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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-6
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: only study summary available and IUCLID data set summary available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anthrachinon

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water and Cremophor
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
2, 10, 20, 50, 250 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
15 females and 15 males
Control animals:
yes, concurrent vehicle
Details on study design:
Two experiments were performed. The dosage in first experiment was 10, 50, 250 mg/kg. The dosage in second experiment was 2 and 20 mg/kg. The application volume was 10 mL/ kg body weight.

Examinations

Observations and examinations performed and frequency:
CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

HAEMATOLOGY: Yes

CLINICAL CHEMISTRY: Yes

URINALYSIS: Yes

Results and discussion

Results of examinations

Details on results:
RESULTS
All dose groups: no deaths
2 mg/kg bw/day: no signs of toxicity
10, 20, 50, and 250 mg/kg bw/day: impairment of the general condition, black-colored spleen, splenic congestion, increased relative weights of the liver and the spleen
10 mg/kg bw/day: hepatocyte enlargement
10, 50, and 250 mg/kg bw/day: increased relative renal weights in the females
20, 50, and 250 mg/kg bw/day: decreased body weight gain in the females, erythropenia
50 and 250 mg/kg bw/day: decreased body weight gain in the males, increased relative weights of the thyroid, the heart, the testes and the kidneys in the males, hepatocyte enlargement
250 mg/kg bw/day: decreased relative weights of the ovaries, clinical chemistry: slightly increased concentrations of glutamate-pyruvate transaminase and of glutamate oxalo-acetate transaminase.

Effect levels

Dose descriptor:
NOAEL
Effect level:
2 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
After administration of the substance orally, impairment of the general condition, black-colored spleen, splenic congestion, increased relative weights of the liver and the spleen were recorded in the treated animals (except the lowest dose level). These histopathological findings were recorded:
10 mg/kg bw/day: hepatocyte enlargement
10, 50, and 250 mg/kg bw/day: increased relative renal weights in the females
20, 50, and 250 mg/kg bw/day: decreased body weight gain in the females, erythropenia
50 and 250 mg/kg bw/day: decreased body weight gain in the males, increased relative weights of the thyroid, the heart, the testes and the kidneys in the males, hepatocyte enlargement
250 mg/kg bw/day: decreased relative weights of the ovaries, clinical chemistry: slightly increased concentrations of glutamate-pyruvate transaminase and of glutamate oxalo-acetate transaminase.