Registration Dossier

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 EU/OECD guideline

Data source

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

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
Mean maximum corneal swelling at up to 75 min
Value:
0
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: ICE Class I
Irritation parameter:
other:
Run / experiment:
Mean maximum corneal swelling at up to 240 min
Value:
0
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: ICE Class I
Irritation parameter:
cornea opacity score
Run / experiment:
Mean maximum corneal opacity
Value:
3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: ICE Class IV
Irritation parameter:
fluorescein retention score
Run / experiment:
Mean fluorescein retentionMean fluorescein retention
Value:
2.33
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: ICE Class III

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
An in vitro eye irritation study of the test item BCS-CL73507-BCS-BS22576 (MYDO) was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (adopted on 7th September 2009, updated on 26th July 2013).
After the zero reference measurements, the eye was held in horizontal position and 30 μL of BCS-CL73507-BCS-BS22576 (MYDO) was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 μL Trichloroacetic acid 30 (w/v) %. The negative control eye was treated with 30 μL of Saline (Salsol solution, NaCl 0.9% w/v).
Executive summary:

Based on this in vitro eye irritation in the isolated chicken eyes test with BCS-CL73507-BCS-BS22576 (MYDO), the test item is not classified as a severe irritant and not classified as non-irritant.