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:
other: Updated OECD Guideline No. 438 (adopted on 25 June 2018)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
chicken

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30 mg
Duration of treatment / exposure:
10 sec
Duration of post- treatment incubation (in vitro):
4 hours
Number of animals or in vitro replicates:
In the study, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
3/3 treated eyes
Value:
ca. 1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Run / experiment:
3/3 treated eyes
Value:
>= -5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
1/3 treated eyes
Value:
ca. 1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
2/3 treated eyes
Value:
ca. 0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in the experiment. Thus, the experiment was considered to be valid.

Any other information on results incl. tables

No significant corneal swelling (mean ≥-5%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (severity 1) was observed on three eyes. Slight fluorescein retention change (severity 0.5 on two eyes and severity 1 on one eye) was noted on all three eyes.Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were cleared at 30 minutes after the post-treatment rinse.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on this in vitro eye irritation assay in isolated chicken eyes with Chondroitin Sulfate Avian, the test item is not classified.