OECD 438 Flashcards
(31 cards)
What is the purpose of the OECD 438 test method?
To identify substances that cause severe eye irritation or damage and classify chemicals according to global hazard regulations.
What type of alternative does the OECD 438 test method represent?
An in vitro (non-animal) alternative.
From where are the eyes obtained for the OECD 438 test?
From slaughtered chickens, typically for food production.
What are the three main endpoints assessed in the OECD 438 test?
- Corneal opacity
- Corneal swelling
- Fluorescein retention
Which regulatory agencies accept the OECD 438 test method?
Regulatory agencies worldwide, including OECD member countries.
What is a significant advantage of the OECD 438 test method?
Reduces reliance on live animal testing.
What is a limitation of the OECD 438 test method?
Not suitable for detecting mild or moderate irritants.
What year was the ICE test endorsed as a valid screening test for serious eye damage?
2006.
What did the 2013 re-evaluation of the ICE test conclude?
ICE could also identify chemicals not requiring classification for eye irritation or serious damage.
What does the ICE test method use to assess eye damage?
An organotypic model measuring corneal swelling, opacity, fluorescein retention, and histopathological changes.
What is the accuracy of the ICE test method in identifying serious eye damage chemicals?
83% accuracy.
What is the false positive rate of the ICE test method?
7%.
What is the false negative rate of the ICE test method?
47%.
What is the recommended procedure if solid materials lead to a GHS No Category outcome?
A second run of three eyes is recommended to confirm the result.
Fill in the blank: The ICE test is not recommended for identifying _______ eye irritants.
mild
What should be included in the test to ensure the validity of results?
- Negative or solvent/vehicle controls
- Positive controls (known irritants)
What is the significance of histopathology in the ICE test?
It can improve prediction for non-extreme pH detergents and surfactants.
What is the minimum number of eyes required for each treatment group in the ICE test?
At least three eyes.
What are the key measurements in the ICE test?
- Corneal opacity
- Fluorescein retention
- Corneal swelling
- Macroscopic morphological damage
What is the recommended temperature range for transporting chicken eyes?
18-25°C.
What happens to eyes with high baseline fluorescein staining in the ICE test?
They are rejected.
What is the purpose of a pathology peer review in the ICE test?
To improve accuracy and quality of pathology diagnoses.
What is the Test Guideline based on for the OECD 438 method?
OECD Guidance Document 160, updated in 2017 and 2018.
What types of chemicals were evaluated in the ICE test validation studies?
184 test chemicals, including 75 substances and 109 mixtures.
