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EC number: 212-714-1 | CAS number: 853-23-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiated in March 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Prasterone
- EC Number:
- 200-175-5
- EC Name:
- Prasterone
- Cas Number:
- 53-43-0
- Molecular formula:
- C19H28O2
- IUPAC Name:
- (3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one
- Test material form:
- solid
- Details on test material:
- white solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EM-760-17
- Expiration date of the lot/batch: not indicated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not indicated
OTHER SPECIFICS:
- CAS Registry Number: 53-43-0
- Generic Name: Prasterone
- Chemical Name: 3β-hydroxy-5-androsten-17-one or 3β-hydroxyandrost-5-en-17-one
- Molecular Weight: 288.4
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- CELLS USED
- Suitability of cells: according to OECD Guideline 473
- Whether whole blood or separated lymphocytes were used if applicable: whole blood
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
RPMI 1640 = culture medium - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Definitive study:
-S9 (4hr exposure): 400, 300, 225, 200, 175,……50 µg/ml - Doses evaluated for chromosome aberrations: 138, 175, 200, 225 µg/ml
-S9 (19 hr exposure): 138, 100, 66, 50……..6.6 µg/ml - Doses evaluated for chromosome aberrations: 25, 50, 66, 100 µg/ml
+S9 (4 hr exposure): 400, 300…………….66 µg/ml - - Doses evaluated for chromosome aberrations: 138, 175, 225; 300 µg/ml
Highest dose was selected based on the solubility limit of the test system - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not indicated
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- 1 % ethanol vehicle
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9; 1.00 µg/mL (4h treatment), 0.300 µg/mL (19h treatment)
- Untreated negative controls:
- yes
- Remarks:
- 1 % ethanol vehicle
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9; 25.0 µg/mL (4h treatment)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (RPMI 1640)
Lymphocytes normally do not divide, but they were stimulated to divide in cultures by exposure to phytohemagglutinin (PHA). At predetermined intervals after exposure to the test article, the lymphocytes were treated with a metaphase arresting substance, Colcemid, harvested, stained, and metaphase cells were analyzed for the presence of chromosomal aberrations.
DURATION
- Exposure duration: 4h or 19h
- Expression time (cells in growth medium): 18h (4h treatment) or 3h (19h treatment); 3h prior to fixation, Colcemid was added
- Fixation time (start of exposure up to fixation or harvest of cells): 22h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): yes
NUMBER OF REPLICATIONS: Duplicates in each test.
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: not specified
NUMBER OF CELLS EVALUATED: 200 cells per dose level scored for aberrations, polyploidy and endoreduplication
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 200
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index (% mitotic index reduction)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes
- Evaluation criteria:
- according to the OECD Guideline 473.
The negative and vehicle control cultures must contain less than 5% cells with aberrations. - Statistics:
- Positive control must be significantly higher (P<0.01) that vehicle controls. Statistical analysis method not specified.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- mitotic index reduced up to 70% at the highest tested dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not specified
RANGE-FINDING/SCREENING STUDIES:
no data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: all positive control values were significantly higher than the vehicle controls (p<0.01)
- Negative (solvent/vehicle) historical control data: not specified
Any other information on results incl. tables
The study was considered valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the study was negative with and without metabolic activation
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.
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