The effects of vehicles on the human dermal irritation potentials of allyl esters.
Allyl esters, frequently used in the fragrance industry, often contain a certain percentage of free allyl alcohol. Allyl alcohol is known to have a potential for delayed skin irritation. Also present in the finished product are different solvent systems, or vehicles, which are used to deliver the fragrances based upon their intended application. This study was conducted to determine whether different vehicles affect the skin irritation potential of five different allyl esters. The allyl esters tested were allyl amyl glycolate, allyl caproate, allyl (cyclohexyloxy)acetate, allyl cyclohexylpropionate, and allyl phenoxyacetate in the vehicles diethyl phthalate, 3:1 diethyl phthalate:ethanol, and 1:3 diethyl phthalate:ethanol at concentrations of 0.1%, 0.5%, 1.0%, and 2.0% (w/w). A modified cumulative irritation test was conducted in 129 human subjects. Test materials (0.3 ml) were applied under occlusion to skin sites on the back for 1 day (24 h) using Hill Top chambers. Irritation was assessed at 1, 2, 4, and 5 days following application of test materials. Cumulative irritation scores varied considerably among test materials. There were no delayed irritation observations. The highest irritation scores were observed at the 2.0% concentration for all test materials. The irritation scores for allyl amyl glycolate, allyl (cyclohexyloxy)acetate, and allyl phenoxyacetate were highest in 1:3 diethyl phthalate:ethanol, thus the resulting calculated no-observed-effect levels, 0.12%, 0.03%, and 0%, respectively, were much lower for this vehicle compared to the diethyl phthalate vehicle, 0.33%, 0.26%, 0.25%, respectively. These data showed a trend for lower concentration thresholds to induce irritation when higher levels of ethanol were used in the vehicle.
Politano
Valerie T
VT
Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ 07677, USA. vpolitano@rifm.org
Isola
Daniel A
DA
Lalko
Jon
J
Api
Anne Marie
AM
D004952:Esters / Q000633:toxicity*; D000431:Ethanol / Q000633:toxicity*; D006801:Humans; D007509:Irritants / Q000633:toxicity*; D010476:Perfume / Q000592:standards; D014677:Pharmaceutical Vehicles / Q000633:toxicity*; D010795:Phthalic Acids / Q000633:toxicity*; D020005:Propanols / Q000633:toxicity; D012867:Skin / Q000187:drug effects / Q000473:pathology; D023422:Skin Irritancy Tests; D012952:Societies / Q000592:standards
D004952:Esters; D007509:Irritants; D010476:Perfume; D014677:Pharmaceutical Vehicles; D010795:Phthalic Acids; D020005:Propanols; D000431:Ethanol; C006463:allyl alcohol; C007379:diethyl phthalate