Assessment of the skin sensitisation hazard of functional polysiloxanes and silanes in the SENS-IS assay

Petry, Thomas; Bosch, Axel; Koraïchi-Emeriau, Farah; Eigler, Dorothea; Germain, Pierre; Seidel, Shawn D.

doi:10.1016/j.yrtph.2018.07.020

Cited by 11 publications

(5 citation statements)

References 18 publications

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“…Clemmensen et al (2010) observed epidermal expression of MMP-3 in experimental irritant contact dermatitis in human skin and suggested that secretion of this protease may release GFs that are sequestered in the extracellular matrix as part of a tissue repair process. The gene transcript for MMP-3 has been detected previously by us and others on analysis of either reconstituted human epidermis or fullthickness HSE when these models were treated with several irritants (Cottrez et al, 2016(Cottrez et al, , 2015Hasan et al, 2019;Petry et al, 2018), underscoring its significance as a marker of skin irritation.…”

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confidence: 70%

Determination of Chemical Irritation Potential Using a Defined Gene Signature Set on Tissue-Engineered Human Skin Equivalents

et al. 2021

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There are no physical or visual manifestations that define skin sensitivity or irritation; a subjective diagnosis is made on the basis of the evaluation of clinical presentations, including burning, prickling, erythema, and itching. Adverse skin reaction in response to topically applied products is common and can limit the use of dermatological or cosmetic products. The purpose of this study was to evaluate the use of human skin equivalents based on immortalized skin keratinocytes and evaluate the potential of a 22-gene panel in combination with multivariate analysis to discriminate between chemicals known to act as irritants and those that do not. Test compounds were applied topically to full-thickness human skin equivalent or human ex vivo skin and gene signatures determined for known irritants and nonirritants. Principle component analysis showed the discriminatory potential of the 22-gene panel. Linear discrimination analysis, performed to further refine the gene set for a more high-throughput analysis, identified a putative seven-gene panel (IL-6, PTGS2, ATF3, TRPV3, MAP3K8, HMGB2, and matrix metalloproteinase gene MMP-3) that could distinguish potential irritants from nonirritants. These data offer promise as an in vitro prediction tool, although analysis of a large chemical test set is required to further evaluate the system.

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confidence: 70%

Determination of Chemical Irritation Potential Using a Defined Gene Signature Set on Tissue-Engineered Human Skin Equivalents

et al. 2021

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“…Although validated for tissue-engineered skin equivalents, these tests are also useful for oral mucosal studies due to the similarities in tissue structure. Similarly, the recently developed molecular test for skin irritation/sensitivity based on a validated gene signature profile (SENS-IS) [ 77 , 78 ] may also be of use in oral mucosal studies if this technology can be translated to oral tissue. Monolayers of cultured oral keratinocytes isolated from healthy tissue or keratinocyte cell lines can be used as in vitro models to test oromucosal materials [ 79 , 80 ].…”

Section: Electrospun Mucoadhesive Materialsmentioning

confidence: 99%

Mucoadhesive Electrospun Fibre-Based Technologies for Oral Medicine

et al. 2020

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Oral disease greatly affects quality of life, as the mouth is required for a wide range of activities including speech, food and liquid consumption. Treatment of oral disease is greatly limited by the dose forms that are currently available, which suffer from short contact times, poor site specificity, and sensitivity to mechanical stimulation. Mucoadhesive devices prepared using electrospinning offer the potential to address these challenges by allowing unidirectional site-specific drug delivery through intimate contact with the mucosa and with high surface areas to facilitate drug release. This review will discuss the range of electrospun mucoadhesive devices that have recently been reported to address oral inflammatory diseases, pain relief, and infections, as well as new treatments that are likely to be enabled by this technology in the future.

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“…Table 2 shows the information on five polyfunctional siliconebased compounds (PS-6: aminoethyl-aminoisobutyl methyl dimethoxysilane, PS-7: reaction products of vinyltriacetoxysilane and glycidoxypropyltrimethoxy silane, PS-8: methylamino siloxane with glycidyl trimethylammonium chloride, silane glycol, and silicone glycol), three crop protection formulations (CPF-1: emulsion concentrate of triclopyr butoxyethyl ester, CPS-2: soluble concentrate of aminopyralid triisopropanolammonium, and CPF-3: suspension concentrate of florasulam), and two surfactant mixtures (XUS-906 and XU-801), respectively. Petry et al (2017Petry et al ( , 2018 have already reported the results of testing that assessed the skin sensitization potential of a heterogeneous group of functionalized polysiloxanes and silanes in two previous articles. In order to compare these substances with the previous publications, the same substance codes as those used in the Petry et al (2017Petry et al ( , 2018 publications were used in this article (Table 2).…”

Section: Test Chemicals and Available Sensitization Datamentioning

confidence: 99%

“…Petry et al (2017Petry et al ( , 2018 have already reported the results of testing that assessed the skin sensitization potential of a heterogeneous group of functionalized polysiloxanes and silanes in two previous articles. In order to compare these substances with the previous publications, the same substance codes as those used in the Petry et al (2017Petry et al ( , 2018 publications were used in this article (Table 2). An aminofunctional alkoxysilane (PS-6), a nonaminofunctional alkoxysilane (PS-7), and an aminofunctional siloxane (PS-8) were evaluated (Table 2).…”

Section: Test Chemicals and Available Sensitization Datamentioning

confidence: 99%

Characterization of dermal sensitization potential for industrial or agricultural chemicals with EpiSensA

Mizumachi

LeBaron

Settivari

et al. 2020

J of Applied Toxicology

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The regulatory community is transitioning to the use of nonanimal methods for dermal sensitization assessments; however, some in vitro assays have limitations in their domain of applicability depending on the properties of chemicals being tested. This study explored the utility of epidermal sensitization assay (EpiSensA) to evaluate the sensitization potential of complex and/or “difficult to test” chemicals. Assay performance was evaluated by testing a set of 20 test chemicals including 10 methacrylate esters, 5 silicone‐based compounds, 3 crop protection formulations, and 2 surfactant mixtures; each had prior in vivo data plus some in silico and in vitro data. Using the weight of evidence (WoE) assessments by REACH Lead Registrants, 14 of these chemicals were sensitizers and, six were nonsensitizers based on in vivo studies (local lymph node assay [LLNA] and/or guinea pig studies). The EpiSensA correctly predicted 16/20 materials with three test materials as false positive and one silane as false negative. This silane, classified as weak sensitizer via LLNA, also gave a “false negative” result in the KeratinoSens™ assay. Overall, consistent with prior evaluations, the EpiSensA demonstrated an accuracy level of 80% relative to available in vivo WoE assessments. In addition, potency classification based on the concentration showing positive marker gene expression of EpiSensA was performed. The EpiSensA correctly predicted the potency for all seven sensitizing methacrylates classified as weak potency via LLNA (EC3 ≥ 10%). In summary, EpiSensA could identify dermal sensitization potential of these test substances and mixtures, and continues to show promise as an in vitro alternative method for dermal sensitization.

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Assessment of the skin sensitisation hazard of functional polysiloxanes and silanes in the SENS-IS assay

Cited by 11 publications

References 18 publications

Determination of Chemical Irritation Potential Using a Defined Gene Signature Set on Tissue-Engineered Human Skin Equivalents

Determination of Chemical Irritation Potential Using a Defined Gene Signature Set on Tissue-Engineered Human Skin Equivalents

Mucoadhesive Electrospun Fibre-Based Technologies for Oral Medicine

Characterization of dermal sensitization potential for industrial or agricultural chemicals with EpiSensA

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