Skip to main content
SpringerLink
Log in

The Use of Visual Grading Scales in Evaluating Skin Irritation and Sensitization: A Historical Perspective

  • Chapter
  • First Online:
Non Invasive Diagnostic Techniques in Clinical Dermatology

  • 2575 Accesses

Abstract

Visual assessment of skin reactions has long been used to evaluate the safety of chemicals and preparations that contact the skin and to meet regulatory requirements. This paper reviews the history of visual grading scales and the results of investigations into the reliability of the method. Some examples are provided illustrating the diverse array of protocols that use visual scoring to evaluate skin irritation. Further, as bioengineering methods are developed that can quantitate certain aspects of skin irritant and sensitization reactions, it is important to consider if such measures should supplement or replace visual assessment. Examples of investigations comparing the outcome of studies that use visual scoring versus bioengineering methods are discussed. These examples provide little evidence that bioengineering measures improve the overall quality of current testing methods that rely on visual assessment. In addition, such measuring techniques can add considerably to the complexity of testing protocols. When benefits and cost are weighed in the balance, the visual assessment scales popularized by Draize and others remain an effective, practical method of evaluation.

Adapted from Farage MA et al (2011) Historical perspective on the use of visual grading scale in evaluating skin irritation and sensitization. Contact Dermatitis 65:65–75. With kind permission from John Wiley & Sons publisher

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 119.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. Movat HZ (1979) The acute inflammatory process. In: Movat HZ (ed) Inflammation, immunity and hypersensitivity, 2nd edn. Harper & Row, Hagerstown, pp 1–162

    Google Scholar 

  2. Devos SA, van der Valk PG (2002) Epicutaneous patch testing. Eur J Dermatol 12(5):506–513

    PubMed  Google Scholar 

  3. Lachapelle JM (2010) Giant steps in patch testing: a historical memoir. SmartPractice, Phoenix

    Google Scholar 

  4. Sulzberger MB, Wise F (1931) The contact or patch test in dermatology: its uses, advantages and limitations. Arch Derm Syphilol 23(3):519–531

    Article  Google Scholar 

  5. Graves JM (1932) The patch test—its use in dermatology – report of cases. Cal West Med 36(3):157–160

    PubMed  CAS  Google Scholar 

  6. Mayer RL (1930) Das Gewerbeekzem. Schriften aus dem Gesamtgebiet der Gewerbehygiene. Verlag von Julius Springer, Berlin, Neue Folge, Heft 30:1–89

    Google Scholar 

  7. Blumenthal F, Jaffé K (1933) Ekzem und Idiosynkrasie. Verlag von S. Karger, Berlin, pp 1–188

    Google Scholar 

  8. Bonnevie P (1939) Aetiologie und Patholgenise de Ekzemkrankheiten. Klinische Studien über due Ursachen der Ekzeme unter besonderer Berücksichtigung des Diagnosticshen Werted der Eksamproben. Busch, Copenhagen/Barth, Letapzig

    Google Scholar 

  9. Schwartz L, Peck SM (1944) The patch test in contact dermatitis. Public Health Rep 59:546–557

    Article  Google Scholar 

  10. Draize JH, Woodard G, Calvery HO (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 82(3):377–390

    CAS  Google Scholar 

  11. Guild TB (1939) Window patch test. Arch Derm Syphilol 39:807

    Article  Google Scholar 

  12. Rokstad I (1940) Patch test, new modification of (the chamber method). Arch Derm Syphilol 41(4):649–653

    Article  Google Scholar 

  13. Cronin E (1980) Technique of patch testing. In: Cronin E (ed) Contact dermatitis. Churchill Livingstone, Edinburgh, pp 1–19

    Google Scholar 

  14. Fisher AA (1986) The role of patch testing. In: Fisher AA (ed) Contact dermatitis, 3rd edn. Lea & Febiger, Philadelphia, pp 9–29

    Google Scholar 

  15. Wilkinson DS, Fregert S, Magnusson B, Bandmann HJ, Calnan CD, Cronin E, Hjorth N, Maibach HJ, Malalten KE, Meneghini CL, Pirilä V (1970) Terminology of contact dermatitis. Acta Derm Venereol 50:287–292

