Document rBpy1gND9j1ZYqQG79E8mpyaV

project no; X-2y ~ t 's T7 REPORT FILE y Younger Laboratories INCORPORATED Q<miultiny and Analytical Seduced. CHEMICAL . . . MICROBIOLOGICAL . . . BIOLOGICAL 123 CLIFF CAVE ROAD Saint Louis, Mo., 63129 PHONE: (314) 846-2 540 June 28th, 1971 Ce/dijficate 0^ Analudid SUBJECT Toxicological Investigation Of: ts*> Decachlorobiphenyl - Aroclor 1272 Lot: OB 179021 Monsanto Sample Number 105 Monsanto Project Number Y-71-105 STUDY CONDUCTED FOR Monsanto Company, St. Louis, Missouri EXPERIMENTAL PROCEDURE - A) Acute Oral Minimal Lethal Dose (Rats, Mixed Sex) The diluted compound was fed by stomach tube to Sprague-Dawley strain albino male and female rats in increasing doses at increments of various, fractional log intervals. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. The data, together with the dilution at which the compound was fed, are shown in Table I. B) Acute Skin Absorption Minimal Lethal Dose (Rabbits, Mixed Sex) The diluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, intact skin of New Zealand white male and female rabbits. The treated areas were covered with plastic strips and the animals held in wooden stocks for periods up to twenty-four hours, after which time they were assigned to individual cages. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. The data, together with the dilution at which the compound was applied, are shown in Table II. DSW 295806 This confidential report is not to be used in any form of advertising without written permission STLCOPCB4065845 To: Monsanto Company St. Louis, Missouri Younger Laboratories Certificate of Analysis - Page 2 (6/28/71) - Y-71-105 EXPERIMENTAL PROCEDURE - (Continued) C) Skin Irritation (Rabbits, Mixed Sex) 0.5 Gram of finely ground sample moistened with water was applied to the clipped, intact skin of New Zealand white male and female rabbits under a one inch by one inch square patch, two single layers thick. The patches were held in place with adhesive tape. The trunk of each animal was wrapped with plastic strips, to retard evaporation and avoid contamination, for the twenty-four hour exposure period. Observations were made over a period of seven days for irritation. The data, scored according to the method of Draize, Woodard and Calvery (Journal of Pharm. and Exp. Therapeutics, Volume 82, December, 1944) are shown in Table III. D) Eye Irritation (Rabbits, Mixed Sex) One Hundred (100.0) milligrams of finely ground sample were placed in the conjunctival sac of the right eye of each of three albino male and female rabbits and observations made over a period of seven days for inflammation. The eyes were rinsed with warm isotonic saline solution after twenty-four hours. The data, scored according to the method of Draize, et al, are shown in Table IV. SUMMARY Dacachlorobiphenyl - Aroclor 1272-- Lot: OR 179021 A) Acute Oral Minimal Lethal Dose (Rats, Mixed Sex) The Acute Oral Minimal Lethal Dose for male and female rats was found to be greater than 7940 milligrams per kilogram. The compound was classed as practically non-toxic by oral ingestion in male and female rats. B) Acute Skin Absorption Minimal Lethal Dose (Rabbits, Mixed Sex) The Acute Skin Absorption Minimal Lethal Dose for male and female rabbits was found to be greater than 7940 milligrams per kilogram. The compound was classed as practically non-toxic by skin absorption in male and female rabbits. C) Skin Irritation (Rabbits, Mixed Sex) The compound was classed as non-irritating when applied as finely ground powder moistened with water to intact skin of male and female rabbits. The average maximum score was 0.0 out of a possible 8 during the seven day observation period. D) Eye Irritation (Rabbits, Mixed Sex) The compound was classed as a slight eye irritant in male and female rabbits. The average maximum score was 4.0 out of a possible 110 in one hour. YOUNGER LABORATORIES, INC. BY: MELVIN D. BIRCH DSW 295807 STLCOPCB4065846 To: Monsanto Company St. Louis, Missouri Younger Laboratories Certificate of Analysis - Page 3 (6/28/71) - Y-71-105 O TABLE I THE ACUTE ORAL MINIMAL LETHAL DOSE OF 'Decachlorobiphenyl - Aroclor 1272 -- Lot: OR 179021' FOR RATS Sample Fed As A 20.0# Solution-Suspension In Corn Oil Animal No. - Sex Weight Gm. Dose Mg._/Kg. Fate 1- Female 225 501 2- Male 230 1000 3- Female 200 2000 4- Male 210 3160 5- Female 200 5010 6- Male 205 7940 7- Female 205 7940 8- Male 200 7940 9- Female 210 7940 10- Male 205 7940 Survived Survived Survived Survived Survived Survived Survived Survived Survived Survived DISCUSSION - The Acute Oral Minimal Lethal Dose for male and female rats was found to be greater than 7940 milligrams per kilogram. The compound was classed as practically non-toxic by oral ingestion in male and female rats. There was no weakness or other outward signs of systemic toxicity. Surviving animals were sacrificed seven days after dosing. The viscera appeared normal by macroscopic examination. T\? : r. in. fins report L. to l.i -j us. d in dev tlopraent of 1 . ' ; : . ' . e !' , ma\ L\: r:i'v . n to ; v-io: - : - US \! *. in ac contacts. /: 7! 3 - - ; - *. .1! ./` ' c; j'cL to he riivi n-'.: ii 1. S 1 . ] ": ; v;i;n s. ',0 r 1. 0 the b-' 1 ' 1.; . i'.'iO:.' rne ; : vni of the b cl iboycvc- IV-*:!'; : . . I.oxvjP v ri-e C/: .rfoirn f :> iv'ouiriiv.i r: T-:n ' iv.a:.-. of i n: a i before to ttie Vied cal Depart- menl: in bt. Lou is for reply. ~ Monsanto Company DSW 295808 STLCOPCB4065847 To: Monsanto Company St. Louis, Missouri Younger Laboratories Certificate of Analysis - Page 4 (6/28/71) - Y-71-105 TABLE II -THE ACUTE SKIN ABSORPTION MINIMAL LETHAL DOSE OF 'Decachlorobiphenyl - Aroclor 1272 -- Lot: OR 179021' FOR RABBITS Sample Applied As A 50.0# Solution-Suspension In Corn Oil mal No. - Sex Weight Kg. Dose Mg./Kg. Weight Change 5 D ay s Later Kg. Fate 1 - Female 2.3 3160 2 - Male 2.4 5010 3 - Female 2.7 7940 4 - Male 2.4 7940 + 0.1 + 0.1 0.0 + 0.1 Survived Survived Survived Survived S76 DISCUSSION - The Acute Skin Absorption Minimal Lethal Dose for male and female rabbits was found to be greater than 7940 milligrams per kilogram. The compound was classed as practically non-toxic by skin absorption in male and female rabbits. There was no weakness or other outward signs of systemic toxicity. Surviving animals were sacrificed fourteen days after dosing. The viscera appeared normal by macroscopic examination. DSW 295809 STLCOPCB4065848 To: Monsanto Company St. Louis, Missouri Younger Laboratories Certificate of Analysis - Page 5 (6/28/71) - Y-71-105 TABLE III SKIN IRRITATION IN RABBITS AFTER APPLICATION OF 'Decachlorobiphenyl - Arcelor 1272 -- Lot: OR 179021' Sample (0.5 Gram) Applied As Finely Ground Powder Moistened With Water Numerical Evaluation At The End Of Animal No. - Sex 1 Hour 24 Hours 48 Hours 72 Hours 120 Hours 168 Hours 1 - Male 0 0 0 0 0 0 2 - Female 0 0 0 0 0 0 3 - Male 0 0 0 0 0 0 Average 0.0 0.0 0.0 0.0 0.0 0.0 <57 DISCUSSION - The compound was classed as non-irritating when applied as finely ground powder moistened with water to intact skin of male and female rabbits. The average maximum score was 0.0 out of a possible 8 during the seven day observation period. Observations following application ~ 1-Hour: 24- 168-Hours: No skin changes; zero readings No skin changes; zero readings SW 295810 STLCOPCB4065849 To: Monsanto Company St. Louis, Missouri Younger Laboratories Certificate of Analysis - Page 6 (6/28/71) - Y-61-105 TABLE IV EYE IRRITATION IN RABBITS AFTER APPLICATION OF 'Decachlorobiphenyl - Aroclor 1272 -- Lot: OR 179021' Sample (100.0 Milligrams) Applied As Finely Ground Powder Numerical Evaluation At The End Of Animal No. - Sex 1 Hour 24 Hours 48 Hours 72 Hours 120 Hours 168 Hours 1 - Male 4 0 0 0 0 0 2 - Female 4 0 0 0 0 0 3 - Male 4 0 0 0 0 0 Average 4.0 0.0 0.0 0.0 0.0 0.0 DISCUSSION - The compound was classed as a slight eye irritant in male and female rabbits. The average maximum score was 4.0 out of a possible 110 in one hour. Observations following application -- Immediate: 10-Minutes: 1-Hour: 24-Hours: 48- 168-Hours Discomfort was slight Slight to moderate discharge; no erythema or edema Moderate discharge; no erythema or edema Eyes normal; zero readings Eyes normal; zero readings DSW 295811 STLCOPCB4065850