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Administrative data

Endpoint:
acute toxicity: dermal
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 exposed to 2000, 3160, 5010, 7940 mg/kg bw Santovar A in corn oil during 24 hours and were observed for 14 days.

GLP compliance:
not specified
Test type:
standard acute method

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Duration of exposure:
24 hours
Doses:
2000, 3160, 5010, 7940 mg/kg bw Santovar A
No. of animals per sex per dose:
1 or 2 at highest dose
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
Yes, at 5010 and 7940 mg/kg bw after 4 and 5 days, resp.
Clinical signs:
Reduced appetite and activity, increasing weakness, collapse, and death.

Body weight:
Only inital weights reported.

Gross pathology:
Lung and liver hyperemia, enlarged gall bladder, and 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
Executive summary:
A study in rabbits suggested that Santovar was slightly toxic, a dermal LD50 of > 3160 mg/kg bw was reported. The study was not performed according to the general guidelines for dermal toxicity under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.