South Korea partially revised the regulations on test methods for chemical substances.

Date
14 Jun 2023

Chemical authorisation

GPC - Global Product Compliance

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted on a draft amendment of the regulation on test methods for chemical substances under the Act on Registration and Evaluation of Chemicals (K-REACH). This was to update the regulation based on updated international chemical regulations, including OECD’s animal alternative test methods. 

On the 2nd of June 2023, according to Article 14 (1) of the Chemical Substances Registration Evaluation Act and Article 5 (1) 1 of the Enforcement Rules of the same Act, 11 items were revised to reflect the latest chemical test methods (122 items). Test methods for chemical substances were partially revised, 9 test items in the field of health effect test and added 2 new items.  

 

 

clause 4 - Eye irritation and serious eye damage test 

clause 5 - Skin Sensitization Test 

clause 14 - Toxicokinetic test 

clause 27 - In vitro skin irritation test (human skin model test) 

clause 33 - Skin hypersensitivity test (regional lymph node test, LLNA) 

clause 34 - Skin sensitization test (regional lymph node test, LLNA: DA) 

clause 36 - Chemical skin sensitization test (peptide binding test, amino acid derivative binding test, dynamic peptide binding test) 

clause 54 - Estrogen receptor transcriptional activity test 

clause 66 - Eye irritation test using Vitrigel. 

 

 

clause 71 - Skin sensitivity test (Defined Approached: 2 out of 3 methods) 

clause 72 - In vitro human skin model (RhE) phototoxicity test  


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