Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 01, 1982 to July 15, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
The acute oral toxicity of the substance was conducted in male and female ICR mice through oral gavage of a single dose at concentrations of 0, 2500 and 5000 mg/kg bw. The mortality, clinical signs and body weights were examined for 2 weeks thereafter. Thereafter, all surviving animals were necropsied for gross pathological examination of main tissues and organs.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
Origin: Charles River Japan Inc.
Acclimatization: at least 7 d
Body weight at start for males: 26 - 31 g and for females: 21 - 25 g
Age: ca. 5 weeks
Temperature and relative humidity: 23 +/- 1°C and 60 +/- 10%, respectively
Food: CE-2 type, ad libitum (withdrawal from about 20 h before to 3-4 h after treatment)
Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance appropriately diluted with distilled water was orally administered into the stomach by using a glass syringe attached gastric probe to groups of 10 animals of each sex at rate of 10 or 20 mL per kg bw.
Doses:
0 (negative control), 2500 and 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
The clinical signs and the mortality were observed at 1/6, 1/2, 1, 2 and 4 hours after administration and daily (at 10 a.m.) for 2 weeks thereafter (observation period). Body weight of each animal was measured at Days 0, 7 and 14. All animals which were alive at the end of the observation period were necropsied for gross pathological examination of main tissues and organs.
Statistics:
- Comparison with the negative controls
T-test for the body weight analysis
Fisher exact test for incidence of gross finding

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in the study.
Clinical signs:
No treatment-related clinical signs were observed at any of the tested doses.
Body weight:
There was no test substance-related body weight change.
Gross pathology:
Some abnormal findings such as accentuated lobular pattern in the liver, vesicle or fade area in the kidney, white substance present or retension of urine in the urinary bladder, uterine horn distended with fluid and fluid filled cyst surrounded in the ovary were found in some animals including controls. However, no remarkable test substance-related macroscopic modifications in main tissues and organs were found in any treated animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 of the substance in mice was determined to be greater than 5000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the substance according to an internal method of the laboratory, in compliance with GLP. Male and female ICR mice were administered by oral gavage a single dose of the test substance at 0, 2500 and 5000 mg/kg bw. Rats were fasted 20 h pre-test to 3 -4 h post-application. The clinical signs and mortality were observed at 10 min, 30 min, 1, 2 and 4 h after administration and daily for 2 weeks thereafter. Body weight of each animal was measured at Days 0, 7 and 14. Thereafter, the surviving animals were necropsied for gross pathological examination of main tissues and organs. No mortality and clinical sign were observed during the study. Also, there were no test substance-related body weight changes or macroscopic modifications. Under the study conditions, the acute oral LD50 of the substance in mice was determined to be greater than 5000 mg/kg bw (Hosokawa, 1982).