Methyl salicylate, N.F. Mustard oil, volatile (allyl isothiocyanate), U.S.P. XII. Peppermint oil, N.F. Phenol, U.S.P. Phenyl salicylate (salol), N.F. XI. Pine oil, N.F. XII. Pine needle oil, dwarf, N.F. Rosemary oil, N.F. XII. Safrole. Sassafras oil, N.F. XI. Spearmint oil, N.F. Spearmint oil, terpeneless. Spike lavender oil, natural. Storax, U.S.P. Thyme oil, N.F. XII. Thymol, N.F. Tolu balsam, U.S.P. Turpentine oil, N.F. XI. If it is shown that none of the above single denaturants or combinations can be used in the manufacture of a particular product, the user may submit an application to the Chief, Chemical Branch, requesting permission to use another essential oil or substance having denaturing properties satisfactory to the Chief, Chemical Branch. In such a case the user shall furnish the Chief, Chemical Branch, with specifications, assay methods, the name and address of the manufacturer, and an 8-ounce sample of the denaturant for analysis. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. (2) A total of at least 3 pounds of any two or more denaturing materials listed under Formula No. 38-B, plus sufficient boric acid, N.F., or Polysorbate 80, N.F., to total 10 pounds of denaturant; or (3) Seven pounds of zinc chloride, U.S.P., 2.6 fluid ounces of hydrochloric acid, N.F., and a total of 3 pounds of any two or more of the denaturing materials listed under Formula No. 38-B. (b) Authorized uses. (1) As a solvent: 132. Mouth washes. 210. External pharmaceuticals, not U.S.P. or N.F. 244. Antiseptic solutions, U.S.P. or N.F. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). § 21.69 Formula No. 39. (a) Formula. To every 100 gallons of alcohol add: Nine pounds of sodium salicylate, U.S.P., or salicylic acid, U.S.P.; 1.25 gallons of fluid extract of quassia, N.F. VII; and % gallon of tert-butyl alcohol. (a) Formula. To every 100 gallons of alcohol add: Two and one-half gallons of diethyl phthalate and % gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soap and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). § 21.73 Formula No. 39-D. (a) Formula. To every 100 gallons of alcohol add: One gallon of bay oil (myrcia oil), N.F. XI, and either 50 avoirdupois ounces of quinine sulfate, U.S.P., 50 avoirdupois ounces of sodium salicylate, U.S.P. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). § 21.74 Formula No. 40. (a) Formula. To every 100 gallons of alcohol add % gallon of tert-butyl alcohol, and: One and one-half avoirdupois ounces of either (1) brucine alkaloid, (2) brucine sulfate, N.F. IX, (3) quassin, or (4) any combination of two or of three of those denaturants. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). § 21.75 Formula No. 40-A. (a) Formula. To every 100 gallons of alcohol add: One pound of sucrose octaacetate and % gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). § 21.76 Formula No. 40-B. (a) Formula. To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, N.F. (BITREX), and % gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. 142. Shampoos. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. 485. Miscellaneous solutions. (2) Miscellaneous uses. 812. Product development and pilot plant uses (own use only). (c) Conditions governing use. This formula shall be used only in the manufacture of products which will be packaged in pressurized containers in which the liquid contents are in intimate contact with the propellant and from which the contents are not easily removable in liquid form. (a) Formula. To every 100 gallons of alcohol add: Twenty-five fluid ounces of phenol, U.S.P., and 4 fluid ounces of methyl salicylate, N.F. (b) Authorized uses. (1) As a solvent: 220. An antiseptic, sterilizing, and bathing solution having restricted use. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). (c) Conditions governing use. This formula may be used only by institutions and organizations which are of a semipublic character and engaged in charitable work. Subpart E-Specifications for Denaturants § 21.91 General. Denaturants prescribed in this part shall comply with the specifications set forth in this subpart. However, in order to meet requirements of national defense of for other valid reasons, the Director may, pursuant to written application filed by the denaturer, authorize variations from such specifications or authorize the use of substitute denaturants if such variation or substitution will not jeopardize the revenue. Each such application shall identify the applicant by name, address, and permit number; state the number of each formula of specially denatured alcohol involved; explain why the use of the substitute denaturant, or the variation from specifications, as the case may be, is necessary; and include, as applicable, either the identity of the approved denaturant for which substitution is desired and the identity of the substitute denaturant (including the name of the manufacturer) or the identity of the prescribed specifications and the proposed variation from those