Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
from Sept. to Oct. 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HAN: WIST (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Miglyol 812
Doses:
2000, 1644, 200, and 161.6 mg/kg
The doses of 1644 and 161.6 mg/kg were due to the determination of only 82 and 81% test substance in these formulations.
No. of animals per sex per dose:
in total 9 males and 3 females were used
Control animals:
no
Details on study design:
- water: demineralized, acidified water, pH 2-3, ad libitum

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 - < 500 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

3 male rats treated with 2000 mg/kg bw and 3 male rats treated with 1644 mg/kg bw died between days 4 and 6 after administration. As clinical signs ruffled fur, incerased defaecation and diarrhea became obvious on the day of application, followed by apathy, emaciation, and atactic gait seen in some of the rats.

No rat receiving 200 or 161.6 mg/kg bw died in the course of the study. As clinical signs ruffled fur and diarrhea became obvious on the day of application. Afterwards the animals were without clinical findings. Autopsy revealed no compound-related findings in these animals.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at the dose of 200 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. As clinical signs ruffled fur and diarrhea became obvious on the day of application. The dose of 2000 mg/kg bw was lethal to all animals between day 4 and 6 after adminstration.

According to OECD TG 423 (1996) the oral LD50 of the test substance is therefore > 300 to < 500 mg/kg body weight.