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DNEL (Derived No-Effect Level) is the exposure level of a chemical substance that will not harm human health. Under the European Union's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation, manufacturers and importers of chemical substances must calculate DNELs as part of their chemical safety assessments.
DNELs are determined for a substance for a specific exposure route (oral, dermal, inhalation) and exposure duration (short or long term). These values are used in human health risk assessments and are an important tool for determining safe exposure levels.
The Derived No-Effect Level (DNEL) calculation is used to assess the potential effects of chemicals on human health. Here is a general method:
Data Collection: Toxicological data for the chemical substance is collected. This data may include animal experiments, in vitro tests, and human data.
Dose-Response Relationship: Using the collected data, the effects of the substance on human health at different doses are evaluated.
Safety Factors: Safety factors are applied to account for different uncertainties and variability. These factors include factors such as differences between humans and animals, individual sensitivities, and data quality.
DNEL Calculation: After the safety factors are applied, the DNEL value is calculated for a specific route of exposure (oral, dermal, inhalation) and duration of exposure (short-term or long-term).