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Diss Factsheets
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EC number: 200-021-7 | CAS number: 50-24-8
- 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:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is classified as reliable with restrictions because, although it is not-GLP compliant, it is an acceptable and a well-documented study report, according or similar to a guideline, that meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Principles of method if other than guideline:
- The test chemical in 0.1 ml dimethyl sulfoxide or H20 was placed in a tube and mixed with 0.5 ml S-9 mix (150 microliter of the S-9 fraction of rat liver pretreated with polychlorinated biphenyl, 2 micromol NADPH, 2 micromol NADH, 2.5 micromol glucose 6-phosphate, 0.25 unit glucose-6-phosphate dehydrogenase, 4 micromol MgCI2, 16.5 micromol KCI, and 50 micromol sodium phosphate buffer, pH 7.4 and 0.1 ml of culture of the bacterial tester strain (1 to 2 x 10E8 cells). Without metabolic activation 50 micromol sodium phosphate buffer, pH 7.4, in 0.5 ml were used instead of S-9 mix. The mixture was preincubated at 37° for 20 min and then mixed with 2 ml top agar (0.7% agar and 0.6% NaCI) at 45° and spread on a minimal glucose agar plate containing 0.1 micromol each L-histidine and biotin. Plates were incubated at 37° for 2 days, and then his+ revertant colonies were counted.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Prednisolone
- EC Number:
- 200-021-7
- EC Name:
- Prednisolone
- Cas Number:
- 50-24-8
- Molecular formula:
- C21H28O5
- IUPAC Name:
- 11,17,21-trihydroxypregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): Prednisolone
- Other: Structure reported. Prednisolone was from Sanwa Research Institute, Tokyo, Japan.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: This strain carryies R-factor plasmid pKM101.
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: This strain carryies R-factor plasmid pKM101.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- Prednisolone was tested at 8.3, 17, and 33 micrograms/plate. Drug contained some vehicle, and the amount of the drug was expressed as micrograms of active principle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Average of values in 20 experiments.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle controls.
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Also daunomycin hydrochloride, and adriamycin hydrochloride were reported as positive controls.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
his+revertants/plate | |||||||||
TA100 | TA98 | ||||||||
micrograms/plate | + S-9 mix | - S-9 mix | + S-9 mix | - S-9 mix | his+revertants/nmola | ||||
Prednisoloneb | 8.3 | 135 | 125 | 37 | 34 | 0 | |||
17 | 145 | 145 | 39 | 33 | |||||
33 | 123 | 144 | 35 | 23 | |||||
Controlc | 147 | 132 | 30 | 16 |
aThe number ofhis+revertants per nmol was calculated from the data obtained under the most active conditions in
the linear dose-responsible range and a yield of 100 colonies more than the background yield.
bDrug contained some vehicle, and the amount of the drug was expressed as micrograms of active principle.
cAverage of values in 20 experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Prednisolone was not mutagenic to either strain with or without S-9 mix, and it was not lethal at doses of up to 33 micrograms/plate.
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