2012
DOI: 10.1016/j.yrtph.2012.05.004
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Decision trees for evaluating skin and respiratory sensitizing potential of chemicals in accordance with European regulations

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Cited by 8 publications
(10 citation statements)
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“…Regulatory authorities require safety profile of chemicals, pharmaceuticals, and personal care products before they are available for public use [3]. There is no generally accepted in vitro cell culture model for assessing respiratory irritation [4]. The Draize rabbit eye test has been the standard test accepted by regulatory authorities for assessment and classification of the capacity of chemicals to damage the mucosa of the eye [5].…”
Section: Introductionmentioning
confidence: 99%
“…Regulatory authorities require safety profile of chemicals, pharmaceuticals, and personal care products before they are available for public use [3]. There is no generally accepted in vitro cell culture model for assessing respiratory irritation [4]. The Draize rabbit eye test has been the standard test accepted by regulatory authorities for assessment and classification of the capacity of chemicals to damage the mucosa of the eye [5].…”
Section: Introductionmentioning
confidence: 99%
“…Alternatively, if appropriate in vitro methods and/or in silico (i.e. computational) tools become available, the fragrance material can be evaluated and the results compared with available read-across data (Enoch et al, 2010, Veith, 2009, Kimber, 2001, Abraham, 1998a, Abraham, 1998b, Enoch, 2009, Selgrade, 2012. If no appropriate analogs are identified or if no in vitro or in silico evaluations can be done, the material moves to Step 3.…”
Section: Usingmentioning
confidence: 99%
“…With the primary exception of nickel as mentioned above, no widely accepted, validated methods currently allow quantitative ACDER assessments and comparisons that address all or most currently identified human sensitizers using methods validated against human patch test data, and this has been an active area of scientific development . Guinea pig tests (e.g., the guinea pig maximization test, the occluded path test, and the open epicutaneous test), the mouse local lymph node assay (LLNA), and human volunteer patch testing can all contribute to the assessment of relative sensitization potency, with LLNA being the most accessible method to generate in vivo experimental data for new chemicals of interest and the currently validated method of choice for sensitizer hazard identification and characterization . For example, quantitative log–log correlations (with R 2 values of ∼0.75–0.80) are observed between “sensitization potency” estimates obtained from LLNA results (as “EC3” values representing concentration “thresholds” each estimated to yield a three‐fold elevation above measured background lymph‐node proliferative activity), and those obtained from human repeated insult patch test (HRIPT) and/or human maximization test (HMT) results (as “threshold” concentrations estimated to elicit a sensitization reaction in 5% of tested individuals) .…”
Section: Introductionmentioning
confidence: 99%
“…For example, quantitative log–log correlations (with R 2 values of ∼0.75–0.80) are observed between “sensitization potency” estimates obtained from LLNA results (as “EC3” values representing concentration “thresholds” each estimated to yield a three‐fold elevation above measured background lymph‐node proliferative activity), and those obtained from human repeated insult patch test (HRIPT) and/or human maximization test (HMT) results (as “threshold” concentrations estimated to elicit a sensitization reaction in 5% of tested individuals) . Although advantageous compared to other sensitization tests because the LLNA provides quantitative end points, data characterizing dose–response relationships, and a proposed basis for “potency” prediction, applications of this assay remain focused on qualitative assignment of different tested chemicals into categories of (e.g., weak vs. moderate vs. strong vs. extreme) capacity to induce the sensitization phase of ACD . Data from in vitro assays can also be used to assess or classify skin sensitizing potency, such as the direct peptide reactivity assay of relative ability of chemicals to react with or modify skin proteins; in vitro (e.g., the human Cell Line Activation Test (h‐CLAT)) assays of dendritic cell (DC) or DC surrogate cell surface marker induction; in vitro (e.g., Keratinosens TM ) measures of oxidative stress‐related Nrf2‐mediated antioxidant response element activation or related keratinocyte or DC cytotoxicity or cytokine (e.g., IL‐18) release; more recently developed Genomic Allergen Rapid Detection (GARD), EpiSenseA, SENS‐IS assays of ACD‐related gene expression, as well as quantitative structure‐activity relationship (QSAR) modeling methods correlated with such in vitro measures and/or with in vivo (e.g., HRIPT or HMT) assays of sensitizing potency …”
Section: Introductionmentioning
confidence: 99%
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