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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Ames mutagencity assay
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Ames, B.N., McCann,J., and Yamasaki, E. "Methods for Detecting Carcinagens and Mutagens with Salmonella/ Mammalian-Microsome Mutagencity Test". Mutation Research 31:347-364, 1975.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-2-nitropropan-1-ol
EC Number:
200-957-6
EC Name:
2-methyl-2-nitropropan-1-ol
Cas Number:
76-39-1
Molecular formula:
C4H9NO3
IUPAC Name:
2-methyl-2-nitropropan-1-ol
Details on test material:
Purity is above 99%.
Specific details on test material used for the study:
2-nitro-2-methyl-1-propanol; liquid concentrate; percent active unknown

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
liver microsomal enzyme preparations Aroclor induced
Test concentrations with justification for top dose:
0.003,0.01,0.03,0.1,0.3,1.0,3.1,10 microliters/plate. The highest test concentration of test material is that which gives a detectable reduction of spontaneous revertants on the 1XSA supplemented plants and/or a reduced survival on the 10X SA supplemented plates
Vehicle / solvent:
Not specified
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
other: 2-aminoanthracene and 1,3-propane sultone

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: No increase in revertants

Applicant's summary and conclusion

Conclusions:
Test material was nonmutagenic in the Ames Salmonella/mammalian-microsome mutagenicity test