Registration Dossier

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: Non GLP, non-guideline, animal experimental study. Restrictions in reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral toxicity of Cetiol R was tested in an approximate manner on 5 male and 5 female rats. A quantity of 2000 mg of the test substance/kg bodyweight in a 2 % aqueous carboxymethyl cellulose preparation (w/w) was administered to the test animals on one single occasion by gavage. After
treatment the animals were observed over a period of 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cetiol R
- Physical state: clear, yellow, viscous liquid.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- Average male body weight: 219 g
- Average female body weight: 165 g
- Animals were fasted for 16 hours prior to dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Concentration in vehicle: 2%


VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: 48 hours, 7 and 14 days
- Necropsy of survivors performed: yes, by means of an overdose of aranaesthetic and dissected.
- Other examinations performed: clinical signs, body weight, pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
No intoxication symptoms were observed.
Body weight:
The treatment did not have any unfavourable influence on their bodyweight development.
Gross pathology:
No anatomicopathological changes in the inner organs or in the body cavities were found.

Applicant's summary and conclusion