    PubMed  CAS  Google Scholar 

  16. National Academy of Sciences (1977) Dermal and eye toxicity tests. In: Principles and procedures for evaluating the toxicity of household substances. National Academy of Sciences, National Research Council, Washington, DC, pp 23–59

    Google Scholar 

  17. Consumer Product Safety Commission CPSC History. http://www.usrecallnews.com/2008/05/us-consumer-product-safety-commission-cpsc.html. Accessed 24 Mar 2010

  18. U.S. Environmental Protection Agency, OPPTS Harmonized Test Guidelines Series 870 – Health Effects Test Guidelines. OPPTS 870.2500 Acute Dermal Irritation. EPA712-C-98-196 (1998) http://www.epa.gov/oppts/pubs/frs/publications/Test_Guidelines/series870.htm. Accessed 6 Apr 2010

  19. OECD Guideline for the Testing of Chemicals 404 (2002) Acute toxicity: dermal irritation/corrosion. http://ecb.jrc.ec.europa.eu/testing-methods/annex5/. Accessed 2 Apr 2010

  20. Title 16: Commercial Practices PART 1500—Hazardous Substances and Articles; Administration and Enforcement Regulations § 1500.41 Method of testing primary irritant substances. http://www.access.gpo.gov/nara/cfr/waisidx_00/16cfr1500_00.html. Accessed 2 Apr 2010

  21. American Society for Testing and Materials (ASTM)-ASTM F 719 – 81 (Reapproved 2007). Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation. http://enterprise.astm.org

  22. U.S. Consumer Product Safety Commission, Office of Compliance Requirements under the Federal Hazardous Substances Act: Labeling and Banning Requirements for Chemicals and Other Hazardous Substances. 15 U.S.C. § 1261 and 16 C.F.R. Part 1500 (2002) http://www.cpsc.gov/businfo/regsumfhsa.pdf. Accessed 2 Apr 2010

  23. Guidance to Regulation (EC) No 1272/2008 on Classification, Labeling and Packaging of substances and mixtures (2009) 3.2.2.1.2.5 Testing methods: In vivo data. p 222. http://ecb.jrc.ec.europa.eu/documents/Classification-Labelling/CLP_Guidance_to_Regulation.pdf. Accessed 2 Apr 2010

  24. OECD Guidelines for the Testing of Chemicals. Tests No. 430, 431 and 435. http://titania.sourceoecd.org/vl=2183769/cl=13/nw=1/rpsv/cw/vhosts/oecdjournals/1607310x/v1n4/contp1-1.htm. Accessed 26 May 2010

  25. Marzulli FN, Maibach HI (1975) The rabbit as a model for evaluating skin irritants: a comparison of results obtained on animals and man using repeated skin exposures. Food Cosmet Toxicol 13(5):533–540

    Article  PubMed  CAS  Google Scholar 

  26. Buehler EV (1965) Delayed contact hypersensitivity in the guinea pig. Arch Dermatol 91(2):171–175

    Article  PubMed  CAS  Google Scholar 

  27. Ritz HL, Buehler EV (1980) Planning, conduct, and interpretation of guinea pig sensitization patch tests. In: Drill VA, Maibach HI (eds) Current concepts in cutaneous toxicity. Academic, New York, pp 25–40

    Google Scholar 

  28. Maguire HC Jr (1973) The bioassay of contact allergens in the guinea pig. J Soc Cosmet Chem 24:151–162

    CAS  Google Scholar 

  29. Kligman AM (1966) The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers. J Invest Dermatol 47:393–409. doi:10.1038/jid.1966.67

    PubMed  CAS  Google Scholar 

  30. Shelanski MV, Gabriel L (1961) Cutaneous toxicity evaluation of Air Force development materials – IV. ASD Technical Report 61–77. McGregor & Werner, Inc, Dayton. Contract No. AF 33(616)-6962, Project No. 7165, Task No. 71836

    Google Scholar 

  31. U.S. Environmental Protection Agency, OPPTS Harmonized Test Guidelines Series 870 – Health Effects Test Guidelines (2003) OPPTS 870.2600. Skin Sensitization. EPA 712–C–03–197. http://www.epa.gov/oppts/pubs/frs/publications/Test_Guidelines/series870.htm. Accessed 6 Apr 2010

