Document B5j5NQRw4bLbe7MZqG04N3kvL

study Title Skin Irritation las. . 1 * B-203M i * M laboratory Project IP Haskell Laboratory Report No. 4-94 Author John V. Sarver Study Completed On February 25, 1994 Performing Laboratory * S ' A S S * - 5 3 a Medicine Haskell Laboratory^! ^ I lSc^ CBl P 06s noA1co^la'0 ,ed S^' Page 1 of 8 J!) Physical Fora: Coapositicn: Contaminants: Purity: Submitter's Notebook No.: cas Registry No._: Sponsor: Stud y Initiated - Completed: In Life Phase t h H a t e d - Completed: Yellow to amber seal-solid (at rooa temperature) Available from Sponsor upon request Available froa Sponsor upon request None submitted Specialty Chemicals . .M n v E. I. du Pont de Nemours and Company Wilmington, Delaware 12/6/93 - 2/25/94 12/7/93 - 12/10/93 - 2- tiiiMi DuPont HU A-94 c n . Irritation Toot with H-203A9 In RabbjH SUMMARY H-203M vas evaluated for acute aV in l r r t tatlon^potetitial^intO ^ ^ oe J= S '5.5.*:K S t g ais'sa s* ' duS^ t . , M.r the conditions of this study, H -203M ..s . uliht skin irritsnt. Work by: Scott Karr Toxicology Technician Revieved and Approved for Issue: Qo-~- T^ & ui John W. Sarver Study Director <2 /aTAll Bryan Crossley also participated in the conduct of this Acknowledgeaent: study. JVS/alv Company Sanitized. Does not contain TSCA CBi DuPont BIA 4-94 nmtopucnoH Thu purpose of this study M i to suslusto b l ' 1* ijahoratorv Practice Standards. ,0 th* *r o li" b l* " * matbbtalS AND METHODS A. AnInal Husbandry Young edult 1 . * -hit. rshhlts - J - * Harlsnd, Hevltt, Hev J'r!'y , ^ suspended, stainless ste*i; h ^ L s . tech rsbblt uss assigned s on a card affixed to the ,, ,, e . Idsntlf t ^ W e ^ f l ' s t i o n nunber .re - * " <> t S i i . S e .irbbi.'s - vlb - o r insoluble rber. a 4 ..el 125 erans of Purina Certified iissstsi-s:. ,, 5 H ! fro. this p r o g ^ a r . " P" S % g e s l i g that the basis of these analyses, there s Mounts which nay have contaninants were present in the feed or wa interfered with the results of this study weighed, and observed for general health Rabbits were quarantined,weigi" ,,Stained on a timer- for approximately 2 ?*" * ? * dark cycie. Environmental conditions controlled, 12-hour i * * ^ 1*"*0" tTM rJ!ure of 20C 2C and relative of the rooms were targeted for a P* iA these ranges were judged to humidity of 50% * 10%. ,,/or duration to have adversely have been of insutficient magnitude ana/or the validity of the study. Protocol On the day prior to mu the" - th' I,bMtS Company Sanitized. Does not contain T SC A CBt - 4- DuPont BUI 4-94 ,, c b robbtt ... p U c b i... < J J g * " i * niece of rubber sheeting, approximately 8 x 1 . . that time did not in the stocks throughout the o.5 nL aliquot of B-20349, have access to food or water. App . ite beneath a 2-inch heated to 50-C was applied directly tJllJon.lrrli.tillg tape. The rubber gauze square that was **Jd J. . aninal and secured with clips to sheeting was then wrapped awund the a n i n a i ^ ^ ^ in contct with the retard evaporation and to keep th bs^ ce o visible evidence to the skic without undue pressure. I . stable under the S S r , . h. ..st job.... " S S r . ..1 S S S ix iS S S S I"'*sl" s00 ,he" r* b M M - ppri..ly 24 hours rubber sheeting was loosened, and the s wraDPingS and gauze squares squares was narked with a vaterpr^f p e . ^ ^ T v i S Ivory* soap were then test subftance. The skin was gently ^ t S " " S d the animals were returned to their cages. Approximately 24, 48, and 72 h o t t e r a p i c a t i < ^ ^ S T t h e r substance, the test site*were ^aluatedj to the Draize scale evidence of dermal effects an untreated skin were used for (Table I). The adjacent areas of the untreated s connarison. Records Retention All raw data and the final report J ^ J j j ^ S d i S n i * * * " - du Pont Haskell Laboratory for Tx^ J og^ 1 redor in the DuPont Records de Nemours and Company, Newark, Manawement Center, Vilmington, Delavare. RESULTS and conclusions H-20349 prodocod f ^ ' . r y . h e o . ythema or edema in 4 rabbits y S S S H m . ,n t,e treated rabbits. " n- ` -- f Company Sanitized. Does not contain T S C ;;, - 5- Sunary of Skin Raaponsea to B-20349 Response Mo Response Slight -71 hr 4/6 2/6 4/6 2/6 ^ 4/6 0/6 7A hr Aft hr 6/6 6/6 0/6 0/6 /ZJUL 6/6 0/6 - * * . - 2" M - * s l " h t irtl," ,, I< these test scores .re t. * ccording to the guide to the labeling of dange 92/325, Annex he Official Journal of B?5Jean12 J J led as a "NON-IRRITANT" until further I), H-20349 probably could be classified as a ata are available. . I Company Sanitized. Dogs not contain TSCA C: - 6- iim M SKIM IRRITATION TEST VUE H-20349 TABLE I DRMZBi 'll. FOR SCORING PRIMiNT SKIM IRRITATION Evaluation of Kin Reactions Erythema and eschar formation: Very^light erytheaa (barely perceptible) Veil-defined erytheaa t t t s s z z t s ? >* . * * -- fnrmorfnn iinluries in depth) ' Valu 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) :ema foraation; Very*slight edema (barely perceptibly Slight edema (edges of area vel- d y Moderate1edema1(raised - ) |ilB Severe edema (raised more than 1.0 mm extending bevond the area of exposure) 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Abbreviations of other dermal effects are: A Abraded I Intact T Thickening C Eschar Mo Effect Fissuring N = Necrosis G - Fissuring with Bleeding S - Epidermal Blanching Scaling L - Sloughing R . Rav Areas X * Compound Adhered to Skin SN - Superficial Necrosis Draie, i. B., "Baraal Tonicity.^ *[tor*alCo!it'of L Aasociation S- S T l i * - *-***-- , ,M ' pp' .Company an,uzad. Docs notcoiaiaTCA.CBi - 7I SKIN IRRITATION TEST WITH E-20349 TABLE II INDIVIDUAL fTM IRRITATION SCORES QgTH RESPONSES OBSERVED IN BABBITS Dufoot BIA 4-94 Rabbit Nuaber 28733 28734 28735 28736 28738 28740 Erytheaa 24 hr 48 hr 7Z_nr 0 00 1 10 0 00 1 1o 0 00 0 00 ____ Ideas 24 hr 48 hr 7Z nr 0 00 0 00 000 000 00 0 0o o Company Sanitized. Does not contain T SC A CB! - 8-