Standardisation and international adoption of defined approaches for skin sensitisation
In the absence of stand-alone one-to-one replacements for existing animal tests, efforts were made to integrate data from in silico, in chemico and in vitro methods to ensure sufficient mechanistic coverage of the skin sensitisation Adverse Outcome Pathway (AOP) and generate predictions suitable for...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-08-01
|
| Series: | Frontiers in Toxicology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/ftox.2022.943152/full |
| _version_ | 1811217410418540544 |
|---|---|
| author | Silvia Casati David Asturiol Patience Browne Nicole Kleinstreuer Michèle Régimbald-Krnel Pierre Therriault |
| author_facet | Silvia Casati David Asturiol Patience Browne Nicole Kleinstreuer Michèle Régimbald-Krnel Pierre Therriault |
| author_sort | Silvia Casati |
| collection | DOAJ |
| description | In the absence of stand-alone one-to-one replacements for existing animal tests, efforts were made to integrate data from in silico, in chemico and in vitro methods to ensure sufficient mechanistic coverage of the skin sensitisation Adverse Outcome Pathway (AOP) and generate predictions suitable for hazard identification and potency sub-categorisation. A number of defined approaches (DAs), using fixed data interpretation procedures (DIP) to integrate data from multiple non-animal information sources, were proposed and documented using a standard reporting template developed by the Organisation for Economic Co-operation and Development (OECD). Subsequent international activities focused on the extensive characterisation of three of these DAs with respect to the reference in vivo data, applicability domains, limitations, predictive performances and characterisations of the level of confidence associated with the predictions. The ultimate product of this project was an OECD Guideline that provides information equivalent to that provided by the animal studies and that can be used to satisfy countries’ regulatory data requirements for skin sensitisation. This Defined Approach Guideline was the first of its kind for the OECD, and provides an important precedent for regulatory adoption of human biology-relevant new approach methodologies with performances equivalent to, or better than, traditional animal tests. This mini review summarizes the principal features of the defined approaches described in OECD guideline 497. |
| first_indexed | 2024-04-12T06:54:39Z |
| format | Article |
| id | doaj.art-405e5bdae3ed4a38a4f1a1b537b6a45d |
| institution | Directory Open Access Journal |
| issn | 2673-3080 |
| language | English |
| last_indexed | 2024-04-12T06:54:39Z |
| publishDate | 2022-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Toxicology |
| spelling | doaj.art-405e5bdae3ed4a38a4f1a1b537b6a45d2022-12-22T03:43:12ZengFrontiers Media S.A.Frontiers in Toxicology2673-30802022-08-01410.3389/ftox.2022.943152943152Standardisation and international adoption of defined approaches for skin sensitisationSilvia Casati0David Asturiol1Patience Browne2Nicole Kleinstreuer3Michèle Régimbald-Krnel4Pierre Therriault5European Commission, Joint Research Centre (JRC), Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), Ispra, ItalyOECD Environment Directorate, Environment Health and Safety Division, Paris, FranceNIH/NIEHS/DNTP/The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, Research Triangle Park, Durham, NC, United StatesEnvironmental Health Science and Research Bureau, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, ON, CanadaHealth Effects Division, Pest Management Regulatory Agency, Health Canada, Ottawa, ON, CanadaIn the absence of stand-alone one-to-one replacements for existing animal tests, efforts were made to integrate data from in silico, in chemico and in vitro methods to ensure sufficient mechanistic coverage of the skin sensitisation Adverse Outcome Pathway (AOP) and generate predictions suitable for hazard identification and potency sub-categorisation. A number of defined approaches (DAs), using fixed data interpretation procedures (DIP) to integrate data from multiple non-animal information sources, were proposed and documented using a standard reporting template developed by the Organisation for Economic Co-operation and Development (OECD). Subsequent international activities focused on the extensive characterisation of three of these DAs with respect to the reference in vivo data, applicability domains, limitations, predictive performances and characterisations of the level of confidence associated with the predictions. The ultimate product of this project was an OECD Guideline that provides information equivalent to that provided by the animal studies and that can be used to satisfy countries’ regulatory data requirements for skin sensitisation. This Defined Approach Guideline was the first of its kind for the OECD, and provides an important precedent for regulatory adoption of human biology-relevant new approach methodologies with performances equivalent to, or better than, traditional animal tests. This mini review summarizes the principal features of the defined approaches described in OECD guideline 497.https://www.frontiersin.org/articles/10.3389/ftox.2022.943152/fulldefined approachesinternational harmonisationmechanistic relevanceadverse outcome pathwaynon-animal alternative methods |
| spellingShingle | Silvia Casati David Asturiol Patience Browne Nicole Kleinstreuer Michèle Régimbald-Krnel Pierre Therriault Standardisation and international adoption of defined approaches for skin sensitisation Frontiers in Toxicology defined approaches international harmonisation mechanistic relevance adverse outcome pathway non-animal alternative methods |
| title | Standardisation and international adoption of defined approaches for skin sensitisation |
| title_full | Standardisation and international adoption of defined approaches for skin sensitisation |
| title_fullStr | Standardisation and international adoption of defined approaches for skin sensitisation |
| title_full_unstemmed | Standardisation and international adoption of defined approaches for skin sensitisation |
| title_short | Standardisation and international adoption of defined approaches for skin sensitisation |
| title_sort | standardisation and international adoption of defined approaches for skin sensitisation |
| topic | defined approaches international harmonisation mechanistic relevance adverse outcome pathway non-animal alternative methods |
| url | https://www.frontiersin.org/articles/10.3389/ftox.2022.943152/full |
| work_keys_str_mv | AT silviacasati standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation AT davidasturiol standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation AT patiencebrowne standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation AT nicolekleinstreuer standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation AT micheleregimbaldkrnel standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation AT pierretherriault standardisationandinternationaladoptionofdefinedapproachesforskinsensitisation |