Evaluation of eye irritation potential of experimental cosmetic formulations containing glycolic acid, salicylic acid and ethanol using the Bovine Corneal Opacity and Permeability Assay

References

• Donahue DA, Kaufman LE, Avalos J, et al. Survey of ocular irritation predictive capacity using chorioallantoic membrane vascular assay (CAMVA) and bovine corneal opacity and permeability (BCOP) test historical data for 319 personal care products over fourteen years. Toxicol In Vitro. 2011;25(2):563–572. doi:10.1016/j.tiv.2010.12.003.
   PubMed Web of Science ®Google Scholar
• OECD. Test No. 437: Bovine Corneal Opacity and Permeability test method for identifying i) Chemicals inducing serious eye damage and ii) Chemicals not requiring classification for eye irritation or serious eye damage; 2023. Available from: https://www.oecd-ilibrary.org/docserver/9789264203846-en.pdf?expires=1717159293&id=id&accname=guest&checksum=7F088AEE446C2816B5E20C8C1E4F04B6. Note: OECD TG 437 was updated in 2023, but no major changes have been made which would affect the assay conduct or interpretations included in this manuscript.
   Google Scholar
• ECHA. Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labeling and packaging (CLP) of substances and mixtures, version 5.0; 2017. Available from: https://echa.europa.eu/documents/10162/23036412/clp_en.pdf/58b5dc6d-ac2a-4910-9702-e9e1f5051cc5
   Google Scholar
• NIH. Newly approved ocular safety methods reduce animal testing; 2008.
   Google Scholar
• US EPA. Use of an alternate testing framework for classification of eye irritation potential of EPA pesticide products; 2015: 1–39.
   Google Scholar
• Casterton PL, Potts LF, Klein BD. A novel approach to assessing eye irritation potential using the bovine corneal opacity and permeability assay. J Toxicol Cutan Ocular Toxicol. 1996;15(2):147–163.
   Web of Science ®Google Scholar
• Gautheron P, Dukic M, Alix D, et al. Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundam Appl Toxicol. 1992;18(3):442–449. doi:10.1177/1091581816651606.
   PubMedGoogle Scholar
• Sina JF, Galer DM, Sussman RG, et al. A collaborative evaluation of seven alternatives to the draize eye irritation test using pharmaceutical intermediates. Fundam Appl Toxicol. 1995;26(1):20–31. doi:10.1006/faat.1995.1071.
   PubMedGoogle Scholar
• Curren RD, Evans MG, Raabe HA, et al. An histological analysis of damage to bovine corneas in vitro by selected ocular toxicants. Toxicol. 2000;54(1):188.
   Google Scholar
• Labib R, Gilberti E, Costin G-E, et al. Observations on the use of the bovine corneal opacity and permeability (BCOP) assay to evaluate the eye irritation potential of prototype cosmetic formulations containing salicylic acid, glycolic acid and ethanol. ALTEX Proc. 2014;3(1):107–108.
   Google Scholar
• Andersen FA. Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and Tea-Lactates, methyl, ethyl, isopropyl, and butyl lactates, and lauryl, myristyl, and cetyl lactates. Int J Toxicol. 1998;17(5_suppl):vii–vii. doi:10.1177/109158189801700101.
   Google Scholar
• Scientific Committee on Consumer Safety (SCCS). Opinion on salicylic acid (CAS 69-72-7). Submission 1. Adopted by written procedure on December 21, 2018; [cited 2023 May 9]. https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf. Last Updated 2019.
   Google Scholar
• Cosmetic Ingredient Review. Final report on the safety assessment of stereth-2, -4, -6, -7, -10, -11, -13, -15, and -20. J Am Coll Toxicol. 1988;7(6):881–910.
   Google Scholar
• Cosmetic Ingredient Review. Safety assessment of glycerin as used in cosmetics; 2014. p. 1–19.
   Google Scholar
• Fiume MM, Heldreth B, Bergfeld WF, et al. Safety assessment of microbial polysaccharide gums as used in cosmetics. Int J Toxicol. 2016;35(1_suppl):5S–49S. doi:10.1177/1091581816651606.
   PubMedGoogle Scholar
• Redden JC, Perry MJ, Leighton T, et al. 2009. Voluntary pilot program to evaluate use of non-animal testing approach to EPA labeling for eye irritation for certain antimicrobial products with cleaning claims. Office of pesticide programs. Washington, DC: US Environmental Protection Agency.
   Google Scholar
• Maurer JK, Parker RD, Jester JV. Extent of initial corneal injury as the mechanistic basis for ocular irritation: key findings and recommendations for the development of alternative assays. Regul Toxicol Pharmacol. 2002;36(1):106–117.
   PubMed Web of Science ®Google Scholar
• Jester JV. Extent of corneal injury as a biomarker for hazard assessment and development of alternative models for the Draize rabbit eye test. Cutan Ocular Toxicol. 2006;25(1):41–54.
   PubMed Web of Science ®Google Scholar
• Jester JV, Li HF, Petroll WM, et al. Area and depth of surfactant-induced corneal injury correlates with cell death. Investig Ophthal Vis Sci. 1998;39(6):922–936.
   PubMed Web of Science ®Google Scholar
• Maurer JK, Parker RD. Light microscopic comparison of surfactant-induced eye irritation in rabbits and rats at three hours and recovery/day 35. Toxicol Pathol. 1996;24(4):403–411. doi:10.1177/019262339602400403.
   PubMed Web of Science ®Google Scholar
• Mofidfar M, Abdi B, Ahadian S, et al. Drug delivery to the anterior segment of the eye: a review of current and future treatment strategies. Int J Pharm. 2021;607:120924. doi:10.1016/j.ijpharm.2021.120924.
