Document mVXd782bDbenQnx6kjzXG23Z

Interoffice Correspondence V Subject : November 14, 1974 ire: H. A. Birnbaum - 220-2E E. J. Deviny - 236-2B C. G. Klaus - 236-3A J. D. LaZerte - 236-1 J. A. Pendergrass - 220-2E F. A. bel - 220-2E TO: D. R. RICKER - COMMERCIAL CHEMICALS - 236-2B FM: J. E. LONG - MEDICAL DEPT. - TOXICOLOGY SERVICES - 220-2E Attached please find copies of the reports on the primary skin irritation and eye irritation assessments conducted with your FC-95 (T-1117) by WARF Institute. FC-95 was found to be non-irritating to the skin of albino rabbits under the study conditions utilized. No signs of dermal irritation were observed in any of the test animals at any time during the study period. This product was found to be minimally to mildly irritating to the eyes of albino rabbits under the study conditions utilized. The ocular irritation was limited to that of the conjunctivae in the six test animals at one, twenty-four, and forty-eight hours post-instillation. No conjunctival irritation was observed at the 72 hour examination. No signs of corneal opacity or iridal irri tation were observed in any of the test animals at any time during the study period. Flushing the eyes with plenty of water immediately upon contact should arrest/reverse the irritation pro cess. Precautionary label text should indicate that this product may be irritating to eyes. -JEL :mn bcc: H. A. Birnbaum - 220-2E E. J. Deviny - 236-2B C. G. Klaus - 236-3A J. D. LaZerte - 236-1 j. A. Pendergrass - 220-2E F. A. bel - 220-2E NOTE FOR 3M COPIES! T-1117 = FC-95, CC#7410-16 October 24, 1974 Dr. Donald L. Harris WARF Institute Biological Department P.0. Box 2599 Madison, WI 53701 Dear Dr. Harris: Under separate cover, I am forwarding one 3M sample labeled T-1117 to your laboratory. Please consider this to be a request/authorization for WARF Institute to con duct eye irritation and primary skin irritation assess ments with this sample. In order to assess the eye irritation potential, please instill one-tenth of one gram of test sample into the conjunctival sac of six albino rabbits. Hold the eyelid shut for one second and then examine the test eyes at one, 24, 48, and 72 hours post-instillation and score for ocular irritation according to the procedure of Draize. For the purpose of assessing the primary skin irri tation potential, apply five-tenths of one gram of test sample to intact (dry and wet) and abraded (dry and wet) skin test sites. At 24 and 72 hours post-application, examine the skin test sites and score for dermal irri tation according to the procedure of Draize. Our purchase order for $200 will be forwarded toyyau in the nearffuture. We thank you for your assistance and cooperation in this matter. Sincerely yours, JELrrnn J. E. Long, Sc.D. Medical Department Manager, Toxicology Services Interoffice Correspondence 3 m c. c. E. J. Deviny C. G. Klaus J. D. LaZerte 236-2A 236-3A 236-1 *f- \ U 1 Subject: Toxicity Testing of FC-95, CC 7^10-16 October 16, 197^ TO: J. E. Long - Toxicology - 220-2E FROM: D. Ricker - Comm. Chems. - 236-2B As per your suggestion, please arrange to have the following studies conducted on FC-95: 1) Primary Skin Irritation Assessment 2) Eye Irritation Assessment. I will send you a sample of FC-95 to be used for this testing. Please let me know under what T No. this testing will be done. Thank you DR:dl 1 ' H WARF INSTITUTE, INC. MAD ISON, W ISCO N SIN .. , . , , . tr. +hp work the results or to the Institute in any form m de Wi' h0:,, WriB' " aU,h ' " ' lOT tr " ' REPORT lnS,i' "" - Sample: T-1117 WARF No. 4102871 Date Received: 10-31-74 Submitted by: J . E . Long 3M Company St. Paul, Minnesota 55101 Testing requested: Skin Irritation Eye Irritation Conclusion: Under the conditions specified the product has a primary skin irritation index of zero and zero for both dry and wet applications and eye irritation scores of 8.00, 9.33, 3.33 and zero at 1, 24, 48 and 72 hours respectively. The product is not irritating to the skin and is irritating to the eye. Report approved by: Signed _ and for WARF Institute, Inc. Date: November 7, 1974 FORM 36- 4 I f f WARF INSTITUTE, IN C . MADISON, WISCONSIN Sample: T-1117 WARF No. 