2018
DOI: 10.1089/aivt.2017.0023
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Alternative Integrated Testing for Skin Sensitization: Assuring Consumer Safety

Abstract: Cosmetics legislation in Europe has driven the validation and acceptance of non-animal alternatives, most recently in the area of skin sensitization. Despite use of these methods to meet regulatory needs, it is also essential that they allow evaluation regarding human safety. For cosmetic product safety, it is necessary to understand how they can be used and with what limitations, and thereby reveal what remains to be addressed. A dataset of 165 ingredients (137 cosmetic ingredients +28 reference substances) h… Show more

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Cited by 16 publications
(7 citation statements)
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“…PG was predicted to be negative for SS via the LLNA: BrdU-FCM, consistent with previous reports that used a traditional LLNA or other alternative approaches, such as KeratinoSens™ or U-SENS™ (Del Bufalo et al, 2018; European Medicines Agency, 2017). Since PG is widely used as a vehicle or excipient for carrying active ingredients in consumer products, more discussion has arisen about how the addition of PG to PHMG, PGH, triclosan, or d -limonene solutions could influence the intensity of their SS effects.…”
Section: Discussionsupporting
confidence: 87%
See 1 more Smart Citation
“…PG was predicted to be negative for SS via the LLNA: BrdU-FCM, consistent with previous reports that used a traditional LLNA or other alternative approaches, such as KeratinoSens™ or U-SENS™ (Del Bufalo et al, 2018; European Medicines Agency, 2017). Since PG is widely used as a vehicle or excipient for carrying active ingredients in consumer products, more discussion has arisen about how the addition of PG to PHMG, PGH, triclosan, or d -limonene solutions could influence the intensity of their SS effects.…”
Section: Discussionsupporting
confidence: 87%
“…PG is considered to be a mild skin irritant; however, its SS potential has been questioned based on LLNA results showing that it is a nonsensitizer. In any case, very low SS potential has been reported in human subjects (Del Bufalo et al, 2018; European Medicines Agency, 2017; Lessmann et al, 2005).…”
Section: Introductionmentioning
confidence: 99%
“…These data were run in 5 different classification models (Boosting, Naive Bayes, support vector machine (SVM), Sparse Partial Least Squares Discriminant Analysis, and Expert Scoring). The validation results were used in the stacking meta-model to evaluate the skin sensitization potential ( Del Bufalo et al, 2018 ). The predictions achieved the accuracies of 93 and 91% for the training set and test set, respectively when compared with LLNA hazard data.…”
Section: In Silico Modelsmentioning
confidence: 99%
“…Three of the four adverse outcome pathway key events can be addressed by regulatory accepted in vitro methods. 49 Multiple IATAs have been published for skin sensitisation [50][51][52][53][54] and the OECD has published guidance on the background and reporting of skin sensitisation IATA. 49 A quantitative evaluation of approaches designed for hazard identification has been summarised by Kleinstreuer et al, 55 who report accuracies of 70.1% and 88.3% for the BASF 'two out of three' approach 50 and 88.3% for the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) support vector machine approach, 54 respectively.…”
Section: In Vitro Testingmentioning
confidence: 99%