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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:
2018-01-18 to 2018-04-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
adopted 9 October 2017
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
dated 27 April 2017

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
30 µL of the test item was applied, as supplied, to the cornea such that the entire surface of the cornea was evently covered with the test item. The test item was applied for 10 seconds and then rinsed from the eye with 20 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° 3012808) and positive control (5% Benzalkonium chloride) were included in this experiment. The 5% Benzalkonium chloride was prepared as follows: 0.25 g of Benzalkonium chloride (Sigma, batch n° BCBQ9761V) was weighed in a flask qsp. 5 mL with physiological saline. The preparation was magnetically stirred during 10 minutes to obtain a colourless solution just before the administration.
Duration of post- treatment incubation (in vitro):
All observations of the cornea and measurement of corneal thickness were performed using a Haag-Streit BP900 slit-lamp microscope with depth-measuring device n° I. For the measurement of corneal thickness, the slit-width was set at 9½ equalling 0.095 mm.
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 0 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
1.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
1.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 75 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
1.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 120 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
1.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 180 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
1.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 240 min
Irritation parameter:
fluorescein retention score
Remarks:
mean
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 0 min
Irritation parameter:
fluorescein retention score
Remarks:
mean
Value:
2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 75 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 120 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 180 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
11
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 240 min
Other effects / acceptance of results:
The ocular reactiond observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 1.8, corresponding to ICE class III;
- mean score of fluorescein retention: 2.0, corresponding to ICE class III;
- maximal mean corneal swelling: 11%, corresponding to ICE class II.
The combination of the three endpoints for the test item was 2 x III, 1 x II.

Any other information on results incl. tables

The combination of the 3 endpoints for the positive control, Benzalkonium chloride, was 2 x IV, 1 x III. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.

The combination of the 3 endpoints for the negative control, physiological saline, was 2 x I, 1 x II. Therefore the negative control as 'No category' as expected.

Applicant's summary and conclusion

Interpretation of results:
other: No prediction can be made.
Conclusions:
In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions lead to the category 'No prediction can be made' as defined by the O.E.C.D. test guideline n° 438. Therefore, the test item is not predicted as causing sever eye damage (Caetegory) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing are required to establish a definitive classification.