17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

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:

Nov 2004 to Nov 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

EC Number:

223-768-0

EC Name:

17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

Cas Number:

4062-46-8

Molecular formula:

C22H34O3

IUPAC Name:

1-methyl-3-oxoandrostan-17-yl acetate

Details on test material:

- Name of test material (as cited in study report): Mesterolone acetate
- Analytical purity: 100.6%
- Lot/batch No.: 94510001
- Expiration date of the lot/batch: Sep 2005

Method

Target gene:

Histidin (S. typhimurium), tryptophan (E.coli)

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 and E.coli WP2uvrA

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

liver homogenate

Test concentrations with justification for top dose:

0.1 - 5 mg/plate

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: +S9-mix. 2-acetylaminofluorene for all strains, i Sp-mix: 2-NF for TA98 and TA 1538, EMS and MNNG for E.coli, NaN3 for TA 1535 and TA 100, 4-NPDA for TA 1537

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 and E.coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

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

No mutagenic potential observed in S. typhimurium strains TA 98, TA 100, TA 102, TA 1535, TA 1537 and E. coli strain WP2uvrA when tested up to the highest recommended dose level of 5.0 mg/pate in the absense or presense of extrinsic metabolic activation.

Positve controls induced marked increase in revertant colony numbers with all strains

Negative controls confirmed the characteristically spontaneous reversion rate.

Precipitates in the agar was found from 2.5 mg/plate onwards in the experiments with S9 mix on strains TA 98, TA 1535 and E.coli WP2uvrA.

Growth inhibition of the background lawn was not observed.

Applicant's summary and conclusion

Conclusions:

Mesterolone acetate is not mutagenic in this test system

Executive summary:

Mesterolone acetate (ZK 5894) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurim strains TA 98, TA 100, TA 102, TA 1535, TA 1537 and E. coli strain WP2uvrA) when tested up to the highest recommended dose level of 5.0 mg/pate in the absense or presense of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats).