Initiatives for alternatives to animal experiments
In 1991, Japan Cosmetic Industry Association (JCIA) established the Expert Committee on Alternatives to Animal Experiments under the Science & Technology Committee and began specific efforts to develop and evaluate alternatives to animal experiments. The Expert Committee has developed into New Approach Methodology Subcommittee and provides the following support for the development, practical application, and promotion of alternatives to animal experiments. We collaborate with the government and academia for the initiatives.
In 2022, JCIA established the Next Generation Risk Assessment Working Group (NGRA WG). Toward a new era, we started to explore safety assessment methods for cosmetics and cosmetic ingredients that do not depend on animal experiments.
Participation in the Study Group on Guidance on Safety Evaluation of Quasi-drugs and Cosmetics
JCIA, together with the Ministry of Health, Labour and Welfare, the National Institute of Health Sciences, the Pharmaceuticals and Medical Devices Agency (PMDA), physicians, researchers at universities and others actively participate in the Quasi-drug Guidance Meeting to evaluate the development of guidance for alternatives to animal experiments. Below is the list of guidance documents that have been released so far.
| Evaluation item | Test method | Time of release | Guidance |
|---|---|---|---|
| Phototoxicity | 3T3-NRU-PT | April 26, 2012 | Guidance on the Use of Phototoxicity Testing for Safety Evaluation of Quasi-drugs and Cosmetics |
| Photo-safety | ROS Assay | October 27, 2022 | Guidance on Photo-safety Testing and Evaluation Systems for Quasi-drugs and Cosmetics |
| Skin sensitization | LLNA | April 26, 2012 | Guidance on the Use of LLNA as an Alternative to Skin Sensitization Testing for Safety Evaluation of Quasi-drugs and Cosmetics |
| LLNA-DA | May 30, 2013 | Guidance on the Use of LLNA: DA as an Alternative to Skin Sensitization Testing for Safety Evaluation of Quasi-drugs and Cosmetics | |
| LLNA-BrdU-ELISA | May 30, 2013 | Guidance on the Use of LLNA: BrdU-ELISA as an Alternative to Skin Sensitization Testing for Safety Evaluation of Quasi-drugs and Cosmetics | |
| In vitro combinatorial evaluation | January 11, 2018 | Guidance on Evaluation Systems Combining Multiple Alternatives to Skin Sensitization Testing for Safety Evaluation of Quasi-drugs and Cosmetics | |
| Eye irritation | BCOP | February 4, 2014 | Guidance on Using Bovine Corneal Opacity and Permeability (BCOP) Assay as an Alternative to Eye Irritation Testing for Safety Evaluation of Quasi-drugs and Cosmetics |
| ICE | November 16, 2015 | Guidance on Using Isolated Chicken Eye (ICE) Assay as an Alternative to Eye Irritation Testing for Safety Evaluation of Quasi-drugs and Cosmetics | |
| STE | December 18, 2018 | Guidance on Short Term Exposure (STE) Using a Rabbit Corneal Cell Line as an Alternative to Eye Irritation Testing in Safety Evaluation of Quasi-drugs and Cosmetics | |
| RhCE | June 24, 2019 | Guidance on Reconstructed Human Cornea-like Epithelium (RhCE) Test Method as an Alternative to Eye Irritation Testing in Safety Evaluation of Quasi-drugs and Cosmetics | |
| Transdermal absorption | In vitro transdermal absorption tests | November 15, 2016 | Guidance on Use of In-vitro Skin Permeability Testing (In-vitro Transdermal Absorption Tests) for Safety Evaluation of Quasi-drugs and Cosmetics |
| Acute toxicity | In vitro single dose toxicity tests | April 22, 2021 | Guidance on Evaluation Systems Combining Multiple Safety Data for Single Dose Toxicity Evaluation of Quasi-drugs and Cosmetics |
| Skin irritation | In vitro skin irritation evaluation systems | April 22, 2021 | Guidance on Skin Irritation Evaluation Systems for Safety Evaluation of Quasi-drugs and Cosmetics |
List of Research Grants for Studies on Alternative Methods
JCIA supports activities to promote alternatives to animal experiments through research grants to the Japanese Society for Alternatives to Animal Experiments. Below is a list of the research grants we have supported so far.
| Fiscal year | Principal Investigator | Affiliation | Research Theme |
|---|---|---|---|
| 2023 | Kaori Abe | Nagoya City University Graduate School | Case studies to promote the application of NGRA in skin sensitization evaluation |
| 2022 | Akinori Takemura | Faculty of Pharmaceutical Sciences & Graduate School of Pharmaceutical Sciences, Chiba University | Study on hepatotoxicity prediction method considering transdermal absorption of a model compound (diclofenac) |
| 2021 | Hidefumi Ikeda | Mandom Corporation | Joint research on expanding the application limits of in vitro skin irritation testing |
| 2021 | Akiko Ohno | National Institute of Health Sciences | Study on evaluation of h-CLAT assay for immunotoxicity of nanomaterials |
| 2020 | Shinsuke Kataoka | LION Corporation | In vitro oral mucosal irritation test using a three-dimensional human buccal oral mucosal model as an alternative |
| 2019 | N/A | ||
| 2018 | Hajime Kojima | National Institute of Health Sciences | Epidermal Sensitization Assay (EpiSensA) using reconstructed human epidermis as an alternative sensitization assay |
| 2017 | Mitsuru Akashi | Graduate School of Frontier Biosciences, Osaka University | Examination of skin irritation tests using a dermal-epidermal skin model |
| 2016 | Toshihiko Kasahara | FUJIFILM Corporation | Amino acid Derivative Reactivity Assay (ADRA) as an alternative to in chemico skin irritation tests |
| 2015 | Setsuya Aiba | Division of Dermatology, Tohoku University Graduate School of Medicine | IL-8 Luc assay Phase IV |
| 2015 | Satoshi Nakahara | Maruishilabo Corporation | LabCyte CORNEA-MODEL eye irritation tests |
| 2014 | Setsuya Aiba | Division of Dermatology, Tohoku University Graduate School of Medicine | Phase III validation on IL-8 Luc Assay |
Recent conference presentations, lectures, symposiums, etc. by JCIA, related to alternatives to animal experiments.
June 29, 2024
New Concept for Safety Assessment of Cosmetics：Challenge for Application of Next Generation Risk Assessment (NGRA) to Regulatory Purposes
November 28, 2023
Current status and future perspectives for developing NGRA/NAMs
November 18 to 20, 2022
Expectations and challenges for the new generation risk assessment
October 13, 2022
Latest trends in Japan and overseas in alternatives to animal experiments from the perspective of cosmetics companies
June 10, 2022
Considering the safety assurance of cosmetics in anticipation of the recent international situation
June 25, 2021
Status of preparation of safety evaluation guidance for quasi-drugs and cosmetics using alternatives to animal experiments
December 1, 2019
Efforts to create guidance for evaluating skin irritation in quasi-drug applications (2nd report)
November 22, 2019
Consideration on the safety of cosmetics: In terms of alternatives to animal experiments
July 11, 2019
The Gap between Regulatory Framework and Safety Assessment -Skin irritation assessment for quasi drug and cosmetic ingredient-
Recently published papers on alternatives to animal experiments in which JCIA was involved.
Support for the Japanese Society for Alternatives to Animal Experiments, etc.
JCIA has been supporting the Japanese Society for Alternatives to Animal Experiments as a platinum member and contributing to research and development of alternatives to animal experiments. We received a letter of appreciation for our long-term contribution.
