Implementation of the dermal sensitization Quantitative Risk Assessment (QRA) for fragrance ingredients.

Significant developments have recently been incorporated in the way dermal sensitization risk assessments are conducted for fragrance ingredients. Based on the RIFM Expert Panel's recommendation, RIFM and IFRA have formally adopted the QRA approach, refined for fragrance ingredients identified as contact allergens, as the core strategy for primary prevention of dermal sensitization to these materials in consumer products. This new methodology is a major improvement over the former approach because it specifically addresses the elements of exposure-based risk assessment that are unique to the induction of dermal sensitization, while being consistent with the principles of toxicological risk assessment. This methodology will be used to determine global fragrance industry product management practices (IFRA Standards) for potentially sensitizing fragrance ingredients, the first of which was implemented in May 2006 with the 40th Amendment to the IFRA Code of Practice. It contained the first four IFRA Standards based on the QRA, limiting the use of the materials for 11 individual product categories. One of the first four IFRA Standards based on the QRA was on the fragrance material citral. The basis for the acceptable exposure limits are presented in this paper.