carbonate (CaCO3).
The pH value was adjusted to 6 ± 0.5 using calcium carbonate. The moisture content was adjusted to 40-60 % of WHCmax using deionised water. The water content of the test substrate was checked weekly by reweighing the test vessels and losses of water were compensated.
The stock solution was mixed with a magnet stirrer for 5 minutes. The dosage solutions were stirred for 2 minutes. 55 mL of the respective solutions were spiked on 210 g quartz sand (2 x 55 mL acetone for the solvent control). After evaporation of the solvent under a fume hood, the coated quartz sand was incorporated into 1890 g artificial soil (total amount of 2100 g) to prepare the different test item soil concentrations. Water was added to adjust the final soil moisture of 40 to 60 % of WHCmax. The prepared soil was mixed for 5 min. - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworms
- Source: Co. Landenberger (D-72355 Schömberg)
- Age at test initiation: at least two months, but not more than one year old
- Weight at test initiation: 300 – 600 mg
ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions: same as test
- Health during acclimation: no mortality observed - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Test temperature:
- 20 ± 2 °C
- pH:
- 6 ± 0.5 °C
- Moisture:
- 40 - 60 % of WHCmax
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Bellaplast containers consisting of inert (non-toxic) plastic (Polystyrol); base area of 11 x 15.5 cm (= 170.5 cm2) and a height of 6 cm
- Amount of soil or substrate: 500 g dw
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 1
- No. of replicates per vehicle control: 2
OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 400 - 800 Iux
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: 0.085, 0.152, 0.274, 0.494, 0.889, 1.60, 2.88 and 5.18 mg/kg soil (dw) - Nominal and measured concentrations:
- Nominal: 0.085, 0.152, 0.274, 0.494, 0.889, 1.60, 2.88 and 5.18 mg/kg soil (dw)
Measured: not determined - Reference substance (positive control):
- yes
- Remarks:
- Boric acid
- Key result
- Duration:
- 56 d
- Dose descriptor:
- EC50
- Effect conc.:
- 1.91 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 95 % confidence limits = 1.39 - 2.63 mg/kg soil (dw)
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.6 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 2.88 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 1.53 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 95 % confidence limits = 1.11 - 2.12 mg/kg soil (dw)
- Key result
- Duration:
- 56 d
- Dose descriptor:
- EC10
- Effect conc.:
- 1.36 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 95 % confidence limits = 0.88 - 2.11 mg/kg soil (dw)
- Duration:
- 28 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 5.18 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.88 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 28 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 5.18 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 28 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 5.18 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Biomass
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.88 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Biomass
- Details on results:
- - Mortality at end of exposure period: < 50 % in all concentrations
- Total mass of adults at beginning of test: 370.6 ± 28.0 mg to 379.0 ± 29.3 mg
- Changes in body weight of live adults (% of initial weight) at end of exposure period: between -37.4 - 64.8 %
- No. of offspring produced: 351.8 and 378.5 in the control and solvent control; uveniles in the test item treatment groups ranged from 0.0 to 428.0.
- Morphological abnormalities: none
- Behavioural abnormalities: none - Results with reference substance (positive control):
- In a separate GLP study, the EC50 value was calculated by Probit analysis using Linear Max. Likelihood Regression as 325.4 mg boric acid/kg soil (dw) (% confidence limits = 314.6 - 349.7 mg boric acid/kg artificial soil (dw)). The estimated EC50 value in this study is slightly lower than aspired by the guideline. However, since the calculated EC50 is lower by factor of 1.3 than the expected range of 400 - 600 mg boric acid/ kg soil (dw) acceptable sensitivity of the test system is assumed.
- Reported statistics and error estimates:
- Statistical evaluation:
Mortality: Fisher's Exact Test with Bonferroni Correction (1-sided, α = 0.05).
Biomass change: Data were checked for normality by R/s test procedure and for homogeneity by Levene's test. Afterwards, treatment means were compared by Dunnett's test (α = 0.05, two-sided) and tested for statistically significant differences compared to the solvent control.
