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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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.