A new alternative method for testing skin irritation using a human skin model: A pilot study

•This new in vitro allows us to assess in a valuable way skin irritation.•Although using fresh skin, we had no false positive and no false negative results.•Samples exposed to irritants showed alteration of epidermis with suffering cells.•With the new added substances to this work, there is now a qu...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Toxicology in vitro Jg. 28; H. 2; S. 240 - 247
Hauptverfasser: Miles, A., Berthet, A., Hopf, N.B., Gilliet, M., Raffoul, W., Vernez, D., Spring, P.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England Elsevier Ltd 01.03.2014
Schlagworte:
1-Bromohexane
Adult
Bentazon
Butylmethacrylate
DEHP
Draize test
Epiderm
Episkin
False Negative Reactions
False Positive Reactions
Female
Folpet
Heptylbutyrate
Hexylsalicylate
Humans
In Vitro Techniques
Irritants - toxicity
Irritation scale
Isoproturon
Methylchloroisothiazolinone (MCI/MI)
Methylisothiazolinone (MI)
Middle Aged
Models, Biological
NaCl
Necrosis
Pilot Projects
Skin - pathology
Skin Diseases - chemically induced
Skin Diseases - pathology
Skin Irritancy Tests - methods
Sodiumlaurylsulfate
Vacuoles - pathology
Butylmethacrylate
Methylisothiazolinone (MI)
Isoproturon
Methylchloroisothiazolinone (MCI/MI)
Bentazon
Hexylsalicylate
Heptylbutyrate
Episkin
DEHP
Irritation scale
NaCl
Sodiumlaurylsulfate
Draize test
Epiderm
1-Bromohexane
Folpet
ISSN:0887-2333, 1879-3177, 1879-3177
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:•This new in vitro allows us to assess in a valuable way skin irritation.•Although using fresh skin, we had no false positive and no false negative results.•Samples exposed to irritants showed alteration of epidermis with suffering cells.•With the new added substances to this work, there is now a qualitative available “irritation scale”.•We obtained 100% accuracy with the HPT model; 80% with the RHE models and 60% with the Draize test for 4 tested substances. Studies assessing skin irritation to chemicals have traditionally used laboratory animals; however, such methods are questionable regarding their relevance for humans. New in vitro methods have been validated, such as the reconstructed human epidermis (RHE) model (Episkin®, Epiderm®). The comparison (accuracy) with in vivo results such as the 4-h human patch test (HPT) is 76% at best (Epiderm®). There is a need to develop an in vitro method that better simulates the anatomo-pathological changes encountered in vivo. To develop an in vitro method to determine skin irritation using human viable skin through histopathology, and compare the results of 4 tested substances to the main in vitro methods and in vivo animal method (Draize test). Human skin removed during surgery was dermatomed and mounted on an in vitro flow-through diffusion cell system. Ten chemicals with known non-irritant (heptylbutyrate, hexylsalicylate, butylmethacrylate, isoproturon, bentazon, DEHP and methylisothiazolinone (MI)) and irritant properties (folpet, 1-bromohexane and methylchloroisothiazolinone (MCI/MI)), a negative control (sodiumchloride) and a positive control (sodiumlaurylsulphate) were applied. The skin was exposed at least for 4h. Histopathology was performed to investigate irritation signs (spongiosis, necrosis, vacuolization). We obtained 100% accuracy with the HPT model; 75% with the RHE models and 50% with the Draize test for 4 tested substances. The coefficients of variation (CV) between our three test batches were <0.1, showing good reproducibility. Furthermore, we reported objectively histopathological irritation signs (irritation scale): strong (folpet), significant (1-bromohexane), slight (MCI/MI at 750/250ppm) and none (isoproturon, bentazon, DEHP and MI). This new in vitro test method presented effective results for the tested chemicals. It should be further validated using a greater number of substances; and tested in different laboratories in order to suitably evaluate reproducibility.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0887-2333
1879-3177
1879-3177
DOI:10.1016/j.tiv.2013.10.022