L’Oréal contributes to an important step towards validating alternative method in China
L’Oréal Chinese Episkin model multicenter study for Skin Irritation
Clichy - At the occasion of the 6th Chinese Society of Toxicology Congress in Guangzhou, Researcher SU Ning from CAIQ on behalf of the multicenter study management group presented the latest advances and very promising results from the multicenter study for the validation of Skin Irritation Alternative Method conducted in China, based on the Chinese Episkin model and ECVAM protocol during the session of “Toxicology Alternatives” exclusively sponsored by L’Oréal China R&I. This study has been led by CAIQ affiliated with AQSIQ3, and jointly conducted by L’Oréal China R&I and the authority laboratories in the AQSIQ, including Beijing CIQ, Shanghai CIQ, and Guangdong CIQ laboratories.
The experts from the multicenter study management group highly appraised that this multicenter study based on L’Oréal Chinese Episkin represents “the very first validation of standardized and normative animal testing alternative methods in accordance with international standards in China”, and “this project provides a solid technical support for corresponding to the new regulation in European Union. It created a novel mode for making accordance with the international technical platform of animal testing alternative methods.”
“More than thirty years of research on skin reconstruction and development of predictive methods have been recognized today”, saidLaurent Attal, Executive Vice-President of Research & Innovation at L’Oréal. “It is a great step towards the promotion of alternative methods in China by sharing knowledge and tools.”
What is a reconstructed epidermis model?
It is a model of epidermis created from epidermal cells grown on a dermal equivalent in vitro.
What is Episkin?
Episkin is a model of human reconstructed epidermis marketed in the form of a kit of 12 tissues which has been validated in Europe as full replacement method for corrosion and skin irritation.
What is Chinese Episkin model?
The Chinese Episkin model is a human epidermis model reconstructed from Asian keratinocytes, produced by the L’Oréal Advanced Research laboratories in China according to the same strict production standard and quality control criteria. The Chinese Episkin models produced at the L’Oreal’s research center in Shanghai are dedicated to tissue engineering and testing research.
What is an alternative method?
An alternative method replaces the use of animal in safety evaluation. Skin irritancy’s potential of chemical substances historically conducted on rabbit is now conducted on Episkin.
What is a multicenter study?
It is a first step towards the validation of the alternative method. A multicenter research study is conducted at more than one laboratory. According to ECVAM, “the benefits of multicenter trials include a larger number of participants, different geographic locations, and the ability to compare results among centers, all of which increase the generalization of the study”.
What is an ECVAM method?
An alternative method to animal tests replaces the use of animals. It is then called a “full replacement” method when it is scientifically proven to be fully relevant in terms of predictive capacity, which is already the case for L’Oreal’s Episkin model in European. To achieve this, a validation process, under the guidance of ECVAM, was conducted from 1999 till 2007, in collaboration with public and private institutions. Sixty chemical substances, selected for their irritancy or non-irritancy potential, had been tested independently by partners. The results had been submitted to the Scientific Committee of ECVAM (ESAC) which had finally endorsed the successful validation of this Episkin method.
What is next?
The next step is to move from Alternative to Predictive Evaluation. Apart from skin models, Predictive Evaluation combines a great number of tools, such as molecular modeling, toxicology expert systems, imaging techniques, automated platforms that carry out high-speed screening, and many more. The shift from alternative methods to predictive methods has already allowed L’Oréal to comply with EU regulation without impact on sustainable innovation and safety.
L’Oréal, the world’s leading beauty company, has devoted itself to all forms of beauty in the world for over 100 years and has built a unique portfolio of 28 international, diverse and complementary brands. With sales amounting to 22.5 billion euros in 2012, L’Oréal employs 72,600 people worldwide. In 2013, the Ethisphere Institute, a leading international think-tank for business ethics, corporate social responsibility and sustainability, recognized L’Oréal as one of the World’s Most Ethical Companies. This is the fourth time that L’Oréal has received this distinction. www.loreal.com
1 CAIQ – Chinese Academy of Inspection and Quarantine
2 ECVAM - European Center for Validation of the Alternative Methods
3 AQSIQ - General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China
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