A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics

Abstract

Almost a decade after the stipulated deadline in the 7th amendment to the EU Cosmetics Directive, which bans the marketing of animal-tested cosmetics in the EU from 2013, animal experimentation for cosmetic-related purposes remains a topic of animated debate. Cosmetic industry continues to be scrutinised for the practice, despite its leading role in funding and adopting innovation in this field. This paper aims to provide a state-of-the-art review of the field on alternative testing methods, also known as New Approach Methodologies (NAMs), with the focus on assessing the safety of cosmetic ingredients and products. It starts with innovation drivers and global regulatory responses, followed by an extensive, endpoint-specific overview of accepted/prospective NAMs. The overview covers main developments in acute toxicity, skin corrosion/irritation, serious eye damage/irritation, skin sensitisation, repeated dose toxicity, reproductive toxicity/endocrine disruption, mutagenicity/genotoxicity, carcinogenicity, photo-induced toxicity, and toxicokinetics. Specific attention was paid to the emerging in silico methodology. This paper also provides a brief overview of the studies on public perception of animal testing in cosmetics. It concludes with a view that educating consumers and inviting them to take part in advocacy could be an effective tool to achieve policy changes, regulatory acceptance, and investment in innovation.

Multiscale Modeling of Molecule Transport through Skin’s Deeper Layers

“…Modified Fick's 2nd law (eq. [14]) was used for diffusion within lipid layer and Fick's 2nd law (eq.…”

“…The development of these products requires in depth permeation studies which are usually conducted using detailed in-vitro/in-vivo experiments. The uprising of animal rights movements and global campaigning efforts culminated with the phasing out of animal testing in cosmetics within European Union (EU) [14]. In addition, the 7th Amendment to the Cosmetic Directive (Directive 76/768/EEC) and REACH demanded the development of novel in vitro methods for future risk assessment of chemicals for their potential to cause toxicity [15,16].…”

Transgenic Zebrafish Expressing Rat Cytochrome P450 2E1 (CYP2E1): Augmentation of Acetaminophen-Induced Toxicity in the Liver and Retina

“…Animal welfare concerns regarding animal experiments become increasingly serious. About ten years ago, major cosmetic manufacturers in the European Union (EU) and other countries declared that they would not use mammalian animals for testing their products [ 4 ]. Since the European Citizens’ Initiative demanded an end to animal testing for medical drugs with signatures from more than one million citizens, the European Medicines Agency has implemented new measures to minimize animal testing during the development of medical drugs [ 5 ].…”

Toxicity Tests for Chemical Pesticide Registration: Requirement Differences among the United States, the European Union, Japan, and China?

“…The U.S. EPA also developed a series of in vitro and in silico NAMs to streamline the toxicity tests . According to reports, the EU and Japan also adopt NAMs in pesticide registration, while NAMs are only applied to the cosmetics industry in China. , If the applicants and registrants are permitted to use the NAMs, there would be great potential to decrease the number of animals needed and costs by over 20 000 per year . Thus, it is greatly beneficial for China to develop and adopt the NAMs for pesticide registration.…”