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

On Oct. 1st and 2nd, 2019, South Korea MFDS released 3 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 AdoptionTest Guidelines3R Principle
12007Skin Sensitization: Local Lymph Node AssayReduction and Refinement
22007 (revised in 2018)In Vitro 3T3 NRU Phototoxicity TestReplacement
32008 (revised in 2018)Acute Oral Toxicity: Fixed Dose ProcedureReduction and Refinement
42008 (revised in 2018)Acute Oral Toxicity: Acute Toxic Class MethodReduction and Refinement
52009Skin Absorption: In Vitro MethodReplacement
62013Skin Sensitization: Local Lymph Node Assay: DAReduction and Refinement
72013Skin Sensitization: Local Lymph Node Assay: BrdU-ELISAReduction and Refinement
82008 (revised in 2014)Bovine Corneal Opacity and Permeability (BCOP) Test MethodReplacement
92014In Vitro Skin Irritation: Reconstructed Human Epidermis Test MethodReplacement
102015Isolated Chicken Eye Test MethodReplacement
112015 (revised in 2018)Acute Oral Toxicity: Up-and-Down-Procedure (UDP)Reduction and Refinement
122016In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)Replacement
132016Reconstructed human Cornea-like Epithelium (RhCE) Test MethodReplacement
142017In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test MethodReplacement
152017In Vitro Skin Sensitization Assays: h-CLATReplacement
162017Short Time Exposure In Vitro Test MethodReplacement
172018Transcutaneous Electrical Resistance Test Method (TER)Replacement
182018Local Lymph Node Assay: BrdU-FCMReduction and Refinement
192019In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens TestReplacement
202019In vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test MethodReplacement
212019In Vitro Membrane Barrier Test Method for Skin CorrosionReplacement

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:

Products1) 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

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