Registration Dossier

Diss Factsheets

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

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).