Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat) > 9900 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
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
doses applied exceed the limit dose
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
Temperature:24-25°C
Humidity: 60-75 %
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5860, 7620, and 9900 mg/kg bw
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 9 900 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
no clinical signs have been reported
Body weight:
no effects have been reported
Gross pathology:
no abnormalities have been reported
Other findings:
no other findings
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 oral (rat) exceeds 9900 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
9 900 mg/kg bw
Quality of whole database:
similar to Guideline

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

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