Criteria for development of a database for safety evaluation of fragrance ingredients.

Over 2000 different ingredients are used in the manufacture of fragrances. The majority of these ingredients have been used for many decades. Despite this long history of use, all of these ingredients need continued monitoring to ensure that each ingredient meets acceptable safety standards. As with other large databases of existing chemicals, fulfilling this need requires an organized approach to identify the most important potential hazards. One such approach, specifically considering the dermal route of exposure as the most relevant one for fragrance ingredients, has been developed. This approach provides a rational selection of materials for review and gives guidance for determining the test data that would normally be considered necessary for the elevation of safety under intended conditions of use. As a first step, the process takes into account the following criteria: quantity of use, consumer exposure, and chemical structure. These are then used for the orderly selection of materials for review with higher quantity, higher exposure, and the presence of defined structural alerts all contributing to a higher priority for review. These structural alerts along with certain exposure and volume limits are then used to develop guidelines for determining the quality and quantity of data considered necessary to support an adequate safety evaluation of the chosen materials, taking into account existing data on the substance itself as well as on closely related analogs. This approach can be considered an alternative to testing; therefore, it is designed to be conservative but not so much so as to require excessive effort when not justified.