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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were administered 1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A in corn oil as single oral dose and were observed for 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Santovar A

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
no information provided

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A
No. of animals per sex per dose:
3 or 2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 900 mg/kg bw
95% CL:
> 1 800 - < 2 000
Mortality:
Yes
Clinical signs:
other: Reduced appetite and activity, increasing weakness, collapse, and death.
Gross pathology:
Hemorrahagic areas of the lungs, slight liver hyperemia, and acute gastrointestinal inflammation.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
A study in rats suggested that Santovar was slightly toxic, an oral LD50 of 1900 mg/kg bw was reported. The study was not performed according to the general guidelines for acute oral toxicity under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.

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