PREVENTION OF HAZARDS FROM CHRONIC TOXICITY' OF COSMETICS 327 indicated the absence of chronic toxicity including carcinogenic activity in these substances. Similar tests have also been carried out on certain non-ionic surfactants used as emulsifiers. These showed no toxic effects at reasonable dosage levels by mouth, but when applied topically, certain of these substances have been found to promote the formation of turnours in mice and rabbits after the application of a known carcinogenic initiating agent. As similar results have been found with sodium stearate, there is need for a clearer understanding of the significance of these experiments and their extension to include a wider range of surface active agents. The 5th Report of the Joint Expert Committee of FAO/WHO entitled "Evaluation of the Carcino- genic Hazards of Food Additives" states: "It has been demonstrated, under certain experimental situations, that carcinogenesis may be a two-stage process involving an 'initiator' and a 'promotor' which may be separate agents. This aspect of carcinogenesis is so far insufficiently understood or generalised to be considered in the present practical context." The demonstration that a substance has a promoting action should not, in itself, justify its exclusion from cosmetic formulations. For surface active substances, not only the individual toxicity but the effect of surface active substances on absorption by the skin of accompanying substances must be considered. Testing should be directed toward the evaluation of complete products as well as of the individual constituents. The published and unpublished evidence on the toxicology of surface active agents should be reviewed for the purpose of developing a list of substances considered unsuitable for use in cosmetics. Hormones Until more evidence is forthcoming, the female sex hormones should only be permitted for use in cosmetics under Category C.-Ext. if the label bears clear statements on the following points: 1. Official name of hormone and full formula of products. 2. The concentration expressed in International Units and this not to exceed 350 I.U. per g. 3. For use only by women over 30 years of age and never more than 15 g of the preparation per week. 4. Not to be used while handling infants and not to be applied to the skin of children.
328 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Vehicles and Solvents The vehicles and solvents in general use comprise the major part of cosmetic products. They are all "resident" materials except Freons, alcohol and water. Subject to further evidence showing contrary indications, the following were considered safe in use for all types of cosmetics: Category C. Solids: Talc, magnesium carbonate, kaolin, starch, zinc oxide, zinc carbonate, zinc stearate, titanium oxide, magnesium stearate, aluminium stearate, calcium stearate, aluminium hydroxide, alu~ minium silicate, calcium sulphate, barium sulphate, bentonite, calcium carbonate, calcium phosphate, calcium hydrogen phos~ phate, calcium pyrophosphate, fatty acids, hydrogenated vegetable and animal oils, spermaceti, fatty alcohols, ozokerite, beeswax, carnauba wax, candelilla wax, sugar cane wax, gum tragacanth, gum acacia, alginates, carragheenates, modified celluloses, poly- vinyl pyrrolidone. (The last six named are used as solutions or dispersions in water or alcohol.) Liquids: Water, aromatic waters, ethyl alcohol, isopropyl alcohol, glycerol, propylene glycol, polyethylene glycols, polypropylene glycols, hexylene glycol, sorbitol 70%, edible oils and fats, fatty acids, the butyl-isopropyl-, and ethyl esters of fatty acids, lanolin, oleyl alcohol, ethyl lactate, butyl lactate. The following were considered acceptable subject to special purity requirements to ensure freedom from carcinogenic impurities: Mineral oil, liquid paraffin, kerosene, petroleum jelly, paraffin wax, microcrystalline WaX o Category C.-t•xt. The following were considered safe in special usages, for example, in nail varnishes--acetone, dibutylphthalate, dioctylphthalate, nitrocellulose, Category C.-W.R. In pressurized products -- trichlorofluoromethane, dichlorodifluoro~ methane, trichlorotrifluoroethane, nitrogen, carbon dioxide, nitrous oxide, vinyl chloride, methylene chloride, propane/butane mixtures in minor concentrations. The following were considered unacceptable for use in cosmetics: Carbon tetrachloride, methyl alcohol except for denaturation of ethyl alcohol.
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