Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 928-541-6 | CAS number: 146939-27-7
Eye irritation
Administrative data
- Endpoint:
- eye 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 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 44.9 mg
- Observation period (in vivo):
- 4 days
Results and discussion
Any other information on results incl. tables
No signs of ocular irritation were detected in cornea, iris, or conjunctivae. However, according to the text, the following were noted: (1) redness of the conjunctiva in the treated eye of each rabbit, (2) iritis and "slight circumcorneal reddening" in the eye of one rabbit; in this rabbit. By 48 hrs, all treated eyes appeared normal. Again, as in the dermal study, no positive controls were included in the study; also, no inert substance was tested to control for mechanical irritation effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of ocular irritation were detected in cornea, iris, or conjunctivae.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
