Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 12, 2012 to October 16, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Remarks:
All testing was conducted in accordance with non-GLP Protoocal M12-4404
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Lot No: 61449

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration tested at 5; 1; 0.5; 0.1 and 0.05 mg/plate
Vehicle / solvent:
Sterile Deionized Water
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
Sterile Deionized Water
Positive controls:
yes
Positive control substance:
other: ICR 191 Acridine
Remarks:
TA97a
Negative solvent / vehicle controls:
yes
Remarks:
Sterile Deionized Water
Positive controls:
yes
Positive control substance:
other: Daunomycin
Remarks:
TA98
Negative solvent / vehicle controls:
yes
Remarks:
Sterile Deionized Water
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA100 & TA1535
Negative solvent / vehicle controls:
yes
Remarks:
Sterile Deionized Water
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
TA102
Negative solvent / vehicle controls:
yes
Remarks:
Sterile Deionized Water
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (w/S9)
Remarks:
All Strains

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion

Conclusions:
The results show that the test strains were sensitive to the positive controil mutagens and had a spontaneous reversion rate well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents. The test samples were not cytotoxic at the concentrations tested. The metabolic activation using the S9 activation mixture shows an active microsomal preparation.
Using the same conditions, there was no detectable genotoxic activity associated with the non-cytotoxic concentrations (5; 1; 0.5; 0.1; 0.05 mg) of test samples M12-4404.01 (D-Panthenyltriacetate Lot#: 61449)