Registration Dossier

Administrative data

Description of key information

The LD50 value of the test item after oral administration was determined to be 3980 mg/kg bw.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % suspension in vehicle
Doses:
500, 2000 and 3980 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 980 mg/kg bw
Based on:
test mat.
Mortality:
at the dose of 3980 mg/kg bw 1/2 animals died.
Clinical signs:
500 mg/kg bw: Animals became drowsy shortly after administration.
2000 mg/kg bw: Animals developed tremors shortly following administration.
3980 mg/kg bw: Animals developed tremors shortly following administration.

Some bilateral hydronephrosis was observed on doses of 500 mg/kg bw and greater.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was 3980 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 980 mg/kg bw
Quality of whole database:
Data from handbook which is considered reliable to cover this endpoint

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

Acute oral toxicity

Based on the available data received from a publication, the LD50 of the test item is considered to 3980 mg/kg bw in rats after oral administration. Thus, the LD50 value is higher than the threshold of 2000 mg/kg bw leading to classification and labelling.

Justification for classification or non-classification

Based on the data provided, the test item is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008.