17β-hydroxy-17-(3-hydroxy-1-propynyl)androst-4-ene-3-one

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 2000

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:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no bacteria strain included to detect cross-linking mutagens (e.g. TA 102)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

17 beta-Hydroxy-17 alpha-(3-hydroxy-1-propynyl)-4-androsten-3-one

IUPAC Name:

17 beta-Hydroxy-17 alpha-(3-hydroxy-1-propynyl)-4-androsten-3-one

Details on test material:

- Name of test material (as cited in study report): ZK 4829
- Batch No.: 59002501

Method

Target gene:

Histidine gene locus

Species / strain

Species / strain / cell type:

bacteria, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Metabolic activation system:

liver S9-mix from Aroclor 1254 -treated rats

Test concentrations with justification for top dose:

Hydroxypropinol: eight concentrations from 0.025 to 5.0 mg/plate
4-Nitro-o-phenylenediamine: 10 µg/plate
2-Aminoanthracene: 2.5 µg/plate
2-Nitrofluorene: 10 µg/plate
Benzo[a]pyrene: 2.5 µg/plate
Sodium azide: 5 µg/plate
Cyclophosphamide: 400 µg/plate

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO or phosphate buffer pH 7.4, 0.1 mol/l

Positive controls:

yes

Positive control substance:

other: 4-Nitro-o-phenylenediamine, 2-Aminoanthracene, 2-Nitrofluorene, Benzo[a]pyrene, Sodium azide, Cyclophosphamide

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

growth inhibition and precipitates in the agar were observed at 5.0 mg/plate

Vehicle 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

Executive summary:

Hydroxypropinol was examined for mutagenic activity up to 5000 µg/plate in the five histidine-dependent Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98 with and without metabolic activation.

A cytotoxic effect as well as precipitates were seen at 5.0 mg/plate.

There was no evidence for a mutagenic activity of Hydroxypropinol, when tested up to the maximum recommended dose level of 5 mg/plate in the absence and presence of S9 mix.