Final amended report on the safety assessment of Mink Oil.

Mink Oil, obtained from the fatty tissues of minks, is a mixture of the natural glycerides of 14 to 20 carbon chain fatty acids. There are 100 current reported uses as a hair-conditioning agent, an occlusive skin-conditioning agent, and as a surfactant; up to a maximum concentration of 3%. Mink Oil is manufactured by harvesting animal hides and scraping the fat layer from the hide. It is rendered and refined using high temperature processes (230 degrees F to 240 degrees F) and saponification to reduce free fatty acids. Analyses demonstrate that Mink Oil can be substantially free of impurities, including pesticides. Mink Oil does not absorb significant UVA or UVB radiation. In a clinical test of skin penetration, 1 h after application, Mink Oil was detected on the skin surface of all five panelists; it was detected within the stratum corneum in 2/5 panelists. Mink Oil has an oral LD50 of > 64.0 cc/kg in albino rats. No erythema or edema was noted after refined Mink Oil was applied for 24 h to intact and scarified area of albino rabbits. A 50% dilution of a Mink Oil cream did not sensitize guinea pigs in a maximization test. Mink Oil was not an ocular irritant to albino rabbits. Clinical studies using single occlusive patches found no irritation with up to 2.8% Mink Oil, although transient mild to no irritation was noted in two exaggerated-use studies. Mink Oil is used in aerosols and sprays. Although there are no inhalation toxicity data available on Mink Oil, the available data on particle sizes of cosmetic aerosols and sprays indicates diameters more than an order of magnitude larger than the diameter of respirable particles. Most of the glycerides in Mink Oil are triglycerides (glyceryl triesters), the safety of which has been substantiated in previous safety assessments; e.g., dermal absorption is nil to slight; there is little or no acute, subchronic, or chronic oral toxicity; dermal application was not associated with significant irritation or sensitization; ocular exposures were, at most, mildly irritating; most of the genotoxicity test systems are negative; use as vehicles in carcinogenicity testing of other chemicals has produced no adverse reaction; and clinical tests produce no irritation or sensitization reactions--but, they may enhance the of penetration of other chemicals. Formulators should be aware of the possible penetration-enhancing properties of Mink Oil. Although pesticide residues have been analyzed and found to be below levels of detection, the Panel is concerned that the available data suggesting the absence of pesticide residues in Mink Oil are limited. The Panel advised the industry that the total polychlorinated biphenyl (PCB)/pesticide contamination should be limited to not more than 40 ppm, with not more than 10 ppm for any specific residue.