Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 September 1983 - 23 September 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-23-1
- Substance type: Organic
- Physical state: Clear liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration.
- Other: Specific gravity = 0.890 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc. Scottdale, Pennsylvania
- Weight at study initiation: 180 - 360 grams after fasting; the weight variation in animals or between groups did not exceed ± 20%
- Fasting period before study:18 hours
- Housing: Animal rooms: Separate isolation by test system; rats housed in groups, according to sex, or individually in stainless steel 1/2 wire mesh cages. Size in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum96+
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Dose-range finding study:
In a dose-range finding study, four fasted animals, two per sex, were administered the test article at 1000, 2000, 4000 and 8000 mg/kg, orally by gavage.
LD50 determination:
In the acute oral toxicity study, five groups of ten rats (5 males and 5 females) were administered at dose levels of 800, 1000, 1250, 1600 and 2000 mg/kg by oral gavage.
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: On days 7 and 14, body weights were recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs:
The rats observed at approximately 1, 2, 4 and 24 hours after dosing and twice daily for 14 days for pharmacotoxic, CNS effects and mortality.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 344 mg/kg bw
Based on:
test mat.
95% CL:
1 153 - 1 567
Sex:
male
Dose descriptor:
LD50
Effect level:
1 332 mg/kg bw
Based on:
test mat.
95% CL:
1 066 - 1 663
Sex:
female
Dose descriptor:
LD50
Effect level:
1 357 mg/kg bw
Based on:
test mat.
95% CL:
1 173 - 1 570
Mortality:
None of the animals died at 800 mg/kg
One of ten died at 1000 mg/kg
Two of ten died at 1250 mg/kg
Nine of ten died at 1600 mg/kg
Ten of ten died at 2000 mg/kg
Clinical signs:
Signs observed included decreased activity, decreased body tone, chromodacryorrhea, piloerection, ptosis, poor grooming, red exudate around the oral and nasal cavities, abnormal gait, abnormal stance, ataxia, body drop, tremors, semi-prostration, and prostration.
Gross pathology:
Necropsy of animals dying on study revealed the stomach mucosa desquamated, dark red cecum and distended intestines. Intestines and bladders were fluid-filled and black in color. Hemorrhagic thymus, congested lungs and dark adrenals were also observed. Hemorrhagic thymus, congested lungs and dark adrenals were also observed. Terminal necropsy revealed one animal with dark foci on the kidneys. No visible lesions were observed in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based upon the results of the acute oral toxicity study in rats, the calculated oral LD50 for male and female rats treated with the substance was determined to be 1344 mg/kg with 95% confidence limits of 1153 to 1567 mg/kg. Therefore, the substance is to be classified as acute oral toxicant category 4 according to the criteria laid down in the CLP Regulation.