Eye irritation – OECD 437, 438, 492

Eye irritation is a crucial safety parameter in the toxicological evaluation of cosmetic, chemical, industrial, and agrochemical products. OECD guidelines offer several validated methods for predicting the irritant or corrosive potential of a substance without resorting to animal testing.

This fact sheet presents three internationally recognized in vitro tests for assessing eye irritation:

• TG 437 (BCOP)
• TG 438 (ICE)
• TG 492 (RhCE)

Objective of the analysis

These tests allow us to:

• Identify substances that cause severe eye damage or irritation
• Classify substances according to CLP, GHS, and REACH criteria
• Replace in vivo tests (e.g., Draize) in accordance with European regulatory requirements (Cosmetics Regulation 1223/2009, REACH, BPR)

OECD 437 – BCOP (Bovine Corneal Opacity and Permeability)

• Uses isolated bovine corneas
• Measures opacity and permeability after exposure to the product
• Validated method for identifying substances that induce severe eye damage (Category 1)
• Not suitable for detecting moderate effects

OECD 438 – ICE (Isolated Chicken Eye)

• Based on isolated chicken eyes (slaughterhouse by-products)
• Assess corneal damage: opacity, vascular effect, thickening
• It allows for the identification of severe or moderate effects

OECD 492 – RhCE (Reconstructed human Cornea-like Epithelium)

• In vitro reconstructed human epithelial model (e.g., EpiOcular, SkinEthic HCE)
• Measures cell viability after exposure to the product
• Validated method for the identification of non-irritating substances (category "No Category")
• Recommended for cosmetic products (animal testing is prohibited in the EU)

Applications

• Cosmetic products (creams, shampoos, makeup removers…)
• Household and industrial products (detergents, solvents)
• Plant protection products or biocides
• Chemical raw materials or formulated ingredients

Why go through YesWeLab?

YesWeLab connects you with accredited partner laboratories specializing in in vitro toxicology and international regulations. Our teams advise you on the method best suited to your product, your sector, and your regulatory objectives.

Need regulatory support or a quote? Contact our scientific team for a personalized analysis tailored to your product safety strategy.

See also:

• In vitro skin absorption (OECD 428)
• In vitro skin irritation test (OECD 439)
• Skin corrosion test (OECD 431)