Updates:
On June 2, 2023, by NEIR Announcement No. 2023-19, South Korea's NIER adopted the revisons to guidelines for 9 testing methods and the addtion of 2 alternatives to animal testing methods, which took effect immediately.
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Recently, South Korea’s National Institute of Environment Research (NIER) drafted updates to the Guide on Testing Methods of Chemicals (hereinafter referred to as Guide), based on K-REACH, K-REACH Enforcement Rules, and OECD Guidelines for the Testing of Chemicals. The proposed updates are focused on health effects, including revisions to guidelines for nine existing testing methods and the addition of two new testing methods. Among the eleven involved testing methods, eight are alternatives to animal testing methods. The public consultation ended on May 8, 2023.
Background
The development of alternatives to animal testing is an important issue in global regulatory affairs, and the OECD Guidelines are accepted internationally as standard methods for safety testing. The guidelines serve as a unique tool for assessing the potential effects of chemicals on human health and the environment and are continuously expanded and updated to reflect the latest scientific techniques. As an OECD member country, South Korea has taken a proactive approach to avoiding unnecessary testing on animals by amending relevant laws and regulations.
The proposed updates to the Guide reflect South Korea's commitment to promoting alternatives to animal testing methods.
Proposed updates
The Guide provides guidelines for testing methods in four sections, including:
I. Physical-Chemical Properties (22 testing methods);
II. Effects on Biotic Systems (16 testing methods);
III. Biodegradability and accumulation (14 testing methods); and
IV. Health Effects (70 testing methods).
The proposed updates focus on ‘Health Effects’. Among the 70 testing methods in this regard, guidelines for 9 testing methods are to be revised (see Table 1 below).
Table 1
No. | Testing Method | OECD TG No. (TG: Testing Guideline) | Alternatives to Animal Testing or Not |
4 | Acute Eye Irritation/Corrosion Test Method | 405 | No |
5 | Skin Sensitization Test Method | 406 | No |
14 | Toxicokinetics Test Method | 417 | No |
27 | In Vitro Skin Irritation (Reconstructed Human Epidermis Test Method) | 439 | Yes |
33 | Skin Sensitization Test Method (Local Lymph Node Assay) | 429 | Yes |
34 | Skin Sensitization Test Method (Local Lymph Node Assay: DA) | 442A | Yes |
36 | In Chemico Skin Sensitization Test Method (Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins) | 442C | Yes |
54 | Estrogen Receptor Transcriptional Activation Assays | 455 | Yes |
68 | Vitrigel-Eye Irritancy Test Method | 494 | Yes |
The NIER also proposed to add 2 alternatives to animal testing methods regarding health effects as follows (see Table 2 below).
Table 2
No. | Testing Method | OECD TG No. (TG: Testing Guideline) | Alternatives to Animal Testing or Not |
71 | Defined Approaches on Skin Sensitization (Defined Approaches: 2 out of 3 methods) | 497 | Yes |
72 | In vitro Phototoxicity - Reconstructed Human Epidermis (RhE) Phototoxicity Test Method | 498 | Yes |