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0 HAZLETON LABORATORIES A(V1ERIGA. INC. ARnko35~- Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (606) 241-4471 TLX 703956 HAZRAL MDS UD REPORT OF ANALYSIS U. C. MCCORMICK MINNESOTA MINING AND MANUFACTURING TOXICOLOGY SERUICES ST. PAUL. MN 55101 SAMPLE: T-3610 PURCHASE ORDER NUMBER: T351371 SAMPLE NUMBER: 407( DATE ENTERED: 07/'! REPORT PRINTED: 10/ ENCLOSED: GUINEA PIG MAXIMIZATION - METHOD, SUMMARY RAW DATA APPENDIX STEUEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY BY AND FOR HAZLETON LABORATORIES AMERICA, INC. RAW DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON LABORATORIES AMERICA, INC., MADISON, WISCONSIN. 005541 HAZLgTOI\ Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRaT m DS UD SAMPLE NUMBER: 40703985 SAMPLE: T-3610 GUINEA PIG MAXIMIZATION Test Animal: Young adult male albino guinea pigs of the Hartley strain wer procured, maintained individually in stainless-steel cages in temperature and humidity-contro1led rooms, provided continuous access to Purina Guine Pig Chow and water and held for an acclimation period of at least 7 days The animals were identified by animal number and corresponding ear tag. Test System: Fourteen male albino guinea pigs, weighing between 430 g and 568 g, were chosen at random for this study. The animals were divided into two groups consisting of a test group of 10 animals and a naive control qroup of four animals. A common vehicle control group of ten animals, weiqhinq between 473 g and 553 g, was utilized for this study and Study Nos. 40703984 and 40705145. Dose Range Study: The purpose of the range-finding study was to find a moderately irritating dose level to use for the topical application and a subirritatinq concentrat ion to be used for the challenge applicat Four additional animals were treated with the test material at concen trations of 25, 50, 75 and 90% w/v in 80% ethanoI/disti1led water. The test mixtures were applied to 2.0 x 2.0-cm Whatman No. 3 filter pap which were applied to the shaved animals' backs and were then overwrapp with Blenderm and Elastoplast tapes. The dressings remained in place f 24 hours. The test sites were evaluated for dermal irritation 24 and 48 hours after bandage removal. Based upon the results obtained, the test material was administered as a 90% w/v suspension for the topical and challenge applications. Preparation of Test Material: Intraderma 1 Inject ions Solution No. 1: The Freund's Complete Adjuvant Solution was prepared by adding 3.0 ml of sterile water for injection in increments to 3.0 ml of Freund's Complete Adjuvant. Solution No. 2: A 5% w/v mixture was prepared by weighing 0.50 g of T-3610 into a 30-ml beaker and adding 80% ethanol/ distilled water to a total volume of 10.0 ml. Solution No. 3: A 5% w/v mixture of test material in Freund's Adjuvant was prepared by adding 2.0 ml of a 10% w/v suspension of T-3610 in 80% ethano1/disti11ed water in increments to 2.0 ml of Freund's Complete Adjuvant. For the topical induction and challenge application, the test materi was administered as a 90% w/v suspension in 80% ethano1/distiI 1ed wa thoroughlv stirred during preparation and dos HAZLETON LABORATORIES A M ERICA. INC. 3301 KINSMAN BLVD. P.0. BOX 7545 MADISON, W ISCONSIN 53707 Chemical & BioMedlcal Sciences Division PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD SAMPLE NUMBER: 40703965 