Use of read-across and computer-based predictive analysis for the safety assessment of PEG cocamines (original) (raw)
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Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics
International Journal of Toxicology, 2018
The Cosmetic Ingredient Review Expert Panel assessed the safety of 47 polyethylene glycols (PEGs) cocamine and related ingredients, which are reported to function mostly as surfactants and antistatic agents. The Panel reviewed the relevant data and developed a framework to satisfy previously identified data deficiencies for this group of materials as well as extend the scope of related materials covered by the analysis. The irritation potential of these ingredients is consistent with the surface active properties that are characteristic of surfactants. The Panel concluded that the PEGs cocamine and related ingredients were safe as ingredients in cosmetic formulations in the current practices of use and concentration when formulated to be nonirritating.
European Commission Joint Research Centre, 2013
Provisions of Regulation No 1223/2009 on cosmetic products require that the European Commission reports on a yearly basis to the European Parliament and Council on the progress made in the development, validation and regulatory acceptance of alternative methods and on the compliance with the deadlines of the animal testing and marketing bans. This EURL ECVAM technical report provides an update since 2010 on the state of play of alternative methods for all the toxicological areas relevant to the Cosmetics Regulation and supplements the 2013 Commission Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics. Overall good progress has been made in the validation and regulatory acceptance in areas such as local toxicity where the underpinning science is more advanced and mature alternative methods are available. For very complex endpoints on the other hand, such as chronic systemic toxicity, carcinogenicity or reproductive toxicity, efforts are predominantly focused on research and development where the emphasis is on the integration of a variety of methods based on mechanistic understanding. The future is bright however, since considerable advances in new in vitro technologies, systems biology, bioinformatics and computational modelling are driving a paradigm shift in toxicological testing and assessment where non-animal methods will ultimately become the tools of choice.
Cosmetics
Cosmetic products need to have a proven efficacy combined with a comprehensive toxicological assessment. Before the current Cosmetic regulation N°1223/2009, the 7th Amendment to the European Cosmetics Directive has banned animal testing for cosmetic products and for cosmetic ingredients in 2004 and 2009, respectively. An increasing number of alternatives to animal testing has been developed and validated for safety and efficacy testing of cosmetic products and cosmetic ingredients. For example, 2D cell culture models derived from human skin can be used to evaluate anti-inflammatory properties, or to predict skin sensitization potential; 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. The aim of this manuscript is to give an overview of the main in vitro and ex vivo alternative models used in the safety testing of cosmetic products with a focus on regulatory re...
Archives of Toxicology
The EU Directive 2010/63/EU on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is conducted. Whilst the Cosmetic Products Regulation bans animal testing altogether, REACH aims for a progressive shift from in vivo testing towards quantitative in vitro and computational approaches. Several endpoints can already be addressed using non-animal approaches including skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, for systemic effects such as acute toxicity, repeated dose toxicity and reproductive and developmental toxicity, evaluation of chemicals under REACH still heavily relies on animal tests. Here we summarise current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetic Products Regulation, considering the more critical endp...