Reproduction: Data were checked for normality by R/s test procedure and for homogeneity by Cochran's test. Treatment means were compared by ANOVA followed by William's test (α = 0.05, one-sided) and tested for statistically significant differences compared to the solvent control (Sachs 1982).
The statistical software package ToxRat Professional 3.2.1 was used for these calculations. - Validity criteria fulfilled:
- yes
- Conclusions:
- In a test according to OECD 222, the following endpoints were determined:
NOEC Mortality = 2.88 mg/kg soil (dw)
LOEC Mortality= 5.18 mg/kg soil (dw)
LC50 > 5.18 mg/kg soil (dw)
NOEC Reproduction = 1.60 mg/kg soil (dw)
LOEC Reproduction = 2.88 mg/kg soil (dw)
EC10 = 1.36 mg/kg soil (dw)
(95 % confidence limits = 0.88 - 2.11 mg/kg soil (dw)).
EC20 = 1.53 mg/kg soil (dw)
(95 % confidence limits = 1.11 -2.12 mg/kg soil (dw)).
EC50 = 1.91 mg/kg soil (dw)
(95 % confidence limits = 1.39 - 2.63 mg/kg soil (dw)).
NOEC Biomass = 2.88 mg/kg soil (dw)
LOEC Biomass = 5.18 mg/kg soil (dw). - Executive summary:
Reproduction toxicity of the test item to the earthworm Eienia fetida in artificial soil with 10% peat was assessed in a study according to OECD Test Guideline 222 and ISO 11268-2 under GLP conditions. The mortality and biomass were determined after 28 days while the reproduction was determined after 56 days. The following endpoints were determined: NOEC/LOECMortality NOEC/LOECBiomass, NOEC/LOECReproduction, and ECX values for reproduction. Statistical analysis was evaluated by Probit analysis using maximum likelihood regression, Fisher's Exact Test with Bonferroni Correction (1-sided, α = 0.05); ANOVA followed by Williams t-test for reproduction (1-sided, α = 0.05); Dunnetts t-test for biomass (2-sided, α = 0.05). All validity criteria were met. The following endpoints were observed.
Mortality
0 % mortality was observed in the control, 1.25 % in the solvent control and 0 - 45.0 % mortality in all concentrations of the test item tested.
Fisher's Exact Test (1-sided, α = 0.05) showed a significant difference concerning mortality between the solvent control and the highest test item concentration, e.g. 5.18 mg/kg soil (dw).
Therefore, NOECMortality was determined to be 2.88 mg/kg soil (dw). Accordingly the LOECMortality was regarded to be 5.18 mg/kg soil (dw).
Since mortality was < 50 % in all concentrations of the test item tested no LC50 value could be calculated but may be regarded to be > 5.18 mg/kg soil (dw).
Biomass change
Statistical analysis showed a significant difference (Dunnetts test, 2-sided; α = 0.05) concerning biomass development of individual adults over 28 days between the solvent control and the highest concentration of the test item tested.
Therefore, the NOECBiomass was determined to be 2.88 mg/kg soil (dw). The LOECBiomass is regarded to be 5.18 mg/kg soil (dw).
Reproduction
The mean number of juveniles was 351.8 and 378.5 in the control and solvent control, respectively. The mean number of juveniles in the test item treatment groups ranged from 0.0 to 428.0.
Statistical analysis (Williams test; 1-sided, α= 0.05) showed a significant difference concerning the number of juveniles between the solvent control and the two highest concentrations of the test item tested, e.g. 2.88 and 5.18 mg/kg soil (dw).
Therefore, the NOECReproduction was determined to be 1.60 mg/kg soil (dw). The LOECReproduction is regarded to be 2.88 mg/kg soil (dw).
The ECX values were calculated using Probit analysis applying linear maximum likelihood regression.
The EC10 was calculated to be 1.36 mg/kg soil (dw) (95 % confidence limits = 0.88 - 2.11 mg/kg soil (dw)).
