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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
Long-term toxicity to fish
Administrative data
- Endpoint:
- adult fish: sub(lethal) effects
- 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: GLP compliant and based on OECD test guideline.
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 204 (Fish, Prolonged Toxicity Test: 14-day Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
- Details on test material:
- White to light yellow crystalline powder. Negligible solubility in water.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- For analysis of the actual test substance concentration, 2 ml of test solution was taken from each test vessel at the beginning, before and after each renewal and at the end of the test.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- 500 µL of test samples, test water spiked samples and test water blank were analyzed by UPLC after adding 1-fold dilution methanol as solubilising agent to make sample dissolve completely.
Test organisms
- Test organisms (species):
- other: Chinese Rare Minnow (Gobiocypris rarus)
- Details on test organisms:
- The test was performed with Gobiocypris rarus which were bred in Bioassay and Safety Assessment Laboratory of Shanghai Academy of Public Measurement (ID: GR-SAPM-130506). This freshwater fish species is suitable for fish toxicity testing because of their ease of culturing and handling, sensitivity to a variety of chemical substances, and the extensive data base for this species. This species complies with OECD Guidelines for the Testing of Chemicals. 204 Fish, Prolonged Toxicity Test: 14-day Study 1984.
Before being used in the test, all fish were acclimatized in the following test conditions for more than 14 days:
Photoperiod: Light : Dark=12 hours : 12 hours;
Feeding: fish were fed with Brine Shrimp Aquarium Flake Food, O.S.I® daily
The criterion of fish selection:
Length was 2.1 ± 0.1cm (Mean± SD). body weight was 0.16 ± 0.02g (Mean± SD) at the beginning of the test. Length was 2.2 ± 0.1 cm (Mean± SD), body weight was 0.18 ± 0.02g (Mean ± SD) at the end of the test.
No diseases were observed during the acclimating period;
No mortality was present within 7 days before test beginning
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Remarks on exposure duration:
- The fish were inspected and recorded once a day for mortality and other observed effects. Study duration: 14 days.
Test conditions
- Hardness:
- Total hardness: 155 mg CaC03 per liter
- Test temperature:
- 21-25°C
- pH:
- 6.0-8.5
- Dissolved oxygen:
- > 80% of air saturation value (ASV)
- Nominal and measured concentrations:
- A nominal concentration of 100 mg/L of the test substance was prepared.
UPLC showed that, the measured concentrations of the test substance in the test solutions were all below LOD21(LOD2=0.04mg/L). - Details on test conditions:
- Test conditions
Water:
The tap water dechlorinated by activated carbon and sterilized by UV lamp was used. The water was aerated continuously over 24h. Water quality parameters were as following:
Total hardness: 155 mg CaC03 per liter;
Oxygen concentration: >90% of ASV.
Test vessels
5L glass tanks were used containing 4L test solution.
Conditions of exposure
Duration: 14d;
Test method: Semi-static and the frequency of renewal was twice a week;
Loading: about 0.41-0.46 fish/litre;
Temperature: 21.6°C-23.4 ·c;
Photoperiod: Light : Dark= 12 hours : 12 hours;
Oxygen concentration: 73.3%-95.0% ASV;
Feeding: fish were fed twice a day and the quantity of food being kept constant. The amount of food was at a level of approximately 1 % of body weight per day
Cleaning: the test vessel was replaced by a clean one each time the test solution was renewed. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- >= 0.04 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: saturated solution
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.04 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: saturated solution
- Details on results:
- The actual test substance concentration of test solutions was determined by using a UPLC analysis method. The limit of detection (LOD2) for the test substance was calculated to be 0.04 mg/L (based on a signal/noise of 6.46).The limit of quantification (LOQ2) for the test substance was calculated to be 1 mg/L (based on a signal/noise of 15.4). It was found that the average recoveries were 101 % and 94.9% of the spiked 0.60 mg/Land 6.00 mg/L sample with RSD value 1.71 % and 4.40%, respectively. During the test, the measured concentrations of the test substance in test solutions were all below the LOD2
There were no mortalities and abnormalities observed in treatment group during the test. At the end of the test, the body weight of the test fish increased in both groups. The specific growth rate of the body weight in treatment group was not significantly different from that of the control (p>0.05) - Results with reference substance (positive control):
- No reference substance used in the study.
- Reported statistics and error estimates:
- To determine the no observed effect concentration (NOEC) and the lowest observed effect concentration (LOEC), the variances among the mortality and the specific growth rate in the treatment group was analyzed by Shapiro-Wilk's Test and F-Test and compared with the control group using Wilcoxon Two-Sample test. The data treatment was carried out with software TOXCALC.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- For the lethal effect and the growth effect , both the the median lethal concentration (LC50)and the lowest observed effect concentration (LOEC) for Gobiocypris rarus exposed to the test substance Proketal (NJBY20130218-0718) in 14d were higher than the concentration of the saturated solution (measured concentrations were
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