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EC number: 919-489-5 | CAS number: -
- 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:
- 2017-10-02 to 2018-01-23
- 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:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All concentration levels and the controls were analytically verified at day 0 and 28. Additionally, the treated quartz sand was analysed at day 0.
- Sampling method: The samples were analysed with a GC-MS method
- Sample storage conditions before analysis: all samples were stored at room temperature - Vehicle:
- yes
- Remarks:
- Acetone
- Details on preparation and application of test substrate:
- The respective test item amount (2440 mg, actual: 2440.1 mg) was weighed out for a stock solution and solved in acetone (100 mL). The stock solution was further diluted to achieve the respective spiking solutions. The appropriate amount of spiking solution (2.5 mL per replicate) was mixed thoroughly with quartz sand (10 g per replicate). Additionally 40 g quartz sand per test item concentration and solvent control were treated likewise and used for analytical measurements. After complete evaporation of the solvent, the spiked quartz sand was added to the artificial soil. Demineralised water was added to the artificial soil to adjust the humidity of the artificial soil to a moisture of 40 - 60 % of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 610 g soil dry weight were filled into each test vessel.
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: earthworm
- Age at test initiation: adult earthworms (with clitellum) aged 2 - 12 months
- Weight at test initiation: 0.37 to 0.54 g
ACCLIMATION
- Acclimation period: one day prior to test start
- Acclimation conditions: same as test
- Health during acclimation, any mortality observed: no - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 8 wk
- Test temperature:
- 20 +/- 2 °C
- pH:
- 6.32
- Moisture:
- Throughout the test the replicates were weighed weekly. Evaporated water was replenished by adding demineralised water to maintain the soil moisture which should not deviate by more than 10% of the initial value at the end of the test.
- Details on test conditions:
- TEST SYSTEM
- Test container: Test units, containing about 610 g soil dry weight, were glass vessels (volume 1.5 L, used for preserving). One transparent and perforated lid and one additional transparent lid enabled sufficient gas exchange and light input thereby preventing the test substrate from drying.
- No. of organisms per container: 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: 16 h
- Light intensity: 400 - 800 lx
EFFECT PARAMETERS MEASURED:
A) no obvious pathological symptoms
B) no reaction to touching
C) no negative phototactical reaction
D) spontaneous segmentation and separation
E) spasmodic winding
F) yellow excretion from the oral aperture
G) ulcer and skin bleedings
H) dead earthworms
VEHICLE CONTROL PERFORMED: yes - Nominal and measured concentrations:
- Nominal: 0.78; 1.56; 3.125; 6.25; 12.5; 25; 50; 100 mg/kg soil dry weight
measured at start of exposure: 202; 104; 119; 105; 109; 111; 119; 105 % respectively
measured 28 days after exposure:- Reference substance (positive control):
- yes
- Remarks:
- Carbendazim
- Key result
- Duration:
- 8 wk
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, biomass, and reproduction
- Remarks on result:
- other: no significant effects occurred at the highest concentration tested
- Details on results:
- Please refer to respective tables under "any other information on results including tables"
- Results with reference substance (positive control):
- Results with reference substance valid: yes
Table 1 Mortality of Adult Earthworms in [%] after 28 days of Exposure
Application rate
Replicate
Mg test item/kg soil dry weight
1
2
3
4
5
6
7
8
Mean
Control
0
0
0
0
10
0
0
0
1.215
Solvent Control
0
0
0
0
0
0
0
0
0
0.78
0
0
0
0
-
0
1.56
0
0
0
0
2.5
3.125
0
0
0
10
0
6.25
0
0
0
0
0
12.5
0
0
0
0
0
25
0
0
0
0
0
50
0
10
0
0
2.5
100
0
0
0
0
0
Table 2 Earthworm Behaviour and Pathological Symptoms after 28 Days of Exposure
Application rate
Replicate
Mg test item/kg soil dry weight
Observation parameter
1
2
3
4
5
6
7
8
Control
A
H
10/10
-
10/10
-
10/10
-
10/10
-
9/10
1/10
10/10
-
10/10
-
10/10
-
Solvent Control
A
10/10
10/10
10/10
10/10
10/10
10/10
10/10
10/10
0.78
A
10/10
10/10
10/10
10/10
-
1.56
A
10/10
10/10
10/10
10/10
3.125
A
H
10/10
-
10/10
-
10/10
-
9/10
1/10
6.25
A
10/10
10/10
10/10
10/10
12.5
A
10/10
10/10
10/10
10/10
25
A
10/10
10/10
10/10
10/10
50
A
H
10/10
-
9/10
1/10
10/10
-
10/10
-
100
A
10/10
10/10
10/10
10/10
A = no obvious pathological symptoms; H = earthworm dead
Table 3 Mean Body Weight Changes of the Adult Earthworms
Application rate
Mg test item/kg soil dry weight
Mean body weight change of earthworms (Test Start – 28 days +/- SD
In percent
Statistical significance (Dunnett´s Multiple t-test Procedure, alpha = 0.05 compared to solvent control
Control
0.05 +/- 0.04
12.1 +/- 8.98
-
Solvent Control
0.11 +/- 0.03
23.9 +/- 6.68
-
0.78
0.09 +/- 0.01
20.3 +/- 2.83
No
1.56
0.12 +/- 0.02
25.9 +/- 4.87
No
3.125
0.09 +/- 0.05
20.3 +/- 10.4
No
6.25
0.14 +/- 0.02
30.9 +/- 3.31
No
12.5
0.12 +/- 0.03
25.9 +/- 7.29
No
25
0.12 +/- 0.03
25.9 +/- 6.76
No
50
0.09 +/- 0.03
20.8 +/- 6.79
No
100
0.12 +/- 0.03
27.0 +/- 6.93
No
Table 4 Reproduction Rate (Number of Juveniles after 8 Weeks)
Application rate
Mg test item/kg soil dry weight
Mean +/- SD
CV [%]
[%] of pooled control
Statistical significance (Dunnett´s Multiple t-test Procedure, alpha = 0.05 compared to solvent control
Control
133 +/- 26.2
19.7
-
-
Solvent Control
139 +/-16.7
12.0
-
-
Pooled control
136 +/- 21.4
15.7
-
-
0.78
155 +/- 35.6
23.0
114
No
1.56
101 +/- 42.4
42.0
74.3
No
3.125
145 +/-8.18
5.64
107
No
6.25
149 +/- 14.3
9.57
110
No
12.5
151 +/- 44.6
29.5
111
No
25
132 +/- 23.8
18.0
97.1
No
50
119 +/-55.2
46.4
87.5
No
100
131 +/- 31.2
23.8
96.3
No
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this study, the test item did not induce evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms in all test item concentrations. There were no statistically significant differences in earthworm body weights at all test item concentrations compared to the solvent control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 136 in the pooled control and ranged from 101 to 155 in the test item treatment rates. There was no statistically significant difference in earthworm reproduction in all treatment rates compared to the pooled control. The NOEC concerning mortality, biomass and reproduction was determined to be > 100 mg/kg soil dry weight. Since no significant effects occurred no LC/ECX - values were determined.