  32. OECD Guideline for the Testing of Chemicals 406 (1992) Skin sensitization. http://ecb.jrc.ec.europa.eu/testing-methods/annex5/. Accessed 2 Apr 2010

  33. American Society for Testing and Materials (ASTM)-ASTM. Active Standard: D 6355 – 07. Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. http://enterprise.astm.org

  34. Klecak G (1987) Identification of contact allergens: predictive tests in animals. In: Marzulli FN, Maibach HI (eds) Dermatotoxicology, 3rd edn. Hemisphere Publishing, New York, pp 227–276

    Google Scholar 

  35. Andersen KE, Maibach HI (1985) Guinea pig sensitization assays: an overview. In: Andersen KE, Maibach HI (eds) Contact allergy: predictive tests in guinea pigs, vol 14, Current problems in dermatology. Karger, Basel, pp 263–290

    Google Scholar 

  36. Marzulli FN, Maibach HI (1987) Contact allergy: predictive testing in humans. In: Marzulli FN, Maibach HI (eds) Dermatotoxicology, 3rd edn. Hemisphere Publishing, New York, pp 319–340, Alternative ref Marzulli 1976

    Google Scholar 

  37. Hjorth N (1987) Diagnostic patch testing. In: Marzulli FN, Maibach HI (eds) Dermatotoxicology, 3rd edn. Hemisphere Publishing, New York, pp 307–317

    Google Scholar 

  38. McNamee PM, Api AM, Basketter DA, Gerberick GF, Gilpin DA, Hall BM, Jowsey I, Robinson MK (2008) A review of critical factors in the conduct and interpretation of the human repeat insult patch test. Regul Toxicol Pharmacol 54:24–34

    Article  Google Scholar 

  39. OECD Guideline for the Testing of Chemicals 429 (2010) Skin sensitization: local lymph node assay. http://ecb.jrc.ec.europa.eu/testing-methods/annex5/. Accessed 29 Oct 2010

  40. Farage MA (2000) Development of a modified forearm controlled application test method for evaluating the skin mildness of disposable wipe products. J Cosmet Sci 51:153–167

    Google Scholar 

  41. Lukacovic MF, Dunlap FE, Michaels SE, Visscher MO, Watson DD (1988) Forearm wash test to evaluate the mildness of cleansing products. J Soc Cosmet Chem 3(9):355–366

    Google Scholar 

  42. Finkelstein P, Laden K, Meichowski W (1963) New methods for evaluating cosmetic irritancy. J Invest Dermatol 40:11–14

    CAS  Google Scholar 

  43. Hannuksela M, Heikki S (1986) The repeated open application test (ROAT). Contact Dermatitis 14:221–227

    Article  PubMed  CAS  Google Scholar 

  44. Andersen KE (1996) Reproducibility of the chamber scarification test. Contact Dermatitis 43:181–184

    Article  Google Scholar 

  45. Farage MA (2006) The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation. Skin Res Technol 12(2):73–82

    Article  PubMed  Google Scholar 

  46. Bannan EA, Griffith JF, Nusair TL, Sauers LJ (1992) Skin testing of laundered fabrics in the dermal safety assessment of enzyme-containing detergents. J Toxicol Cutan Ocul Toxicol 11(4):327–339

    Article  CAS  Google Scholar 

  47. Rodriguez C, Calvin G, Lally C, Lachapelle JM (1994) Skin effects associated with wearing fabrics washed in commercial laundry detergents. J Toxicol Cutan Ocul Toxicol 13(1):39–45

    Article  Google Scholar 

  48. Frosch PJ, Kligman AM (1979) The soap chamber test; a new method for assessing the irritancy of soaps. J Am Acad Dermatol 1:35–41

    Article  PubMed  CAS  Google Scholar 

  49. Frosch PJ, Kligman AM (1976) The chamber-scarification test for irritancy. Contact Dermatitis 2(6):314–324

    Article  PubMed  CAS  Google Scholar 

  50. Falk M, Anderson C (2010) Reliability of self-assessed reading of skin tests: a possible approach in research and clinical practice? Dermatol Online J 16(2):4

