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EC number: 274-581-6 | CAS number: 70356-09-1
- 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: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 07 March 2022 to 15 August 2022
- 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:
- 2016
- Deviations:
- yes
- Remarks:
- Food was provided on day 0 instead of day 1. At test end, soil moisture deviated by more than 10 % from the initial value in all treatments. Temperature decreased to min. 17 °C for in total about 32 h. These deviations are considered to have no impact.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: The respective test item amount was weighed out for each test item concentration and mixed thoroughly with quartz sand (10 g per replicate). The spiked quartz sand was given to the artificial soil (2360 g SDW). Demineralised water (300 g) was added to adjust the humidity of the artificial soil to a moisture of 54% of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 600 g soil dry weight was filled into each test vessel.
- Controls: Artificial soil moistened with demineralised water without test or reference item was used as control medium - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworm
- Source: Breeding stock culture maintained at the test facility
- Breeding: Organisms of the species Eisenia fetida are bred at the test facility in covered plastic vessels containing potting compost.
- Synchronisation of the earthworm population: Earthworms of homogeneous age and body weight were used in the definitive test. Synchronisation of the population was achieved by placing adult earthworms into breeding boxes and removing the adults after 4 weeks. Offspring from the remaining cocoons reached the adult age after 2 months at the earliest.
- Age at test initiation: Adult earthworms (with clitellum) aged 2 -12 months - Weight at test initiation: 0.38 to 0.57 g (wet mass)
- Feeding during breeding: Earthworms were fed with a litter of dried stinging nettle leaves and porridge oats. A sufficientamount of the food was provided depending on the feeding rate and the density of the earthworm population in the vessels.
- Homogeneity of groups: The worms were washed with demineralised water and dried gently on a paper towel. Thehomogeneity of the population was checked by weighing the earthworms. After confirmation of homogeneity, groups of 10 earthworms (chosen by a randomised procedure) were weighed and introduced into each test vessel.
ACCLIMATION
- Acclimation period: 2 days
- Acclimation conditions: Earthworms were acclimatised to the artificial soil to be used for the test (moisture content 54 % of the water holding capacity) - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 8 wk
- Test temperature:
- 17 - 22 °C
- pH:
- 6.14 - 6.61
- Moisture:
- 23.9 - 31.4 % of dry weight
- Details on test conditions:
- TEST SYSTEM
- Test container: Round plastic boxes with an inner diameter of 15.0 cm corresponding to a bottom surface area of 177 cm2 and a height of 14 cm. Transparent and perforated lids enabled sufficient gas exchange, light input and prevented the test substrate from drying.
- Amount of soil or substrate: 600 g soil (dry weight)
- No. of organisms per container: 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
SOURCE AND PROPERTIES OF SUBSTRATE
- Composition of artificial soil:
10 % peat, air-dried and finely ground
20 % kaolin, clay, kaolinite content > 30 %
69 % air-dried quartz sand (sand with > 50 % particle size of 0.05 - 0.2 mm)
0.30 % calcium carbonate (CaCO3) to achieve a pH of 6.0 ± 0.5
- Maximum water holding capacity: 45.0 (g/100 g dw)
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark
- Light intensity: 529 ± 102 lx
EFFECT PARAMETERS MEASURED: After the first 4 weeks of the test, mortality and biomass of the adult worms were determined. After further 4 weeks the reproduction rate was determined by counting the hatched juveniles.
TEST CONCENTRATIONS
- Range finding study: A preliminary range finding test was performed with 4 test item concentrations each containing 2 replicates with 10 earthworms each.
- Test concentrations in range finding study: control, 1, 10, 100, 1000 mg/kg soil dry weight
- Results used to determine the conditions for the definitive study: No mortality was observed in neither test concentration in the range findings study. The highest change of live weight was observed in test concentration 1 mg/kg soil dry weight with -15 % (decrease of live weight). - Nominal and measured concentrations:
- Nominal concentrations: 31.25, 62.5, 125, 250, 500, 1000 mg test item/kg soil dry weight (SDW).
- Reference substance (positive control):
- yes
- Remarks:
- Carbendazim; Test concentrations 0.5 - 1 - 2 - 4 mg a.i./kg SDW; According to guideline, significant effects should be between 1 and 5 mg a.i./kg SDW.
- Key result
- Duration:
- 8 wk
- Dose descriptor:
- EC10
- Effect conc.:
- 202 mg/kg soil dw
- 95% CI:
- 134 - 368
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 8 wk
- Dose descriptor:
- other: EC20
- Effect conc.:
- 454 mg/kg soil dw
- 95% CI:
- 298 - 791
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 8 wk
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 8 wk
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- biomass
- Duration:
- 8 wk
- Dose descriptor:
- NOEC
- Effect conc.:
- 250 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 8 wk
- Dose descriptor:
- LOEC
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- biomass
- Duration:
- 8 wk
- Dose descriptor:
- LOEC
- Effect conc.:
- 500 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality at end of exposure period: Earthworm mortalities < 10 %
- Total mass of adults at beginning of test: 36.3 g in control, 18.1 - 18.2 g in each test vessel.
