[No public or meaningful name is available]

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:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V (Micronucleus)

GLP compliance:

yes

Type of assay:

other: micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea

EC Number:

406-370-3

EC Name:

3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea

Cas Number:

58890-25-8

Molecular formula:

C27H36N4O2

IUPAC Name:

3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea

Test material form:

solid: particulate/powder

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

Corn oil

Details on exposure:

The dose of the test substance was judged to be the maximum attainable.

Duration of treatment / exposure:

Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours

Frequency of treatment:

Not specified

Post exposure period:

Not specified

Doses / concentrations

Dose / conc.:

5 000 mg/kg bw/day (nominal)

No. of animals per sex per dose:

15 male and 15 females

Control animals:

not specified

Positive control(s):

Cyclophosphamide

Examinations

Tissues and cell types examined:

Not specified

Evaluation criteria:

Micronucleus formation

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No increase in micronucleus formation was observed. The positive control substance cyclophosphamide led to an increase in the incidence of micronuclei.
Toxicity: yes. Doses producing toxicity: Mitotic index: 5000 mg/kg; In a preliminary experiment 2 males and 2 females were treated with 5000 mg/kg of the test substance and exhibited a reduction in spontaneous activity.

Applicant's summary and conclusion

Conclusions:

The in vivo genetic toxicity of the test item was assessed in a micronucleus assay. The result was negative for the test item.

Executive summary:

The in vivo genetic toxicity of the test item was assessed in a micronucleus assay. The result was negative for the test item.

In vivo genetic toxicity was assessed in a micronucleus assay following a standard guideline. 15 male and female mice were exposed at a concentration of 5000 mg/kg, with 5 of each sex being sacrificed after 24, 48 and 72 hours. The study was negative, as no increase in micronucleus formation was observed.

In a preliminary experiment, 2 males and 2 females were treated with 5000 mg/kg of the test substance and exhibited a reduction in spontaneous activity.

The study is a GLP compliant, guideline experimental study and is acceptable with restrictions for assessment.