Registration Dossier

Administrative data

Description of key information

The acute oral toxicity study was conducted by using the given test chemical in Male Wistar rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality and signs of toxicity. No mortality and clinical symptoms were observed. Hence, the LD50 value was considered to be >5000 mg/kg bw, when Wistar male rats were treated with the given test chemical via oral route.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study for the given test chemical.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Preliminary study:
not specified
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No symptoms
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
The LD50 value was considered to be >5000 mg/kg bw, when Wistar male rats were treated with the given test chemical via oral route.

Executive summary:

The acute oral toxicity study was conducted by using the given test chemical in Male Wistar rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality and signs of toxicity. No mortality and clinical symptoms were observed. Hence, the LD50 value was considered to be >5000 mg/kg bw, when Wistar male rats were treated with the given test chemical via oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is from secondary source.

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

The acute oral toxicity study was conducted by using the given test chemical in Male Wistar rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality and signs of toxicity. No mortality and clinical symptoms were observed. Hence, the LD50 value was considered to be >5000 mg/kg bw, when Wistar male rats were treated with the given test chemical via oral route.

Justification for classification or non-classification

The given test chemical is not classified for acute oral toxicity as per CLP criteria.