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EC number: 606-078-8 | CAS number: 186321-96-0
- 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
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 04 April 2016 and 15 August 20016
- 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:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Batch No. Ei 2985
- Expiration date of the lot/batch: 01 December 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient 10 - 30”C - Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- Water
- Details on preparation and application of test substrate:
- Method of mixing into soil (if used):
Prior to treatment the initial moisture content of the soil was determined as 25.23% and the maximum water holding capacity (MWHC) as 65.17%. A moisture content equivalent to 55% of MWHC was selected as providing suitable conditions for earthworm development and the soil was pre-moistened to 27.5% MWHC. The volume required to achieve 55% of the maximum water holding capacity was calculated as 233.5 mL water/2200 g dry ISO earthworm soil.
The amount of test item required to achieve the final soil concentration was added as a solution in 233.5 mL of reverse osmosis water to bring the soil moisture content to 55% MWHC. The treated soil was then mixed in for approximately two minutes using a hand held electric mixer.
Prior to treatment the initial moisture content of the soil was determined as 25.23% and the maximum water holding capacity (MWHC) as 65.17%. A moisture content equivalent to 55% of MWHC was selected as providing suitable conditions for earthworm development and the soil was pre-moistened to 27.5% MWHC. The volume required to achieve 55% of the maximum water holding capacity was calculated as 233.5 mL water/2200 g dry ISO earthworm soil.
The amount of test item required to achieve the final soil concentration was added as a solution in 233.5 mL of reverse osmosis water to bring the soil moisture content to 55% MWHC. The treated soil was then mixed in for approximately two minutes using a hand held electric mixer.
- Controls:
For the water control 445.77 mL RO water was mixed into a 4200 g dry weight equivalent of moist soil to bring the soil to 55% moisture content.
For the toxic reference 100 mL of Mascot Systemic treatment solution was mixed into a 4200 g dry weight equivalent of moist soil. A further 345.77 mL of reverse osmosis water was added to bring the soil to 55% of the maximum water holding capacity.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Water
- Concentration of vehicle in test medium (stock solution and final test solution): Final = 9.42, 5.234, 2.908, 1.615, 0.8976, 0.4985, 0.277, 0.1538 mg/mL
- Evaporation of vehicle before use: no- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: earthworm
- Source: detailed in raw data
- Age at test initiation (mean and range, SD): adult
- Weight at test initiation (mean and range, SD): 250-600 mg
ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions (same as test or not): yes
- Health during acclimation (any mortality observed): not specified - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Remarks:
- On Day 28 of the study the soil was removed from the containers the numbers of live adults were recorded, the soil was returned to the containers and the adult worms discarded. The no. of surviving juvenile worms in each replicate was determined on Day 56
- Test temperature:
- 18 - 22.1 ”C
- pH:
- 6.2
- Moisture:
- 55% Maximum Water Holding Capacity (MWHC)
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): plastic; 11 x 17 x 5 cm
- Amount of soil or substrate: 679.2g moist soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- No. of replicates per vehicle control: 8
OTHER TEST CONDITIONS
- Photoperiod: 16h light: 8h dark
- Light intensity: 411 - 800 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
VEHICLE CONTROL PERFORMED: yes
- Nominal and measured concentrations:
- 9.42, 5.234, 2.908, 1.615, 0.8976, 0.4985, 0.277, 0.1538 mg/mL equivlent to
1000, 555.6, 308.6, 171.5, 95.3, 52.9, 29.4, 16.3 mg/kg dry soil - Reference substance (positive control):
- yes
- Remarks:
- Carbendazim (Mascot Systemic)
- Key result
- Duration:
- 28 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 ng/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- Adult
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1 000 ng/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- Adult
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1 000 ng/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- not specified
- Remarks:
- Juveniles
- Details on results:
- Health and Mortality
Adult mortality was 0% at all rates of application and in both the water control and toxic reference groups.
The LC50 for adult mortality at Day 28 was >1000 mg/kg dry soil. A NOEC of 1000 mg/kg dry soil was achieved.
Bodyweights
There was no statistically significant impact on adult bodyweight at any treatment rate.
The adjusted mean bodyweights on Day 28 at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil were 514.1, 483.8, 514.6, 481.5, 501.0, 501.0, 497.7,
453.1 mg respectively compared to 491.0 mg in the water control.
The LC50 for mean bodyweight of the adult earthworm at Day 28 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
There was a statistically significant reduction (p<0.001**) in the bodyweight of the Mascot Systemic group at 5 mg a.i./kg dry soil.
Juvenile Worms
Control group productivity was acceptable (mean of 294.8 juveniles per replicate). The coefficient of variation of the number of juveniles in the negative water control group was 4.98%.
The mean number of juveniles produced at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil was 306.0, 321.8, 305.0, 220.8, 251.5, 298.8, 271.3, 275.8 respectively compared to 294.8 in the water control.
There was a significant reduction in the number of juveniles produced at 95.3 mg/kg dry soil.
