Dermal sensitization quantitative risk assessment (QRA) for fragrance ingredients

Api, A.M.; Basketter, David A.; Cadby, Peter A.; Cano, Marie-France; Ellis, Graham; Gerberick, G. Frank; Griem, Peter; Maiello, Pauline; Ryan, Cindy A.; Safford, R.J.

doi:10.1016/j.yrtph.2007.10.008

Cited by 269 publications

(157 citation statements)

References 72 publications

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“…In this regard, animal data is consistent with human clinical data . These observations are consistent with the immunological mechanism presented with this AOP, where it is assumed that for an adverse outcome to commence, a certain number of dendritic cells is required to be activated and to migrate to the nearest lymph node in order to instigate the further cascade of biological events (see Api et al, 2008).…”

Section: Steps 9-11; In Vivo Skin Sensitisationsupporting

confidence: 87%

The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins

2014

OECD Series on Testing and Assessment

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Complete document available on OLIS in its original formatThis document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area. No. 1, Guidance Document for the Development of OECD Guidelines for Testing of Chemicals (1993; reformatted 1995, revised 2006 No. 2, Detailed Review Paper on Biodegradability Testing (1995) No. 3, Guidance Document for Aquatic Effects Assessment (1995) No. HPV Chemicals, 5-6 July Bern Switzerland (2007) No. 85

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Section: Steps 9-11; In Vivo Skin Sensitisationsupporting

confidence: 87%

The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins

2014

OECD Series on Testing and Assessment

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“…Success, therefore, will be the development of a non-animal approach that provides a basis for reliable hazard and risk assessments of at least comparable accuracy to those afforded by the of accurate risk assessments (Api et al, 2008;Rovida, 2011). However, it has to be acknowledged that, as with all test methods, the LLNA is not without limitations.…”

Section: Special Research Areasmentioning

confidence: 99%

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

Basketter

Clewell

Kimber

et al. 2012

ALTEX

203

165

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“…First, as has already been proposed by both industry (38) and regulatory (39) expert groups, potency data can lead to improvements in hazard classification and thus risk management. Second, potency data can facilitate improved risk assessments for skin sensitization (40)(41)(42)(43)(44). Both of these are in our highly desirable goals, but the details fall outside the remit of this article, which is simply to discuss the status of validation of EC3 potency determinations in the LLNA.…”

Section: Llna Ec3 Database and Its Applicationmentioning

confidence: 99%

The local lymph node assay and the assessment of relative potency: status of validation

2007

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For the prediction of skin sensitization potential, the local lymph node assay (LLNA) is a fully validated alternative to guinea-pig tests. More recently, information from LLNA dose-response analyses has been used to assess the relative potency of skin sensitizing chemicals. These data are then deployed for risk assessment and risk management. In this commentary, the utility and validity of these relative potency measurements are reviewed. It is concluded that the LLNA does provide a valuable assessment of relative sensitizing potency in the form of the estimated concentration of a chemical required to produce a threefold stimulation of draining lymph node cell proliferation compared with concurrent controls (EC3 value) and that all reasonable validation requirements have been addressed successfully. EC3 measurements are reproducible in both intra-and interlaboratory evaluations and are stable over time. It has been shown also, by several independent groups, that EC3 values correlate closely with data on relative human skin sensitization potency. Consequently, the recommendation made here is that LLNA EC3 measurements should now be regarded as a validated method for the determination of the relative potency of skin sensitizing chemicals, a conclusion that has already been reached by a number of independent expert groups.

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Dermal sensitization quantitative risk assessment (QRA) for fragrance ingredients

Cited by 269 publications

References 72 publications

The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins

The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

The local lymph node assay and the assessment of relative potency: status of validation

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