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Description of key information

Acute oral toxicity testing has been conducted in two studies in rodents. The key study, equivalent to the OECD 401 guideline, was conducted in male Wistar rats and derived an LD50 value of 455 mg/kg bw based upon 9 tested doses between 100 and 754 mg/kg bw delivered in olive oil by oral gavage. A supporting study conducted in mice (non-GLP, non-guideline) determined the LD50 to be 590 mg/kg bw; no details on doses, number or sex of animals is available. Testing by the inhalation and dermal routes was waived for animal welfare reasons based upon the dermal corrosivity of the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 174 g
Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
solution was heated a little bit
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Injection volume 30 cm3/kg



Doses:
100, 251, 316, 398, 501, 631, 794, 713, 754 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not determined
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
455 mg/kg bw
Based on:
test mat.
Mortality:
251 mg/kg bw: 1/ 10
316 mg/kg bw: 3/ 10
398 mg/kg bw: 4/ 10
501 mg/kg bw: 5/ 10
631 mg/kg bw: 6/ 10
713 mg/kg bw: 8/ 10
754 mg/kg bw: 9/ 10
Clinical signs:
at 100 mg/kg bw:
cutting and accelerated breathing, staggering, after 2 days extreme nerve symptoms (agitation, shaking, rotary motion)
Interpretation of results:
Category 4 based on GHS criteria
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP and non-guideline compliant study
Qualifier:
no guideline followed
GLP compliance:
no
Test type:
other: no data
Species:
mouse
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
590 mg/kg bw
Interpretation of results:
Category 4 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
455 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

Based upon an LD50 established as 455 mg/kg bw, the test substance is classified for acute oral toxicity Category 4 in accordance with the classification criteria set out in 1272/2008/EC. Testing by the inhalation and dermal routes was waived for animal welfare reasons based upon the dermal corrosivity of the test substance; therefore no classification for the dermal or inhalation routes may be derived.