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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-120-9 | CAS number: 2634-33-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Principles of method if other than guideline:
- Method: other: INVITTOX Protocol No 124. In-vitro Bovine Corneal Opacity and Permeability Assay (BCOP).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one
- EC Number:
- 220-120-9
- EC Name:
- 1,2-benzisothiazol-3(2H)-one
- Cas Number:
- 2634-33-5
- Molecular formula:
- C7H5NOS
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch LHW 1355
>99%
Test animals / tissue source
- Species:
- other: In-vitro Bovine Corneal Opacity and Permeability Assay (BCOP)
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- other: 7500, 750 and 75 ppm
- Duration of treatment / exposure:
- 2 hour(s)
- Details on study design:
- The eye irritancy potential of 1,2-benzisothiazolin-3-one was assessed using the in-vitro BCOP assay at concentrations of 75, 750 and 7500 ppm. 1,2-benzisothiazolin- 3-one was found to be non-irritant using the in-vitro scoring method at the dilutions tested. This is comparable to the minimal score in the corresponding Dralze assay. A 7500 ppm solution of 1,2-benzisothiazolin-3-one was prepared as its sodium salt. The pH of the solution was adjusted to 8.43, being the pH nearest neutral at which this concentration of BIT was soluble. BIT was tested at 7500 ppm, 750 ppm and 75 ppm. Each dilution was tested in the experimental system on a separate day (n=9) against negative (saline) and positive (ethanol) controls. The In-vitro Scores obtained were related to the Dralze classification system.
Comment: other: the procedure was conducted 9 times at each concentration
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 7500 ppm
- Value:
- 3.012
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 750 ppm
- Value:
- 0.666
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 75 ppm
- Value:
- -0.207
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
BIT was found to be non-irritant using the in-vitro scoring method when tested at dilutions of 75 ppm, 750 ppm and 7500 ppm. This is comparable to the minimal score in the corresponding Draize assay.
Applicant's summary and conclusion
- Conclusions:
- BIT was found to be non-irritant using the in-vitro scoring method when tested at dilutions of 75 ppm, 750 ppm and 7500 ppm. This is comparable to the minimal score in the corresponding Draize assay.
- Executive summary:
The acute eye irritation potential of the substance was determined according to a method similar to OECD Guideline 437. The in vitro bovine corneal opacity assay was performed with the substance at concentrations of 0, 75, 750 and 7500 ppm. The in vitro irritation scores of the test concentrations were found to be 3.012, 0.666 and -0.207 respectively for 7500, 750 and 75 ppm. Under the study conditions, no prediction of eye irritation could be made based on the score of 3.012 at the highest test concentration (Smith, 2003).
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.
