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EC number: 243-175-0 | CAS number: 19592-55-3
- 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
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-09-23 to 2014-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed in accordance with OECD method and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- EC Number:
- 243-175-0
- EC Name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- Cas Number:
- 19592-55-3
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
- Test material form:
- solid: crystalline
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test substrate
- Vehicle:
- no
Test organisms
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- The earthworms were purchased from Shanghai Yinquan Agriculture Development
Co., Ltd. (ID: EF-MKT-130603). All newly acquired earthworms were quarantined and observed for 14 days prior to use in the test. Earthworms are bred on a substrate consisting of 50% by volume peat and 50% by volume cow manure and kept under ,
20 ± 2·c for 7 days prior to testing. The test organisms were with clitellum and were
transferred into artificial soil (without test substance) approximately 24hours prior to
the start of the test. At the start of the test, the adult earthworms used originated from ..
the same population, were with clitellum and wet weight of 300 to 600 mg.
Study design
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Remarks:
- The nominal concentration is 1000 mg/kg.
- Post exposure observation period:
- none
Test conditions
- Test temperature:
- Temperature of climate chamber is measured daily.The measured temperature of climate chamber remained at 19.4 to 20.1 ·c throughout the study, which should be in the range of 18-22 °C.
- pH:
- The pH of the artificial soil was adjusted to 6.0 +0.5 by the addition of calcium carbonate. The measured pH values and soil moisture content in the control and test cultures were 5.79 - 5.85 at initiation and 6.13 to 6.24 at termination
- Moisture:
- Moisture content of the test substrate was adjusted to 40-60 % by mass of the total water-holding capacity with the deionized water. The measured value was 54% before the test initiation. In the limit / definitive test, the moisture content of the artificial soil was in the range of 22%- 32%. Soil moisture content in the control and test groups were 28.81 to 29.80 at initiation and 27.93 to 29.47 at termination.
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 1 liter closed glass vessel
- Amount of soil or substrate: 750 wet weight substrate
- No. of organisms per container (treatment): 10
no replicates in range finding test.
4 replicates in limit test.
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
A defined artificial soil was used as a basic test substrate with the following composition ,
sphagnum peat 10% w/w;
kaolinite clay; 20% w/w and
silica sand (screened with 0.2 mm sieve); 70% w/w.
OTHER TEST CONDITIONS
- Photoperiod:The vessels were covered and maintained under continuous illumination (400-498 lux)
- Light intensity:bThe light intensity was 473-510 lux which should be in the range of 400-8001ux.
The total gross weights of the worm added to each beaker of the controls and test groups were recorded on Day O before addition to the test or control vessels. The surviving earthworms of each beaker were weighed on Day 14.
Any mortalities were recorded at 7 and 14 days after the start of treatment. - Nominal and measured concentrations:
- range finding 10, 100 and 1000 mg/kg
limit test 1000 mg/kg - 4 replicates with a blank control - Reference substance (positive control):
- yes
- Remarks:
- chloroacetamide
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 7 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- not specified
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- In range-finding test, cumulative mortality data from the exposure of Eisenia fetida to the test substance showed no mortalities at 1000 mg/kg on the 7th day and 14th day.
The mortality rate of the control group were 0% at 7th day and 2.5% at 14th day, the mortality rate of the 1000 mg/kg dry weight soil treatment group were both 2.5% at 7th and 14th day. Compared with 1000 mg/kg treatment group, there was no significant differences)
(According to the result of F-Test, p=0.46, p>0.05) of the variance t test at the end of the test - Results with reference substance (positive control):
- The most recent test with chloroacetamide was performed from 16 Oct. 2013 to 30 Oct. 2013 (14 days test). In this study, the reference substance was tested at 5 concentrations of 3.75, 7.50, 15, 30 and 60 mg/kg dry artificial soil weight. The Mortality of chloroacetamide treatment group
were shown to be between 2.5% to 100%. The 14-days LC50 for chloroacetamide was 15.33 mg/kg dry soilweight.
Test from this reference substance conducted over 5 years in the laboratory and show that the range of LC50 is between 10 to 31 mg/kg, so the 15.33 mg/kg was an acceptable value. - Reported statistics and error estimates:
- 2.5% of the earthworms died in the control group. Thus, the test fullfills the validity criterion that control mortality should not exceed 10%.
The differences of the average body weight of the surviving earthworms between the control group and the treatment groups were determined by using the F-Test at the end of the study. The data analyses were carried out with Toxcalc software v5 .0.26.
Any other information on results incl. tables
Number and average body weight of the surviving earthworms atthe beginning and the end of the definitivetest
|
-:nocalculation;
n.s.not significantly different compared to the control, F-test, p>0.05;
s.significantly different compared to the control, F-test,p<0.05
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Expressed as nominal test substance concentration, the median lethal concentrations of Proketal on Eisenia fetida (earthworms) are as follows :
The 7-day LC50 value > 1000 mg/kg dry soil weight.
The 14-day LC50 value > 1000 mg/kg dry soil weight.
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