3-oxopregn-4-ene-21,17α-carbolactone

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:

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

Test material information

Constituent 1

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

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).