SAMPLE: T-3610 BEST COPY AVAILABLE PAGE GUINEA PIG MAXIMIZATION (CONTINUED) Preparation of Uehicle Control Mixtures: Intradermal Injections Solution No. 1: The Freund's Complete Adjuvant Solution was prepared by adding 3.0 ml of sterile water for injection in increments to 3.0 ml of Freund's Complete Adjuvant. Solution No. 2: A 596 w/v mixture of 8096 ethano1/disti 1led water in sterile water was prepared by adding 0.5 g of 8096 ethano 1/d ist i1led water into a 30 ml beaker and adding sterile water for injection to a total volume of 10 ml. Solution No. 3: A 596 w/v mixture of 8096 e thano 1/d is t i11ed water in Freund's Adjuvant was prepared by adding 1.3 ml of a 1096 w/v mixture of 8096 ethano1/disti11ed water in sterile water for injection in increments to 1.3 ml of Freund's Ad juvan t. For the topical induction and challenge application, the vehicle control animals were treated with 8096 ethanol in distilled water. All vehicle control mixtures were thoroughly stirred during preparatii and dosing. Method: A 4.0 x 6.0-cm area was clipped along the midline over the sho reqion. Two rows of three-deep intradermal injections (total of six injection sites) were made within the boundaries of a 2.0 x 4.0-cm ar one row on each side of the midline as foilows per site: 0.05 ml of prepared Freund's Adjuvant Solution, 0.05 ml of the 596 w/v test mixtu and 0.05 ml of the 596 w/v test material in Freund's Complete Adjuvanl mixture. The respective vehicle control mixtures were administered to the vehicle control animals in a similar manner. Because the test and vehicle control materials were non-irritating , areas of the intradermal injections were pretreated with a 1096 w/w sodium lauryl sulfate (SLS) suspension in petrolatum 24 hours prior topical application. Six days after the intradermal injections the area was closely shaved and the 1096 SLS was massaged into the skin w a glass rod. Twenty-four hours after pretreatment a 2.0 x 4.0-cm pa of Whatman No. 3 filter paper was saturated with a 9096 w/v suspensic of T-3610 in 8096 e thano 1/d is t i11ed water, placed over the injection then covered with an overlapping of Blenderm tape and secured by an overwrap of Elastoplast tape. The dressing remained in place for 48 hours. The vehicle control animals were dosed in the same mannei using 8096 ethanol/distilled water only. C05543 HAZLETON LABORATORIES AM ERICA, INC. Chemical & BfoMedical Sciences Division 3301 KINSMAN BLVD. P.0. BOX 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD SAMPLE NUMBER: 40703985 SAMPLE: T-3610 BEST COPY AVAILABLE PAGE GUINEA PIG MAXIMIZATION (CONTINUED) Two weeks after topical induction the test and naive control (previousl untreated) animals received a challenge dose. The hair was removed from a 5.0 x 5.0-cm area on the right flank by shaving as before. The 90% w/V suspension of test material in 80% ethano1/disti1led water was applied to saturation on a 2.0 x 2.0-cm piece of filter paper. The vehicle control animals were dosed in the same manner using 80% ethanol distilled water. The patch was sealed to the right flank for 24 hours under strips of Blenderm tape. Complete occlusion was made by an overt with Elastoplast tape wound around the trunk. Observations: Twenty-four hours following patch removal the test sites i examined for erythema and edema. The sites were examined again at 48 I after patch removal to detect any weak, slowly