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EC number: 610-527-3 | CAS number: 50407-76-6
- 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 aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 h
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (8R,9S,10R,13S,14S,17R)-17-ethynyl-10,13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17,-tetradecahydrospiro[cyclopenta[a]phenanthrene-3,2´-[1,3]dioxolan]-17-ol
- EC Number:
- 610-527-3
- Cas Number:
- 50407-76-6
- Molecular formula:
- C23H32O3
- IUPAC Name:
- (8R,9S,10R,13S,14S,17R)-17-ethynyl-10,13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17,-tetradecahydrospiro[cyclopenta[a]phenanthrene-3,2´-[1,3]dioxolan]-17-ol
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Details on test solutions:
- The test organism was grown and hold in OECD medium which was used also for preparing test item solutions.
The Ethisterone-ketal has a very low solubility in aquatic solutions so its concentration cannot be determined by HPLC from aquatic solutions directly.
The stock solution was prepared by measuring 200.15 mg of test item into 2 000 ml OECD growth medium. After one hour stirring the suspension was filtered through 0.2 μm WhatmannTM ME24 filter. The concentration of the filtrate (stock solution) was 0.119 mg/L.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Test species: Pseudokirchneriella subcapitata (Korshikov) F.Hindák (formerly known as Selenastrum capricornutum and Raphidocelis subcapitata)
Source: Culture Collection of Algae and Protozoa, Scottish Marine Institute (www.ccap.ac.uk)
Batch: CCAP 278/4
Date of arriving: 27 October 2017
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- The vessels were kept in incubator at 21 ± 2 °C with continuous illumination. The treatments of control and test vessels were identical.
- pH:
- At the beginning of the test the pH values were measured in the remaining test solution of the concurrent test vessels at each dilution level.
At the end of the test the pH values were measured in each test vessel. The pH of test solutions was not adjusted at the beginning of the test. - Nominal and measured concentrations:
- The stock solution was prepared by measuring 200.15 mg of test item into 2 000 ml OECD growth medium. After one hour stirring the suspension was filtered through 0.2 μm WhatmannTM ME24 filter. The concentration of the filtrate (stock solution) was 0.119 mg/L.
The toxic property of test item was investigated at five concentrations which were prepared by different dilutions of stock solution of test item. OECD medium was used for dilution of stock solution. - Details on test conditions:
- Preparation and breeding of inoculum culture:
The inoculum culture was prepared four days before starting the test and it was bred in incubator at 21 ± 2 °C. At the end of incubation the cell density of the inoculum culture was determined with a Bürker chamber. The cell concentration was 1 305 556 cell/ml
reparation of stock solution:
The preparation of stock and test solutions was based on the preliminary non GLP range finding test [9]. As the Range Finding Test was not performed in compliance with the GLP-Regulations it is excluded from the Statement of Compliance in the final report, but the raw data of this test are archived under the study code of present study. The stock solution was prepared by measuring 200.15 mg of test item into 2 000 ml OECD growth medium. After one hour stirring the suspension was filtered through 0.2 μm WhatmannTM ME24 filter. The concentration of the filtrate (stock solution) was 0.119 mg/L.
Preparation of test solutions
Five test solutions of different concentration were prepared by mixing appropriate volume of OECD medium and stock solution of the test item. The maximum separation factor between of test vessels was 1.5. The following table shows the preparation of test solutions. The volume of the prepared dilution levels was 300 ml except the control solution which was 600 ml. The alga inoculum culture was diluted 263.16 times so the initial alga cell concentration in every dilution and the control levels were 4 961 cells/ml.
Preparation of test vessels:
Three replicates were prepared at every test and six at the control level. The vessels contained 75 ml test media.
Test procedure:
The test vessels were closed with silicone stopper and kept in the Binder KBW 400 incubator. For the proper mass transfer of carbon dioxide glass tubes with filter were placed through silicone stoppers. The test was maintained under static conditions for a period of 72 hours. The temperature during the test remained in the 21 ± 2 °C range. The temperature data were harvested by Extech SD200 datalogger. The vessels were shaken and illuminated continuously in the incubator. The vessels were placed randomly into the incubator and were repositioned daily after sampling.
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks on result:
- not determinable
- Details on results:
- According to the test results Ethisterone-ketal has no toxic effect on alga growth rate even at its saturated concentration (0.119 mg/L).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to the Council Regulation (EC) 440/2008 Ethisterone-ketal is not hazardous to the aquatic environment [72 h EC50 (for algae or other aquatic plants) > saturated concentration of Ethisterone-ketal (0.119 mg/L)]. As the reported results are based on calculated concentration data which are gained out of a non-validated UHPLC method, the toxicity results must be interpreted by precaution!
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