Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo

ABSTRACT: To prevent the potential risk of dermal irritability from a cream and a lotion for babies, in order to obtain health registration and to reduce possible health risks. Methods: in vivo predictive bioanalysis of dermal tolerance carried out in rabbits through a qualitative and histopathologi...

Full description

Autores:
Tobón Marulanda, Flor Ángela
López Giraldo, Luis Alirio
Ramírez Villegas, John Fernando
Tipo de recurso:
Article of investigation
Fecha de publicación:
2013
Institución:
Universidad de Antioquia
Repositorio:
Repositorio UdeA
Idioma:
spa
OAI Identifier:
oai:bibliotecadigital.udea.edu.co:10495/6038
Acceso en línea:
http://hdl.handle.net/10495/6038
Palabra clave:
Cosméticos
Rights
openAccess
License
http://creativecommons.org/licenses/by-nc-nd/2.5/co/
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dc.title.spa.fl_str_mv Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
dc.title.translated.spa.fl_str_mv Predictive bioanalysis of skin tolerance of cosmetics for babies in vivo
title Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
spellingShingle Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
Cosméticos
title_short Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
title_full Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
title_fullStr Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
title_full_unstemmed Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
title_sort Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo
dc.creator.fl_str_mv Tobón Marulanda, Flor Ángela
López Giraldo, Luis Alirio
Ramírez Villegas, John Fernando
dc.contributor.author.none.fl_str_mv Tobón Marulanda, Flor Ángela
López Giraldo, Luis Alirio
Ramírez Villegas, John Fernando
dc.contributor.researchgroup.spa.fl_str_mv Grupo de Investigación de Tecnología en Regencia de Farmacia
Unipluriversidad
dc.subject.none.fl_str_mv Cosméticos
topic Cosméticos
description ABSTRACT: To prevent the potential risk of dermal irritability from a cream and a lotion for babies, in order to obtain health registration and to reduce possible health risks. Methods: in vivo predictive bioanalysis of dermal tolerance carried out in rabbits through a qualitative and histopathological clinical exploratory-type study, based on the Lex Artis approach to explain the comparable risk/effectiveness in humans. There was applied the single acute exposure technique (occlusive patch test) in six rabbits to test each product. Dermal effects were then measured in a value scale defining the cosmetic exposure-attributed unsafeness probabilities, according to the dermal toxicity test of the Organization for Economic Cooperation and Development, with some modifications by the authors. Results: the bioanalysis found some dermal irritability in the rabbits' skin after using the single dose of cosmetic for 92 days. The clinical study was supplemented with the histopathological analysis of a sample of irritated skin, without significant changes other than those observed. Conclusions: the clinical and hisopathological analysis showed mild to negligible dermal irritability, which indicates the need for improvements to the formulation of the studied cosmetics in order to obtain the health registration and thus to early advise the manufacturer and the community about the safety and efficacy of products.
publishDate 2013
dc.date.issued.none.fl_str_mv 2013
dc.date.accessioned.none.fl_str_mv 2017-01-26T22:51:59Z
dc.date.available.none.fl_str_mv 2017-01-26T22:51:59Z
dc.type.spa.fl_str_mv Artículo de investigación
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dc.identifier.citation.spa.fl_str_mv Tobón Marulanda, F. Á., López Giraldo, L. A., & Ramírez Villegas, J. F. (2013). Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo. Revista Cubana de Farmacia, 47(2), 193–204.
dc.identifier.issn.none.fl_str_mv 0034-7515
dc.identifier.uri.none.fl_str_mv http://hdl.handle.net/10495/6038
dc.identifier.eissn.none.fl_str_mv 1561-2988
identifier_str_mv Tobón Marulanda, F. Á., López Giraldo, L. A., & Ramírez Villegas, J. F. (2013). Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo. Revista Cubana de Farmacia, 47(2), 193–204.
0034-7515
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dc.relation.citationstartpage.spa.fl_str_mv 193
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dc.relation.ispartofjournal.spa.fl_str_mv Revista Cubana de Farmacia
