Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline no. 437
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Vehicle:
other: PEG400
Controls:
other: positive and negative controls were used
Amount / concentration applied:
20% (w/v) concentration in PEG 400
Duration of treatment / exposure:
Corneas were exposed for 4 hours
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure, corneas were rinsed thoroughly with EMEM with phenol red.
- Time after start of exposure: 4h

SCORING SYSTEM: IVIS = opacity + (15 x Permeability OD490 value)

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
other: IVIS
Score:
ca. 15.6
Irritant / corrosive response data:
Eyes were examined for the presence of any defects which render the eye unsuitable for use (opacity, scratches or pitting of the corneal surface, vascularisation or pigmentation).
The permeability of the corneas (0.1347) was higher than that of negative control (0.0097), but lower than the value recorded for the vehicle (0.9797).This may indicate that the test item presence may have protected the corneas from the increase of permeability due to PEG 400 vehicle.

Any other information on results incl. tables

Treatment
code

 

Opacity
Value

 

Macroscopic observation

 

OD490

 

 

 

 

 

 

 

N1

 

1

 

No macroscopic changes

 

0.004

N2

 

2

 

No macroscopic changes

 

0.015

N3

 

1

 

No macroscopic changes

 

0.010

 

Mean

1.3

 

 

Mean

0.0097

 

SD

0.6

 

 

SD

0.0055

 

CV %

46.2

 

 

CV %

56.70

 

 

 

 

 

 

 

 

 

 

 

 

 

 

P1

 

42

 

Cornea totally opaque; slight exfoliation

 

1.631

P2

 

63

 

Cornea totally opaque; slight exfoliation

 

1.357

P3

 

40

 

Cornea totally opaque; slight exfoliation

 

1.970

 

Mean

48.3

 

 

Mean

1.6527

 

SD

12.7

 

 

SD

0.3071

 

CV %

26.3

 

 

CV %

18.58

 

 

 

 

 

 

 

Corrected Mean

47.0

 

Corrected Mean

1.6430

(negative control)

 

 

(negative control)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A1

 

8

 

Irregular opacity; presence of precipitate

 

0.168

A2

 

5

 

Irregular opacity; presence of precipitate

 

0.158

A3

 

6

 

Irregular opacity; presence of precipitate

 

0.078

 

Mean

6.3

 

 

Mean

0.1347

 

SD

1.5

 

 

SD

0.0493

 

CV %

23.8

 

 

CV %

36.60

 

 

 

 

 

 

 

Corrected Mean

5.0

 

Corrected Mean

0.1250

(negative control)

 

 

(negative control)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B1

 

2

 

Slightly irregular opacity pattern

 

1.018

B2

 

4

 

Slightly irregular opacity pattern

 

0.919

B3

 

1

 

Slightly irregular opacity pattern

 

1.002

 

Mean

2.3

 

 

Mean

0.9797

 

SD

1.5

 

 

SD

0.0531

 

CV %

65.2

 

 

CV %

5.42

 

 

 

 

 

 

 

Corrected Mean

1.0

 

Corrected Mean

0.9700

(negative control)

 

 

(negative control)

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: potential slight irritant
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
According to the criteria stated in the OECD guideline for this test, the test item is not defined as corrosive or severely irritant to the eye.
Executive summary:

Opacity and permeability of all corneas were determined. The treatment with the test item induced a very slight effect on corneal opacity and permeability. However, on one hand the physical nature of the test item may have affected the opacity while, on the other hand, the vehicle used may have influenced the permeability alteration of the test system.