1,2,4-triazole

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:

From Jun. 28, 1985 to Aug. 25, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study [OECD 471] with acceptable restrictions. No indication on the purity on the test item.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983 followed, reliability scoring based on 1997 guideline.

Deviations:

yes

Remarks:

Salmonella typhimurium TA102 or Escherichia coli WP2 uvrA strain missing; 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,2,4-triazole

EC Number:

206-022-9

EC Name:

1,2,4-triazole

Cas Number:

288-88-0

Molecular formula:

C2H3N3

IUPAC Name:

1H-1,2,4-triazole

Details on test material:

- Name of test material (as cited in study report): 1-2-4 Triazole
- Physical state: solid
- Lot/batch No.: 40
- Storage condition of test material: Stored at room temperature

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1537

Additional strain / cell type characteristics:

not applicable

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not applicable

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

Dose range finding test: 5000, 500, 50, 5 µg/plate
Test 1 & 2: 1500, 500, 150, 50, 15 µg/plate

Vehicle / solvent:

Water

Controls

Untreated negative controls:

yes

Remarks:

untreated

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see Table 1

Evaluation criteria:

not precised

Statistics:

no

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000µg/plate

Untreated negative controls validity:

valid

True negative controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No substantial increases in revertant colony numbers of any of the five tester stains were observed following treatment with 1-2-4 Triazole at any dose level, either in the presence or absence of metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

1-2-4 Triazole was toxic towards the tester strains at the highest dose level (5000 µg/plate) in the dose range finding test. Therefore, 1500 µg/plate was chosen as the top dose level in the mutation tests.

Applicant's summary and conclusion

Conclusions:

No evidence of mutagenic potential of 1-2-4 Triazole was obtained in this bacterial test system at the dose levels used.

Executive summary:

An Ames test was carried out with 1,2,4 -triazole (OECD 471 guideline study).

Test material was tested on 5 S. typhimurium strains (TA 1535, TA1538, TA 1537, TA 98 and TA 100) with and without metabolic activation (S9 -mix).

No substantial increases in revertant colony numbers of any of the five tester stains were observed following treatment with 1-2-4 Triazole at any dose level, either in the presence or absence of metabolic activation.