Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-690-3
- EC Name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 43136-14-7
- Molecular formula:
- C51H88N4O2
- IUPAC Name:
- 3-octadecyl-1-[4-({4-[(octadecylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: oral (not specified)
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Duration of treatment / exposure:
- 24, 48 and 72 hours
Doses / concentrations
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Positive control(s):
- Not specified
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- Based on P/N ratio
- Additional information on results:
- Other toxic signs: Dosing at 5000 mg/kg in a preliminary test for toxicity using 20 mL/kg b.w. resulted in a reduction in activity in all animals up to 6 hours post-dosing but these effects are not clearly substance related. No signs of toxicity were stated for the main study.
Applicant's summary and conclusion
- Conclusions:
- The test item was concluded to be negative for mammalian chromosome aberration. No signs of toxicity or cytotoxicity (based on P/N ratio) were observed.
- Executive summary:
The test item was investigated for in vivo chromosome aberration in male and female NMRI mice following EU Annex V guidelines (micronucleus test). Test animals were administered 5000 mg/kg test item by oral gavage and sacrificed at 24, 48 and 72 hours. The test item was concluded to be negative for mammalian chromosome aberration. No signs of toxicity or cytotoxicity (based on P/N ratio) were observed.
The study is a GLP compliant, guideline experimental study and is acceptable with restrictions for assessment of this endpoint.
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