Registration Dossier
Registration Dossier
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EC number: 602-927-1 | CAS number: 123312-89-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21 Sep 1998 to 26 Oct 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- May 1983
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- July 31, 1992
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Ministry of International Trade and Industry, Japan, 62 Notification of Basic Industries Bureau, No. 303, (Sho-62).
- Version / remarks:
- March 31, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
- EC Number:
- 602-927-1
- Cas Number:
- 123312-89-0
- Molecular formula:
- C10H11N5O
- IUPAC Name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
Constituent 1
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
At the high dose of 2000 mg/kg, two males out of 10 males were found dead on the day after treatment and were replaced by reserve animals. All other animals survived until scheduled necropsy. None of the animals showed signs of toxicity. In all groups exposed to the test substance assessed at the different time points after treatment, neither statistically significant nor biologically relevant increase in the number of micronucleated polychromatic erythrocytes was observed when compared with the respective negative control group. The positive control group showed a clear mutagenic effect.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that there was no evidence of clastogenic or aneugenic effects in mice treated with the test substance in this study.
- Executive summary:
The micronucleus test in mice was conducted at single oral dose levels of 0, 200, 600 and 2000 mg/kg body weight on male and female mice (administration: 10 mL/kg bw via gavage). The high dose of 2000 mg/kg is currently the highest limit dose set in the appropriate guideline. The test compound was formulated in a mixture of aqueous CMC (0.5%) and Tween 80 (0.4%). The mouse strain was TifIbm:MAG. This strain is identical with the former Tif MAG f (SPF) mouse. An additional (positive control) group received 64 mg/kg cyclophosphamide and was sacrificed 24 hours after application. At all dose levels, groups of 5 male and 5 female mice were sacrificed at 24 and 48 hours after dosing. Femoral bone marrow cells were prepared and polychromatic erythrocytes were scored for the presence of micronuclei, indicative of clastogenic and/or aneugenic effects.
At the high dose of 2000 mg/kg, two males out of 10 males were found dead on the day after treatment and were replaced by reserve animals. All other animals survived until scheduled necropsy. None of the animals showed signs of toxicity. In all groups exposed to the test substance assessed at the different time points after treatment, neither statistically significant nor biologically relevant increase in the number of micronucleated polychromatic erythrocytes was observed when compared with the respective negative control group. The positive control group showed a clear mutagenic effect.
It is concluded that there was no evidence of clastogenic or aneugenic effects in mice treated with the test substance in this study.
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