Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.10.-06.11.1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: E. Merck, Darmstadt- Age at study initiation: young- Weight at study initiation: 161 (152 - 171) g - Fasting period before study: 17 hours before until up to 4 hours after treatment- Housing: separately in type III Makrolon cages - Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 °C - Humidity (%): 36 to 45 %- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regimeIN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methocel KM4 Premium
Details on oral exposure:
Test materialVolume of administrationDose levelin g/100 mLml/100 gmg/kg----------------------------------------------------10550005control
Doses:
5000 mg/kg bwcontrol
No. of animals per sex per dose:
test group: 10: 5 (m) / 5 (f)control group: 10: 5 (m) / 5 (f)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 15 days- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One female rat died on the second day. All other animals survived the observation periond up to day 15.
Clinical signs:
No signs of toxicity were seen after treatment.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg bw after single oral administration in rats.
Executive summary:

Study design

In this study, the acute toxicity of the test material in rats after single oral administration of 5000 mg/kg body weight was investigated. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401.

Results

No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with the test item. One female rat died on the second day. All other animals survived the observation periond up to day 15.
There was a small difference in body weight gain between treated and control group on the second day of the study. Otherwise the body weight development of the rats was inconspicuous during the study.
The female rat died on day 2 had changes in the gaster, locally blood content in the small intestine and a moderate hydrometra. No findings have been recorded for the rats killed after the observation period (day 15).

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50value is higher than 5000 mg/kg bw after single oral administration in rats.