Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
to 2000-6-8
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
113 mg/kg bw
95% CL:
64 - 199
Clinical signs:
The test substance caused effects on the autonomous and central nervous system as well as a gastro intestinal irritation together with cardiovascular changes.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
In an acute oral toxicity study similar to OECD 401 the LD50 was determined to be 113 mg/kg bw in female rats.
Executive summary:

The test substance caused effects on the autonomous and central nervous system as well as a gastro intestinal irritation together with cardiovascular changes. These changes together may have been the cause of death. The following LD50 was calculated for females: 113 mg/kg body weight. The limits of confidence were 64 and 199 mg per kg body weight. The slope was 2.98.