2,5-bis(p-toluidino)terephthalic acid

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 471(1983) and OECD TG 472(1983))

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

Principles of method if other than guideline:

Testing guidelines 471 (1983) and 472 (1983) were combined in the OECD guideline 471 (1997).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,5-bis(p-toluidino)terephthalic acid

EC Number:

233-651-6

EC Name:

2,5-bis(p-toluidino)terephthalic acid

Cas Number:

10291-28-8

Molecular formula:

C22H20N2O4

IUPAC Name:

2,5-bis[(4-methylphenyl)amino]benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Toluidinosäure (Op. 50)
- Substance type: red-brown particulates
- Storage condition of test material: dark at 22°C

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

induced rat liver S9-mix

Test concentrations with justification for top dose:

Experiment I: 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment II: 4, 20, 100, 500, 2500, 5000 µg/plate
Experiment III: 20, 100, 500, 2500, 5000, 7500, 10000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (TA 100, TA 1535), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98, TA 1538), N-methyl-N-nitro-N-nitrosoguanidine (WP2 uvrA)

Remarks:

without metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: benzo[a]pyrene and 2-aminoanthracene (TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2 uvrA)

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION:
in agar (plate incorporation)
induction of rat liver S9 with Aroclor 1254

DURATION
- Exposure duration: for at least 48 to 72 hours

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls

Statistics:

Arithmetic means of the counted colonies were calculated.

Results and discussion

Test results

Test results 1

Species / strain:

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

Test results 2

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

Test results 3

Species / strain:

E. coli WP2 uvr A

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

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: visible precipitation of the test item on the plates has been observed at 2500 µg/plate and above.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The test item (Toluidinosäure Op.50) showed no mutagenic activity with or without metabolic activation for the concentrations tested.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test item did not exert mutagenic activity in the reverse bacterial mutation assay (plate incorporation test) with and without metabolic activation.

Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98, 100 and 1538 as well as Escherichia coli WP2 uvrA with and without metabolic activation (induced rat liver S9-mix) at concentrations of 4, 20, 100, 500, 2500, 5000, 7500 and 10000 µg/plate. Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed.

Therefore the test item is not considered mutagenic under the tested conditions in this reverse bacterial mutation assay.