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Toxicological information

Genetic toxicity: in vivo

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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:
1986
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

Constituent 1
Chemical structure
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

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.