Registration Dossier
Registration Dossier
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EC number: 212-686-0 | CAS number: 846-48-0
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:
- Oct to Nov 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- Boldenone
- EC Number:
- 212-686-0
- EC Name:
- Boldenone
- Cas Number:
- 846-48-0
- Molecular formula:
- C19H26O2
- IUPAC Name:
- 17-hydroxyandrosta-1,4-dien-3-one
- Details on test material:
- - Name of test material (as cited in study report): boldenone (ZK5320)
- Analytical purity: 99%
- Lot/batch No.: 8145-3/08
- Expiration date of the lot/batch: 11 Jul 2011
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix from Aroclor 1254 -treated rats
- Test concentrations with justification for top dose:
- Six concentrations from 0.1 to 5 mg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without S9-mix: 2-NF, NaN3; 4-NPDA, Cum, MMC; with S9-mix: 2-AA, BP, CP, DMNA
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Boldenone (ZK 5320) is not genotoxic under the conditions of this test system and therefore classification is not required. - Executive summary:
Boldenone (ZK 5320) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 102, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats).
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