developing reactions, test sites were shaved 3 hours prior to the 24-hour reading. The reac were scored according to the following 4-point scale: 0 no react ion 1 = scattered mild redness 2 = moderate and diffuse redness 3 = intense redness and swelling The important statistic in maximization testing is the frequency of sensitization, not the intensity. Sensitization Rate 0% 1% - 9% 10% - 39% 40% - 69% 70% - 100% Classi f icat ion Not a Skin Sensitizer Weak Sensitizer Mild Sensitizer Moderate Sensitizer Strong Sensitizer 005544 HAZLETON laboratories america,inc.____________ Oiemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.0. BOX 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD SAMPLE HUMBER: 40703985 SAMPLE: T-3610 PAGE GUINEA PIG MAXIMIZATION (CONTINUED) Test Animal: Albino guinea pigs Source: Hazleton Dutchland, Inc.., Denver PA Date Animals Received: 07/10 and 07/24/84 Date Test Started: 08/08/84 Date Test Completed: 09/07/84 Test Material: T-3610 Dermal Reactions to Challenge Application An ima 1 Number 24-Hour Scor 48-Hour Score Test Group EO-2132 EO-2134 EO-2136 EO-2137 EO-2138 EO-2139 EO-2141 EO-2142 E-2143 EO-2144 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 Average Score 0.1 0.1 ive Control Group EO-2150 EO-2147 EO-2148 EO-2145 0 0 0 0 0 0 0 0 Average Score 0.0 0.0 CCS543 HAZLETON LABORATORIES AM ERICA. INC. Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD SAMPLE HUMBER: 40703985 SAMPLE: T-3610 i r COPYAVAILABLE PAGE GUINEA PIG MAXIMIZATION (CONTINUED) Uehicle Control (80% Ethanol in Distilled Water) Animal Number 24-Hour Score 48-Hour Score Test Group EO-203Q EO-2027 EO-2051 EO-2052 EQ-2053 EO-2135 EO-2140 EO-2054 EO-2055 EO-205 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Average Score 0.1 0.0 General Behavior and Appearance: All of the guinea pigs used in this stu appeared normal throughout the study period with the exception of one vehicle control group animal, EO-2140, which had diarrhea on Day 3. Normal body weight gains were recorded for all animals during the stud^ with the exception of one vehicle control group animal which exhibited a body weight loss of 3 g during the first week of the study and one test animal which exhibited a body weight loss of 67 g during the secor week. During the last three days of the study, nine test, three naive control and five vehicle control animals exhibited body weight losses of 2-28 g. Skin Reactions to T-3610: A slight dermal reaction was observed in one test group animal at 24 and 48 hours following the challenge appli cation. The dermal reaction in this animal (No. EO-2144) was possibly caused by tape irritation. The other nine test group and all of the naive control animals did not react to the challenge application of the test material. A slight dermal reaction was observed inone vehic control animal following the challenge application with 8096 ethanol/ d ist i1led water. Conclusion: Based on the results obtained, the test material, T-3610, is not considered to be a skin sensitizer in guinea pigs. HAZLETON LABORATORIES AM ERICA, INC. ... Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.0. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD - SAMPLE NUMBER: 40703985 SAMPLE: T-3610 PAGE GUINEA PIG MAXIMIZATION (CONTINUED) References: 1. Magnusson, B . , MD, and A. Kligman, PhD, MD, Allergic Contact Dermatiti in the Guinea Pig, Charles C. Thomas Pub., pp. 113-117 (1970). 