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Diss Factsheets

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

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.