Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-563-4 | CAS number: 981-34-0
- 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:
- 08/08/2016-05/09/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Qualifier:
- according to guideline
- Guideline:
- other: UNI EN ISO 8692:2012 “Fresh water algal growth inhibition test with unicellular green algae”.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on Testing and Assessment No 23 - Guidance Document On Aquatic Toxicity Testing Of Difficult Substances And Mixtures ENV/JM/MONO(2000)6.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
- EC Number:
- 213-563-4
- EC Name:
- 9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
- Cas Number:
- 981-34-0
- Molecular formula:
- C22H28O5
- IUPAC Name:
- 17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the Sponsor, batch N. 14192-00816
- Expiration date of the lot/batch: January 26, 2018
- Purity test date: 98.6%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item is stored at room temperature at the dark,
following Test Substance Data Sheet (TSDS) supplied by the Sponsor.
Sampling and analysis
- Details on sampling:
- The test item is stored at room temperature at the dark, following Test Substance Data Sheet (TSDS) supplied by the sponsor.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Study design
- Test type:
- not specified
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- the incubation temperature was continuously monitored during the course of the study by a PT100 probe installed in the environmental test chamber. It was in the range 23.9 – 24.0 °C with a mean value of 24.0 °C and a standard deviation of 0.02°C. The temperature range provided by OECD guideline is 24 ± 2 C. The temperature values during the test were within the provided range by guideline.
- pH:
- Test medium pH was measured with a portable pH meter at the beginning of the test and in each test flask at the end of the test. At the test start, in fresh test media, the pH values were measured sampling an aliquot immediately after test solution preparation, before pouring it in the test flasks. For spent solutions (after 72 hours), pH were measured in each test flask.
- Details on test conditions:
- The study was performed with the unicellular, fresh water green algae Pseudokirchneriella subcapitata strain, cultured in the laboratories, of the Test Facility and originally purchased from the Institute of Plant Physiology of the university of Goettingen, germany.
The algae were cultured in a climatic chamber at 24°C +/-2°C under continuous uniform illumination in the range 4440-8880 Lux in the spectral range 400-700 nm. The culture medium was the same of the test mediu,: the stock cultures were weekly transferred to fresh medium and maintained in continuous shaking to ensure the necessary amount of CO2 and to keep algae in suspension. Cultures containing deformed or abnormal cells were discarded. Only exponentially growing algal cultures have been used to start the test.
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- growth rate
- Remarks on result:
- other: The algae were exposed at only one nominal concentration, 1.0 mg/L, corresponding to the maximum solubility obtainable in test medium and in test conditions.
- Details on results:
- For the tested concentration, the algal growth rate (r) after 72 hours of exposure was slightly higher than the negative control (mean % inhibition: -0.4%).
At the test end the cell density in the negative control increased on average by a factor of 345. This value complies with the validity criterion of the test, according to the mentioned guidelines, which indicates a minimum increase factor of 16. The negative control also met the other validity criterion, with a coefficient of variation of daily growth rates of 6.5 % (maximum acceptable value 35%) and a coefficient of variation of average growth in negative control replicates during the test period of 5.4 %(maximum acceptable value 7%).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity of test item BETA-METHYLEPOXY was tested on Pseudokirchneriella subcapitata.
The percent inhibition of growth rate and yield at 24, 48 and 72 hours of exposition compared to the negative control.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.