3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

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:

1995-10-11 - 1995-11-20

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

EC Number:

407-830-6

EC Name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

Cas Number:

103335-54-2

Molecular formula:

Hill formula: C19H27NO3 CAS formula: C19H27NO3

IUPAC Name:

4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid

Details on test material:

Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark

Method

Target gene:

Histadine synthesis

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 50, 150, 500, 1500, 5000 µg/plate

Vehicle / solvent:

PEG 400

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG 400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

Added to TA100 at 3µg/plate and TA1535 at 5µg/plate

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG 400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Added to TA1537 at 80µg/plate

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG 400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

Added to TA102 at 0.5µg/plate

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG 400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

Added to TA98 at 0.2µg/plate

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

Added to TA1535 at 2µg/plate and TA1537 at 0.5µg/plate

Controls 6

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PEG 400

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Danthron

Remarks:

Added to TA102 at 10µg/plate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Evaluation criteria:

For a substance to be considered positive in this test system, it should have induced a dose-related and statistically significant increase in mutation rate in one or more strains of bacteria in the presence and/or absence of the S9 microsomal enzymes in both experiments at sub-toxic dose levels. To be considered negative the number of induced reverants compared to spontaneous reverants should be less than twofold at each dose level employed.

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

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'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material was found to be non-mutagenic under the conditions of this test.

Executive summary:

No significant increases in the frequency of reverant colonies was recorded for any of the bacterial starins with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of this test.