   PubMed Web of Science ®Google Scholar
• Löscher M, Seiz C, Hurst J, et al. Topical drug delivery to the posterior segment of the eye. Pharmaceutics. 2022;14(1):134. doi:10.3390/pharmaceutics14010134.
   PubMed Web of Science ®Google Scholar
• Gettings S, Teal J, Bagley D, et al. The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the draize primary eye irritation test (phase 1) hydro-alcoholic formulations; (part 2) data analysis and biological significance. In Vitro Toxicol. 1991;4(4):247–288.
   Google Scholar
• SCCNFP. Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for consumers concerning salicylic acid. SCCNFP/0522/01; 2002.
   Google Scholar
• Villard H. Chemical burns of the eye. Arch Ophthalmol. 1927;44:21–40; 93-111; 167-177; 222–223.
   Google Scholar
• Lee J, Jun JH. Ocular chemical burn associated with gel type alcohol-based hand sanitizer: a case report. Medicine (Baltimore). 2021;100(42):e27292. doi:10.1097/MD.0000000000027292.
   PubMed Web of Science ®Google Scholar
• Jinagal J, Gupta PC, Gupta G, et al. Ocular chemical burns from accidental exposure to topical dermatological medicinal agent. Indian J Ophthalmol. 2018;66(10):1476–1477.
   PubMed Web of Science ®Google Scholar
• Shazly TA. Ocular acid burn due to 20% concentrated salicylic acid. Cutan Ocul Toxicol. 2011;30(1):84–86.
   PubMed Web of Science ®Google Scholar
• Scott L, Eskes C, Hoffmann S, et al. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In Vitro. 2010;24(1):1–9. doi:10.1016/j.tiv.2009.05.019.
   PubMed Web of Science ®Google Scholar
• Trommer H, Neubert RH. Overcoming the stratum corneum: the modulation of skin penetration. Skin Pharmacol Physiol. 2006;19(2):106–121.
   PubMed Web of Science ®Google Scholar
• Williams AC, Barry BW. Penetration enhancers. Adv Drug Deliv Rev. 2004;56(5):603–618.
   PubMed Web of Science ®Google Scholar
• Campbell PS, Chandrasekaran SK. US Patent 4379454. Dosage for coadministering drug and percutaneous absorption enhancer; 1983.
   Google Scholar
• Good WR, Powers MS, Campbell P, et al. A new transdermal delivery system for estradiol. J. Control Release. 1985;2:89–97.
   Google Scholar
• Pershing LK, Lambert LD, Knutson K. Mechanism of ethanol-enhanced estradiol permeation across human skin in vivo. Pharm Res. 1990;7(2):170–175. doi:10.1023/a:1015832903398.
   PubMed Web of Science ®Google Scholar
• Morimoto Y, Wada Y, Seki T, et al. In vitro skin permeation of morphine hydrochloride during the finite application of penetration-enhancing system containing water, ethanol and L-menthol. Biol Pharm Bull. 2002;25(1):134–136.
   PubMed Web of Science ®Google Scholar
• Kadir R, Stempler D, Liron Z, et al. Delivery of theophylline into excised human skin from alkanoic acid solutions: a ‘push-pull’ mechanism. J Pharm Sci. 1987;76(10):774–779.
   PubMed Web of Science ®Google Scholar
• Ghanem A, Mahmoud H, Higuchi WI, et al. The effect of ethanol on the transport of b-estradiol and other permeants in hairless mouse skin. II. A new quantitative approach. J Controlled Release. 1987;6(1):75–83.
   Google Scholar
• Ghanem AH, Mahmoud H, Rohr U, et al. Mechanism of action of ethanol in enhancing the transport of estradiol and other permeants in hairless mouse skin. Pharm Res. 1986;3:S56.
   PubMedGoogle Scholar
• Kurihara-Bergstrom T, Knutson K, DeNoble LJ, et al. Percutaneous adsorption enhancement of an ionic molecule by ethanol-water systems in human skin. Pharm Res. 1990;7(7):762–766. doi:10.1023/a:1015879925147.
   PubMed Web of Science ®Google Scholar
• Levang AK, Zhao K, Singh J. Effect of ethanol/propylene glycol on the in vitro percutaneous absorption of aspirin, biophysical changes and macroscopic barrier properties of the skin. Int J Pharm. 1999;181(2):255–263. doi:10.1016/s0378-5173(99)00055-1.
   PubMedGoogle Scholar
• Manabe E, Sugibayashi K, Morimoto Y. Analysis of skin penetration enhancing effect of drugs by ethanol-water mixed systems with hydrodynamic pore theory. Int J Pharm. 1996;129(1-2):211–221. doi:10.1016/0378-5173(95)04328-4.
   Google Scholar
• Harada K, Murakami T, Kawasaki E, et al. In-vitro permeability to salicylic acid of human, rodent and shed snake skin. J Pharm Pharmacol. 1993;45(5):414–418. doi:10.1111/j.2042-7158.1993.tb05567.x.
   PubMed Web of Science ®Google Scholar
• Barratt MD. Quantitative structure-activity relationships (QSARs) for skin corrosivity of organic acids, bases and phenols: Principal components and neural network analysis of extended datasets. Toxicol In Vitro. 1996;10(1):85–94. doi:10.1016/0887-2333(95)00101-8.
   PubMed Web of Science ®Google Scholar
• Jiang M, Qureshi SA. Assessment of in vitro percutaneous absorption of glycolic acid through human skin sections using a flow-through diffusion cell system. J Dermatol Sci. 1998;18(3):181–188.
   PubMed Web of Science ®Google Scholar
• Cooper ER. Increased skin permeability for lipophilic molecules. J Pharm Sci. 1984;73(8):1153–1156. doi:10.1002/jps.2600730831.
   PubMed Web of Science ®Google Scholar