9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione

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:

supporting study

Study period:

16th November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD method and in accordance with GLP. Study material is well characterized.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The purpose of this study was to assess the potential of GR-46708X to induce gene mutations in vitro in bacterial strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and Escherichia coli WP2 uvrA (pKM101).

GR-46708X (parent compound), is a synthesis intermediate. In this study all formulations of the test article were prepared and all concentrations expressed in terms of parent compound, which for the purposes of this report is referred to as GR-46708.
A single plate incorporation test was conducted for each tester strain both in the presence and absence of rat liver S9-mix, together with appropriate vehicle and positive controls

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione

EC Number:

246-529-2

EC Name:

9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Cas Number:

24916-90-3

Molecular formula:

C22H28O5

IUPAC Name:

9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Test material form:

not specified

Details on test material:

No Data

Method

Target gene:

4 histidine-requiring strains

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium: TA1535, TA1537, TA98, TA100

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix(2.5%) from Aclor 1254-induced rat liver

Test concentrations with justification for top dose:

Dose level per plate (ug) 50,150,500,1500,2500,5000

Vehicle / solvent:

solvent- DMSO

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

vehicle controls used in parallel with the test material)

Positive controls:

yes

Positive control substance:

sodium azide

Controls 2

Positive controls:

yes

Positive control substance:

9-aminoacridine

Controls 3

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Controls 4

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Details on test system and experimental conditions:

No data

Evaluation criteria:

No data

Statistics:

Mean and standard deviation of the plate counts for each treatment were determined

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

GR-46708X (parent compound) was not mutagenic when tested in either the presence or absence of S9-mix.

The maximum concentration analysed was limited by precipitation (observed by eye on test plates at the end of incubation) to 1500 µg per plate, in the presence and absence of S9-mix