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Description of key information

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:
supporting study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not performed in GLP laboratory No indication of Guideline in report, but found to be similar to OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA/CREDO (Saint-Germain sur l'Arbresle - France)
- Age at study initiation: about 6 weeks
- Weight at study initiation: around 150 g
- Fasting period before study: 15 to 20 hours
- Housing: dust free sawdust (Litalabo)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 to 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Route of administration:
oral: gavage
Vehicle:
other: 5% gommi arabicum
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 1 ml for 100 g of body weight

MAXIMUM DOSE VOLUME APPLIED: 3750 mg/kg
Doses:
2750 mg/kg - 3500 mg/kg - 3750 mg/kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 3, 7, 10 and 14
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
Calculation accordingly to Bliss model
Sex:
male
Dose descriptor:
LD50
Effect level:
3 257.22 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 159.83 - <= 3 357.6
Mortality:
2750 mg/kg: 20 %
3500 mg/kg: 60 %
3750 mg/kg: 80 %
Clinical signs:
At high doses, animals suffer from epileptiform crisis, followed by death.
For survivors, the substance has a sedative effect. They recover normal activity after 2 days without weight variation.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 (orl, rat) is > 2.000 mg/kg: intermediate substance is not classified with regards to Acute toxicity via oral route according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 257 mg/kg bw

Additional information

Justification for classification or non-classification

LD50 (orl, rat) is > 2.000 mg/kg: intermediate substance is not classified with regards to Acute toxicity via oral route according to CLP criteria.