Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 April 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

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)
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: White to pale yellow powder, slightly characteristic odour.
- Storage condition of test material: Room temperature.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg
Duration of treatment / exposure:
Single application, removed after 10 seconds.

Results and discussion

In vivo

Irritant / corrosive response data:
The results suggest that the test material is moderately irritating but not a severe irritant.
Other effects:
Controls:
The positive control imidazole was classed as severely irritating.
The negative control Sodium chloride (Salsol solution 0.9%) had no significant effects on the chicken eye in this study.

Any other information on results incl. tables

Table 4: Test Material Results 

Observations

Value

ICE Class

Mean maximum corneal swelling at up to 75 min

1 %

I

Mean maximum corneal swelling at up to 240 min

1 %

I

Mean maximum corneal opacity

2.00

III

Mean fluorescein retention

2.00

III

Other Observations

The test material was stuck on the cornea surface after the post-treatment rinse. All corneal surfaces were cleared 75 minutes after the post-treatment rinse.

Overall ICE Class

1 x I, 2 x III

Table 5: Positive Control Results

Observations

Value

ICE Class

Mean maximum corneal swelling at up to 75 min

3 %

I

Mean maximum corneal swelling at up to 240 min

8 %

II

Mean maximum corneal opacity

4.00

IV

Mean fluorescein retention

2.83

IV

Other Observations

The Imidazole was stuck on the cornea surface after the post treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse.

Overall ICE Class

1 x II 2 x IV

 

Table 6: Negative Control Results

Observations

Value

ICE Class

Mean maximum corneal swelling at up to 75 min

0 %

I

Mean maximum corneal swelling at up to 240 min

0 %

I

Mean maximum corneal opacity

0.00

I

Mean fluorescein retention

0.00

I

Other Observations

None

Overall ICE Class

3 x I

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the results suggest that the test material is moderately irritating.
Executive summary:

An in vitro eye irritation study in isolated chicken eyes was conducted under GLP conditions and according to the OECD guideline 438 and EU Method B.48 to determine if the test material caused corrosion or severe eye irritation. Three chicken eyes were exposed to the test material (30 mg) for 10 seconds, rinsed with isotonic saline, and then assessed for irritation at intervals for up to 240 minutes. Toxic effects to the cornea were measured by a qualitative assessment of opacity, damage to epithelium based on application of fluorescein to the eye (fluorescein retention), and measurement of cornea thickness (swelling). Damage was assessed individually and then combined to derive an Eye Irritancy Classification. Positive and negative controls were run concurrently to assess the viability of the test system.

Under the conditions of the study, exposure to the test material resulted in an overall ICE class of 1 x I and 2 x III, which corresponds to a classification of moderately irritating in accordance with the OECD guideline. The results suggest that the test material is moderately irritating, but should not be classified as a severe eye irritant.