Registration Dossier
Registration Dossier
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EC number: 257-861-2 | CAS number: 52338-87-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 3-(dimethylamino)propylurea
- EC Number:
- 401-950-2
- EC Name:
- 3-(dimethylamino)propylurea
- Cas Number:
- 31506-43-1
- Molecular formula:
- C6H15N3O
- IUPAC Name:
- 3-dimethylaminopropyl urea
- Test material form:
- liquid
- Remarks:
- extremely pale straw coloured viscous liquid
Constituent 1
Test animals
- Species:
- mouse
- Sex:
- male/female
Administration / exposure
- Control animals:
- yes
- Positive control(s):
- The known clastogen and cytostatic agent cyclophosphamide served as a positive controll - cyclophosphamide.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- No indications of a clastogenic effect of 3-(dimethylamino)propylurea were found after a sinde oral treatment of 5000 mg/kg.
- Toxicity:
- no effects
- Remarks:
- No indications of a clastogenic effect of 3-(dimethylamino)propylurea were found after a sinde oral treatment of 5000 mg/kg.
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Remarks:
- Negative and positive controls were sacrificed after 24 hours only.
- Positive controls validity:
- valid
- Remarks:
- Cyclophosphamide, the positive control, had a clear clastogenic effect, as can be seen fiom the biologically relevant increase in polychromatic erythrocytes with micronuclei. An inhibition of erythropoiesis was not found here.
Applicant's summary and conclusion
- Conclusions:
- No indications of a clastogenic effect of 3-(dimethylamino)propylurea were found after a sinde oral treatment of 5000 mg/kg.
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