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ROUTES OF EXPOSURE The toxicity of an elemental impurity is related to its extent of exposure (bioavailability). The extent of exposure has been determined for each of the elemental impurities of interest for three routes of administration: oral, parenteral, and inhalational. These limits are based on chronic exposure.
Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day. 3.2. Methods for establishing exposure limits
24 de sept. de 2022 · This document presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.
Recommended limits of Class 1 and 2 solvents or classification of solvents may change as new safety data becomes available. Supporting safety data in a marketing application for a new drug product containing a new solvent may be based on concepts in this guideline or the concept of
17 de feb. de 2022 · The updated EU law aims at strengthening workers’ protection against carcinogenic and other hazardous substances, by setting EU-wide occupational exposure limits. MEPs succeeded in including reprotoxic substances within the scope of the Directive for the first time.
Occupational exposure limit (OEL) values are derived within two legal frameworks that form an integral part of the EU’s mechanism for protecting the health of workers.
The paper states that at an exposure level below 0.5 ppm, cancer risks are low, and below 0.25 ppm, cancer risks can be ruled out. According to the position paper, 0.25 ppm can be considered a safe exposure level, and lowering exposure below this safe level brings no actual health benefits.
