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

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

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)

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:

Test for carcinogenicity

GLP compliance:

no

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:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

- no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sun flower oil

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

- lifetime

Frequency of treatment:

- two times per week

Post exposure period:

- no data

Doses / concentrations

Remarks:

Doses / Concentrations:
30 mg
Basis:
actual ingested

No. of animals per sex per dose:

90 treated animals were evaluated (no further information)
84 control animals were evaluated (no further information)

Control animals:

yes, concurrent vehicle

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:

A carcinogenicity study with rats which received the test item perorally or subcutaneously was performed. The documentation of the study is insufficient for assessment. As is stated by the authors, the test item contained 3,3'-dichlorobenzidine, which is a known carcinogen. The carcinogenic effects observed in rats are probably due to this impurity. This report is regarded inadequate for the assessment of a possible carcinogenic potential of the submission substance.

Effect levels

Dose descriptor:

LOAEL

Effect level:

30 other: mg/treatment (2 times per week)

Sex:

male/female

Basis for effect level:

other: increased tumour incidence in treated rats

Remarks on result:

other: Effect type: carcinogenicity (migrated information)

Any other information on results incl. tables

- 53/90 animals (59%) had tumours after peroral application

- 70/88 animals (80%) had tumours after subcutaneous application

- treated animals had higher incidences and variabilities of tumours than control animals (tumour incidence: about 28% after oral and subcutaneous application)

- tumours of treated animals occurred mainly in the haematopoietic system, additionally tumours of e.g. the mammary, urinary bladder, adrenals, pituitary and on the site of application