specifications. The application shall be accompanied by an 8ounce sample of the proposed denaturing material for analysis. § 21.92 Denaturants listed as U.S.P. or N.F. Denaturing materials and products listed in this part as "U.S.P." or "N.F." shall meet the specifications set forth in the current United States Pharmacopoeia or National Formulary, or the latest volume of these publications in which the denaturants appeared as official preparations. § 21.93 Acetaldehyde. (a) Aldehyde content (as acetaldehyde). Not less than 95.0 percent by weight. (b) Color. Colorless. (c) Odor. Characteristic pungent, fruity odor. (d) Specific gravity at 15.56°/15.56° C. Not less than 0.7800. § 21.94 Acetaldol. (a) Purity. Not less than 90 percent by weight acetaldol as determined by the following method: Dissolve 15 grams of the acetaldol in distilled water and dilute to 1 liter in a volumetric flask. Transfer 5 ml of this solution to a 250 ml glass-stoppered flask containing 25 ml distilled water. Add 25 ml of a freshly prepared 1 percent sodium bisulfite solution. Prepare a blank omitting the acetaldol solution. Place the flasks in a dark place away from excessive heat or cold and allow to stand six hours. Remove flasks and titrate free bisulfite with 0.1 N iodine solution using starch indicator. Percent acetaldol by weight=(ml blank - ml test)x200×0.44/weight of sample Titrations in excess of 100 percent may be obtained if the sample contains appreciable amounts of acetaldehyde. (b) Specific gravity at 20° C. 1.098 to 1.105. § 21.95 Ammonia, aqueous. (a) Alkalinity. Strongly alkaline to litmus. (b) Ammonia content. 27 to 30 percent by weight. Accurately weigh a glass-stoppered flask containing 25 ml of water, add about 2 ml of the sample, stopper, and weigh again. Add methyl red indicator, and titrate with 1 N sulfuric acid. Each ml of 1 N sulfuric acid is equivalent to 17.03 mg of NH3 (c) Color. Colorless liquid. (d) Non-volatile residue. 2 mg maximum. Dilute a portion of the sample with 11⁄2 times its volume of distilled water. Evaporate 10 ml of this product to dryness in a tared platinum or porcelain dish. Dry residue at 105° C. for 1 hour, cool and weigh. (e) Odor. Characteristic (exceedingly pungent). (f) Specific gravity at 20°/4° C. 0.8920 to 0.9010. $21.96 Benzene. (a) Distillation range. (For applicable ASTM method, see 1980 Annual Book of ASTM Standards, Part 29, page 573, Standard No. D 836-77; for incorporation by reference, see § 21.6(b).) When 100 ml of benzene are distilled by this method, not more than 1 ml should distill below 77° C., and not less than 95 ml below 85° C. (b) Odor. Characteristic odor. (c) Specific gravity at 15.6°/15.6° C. 0.875 to 0.886. (d) Water solubility. When 10 ml of benzene are shaken with an equal volume of water in a glass-stoppered bottle, graduated to 0.1 ml, and allowed to stand 5 minutes to separate, the upper layer of liquid shall measure not less than 9.5 ml. § 21.97 Bone oil (Dipple's oil). (a) Color. The color shall be a deep brown. (b) Distillation range. When 100 ml are distilled in the manner described for pyridine bases, not more than 5.0 ml should distill below 90° C. (c) Pyrrol reaction. Prepare a 1.0 percent solution of bone oil in 95 percent alcohol. Prepare a second solution containing 0.025 percent bone oil by diluting 2.50 ml of the first solution to 100 ml with 95 percent alcohol. Dip a splinter of pine, previously moistened with concentrated hydrochloric acid, into 10 ml of the 0.025 percent bone oil solution. After a few minutes the splinter should show a distinct red coloration. (d) Reaction with mercuric chloride. Add 5 ml of the 1.0 percent bone oil solution above to 5 ml of a 2 percent alcoholic solution of mercuric chloride. A turbidity is formed at once which separates into a flocculent precipitate on standing several minutes. Add 5.0 ml of the 0.025 percent bone oil solution to 5.0 ml of a 2.0 percent alcoholic solution of mercuric chloride. A faint turbidity appears after several minutes. § 21.98 Brucine alkaloid. (a) Identification test. Add a few drops of concentrated nitric acid to about 10 mg of brucine alkaloid. A vivid red color is produced. Dilute the red solution with a few drops of water and add a few drops of freshly made dilute stannous chloride solution. A reddish purple (violet) color is produced. (b) Melting point. 178° ±1° C. Dry the alkaloid in an oven for one hour at 100° C., increase the temperature to 110° and dry to a constant weight before taking melting point. NOTE.-Brucine alkaloid tetrahydrate melts at 105° C. while the anhydrous form melts at 178° C. (c) Strychnine test. Brucine alkaloid shall be free of strychnine when tested by the method listed under Brucine Sulfate, N.F. IX. NOTE. If the brucine contains as much as 0.05 percent strychnine, a clear distinctive violet color, characteristic of strychnine, will be obtained. (d) Sulfate test. No white precipitate is formed that is not dissolved by hydrochloric acid when several drops of a |