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Toxicological information

Carcinogenicity

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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

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'-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

Applicant's summary and conclusion