Specific concentration limit as a tool for classifying mixtures by human health hazards. Part 2. Methods of determination: A systematic review

UDC: 
66-914.7-026.86 (1-67ОЭСР) + 615.9: 54.01 (1-67ОЭСР)
DOI: 
10.21668/health.risk/2026.1.17.eng
Authors: 

D.S. Valuyeu

Organization: 

Avrora Production Complex LLP., 401-40 Maskeu Str., Astana, Z10X5D6, Republic of Kazakhstan

Abstract: 

The work is a systematic review focused on analyzing methods for determining specific concentration limits (SCL) for chemicals hazardous to human health.

The literature search was conducted up to November 2024 in the electronic databases PubMed, Google Scholar, and CyberLeninka, and up to April 2025 in ScienceDirect and eLIBRARY.RU. Outside the scope of the systematic review, the possibility of determining SCL using alternative methods (AM) described in OECD standards was analyzed for substances cor-rosive/irritating to skin, able to cause serious eye damage/irritation, or skin sensitizers.

The review included publications in Russian and English describing experimental and calculation approaches to es-tablishing SCL. Studies related to waste were excluded. Screening and assessment of publications were performed by a single author; data synthesis was descriptive.

A total of 14 studies were included in the systematic review. No methods for determining SCL were identified for respiratory sensitizers and mutagens. For substances causing skin corrosion/irritation, serious eye damage/irritation, and for skin sensitizers, current regulatory practice relies on in vivo approaches and human data. To reduce the number of laboratory animals and optimize the procedure for establishing SCL for substances corrosive/irritating to skin and eyes, the author proposed a basic concentration range (BCR) designed to enable more efficient use of AM.

For skin sensitizers, carcinogens, and reproductive toxicants, SCL are determined based on toxicant potency and hazard (sub)class, which may complicate the implementation of a similar approach in the EAEU. Moreover, the numerical descriptor ranges used for substance categorization are often based on expert consensus.

The review did not include publications in other languages or those from paid-access databases; quantitative synthesis was not conducted due to the qualitative nature of the data.

This work identified critical gaps in the existing methods for determining SCL, highlighting the need developing and validating new test systems suitable for integration into regulatory practice.

Keywords: 
specific concentration limit, methods of determination, systematic review, cut-off value, concentration limit, chemicals, alternative methods, OECD standards
Valuyev D.S. Specific concentration limit as a tool for classifying mixtures by human health hazards. Part 2. Methods of determination: a systematic review. Health Risk Analysis, 2026, no. 1, pp. 176–189. DOI: 10.21668/health.risk/2026.1.17.eng
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Received: 
15.10.2025
Approved: 
01.12.2025
Accepted for publication: 
26.03.2026

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