RIFM publishes special issue on safety assessment of unsaturated alcohols

The Research Institute for Fragrance Materials, Inc. (RIFM) has now published on the RIFM web site, www.rifm.org, in the Publications section, a special issue of Food and Chemical Toxicology, Volume 48, Supplement 3, on the RIFM Human Health Group Summary, A Safety Assessment of Non-cyclic Alcohols with Unsaturated Branched Chain when used as Fragrance Ingredients. It also continues to be available to subscribers of the RIFM Database.

“The Group Summary approach is part of our proactive program. We now have nine group summaries and 192 FMRs published.”

The Expert Panel is of the opinion that there are no safety concerns regarding unsaturated branched chain alcohols under the present declared levels of use and exposure. These alcohols are used in decorative cosmetics, fine fragrances, shampoos, and toilet soaps as well in non-cosmetic products such as household cleaners and detergents. The present group consists of eight primary, nine primary allylic, four secondary, one secondary allylic, five tertiary, and 15 tertiary allylic non-cyclic alcohols. Their common characteristic structural elements are one hydroxyl group per molecule, a C₄ to C₁₆ carbon chain with one or several methyl or ethyl side chains, and up to four non-conjugated double bonds. No evidence or only minimal evidence of skin irritation in humans was associated with current levels of use at 2-30% for individual compounds considered. The use of these materials under the declared levels of use and exposure will not induce sensitization; however for those already sensitized there may be a possibility of elicitation. All available data suggest that there is no indication for phototoxicity, acute toxicity, systemic toxicity (after repeated application), developmental toxicity, genotoxicity, or carcinogenicity. This assessment of unsaturated branched chain alcohols when used as fragrance ingredients was authored by the Expert Panel. The accompanying Fragrance Material Reviews were authored by RIFM staff.

The group assessment approach is based on structural relationship, enabling consistency in predicting metabolism and toxicity, and conserves resources by reducing duplicate testing. The group summary publications and related FMRs provide the scientific and regulatory communities with all the toxicological data available to RIFM on these fragrance ingredients. This includes RIFM sponsored studies, company sponsored studies and data that appear in the peer-reviewed literature. And, they provide the Expert Panel's safety assessment of these groups. The group summaries and FMR's continue to support the structure of RIFM's safety assurance program. They also are used by industry to meet REACH requirements. Dr. Anne Marie Api, RIFM Vice President, Human Health Sciences said, "The Group Summary approach is part of our proactive program. We now have nine group summaries and 192 FMRs published." There are plans to publish human health group summaries on Alcohol Branched Chain Saturated; Macrocyclic Ketones, Macrocyclic Lactones and Lactides, Aryl Alkyl Alcohols and Aryl Alkyl Alcohol Simple Acid Esters.