The EC50 for the number of juveniles on Day 56 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
There was a statistically significant reduction (p<0.001***) in the mean number of juveniles of the Mascot Systemic group at 5 mg a.i./kg dry soil.. - Results with reference substance (positive control):
- Bodyweights
There was a statistically significant reduction (p<0.001**) in the bodyweight of the Mascot Systemic group at 5 mg a.i./kg dry soil
Juvenile worms
There was a statistically significant reduction (p<0.001***) in the mean number of juveniles of the Mascot Systemic group at 5 mg a.i./kg dry soil. - Validity criteria fulfilled:
- yes
- Conclusions:
- No adult mortality was recorded at any treatment rate.
The LC50 for adult mortality at Day 28 was >1000 mg/kg dry soil. The confidence intervals could not be obtained. A NOEC of 1000 mg/kg dry soil was achieved.
There was no statistically significant impact on adult bodyweight at any treatment rate.
The adjusted mean bodyweights on Day 28 at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil were 514.1, 483.8, 514.6, 481.5, 501.0, 501.0, 497.7 and
453.1 mg respectively compared to 491.0 mg in the water control.
The LC50 for mean bodyweight of the adult earthworm at Day 28 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
There was a statistically significant reduction in the number of juveniles produced at 95.3 mg/kg dry soil and in the toxic reference group Mascot systemic.
The mean number of juveniles produced at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil was 306.0, 321.8, 305.0, 220.8, 251.5, 298.8, 271.3, 275.8 respectively compared to 294.8 in the water control.
The EC50 for the number of juveniles on Day 56 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
The study was considered valid as there was ≤ 10% adult mortality at four weeks and ≥30 juveniles had been produced in each water control replicate by the end of the test with the coefficient of variation of reproduction ≤ 30%. In addition application of the toxic reference Mascot Systemic at 5 mg a.i./kg dry soil resulted in substantial and unequivocal toxic effects. - Executive summary:
A study was performed to determine the effects of TOFA_TETA_PAA_BADGE_CGE_Adduct (hereafter referred to as TOFA or the test item in the text and as TOFA in tables) on the reproduction and growth of the earthworm, Eisenia fetida, in an artificial soil under laboratory conditions. The method followed was that described in OECD 222 Guideline for the testing of Chemicals, Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) 2004.
Ten groups of worms were allocated to the reproduction study. Eight groups of 40 worms were treated with the test item at test rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil weight, mixed into the soil. A similar control group, 80 worms, was maintained in untreated soil to act as a negative control, and a positive control group, 80 worms, was treated with Mascot Systemic (active ingredient carbendazim) at 5 mg a.i./kg dry soil weight. Adult worms were removed from the soil four weeks after treatment and the juvenile worms reared for a further four weeks.
Findings
No adult mortality was recorded at any treatment rate.
The LC50 for adult mortality at Day 28 was >1000 mg/kg dry soil. The confidence intervals could not be obtained. A NOEC of 1000 mg/kg dry soil was achieved. T
here was no statistically significant impact on adult bodyweight at any treatment rate.
The adjusted mean bodyweights on Day 28 at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil were 514.1, 483.8, 514.6, 481.5, 501.0, 501.0, 497.7, 453.1 mg respectively compared to 491.0 mg in the water control.
The LC50 for mean bodyweight of the adult earthworm at Day 28 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
There was a statistically significant reduction in the number of juveniles produced at 95.3 mg/kg dry soil and in the toxic reference group Mascot systemic.
The mean number of juveniles produced at rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil was 306.0, 321.8, 305.0, 220.8, 251.5, 298.8, 271.3, 275.8 respectively compared to 294.8 in the water control.
The EC50 for the number of juveniles on Day 56 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
The study was considered valid as there was ≤ 10% adult mortality at four weeks and ≥30 juveniles had been produced in each water control replicate by the end of the test with the coefficient of variation of reproduction ≤ 30%. In addition application of the toxic reference Mascot Systemic at 5 mg a.i./kg dry soil resulted in substantial and unequivocal toxic effects.
Reference
Description of key information
A study was performed to determine the effects of TOFA_TETA_PAA_BADGE_CGE_Adduct (hereafter referred to as TOFA or the test item in the text and as TOFA in tables) on the reproduction and growth of the earthworm, Eisenia fetida, in an artificial soil under laboratory conditions. The method followed was that described in OECD 222 Guideline for the testing of Chemicals, Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) 2004.
Ten groups of worms were allocated to the reproduction study. Eight groups of 40 worms were treated with the test item at test rates of 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry soil weight, mixed into the soil. A similar control group, 80 worms, was maintained in untreated soil to act as a negative control, and a positive control group, 80 worms, was treated with Mascot Systemic (active ingredient carbendazim) at 5 mg a.i./kg dry soil weight. Adult worms were removed from the soil four weeks after treatment and the juvenile worms reared for a further four weeks.
The LC50 for adult mortality at Day 28 was >1000 mg/kg dry soil. The confidence intervals could not be obtained. A NOEC of 1000 mg/kg dry soil was achieved. There was no statistically significant impact on adult bodyweight at any treatment rate.
The LC50 for mean bodyweight of the adult earthworm at Day 28 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.
The EC50 for the number of juveniles on Day 56 could not be estimated because there was not a dose-response relationship. A NOEC of 1000 mg/kg dry soil was achieved.Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 1 000 mg/kg soil dw
Additional information
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