Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature

Data source

Reference
Title:
No information
Author:
GUROVA AI, ALEKSEEVA NP, GORLOVA OE, CHERNYSHOVA RA (1976)|Gig Tr Prof Zabol, 3, 53-55 (Russian)

Materials and methods

Principles of method if other than guideline:
The test substance was applied by repeated introduction in stomach for 22, 45, or 90 days. Animals were observed for mortality and clinical signs.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Test substance: no data

Test animals

Species:
other: rodent
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
22, or 45, or 90 days
Frequency of treatment:
no details reported
Doses / concentrations
Remarks:
Doses / Concentrations:
ca. 200, 100, and 50 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

repeated introduction in stomach in doses of 1/5, 1/10, and 1/20 LD50 (total cumulative dose= 4.5 times LD50; LD50= 975
mg/kg in rat and mouse) did not provoke the death of animals; increasing excitement, body weight loss, respiratory effects

Applicant's summary and conclusion

Executive summary:

The test substance was applied by repeated introduction in stomach for 22, 45, or 90 days. Animals were observed for mortality and clinical signs.

Doses of 1/5, 1/10, and 1/20 LD50 (total cumulative dose= 4.5 times LD50; LD50= 975 mg/kg bw in rats and mouse). These doses did not provoke the death of animals; an increasing excitement, body weight loss, and respiratory effects were found.