Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Principles of method if other than guideline:
Ten male Wistar rats were exposed to test substance dissolved in olive oil via oral gavage. Animals received 5000 mg/kg bw. Animals were observed for 7 days and the LD50 was determined.
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): Edenol 817 RV

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Weight at study initiation: mean 160 g
- Fasting period before study: 16 hours
- Housing: five animals per cage, in Makrolon 3 cages with Weichholzgranlat bedding (ARWI-Center Essen)
- Diet: ad libitum, Altromin-Haltungsdiät 1324, Fa. Altromin GmbH, 4937 Lage, Germany
- Water: ad libitum, tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % (g/v)
- Amount of vehicle (if gavage): 20 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: Clinical signs and mortality: multiple days on the day of administration and twice daily on the following days
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Diarrhea was observed in all animals. Effect was reversible.
Body weight:
The body weight was only measured to calculate the administration dose.
Gross pathology:
Gross pathology was not performed.

Applicant's summary and conclusion