Registration Dossier
Registration Dossier
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EC number: 201-476-4 | CAS number: 83-43-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Methylprednisolone, Summary Report
- Author:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Year:
- 2 001
- Bibliographic source:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ames test was conducted in Salmonella typhimurium TA98, TA100, TA1535 and TA1538 with concentrations in the range 250 to 2000 μg/plate.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-, monosodium salt, (6α,11β)-
- EC Number:
- 219-156-8
- EC Name:
- Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-, monosodium salt, (6α,11β)-
- Cas Number:
- 2375-03-3
- IUPAC Name:
- sodium 4-[(11,17-dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl)oxy]-4-oxobutanoate
- Reference substance name:
- Methylprednisolone sulfonate
- IUPAC Name:
- Methylprednisolone sulfonate
- Reference substance name:
- Pregna-1,4-diene-3,20-dione, 11β,17,21-trihydroxy-6α-methyl-, 21- (hydrogen succinate), monosodium salt
- IUPAC Name:
- Pregna-1,4-diene-3,20-dione, 11β,17,21-trihydroxy-6α-methyl-, 21- (hydrogen succinate), monosodium salt
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 250 to 2000 μg/plate
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:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Negative results were obtained in an in vitro assay for gene mutation in Salmonella typhimurium TA98, TA100, TA1535 and TA1538 with concentrations in the range 250 to 2000 μg/plate.
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