Registration Dossier
Registration Dossier
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EC number: 200-004-4 | CAS number: 50-03-3
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:
- 31. Oct 2002 to 04 Nov 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrocortisone 21-acetate
- EC Number:
- 200-004-4
- EC Name:
- Hydrocortisone 21-acetate
- Cas Number:
- 50-03-3
- Molecular formula:
- C23H32O6
- IUPAC Name:
- 11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): hydrocortioson-21-aecate (ZK5192)
- Lot/batch No.: 10035003
Constituent 1
Method
- Target gene:
- histidin gene locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix)
- Test concentrations with justification for top dose:
- 0.003 to 5 mg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without S9 mix: strain TA 1535 and TA100: NaN3; strain TA 1537 and TA 98: 4-NOPD; strain TA 102: MMS; woth S9 mix: all strains: 2-AA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
no substancial increase in revertant colonies in any of the test strains were observed
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No mutagenic potential with and without metabolic activation - Executive summary:
Hydrocortisone 21-acetate did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA100, TA102, TA1535, TA1537) when tested up to the highest recommended dose level of 5.0 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix form Aroclor 1254 -treated rats).
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