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Toxicological information

Eye irritation

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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:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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).