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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:
1969-05-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In principle, the methods described in OECD Guideline 401 (Acute Oral Toxicity) were used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Purity: assumed to contain 100% active ingredient
- Appearance: clear, colorless liquid, pungent odor
- Date received:1969-03-25

Test animals

Species:
rat
Strain:
other: Carworth (Sprague-Dawley-derived) strain
Sex:
male

Administration / exposure

Route of administration:
other: gastric intubation
Vehicle:
water
Details on oral exposure:
After a three to four-hour fasting period, the test material was administered by gastric intubation as a 50% weight-per-volume suspension in distilled water to groups of five male rats each at dosage levels of 100, 215, 464, 1000 and 2150 mg/kg of body weight.
Doses:
100, 215, 464, 1000, 2150, and 4640 mg/kg bw
No. of animals per sex per dose:
5 males per dose
Control animals:
no
Details on study design:
- Fasting period: three to four hours before exposure
- Diet (postdose): Purina Laboratory Chow and water available ad libitum
- Frequency of weighing: initially and terminally
- Frequency of observations on mortality and toxic effects: 1, 4 and 24 hours after dosing; once daily thereafter
- Necropsy of survivors performed: yes (on all animals which died during the study or were sacrificed at termination)
- Other examinations performed: clinical signs
- Duration of observation period following administration: 7 days
- Sacrifice: barbiturate (Diabutal) overdose after observation period
Statistics:
Analysis of mortality data was performed according to Thompson, W. R., Bact. Rev. 11, 115-145, 1947, using the tables of Horn, H. J., Biometrics 11, 311, 1956. No confidence limits were determined due to "all-or-none" response.

Results and discussion

Preliminary study:
Not performed.
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 470 mg/kg bw
Based on:
test mat. (dissolved fraction)
Mortality:
Five of five male rats died on day four at the 2150 mg/kg bw level.
Clinical signs:
DOSE-DEPENDEND PRINCIPAL TOXIC EFFECTS
- 100 mg/kg bw: no effects
- 215 mg/kg bw: slight depression (1-24 hours)
- 464 mg/kg bw: slight depression (1-24 hours)
- 1000 mg/kg bw: labored respiration, ptosis, lacrimation, ataxia, bloody crust on eyes, and gasping
- 2150 mg/kg bw: labored respiration, ptosis, lacrimation, ataxia, bloody crust on eyes, and gasping

RECOVERY
- by Day 6 (dose: 1000 mg/kg bw)
Body weight:
139 - 191 g (at initiation)
Gross pathology:
AT DEATH
- 2150 mg/kg bw: dark red zone at corticomedullary junction of kidney, stomach distended with dark red fluid, soft consistency of stomach walls, lining of pyloric portion dark red, cardiac portion thickened and pink in color.

AT SACRIFICE
- no gross pathology observed

Any other information on results incl. tables

Table 1: Mortality after 1 h, 4 h, 24 h and 2 -7 d due to an initial application of an aqueous solution of the test substance at dose levels of 100, 215, 464, 1000 and 2150 mg/kg bw. Number of animals dead per number of animals tested, cumulative.

Time of Death

Dose [mg/kg bw]

Immediate

Hours

Days

1

4

24

2 -7

100

0/5

0/5

0/5

0/5

0/5

215

0/5

0/5

0/5

0/5

0/5

464

0/5

0/5

0/5

0/5

0/5

1000

0/5

0/5

0/5

0/5

0/5

2150

0/5

0/5

5/5

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria