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Description of ASTM-D8588 2024ASTM D8588-24Active Standard: Standard Practice for Approach to Calculating the Daily Inhalation Exposure Limit for a Non-cannabinoid Ingredient Intended for use in Cannabinoid Products for VaporizationASTM D8588Scope 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. Keywords additive; cannabis; CBD; CBDA; component; concentration; d9-THC; delta-8; formulation; hemp; industrial hemp; intoxicating; limit; marijuana; non-intoxicating; safety; THC; THCA; toxicity; toxicology; ICS Code ICS Number Code n/a DOI: 10.1520/D8588-24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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