    PubMed  Google Scholar 

  51. Ivens U, Serup J, O’goshi K (2007) Allergy patch test reading from photographic images: disagreement on ICDRG grading but agreement on simplified tripartite reading. Skin Res Technol 13(1):110–113

    Article  PubMed  CAS  Google Scholar 

  52. Uter W, Becker D, Schnuch A, Gefeller O, Frosch PJ (2007) The validity of rating patch test reactions based on digital images. Contact Dermatitis 57:337–342

    Article  PubMed  Google Scholar 

  53. Lock-Andersen J, Wulf HC (1996) Threshold level for measurement of UV sensitivity: reproducibility of phototest. Photodermatol Photoimmunol Photomed 12:154–161

    Article  PubMed  CAS  Google Scholar 

  54. Griffiths HA, Wilhelm K-P, Robinson MK, Wang XM, McFadden J, York M, Basketter DA (1997) Interlaboratory evaluation of a human patch test for the identification of skin irritation potential/hazard. Food Chem Toxicol 35:255–260 (Hard copy)

    Article  PubMed  CAS  Google Scholar 

  55. Basketter D, Reynolds F, Rowson M, Talbot C, Whittle E (1997) Visual assessment of human skin irritation: a sensitive and reproducible tool. Contact Dermatitis 37(5):218–220

    Article  PubMed  CAS  Google Scholar 

  56. Willis CM, Stephens CJ, Wilkinson JD (1988) Assessment of erythema in irritant contact dermatitis. Comparison between visual scoring and laser Doppler flowmetry. Contact Dermatitis 18(3):138–142

    Article  PubMed  CAS  Google Scholar 

  57. Seidenari S, Belletti B (1998) The quantification of patch test responses: a comparison between echographic and colorimetric methods. Acta Derm Venereol 78(5):364–366

    Article  PubMed  CAS  Google Scholar 

  58. Agner T, Serup J (1990) Sodium lauryl sulphate for irritant patch testing—a dose–response study using bioengineering methods for determination of skin irritation. J Invest Dermatol 95(5):543–547

    Article  PubMed  CAS  Google Scholar 

  59. Lahti A, Kopola H, Harila A, Myllylä R, Hannuksela M (1993) Assessment of skin erythema by eye, laser Doppler flowmeter, spectroradiometer, two-channel erythema meter and Minolta chroma meter. Arch Dermatol Res 285(5):278–282

    Article  PubMed  CAS  Google Scholar 

  60. Wahlberg JE (1984) Erythema-inducing effects of solvents following epicutaneous administration to man – studied by laser Doppler flowmetry. Scand J Work Environ Health 10(3):159–162

    Article  PubMed  CAS  Google Scholar 

  61. Babulak SW, Rhein LD, Scala DD, Simion FA, Grove GL (1986) Quantification of erythema in a soap chamber test using the Minolta chroma (reflectance) meter: comparison of instrumental results with visual assessments. J Soc Cosmet Chem 37:475–479

    Google Scholar 

  62. Zuang V, Archer G, Rona C, Vignini M, Mosca M, Berardesca E (2000) Predicting visual assessment of allergic patch test reactions by non-invasive measurements. Skin Pharmacol Appl Skin Physiol 13(1):39–51

    Article  PubMed  CAS  Google Scholar 

  63. Fluhr JW, Kuss O, Diepgen T, Lazzerini S, Pelosi A, Gloor M, Berardesca E (2001) Testing for irritation with a multifactorial approach: comparison of eight non-invasive measuring techniques on five different irritation types. Br J Dermatol 145(5):696–703

    Article  PubMed  CAS  Google Scholar 

  64. Magnusson BM, Koskinen LD (1996) Effects of topical application of capsaicin to human skin: a comparison of effects evaluated by visual assessment, sensation registration, skin blood flow and cutaneous impedance measurements. Acta Derm Venereol 76:129–132

    PubMed  CAS  Google Scholar 

  65. Ollmar S, Nyren M, Nicander I, Emtestam L (1994) Electrical impedance compared with other non-invasive bioengineering techniques and visual scoring for detection of irritation in human skin. Br J Dermatol 130:29–36

    Article  PubMed  CAS  Google Scholar 

  66. Fullerton A, Rode B, Serup J (2002) Skin irritation typing and grading based on laser-Doppler perfusion imaging. Skin Res Technol 8:23–31

