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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
Type of genotoxicity: other: DNA-binding capacity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed database

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Synthesis and quantification of DNA adducts of 4,4-methylendianiline.
Author:
Schuetze, D. et al.
Year:
1996
Bibliographic source:
Chem. Res. Toxicol., 9, 1103-1112
Reference Type:
secondary source
Title:
Synthesis and quantification of DNA adducts of 4,4-methylenedianiline
Author:
Schuetze, D. et al
Year:
1996
Bibliographic source:
Chem. Res. Toxicol., 9, 1103-1112 (1996); Cited in: European Union Risk Assessment Report 4,4'-methylenedianiline, Vol:9; 2001
Reference Type:
secondary source
Title:
Synthesis and quantification of DNA adducts of 4,4-methylenedianiline
Author:
Schuetze, D.
Year:
1996
Bibliographic source:
Chem. Res. Toxicol., 9, 1103-1112 (1996); Cited in: OECD SIDS 4,4-Methylenedianiline (2002)

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Radiolabeled (3H)test substance was administered intraperitoneally to groups of 6 male Wistar rats at single doses of 5.6 and 116.5 μmol/kg. In the liver relatively binding indices were determined.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Fluka, Neu-Ulm, Germany

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
unspecified
Frequency of treatment:
single exposure
Doses / concentrationsopen allclose all
Dose / conc.:
5.6 other: µmol/kg
Remarks:
equivalent to 1.1 mg/kg bw
Dose / conc.:
116.5 other: mmol/kg
Remarks:
equivalent to 23.1 mg/kg bw
No. of animals per sex per dose:
6 male rats

Examinations

Tissues and cell types examined:
liver

Results and discussion

Any other information on results incl. tables

In the liver relatively low covalent binding indices of 1.05 (low dose) and 2.3 (high dose) were determined [CBI = (µmol of MDA bound / mol of DNA) / (mmol of MDA applied / kg bodyweight)].

Applicant's summary and conclusion