South Korea Releases Guidelines for Animal Testing Alternative Methods and Risk Assessment

1. Two Guidelines for animal testing alternative methods: In Vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method ^[3] and In Vitro Membrane Barrier Test Method for Skin Corrosion ^[4]

These 2 Guidelines include principles of the test, considerations and limitations, method of the test, approval requirements, result and report of the test.

Until now, South Korea has released 21 guidelines for alternative methods. The following shows the details: ^[5]

No.	Year of Adoption	Test Guidelines	3R Principle
1	2007	Skin Sensitization: Local Lymph Node Assay	Reduction and Refinement
2	2007 (revised in 2018)	In Vitro 3T3 NRU Phototoxicity Test	Replacement
3	2008 (revised in 2018)	Acute Oral Toxicity: Fixed Dose Procedure	Reduction and Refinement
4	2008 (revised in 2018)	Acute Oral Toxicity: Acute Toxic Class Method	Reduction and Refinement
5	2009	Skin Absorption: In Vitro Method	Replacement
6	2013	Skin Sensitization: Local Lymph Node Assay: DA	Reduction and Refinement
7	2013	Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA	Reduction and Refinement
8	2008 (revised in 2014)	Bovine Corneal Opacity and Permeability (BCOP) Test Method	Replacement
9	2014	In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method	Replacement
10	2015	Isolated Chicken Eye Test Method	Replacement
11	2015 (revised in 2018)	Acute Oral Toxicity: Up-and-Down-Procedure (UDP)	Reduction and Refinement
12	2016	In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)	Replacement
13	2016	Reconstructed human Cornea-like Epithelium (RhCE) Test Method	Replacement
14	2017	In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test Method	Replacement
15	2017	In Vitro Skin Sensitization Assays: h-CLAT	Replacement
16	2017	Short Time Exposure In Vitro Test Method	Replacement
17	2018	Transcutaneous Electrical Resistance Test Method (TER)	Replacement
18	2018	Local Lymph Node Assay: BrdU-FCM	Reduction and Refinement
19	2019	In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test	Replacement
20	2019	In vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method	Replacement
21	2019	In Vitro Membrane Barrier Test Method for Skin Corrosion	Replacement

2. Guideline for Risk Assessment of Human Applied Products ^[6]

This guideline includes the overview, risk assessment system, methods, related regulations, etc. and applies to cosmetics, food, medicines, medical devices, etc.

Products Require Risk Assessment:

Products

1) Human applied products that are prohibited from being manufactured or sold by international institutions and foreign governments in consideration of possible harm to human health

2) Human applied products that do not specify safety standards and specifications

3) Other human applied products that have been proven to be harmful to human health

Risk Elements

Chemical: Pesticide residues, heavy metals, food additives, residues of medicines for animals, environmental pollutants, substances produced in manufacturing/processing/cooking, radioactivity, etc.
Physical: The state and foreign matters of food
Microorganism: bacteria that induce food poisoning, antibiotic-resistant bacteria, etc.
Other ingredients used in human applied products, and chemical, physical and microorganism factors