2 Hitch, R.K., "Dermal Sensitization Study," Pesticide Assessmen t Guidelines, Subdivision F, Hazard Evaluation: Human and Domest ic Animals, u!.S. Environmental Protection Agency Office o f Pes t ic ide and Toxic Substance Series 81-1, p p . 59-62, November 1982. 005547 STcopy AVAHAME RT No. </07D39XS~ o " t e s t Group: _____________ P o s itiv e C o ntrol Group Guinea Pigs - Body Weights (grams) T -3 I0 V ehicle %D%>B-thonol/Cfishllat a Loafer' V e h ic le A J /t V e h ic le C ontrol Group MA N eive C ontrol Group joft V e h ic le av? Animal Number &Q~ 2V32. 2 1 3 4 Z13W 2 .1 3 1 2139 2 .1 3 1 2I41 Tech n ic ia n _Da /9?< 524 5 3 e/ S 9 7 (all (oOd \' 5 9 J {,-iU 441 511 C?DX 502 S3(a Sl% 34 b io M 30 SVY S 7 sm 5W 0>32 bs3 iis (o f 3 434 S<3 591 59 m u 9 -l` n* r r * &*?, 5k 5P ? / ` SP V Animal Number 6TO ~ 2\42 2143 2144 Tech n ic ia n 5H 91 S77 SD% 5S3 5 13 ('<?. S-Vj 3<tL NA - Not A p p licab le 303 5 ( b 5D 47/ 7 Scale Used: 134 Scale Used: KTro/J / S H / f Scale Used: kTrOPt (STGtl Scale Used: I^TVon 52-2% rort ? rr / V s* $- . h v P . Scale Used: J C T r o n .CP 1 Scale Used: Reviewed b y ____________ _____________Date 4 - OC5548 Test Group: _ _ _ _ _ _ _ Positive Control Group Vehicle Control Group _ Naive Control Group RT No. tjQTQ399?r Room No. e-/ Guinea Pigs - Daily Observations T ' 3C>IO ufi Vehicle %Q?oGthanp//Q/ Sh HeJ A uxx+cr Vehicle !Orr._________ AJ# Vehicle AJ# 913V Animal Number & ~ Pi31 <7138" ?I3? S N i PtV2 P/VJ Tech nician Date my-' AJ Ai f0 aJ Ai Ai pj -v }0 /V A / Ai V /0 , Ai A N ri ri V r i (ri N < \i r i / / tj fj fd iO AJ kJ Ai ri AJ a/ aa A A A (4 id (J f\) . k ! fs) n- a) a ) fd (J 10 aJ a ) AJ aJ rJ - I O . . Af A> /Vi a ) A3 A) M ( j (0 n ) A i A i A/ A) Ai jO A i /ti 4 A) ri tV a ria/ A/ a/ A/ A/ A l M Ai A i /V1 k Ai Ai A i aJ |0 N --aL . f j A) r i -- c J . . I pi A) _JU__ 1 l a ; /ri N A / td A i V Ai ri A) fsi A i fJ a/ a / fJ AJ A J Al A i AJ Ai Ai A> Ai Ai Ai Ai A ) A) IO A A) A> fi h) N AJ N a a) A/> Ai JO pj N Ai N fJ ...hi.. AJ /y? 8-/y ft? f'/S~ SP -/U. fr /7 < 4 'fd k$> * t o r/> % k > rp> */*! sr % 2 ft? $3 rf* Z/iy m %k S /a -s " %-Zi> S P -JO rr /y f f Z~3o s P %3i 00S549 BEST COPY AVAILABLE RT No. </07O39&S" o Roots No. V Guinea Pigs - Dally Observations Test Group: Positive Control Group Vehicle Control Group __ Naive Control Group T -3 G IO jort U. Vehicle $0?o tt&fiol/Pisft"lied / ioa+tr- Vehlde Ai Vehicle N - No Visible Abnormalities t.1 55550 BretnwwjinE *rs GUINEA PIG MAXIMIZATION TEST les-h Grouf> Test Compound Oat* Animals Received T-3UO 7~ Data o Intradarmal Injections "/ V ~ < ? V s i . 90703 99?- Saure Technician r f Data of Topical Application Data of Challenge ... S* */ 9 -V -?V Tachnician _ Technician /y7 ISP AnimalNo.. Sex GO- 3132 3139 2i3Ca 3137 am 3139 3Nl am . am . ... s/W Technician Recorded Br Data 1 9 ?^ 2*Roars 48Hoars Rieht Left o o\ o\ o\ > o o o o .1 * . \ \ \ \ \ \ \ Rieht 0 O o O o o 0 1* SP Left \ \ \ \ \ '\ \ .. vt \ SP \ ___ i l l __ . Scoring Coda: 0 Normal* No Enaction 1 Scattered Mild Redness 2 Moderata and Diffusa Redness 3 " Intense Redness end Swelling * POSS\feV_i BEVISWED BY: ________ OAT S b ^-VarSV P 0OS551 itsummim Guinea Pigs - Body Weights (grams) RT No. V7Q39S~ "- Test Group: _________ P o s itiv e Control Group V e h icle Control Group _ Naive Control Group aoA M/V /Ofr 2 \5 2 i m 5tnS Animal Number GO \ 2m s 50S 21H5 MUO X N \ 5"?3 f r a y . . . . \ >0$ M S l 3 0 * a / iVdL .. y .o .. 