- Changes in body weight of live adults at end of exposure period: There were no statistically significant differences in earthworm biomass at any test item concentration compared to the control.
- No. of mean offspring produced: 84 - 122
- Morphological abnormalities: No significant pathological symptoms or changes in the behaviour of adult earthworms were observed in the control and all test item concentrations on day 28. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
According to OECD 222 significant effects of Carbendazim should be observed between 1 and 5 mg a.i./kg SDW.
- Significant effects levels: 0.5, 1, 2, 4 mg a.i./kg soil dry weight - Reported statistics and error estimates:
- see "attachments"
- Validity criteria fulfilled:
- yes
- Conclusions:
- Following long-term toxicity effects were determined after 8 weeks:
LOEC (mortality, biomass) > 1000 mg/kg soil dry weight
NOEC (mortality, biomass) ≥ 1000 mg/kg soil dry weight
LOEC (reproduction) = 500 mg/kg soil dry weight
NOEC (reproduction) = 250 mg/kg soil dry weight
EC10, EC20, EC50 (reproduction): 202, 454 and > 1000 mg/kg soil dry weight, respectively. - Executive summary:
The long-term effects of Butyl methoxydibenzoyl methane on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida (Annelida, Lumbricidae) were determined according to OECD 222 (2016). The study was conducted under static conditions over 8 weeks with the test item concentrations 31.25, 62.5, 125, 250, 500, 1000 mg test item/kg soil dry weight (SDW). A control was tested under the same conditions as the test item treatments. 80 test organisms were inserted into 8 control replicates and 40 test organisms were divided into 4 replicates for each test item treatment (10 earthworms per replicate). The inserted earthworms had an individual body weight between 0.38 and 0.57 g at experimental starting. Neither evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms were observed in the control and all test item concentrations after four weeks of exposure. There were no statistically significant differences in earthworm biomass at any test item concentration compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 124 in the control and ranged from 84 to 122 in the test item treatments. No statistically significant differences in earthworm reproduction were determined in the test item concentrations 31.25 to 250 mg/kg SDW compared to the control. However, at the test item concentrations 500 and 1000 mg/kg SDW the earthworm reproduction was statistically significantly reduced. The following effect levels were determined (mg/kg soil dry weight):
LOEC (mortality, biomass): > 1000
NOEC (mortality, biomass): ≥ 1000
LOEC (reproduction) = 500
NOEC (reproduction) = 250
EC10, EC20, EC50 (reproduction): 202, 454 and > 1000, respectively.
Reference
Validity criteria:
- Adult mortality in the control group after the first four weeks of the definitive test should be ≤ 10 %; mortality in actual test: 0 %
- Number of juveniles per replicate in the control group should be ≥ 30; number of juvenils in actual test: 96 - 158
- Coefficient of variation calculated for the reproduction of the control group should be ≤ 30 %, coefficient in actual test: 15.5 %
Description of key information
Following long-term toxicity effects to Eisenia fetida were determined after 8 weeks:
LOEC (mortality, biomass)> 1000 mg/kg soil dry weight
NOEC (mortality, biomass) ≥ 1000 mg/kg soil dry weight
LOEC (reproduction) = 500 mg/kg soil dry weight
NOEC (reproduction) = 250 mg/kg soil dry weight
EC10, EC20, EC50 (reproduction): 202, 454 and > 1000 mg/kg soil dry weight, respectively.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 202 mg/kg soil dw
Additional information
The long-term effects of the test item on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida (Annelida, Lumbricidae) were determined according to OECD 222 (2016). The study was conducted under static conditions over 8 weeks with the test item concentrations 31.25, 62.5, 125, 250, 500, 1000 mg test item/kg soil dry weight (SDW). A control was tested under the same conditions as the test item treatments. 80 test organisms were inserted into 8 control replicates and 40 test organisms were divided into 4 replicates for each test item treatment (10 earthworms per replicate). The inserted earthworms had an individual body weight between 0.38 and 0.57 g at experimental starting. Neither evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms were observed in the control and all test item concentrations after four weeks of exposure. There were no statistically significant differences in earthworm biomass at any test item concentration compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 124 in the control and ranged from 84 to 122 in the test item treatments. No statistically significant differences in earthworm reproduction were determined in the test item concentrations 31.25 to 250 mg/kg SDW compared to the control. However, at the test item concentrations 500 and 1000 mg/kg SDW the earthworm reproduction was statistically significantly reduced. The following effect levels were determined (mg/kg soil dry weight):
LOEC (mortality, biomass): > 1000
NOEC (mortality, biomass): ≥ 1000
LOEC (reproduction) = 500
NOEC (reproduction) = 250
EC10, EC20, EC50 (reproduction): 202, 454 and > 1000, respectively.
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