Registration Dossier

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity studies on rats and rabbits
Author:
Moreno O.M.
Year:
1973
Bibliographic source:
Unpublished report to RIFM. Report 2021
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Doses:
1480, 2200, 3330 and 5000 mg/kg bw
No. of animals per sex per dose:
10 (total number of animals per dose, sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 300 mg/kg bw
Based on:
test mat.
Mortality:
Dose 2220 mg/kg bw = 2 animals
Dose 3330 mg/kg bw= 4 animals
Dose 5000 mg/kg bw= 10 animals
Clinical signs:
5000 mg/kg bw = Lethargy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw.
Executive summary:

In a study of Moreno, 1973, the acute oral toxicity of the test item was determined. The study was conducted with 10 rats per group. The test item was administered in doses of 1480, 2220, 3330 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2200 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw. Lethargy was observed in animals of the highest dose group.