Registration Dossier

Administrative data

Description of key information

ZK 9340 is harmful after single oral exposure (LD50 cut-off, rat: > 300 - < 500 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
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
Sex:
male/female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 300 - < 500 mg/kg bw
Based on:
test mat.

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 (Kurth, 1996). 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.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Based on the study results (oral LD50 cut-off value: > 300 - < 500 mg/kg bw ) a classification with R22 (harmful if swallowed) according to Directive 67/548/EEC or with Acute Toxicity Cat. 4 (H302:harmful if swallowed) according to Regulation (EC) No. 1272/2008 (CLP) is required.