Fragrance material review on 16-hydroxy-7-hexadecenoic acid lactone

Abstract

A toxicologic and dermatologic review of 16-hydroxy-7-hexadecenoic acid lactone when used as a fragrance ingredient is presented. 16-Hydroxy-7-hexadecenoic acid lactone is a member of the fragrance structural group macrocyclic lactone and lactide derivatives. The fragrance ingredient described herein is one of 12 structurally diverse C14, C15 and C16 compounds that include (1) saturated mono-and (2) saturated di-ester lactones and (3) unsaturated lactones. For the latter, the double bond is not adjacent to (in conjugation with) the ester group. This review contains a detailed summary of all available toxicology and dermatology papers that are related to 16-hydroxy-7-hexadecenoic acid lactone and is not intended as a stand-alone document. Available data were evaluated, then summarized, and include physical properties data. A safety assessment of the entire macrocyclic lactone and lactide derivatives will be published simultaneously with this document. Please refer to Belsito et al., 2011 for an overall assessment of the safe use of this material and all macrocyclic lactone and lactide derivatives in fragrances.

Belsito, D., Bickers, D., Bruze, M., Calow, P., Dagli, M., Fryer, A.D., Greim, H., Hanifin, J.H., Miyachi, Y., Saurat, J.H., Sipes, I.G., 2011. A toxicologic and dermatologic assessment of macrocylic lactones and lactide derivatives when used as fragrance ingredients.

Introduction

This document provides a comprehensive summary of the human health toxicological data currently available pertaining to the safety evaluation of 16-hydroxy-7-hexadecenoic acid lactone when used as a fragrance ingredient. All safety data on 16-hydroxy-7-hexadecenoic acid lactone (see Fig. 1; CAS Number 123-69-3) was compiled with due diligence including published and unpublished data.

In 2010, a complete literature search was conducted on 16-hydroxy-7-hexadecenoic acid lactone. On-line toxicological databases were searched including those from the Chemical Abstract Services (e.g. ToxCenter [which in itself contains 18 databases including Chemical Abstracts]) and the National Library of Medicine (e.g. Medline, Toxnet [which contains 14 databases]) as well as 26 additional sources (e.g. BIOSIS, Embase, RTECS, OSHA, ESIS). In addition, all RIFM sponsored studies and studies from fragrance companies are included in this summary.

Data from all relevant references are summarized in this fragrance material review (FMR). Commonly used terms and their abbreviations are listed in Appendix A. References that are not included are listed in Appendix B. More details have been provided for unpublished data. The number of animals, sex and strain are always provided unless they are not given in the original report or paper. Papers in which the vehicles and/or the doses are not given were included and noted in this summary because either they demonstrated an adverse effect or there were limited to no data on this fragrance ingredient.