Registration Dossier
Registration Dossier
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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
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:
- not specified
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Micronucleus)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-370-3
- EC Name:
- 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 58890-25-8
- Molecular formula:
- C27 H36 N4 O2
- IUPAC Name:
- 1-cyclohexyl-3-[4-({4-[(cyclohexylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): MDI/CHA
Constituent 1
Test animals
- Species:
- other: Mouse (NMRI)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- No. of animals per sex per dose:
- Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- (Doses producing toxicity: Mitotic index: 5000 mg/kg In a preliminary experiment 2 males and 2 females were treated with 5000 mg/kg of the test substance and exhibited a reduction in spontaneous activity.)
- Additional information on results:
- Observations:
No increase in micronucleus formation was observed. The positive control substance cyclophosphamide led to an increase in the incidence of micronuclei.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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