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EC number: 612-953-5 | CAS number: 6218-29-7
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jul 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- EC Number:
- 612-953-5
- Cas Number:
- 6218-29-7
- Molecular formula:
- C18 H24 O2
- IUPAC Name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 47359
- Batch No.: 54512003
- purity: 99.916%
Constituent 1
Method
- Target gene:
- Histidine (Salmonella) or Tryptophan (E. coli) gene locus
Species / strain
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix from Aroclor 1254 -treated rats
- Test concentrations with justification for top dose:
- Hydroxyestradienon: six concentrations from 0.1 to 5.0 mg/plate
4-Nitro-o-phenylenediamine: 10 µg/plate
2-Aminoanthracene: 2.5 and 10 µg/plate
2-Nitrofluorene: 10 µg/plate
Benzo[a]pyrene: 2.5 µg/plate
Sodium azide: 5 µg/plate
Cyclophosphamide: 400 µg/plate
N-Methyl-N-nitro-N-nitrosoguanidine: 5 µg/plate
Ethyl methanesulfonate: 5 µl/plate
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO or phosphate buffer pH 7.4, 0.1 mol/l
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylenediamine, 2-Aminoanthracene, 2-Nitrofluorene, Benzo[a]pyrene, Sodium azide, Cyclophosphamide, N-Methyl-N-nitro-N-nitrosoguanidine, Ethyl methanesulfonate
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition was observed only in the strain TA 100 from 2.5 mg/plate onwards; precipitates in the agar were found starting at 2.5 mg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- other: yes, but cyclophosphamide did not give a positive result with metabolic activation in strain TA1535; nevertheless, experiment was considered valid since activity of the S9 mix was demonstrated with the second positive control substance 2-Aminoanthracene
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Executive summary:
Hydroxyestradienon was examined for mutagenic activity up to 5000 µg/plate in the five histidine-dependent Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98 and in the tryptophan-dependent Escherichia coli strain WP2uvrA using the direct plate incorporation procedure with and without metabolic activation.
A cytotoxic effect was seen from 2.5 mg/plate onwards in the strain TA 100. Precipitates in the agar were found starting at 2.5 mg/plate.
There was no evidence for a mutagenic activity of Hydroxyestradienon, when tested up to the maximum recommended dose level of 5 mg/plate in the absence and presence of S9 mix.
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