- MFDS released a Guideline on the In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test.
- Guideline for Cosmetic Ingredient Analysis is to be amended. Analytical methods for 6 preservatives and a UV filter are newly added.
1. On July 10, 2019, South Korean MFDS released a Guideline for the animal testing alternative method: In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test .
Until now, South Korea has released 19 Guidelines for alternative methods. The following shows the details .
|No.||Year of Adoption||Test Guidelines|
|1||2007||Skin Sensitization: Local Lymph Node Assay|
|2||2007 (revised in 2018)||In Vitro 3T3 NRU Phototoxicity Test|
|3||2008 (revised in 2018)||Acute Oral Toxicity: Fixed Dose Procedure|
|4||2008 (revised in 2018)||Acute Oral Toxicity: Acute Toxic Class Method|
|5||2009||Skin Absorption: In Vitro Method|
|6||2013||Skin Sensitization: Local Lymph Node Assay: DA|
|7||2013||Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA|
|8||2008 (revised in 2014)||Bovine Corneal Opacity and Permeability (BCOP) Test Method|
|9||2014||In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method|
|10||2015||Isolated Chicken Eye Test Method|
|11||2015 (revised in 2018)||Acute Oral Toxicity: Up-and-Down-Procedure (UDP)|
|12||2016||In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)|
|13||2016||Reconstructed human Cornea-like Epithelium (RhCE) Test Method|
|14||2017||In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test Method|
|15||2017||In Vitro Skin Sensitization Assays: h-CLAT|
|16||2017||Short Time Exposure In Vitro Test Method|
|17||2018||Transcutaneous Electrical Resistance Test Method (TER)|
|18||2018||Local Lymph Node Assay: BrdU-FCM|
|19||2019||In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test|
2. On July 25, 2019, South Korea released an announcement amending Guideline for Cosmetic Ingredient Analysis . The main amendments are as follows.
- Analytical methods for 6 preservatives are newly added.
- Analytical method for UV filter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, is newly added.
- Analytical method for 2,4-Diamino- pyrimidine-3-Oxide is newly added.
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