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spelling Tobón Marulanda, Flor ÁngelaLópez Giraldo, Luis AlirioRamírez Villegas, John FernandoGrupo de Investigación de Tecnología en Regencia de FarmaciaUnipluriversidad2017-01-26T22:51:59Z2017-01-26T22:51:59Z2013Tobón Marulanda, F. Á., López Giraldo, L. A., & Ramírez Villegas, J. F. (2013). Bioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivo. Revista Cubana de Farmacia, 47(2), 193–204.0034-7515http://hdl.handle.net/10495/60381561-2988ABSTRACT: To prevent the potential risk of dermal irritability from a cream and a lotion for babies, in order to obtain health registration and to reduce possible health risks. Methods: in vivo predictive bioanalysis of dermal tolerance carried out in rabbits through a qualitative and histopathological clinical exploratory-type study, based on the Lex Artis approach to explain the comparable risk/effectiveness in humans. There was applied the single acute exposure technique (occlusive patch test) in six rabbits to test each product. Dermal effects were then measured in a value scale defining the cosmetic exposure-attributed unsafeness probabilities, according to the dermal toxicity test of the Organization for Economic Cooperation and Development, with some modifications by the authors. Results: the bioanalysis found some dermal irritability in the rabbits' skin after using the single dose of cosmetic for 92 days. The clinical study was supplemented with the histopathological analysis of a sample of irritated skin, without significant changes other than those observed. Conclusions: the clinical and hisopathological analysis showed mild to negligible dermal irritability, which indicates the need for improvements to the formulation of the studied cosmetics in order to obtain the health registration and thus to early advise the manufacturer and the community about the safety and efficacy of products.RESUMEN: Prever el riesgo potencial de irritabilidad dérmica de una crema y una loción para bebés, con el fin de obtener el registro sanitario y disminuir la eventualidad de riesgo para la salud. Métodos: se realizó el bioanálisis predictivo de tolerancia dérmica in vivo en conejos, a través de un estudio de tipo exploratorio clínico cualitativo e histopatológico, basado en el enfoque de la ley del Arte para explicar el riesgo/efectividad comparable en humanos. Se aplicó la técnica de exposición aguda simple (prueba parche oclusivo) en seis conejos, por cada producto. Se estimaron los efectos dérmicos mediante una escala de valores que define la probabilidad de inseguridad atribuible por la exposición al cosmético, según prueba de toxicidad dérmica de la Organización para la Cooperación Económica y Desarrollo 2004 (OCED), con ciertas modificaciones por los autores. Resultados: en el bioanálisis se encontró cierta irritabilidad dérmica en la piel de los conejos al aplicarles el cosmético en una dosis única por 92 días. El estudio clínico se complementó con el análisis histopatológico de una muestra de piel irritada y no mostró cambios significativos a los observados.Conclusiones: el bioanálisis clínico e histopatológico permite inferir una irritabilidad dérmica entre insignificante y leve, lo que sugiere la necesidad de mejorar la formulación de los cosméticos estudiados para obtener el registro sanitario, y así alertar tempranamente al productor y a la comunidad de la seguridad y eficacia de los productos.12application/pdfspaEditorial Ciencias MédicasCubahttp://creativecommons.org/licenses/by-nc-nd/2.5/co/https://creativecommons.org/licenses/by-nc-nd/4.0/Atribución-NoComercial-SinDerivadas 2.5info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2CosméticosBioanálisis predictivo de tolerancia dérmica de cosméticos para bebés in vivoPredictive bioanalysis of skin tolerance of cosmetics for babies in vivoArtículo de investigaciónhttp://purl.org/coar/resource_type/c_2df8fbb1https://purl.org/redcol/resource_type/ARThttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionRev. cuba. farm.204219347Revista Cubana de FarmaciaPublicationORIGINALTobonFlor_2013_BioanalisisDermicaCosmeticos.pdfTobonFlor_2013_BioanalisisDermicaCosmeticos.pdfArtículo de investigaciónapplication/pdf174367https://bibliotecadigital.udea.edu.co/bitstreams/b8ddee25-38de-4f66-8283-25ee67f9f38b/download9717f0bf13021207511951ac4fae92edMD51trueAnonymousREADCC-LICENSElicense_urllicense_urltext/plain; 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