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EC number: 213-254-4 | CAS number: 932-64-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- EC Number:
- 213-254-4
- EC Name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- Cas Number:
- 932-64-9
- Molecular formula:
- C2H2N4O3
- IUPAC Name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material : 3-NITRO-1 ,2,4-TRIAZOL-5-0NE (NTO)
- Substance type: energetic explosive
- Physical state: light green to white crystalline solid with no odor
- Purity ca.99%
Constituent 1
- Specific details on test material used for the study:
- Supplied by Ordnance Systems, Inc., Kingsport, Tennessee
Lot no.:BAE 07B 305001
Purity:99.6%
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- None stated
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: neat polyethylene glycol (PEG 200)
No additional data - Details on exposure:
- None stated
- Duration of treatment / exposure:
- 14 day
- Frequency of treatment:
- Daily
- Post exposure period:
- None stated
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 1500, and 2000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 rats/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive control group received a single dose of 200 mg/kg of EMS two days prior to study termination.
Examinations
- Tissues and cell types examined:
- The samples for micronucleus assay evaluations were prepared using the MicroFlow Plus Kit® (Litron Laboratories) following the manufacturer’s instructions. Briefly, peripheral blood (approximately 120 μL) was collected from the saphenous vein by puncturing the vein with an 18 gauge needle and collecting the blood using a pipette with a tip that was pre-coated in anti-coagulant.
Peripheral blood samples were processed for flow cytometric evaluation of micronucleated reticulocytes (MN-RET). - Details of tissue and slide preparation:
- None stated
- Evaluation criteria:
- None stated
- Statistics:
- A one-way analysis of variance (ANOVA) was used to test for significant differences in %MN-RET for female and male rats separately. The Tukey multiple comparison test was used to evaluate the differences between dose groups. The results were considered to be statistically significant at p < 0.05. SPSS® version 16.0 was used for all analyses.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The frequency of micronucleated reticulocytes (%MN-RET) ranged from 0.20 to 0.23% in female rats and 0.21 to 0.27% in male rats treated with 1, 1.5, and 2 g/kg per day of the test substance in neat PEG 200. Treatment with the test substance did not statistically significantly (p = 0.096 and p = 0.616, respectively) increase the frequency of micronucleated reticulocytes (%MN-RET) in the peripheral blood of female or male rats. The positive control significantly increased, relative to the untreated control, the frequency of micronucleated reticulocytes in the peripheral blood of female and male rats (p = 0.005 and p = 0.047, respectively). These results indicate that the test substance is not genotoxic in rat peripheral blood under the test conditions.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance is not genotoxic in rat peripheral blood under the test conditions.
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