Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
chicken

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30μL of test item with no vehicle.
Duration of treatment / exposure:
10 seconds, after which the eyes were rinsed with physiological saline
Duration of post- treatment incubation (in vitro):
4 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
0
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance has caused no irritation.
Executive summary:

The neat test item has been exposed to isolated chicken eyes for 10 seconds, after which the eyes were rinsed with physiological saline. Concurrent positive and negative controls were undertaken. The test vitem cause no severe or mild irritation, while controls responded as expected.