Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose
Joint Authors
Raposo, Sara
Salgado, Ana
Gonçalves, Lídia
Pinto, Pedro C.
Urbano, Manuela
Ribeiro, Helena M.
Source
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-11-05
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions.
A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product.
The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion).
The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient.
EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data.
The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days.
According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53).
EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin.
The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use.
Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.
American Psychological Association (APA)
Raposo, Sara& Salgado, Ana& Gonçalves, Lídia& Pinto, Pedro C.& Urbano, Manuela& Ribeiro, Helena M.. 2013. Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose. BioMed Research International،Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-1003631
Modern Language Association (MLA)
Raposo, Sara…[et al.]. Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose. BioMed Research International No. 2013 (2013), pp.1-10.
https://search.emarefa.net/detail/BIM-1003631
American Medical Association (AMA)
Raposo, Sara& Salgado, Ana& Gonçalves, Lídia& Pinto, Pedro C.& Urbano, Manuela& Ribeiro, Helena M.. Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose. BioMed Research International. 2013. Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-1003631
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1003631