Setting Occupational Exposure Limits for Genotoxic Substances in the Pharmaceutical Industry
In the pharmaceutical industry, genotoxic drug substances are developed for life-threatening indications such as cancer. Healthy employees handle these substances during research, development, and manufacturing; therefore, safe handling of genotoxic substances is essential. When an adequate preclini...
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Veröffentlicht in: | Toxicological sciences 2016-05, Vol.151 (1), p.2-9 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | In the pharmaceutical industry, genotoxic drug substances are developed for life-threatening indications such as cancer. Healthy employees handle these substances during research, development, and manufacturing; therefore, safe handling of genotoxic substances is essential. When an adequate preclinical dataset is available, a risk-based decision related to exposure controls for manufacturing is made following a determination of safe health-based limits, such as an occupational exposure limit (OEL). OELs are calculated for substances based on a threshold dose-response once a threshold is identified. In this review, we present examples of genotoxic mechanisms where thresholds can be demonstrated and OELs can be calculated, including a holistic toxicity assessment. We also propose a novel approach for inhalation Threshold of Toxicological Concern (TTC) limit for genotoxic substances in cases where the database is not adequate to determine a threshold. |
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ISSN: | 1096-6080 1096-0929 |
DOI: | 10.1093/toxsci/kfw028 |