Registration Dossier
Registration Dossier
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EC number: 202-974-4 | CAS number: 101-77-9
Genetic toxicity: in vivo
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:
- 1 996
- 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:
- 1 996
- 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:
- 1 996
- 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 substance name:
- 4,4'-methylenedianiline
- EC Number:
- 202-974-4
- EC Name:
- 4,4'-methylenedianiline
- Cas Number:
- 101-77-9
- Molecular formula:
- C13H14N2
- IUPAC Name:
- 4,4'-methylenedianiline
Constituent 1
- 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
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