Registration Dossier

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

Constituent 1
Chemical structure
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'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]
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.