3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 11, 1990

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

not specified

Type of assay:

mammalian germ cell cytogenetic assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]

EC Number:

223-765-4

EC Name:

3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]

Cas Number:

4058-30-4

Molecular formula:

C18H15ClN6O2

IUPAC Name:

3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]

Test material form:

not specified

Test animals

Species:

mouse

Strain:

other: C57BL/6JfCD-l/Alpk

Sex:

male/female

Administration / exposure

Route of administration:

not specified

Post exposure period:

72 h

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

3 130 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

5 000 mg/kg bw/day

Control animals:

yes, concurrent vehicle

Positive control(s):

cyclophosphamide

Results and discussion

Test results

Sex:

male/female

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

Small but statistically significant increases in the incidence of micronucleated polychromatic erythrocytes were noted in male mice 48 hours after being dosed at 5000 mg/kg bw and in female mice 72 hours after being dosed at 5000 mg/kg bw. No such increases were observed in any other group of male or female animals. Consideration of the data shows that the increased values are similar to the concurrent vehicle control data and it is considered that the observed increases are not biologically significant.

Applicant's summary and conclusion

Conclusions:

Not clastogenic

Executive summary:

Method:

The substance was tested for its genetic toxicity potential in C57BL/6JfCD-l/Alpk male and female mice at dose levels of 3130 and 5000 mg/kg, the higher level being the limit dose for this assay. Bone marrow samples were taken 24, 48 and 72 hours after dosing at 5000 mg/kg and 24 hours after dosing at 3130 mg/kg. No information about the guideline used.

 

Observation:

No statistically or biologically significant increases in the incidence of micronucleated polychromatic erythrocytes, over the vehicle control values, were seen at either dose level at any of the sampling times investigated when the data from both sexes was pooled prior to statistical analysis. Small but statistically significant increases in the incidence of micronucleated polychromatic erythrocytes were noted in male mice 48 hours after being dosed at 5000 mg/kg bw and in female mice 72 hours after being dosed at 5000 mg/kg bw. No such increases were observed in any other group of male or female animals. Consideration of the data shows that the increased values are similar to the concurrent vehicle control data and it is considered that the observed increases are not biologically significant.

The test system positive control, cyclophosphamide, induced statistically and biologically significant increases in the incidence in micronucleated polychromatic erythrocytes, thus verifying the sensitivity of the test system to a known clastogen.

 

Conclusion:

It is therefore concluded that the test substance under the conditions of test, is not clastogenic in the mouse micronucleus test.