Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs)

Barthe, Manon; Bavoux, Clarisse; Finot, F.; Mouche, I.; Cuceu-Petrenci, Corina; Forreryd, Andy; Hansson, Anna Chérouvrier; Johansson, Henrik; Lemkine, Gregory F.; Thénot, Jean-Paul; Osman‐Ponchet, Hanan

doi:10.3390/cosmetics8020050

Cited by 33 publications

(15 citation statements)

References 85 publications

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“…1223/2009 and the specific Regulation No. 655/2013 specify the required data to prove the safety and support the claims [8]. Historically, the ethical dimension was put forward by Russell and Burch [9] with the rule of the three 'Rs' for Reduction, Refinement and Replacement; currently replacement is the primary goal of the 3Rs.…”

Section: Skin Toxicology Evaluationmentioning

confidence: 99%

“…DPRA and ADRA, for example, have no metabolic capacity and are therefore unable to identify prohaptens, sensitizers that require metabolism to be activated. Thus, these methods should be considered in the context of a tiered testing strategy, a so-called defined approach (DA), where a fixed data integration procedure is used to arrive at a final classification, based on the readout from several NAMs [8].…”

Section: Skin Sensitizationmentioning

confidence: 99%

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Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

Filaire

Nachat‐Kappes²,

Laporte

et al. 2022

Intern J of Cosmetic Sci

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Background: Guided by ethical considerations and regulatory requirements such as the 7th Amendment to the European Cosmetics Directive N° 1223/2009, the cosmetic industry has developed and evaluated alternative test strategies such as in vitro assays, in silico approaches for toxicological endpoints and efficacy of cosmetic products and cosmetics ingredients. In consequence, the European Centre for the Validation of Alternative Methods (ECVAM) has proposed a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. For example, 3D human skin equivalent models are used to evaluate skin irritation potential; and excised human skin is used as the gold standard for the evaluation of dermal absorption.Objective: This review presents, in relation to the regulatory requirements, the main alternative in vitro models used in the safety tests of cosmetic products, focusing on skin sensitization, skin corrosion, skin irritation and skin absorption, with advantages and limitations of each model. Recent innovative 3D cell technologies such as Organ-on-a-Chip (OoC) models that can bring significant improvements for toxicology and efficacy testing are also presented. Conclusion:The development of OoC technology is promising for assessing the toxicity of substances contained in cosmetics, particularly for repeated dose toxicity, for which no alternative in vitro methods are currently available.Nevertheless, aside from the challenges, the technology needs to be validated and accepted by regulatory organizations as an effective method. Collaboration between researchers, regulatory organizations and industry would be required to achieve this validation. K E Y W O R D S chemical analysis, in vitro, skin, skin-on-a-chip, three-dimensional skin cell model, toxicology Résumé Contexte: Guidée par des considérations éthiques et des exigences réglementaires telles que le 7e amendement à la directive européenne sur les cosmétiques

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Section: Skin Toxicology Evaluationmentioning

confidence: 99%

Section: Skin Sensitizationmentioning

confidence: 99%

Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

Filaire

Nachat‐Kappes²,

Laporte

et al. 2022

Intern J of Cosmetic Sci

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“…At present, many alternatives to animal testing have been developed and validated for the safety and efficacy testing of cosmetic products and cosmetic ingredients. For example, 2D cell culture models derived from the human skin for evaluating anti-inflammatory properties, or predicting skin sensitization potential and 3D human skin equivalent models for evaluating skin irritation potential and excised human skin are being currently used as the gold standard for evaluating dermal absorption [138]. If a medicinal plant ingredient is safe and stable, it can move on to the formulation phase, where it is added to a cosmetic formula and retested for the same parameters, safety, and stability.…”

Section: Major Challenges and Possible Solutions For Sri Lankamentioning

confidence: 99%

Global Perspective of Plant-Based Cosmetic Industry and Possible Contribution of Sri Lanka to the Development of Herbal Cosmetics

Gamage

Dharmadasa

Abeysinghe

et al. 2022

Evidence-Based Complementary and Alternative Medicine

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The global consumption of plant-based cosmetics has shown spectacular growth in recent years because of rising consumer awareness regarding the long-term health benefits of natural ingredients. As the global demand for herbal cosmetics increases, there are ample opportunities for Sri Lanka as a tropical Asian country to expand its productions and global exports along with its unique biodiversity and inherited traditional knowledge. Therefore, the present review attempts to give an overview of the widely used medicinal plants in the global herbal cosmetic industry and strengths, challenges, and possible solutions for the development of the herbal cosmetic industry of Sri Lanka. Information was collected using electronic search (using Pub Med, Science Direct, Web of Science, Google Scholar, TEEAL, and Scopus) for articles published in peer-reviewed journals, industrial reports, market surveys, and library search for local books on ethnobotany. Important plant-derived ingredients used in the global herbal cosmetic industry are essential oils, colorants, oils, fats, and waxes. The traditional usage of 108 medicinal plant species (belonging to 58 families) in cosmetic treatments was identified from the local books of Sri Lanka. Of these, 49 plant species were reported as new ingredients for the herbal cosmetic industry. However, the lack of ethnobotanical and ethnopharmacological surveys to identify the cosmetic potential plants, insufficient or absence of continuous supply of raw materials for production in line with the existing demand, the lack of quality control of raw materials and finished cosmetic products, improper systematic cultivation systems for medicinal plants, poor postharvest practices, and the lack of innovations are major challenges encountered in Sri Lanka for the development of the herbal cosmetic industry. In conclusion, addressing these vital knowledge gaps is a timely requirement of the country for the sustainable development of the herbal cosmetic industry in Sri Lanka. Furthermore, assembling of the multidisciplinary cooperation of botanists, chemists, toxicologists, researchers, and biologists is crucial to analyze the interesting functional properties, efficacy, and effectiveness of documented medicinal plants with cosmetic potential.

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“…5 For skin irritation studies, 03 albino rats (300-500 g) of either sex were used. 6 Backs are shaved, and care was taken to avoid abrading the skin, and only animal with healthy and intact skin was used. The test patch P13 was applied to the skin (approximately 6 cm 2 ) and covered with gauze patch.…”

Section: Skin Irritation Studiesmentioning

confidence: 99%

Preclinical Assessment of Aceclofenac Transdermal Patch by Freund’s Complete Adjuvant-induced Arthritis in Rats

Bajaj¹,

Yadav²,

Singh³

et al. 2022

IJPQA

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>The hydroxypropyl methylcellulose (HPMC) based transdermal patches of aceclofenac were prepared. On the basis of in-vitro potential, the formulation was additionally chosen and assessed for their in-vivo anti-arthritic activity and acute skin irritation tests using the primary skin irritation (draize) test and freund’s complete adjuvant (FCA) caused arthritis technique. Furthermore, stability studies were conducted in compliance with ICH standards. The studied compositions had no irritant potential, and no edema production was ever noticed. All of the formulations had a zero irritation score (primary skin irritation index), indicating their safety and acceptability for transdermal administration. The stability investigations confirmed the produced patch’s stability, and the in-vivo analysis showed a considerable decrease in the volume of irritated paws compared to the marketed formulation. The created transdermal patches may serve as a platform for the delivery of medication for the treatment of arthritis

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Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs)

Cited by 33 publications

References 85 publications

Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

Global Perspective of Plant-Based Cosmetic Industry and Possible Contribution of Sri Lanka to the Development of Herbal Cosmetics

Preclinical Assessment of Aceclofenac Transdermal Patch by Freund’s Complete Adjuvant-induced Arthritis in Rats

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