Registration Dossier
Registration Dossier
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EC number: 202-448-4 | CAS number: 95-76-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Biological effects and nontoxic concentrations of dichloroaniline isomers in water
- Author:
- Rusakov, NV
- Year:
- 1 968
- Bibliographic source:
- Gigiena i Sanitariia 33:8-13
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- ; only one dose tested, documentation insufficient
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,4-dichloroaniline
- EC Number:
- 202-448-4
- EC Name:
- 3,4-dichloroaniline
- Cas Number:
- 95-76-1
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 3,4-dichloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 3,4-dichloroaniline
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: sunflower oil
- Details on oral exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
70 mg/ kg bw
Basis:
other: nominal in sun flower oil
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- no data
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Hematotoxicity:
Considerable amounts of methemoglobin (2,4 %) were detected in the blood after 2 weeks of treatment. A decrease in erythrocytes and hemoglobin as well as an increase of heinz bodies and reticulocytes was observed after 1 month of treatment. After 3 months an increase of the catalase index and the blood cholinesterase activity was evident and decreased phagocytic activity of leukocytes was detected. Possible development of an auto-allergy against erythrocytes.
Body composition:
The relative spleen weight (organ weight/ body weight) was increased at the end of the treatment (1/10 LD50 for 3 months and its Vitamin C content decreased.
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