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

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Remarks:

Type of genotoxicity: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

year of publication: 1985

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment (e.g. no data on test item purity, insufficient reporting of study details and study results) and shortcomings in the study design (e.g. only 20 metaphases per animal evaluated instead of 50)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Principles of method if other than guideline:

Sister Chromatid Exchange Assay in vivo

GLP compliance:

no

Type of assay:

sister chromatid exchange 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-(2-methoxyphenyl)-3-oxobutyramide]

EC Number:

224-867-1

EC Name:

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

Cas Number:

4531-49-1

Molecular formula:

C34H30Cl2N6O6

IUPAC Name:

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

Test material form:

not specified

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- DMSO

Doses / concentrations

Remarks:

Doses / Concentrations:
5, 10, 50, 100, 200, 400 mg/kg
Basis:
other: nominal applied

No. of animals per sex per dose:

5-6 males

Control animals:

yes, concurrent vehicle

Positive control(s):

- 3,3'-Dichlorobenzidine

Examinations

Tissues and cell types examined:

- bone marrow

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The test item did not induce SCE in vivo under the conditions tested. Due to insufficient documentation and shortcomings in the study design the assay was judged not to be reliable and to be insufficient to cover this endpoint.

Executive summary:

An in vivo assay for the induction of sister chromatide exchanges (SCE) was performed with male Balb/c mice, which received 5, 10, 50, 100, 200, 400 mg/kg test item intraperitoneally. The test item did not induce SCE under the conditions tested.