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Korea Updates Guide for Chemical Testing Methods (Updated on June 2, 2023)

South Korea’s authority shows strong commitment to promoting alternatives to animal testing methods.

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

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