Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials.
Regul Toxicol Pharmacol
; 118: 104805, 2020 Dec.
Article
em En
| MEDLINE
| ID: mdl-33075411
ABSTRACT
In 2008, a proposal for assessing the risk of induction of skin sensitization to fragrance materials Quantitative Risk Assessment 1 (QRA1) was published. This was implemented for setting maximum limits for fragrance materials in consumer products. However, there was no formal validation or empirical verification after implementation. Additionally, concerns remained that QRA1 did not incorporate aggregate exposure from multiple product use and included assumptions, e.g. safety assessment factors (SAFs), that had not been critically reviewed. Accordingly, a review was undertaken, including detailed re-evaluation of each SAF together with development of an approach for estimating aggregate exposure of the skin to a potential fragrance allergen. This revision of QRA1, termed QRA2, provides an improved method for establishing safe levels for sensitizing fragrance materials in multiple products to limit the risk of induction of contact allergy. The use of alternative non-animal methods is not within the scope of this paper. Ultimately, only longitudinal clinical studies can verify the utility of QRA2 as a tool for the prevention of contact allergy to fragrance materials.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Pele
/
Alérgenos
/
Dermatite Alérgica de Contato
/
Testes de Irritação da Pele
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Odorantes
Tipo de estudo:
Etiology_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2020
Tipo de documento:
Article