Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A non-GLP conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
30D11
Appearance: clear, colourless liquid with a pungent odour.

Test animals

Species:
rat
Strain:
other: Carworth (Sprague-Dawley derived)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 139 - 191 g
- Fasting period before study: 3 - 4 hours
- Diet (e.g. ad libitum): Purina Laboratory Chow available ad libitum.
- Water (e.g. ad libitum): water available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
50% weight per volume suspension in distilled water.
Doses:
100, 215, 464, 1000 and 2150 mg/kg/bw.
No. of animals per sex per dose:
5 male rats per dose level.
Control animals:
no
Details on study design:
Administration: 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 level.

OBSERVATIONS AND RECORDS
Mortality and Toxic Effects: Recorded immediately after dosing; at one, four, and 24 hours; and once daily thereafter for a total of seven days.
Body Weights: Recorded at study initiation and again at termination.

TERMINAL STUDIES
Surviving animals sacrificed by exsanguination following barbiturate (Diabutal) overdose after a seven-day observation period.
Gross Necropsy Performed on all animals which died during the study and on those sacrificed at termination.
Statistics:
Statistical Analysis: Mortality data analyzed by the method of Thompson, W. R., Bact. Rev. 11, 115-145, 1947, utilizing the tables of Horn, H. J., Biometrics 12, 311, 1956.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 470 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits due to 'all-or-none' response
Mortality:
All five animals dosed 2150 mg/kg test material had died 4 hours following test material administration.
Clinical signs:
At the 100 mg/kg dose level, no effects were observed.

At the 215 and 464 mg/kg dose levels, slight depression noted from one through 24 hours.

At the 1000 and 2150 mg/kg dose levels, additional effects included laboured respiration, ptosis, lacrimation, ataxia, bloody crust on eyes, and gasping with recovery at the 1000 mg/kg level by Day 6.
Body weight:
Not reported.
Gross pathology:
At sacrifice, no gross pathology was observed.

Major necropsy findings at death: gross changes at the 2150 mg/kg level consisted of a dark red zone at the corticomedullary junction of kidney, stomach distended with dark red fluid, soft consistency of stomach walls, lining of pyloric portion dark red, and cardiac portion thickened and pink in colour.

Any other information on results incl. tables

No further information is available on results.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of the test substance was determined to be 1470 mg/kg/bw when dosed to male rats.
Executive summary:

Under the conditions of the study, the LD50 of the test substance was determined to be 1470 mg/kg/bw when dosed to male rats.