Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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

Test system

Amount / concentration applied:
2000 mg
Duration of treatment / exposure:
24 h.
Number of animals:
5

Results and discussion

Any other information on results incl. tables

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 of dermal irritation detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of dermal irritation are detected.