    Article  PubMed  Google Scholar 

  67. Wigger-Alberti W, Hinnen U, Elsner P (1997) Predictive testing of metalworking fluids. A comparison of 2 cumulative human irritation models and correlation with epidemiological data. Contact Dermatitis 36:14–20

    Article  PubMed  CAS  Google Scholar 

  68. Held E, Lorentzen H, Agner T, Menné T (1998) Comparison between visual score and erythema index (DermaSpectrometer) in evaluation of allergic patch tests. Skin Res Technol 4(4):188–191

    Article  Google Scholar 

  69. Andersen KE, Straberg B (1985) Quantification of contact allergy in guinea pigs by measuring changes in skin blood flow and skin fold thickness. Acta Derm Venereol 65:37–42

    PubMed  CAS  Google Scholar 

  70. Breternitz M, Fluhr JW, Berardesca E (2006) Technical bases of biophysical instruments used in sensitive skin testing. In: Berardesca E, Fluhr JW, Maibach HI (eds) Sensitive skin syndrome. Taylor & Francis, New York, pp 75–106

    Google Scholar 

  71. Farage MA (2005) Are we reaching the limits or our ability to detect skin effects with our current testing and measuring methods for consumer products? Contact Dermatitis 52(6):297–303

    Article  PubMed  Google Scholar 

  72. Farage MA (2008) Enhancement of visual scoring of skin irritant reactions using cross-polarized light and parallel-polarized light. Contact Dermatitis 58(3):147–155

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The authors are grateful to Drs. F. Ajayi, K.W. Miller, M. Simone, R. Bartolo, and M. Lafranconi for the technical review of this manuscript and to Terresa L. Nusair, Ph.D., of the Health and Environmental Safety Alliance (Cincinnati, Ohio) for technical input.

Author information

Authors and Affiliations

  1. Clinical Sciences Innovation Center, The Procter & Gamble Company, Winton Hill Business Center, 6110 Center Hill Avenue, Cincinnati, OH, 45224, USA

    Miranda A. Farage PhD

  2. Dermatology Department, University of California, San Francisco, CA, USA

    Howard Maibach MD

  3. Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark

    Klaus E. Andersen DMSc

  4. Department of Dermatology, Catholic University of Louvain, Brussels, Belgium

    Jean-Marie Lachapelle MD, PhD

  5. The Procter and Gamble Company, Brussels, Belgium

    Petra Kern PhD

  6. Global Product Surveillance, The Procter & Gamble Company, Mason Business Center, 8700 Mason-Montgomery Rd, Mason, 45040, USA

    Cindy Ryan BS

  7. Global Product Surveillance, The Procter & Gamble Company, Winton Hill Business Center, 6110 Center Hill Avenue, Cincinnati, OH, 45224, USA

    Jeanne Ely BSMD

  8. Global Product Surveillance, The Procter & Gamble Company, Sharon Woods Business Center, 11530 Reed Hartman Highway, Cincinnati, OH, 45224, USA

    Amita Kanti PhD

Authors
  1. Miranda A. Farage PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Howard Maibach MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Klaus E. Andersen DMSc
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jean-Marie Lachapelle MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Petra Kern PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Cindy Ryan BS
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Jeanne Ely BSMD
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Amita Kanti PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Miranda A. Farage PhD .

Editor information

Editors and Affiliations

  1. Clinical Dermatology, San Gallicano Dermatological Institute, Rome, Roma, Italy

    Enzo Berardesca

  2. Dermatology, University of California San Francisco, San Francisco, CA, California, USA

    Howard I. Maibach

  3. Proderm, Schenefeld/Hamburg, Germany

    Klaus-Peter Wilhelm

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer Berlin Heidelberg

About this chapter

Cite this chapter

Farage, M.A. et al. (2014). The Use of Visual Grading Scales in Evaluating Skin Irritation and Sensitization: A Historical Perspective. In: Berardesca, E., Maibach, H., Wilhelm, KP. (eds) Non Invasive Diagnostic Techniques in Clinical Dermatology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32109-2_34

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-32109-2_34

  • Published:

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-32108-5

  • Online ISBN: 978-3-642-32109-2

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation