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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
The tests were performed according to the original protocol with some minor technical modifications.
GLP compliance:
not specified
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
Fenuron
EC Number:
202-941-4
EC Name:
Fenuron
Cas Number:
101-42-8
Molecular formula:
C9H12N2O
IUPAC Name:
fenuron
Test material form:
not specified
Specific details on test material used for the study:
Fenuron was synthesized in our laboratory by the reaction of methyl- or dimethyl-amine with an appropriately substituted phenyhsocyanate. These mostly very vigorous reactions were carried out in ethereal solutions at 5°C, yielding pure crystalline ureas after standing overnight at room temperature.

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Doses / concentrations
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
6
Control animals:
not specified

Examinations

Tissues and cell types examined:
bone marrow

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Table1. Percentage of Micronucleated polychromatic erythrocytes in bone marrow of mice treated with FenuronO MICE TREATED

Dose (mg/kg) per os

Number of animals

Micronucleated erythrocytes (%)

1000

6

0.17

 

Applicant's summary and conclusion

Conclusions:
Fenuron tested negative in the in vivo micronucleus test in mice after oral dosing at 1000 mg/kg bw/day.
Executive summary:

The in vivo micronucleus test was performed according to the original protocol with some minor technical modifications.

6 mice received 1000 mg/kg bw/day Fenuron per os. As a result, 0.17% micronucleated polychromatic erythrocytes were observed in bone marrow cells of the treated mice.

Fenuron was negative under the test conditions used.

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