The Fragrance Materials Association (FMA) has announced the publication of its study "Skin contact transfer of three fragrance residues from candles to human hands." This study is the first publication of fragrance material transfer from a candle which previously was assumed to be a non-skin contact product. The study demonstrated that the transfer of limonene was below the limit of detection and that the transfer of cinnamic aldehyde and eugenol, 0.255 µg/cm2 and 0.279 µg/cm2 , respectively, were well below published No Effect Levels (NOEL) of 591 µg/cm2 and 5906 µg/cm2, respectively. The hand transfer data provide at least 1000 and 10,000 fold safety factors for cinnamic aldehyde and eugenol, respectively.
This study was commissioned in response to a new standard for cinnamic aldehyde in the 38th Amendment, one seen by FMA members as overly restrictive at 0.5%. Members had also raised concerns about the methodology used for setting non-skin contact use levels and the potential for the new restrictions to eliminate whole product lines such as scented candles, air fresheners and cleaning products.
FMAs William Troy brought these concerns to the attention of both the FMA Board and the IFRA Scientific Committee. The result was that the FMA Board agreed to the formation of a working group and the funding necessary to generate data that would save important product lines, and IFRA agreed to suspend the new standard for six months while FMA gathered data to fit into the Quantitative Risk Assessment (QRA) model that, at the time, was under development by RIFM.
In July 2004, representatives from FMA member companies formed a working group headed by Richard Signorelli, an expert in analytical chemistry. The committee comprised of Richard Signorelli (Belmay), Eileen Hedrick (Belmay), Steven Tanner (Arylessence), William Troy (Firmenich), David Niemeira (Novelle), Kevin Renskers (Takasago), Richard Sgaramella (Givaudan), Uma Parasar (IFF) and Margaret McGowen (FMA). The goal of the working group was to have a real world model for incidental skin contact for product categories including candles, air fresheners, fragranced blotters, cleaning agents, etc. The model product category chosen for this study was a candle.
In August 2004, a hand transfer study was designed, with FMA member companies providing fragrance mixtures, candles and technical expertise. Golden Pacific Labs, a contract lab with experience in skin transfer analysis, performed the study using state of the art HPLC/MS/MS technology under the direction of Sami Selim with FMA technical advisor Kevin Renskers and oversight by Margaret McGowen. The study design was based on routine hand transfer studies required by the EPA for pesticide testing. The study design used 10 human volunteers (20 hands). The volunteers were asked to grasp 3 x 6 inch pillar candles containing 5% by volume of a fragrance mixture with equal parts cinnamic aldehyde, limonene, eugenol and benzylacetate (solvent). Any fragrance material transferred to the hand was removed by isopropanol wipes. The wipes were analyzed and the results validated.
The study was designed and the data were gathered in less than six months so that the IFRA Board and Science Committee could evaluate the data. The final draft report of the study was accepted and approved by the working group in January 2005. As a result the 6 month suspension of the cinnamic aldehyde and eugenol Standards published in the 38th Amendment were continued with previous Standards reinserted until publication of the new Standards incorporating the FMA data. RIFM incorporated the data from the study into the QRA model and new standards for cinnamic aldehyde and eugenol were published as part of the 40th Amendment in May 2006. The Standards now read "Due to negligible skin contact, the concentration of the fragrance ingredient should not exceed the usual concentration of the fragrance compound in the finished product." This translates into 5% for cinnamic aldehyde since that is what the data support. The FMA wishes to thank RIFM for writing up the findings of the FMA study into the publication we announce in this article.
The FMA is pleased to have taken this initiative which fills a gap in the science of fragrance materials safety.
"Skin contact transfer of three fragrance residues from candles to human hands", Api A., Breadbenner A., McGowan M., Niemiera D., Parker L., Renskers K., Selim S., Sgaramella R., Signorelli R., Tefrow S, and Troy W. (2002) Regulatory Toxicology and Pharmacology 48, 279-283.