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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:
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

Constituent 1
Chemical structure
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
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
vehicle controls used in parallel with the test material)
Positive controls:
yes
Positive control substance:
sodium azide
Positive controls:
yes
Positive control substance:
9-aminoacridine
Positive controls:
yes
Positive control substance:
2-nitrofluorene
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