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Titolo:
Skin sensitization testing in potency and risk assessment
Autore:
Kimber, I; Basketter, DA; Berthold, K; Butler, M; Garrigue, JL; Lea, L; Newsome, C; Roggeband, R; Steiling, W; Stropp, G; Waterman, S; Wiemann, C;
Indirizzi:
Zeneca Cent Toxicol Lab, Macclesfield SK10 4TJ, Cheshire, England Zeneca Cent Toxicol Lab Macclesfield Cheshire England SK10 4TJ e, England Unilever Res Labs Vlaardingen, SEAC Toxicol Unit, Sharnbrook MK44 1LQ, Beds, England Unilever Res Labs Vlaardingen Sharnbrook Beds England MK44 1LQ s, England Asta Med, D-33790 Halle, Germany Asta Med Halle Germany D-33790Asta Med, D-33790 Halle, Germany ECETOC, B-1160 Brussels, Belgium ECETOC Brussels Belgium B-1160ECETOC, B-1160 Brussels, Belgium LOreal Rech, F-93601 Aulnay Sous Bois, France LOreal Rech Aulnay Sous Bois France F-93601 601 Aulnay Sous Bois, France Union Carbide Benelux NV, B-2030 Antwerp, Belgium Union Carbide Benelux NV Antwerp Belgium B-2030 B-2030 Antwerp, Belgium Procter & Gamble Co, B-1853 Strombeek Bever, Belgium Procter & Gamble Co Strombeek Bever Belgium B-1853 ombeek Bever, Belgium Henkel KGAA, D-40191 Dusseldorf, Germany Henkel KGAA Dusseldorf Germany D-40191 KGAA, D-40191 Dusseldorf, Germany Bayer AG, D-42096 Wuppertal, Germany Bayer AG Wuppertal Germany D-42096Bayer AG, D-42096 Wuppertal, Germany Exxon Biomed Sci Inc, E Millstone, NJ 08875 USA Exxon Biomed Sci Inc E Millstone NJ USA 08875 , E Millstone, NJ 08875 USA BASF Aktiengessell, D-67056 Ludwigshafen, Germany BASF Aktiengessell Ludwigshafen Germany D-67056 56 Ludwigshafen, Germany
Titolo Testata:
TOXICOLOGICAL SCIENCES
fascicolo: 2, volume: 59, anno: 2001,
pagine: 198 - 208
SICI:
1096-6080(200102)59:2<198:SSTIPA>2.0.ZU;2-5
Fonte:
ISI
Lingua:
ENG
Soggetto:
LYMPH-NODE ASSAY; PIG MAXIMIZATION TEST; ALLERGIC CONTACT SENSITIZATION; FALSE-POSITIVE RESPONSES; PREDICTIVE TEST METHODS; GUINEA-PIG; CELL; PRODUCTS; AGENTS; SENSITIVITY;
Keywords:
skin sensitization; sensitization potency; risk assessment; guinea pig tests; local lymph node assay; human sensitization;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
76
Recensione:
Indirizzi per estratti:
Indirizzo: Kimber, I Zeneca Cent Toxicol Lab, Alderley Pk, Macclesfield SK10 4TJ, Cheshire, England Zeneca Cent Toxicol Lab Alderley Pk Macclesfield Cheshire England SK10 4TJ
Citazione:
I. Kimber et al., "Skin sensitization testing in potency and risk assessment", TOXICOL SCI, 59(2), 2001, pp. 198-208

Abstract

The purpose of this article is to review, and make recommendations for, the use of relevant skin sensitization test methods, for the purposes of determination of relative potency and the threshold dose necessary for the induction of skin sensitization, and for risk assessment, In addressing the first area, the utility of three guinea pig tests (the guinea pig maximizationtest, the occluded patch test, and the open epicutaneous test) of the local lymph node assay (LLNA) and of human volunteer testing for the assessmentof relative potency and identification of thresholds for sensitization were considered. The following conclusions were drawn. (1) Although attempts have been made to modify the guinea pig maximization test for the purposes of deriving dose-response relationships, this method is usually unsuitable for determination of relative sensitizing potency. (2) Guinea pig methods that do not require the use of adjuvant and which employ a relevant route of exposure (the occluded patch test and the open epicutaneous test) are more appropriate for the assessment of relative skin-sensitizing potency. (3) The LLNA is suitable for the determination of relative skin sensitizing potency, and the adaptation of this method for derivation of comparative criteria such as EC3 values (the estimated concentration of test chemical requiredto induce a stimulation index of 3 in the LLNA) provides an effective and quantitative basis for such measurements, (4) For all the methods identified above, potency is assessed relative to other chemical allergens of known skin sensitizing potential. The estimation of likely threshold concentrations is dependent upon the availability of suitable benchmark chemicals of known potency for human sensitization. (5) Human testing (and specifically, the Human Repeat Insult Patch Test) can provide information of value in confirming the absence of skin sensitizing activity of formulations and products under specific conditions of use and exposure. Based on the above, the following recommendations are made. (1) If results are already available fromsuitable guinea pig tests, then judicious interpretation of the data may provide information of value in assessing relative skin sensitizing potency. This option should be explored before other analyses are conducted. (2) The LLNA is the recommended method for new assessments of relative potency, and/or for the investigation of the influence of vehicle or formulation on skin sensitizing potency. (3) Whenever available, human skin sensitization data should be incorporated into an assessment of relative potency. With respect to risk assessment, the conclusion drawn is that all the available data on skin-sensitizing activity in animals and man should be integrated intothe risk-assessment process. Appropriate interpretation of existing data from suitable guinea pig studies can provide valuable information with respect to potency, as the first step in the development of a risk assessment. However, for de novo investigations, the LLNA is the method favored for providing quantitative estimations of skin-sensitizing potency that are best suited to the risk assessment process. Finally, human testing is of value in the risk assessment process, but is performed only for the purposes of confirming product safety.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/04/20 alle ore 00:10:49