Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives

Detalhes bibliográficos
Autor(a) principal: Canavez, Andrezza Di Pietro Micali
Data de Publicação: 2021
Outros Autores: de Oliveira Prado Corrêa, Gabriela [UNESP], Isaac, Vera Lucia Borges [UNESP], Schuck, Desiree Cigaran, Lorencini, Marcio
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1002/jat.4156
http://hdl.handle.net/11449/208440
Resumo: The safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst-case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.
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spelling Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservativescosmetic preservativesexposure assessmenthazard assessmentrisk characterizationsafety evaluationThe safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst-case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.Department of Safety Assessment Grupo BoticárioSchool of Pharmaceutical Sciences UNESP - Univ Estadual PaulistaSchool of Pharmaceutical Sciences UNESP - Univ Estadual PaulistaGrupo BoticárioUniversidade Estadual Paulista (Unesp)Canavez, Andrezza Di Pietro Micalide Oliveira Prado Corrêa, Gabriela [UNESP]Isaac, Vera Lucia Borges [UNESP]Schuck, Desiree CigaranLorencini, Marcio2021-06-25T11:12:13Z2021-06-25T11:12:13Z2021-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1002/jat.4156Journal of Applied Toxicology.1099-12630260-437Xhttp://hdl.handle.net/11449/20844010.1002/jat.41562-s2.0-85101320140Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJournal of Applied Toxicologyinfo:eu-repo/semantics/openAccess2021-10-23T19:02:10Zoai:repositorio.unesp.br:11449/208440Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462021-10-23T19:02:10Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
title Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
spellingShingle Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
Canavez, Andrezza Di Pietro Micali
cosmetic preservatives
exposure assessment
hazard assessment
risk characterization
safety evaluation
title_short Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
title_full Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
title_fullStr Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
title_full_unstemmed Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
title_sort Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives
author Canavez, Andrezza Di Pietro Micali
author_facet Canavez, Andrezza Di Pietro Micali
de Oliveira Prado Corrêa, Gabriela [UNESP]
Isaac, Vera Lucia Borges [UNESP]
Schuck, Desiree Cigaran
Lorencini, Marcio
author_role author
author2 de Oliveira Prado Corrêa, Gabriela [UNESP]
Isaac, Vera Lucia Borges [UNESP]
Schuck, Desiree Cigaran
Lorencini, Marcio
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Grupo Boticário
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Canavez, Andrezza Di Pietro Micali
de Oliveira Prado Corrêa, Gabriela [UNESP]
Isaac, Vera Lucia Borges [UNESP]
Schuck, Desiree Cigaran
Lorencini, Marcio
dc.subject.por.fl_str_mv cosmetic preservatives
exposure assessment
hazard assessment
risk characterization
safety evaluation
topic cosmetic preservatives
exposure assessment
hazard assessment
risk characterization
safety evaluation
description The safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst-case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.
publishDate 2021
dc.date.none.fl_str_mv 2021-06-25T11:12:13Z
2021-06-25T11:12:13Z
2021-01-01
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1002/jat.4156
Journal of Applied Toxicology.
1099-1263
0260-437X
http://hdl.handle.net/11449/208440
10.1002/jat.4156
2-s2.0-85101320140
url http://dx.doi.org/10.1002/jat.4156
http://hdl.handle.net/11449/208440
identifier_str_mv Journal of Applied Toxicology.
1099-1263
0260-437X
10.1002/jat.4156
2-s2.0-85101320140
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Journal of Applied Toxicology
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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