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Description of key information

Oral route: Following a single oral dose of 2.0 g/kg bw test material, the LD50 was found to be > 2.0 g/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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Single dose of 2.0 g/kg bw
No. of animals per sex per dose:
Five males and five females
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died on study Day 2
Clinical signs:
Piloerection, abnormal body carriage (hunched posture, abnormal gait (waddling), lethargy, decreased respiratory rate, partially closed eyelids, apllor of extremities, increased salivation, noisy respiration and walking on toes. Recovery was complete by Day 4.
Body weight:
Bodyweight gain was as expected for all animals surviving treatment.
Gross pathology:
No abnormalities noted at macroscopic examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was found to be > 2.0 g/kg bw.
Executive summary:

Following a single oral dose of 2.0 g/kg bw test material, the LD50 was found to be > 2.0 g/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Dermal route

The study need not be conducted because the substance is classified as corrosive to the skin.

 

Inhalation route

The study need not be conducted because the substance is classified as corrosive to the skin.

Justification for classification or non-classification

The LD50 value reported following oral administration of the substance was > 2000 mg/kg bw and classification under the criteria given by Regulation EC No. 1272/2008 is not required.