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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:
other: GLP study according to EU/OECD-guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
30 mg
Duration of treatment / exposure:
10 s
Observation period (in vivo):
240 min
Number of animals or in vitro replicates:
in vitro
Details on study design:
The positive control eyes were treated in a similar way with 30 mg powdered Imidazole.
The negative control eye was treated with 30 μL of isotonic saline.
One eye was treated with isotonic saline, three eyes with the test item and other three ones with Imidazole.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean maximum corneal swelling at up to 75 min
Basis:
mean
Time point:
other: 75 min
Remarks on result:
other: Value 1%; ICE Class I
Irritation parameter:
other: Mean maximum corneal swelling at up to 240 min
Basis:
mean
Time point:
other: 240 min
Remarks on result:
other: value 2%; ICE Class I
Irritation parameter:
other: Mean maximum corneal opacity
Basis:
mean
Remarks on result:
other: value 0.50; ICE Class I
Irritation parameter:
other: Mean fluorescein retention
Basis:
mean
Remarks on result:
other: value 0; ICE Class I
Irritant / corrosive response data:
Overall ICE Class: 3xI
Other effects:
Other Observations: The Test Item was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse.

Any other information on results incl. tables

Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant. No conclusion of in vivo significance can be made from the adherence of the test item to the cornea, since in vivo eye lids will probably clear the surface, but abrasion may occur. It is concluded that an in vivo study is required for classification.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant. It is concluded that an in vivo study is required for classification.