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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
chicken
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
Amount / concentration applied:
30 mg
Duration of treatment / exposure:
10 sec
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
maximal mean score
Value:
0
Positive controls valid:
yes
Irritation parameter:
fluorescein retention score
Run / experiment:
mean score
Value:
0.5
Positive controls valid:
yes
Irritation parameter:
percent corneal swelling
Run / experiment:
maximal mean
Value:
1
Positive controls valid:
yes
Other effects / acceptance of results:
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.0, corresponding to ICE class I;
- mean score of fluorescein retention: 0.5, corresponding to ICE class I;
- maximal mean corneal swelling: 1%, corresponding to ICE class I.
The combination of the three endpoints for the test substance was 3 x I.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The combination of the three endpoints for the negative control, physiological saline, was 3 x I.
Therefore, the negative control is classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye.
Executive summary:

The eye irritation ptential was evaluated accordine OECD438 method.

The combination of the three endpoints for the negative control, physiological saline, was 3 x I.

Therefore, the negative control is classified as “No Category”, as expected.

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye.