Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.