scholarly journals Comparative assessment of 24-hr primary skin irritation test and human patch test data with in vitro skin irritation tests according to OECD Test Guideline 439 (for quasi-drugs in Japan)

2018 ◽  
Vol 43 (12) ◽  
pp. 751-768 ◽  
Author(s):  
Mariko Sugiyama ◽  
Masaharu Akita ◽  
Nathalie Alépée ◽  
Miyuki Fujishiro ◽  
Shigenobu Hagino ◽  
...  
Keyword(s):  
Patch Test ◽  
Test Data ◽  
Skin Irritation ◽  
Comparative Assessment ◽  
Irritation Test ◽  
Skin Irritation Test ◽  
Test Guideline ◽  
Oecd Test Guideline

scholarly journals Review of skin irritation/corrosion hazards on the basis of human data: a regulatory perspective

2012 ◽  
Vol 5 (2) ◽  
pp. 98-104 ◽  
Author(s):  
David Basketter ◽  
Dagmar Jírova ◽  
Helena Kandárová
Keyword(s):  
Patch Test ◽  
Skin Irritation ◽  
Alternative Methods ◽  
Test Protocol ◽  
Rabbit Skin ◽  
Irritation Test ◽  
Skin Irritation Test

Abstract Regulatory classification of skin irritation has historically been based on rabbit data, however current toxicology processes are transitioning to in vitro alternatives. The in vitro assays have to provide sufficient level of sensitivity as well as specificity to be accepted as replacement methods for the existing in vivo assays. This is usually achieved by comparing the in vitro results to classifications obtained in animals. Significant drawback of this approach is that neither in vivo nor in vitro methods are calibrated against human hazard data and results obtained in these assays may not correspond to situation in human. The main objective of this review was to establish an extended database of substances classified according to their human hazard to serve for further development of alternative methods relevant to human health as well as resource for improved regulatory classification. The literature has been reviewed to assemble all the available information on the testing of substances in the human 4 h human patch test, which is the only standardized protocol in humans matching the exposure conditions of the regulatory accepted in vivo rabbit skin irritation test. A total of 81 substances tested according to the defined 4 h human patch test protocol were found and collated into a dataset together with their existing in vivo classifications published in the literature. While about 50% of the substances in the database are classified as irritating based on the rabbit skin test, on using the 4 h HPT test, less than 20% were identified as acutely irritant to human skin. Based on the presented data, it can be concluded that the rabbit skin irritation test largely over-predicts human responses for the evaluated chemicals. Correct classification of the acute skin irritation hazard will only be possible if newly developed in vitro toxicology methods will be calibrated to produce results relevant to man.

Comparison of results of the 4h human skin irritation patch test and in vitro human skin irritation test (EpiDerm SIT) with existing classifications of chemicals

2008 ◽  
Vol 180 ◽  
pp. S108
Author(s):  
Dagmar Jirova ◽  
David Basketter ◽  
Hana Bendová ◽  
Marie Marriott ◽  
Kristina Kejlová ◽  
...  
Keyword(s):  
Patch Test ◽  
Human Skin ◽  
Skin Irritation ◽  
Comparison Of Results ◽  
Irritation Test ◽  
Skin Irritation Test

scholarly journals Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm™

2018 ◽  
Vol 50 ◽  
pp. 407-417 ◽  
Author(s):  
Helena Kandarova ◽  
Jamin A. Willoughby ◽  
Wim H. De Jong ◽  
Silvia Letasiova ◽  
Tatiana Milasova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Development, optimization and standardization of an in vitro skin irritation test for medical devices using the reconstructed human tissue model epiderm

2015 ◽  
Vol 238 (2) ◽  
pp. S351-S352 ◽  
Author(s):  
H. Kandarova ◽  
J. Willoughby ◽  
W. de Jong ◽  
M. Bachelor ◽  
S. Letasiova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Optimized Preparation of Capsaicin-Loaded Nanoparticles Gel by Box-Behnken Design

2014 ◽  
Vol 1061-1062 ◽  
pp. 359-368 ◽  
Author(s):  
Mei Ling Tang ◽  
Li Hua Chen ◽  
Dong Sheng Zhou ◽  
Wei Feng Zhu ◽  
Yong Mei Guan ◽  
...  
Keyword(s):  
Skin Permeation ◽  
Skin Irritation ◽  
Morphological Characteristics ◽  
Entrapment Efficiency ◽  
Box Behnken Design ◽  
Irritation Test ◽  
Predicted Values ◽  
Skin Irritation Test

A three-factor three-level Box-Behnken design(BBD) was employed to optimize capsaicin-loaded nanoparticles(Cap-NPs), and its properties in vitro and in vivo were evaluated. Particle size, morphological characteristics, entrapment efficiency of Cap-NPs were investigated respectively by Zetasizer, H7000 TEM and HPLC. Release, skin permeation and skin irritation test were investigated on mouse and rabbits. The predicted values of Cap-NPs were 94.50±6.33% for entrapment efficiency(EE) and 170.30±7.81 nm for particle mean diameter(PMD) under optimal conditions which were 346.33 bar (homogenization pressure, X1), 4.67 min(homogenization time, X2), and 15421.42 rpm (shear rate, X3). The in vitro permeation study showed that capsaicin permeability in NPs-gel was a 2.80-fold greater flux values than conventional ointment after 24 h. Cap-NPs-gel produce no observable skin irritation in rabbits within 72h. The optimized Cap-NPs-gel would be a good candidate for transdermal delivery.

In vitro skin irritation test: Increasing the sensitivity of the EpiDerm skin irritation protocol evaluated in the ECVAM skin irritation validation study

2007 ◽  
Vol 172 ◽  
pp. S81 ◽  
Author(s):  
Helena Kandárová ◽  
Patrick Hayden ◽  
Erin Spiller ◽  
Mitch Klausner ◽  
Joseph Kubilus ◽  
...  
Keyword(s):  
Validation Study ◽  
Skin Irritation ◽  
Irritation Test ◽  
Skin Irritation Test
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