The EC20 was calculated to be 1.53 mg/kg soil (dw) (95 % confidence limits = 1.11 -2.12 mg/kg soil (dw)).
The EC50 was calculated to be 1.91 mg/kg soil (dw) (95 % confidence limits = 1.39 - 2.63 mg/kg soil (dw)).
Reference
Table 1: Number of dead earthworms after 28 days (n = 80 for solvent control; n = 40 for control and the concentrations). Data are given as absolute values and in percent of the total number (mortality).
Concentration [mg Thiophanate-methyl/ kg soil (dw)] | Number of dead adult worms | Mortality [%] |
Day 28 | Day 28 | |
Control | 0 | 0.0 |
Solvent Control | 1 | 1.25 |
0.085 | 0 | 0.0 |
0.152 | 1 | 2.5 |
0.274 | 0 | 0.0 |
0.494 | 1 | 2.5 |
0.889 | 0 | 0.0 |
1.60 | 0 | 0.0 |
2.88 | 1 | 2.5 |
5.18 | 18 | 45.0* |
*Significantly different to solvent control (Fisher exact test, α = 0.05, one-sided)
Table 2: Average live weight (mg) per surviving adult earthworm at the beginning of the test and after 28 days (n = 80 for solvent control; n = 40 for control and the concentrations). Data are given as absolute value and in mean percent of the initial weight change per replicate.
Concentration [mg Thiophanate-methyl/ kg soil (dw)] | Biomass (mg fresh weight) | Mean change in % of the initial weight per replicate | |
Day 0 | Day 28 | Day 28 | |
Control | 379.0 ± 29.3 | 610.6 ± 28.0 | 61.6 |
Solvent Control | 376.6 ± 28.0 | 564.4 ± 30.8 | 50 5 |
0.085 | 377.8 ± 22.2 | 556.8 ± 34.1 | 47.4 |
0.152 | 373.0 ± 23.9 | 612.0 ± 20.7 | 64.8 |
0.274 | 370.6 ± 28.0 | 592.7 ± 47.7 | 60.0 |
0.494 | 375.3 ± 21.1 | 601.8 ± 37.4 | 61.0 |
0.889 | 375.7 ± 18.8 | 598.5 ± 41.3 | 59.2 |
1.60 | 371.3 ± 22.1 | 615.2 ± 27.8 | 66.1 |
2.88 | 373.9 ± 20.6 | 532.7 ± 16.8 | 42.6 |
5.18 | 377.5 ± 16.2 | 238.1 ± 97.3 | -37.4* |
* Significantly different to solvent control (Dunnett test, α = 0.05, two-sided)
Table 3: Reproduction after 56 days. Data are given as mean number of juveniles ± standard deviation and as % of the solvent control (n = 8 for solvent control; n = 4 for treatment and deionised water control).
Concentration [mg Thiophanate-methyl/ kg soil (dw)] | Number of Juveniles per Treatment (mean ± sd) | Number of Juveniles [% of Solvent Control] |
Control | 351.8 ± 40.6 | 92.9 |
Solvent Control | 378.5 ± 84.3 | 100.0 |
0.085 | 411.3 ± 116.0 | 108.7 |
0.152 | 388.3 ± 71.7 | 102.6 |
0.274 | 354.0 ± 73.0 | 93.5 |
0.494 | 428.0 ± 125.7 | 113.1 |
0.889 | 346.8 ± 109.9 | 91.6 |
1.60 | 285.0 ± 130.8 | 75.3 |
2.88 | 21.0 ± 12.4 | 5.5 * |
5.18 | 0.0 ± 0.0 | 0.0 * |
*significantly different to solvent control (Williams t-test, α = 0.05, one-sided)
Validity Criteria
Mortality of the adult test animals in the solvent control (required: equal or less than 10 %): 1.25 %
Mean number of juveniles per replicate in the solvent control (required: > 30): (± standard 378.5 ± 84.3 deviation)
The coefficient of variation for the number of juveniles in the solvent (required: < 30 %): 22.3 % control
The data provide evidence that the quality criteria have been fulfilled.
