Determination of skin irritation potential in the human 4-h patch test

Contact Dermatitis

Volumn 51, Issue 1, 2004, Pages 1-4

  Basketter, David A ^a   York, Michael ^a   McFadden, John P ^b   Robinson, Michael K ^c  

^a UNILEVER RESEARCH   (United Kingdom)

^b ST THOMAS HOSPITAL   (United Kingdom)

^c PROCTER AND GAMBLE COMPANY   (United States)

Author keywords

Human 4 h patch test; Regulatory toxicology; Skin irritation hazard; Visual assessment

Indexed keywords

CLINICAL PROTOCOL; CORRELATION ANALYSIS; DATA ANALYSIS; DATA BASE; EUROPE; FISHER EXACT TEST; HEALTH HAZARD; HUMAN; LAW; MOTIVATION; PATCH TEST; QUALITY CONTROL; RATING SCALE; REVIEW; STATISTICAL SIGNIFICANCE; TOXICITY TESTING;

ANIMAL TESTING ALTERNATIVES; DATABASES, FACTUAL; DERMATITIS, IRRITANT; HUMANS; IRRITANTS; PATCH TESTS; RETROSPECTIVE STUDIES; SKIN IRRITANCY TESTS;

EID: 4344622552     PISSN: 01051873     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.0105-1873.2004.00385.x     Document Type: Review

References (20)

1. EC Annex to Commission Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Off J Eur Communities 1992: L383A: 35.
2. EC Council regulation EEC No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. Off J Eur Communities 1993: L84: 1.
3. EC Council Directive of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Off J Eur Communities 1998: L18: 14.
4. Draize J H, Woodard G, Calvery H O. Methods for the study of imitation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 1944: 82: 377-390.
5. Draize J H. Dermal Toxicity. In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Littleton, CO, Association of Foods and Drugs Officials of the United States, 1959: 46-59.
6. Basketter D A. Strategic hierarchical approaches in acute toxicity testing. Toxicol Vitro 1994: 8: 855-859.
7. Basketter D A, Whittle E, Griffiths H A, York M. The identification and classification of skin irritation hazard by human patch test. Food Chem Toxicol 1994: 32: 769-775.
8. Basketter D A, Whittle E, Chamberlain M. Identification of irritation and corrosion hazards to skin: an alternative strategy to animal testing. Food Chem Toxicol 1994: 32: 539-542.
9. York M, Griffiths H A, Whittle E, Basketter D A. Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis 1996: 34: 204-212.
10. Basketter D A, Chamberlain M, Griffiths H A, York M. The classification of skin irritants by human patch test. Food Chem Toxicol 1997: 35: 845-852.
11. Rougier A, Goldberg A M, Maibach H I. In: Vitro Skin Toxicology. New York, Liebert Inc., 1994.
12. Balls M, Blaauboer B, Fentem J H et al. Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM Workshop 5. Alternatives Lab Anim 1995: 23: 398-409.
13. Griffiths H A, Wilhelm K-P, Robinson M K, York M, Basketter D A. Interlaboratory evaluation of a human 4-h patch test for the evaluation of skin irritation potential/hazard. Food Chem Toxicol 1996: 35: 255-260.
14. Basketter D A, Griffiths H A, Wang X M, Wilhelm K-P, McFadden J. Individual, ethnic and seasonal variability in irritant susceptibility of skin: the implications for a predictive human patch test. Contact Dermatitis 1996: 35: 208-213.
15. Basketter D A, Blaikie L, Reynolds F. The impact of atopy on a predictive test of acute skin irritation potential. Contact Dermatitis 1996: 35: 33-39.
16. McFadden J, Wakelin S, Basketter D A. Irritant thresholds in Type I-VI skin. Contact Dermatitis 1997: 38: 147-149.
17. Robinson M K, Perkins M A, Basketter D A. Application of a four hour human patch test method for comparative and investigative assessment of skin irritation. Contact Dermatitis 1998: 38: 194-202.
18. Robinson M K, Whittle E, Basketter D A. A two center study of the development of acute irritation responses to fatty acids. Am J Contact Dermatitis, 1999: 10: 136-145.
19. Robinson M K, McFadden J P, Basketter D A. Validity and ethics of the human 4 hour patch test as an alternative method to assess acute skin irritation potential. Contact Dermatitis 2001: 45: 1-12.
20. EEC, 1967. EC Directive, 67/548/EEC, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances. L196 (16-08-1967). Amended for the seventh time by 92/32/EEC. Off J Eur Communities 1992: L1540.