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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
Reference substance name:
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrate;hydrochloride
Cas Number:
138982-67-9
Molecular formula:
C21H24Cl2N4O2S
IUPAC Name:
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrate;hydrochloride
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.

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