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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:
Oct 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

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

Constituent 1
Chemical structure
Reference substance name:
3-oxopregn-4-ene-21,17α-carbolactone
EC Number:
213-552-4
EC Name:
3-oxopregn-4-ene-21,17α-carbolactone
Cas Number:
976-70-5
Molecular formula:
C22H30O3
IUPAC Name:
(1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
Details on test material:
- Name of test material (as cited in study report): aldona (ZK 57564)
- Analytical purity: 95.5% (HPLC)
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002

Method

Target gene:
Histidin gene locus
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate (S9 mix)
Test concentrations with justification for top dose:
0.025 to 5.0 mg/plate (8 doses)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9 mix: NaN3 used for strain TA 1535, TA 100; 4-NPDA used for TA 1537; 2-NF used for TA 1538 and TA 98 with S9 mix: 2-AA used for TA 1535, TA 100, TA 1537, 1538, TA 98; cyclophosphamide used for TA 1535; Benzo[a]pyrene used for TA 100 and TA

Results and discussion

Test results
Species / strain:
other: TA 98, 100, 1535, 1537 and 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
growth inhibition of the background lawn from 2.5 mg/plate onwards without S9 mix.
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

Precipitates in the agar were found starting at 1.0 mg/plate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

not mutagen, no classifiction required
Executive summary:

Aldona (ZK 57564) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA100, TA1538, TA1535, TA1537) when tested up to the highest recommended dose level of 5.0 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix form Aroclor 1254 -treated rats).

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