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Employing the Forced Oscillation Technique for the Assessment of Respiratory Mechanics in Adults

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Evaluation of inhalation TTC values with the database RepDose.

S E Escher¹, I Tluczkiewicz, M Batke

¹Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany. Sylvia.Escher@item.fraunhofer.de

Regulatory Toxicology and Pharmacology : RTP

|July 6, 2010

Summary

The thresholds of toxicological concern (TTCs) can be applied to inhalation exposure, establishing safe limits for industrial chemicals. Proposed TTCs for non-genotoxic compounds are 3.6×10(-3) ppm for low toxicity and 2.4×10(-5) ppm for high toxicity.

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Area of Science:

Toxicology
Risk Assessment
Environmental Health

Background:

The thresholds of toxicological concern (TTCs) are established limit values for substances with unknown toxicity, ensuring safety for dietary intake.
The TTC concept is widely used for risk assessment of various substances and is being considered for broader applications, including cosmetic ingredients and pharmaceutical impurities.

Purpose of the Study:

To evaluate the applicability of the TTC concept for defining safe inhalation exposure limits for industrial chemicals.
To analyze inhalation thresholds for different toxicity classes (Cramer classes 1-3) using data from the RepDose database.

Main Methods:

Utilized a dataset of 203 industrial chemicals from the RepDose database.
Analyzed NOEC (no observed effect concentration) values for Cramer classes 1, 2, and 3 to determine inhalation thresholds.
Calculated thresholds using the 5th percentile of NOEC values and compared them to oral TTCs.

Main Results:

Inhalation thresholds for Cramer class 1 (low toxicity) and class 3 (high toxicity) were determined as 1.5×10(-3) ppm and 2.2×10(-5) ppm, respectively.
Inhalation thresholds, when converted to body doses, were found to be lower than oral TTCs, potentially due to the respiratory tract's sensitivity.
Excluding genotoxic compounds and organophosphates refined the TTCs, resulting in proposed values of 3.6×10(-3) ppm for class 1 and 2.4×10(-5) ppm for class 3.

Conclusions:

The TTC concept is applicable for setting inhalation exposure limits for industrial chemicals.
The respiratory tract's sensitivity necessitates lower TTC values for inhalation compared to oral exposure.
Specific inhalation TTCs for non-genotoxic compounds in Cramer classes 1 and 3 provide valuable benchmarks for risk assessment.