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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:
data from handbook or collection of data
Justification for type of information:
Data is from peer revewed publication

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of Aminophenyl and Nitrophenyl Ethers, Sulfides, And Disulfides
Author:
Edmond Lavoie, Lorraine Tulley, Elizabeth Fow and Dietrich Hoffmann
Year:
1979
Bibliographic source:
Mutation Research, 67 (1979) 123-131

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
The test chemical 4-Aminophenyl sulfone was studied to for its ability to induce mutations in strains of Salmonella typhimurium.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 4-Aminophenyl sulfone
- Molecular formula: C12H12N2O2S
- Molecular weight: 248.305 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
Specific details on test material used for the study:
- Name of test material: 4-Aminophenyl sulfone
- Molecular formula: C12H12N2O2S
- Molecular weight: 248.305 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: TA98 and TA100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
The S9 fraction was prepared Male Fisher-344 rats from Charles River injected with Aroclor 1254
Test concentrations with justification for top dose:
0, 25, 50, 100, 250 or 500 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Duplicate

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data
Rationale for test conditions:
No data
Evaluation criteria:
Compounds were considered mutagenic when the average number of histidine revertant colonies (His+ rev.) obtained at any dose level assayed were at least twice that of the solvent control
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data

Any other information on results incl. tables

Table: Results from the mutagenic study for 4-Aminophenyl sulfone

Dose

His revertants

TA100/-S9/ % survival

TA100/+S9/ % survival

TA100/+S9

TA100/-S9

TA98/+S9

500

163

153

98

39

112

250

171

152

108

80

98

100

174

163

94

97

107

50

139

134

113

102

89

25

141

146

113

105

90

DMSO (50µL)

135±16

160±12

78±110

100

100

Applicant's summary and conclusion

Conclusions:
4-Aminophenyl sulfone is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of S9 metabolic activation system.
Executive summary:

4-Aminophenyl sulfone was studied for its ability to induce mutations in strains of Salmonella typhimurium. The test compound was dissolved in DMSO and was tested at concentration of 0, 25, 50, 100, 250 or 500 µg/plate using Salmonella typhimurium TA100 and TA98 in the presence and absence of S9 metabolic activation system. 4-Aminophenyl sulfone is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of S9 metabolic activation system.