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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
Study period:
8 December 1972 - 2 January 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, restriction due to the fact that this is a summary report

Data source

Reference
Reference Type:
other: summary of study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
Source: no data available.
Age at study initiation: no data available.
Weight at study initiation: average weigh was 150~250 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: no data available.
Diet: laboratory chow.
Water: available ad libitum.
Acclimation period: no data available.

ENVIRONMENTAL CONDITIONS
Temperature (°C): no data available.
Humidity (%):no data available.
Air changes: no data available.
Photoperiod: no data available.

IN-LIFE DATES: no data available.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000, 7500 and 10,000 mg/kg bw
No. of animals per sex per dose:
6/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available.
- Necropsy of survivors performed: no data available.
Statistics:
no data available

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Mortality:
10, 0000 mg/kg bw; Number of animals: 6; Number of deaths: 3
7, 5000 mg/kg bw; Number of animals: 6; Number of deaths: 0
5, 0000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
no data available
Body weight:
no data available
Gross pathology:
no data available

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain Albino male rats was found to be 10,000 mg/kg bodyweight. The test substance was classified as non-toxic.
Executive summary:

In an acute oral toxicity study, 3 groups fasted Sprague-Dawley strain albino rats (6 male per dose) were given a single oral dose of undiluted test material at a dose level of   5,000, 7,500 and 10,000  mg/kg bw and observed for14 days. 3/6 animals in the highest dose group found dead one day after the treatment, no mortality occurred in the other two groups. The oral LD50 value of test material in rats has been determined to be 10,000 mg/kg bw.