4102871 Primary Skin Irritation: Method: Albino rabbit? were used for this work. They were housed in individual screen bottom cages and fed water and rabbit chow ad libitum. The hair was clipped from the back and flanks of the animal. Five tenths of one gram of test material was placed in intimate contact with the skin on prepared test sites (intact-wet; abraded-wet), and covered with gauze patch and tape to maintain contact with the skin. After a 24 hour contact period, the coverings were removed and the degree of erythema and edema was recorded according to the scale below. Readings were taken again at 72 hours and the 24 and 72 hour readings used to determine the primary skin irritation score. Results : Animal Number ______24 Hours_____ Abraded Unabraded _____ 72 Hours_____ Abraded Unabraded Average 1 2 3 no noted irritation 4 all sites read negative 5 6 Primary skin irritation score: 0 Scale for Evaluation of Skin Reaction Erythema and Eschar Formation Score Edema Formation Score Slight erythema Defined erythema Moderate to severe erythema Severe erythema to slight eschar formation 1 Slight edema (barely 2 perceptible) 1 3 Defined edema (edges definite rising) 2 4 Moderate edema (area raised 1 mm) 3 Severe edema (raised more than 1 mm) 4 Score equals sum of erythema and edema readings. Skin irritation index equals average of 24 and 72 hour scores. F O R M 2B-4  WARF INSTITUTE, IN C . MADISON, WISCONSIN , Sample: T-1117 WARF No. 4102871 Primary Skin Irritation: Method: Albino rabbits were used for this work. They were housed in individual screen bottom cages and fed water and rabbit chow ad libitum. The hair was clipped from the back and flanks of the animal. Five tenths of one gram of test material was placed in intimate contact with the skin on prepared test sites (intact-dry; abraded-dry) , - cf*ecl with gauze patch and tape to maintain contact with the skin. After a 24 hour contact period, the coverings were removed and the degree of erythema and edema was recorded according ?o the scal below. Readings were taken again at 72 hours and the 24 and 72 hour readings used to determine the primary skin irritation score. Results : Animal Number _____ 24 Hours ____ Abraded Unabraded _____ 72 Hours_____ Abraded Unabradd Average 1 2 3 4 no noted irritation all sites read negative 5 6 Primary skin irritation score: 0 Scale for Evaluation of Skin Reaction Erythema and Eschar Formation Slight erythema Defined erythema Moderate to severe erythema Severe erythema to slight eschar formation Score 1 2 3 Edema Formation Score Slight edema (barely perceptible) Defined edema (edges definite rising) Moderate edema (area raised 1 mm) Severe edema (raised more than 1 mm) 1 2 3 4 Score equals sum of erythema Skin irritation index equals and edema readings, average of 24 and 72 hour scores. F O R M 2B-4 H WARF INSTITUTE, IN C . MADISON. WISCONSIN Sample: T-1117 WARF No. 4102871 Eye Irritation: Method: Adult albino rabbits of the New Zealand White variety were o l a c e ^ I c o l l a r such that the animals could not rub their eyes. Onetenth of a milliliter (0.1 gm for solids) of test substance was instilled in one eye, the other untreated eye served as a control. A series of six albino rabbits was used for each substance. The reaction to the test material was read according to the scale of scoring for damage to the cornea, iris and the bulbar and palpebral con^unctivae at 1, 24, 48 and 72 hours after eye instillation. Any residue of the test material and accumulated discharge are flushed from the eye each time they are scored. Administration: Concentration of test sample: as submitted Diluent or solvent: none Special washing: none Results : Rabbit Cornea Number Opacity H Iris Conjunctivae Redness Chemosis Discharge 1 hour 1 2 3 4 0 00 0 00 0 00 000 2 2 2 2 1 1 1 1 1 1 1 1 5 0 00 2 6 000 2 1 1 1 1 1 hour eye irritation score: 8 . 0 0 24 hours 1 2 3 4 5 6 000 000 000 0 00 000 000 2 2 2 2 2 2 1 1 2 1 2 2 1 1 1 1 1 2 24 hour eye irritation score: 9.33 48 hours 1 2 3 4 5 6 000 000 0 00 000 000 0 00 1 1 1 1 1 1 0 0 1 0 1 1 0 0 0 0 0 1 48 hour eye irritation score: 3.33 72 hour eye irritation score was zero. All readings were negative, F O R M 28-4