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.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
