Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15/09/2016-06/10/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
EC Number:
213-563-4
EC Name:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
Cas Number:
981-34-0
Molecular formula:
C22H28O5
IUPAC Name:
17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione
Test material form:
solid: particulate/powder

Method

Vehicle / solvent:
- Vehicle used:Dimethyl sulfoxide
- Justification for choice of vehicle: Based on the solubility test

Results and discussion

Test results
Species / strain:
other: all strain tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
On the basis of the results of this study, it is concluded that Beta-methylepoxy is non mutagenic as it did not induce (point) gene mutation at histidine locus by base pair changes or frameshift in the presence and absence of metabolic activation system in all five tester strains of salmonella typhimurium TA 1537, TA 1535, TA 100 and TA 102.