2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-ethoxyphenyl)-3-oxobutyramide]

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 26 APR 1994 to 06 JUN 1994

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

only 1000 instead of 2000 immature erythrocytes were evaluated per animal

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

only 1000 instead of 2000 immature erythrocytes were evaluated per animal

GLP compliance:

yes (incl. QA statement)

Remarks:

in accordance with Directive 88/320/EEC

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methoxyphenyl)-3-oxobutyramide]

EC Number:

250-797-6

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methoxyphenyl)-3-oxobutyramide]

Cas Number:

31775-16-3

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(4-methoxyphenyl)-3-oxobutanamide]

Test animals

Species:

mouse

Strain:

ICR

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Duration of treatment / exposure:

1250 and 2500 mg/kg group: 24 hrs
5000 mg/kg group: 24, 48 and 72 hrs

Frequency of treatment:

single

Post exposure period:

none

Doses / concentrations

Remarks:

Doses / Concentrations:
1250, 2500, 5000 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

5 males and 5 females per dose and exposure duration

Control animals:

yes, concurrent vehicle

Examinations

Tissues and cell types examined:

bone marrow cells from the femur

Evaluation criteria:

- a statistically significant increase in the number of micronucleated polychromatic erythrocytes in the treatment groups in comparison to the control group is evaluated as positive mutagenic response
- a positive response for bone marrow toxicity is demonstrated when the dose group mean polychromatic to normochromatic ratio is shown to be statistically significant from the concurrent vehicle control group

Statistics:

- Student's t-test
- one way analysis of variance

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative