Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1985 - Febraury 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
Principles of method if other than guideline:
The test was largely carried out as described by Ames:
Amea,B.N.; J, McCenn and e:. Yamasaki. Methods for detecting carcinogens and mutagens with the Selmonella/Mammallan-Microsome Mutagentclty Test.
Mut. Res..31, 347-364, 1975
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-bromo-6-(4-methylbenzoyl)pyridine
EC Number:
618-079-0
Cas Number:
87848-95-1
Molecular formula:
C13H10BrNO
IUPAC Name:
2-bromo-6-(4-methylbenzoyl)pyridine
Specific details on test material used for the study:
(E)-Ethyl 3-(6-(4-toluoyl)-2-pyridyl)acrylate
Batch WDCP/78/24/178/1
White/buff powder.

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
liver microsome prepantlon (S9)
Controlsopen allclose all
Positive control substance:
other: Sodium nitrite
Positive control substance:
other: 2-Aminoanthracene
Positive control substance:
9-aminoacridine
Positive control substance:
other: Hycanthone
Positive control substance:
other: Daunomycin
Positive control substance:
other: Azaserine
Untreated negative controls:
yes

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity

Any other information on results incl. tables

The test article did not induce a twofold increase in the number of revertants for any of the tester strains, with or without the liver microsome preparation (S9) in either test. It is therefore concluded that ((E)-Ethyl 3-(6-(4-toluoyl)-2-pyridyl)acrylate is non-mutagenic at concentrations up to and including that of 50 µg/plate (18.5 µg/cm3) in the first test in the presence and absence of a liver microsome preparation (S9), and In the second test in the absence of S9; and 158 µg/plate (58.5 µg/cm3) in the second test in the presence of S9. Above these concentrations, reduced background growth of tester strains indicated toxicity of the compound precluding further evaluation of results.

Applicant's summary and conclusion

Conclusions:
Substance was determined not to be mutagenic, observed in all strains at the concentrations tested.