Registration Dossier

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:
Aug 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
Chemical structure
Reference substance name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
EC Number:
606-280-6
Cas Number:
192704-54-4
Molecular formula:
C24 H29 N O5
IUPAC Name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
Details on test material:
- Name of test material (as cited in study report): ZK 233744
- Batch No.: 1366
- Purity: 92.3%

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:
Diketon: 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:
no cytotoxicity
Vehicle controls validity:
valid
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 growth inhibition or precipitates in the agar were observed.

Applicant's summary and conclusion

Executive summary:

Diketon 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.

No growth inhibition and no precipitates were seen up to 5.0 mg/plate.

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

Categories Display