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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
standard acute toxicity procedure with 14 day observation
Principles of method if other than guideline:
A standard acute toxicity method was used in this test which predates establishment of OECD guidelines and GLP.
GLP compliance:
Predates GLP
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Test material form:
Details on test material:
Yellowish Brown Liquid

Test animals

other: Sherman-Wistar
Details on test animals or test system and environmental conditions:
Five groups of five male rats of the Sherman-Wistar strain weighing between 200 and 300 grams were used for the study.

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
The rats were deprived of food but not water 24 hours prior to dosing. Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. The sample was doses as a 25% w/v suspension in corn oil.
The doses given are the doses of suspension (25% in corn oil):
0.5 ml/kg, equivalent to 125 mg/kg bw,
1.0 ml/kg, equivalent to 250 mg/kg bw,
2.0 ml/kg, equivalent to 500 mg/kg bw,
4.0 ml/kg, equivalent to 1000 mg/kg bw,
8.0 ml/kg, equivalent to 2000 mg/kg bw.
No. of animals per sex per dose:
5 males were used per individual dose. 25 rats were used in total.
Control animals:
Details on study design:
Following administration of the test material, the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities.
no data. Interpolation was undertaken, with 95% confidence limits established.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
400 mg/kg bw
Based on:
test mat.
95% CL:
> 250 - < 625
Mortalities were found in rats at doses of 1.0 mL/kg bw and above.
1 rat died at dose level of 1.0 mL/kg bw
3 rats died at dose level of 2.0 mL/kg bw
5 rats died at dose level of 4.0 mL/kg bw
5 rats died at dose level of 8.0 mL/kg bw
Clinical signs:
At 0.5 mL/kg bw (125 mg/kg bw), the rats appeared lethargic after 2 hours of dosing, but were normal after 24 hours. Weight gain in this group was below normal.
At 1.0 mL/kg bw (250 mg/kg bw), the rats were moderately depressed after one hour and did not appear normal after 72 hours with one death occuring. Weight gains were substantially below normal.
At 2.0 mL/kg bw (500 mg/kg bw), the rats were comatose after one hour with deaths occuring over the next 48 hours. Survivors did not appear normal for 5-7 days and lost weight at the conclusion of the study.
At 4.0-8.0 mL/kg bw, the rats become comatose after 30 minutes, and deaths occured in all animals within 4-8 hours.
Body weight:
Body weights of all rats were below normal levels, with the group 3 rats at 2.0 mL/kg bw (500 mg/kg bw) losing weight by the end of the study.
Gross pathology:
No abnormal gross pahtological signs were observed.

Any other information on results incl. tables

Many rats showed signs of lethargy, depression, and comatose states depending on their levels of dosing. Mortalities were seen above 0.5 mL/kg bw (125 mg/kg bw), and all rats died at 4.0 mL/kg bw (1000 mg/kg bw) and above. The LD50 of the test material was calculated to be 400 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
The LD50 was above 300 mg/kg bw and below 2000 mg/kg bw.
In a study similar to OECD 401, the acute oral toxicity of the test material was investigated in male rats. The LD50 was between 250 and 500 mg/kg bw, and was calculated to be 400 mg/kg bw.