3-amino-p-toluamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: performed in accordance with OECD and GLP guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-p-toluamide

EC Number:

243-039-0

EC Name:

3-amino-p-toluamide

Cas Number:

19406-86-1

Molecular formula:

C8H10N2O

IUPAC Name:

3-amino-p-toluamide

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9-mix

Test concentrations with justification for top dose:

1st experiment: 50 - 5000 µg/plate
2nd experiment: 500 - 5000 µg/plate (only TA98)

Vehicle / solvent:

Tested substance suspended in deionized water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (TA100, TA1535), 9-aminoacridine (TA1537), 2-nitrofluorene (TA98), Mitomycin C (TA 102)

Remarks:

without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (all strains)

Remarks:

with metabolic activation

Details on test system and experimental conditions:

Method of application:
in agar (plate incorporation assay)
duration of incubation: approximatelyt 48h at 37°C in the dark

Evaluation criteria:

Increase of revertant colonies

Statistics:

Number of colonies per plate for each strain as well as mean values of the colonies of 3 plates/dose were counted.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 100, TA 102

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 100, TA 102

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No visible precipitation of the test compound was observed in the 1st and 2nd experiment at any tested concentration.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
negative with metabolic activation S. typhimurium TA 1535, TA 1537, TA 100 and TA 102
positive with metabolic activation S. typhimurium TA 98

The results lead to the conclusion that 3-amino-4-methyl benzamide is mutagenic in these bacterial test systems in the presence of an exogenous metabolizing system.

Executive summary:

3-amino-4-methylbenzamide was tested for mutagenicity with the strains TA 100, TA1535, TA 1537, TA 98, TA102 of Salmonella typhimurium. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 5 different doses from 50 to 5000 µg/plate (1st exp), 500 to 5000 µg/plate (2nd exp.) respectively were used.

Toxicity: The tested compound was proved to be not toxic to the bacterial strains with and without metabolic activation.

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. In the presence of the metabolic activation system the test compound showed a dose dependent increase in the number of revertants in the bacterial strain TA98.

It can be stated that the tested sample of 3-amino-4-methylbenzamide is mutagenic in these bacterial test systems with exogenous metabolic activation.