Safety and health risk assessment methodology of dermal and inhalation exposure to formulated products ingredients

Consumers are commonly exposed to numerous chemical ingredients found in various formulated products especially household and personal care products. Therefore, identification of hazardous ingredients contained in those products should be performed at the early stages of product design to reduce the high cost of redesigning the products at the final stage. Thus, a systematic safety and health risk assessment methodology is required for the product formulation design. In this work, a two-step index-based methodology is presented to estimate the severity of the hazards and the magnitude of risks. In Tier 1 assessment, potential hazards of the ingredients were identified by following the Product Ingredient Safety Index (PISI). The basic toxicology information of ingredients was required for this assessment. In Tier 2 assessment, the extent of risks of the ingredients via dermal and inhalation exposure routes were evaluated. At this stage, the concentration of ingredients and the amount of exposure were considered. The value of Margin of Exposure (MOE) was used as an indicator in the development of Product Ingredient Exposure Index (PIEI). To demonstrate the proposed methodology, a case study on the evaluation of potential hazards and the risks from ingredients used in personal care product formulations were performed.