ASTM D 8588:2024

1.1 This practice is not meant to classify the non-cannabinoid ingredient or final product as safe for inhalation. Inhaling anything other than clean air poses an inherent human health risk. 1.2 This practice shall outline the steps for calculating the acceptable daily inhalation limit from a point of departure (POD) for a non-cannabinoid ingredient intended for use in a cannabinoid product for vaporization. Note 1: To use this practice, the user must have previously determined the POD for the non-cannabinoid ingredient under investigation and six uncertainty factors stated in this standard and correction factors. 1.3 This practice shall outline the steps for identifying the maximum allowable concentration limit of a non-cannabinoid ingredient that could be used in a proposed formulation from a POD or a defined TTC. 1.4 This practice shall outline the steps for comparing the concentration of a non-cannabinoid ingredient in an existing formulation to the calculated acceptable daily inhalation limit from a POD or a defined TTC of the non-cannabinoid ingredient under investigation. 1.5 This practice shall provide example scenarios to aid in the usage of the practice and understanding of how to perform the calculation. 1.6 This practice shall not define the means for calculating the acceptable daily inhalation limit from data generated in vitro . 1.7 This practice shall not define the means for calculating the acceptable daily inhalation limit from a lethal dose (for example, LC50 or LD50). 1.8 This practice shall not define the means for determining a POD or TTC for the non-cannabinoid ingredient under investigation. 1.8.1 A user must complete a toxicological risk based assessment to determine a POD or TTC for a non-cannabinoid ingredient under investigation. It is recommended to consult an experienced toxicologist when conducting the risk assessment. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

11.120.99