Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Nov to Dec 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidest water
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
200 mg/kg: 3 males and 3 females; 2000 mg/kg: 3 males
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 300 - < 500 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

All male animals died after application of 2000 mg/kg bw on day 1. After application of 200 mg/kg bw all male and female animals survived.

The main clinical findings were apathy, disturbances in position and in gait at 200 and 2000 mg/kg bw. Retarded respiration and eyelid closure were also observed after application of 2000 mg/kg bw. All surviving animals were without findings from day 2 onwards.

The body weight gain on days 7, 14 and 21 was within the normal range for rats of this age and strain, which are routinely used in the laboratory.

Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of ZK 9340 was moderate with a LD50 > 300 - < 500 mg/kg bw in rats (cut-off value) according to OECD TG 423. All males died after administration of 2000 mg/kg bw. All males and females of the dose group 200 mg/kg bw survived. Clinical signs were observed at 200 mg/kg bw and above in both genders. Body weight development was not affected until 2000 mg/kg bw. Autopsy revealed no compound-related findings.