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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
APPROVAL PACKAGE FOR: APPLICATION NUMBER 20-825. Pharmacology Review(s).
Bibliographic source:
Food and Drug Administration - Center for Drug Evaluation and research.
Report Date:
2000

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the dermal study, no drug-related mortality or clinical signs or changes in body wt or food consumption were observed, nor were any signs if dermal irritation detected.