Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Method: other acute oral toxicity study
GLP compliance:
no
Test type:
other: acute oral toxicity study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Bantex

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
5000, 6310, 7940, 10000 mg/kg
No. of animals per sex per dose:
5 combined males and females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 500 mg/kg bw
Based on:
test mat.
95% CL:
6 820 - 8 250
Remarks on result:
other: clinical signs and death

Any other information on results incl. tables

Mortality

5000 mg/kg: male (0/3), female (0/2), combinded (0/5)

6310 mg/kg: male (1/2), female (0/3), combinded (1/5)

7940 mg/kg: male (1/3), female (2/2), combinded (3/5)

10000 mg/kg: male (2/2), female (3/3), combinded (5/5)

Time of mortality: One to two days after test substance application

Clinical signs:

Reduced appetite and activity (one to three days in survivors), increasing weakness, collapse, and death

Gross autopsy

Decedents: hemorrhagic areas of the lungs, liver hyperemia, and gastrointestinal inflammation

Survivors (14 day): viscera appeared normal

Applicant's summary and conclusion