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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
Study period:
April 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according 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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Vehicle:
physiological saline
Controls:
yes
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
800 mg suspended in 4 mL saline
Duration of post- treatment incubation (in vitro):
240 min
Number of animals or in vitro replicates:
3
Details on study design:
According to guideline

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
mean
Value:
1.88
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
4.41
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
2
Value:
0.08
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
3
Value:
1.16
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
With the negative control (0.9% NaCl solution) an increase of opacity or permeability of the corneae could not be observed.
The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the test item is not considered to be an eye irritant in this study and under the experimental conditions reported.
Executive summary:

This in vitro study was performed to assess the corneal irritation and damage potential of the test material by means of the BCOP assay (OECD 437) using fresh bovine corneae. Damage is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an in vitro irritation score, which is used to assign an in vitro irritancy category.

After a first opacity measurement of the fresh bovine corneae (t0), the test item/saline (0.9% (w/v) NaCl in deionised water) stock, the positive, or the negative controls were applied to the epithelial surface of three corneae each and incubated for 240 minutes at 32 ± 2 °C. After the incubation phase the test item, the positive, or the negative controls were each rinsed from the corneae and opacity was measured again (t240).

After the opacity measurements, permeability of the corneae was determined by addition of 1 mL of a fluorescein solution to the anterior chamber of the corneal holder and subsequent incubation in a horizontal position at 32 ± 2 °C for 90 minutes. The permeability of the corneae was measured quantitatively by determination of the increase in fluorescein in the posterior chamber medium.

With the negative control (0.9% NaCl solution) an increase of opacity or permeability of the corneae could not be observed.

The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant.

The test item did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro irritation score was 1.88 and therefore, the test item was classified as non eye irritant.

In conclusion, the test item is not considered to be an eye irritant in this study and under the experimental conditions reported.