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Administrative data

Description of key information

Acute oral toxicity: OECD TG 401: > 5000 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
Study period:
19 December 1983 - 02 January 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Labs, Wilmington, Massachusetts
- Age at study initiation: no data
- Weight at study initiation: 180 - 200 g
- Fasting period before study: 18 hours
- Housing: Housed in groups, according to sex, or individually in stainless steel 4" wire mesh cages.
- Diet: Free access to Wayne Lab Blox.
- Water: Free access to fresh tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Dose levels were based on a dose range finding study.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed immediately and at 1, 4 and 24 hours after dosing and twice daily for 14 days for pharmacotoxic, CNS effects and mortality. On day 14 body weights were recorded.
- Necropsy of survivors performed: The rats were sacrificed by CO2 inhalation and a gross necropsy was performed.
Statistics:
Not performed.
Preliminary study:
In a dose range finding study, four fasted animals, two per sex, were administered to the test substance at 500, 1600 and 5000 mg/kg bw, orally, by gavage. Signs observed included diarrhea, decreased activity and body tone, hypersensitivity and poor grooming. None of the animals died.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Clinical signs observed included decreased activity, abnormal gait, poor grooming, diarrhea, abnormal stance and piloerection.
Body weight:
No data.
Gross pathology:
Terminal necropsy revealed no test substance related lesions in none of the animals.
Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008 and its updates.
Conclusions:
The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw. Based on the results, the substance is not acute harmful.
Executive summary:

In this study performed equivalent to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered to the substance at a dose level of 5000 mg/kg bw. No mortality was seen. Clinical signs observed included decreased activity, abnormal gait, poor grooming, diarrhea, abnormal stance and piloerection. Terminal necropsy revealed no test substance related lesions in none of the animals.

Based on these results, the substance is not acute harmful and the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

In this study performed equivalent to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered to the substance at a dose level of 5000 mg/kg bw. No mortality was seen. Clinical signs observed included decreased activity, abnormal gait, poor grooming, diarrhea, abnormal stance and piloerection. Terminal necropsy revealed no test substance related lesions in none of the animals.

Based on these results, the substance is not acute harmful and the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008 and its updates.

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