Registration Dossier
Registration Dossier
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EC number: 209-002-8 | CAS number: 551-93-9
Genetic toxicity: in vitro
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:
- 1 976
- 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
- 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
Constituent 1
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.
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