Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-07-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Company guideline previous to OECD guideline implementation that is similar to OECD 401
Deviations:
not applicable
Principles of method if other than guideline:
A single dose of 15000 mg/kg bw was tested by administering 25% Aminolon in starch mucilage once per oral gavage to 20 female Wistar rats. Median body weight was 105g (90-116g). 12hrs before administration food was withdrawn. Post administrational observation time was 14d. During this time the rats were fed with standard diet (Altromin R, Altrogge Lage/Lippe) and tap water.
GLP compliance:
no
Remarks:
- prior to GLP
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): Aminolon = 5-Aminobenzimidazolon

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
12hrs prior to administration food was withdrawn.
During the observation period rats were fed with a standard diet (Altromin R, Company Altrogge Lage/Lippe) and tap water.
Mean body weight was 105g (range: 90-116g)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: starch mucilage
Details on oral exposure:
25% Aminolon was administered in starch mucilage using oral gavage.
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
20 female rats
Control animals:
no
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
4 of 20
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50: >15000 mg/kg bw
Executive summary:

Aminolon was tested for acute oral toxicity following a protocol similar to OECD 401 (limit test). A single dose of 15000 mg/kg bw was tested by administering 25% Aminolon in starch mucilage once per oral gavage to 20 female Wistar rats. Median body weight was 105g (90-116g). 12hrs before administration food was withdrawn. Post administrational observation time was 14d. During this time the rats were fed with standard diet and tap water.

During the observation period lethality was 4 out of 20 animals. These findings demonstarte that LD50 exceeds 15000 mg/kg bw.