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EC number: 200-023-8 | CAS number: 50-28-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies for a Genotoxic Potential of Some Endogenous and Exogenous Sex Steroids
- Author:
- Rainer Lang and Roland Reimann
- Year:
- 1 993
- Bibliographic source:
- Environmental and Molecular Mutagenesis 21 :272-304 (1993)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- only one method: plate incorporation method, TA102 or E.coli WP2 not tested
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Estradiol
- EC Number:
- 200-023-8
- EC Name:
- Estradiol
- Cas Number:
- 50-28-2
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estra-1,3,5(10)-triene-3,17-diol
Constituent 1
Method
- Target gene:
- His locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Sprague-Dawley rats
- method of preparation of S9 mix: pretreated with Aroclor 1254, commercially available
- concentration or volume of S9 mix and S9 in the final culture medium: The components of the standard S 9 mix were 8 mM MgCI,, 33 mM KCI, 5 mM glucose-6-phosphate, 4 mM NADP, 100 mM sodium phosphate, pH 7.4, and S 9 at a concentration of 0.1 ml (plate incorporation assay) - Test concentrations with justification for top dose:
- 0, 5, 25, 125, 500, 2500 µg/plate
- Vehicle / solvent:
- DMSO for the positive controls and Phosphate buffer for the treatment groups
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Phosphate buffer
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-dimethylnitrosamine
- benzo(a)pyrene
- cyclophosphamide
- ethylmethanesulphonate
- other:
- Remarks:
- For testing of Estradiol only anthracene-2-amine and 2-aminofluorene were used at concentrations of 2µg/plate each substance
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS
- Number of cultures per concentration: triplicate
- Number of independent experiments: one
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1E-+06 cells/plate
- Test substance added in medium; in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Evaluation criteria:
- The plates were scored for the number of mutant colonies manually in the very early experiments and later with an automated colony counter (Biotran II, Model] C 11 1, New Brunswick Scientific Co., Edison, NJ, and Artek M 982B, Artek Systems Corp.. Farmingdale, NY). The arithmetic means of the number of mutant colonies of the three parallel plates in the negative control groups were compared with those of the compound groups. A positive response was considered if at least 5 mg/plate or up to a toxic dose had been tested (or the compound formed precipitates in the agar) and if the number of induced revertants compared to the number of spontaneous ones was higher than twofold. Also, a dose-dependent increase in the number of revertants was considered to indicate a mutagenic effect. A toxic effect of the substance on the background lawn of nonrevertant bacteria and precipitates in the agar were examined stereomicroscopically.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: at 2500 µg/plate after 72 h
Ames test:
- Signs of toxicity: no reduced background lawn observed
- Mean number of revertant colonies per plate and standard deviation: see 'Additional information on results incl. tables'
Any other information on results incl. tables
Mutant colonies per plate (mean of three plates ± SD) | ||||||||||||||||
| TA1535 | TA100 | TA1537 | TA1538 | TA98 | |||||||||||
|
| +S9 |
| +S9 |
