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Description of key information

LD50 = 226.3 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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
Species:
rat
Strain:
other: RAI
Sex:
male/female
Details on test animals or test system 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
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)
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
226.3 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

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

The acute oral LD50 in rats was established to be ca. 226.3 mg/kg bw.

Therefore, the substance is classified for oral acute toxicity in Category 3 according to the CLP Regulation (EC n. 1272/2008).

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