6 9 3 i *3(o . r ? 3 ? 76 Vehicle fO/p Vehicle _____ ff' Vehicle ^QfoYhono//Picklig oa/cr Tech nician Da \ \\ \ \ NW rr f - * ?/ SP ?/ Animal Number GO ~ \ \ N \ \ Tech nician /? Scale Used: Scale Used: yCTftfcU 1 3 4 $ K-TYo/J /SO/? MW V /y $ \ \ \ Scale Used: Scale Used: Scale Used: \CTTr&H fcrYc>h k Tmut tSTQ)ty ff* S2L3L?___ - W . SP (i 5 3 Q -if Sfi it _______^ NA - Not Applicable ' Scale Used: Reviewed by t'|2'4|s4nvM r.A"t\-JrOe'-5p*2 BTC m M JU H f Guinea Pigs - Dally Observations RT No. 97Q39SS Room No. 4 Test Group: _____________________ tjB ._______________ Vehicle IQ#________ Positive Control Group A Vehicle Vehicle Control Group Naive Control Group //OOAA ~1~"3($lO cO~Animal Number Vehicle f'kanq//fii<t'hHft LOaUr^ J/f9H1?N?J/Yf fi(fh/iJJJ faiJ/ AIAshh(f))iiiJ///fffiifaUif}i)/i/lt AffaaffJijiJ)JJ (f0il M /vi N /vi K) /\) i a) a) A? hJ ivi A/ a/ |4 V Ai hi ri/ a) V ft] Ai a aJ aJ Ai JyL.-id,... A) -iJ__ /?%Tech nician Date ' \ \ \ * \ \ \ \\ \ \ \ V ./.i/r/rrrfyrfrmyfSrXitf?PffiSbfff>hff,,f_*Sz&&ttzirzSii/2iiA/V---:ri< SP N - No Visible Abnormalities NA - Not Applicable 005553 BEST COPY AVAIUBLE Test Group: Positive Control Group Vehicle Control Group a Naive Control Group Guinea Pigs - Dally Observations RT No. 01Q39 Room No. </ _ A 2 ^ _____ ____ T-2.IO Vehicle Vehicle AJ# Vehicle Bf)u>nc//Q]si o-Ur~ N - No Visible Abnormalities NA - Not Applicable 00S554 BEST COPY AVAILABLE o 7r CtTOTEA ?IS MATTMT ATTQW TOST V. Test Compound Dae Anlaa Received T - M O _____ l~ 2 Lf -^?c/ wife. V>7Q3?5~ Source Hazkfefl QaklHd Oaea of lacradarami Xnjacciona A Tmfhm4*4wn M/f Daca of Topical Application Oaea of Challenge 9" lO ft Taolw<<4it Tachaleimn 10 S'P_____ 24 Sours 48 Sours Animal So.. Sax (T* Biabe Left Riaht Left e o ' 3i s o \o .... 0V QN1 D\ 0` \ 0 \0 \ ;j 3 N S ~ o \0 * Technician Recorded Bv ssa____ S L -. V5 C ? _____ 4P V SP \ > \h Scoring Coda: 0 Borasi, Sfo Sanction 1 * Scattered Mild Rednern 2 Moderata ir Diffusa Redness 3 Intensa Sadness and Swelling 'ir REVIEWED 3T: DATS: 00555S BESTCOPYAVAILABLE Gulosa Pig* - Body Valghe* (grams) V7S7</J^ KC Ito, v o m . WS-/ < /o 7 e J 9 tS 's-- Teat Group: ___________________ ___ ^_______Positive Control Group Vehicle Control Group _ 0% EfUriel / O'iS^Afti U3aW- Vehicle Vehicle Naive Control Group iMft-______________ Vehicle lOfl m Animal Number 9 203 z o z n !2 0 5 1 2053 2155 iUO Tech nician Da 52T 5H U q Co5 ^ e. i o 3M<i S"J? / U ff is<+ 5\n .r v ? .e ff feia. 4(37 35?. 5-fJ n9 LU UO vu Mm P&2> 513 5 1 -7 -*<rD * M W ft-t r- % 5"/ f- Animal Number f-- 2054 2 0 5 5 t O S U ! Tech nician /fi 413 520 i^vTC$T*h' 53* .57*/ 5 1 (. &3l , w? NA - Not Applicable 'w-' Mnu j?A<p iT/? 5 "V O (alA S IS Scale Ded: UTttriM 1349 MW ? Scala Used: KTftt /<T>/<? /y Scale Uaed: kTTran ^ 0 / 9 Scale Used: f<TdO S ^ "S Scale Used: Kt TM ^ 2 ? SP > * w <? S'/ Scale Used: Reviewed by AhD.t. 0 & \ + r y irrori /y* T - J / - Y 0S556 M S T COPY AVAILABLE Gulaaa Figs - D a lly Obaarracion* r r . vH0ej7cosvvs- <em No. t/~ Taae Croup: F o ald v a Coacrol Croup V a h d o Coacrol Croup Naive Coacrol Group MA M /V StianoI/ TS',&h'llceJ LOa'kr MA V a h d o Vohlcla V a h d o fjA h)A AJ A Aniaal Suabar eo- 2fi3 orai rxr/ OS"?J/3S' i3/V(? 20SH ^osy" sHfaochlt-ili' Duci A> tJ r i aJ ij /V/ y y. a/ t i M A rJ Ai Ai AJ /Ni a/ (V ,/sf a Ai y /!