Registration Dossier
Registration Dossier
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EC number: 200-020-1 | CAS number: 50-23-7
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrocortisone
- EC Number:
- 200-020-1
- EC Name:
- Hydrocortisone
- Cas Number:
- 50-23-7
- Molecular formula:
- C21H30O5
- IUPAC Name:
- 11,17,21-trihydroxypregn-4-ene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): hydrocortisone (ZK5191)
Constituent 1
Method
- Target gene:
- histidin gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538; TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix)
- Test concentrations with justification for top dose:
- 0.1 to 5 mg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: NaN3, 2-NF, 9-AA (without S9); 2-AA, BP, CP (with S9), DMNA after preincubation with S9
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538; TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- weak positive in TA 100 in absence and presence of S9
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
Growth inhibition of background lawn without extrinsic metabolic activation system
on TA1538 at 5 mg/plate and on TA 100 in preincubation test at 4 and 6 mg/plateWeak increase in revertant colonies in strain TA 100 was observed
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
hydrocortisone is weak positive in strain TA100 - Executive summary:
ZK 5191 was tested to be a weak mutagen in a bacterial reverse mutation assay with the S. typhimurium strains TA100. The study was conducted with substance concentration from 0.1 to 5 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix form Aroclor 1254 -treated rats).
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