Registration Dossier
Registration Dossier
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EC number: 700-475-0 | CAS number: 145783-14-8
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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
- EC Number:
- 700-475-0
- Cas Number:
- 145783-14-8
- Molecular formula:
- C7H7Cl2N3O2S
- IUPAC Name:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
- Test material form:
- solid - liquid: suspension
- Remarks:
- migrated information: dispersion
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% w/v sodium carboxymethylcelulose and 0.1% w/v
polysorbate 80 in purified water. - Frequency of treatment:
- once
- No. of animals per sex per dose:
- 7 males per dose
- Positive control(s):
- cyclophosphamide
Examinations
- Tissues and cell types examined:
- Mature and immature erythrocytes in bone marrow
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It was concluded that, UL111 did not increase the incidence of micronucleated immature
erythrocytes in the bone marrow of Wistar Han rats when administered by the oral route up to
the maximum tolerated dose, 1000 mg/kg (3730 μmol/kg).
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