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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 927-431-5 | CAS number: 1178896-82-6
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Nov 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- GLP compliance:
- yes
Test material
- Reference substance name:
- (9aR,11aS)-9a,11a-dimethyl-1-oxo-1H,2H,3H,3aH,3bH,4H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-yl acetate
- EC Number:
- 927-431-5
- Cas Number:
- 1178896-82-6
- Molecular formula:
- C26 H38 O4
- IUPAC Name:
- (9aR,11aS)-9a,11a-dimethyl-1-oxo-1H,2H,3H,3aH,3bH,4H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Dienolacetat-ketal
(ZK 67985, 3-Acetoxy-17,17-(2,2-dimethyltrimethylenedioxy)-androst-3,5-diene)
- Analytical purity: 98.6%
- Lot/batch No.: 51537013-021
Constituent 1
Test organisms
- Test organisms (species):
- Daphnia magna
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
Any other information on results incl. tables
The range of the measured dissolved oxygen was between 7.3 and 8.8 mg/L, the temperature was 21.6 to 21.9°C and the pH varied between 7.4 at the beginning and 8.5 at the end of the test. The increase in pH in the control solution was slightly outside the recommended range. This had no effect on the validity of the test.
The organic carbon concentration ofthe test solution was analyzed with a TOC analyzer at the start of exposure and 48 hours thereafter. The substance concentration was calculated on the basis of the molecular fonnula. It was below 1 mg/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50/48 hours of Dienolacetat-ketal to Daphnia magna is >1 mg/L, as determined by TOC analysis.
- Executive summary:
The purpose ofthe study was to detennine the acute toxicity (immobilization, EC50/48 hours) of Dienolacetat-ketal (ZK 67985) with Daphnia magna in order to evaluate the aquatic toxicity. Dienolacetat-ketal is an intermediate of the synthesis of drospirenone.
The study was conducted as a limit test according to the following guidelines of the OECD, no 202, and the EC guideline Part 2 - Testing Methods, Part C.2.
20 juvenile Daphnia magna were used for the test solution of Dienolacetat-ketal and 20 for the tap water control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours.
The EC50/48 hours of Dienolacetat-ketal to Daphnia magna is expected to be higher than a saturated
solution (> 1 mg/L, as determined by TOC analysis). Therefore, ZK 67985 is not acutely toxic to Daphnia magna.
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.