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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
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 resultsopen allclose all
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:
cytotoxicity
Remarks:
5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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:
Interpretation of results (migrated information):
negative

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.