All validity criteria recommended by the test guideline were fulfilled.- Executive summary:
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 0.78 - 1.56 - 3.125 - 6.25 - 12.5 - 25 - 50 - 100 mg/kg soil dry weight (SDW). Each application rate was mixed into artificial soil containing 5 % peat. A control using untreated artificial soil as well as a solvent control using artificial soil spiked with the solvent was tested under the same conditions as the test item treatments. For the controls 80 test organisms were inserted into 8 replicates, each. 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). They had an individual body weight between 0.37 and 0.54 g at experimental starting.
Each concentration level, control and solvent control were analysed via GC-MS analysis subsequently to their preparation on day 0 and after 28 days. The recovery rates at day 0 were between 104 and 119 % of nominal concentrations with one exceptional value of 202 % measured in the lowest test item concentration. After 28 days recovery rates were between < LOQ and 9 %. Control and solvent control samples were < LOQ.
The method was validated according to SANCO/3029/99 rev.4 (2000) prior to the start of exposure.
Since no statistically significant differences concerning mortality after four weeks and reproduction after eight weeks of exposure in soil were observed between the control and the solvent control, the two controls were pooled for these parameters.
Neither evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms were observed in the controls and all test item concentrations. Since a statistically significant difference concerning biomass after four weeks of exposure in soil was observed between the control and the solvent control, the solvent control was used for further evaluation. There were no statistically significant differences in earthworm body weights at all test item concentrations compared to the solvent control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 136 in the pooled control and ranged from 101 to 155 in the test item treatment rates. There was no statistically significant difference in earthworm reproduction in all treatment rates compared to the pooled control. The NOEC concerning mortality, biomass and reproduction was determined to be > 100 mg/kg soil dry weight. Since no significant effects occurred no LC/ECX - values were determined. All validity criteria recommended by the test guideline were fulfilled.
Reference
Description of key information
Under the conditions of a OECD 222 test, the test item did not induce evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms in all test item concentrations. The NOEC concerning mortality, biomass and reproduction was determined to be > 100 mg/kg soil dry weight. Since no significant effects occurred no LC/ECX - values were determined.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 100 mg/kg soil dw
Additional information
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 0.78 - 1.56 - 3.125 - 6.25 - 12.5 - 25 - 50 - 100 mg/kg soil dry weight (SDW). Each application rate was mixed into artificial soil containing 5 % peat. A control using untreated artificial soil as well as a solvent control using artificial soil spiked with the solvent was tested under the same conditions as the test item treatments. For the controls 80 test organisms were inserted into 8 replicates, each. 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). They had an individual body weight between 0.37 and 0.54 g at experimental starting.
Each concentration level, control and solvent control were analysed via GC-MS analysis subsequently to their preparation on day 0 and after 28 days. The recovery rates at day 0 were between 104 and 119 % of nominal concentrations with one exceptional value of 202 % measured in the lowest test item concentration. After 28 days recovery rates were between < LOQ and 9 %. Control and solvent control samples were < LOQ.
The method was validated according to SANCO/3029/99 rev.4 (2000) prior to the start of exposure. Since no statistically significant differences concerning mortality after four weeks and reproduction after eight weeks of exposure in soil were observed between the control and the solvent control, the two controls were pooled for these parameters. Neither evident earthworm mortalities (< 10 %) nor pathological symptoms or changes in the behaviour of adult earthworms were observed in the controls and all test item concentrations. Since a statistically significant difference concerning biomass after four weeks of exposure in soil was observed between the control and the solvent control, the solvent control was used for further evaluation. There were no statistically significant differences in earthworm body weights at all test item concentrations compared to the solvent control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 136 in the pooled control and ranged from 101 to 155 in the test item treatment rates. There was no statistically significant difference in earthworm reproduction in all treatment rates compared to the pooled control. The NOEC concerning mortality, biomass and reproduction was determined to be > 100 mg/kg soil dry weight. Since no significant effects occurred no LC/ECX - values were determined. All validity criteria recommended by the test guideline were fulfilled.
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