106 TESTING
'No tears' testing for cosmetic products
Janina Tiemann-Hesselbarth, Sarah Risse, Tim Meyersick-Püchel, Marcel Voss – Dermatest ABSTRACT
When developing products, toxicological testing is essential in order to protect the user from the possible harmful effects of the various ingredients. In the case of household products, cosmetics, body cleansing and personal care products, as well as chemicals, the skin or mucous membranes are usually the areas of the body most likely to come into contact with the products. A potential consequence of exposure and contact is irritation of the eyes and skin. Basically, irritations are physiological
reactions to chemical stimuli that can manifest themselves in objective symptoms, such as redness and swelling as well as subjective sensations such as itching and pain. Before people come into contact with such substances, the risk of the products causing eye or skin irritation must be determined.1 For products that are not intended for skin
or eye contact, the aim is to ensure that no serious irritation is caused or to determine whether special warnings need to be affixed to the products. For products that are specifically applied to the skin and can potentially come into contact with the eyes, the aim of testing is to determine how mild or well tolerated the products are - labelling of particularly mild and well tolerated products is important information for all end consumers and especially consumers with sensitive skin and eyes.
PERSONAL CARE April 2025 In the 20th century, the Draize Eye Irritation
Test was developed, which is able to determine the irritant potential of products by testing them on rabbits.2,3
The test involves applying
a small amount of the test substance directly to the rabbit’s eye. The rabbit is then observed for a specified time, typically up to 72 hours, to evaluate any adverse effects. The assessment focuses on various
parameters, including redness and swelling. All parameters are scored on a scale to determine the severity of irritation and the results are used for the regulatory agencies to proof whether a product is safe.4 Because of strong ethical concerns and the
push for cruelty-free testing, the Draize test has been banned or restricted in many countries.1,5-6 Therefore, alternative testing strategies have been developed to evaluate the ocular irritation potential of products without resorting to animal testing. These new testing methods should not only
align with ethical considerations but also aim to provide more accurate results for human safety. These alternatives include among others the Bovine Corneal Opacity and Permeability (BCOP, OECD TG 437) Test, the Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM) Test, the Eye Instillation Test on humans, and the more recent OECD TG 492 test, which uses reconstructed human cornea-like epithelium (RhCE) models.
The safety of products that may come into contact with the human eye is critical for consumers. The OECD testing framework, such as OECD TG 492, has become a widely accepted standard. However, while it provides robust insights for certain categories, its limitations become evident when addressing diverse products like cosmetics. A more nuanced evaluation of irritation levels is needed, particularly in the mild to extra-mild range that OECD methods cannot adequately capture. To address this gap, we reviewed alternative testing methods. Established in vivo methods such as the eye installation test are not justifiable for ethical reasons, as damage to the eyes of the test subjects cannot be ruled out. Other in vitro methods fail to offer the quantitative evaluation necessary for products designed for sensitive areas like the eye or are not a good alternative to simulate the human cornea. In response, we established the Dermatest ‘No Tears’ testing method. This innovative approach is tailored to assess the irritation potential, providing reliable, quantitative safety evaluations for cosmetics. Our findings emphasize the importance of choosing appropriate testing methods for specific product properties and questions, ensuring both safety and ethical compliance. The ‘No Tears’ test represents a breakthrough in ocular safety testing, aligning with ethical standards, consumer trust, and the growing demand for cruelty- free testing approaches.
The cosmetic industry can, therefore, choose
between various in vivo and in vitro methods to analyse the properties of their products, even without the Draize test. Yet which test is the most suitable method for the variety of cosmetic products, from creams to shampoos? Dermatest, as an independent scientific
dermatological test institute, has its own quality standards to establish new methods that provide reliable data for customers and guarantee product safety for the end consumer. We, therefore, carried out intensive research in a first step and compared the methods in a second step based on internally defined high quality standards. Table 1 shows the results of the literature research.
www.personalcaremagazine.com
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