Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: Lab SOP PH-402 followed
Deviations:
not specified
Principles of method if other than guideline:
Followed Test Facility SOP No. PH-402. Study in compliance with the Good Laboratory Practice Regulations.
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Noted in study as Compound 81-205-01

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
4300, 4500, 4700 & 5000 mg/kg
No. of animals per sex per dose:
10 animals per dose. 5 males and 5 females. 5 animals per sex per dose.
Control animals:
not specified

Results and discussion

Preliminary study:
Three groups of four rats per group (2 males and 2 females) were orally administered at 5000, 1600 and 500 mg/kg
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 500 mg/kg bw
Based on:
test mat.
95% CL:
4 286 - 4 725

Applicant's summary and conclusion

Conclusions:
The calculated acute oral LD50 in male and female rats is 4500 mg/kg.
Executive summary:

The calculated acute oral LD50 in male and female rats is 4500 mg/kg.