/ ' V /t/ / / /t/ aJ Ai Ai Ai hi P a/ (S y AT y Ai Ai /vi y y Ai M r r g~/< h) a> r? t-/i ri M iOaJ y A / vi/ l-i nf> ~t M/6 Vs r/ fj y y w fi/ /i/ aJ A/ y SP r/ N Jsl fs N fM N * 'M :M ? / ft/ a) aJ /si A) A/ a/ Ai , AJ st K A> Ai N N> A> y Tvr <\i r r f |V) fi} /o N N A1 AJ A] a; / f *7 N k kl fi! A M M a/ '|i AJ Ai hi fi Ai - m M $L 8 <i fj M Ai /\J Ai aj Ai Ai M rp /J Ni A fi> Ai ai Ai Ai Ai fi a) N) (V) M A) fi! (0 AT Ai n* /*> f < O 1 M M aJ Ni M AJ to Ni r r Al _iL. -J L t i ' ri A/ _A__LL JfiL .. L 8P O * 1 Diarrfi^x Se H - No Vlalbla Abuorualldee SA * Noe Applicable QQSSS7 K S T COPY AVAILABLE Guio Pig - Dolly Obrrcion* *07037*'; .VO7039& BT HO. </07O 3<?< Room No. V Tt Group: 'Posici Control Group Vhiel Concroi Group Kalv Gouerol Group M A Vhicl AJA _ Vhicl G i - h a n o ! / LOnAer~ 1 NJfr hiel fOfl hft 9 Q3 AttlBul Nuabar 0 -- Tchn lcln a A S 0 5 3 - 9 0 5 3 Q!3 3 >t*fO <PC&S 9 0 3 S 2 0 SU> Da /fi f / aT a J / A ) aJ aJ i Al A ..A .... aI aI kI 4 N 4 (0 f i- N i ) t i A/ A/ t i h i J A/ A a ) A / aJ W w ti w li/ t i aJ / d f i / a/ V a/ flj fS K fs5 n S AJ A fi/ t j . a/ Ay d o i c SP s fi < i P 5 - Ho Viaibl Abnoraallel HA - Noe Applicubi : ! * \ 005558 BEST COPY AVAILABLE / (HUBEI PIP MATTMTEATIOH TEST Tese Compound $0 % Bikxnol^ / Di s4n Wc l O f t k r p8 Basalt M / V ___________ Osea fatili Bsealvad 7-JV-gV O cW 'vc \c Group * V07057V5* V01029VY M IQ if S L ____ Sponsor HO. /Qj4 Soarca faite-hn ukkianef Dae o Xneradsmal Injections Data of Topical Application _ KW r-3-g f Tachletsn Tachnlclaa z y f. Data of Challanga ..... Technician Jo. 24 B ern 48 Boors Anlnal So., Saz Biche Left Biche Left fii* 2030 303T1 OSI O 30S3- 20S3 o O1 O? .O ! o p' ;o o o o o \ \ \ \ \ 2I3S~ o )o \. 2m , IU3 " ' < ) o *\ 30S4 <2oSST n O )a )o \ \ 30SC. O b' o Tailw< <m% *S(j J p SP Bacordad Br sjp SP Sass........... ...Z f f f f r L . i/t ih Scorlat Codt 0 Bemal SO Baaetlon 1 * Scattered Stlld Badness 2 Moderst and Diffusa Badness 3 Intensa Badness and Swalling 0 "h "Q errer* Q & c e n h y^evvorr S? 9-T-r* 2E7IEWED 81: - (kbdAXZ 005559 m um m m u I^ose. Rcur\<^eL* Guinea Pigs - Body Weights (grams) RT No* H Q H Q ^ S 8: 3-lest Group: ______ ~ T -- io \O _________________________ Positive Control Group ,______ N A Vehicle Control G r o u p _________ hJ A Naive Control G r o u p ___________ A/ A*______________________ Vehicle ?>% E^ano//0 shHed vOa^cT Vehicle ______A / f\__________ Vehicle A/ A __________ 005560 RT No. H O I 0 3 9 S S " ? Dose. Pvanc^. Room No. H- Guinea Pigs - Daily Observations Test Group: T --3lo\ O Positive Control Group Vehicle Control Group fSj A bJ A Naive Control Group f\| At Vehlcle -SQ& .GHwio//V sh'llec) Vehicle N .a n COoWr__________ Mel. HA______ 005561 Dose- Rour\^fc- o r GUINEA PIP MATTWT7ATI0N TEST Test Compound . . . T - B(o t O _______ Dae Animala Bacaivad ~i - t o - S 4 - Dasa of laeradaraal InJactions Ni A Osca of Topical Application MA Data of Oiallanga ~ HI Hb. tj-0~7Q'3(i? S Sourca Uq x Ie.-Vom T)ulcK iand Tachnlcian Ni A Tachnlclan T^tw< aw M iA 24 Bonn Animal S o .. San (S 1 W/v B lah t ^ L aft o1933^ S ^ o . as% safo 0 O 3LOIS* 3 -o ik 50% ^ i? : 15% O 90?o O 43 Hour* B laht f> ' 0 .....0 n L aft D 0 0 .0 T ac h n lc la n Baeordad By D ata \Q % 4 / &o dc& m -aU U . s 4 k f `U ^ _____: Rec-errjU Scoring Coda: Evror 0 1 2 3 Sonai So Sanction Scattarad Mild Badnasa ttodarata and Diffusa Badnaaa Intanaa Sadnaaa ^ Swalling REVIEWED BY: Q k U DATE: 9'11-ft 005562