Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no
Species:
rat
Sex:
male/female
Route of administration:
oral: gavage
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
133 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test substance has an LD50 for females of 113 mg/kg body weight. According to regulation (EC) 1272/2008 (CLP), the test item is classified for acute oral toxicity (Acute 3, H301).