The purpose of this study is to analyze transcutaneous penetration pathway and rate of ingredients topically applied on human skin. To visualize the distribution of penetrated ingredients in stratum corneum non-invasively, a combination of adhesive tape stripping method and TOF-SIMS (Time-of-Flight Secondary Ion Mass Spectrometry) analysis was used. l-Ascorbic acid 2-phosphoric acid magnesium salt (APM) and sodium dl-α-tocopheryl phosphate (VEP), one of whitening ingredients, were selected as the evaluation target of transcutaneous penetration. APM and VEP were applied topically on the skin surface and then corneocytes were stripped from those area using adhesive tapes in series. These tape-stripping samples were subjected to TOF-SIMS analysis and the horizontal molecular distribution of tape, corneocytes, APM and VEP could be visualized respectively by two-dimensional mapping of each specific ion desorbed from the sample surface. APM and VEP were penetrated into the 7th stripped stratum corneum in 5 and 60 min, respectively and located mainly around the peripheral area of corneocytes, especially around clustered corneocytes. On the basis of these results, a combination of adhesive tape stripping method and TOF-SIMS analysis is considered to make it possible to analyze the transcutaneous penetration pathway and rate of ingredients. Furthermore, the evaluation method of transcutaneous penetration in this study may be a safe and effective method because it could non-invasively and directly detect the distribution of materials in the stratum corneum without a labeled substance.

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Conventionally, in social psychology research, “perceived competence” that is rooted in a specialized technique and knowledge, and “perceived motivation” that is rooted in the attitude to carry out one's duty have been targeted, as important factors for earning trust. Today, attention is being drawn to the salient value similarity (SVS) model whose viewpoint differs from that of these two factors. In the SVS model, trust is assumed not only to be dependent on characteristics of the trusted party but also to be determined by the commonality of both the trusting and trusted parties, in particular, by sharing salient values. That is to say that the SVS model insists that “we can trust in and entrust something to a person who has the same viewpoint and shares similar feelings.” Studies related to trust in recent years have clarified that all of the perception of competence, motivation, and value sharing are significant defining factors of trust. In addition, it is reported that the weight of trust in value-sharing perception increases and the weight of competence perception decreases relatively, in the event that the problem someone faces is important to the individual, in the event that there exists an argument in the society concerning the pros and cons of the problem, and in the event that trust in the risk management organization subject to assessment is reduced.

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The use of animals in research, testing, or teaching is an essential part of scientific and/or educational activities. Animal experimentations have an enormous impact on progress of disease prevention and cures, and drug development, thereby contributing to human as well as animal health and welfare. However, social resistance against animal experimentations has also increasingly and globally prevailed, as social attention to the welfare of laboratory animals increases. Thus, the highest scientific, humane, and ethical principles for animal experimentations must be implemented. The concept of the 3Rs: Replacement, Reduction, and Refinement, proposed by Russel and Burch in 1959 have become an internationally accepted approach for scientists and educators to use animals. More recently, two international organizations, the Council for International Organization for Medical Science and the International Council for Laboratory Animal Science, have jointly published “International Guiding Principles for Biomedical Research Involving Animals” to promote laboratory animal welfare and support high-quality scientific data. In Japan, “The Law Concerning Humane Treatment and Management of Animals” revised by the Ministry of Environment (MOE), in which the 3Rs was clearly specified, went into operation as of 2006. MOE also made a notification of “Standard for Care and Management of Laboratory Animals and Alleviations of Pain.” In the same year, “The Basic Policy on Animal Experimentation Performed at Research Organization etc.” has been each established by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour, and Welfare, and the Ministry of Agriculture, Forestry and Fisheries. Furthermore, the Science Council of Japan has published “Guidelines on Animal Experimentations.” Implementation and extension of policies defined by such framework of laws, regulations, and guidelines will pave the way towards establishment of a credible animal care and use program in Japan, which meets international standards in ways judged to be scientifically and humanely appropriate.

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In the European Union (EU), the marketing ban of cosmetics tested on animals has been in effect since March 2013 by the 7th amendment of the EU cosmetics directive. On the other hand, The European Centre for the Validation of Alternative Methods (ECVAM) in the EU, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the United States and the Japanese Centre for the Validation of Alternative Methods (JaCVAM) in Japan have made positive approaches to acquire adoption of alternatives to animal tests as the OECD test guidelines (TG). As the results of their efforts, primary skin irritation test (OECD TG 439), eye irritation test (OECD TG 437, 438), phototoxicity test (OECD TG 432), percutaneous absorption test (OECD TG 428) and genotoxicity test (OECD TG 471, 473) have reached into the OECD TG as alternatives to animal tests. However, alternative methods for skin sensitization test, photosensitization test and some systemic toxicity tests still have not been established since the EU Cosmetic Directive was enforced, because of their intricate toxicity mechanisms. While thinking of such a situation, we have been developing an in silico prediction system that might be possible to assess safety risk for cosmetic ingredients by combination of a molecular orbital calculation method and an artificial neural network system, each of which is respectively expected to reflect structural information in detail using descriptors and as a method to clarify the intricate toxicity mechanisms in the body. In addition, we have attempted the prediction for the risk assessment of cosmetic ingredients by the read-across method and category approach using the safety information that was obtained from similar materials considering toxicity mechanism of compounds. In this report, I introduce the approach for safety assessment by in silico methods.

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The two bills to amend Pharmaceutical Affairs Act have passed 185th Session of the Diet held in 2014. There were four major pillars in the one of the bill: Strengthen Safety Measures regarding Drugs, Medical Devices, etc.; Formulating a framework of legislation considering the natures of medical devices; and Formulating a framework and legislation considering regenerative medicinal products. Under another bill, there were two major pillars: Reviewing a framework of legislation concerning sales licence for pharmaceuticals; and Prohibiting possession/use of illegal drug (new psychoactive substances). Japanese Pharmacopoeia is a set of standards established by the Ministry of Health, Labour and Welfare of Japan to ensure qualities/products demonstration of pharmaceuticals. The Supplement 2 of the 16th Edition has just issues at February of 2014. The standards for hair dyes, permanent wave solution is expected to be under the review soon. Also, discussions for authorization of quasi drug are ongoing about how the transparency should be ensured and what approval examination method should be newly added.

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