| +S9 |
| +S9 |
| +S9 | ||||||
Test substance | Dose/ plate | -S9 | Rat | Mouse | -S9 | Rat | Mouse | -S9 | Rat | Mouse | -S9 | Rat | Mouse | -S9 | Rat | Mouse |
Direct plate incorporation assay | ||||||||||||||||
DMSO |
| 34 ± 8 | 15 ± 3 | 10 ± 4 | 81 ± 16 | 117 ± 9 | 73 ± 13 | 8 ± 5 | 10 ± 3 | 8 ± 2 | 14 ± 3 | 26 ± 4 | 16 ± 4 | 31 ± 3 | 33 ± 8 | 21 ± 3 |
Phosphate buffer |
| 41 ± 5 | - | 14 ± 4 | 90 ± 7 | - | 79 ± 11 | 7 ± 2 | - | 7 ± 1 | 12 ± 1 | - | 21 ± 2 | 27 ± 7 | - | 23 ± 3 |
Estradiol [µg] | 5 | 31 ± 3 | 10 ± 2 | 9 ± 3 | 68 ± 10 | 101 ± 4 | 84 ± 16 | 7 ± 4 | 6 ± 2 | 8 ± 4 | 15 ± 4 | 17 ± 8 | 25 ± 4 | 25 ± 5 | 30 ± 5 | 28 ± 3 |
| 25 | 36 ± 18 | 14 ± 2 | 13 ± 4 | 73 ± 9 | 96 ± 14 | 73 ± 10 | 6 ± 2 | 5 ± 2 | 5 ±1 | 12 ±1 | 17 ±4 | 23 ±1 | 27 ± 5 | 28 ±12 | 23 ±3 |
| 125 | 51 ± 9 | 12 ± 1 | 12 ± 8 | 68 ± 5 | 99 ± 5 | 78 ± 5 | 8 ± 1 | 9 ± 2 | 10 ± 3 | 13 ± 1 | 21 ± 2 | 18 ± 3 | 22 ± 1 | 26 ± 2 | 28 ± 1 |
| 500 | 55 ± 7 | 13± 2 | 11 ± 3 | 72 ± 8 | 85 ± 9 | 70 ± 3 | 8 ± 1 | 7 ± 2 | 5 ±1 | 14 ±5 | 25 ± 3 | 24 ± 2 | 16 ± 3 | 29 ± 6 | 30 ± 6 |
| 2500 | P 45 ± 12 | P 11 ± 5 | P 9 ± 2 | P 68 ± 11 | P 91 ± 3 | P 83 ± 11 | P 8 ± 1 | P 5 ± 2 | P 5 ± 2 | P 19 ± 3 | P 27 ± 2 | P 18 ± 2 | P 15 ± 2 | P 34 ± 5 | P 23 ± 4 |
2-AA [µg] | 2 | 59 ± 4 | 92 ± 16 | 348 ± 15 | - | 631 ±136 | - |
| - | - | - | 781 ± 165 |
| - | 555 ± 110 | - |
2-AF [µg] | 2 | - | - | - | - | - | - |
| - | - | 22 ± 3 | - | 1542 ± 94 | - | - | - |
| 10 | - | - | - | 88 ± 3 | - | 1533 ± 165 | 8 ± 2 | 281 ± 27 | 86 ± 5 | - | - | - | - | - | > 3000 |
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Applicant's summary and conclusion
- Conclusions:
- In the present test Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA 1538 were exposed to Estradiol at concentations of 0, 5, 25, 125, 500, 2500 µg/plate in the plate incorporation assay similar to OCED Guideline 471(1983). Precipitates were observed at the highest concentration in each tester strain, no reduced background lawn was observed. The number of revertants did not increase at least twofold as compared with the respective negative control, thus, Estradiol is not considered a mutagen under the conditions of the test.
- Executive summary:
In a reverse gene mutation assay in bacteria similar to OECD guideline 471 (1983), Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 were exposed to Estradiol in phosphate buffer in concentrations of 0 (control), 5, 25, 125, 500, and 2500 µg/plate in all strains in the absence and presence of mammalian metabolic activation (rat liver S9 mix and mouse liver S9 mix). The assay was performed using the plate incorporation method.
The test substance was tested up to precipitating concentrations. Cytotoxic effects were not noted in all tester strains. Precipitation was observed at the highest concentration of 2500 µg/plate.The positive controls induced the appropriate responses in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the five tester strains (TA98, TA 100, TA1535, or TA1537 and TA1538) examined at dose levels up to 2500 µg/plate in the absence and presence of a metabolic activation source (S9). Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA98, TA100, TA1535, TA1537 and TA 1538 under the conditions employed (plate incorporation assay).
There was no evidence of induced mutant colonies over background.
Under the conditions of the study, the test substance was negative for mutagenic potential.
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