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Toxicological information

Repeated dose toxicity: oral

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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:
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:
1968
Bibliographic source:
Gigiena i Sanitariia 33:8-13

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3,4-dichloroaniline
- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: albino
Sex:
not specified
Details on test animals 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