Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short report; no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
exeeds limit dose, female rats only
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 204 - 220 g
- Fasting period before study: 16 h

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
A 25 % suspension (w/v) in sesame oil was applied.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: regular observation and weekly weighing;
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
piloerection and squatting posture for less than 24 h after application.
Body weight:
no effects
Gross pathology:
no effects
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was above 5000 mg/kg bw in female rats.
Executive summary:

Single oral administration (gavage) of a 25 % suspension in sesame oil of the test item to 10 female Wistar rats resulted in no martality and only minor clinical signs within 24 hours after treatment. Body weight and behavior were normal during the follwing 14 day observation period. No effects were recorded at necropsy.

The acute oral LD50 was above 5000 mg/kg bw in female rats.