110 TESTING
TABLE 2: SUMMARY OF CHARACTERISTICS OF DIFFERENT TEST DESIGN Testing Standards
Draize Eye Irritation Test Reproducible Data Objective Data Ethical Compliance Tailored Test Design - Minimal + Acceptable ++
+ - - -
Very Good As Figure 4 roughly indicates, exemplary ‘No
Tears’ test measurements of different surfactant- containing products have already shown that the difference in irritation potential for the eyes can be strikingly large (classical shampoo versus baby shampoo), but even with mild products there can be a difference in irritation potential (baby shampoo versus mild cleansing product) which, although not huge, may make the difference for the manufacturer’s decision of producing or the actual end consumer. For surfactant-containing products in
particular, where there can be major differences in irritant potential, this offers new possibilities for testing the safety of the products and the opportunity for simple, transparent end consumer communication through labelling. Thus, the Dermatest’s ‘No Tears’ test design
provides a comprehensible product type specific reliable declaration of products by using an ethically acceptable and meaningful test method that meets the needs of the cosmetics industry. The Dermatest’s ‘No Tears’ test provides differentiated results for all cosmetic products
applied above the neckline and provides the chance to label mild and extra mild products with a corresponding ‘No Tears’ seal.
for ocular irritation. Environ Health Perspect. 1998; 106, Suppl 2, 485-492
PC
References 1. Adriaens E, Barroso J, Eskes C et al. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods. Arch Toxicol. 2014; 88, 701-723.
2. Green K. A brief history of ocular toxicology. Lens Eye Toxic Res. 1992; 9:153–159
3. Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther. 1944; 8, 377-390
4. Wilhelmus KR. The Draize eye test. Surv Ophthalmol. 2001;45:493–515.
5. Sharpe R. The Draize test – motivations for change. Food Chem Toxicol. 1985; 23, 139-143 6. Curren RD, Harbell JW. In vitro alternatives
Development of vitality over time ■ Classic Shampoo ■ Baby Shampoo ■ Mild Cleansing Product ■ 5% SDS ■Water
110 90 70 50 30 10
-10 0 30 Time (min)
Figure 4: Exemplary presentation of results of the Dermatest‘s ‘No Tears’ test of different surfactant- containing products. The development of vitality under the influence of the products over time is shown
PERSONAL CARE April 2025 60 120
7. Luechtefeld T, Maertens A, Russo DP et al. Analysis of draize eye irritation testing and its prediction by mining publicly available2008–2014 REACH data. Altern Anim Exp. 2016;33:123–134
8. OECD (2009a). Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants. OECD Guidelines for the Testing of Chemicals, Section 4. Paris: OECD Publishing
9. OECD (2013c). Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Clas-sification for Eye Irritation or Serious Eye Damage. OECD Guidelines for the Testing of Chemicals, Section 4. Paris: OECD Publishing)
10. Luepke NP. Hen’s egg chorioallantoic membrane test for irritation potential. Food Chem Toxicol. 1985; 23, 287-291
11. Luepke NP, Kemper FH. The HET-CAM test: An alternative to the draize eye test. Food Chem Toxicol. 1986; 24, 495-496
12. Pfannenbecker U, Bessou-Touya S, Faller C. et al. Cosmetics Europe multi-laboratory prevalidation of the Epi-Ocular reconstituted human tissue test method for the prediction of eye irritation. Toxicology in Vitro. 2013; 27, 619-626
13. Kaluzhny Y, Kandarova H, Hayden P et al. Development of the EpiOcular(TM) eye irritation test for hazard identification and labelling of eye irritating chemicals in re-sponse to the requirements of the EU cosmetics directive and REACH legislation. Altern Lab Anim. 2011; 39, 339-364
14. OECD (2015). Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. OECD Guidelines for the Testing of Chemicals, Section 4. Paris: OECD Publishing
15. Mosmann T. Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays. J Immunol Meth. 1983;65:55–63
www.personalcaremagazine.com
++ - + -
++
+ -
-
BCOP-OECD TG 437
HET-CAM Test
Eye Instillation Test
OECD TG 492
+ ++ - ++ - ++ -
-
" No Tears" Test
++ ++ ++ ++
Vitality (%)
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