Assessment of the dermal and ocular irritation potential of alcohol hand sanitizers containing aloe vera with in vitro and in vivo methods

Molecular and Cellular Toxicology

Volumn 6, Issue 4, 2010, Pages 401-408

  Ahn, Jun Ho ^a   Eum, Ki Hwan ^a   Kim, Yun Ki ^a   Oh, Se Wook ^b   Kim, Yun Ji ^c   Lee, Michael ^a  

^a SolarLight Ltd   (South Korea)

^b Kookmin University   (South Korea)

^c Korea Food Research Institute   (South Korea)

Author keywords

Alcohol; Dermal irritation; Hand sanitizer; Keratinocytes; Ocular irritation

Indexed keywords

EID: 79951709784     PISSN: 1738642X     EISSN: 20928467     Source Type: Journal    
DOI: 10.1007/s13273-010-0053-y     Document Type: Article

References (34)

1. Rotter, M. L. Hand washing and hand disinfection. Hospital Epidemiology and Infection Control 2nd edition (Mayhall, C. G. ed.), Lippincott Williams & Wilkins, Philadelphia. 1339-1355 (1999).
2. Paulson, D. S., Fendler, E. J., Dolan, M. J. & Williams, R. A. A close look at alcohol gel as an antimicrobial sanitizing agent. Am J Infect Control 27:332-338 (1999).
3. Wolf, R. Alcohol and the skin. Clin Dermatol 17:351-352 (1999).
4. Pendlington, R. U., Whittle, E., Robinson, J. A. & Howes, D. Fate of ethanol topically applied to skin. Food Chem Toxicol 39:169-174 (2001).
5. Kramer, A. et al. Quantity of ethanol absorption after excessive hand disinfection using three commercially available hand rubs is minimal and below toxic levels for humans. BMC Infect Dis 7:117 (2007).
6. Johnston, G. A. & English, J. S. The alcohol hand rub: a good soap substitute? Br J Dermatol 157:1-3 (2007).
7. Calvin, G. New approaches to the assessment of eye and skin irritation. Toxicol Lett 64-65:157-164 (1992).
8. Vinardell, M. P. & Mitjans, M. Alternative methods for eye and skin irritation tests: an overview. J Pharm Sci 97:45-59 (2008).
9. Fitzhugh, O. G., Woodard, G. & Braun, H. A. The toxicities of compounds related to 2,3-dimercaptopropanol (BAL) with a note on their relative therapeutic efficiency. J Pharmacol Exp Ther 87:23-27 (1946).
10. Rosdy, M. & Clauss, L. C. Terminal epidermal differentiation of human keratinocytes grown in chemically defined medium on inert filter substrates at the air-liquid interface. J Invest Dermatol 95:409-414 (1990).
11. Brantom, P. G. et al. A summary of the COPILA international validation study on alternatives to the Draize Rabbit Eye irritation test. Toxicol In Vitro 11:141-179 (1997).
12. OECD Harmonised Integrated Hazard Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures. OECD Series on Testing and Assessment, Number 33, ENV/JM/MONO(2001)6; Paris, France (2001).
13. Kampf, G. & Kramer, A. Epidemiologic background of hand hygiene and evaluation of the most important agents for scrubs and rubs. Clin Microbiol Rev 17:863-893 (2004).
14. Loffler, H., Kampf, G., Schmermund, D. & Maibach, H. I. How irritant is alcohol? Br J Dermatol 157:74-81 (2007).
15. Lachenmeier, D. W. Safety evaluation of topical applications of ethanol on the skin and inside the oral cavity. J Occup Med Toxicol 3:26 (2008).
16. Kamkaen, N. et al. The investigation of the rabbit and human skin irritation of herbal anti-wrinkle cream. Thai Pharm Health Sci J 2:20-25 (2007).
17. York, M. & Steiling, W. A critical review of the assessment of eye irritation potential using the Draize rabbit eye test. J Appl Toxicol 18:233-240 (1998).
18. Jung, K. M. et al. A new 3D reconstituted human corneal epithelium model as an alternative method for the eye irritation test. Toxicol In Vitro (in Press) doi: 10.1016/j.tiv.2010.10.019 (2010).
19. Cotovio, J. et al. In vitro assessment of eye irritancy using the reconstructed human corneal epithelial Skin-Ethic HCE model: application to 435 substances from consumer products industry. Toxicol In Vitro 24:523-537 (2010).
20. Alépée, N. et al. A catch-up validation study on reconstructed human epidermis (SkinEthic RHE) for full replacement of the Draize skin irritation test. Toxicol In Vitro 24:257-266 (2010).
21. Combes, R. D., Guant, I. & Balls, M. A scientific and animal welfare assessment of the OECD health effects test guidelines for the safety testing of chemicals under the European Union REACH system. Altern Lab Anim 32:163-208 (2004).
22. Mosman, T. Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays. J Immunol Methods 65:55-63 (1983).
23. Corsini, E., Bruccoleri, A., Marinovich, M. & Galli, C. L. Endogenous interleukin-1 alpha associated with skin irritation induced by tributyltin. Toxicol Appl Pharmacol 138:268-274 (1996).
24. Spielmann, H. et al. The ECVAM international validation study on in vitro tests for acute skin irritation: report on the validity of the EPISKIN and EpiDerm assays and on the skin integrity function test. Altern Lab Anim 35:559-601 (2007).
25. European Centre for the Validation of Alternative Methods Local toxicity: acute dermal and ocular effects. In Alternative (non animal) methods for chemical testing: current status and future prospects (Worth, A. P., Balls, M., eds.). Altern Lab Anim 30:35-47 (2002).
26. Spielmann, H. et al. Modern biostatistical methods for assessing in vitro/in vivo correlation of severely eye irritating chemicals in a validation study of in vitro alternatives to the Draize eye test. Toxicol In Vitro 9:549-556 (1995).
27. Aaronson, S. A. & Todaro, G. J. Development of 3T3-like lines from Balb-c mouse embryo cultures: transformation susceptibility to SV40. J Cell Physiol 72:141-148 (1968).
28. OECD OECD Guidelines for the Testing of Chemicals (December, 2007) Draft proposal for a new guideline 'In Vitro Skin Irritation: Human Skin Model Test'. (2007).
29. Jung, K.-M. et al. The validation of alternative methods of reconstructed human skin equivalents for the assessment of skin irritation. J Altern Animal Exp 2:31-38 (2008).
30. NICEATM Test Method Protocol for BALB/c 3T3 Neutral Red Uptake Cytotoxicity Assay Phase III - Validation Study (November 4, 2003). (2003).
31. Lee, H.-K. et al. Establishment of the neutral red uptake assay as alternatives to the Draize test and its validation. J Altern Animal Exp 2:5-9 (2008).
32. Yang, X. et al. Preliminary study on neutral uptake assay as an alternative method for eye irritation test. AATEX 14:509-514 (2007).
33. Jones, P. A., Bracher, M., Marenus, K. & Kojima, H. Performance of the neutral red uptake assay in the COLIPA international validation study on alternatives to the rabbit eye irritation test. Toxicol In Vitro 13:325-333 (1999).
34. Draize, J. H., Woodard, G. & Calvery, H. O. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 82:377-390 (1944).