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Description of key information

Under the experimental conditions adopted, oral administration of the test substance at a dose of 2000 mg/kg caused no mortality and did not require enthanasia during 14-day periods, in the female Sprague-Dawley Rat: LD50 (oral) is higher than 2000 mg/kg.

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:
other information
Study period:
2003-2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study. Adequate for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Females are to be nulliparous and non-gravid.
Age: 8-12 weeks at the time of administration.
Number: 3 animals per step.
Weight: within ± 20% of the mean weight of any previously dosed animals.
Food was available ad libitum.
Water was available ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Sterile water was chosen on the basis of the physical-chemical characteristics of the test substance as vehicle.
Doses:
The dose volume was 10 mL/kg.
The substance was administered to animals deprived of food since the previous day. It was administered to the animals as a single dose, by gavage, using a cannula of appropriate size.
Control animals:
not specified
Statistics:
All data were recorded as and when obtained using forms identified by the study number. Data were presented tabulated by dose level and time, nature, severity and durati an of effects. Results of the body weight were given as means ± SEM (Standard Errar of the Mean).
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No clinical signs were observed during the generai clinica! examination of the study. During the full clinical examination on D7, reduced or increased spontaneous locomotor activity or vocalisation were noted in two animals of the first step.
Gross pathology:
Necroscopy: no organ or tissue gross findings were seen at necropsy of animals except far two animals of the first step which presented a whitening of the glandular zone of the stomach or black points on the glandular zone of the stomach.
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions adopted, oral administration of the test sabstance at a dose of 2000 mg/kg caused no mortality and did not reqnire enthanasia during 14-day periods, in the female Sprague-Dawley Rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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 selection of acute toxicity – oral endpoint
Key study, performed under GLP.

Justification for classification or non-classification

According to CLP Regulation, the substance was classified for the class Acute toxicity: oral as not hazardous because the LD50 oral, rat is higher than 2000 mg/kg bw.