Registration Dossier
Registration Dossier
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EC number: 210-157-9 | CAS number: 608-27-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,3-dichloroaniline
- EC Number:
- 210-157-9
- EC Name:
- 2,3-dichloroaniline
- Cas Number:
- 608-27-5
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 2,3-dichloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 2,3-dichloroaniline
- Physical state: solid
- Analytical purity: 99.1%
- Lot/batch No.: 3
- Storage condition of test material: refrigerator
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 and 3500 mg/kg bw
Basis:
nominal conc.
- Positive control(s):
- cyclophosphamide
- Route of administration: gavage
Examinations
- Tissues and cell types examined:
- bone marrow
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Mortality: 13/40 mice
Clinical signs:
The treated mice showed compound-related symtoms up to 72 hours including apathy, roughened fur, pallor, prone position, spasm, twitching, shivering, difficulty in breathing, breathing sounds.
Micrroscopic evaluation:
The ratio between normochromatic and polychromatic cells vary in comparison to the negative control,
The positive control, cyclophosphamide, was functional.
Applicant's summary and conclusion
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