278 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS I. Acu'rm O•A•. ToxiciTY These studies were conducted on white rats and guinea pigs. The ma- terials to be studied were administered directly into the stomachs of the animals by means of a stomach tube, thereby insuring accurate dosage. The following results were obtained. (See Table I for details.) TA•L•. 1 White Rats-- - Guinea Pigs L.D., 0 L.D., 50 L.D., 100 L.D., 0 L.D., 50 L.D., 100 10% aqueous 70 cc./kg. 80 cc./kg. 90 cc./kg. 75 cc./kg. 90 cc./kg. 100 cc./kg solution of (7 grn.) (8 grn.) (9 grn.) (7.5 gm.) (9 gm.) (lO gin.) a soap con- taining 2070 Actaruer 10% aqueous 75 cc./kg. 85 cc./kg. 90 cc./kg. 75 cc./kg. 85 cc./kg. 95 cc./kg. solution of (7.5 grn.) (8.5 gin.) (9 grn.) (7.5 grn.) (8.5 grn.) (9.5 grn.) control (no Actaruer) Acute oral toxicity studies with Actamer in several solvents and suspend- ing agents are under way, but as yet have not been completed. The re- sults obtained in Table I on the acute oral toxicity studies indicate that soap containing ActameT is no more toxic than the control soap alone. II. EYE IRRITATION STUDIES These studies were conducted on albino rabbits in accordance with the method of Woodard and Draize of the Food and Drug Administration. Three materials were studied: 1. An aqueous 0.2% ActameT solution prepared from a soap containing 2% Actamer. 2. A 10% aqueous solution of control soap. (No ActameT.) 3. A 5% suspension of Actamer in Corn Oil. Results The above three substances produced no evidence of eye irritation or damage in the animals studied. III. NINET¾-D^¾ SUIt^CUTE PEP. CUTANEOUS STUDIES A 1% solution of Actamer was prepared in dimethyl phthalate. Four groups often rabbits each were treated as follows: Group I--1 cc/kg. of a 1% solution of ActameT in dimethyl phthalate. Group II--2 cc./kg. of a 1% solution of ActameT in dimethyl phthalate. Group III--4 cc./kg. of a I% solution of ActameT in dimethyl phthal- ate. Group IV--Dimethyl phthalate control, using 4 cc./kg. of dimethyl
:r:. TOXICITY STUDIES ON ACTAMER 279 ?:Phthalate. Approximately 10% of the total body area of each animal was )::.clipped to expose the skin. It was to this exposed area that the Actamet i.?ii!solutJon was applied daily, five days per week, for ninety days. •!•/. Table 2 shows the average weights of the animaIs in each group, at the il)11i beginning of the experiment, at the end of thirty days, at the end of sixty i(days, and at the end of ninety days. As may be seen from this chart, the !'•:i:.: average gain in groups 1, 2, and 4 was considerably greater than the weight !!i::gain in group 3. .... ili:' TABLE 2--AVERAGE WEIGHTS OF RABBITS (90-DAY ACTAMER STUDIES) Group Start 30 days 60 days 90 days I--1 cc./kg. Actamer 2652 2902 3128 3222 I1--2 cc./kg. 2484 2687 3014 3090 1II--4 cc./kg. 2028 2118 2264 2383 IV--Control 1719 2055 2574 2915 7•,: Group I--None died. ß :. Group II--Two died one on the 41st day and one on the 84th day. "(' Group III--Four died one on the 15th day, one on the 26th day, one on ß the 37th day, one on the 75th day. Group IV--One died on the 23rd day, one died on the 27th day. All ß ß-.animals which died were autopsied and tissues were taken for histologic' -:i 'studies. In addition to the animals which died at least five animals in each :::group were sacrificed for autopsy at the end of the ninety-day period. The : following reports are the average findings for each group: ß :::) Group 1--Low Dosage: ::: Gross--Negative ::::" Histologic: i:5:: Skin--Normal. . Striate Muscle--Normal. .•.: Stomach--Normal. if: Intestine--Normal. Liver--Cloudy, swelling. Spleen--Normal (congestion). Lung--Congestion, focal atelectasis, and emphysema. Kidney--Glomerular hyperemia. Cloudy swelling of uriniferous tubules. Brain--Focal edema, congestion, occasional neuronal degeneration. Group II--Mediu m Dosage: Gross--Negative. Histologic: Skin--Normal. Striate Muscle--Normal. Stomach--Edema of surface mucosa. Intestine--Normal.
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