Description of key information
In a test according to OECD 222, the following endpoints were determined:
NOEC(Mortality) = 2.88 mg/kg soil (dw)
LOEC(Mortality) = 5.18 mg/kg soil (dw)
LC50 (Mortality) > 5.18 mg/kg soil (dw)
NOECReproduction = 1.60 mg/kg soil (dw)
LOECReproduction = 2.88 mg/kg soil (dw)
EC10(Reproduction) = 1.36 mg/kg soil (dw) (95 % confidence limits = 0.88 - 2.11 mg/kg soil (dw)).
EC20(Reproduction) = 1.53 mg/kg soil (dw) (95 % confidence limits = 1.11 -2.12 mg/kg soil (dw)).
EC50(Reproduction) = 1.91 mg/kg soil (dw) (95 % confidence limits = 1.39 - 2.63 mg/kg soil (dw)).
NOECBiomass = 2.88 mg/kg soil (dw)
LOECBiomass = 5.18 mg/kg soil (dw).
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 1.6 mg/kg soil dw
Additional information
Reproduction toxicity of the test item to the earthworm Eienia fetida in artificial soil with 10% peat was assessed in a study according to OECD Test Guideline 222 and ISO 11268-2 under GLP conditions. The mortality and biomass were determined after 28 days while the reproduction was determined after 56 days. The following endpoints were determined: NOEC/LOECMortality NOEC/LOECBiomass, NOEC/LOECReproduction, and ECX values for reproduction. Statistical analysis was evaluated by Probit analysis using maximum likelihood regression, Fisher's Exact Test with Bonferroni Correction (1-sided, α = 0.05); ANOVA followed by Williams t-test for reproduction (1-sided, α = 0.05); Dunnetts t-test for biomass (2-sided, α = 0.05). All validity criteria were met. The following endpoints were observed.
Mortality
0 % mortality was observed in the control, 1.25 % in the solvent control and 0 - 45.0 % mortality in all concentrations of the test item tested.
Fisher's Exact Test (1-sided, α = 0.05) showed a significant difference concerning mortality between the solvent control and the highest test item concentration, e.g. 5.18 mg/kg soil (dw).
Therefore, NOECMortality was determined to be 2.88 mg/kg soil (dw). Accordingly the LOECMortality was regarded to be 5.18 mg/kg soil (dw).
Since mortality was < 50 % in all concentrations of the test item tested no LC50 value could be calculated but may be regarded to be > 5.18 mg/kg soil (dw).
Biomass change
Statistical analysis showed a significant difference (Dunnetts test, 2-sided; α = 0.05) concerning biomass development of individual adults over 28 days between the solvent control and the highest concentration of the test item tested.
Therefore, the NOECBiomass was determined to be 2.88 mg/kg soil (dw). The LOECBiomass is regarded to be 5.18 mg/kg soil (dw).
Reproduction
The mean number of juveniles was 351.8 and 378.5 in the control and solvent control, respectively. The mean number of juveniles in the test item treatment groups ranged from 0.0 to 428.0.
Statistical analysis (Williams test; 1-sided, α= 0.05) showed a significant difference concerning the number of juveniles between the solvent control and the two highest concentrations of the test item tested, e.g. 2.88 and 5.18 mg/kg soil (dw).
Therefore, the NOECReproduction was determined to be 1.60 mg/kg soil (dw). The LOECReproduction is regarded to be 2.88 mg/kg soil (dw).
The ECX values were calculated using Probit analysis applying linear maximum likelihood regression.
The EC10 was calculated to be 1.36 mg/kg soil (dw) (95 % confidence limits = 0.88 - 2.11 mg/kg soil (dw)).
The EC20 was calculated to be 1.53 mg/kg soil (dw) (95 % confidence limits = 1.11 -2.12 mg/kg soil (dw)).
The EC50 was calculated to be 1.91 mg/kg soil (dw) (95 % confidence limits = 1.39 - 2.63 mg/kg soil (dw)).
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