Gestonorone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Study period:

5. Oct - 14. Nov 1977

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well reported pre-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): 17-alpha-hydroxy-19-norprogesterone-caproate

Method

Target gene:

histidin

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 used for base pair substitutions and frame shift mutations.

Metabolic activation:

with and without

Metabolic activation system:

rat liver homogenate (S9 mix)

Test concentrations with justification for top dose:

0.005 - 2.5 mg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-AA, Benzo(a)pyren, MNNG

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

TA 1537 and TA 98 at highest concentration +S9

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

Gestonorone caproate did not show a mutagenic potential in the bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA 100, TA 1538, TA 1535 and TA1537) up to the highest tested concentration of 2.5 mg/plate (at which precipitates of test compound were observed) in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Due to the negative result no classification required.

Executive summary:

No mutagenicity assay was performed with ZK 5668 (gestonorone), results of studies with an ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative:

ZK 5623 (gestonorone caproate) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA 98, TA 100, TA 1538, TA 1535 and TA1537) up to the highest tested concentration of 2.5 mg/plate (at which precipitates of test compound were observed) in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats).