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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
publication
Title:
Mutagenic Activity of Tryptophan Metabolites Produced by Rat Intestinal Microflora
Author:
Bowden, P.; Chung, K.-T.; Andrews, A.W.
Year:
1976
Bibliographic source:
Journal of the National Cancer Institute 57(4), pp. 921-924

Materials and methods

Principles of method if other than guideline:
- Principle of test: Bacterial mutagenesis assay according to:

AMES BN. LEE FD. DURSTON WE: An improved bacterial test system for the detection and classification of mutagens and carcinogens. Proc Nat! Acad Sci USA 70:782-786. 1973

AMES BN, DURSTON WE. YAMASAKI E. et al: Carcinogens are mutagens: A simple test combining liver homogenates for activation and bacteria for detection. Proc Natl Acad Sci USA 70:2281-2285. 1973

MCCANN J. SPINGARN N E. KOBORI J, et al: Detection of carcinogens as mutagens: Bacterial tester strains with R factor plasmids. Pmc Natl Acad Sci USA 72:979-983. 1975
GLP compliance:
no
Remarks:
study pre-dates implementation of GLP
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2'-aminoacetophenone
EC Number:
209-002-8
EC Name:
2'-aminoacetophenone
Cas Number:
551-93-9
Molecular formula:
C8H9NO
IUPAC Name:
1-(2-aminophenyl)ethan-1-one
Test material form:
solid: crystalline

Method

Target gene:
his operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
50 to 500 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
other: N-methyl-N'-nitro-N-nitrosoguanidine (2 µg/plate); 2-Aminoanthracene (2 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: not specified

NUMBER OF REPLICATIONS: not specified

DETERMINATION OF CYTOTOXICITY
- Method: reduction in background bacterial lawn
Rationale for test conditions:
not specified
Evaluation criteria:
not specified
Statistics:
not specified

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The substance was reported to be not mutagenic in bacteria at up to 500 µg/plate with and without metabolic activation.