Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD and GLP conform study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld, Germany
- Weight at study initiation: m: 246.3 - 251.6 g f: 195.3 - 203.1 g
- Fasting period before study: 16 h
- Housing: collective caging
- Diet: ad libitum Ssniff-R Alleindiät für Ratten (Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen, Germany)
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-80
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw were applied.



Doses:
One limit dose of 2 mL/kg bw were applied.
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 observations and weighing: day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not required

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 021 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 021 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No clinical symproms were observed.
Body weight:
Normal weight gains were observed.
Gross pathology:
No macroscopic findings in the cranial-, thoracic- and abdominal cavity were found.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value was found to be greater than 2021 mg/kg bw in rats.
Executive summary:

The acute oral toxicity was investigated in one group of 5 fasted male and 5 female Wistar-rats. One (limit) concentration of 2021 mg/kg bw was applied by gavage. Any signs of toxicity were recorded during the 14 days observation period and the animals were subjected to necropsy afterwards. As a result, no mortalities were observed and also no clinical signs were noted. At necropsy, no abnormalities were observed. As a result, the LD50 was determined to be 2021 mg/kg bw.