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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
In order to determine the dose/response relationship of the test substance, groups of 5 male and 5 female rats were treated with various single doses of the compound, suspended with carboxymethylcellulose and administered by oral intubation. Symptoms and mortality after administration were recorded during an observation period of 7 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 7 weeks
- weight: 160 - 180 g
- Water and food (NAFAG, Gossau SG, rat food) ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: ca. 50 %
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
single oral administration by gavage
Doses:
215, 317, 464, 600 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Details on study design:
Preparation:
The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 2, 3 and 5 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Statistics:
The LD50 was calculated by probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 365 mg/kg bw
Based on:
test mat.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased.
Gross pathology:
No substance related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:
other: Category 4 according to the CLP Regulation
Conclusions:
The acute oral LD50 of the substance in rats of both sexes observed over a period of 7 days is 365 mg/kg bw.
Executive summary:

The oral acute toxicity study was performed according to an internal method: groups of 5 male and 5 female rats were treated with various single doses of the compound, suspended with carboxymethylcellulose and administered by oral intubation. Symptoms and mortality after administration were recorded during an observation period of 7 days.

The acute oral LD50 of the substance in rats of both sexes observed over a period of 7 days is about 365 mg/kg bw.