Document ymM0Kvpdo9YKx4qXnR1EVonvE

HAZLETON LABORATORIES AMERICA, INC. A R 2 .U -0 3 Q T Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS. UD REPORT OF ANALYSIS Ul. C. MCCORMICK MINNESOTA MINING AND MANUFACTURING TOXICOLOGY SERUICES ST. PAUL, MN 55101 SAMPLE: T-3609 PURCHASE ORDER NUMBER: T351371 SAMPLE NUMBER: 407039 DATE ENTERED: 07/19/ REPORT PRINTED: 10/05/ ENCLOSED: GUINEA PIG MAXIMIZATION - METHOD, SUMMARY RAW DATA APPENDIX SIGNED: STEUEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY BY AND FOR HAZLETON LABORATORIES AMERICA, INC. RAUI DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON LABORATORIES AMERICA, INC., MADISON, WISCONSIN. 005219 HAZLETON 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 NUMBER: 40705984 SAMPLE: T-3609 PAGE GUINEA PIG MAXIMIZATION Test Animal: Young adult male albino guinea pigs of the Hartley strain were procured, maintained individually in stainless-steel cages in temperatureand humidity-contro11ed rooms, provided continuous access to Purina Guinea 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 443 g and 549 g, were chosen at random for this study. The animals were divided into two qroups consisting of a test group of 10 animals and a naive control group of four animals. A common vehicle control group of ten animals, weighing between 473 g and 553 g, was utilized for this study and Study Nos. 40703985 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 subirritating concentration to be used for the challenge application Four additional animals were treated with the test material at concen trations of 25, 50, 75 and 90% w/v in 80% ethano1/disti11ed water. The test mixtures were applied to 2.0 x 2.0-cm Whatman No. 3 filter papers which were applied to the shaved animals' backs and were then overwrapped with Blenderm and Elastoplast tapes. The dressings remained in place for 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: Intradermal Injections Solution No. 1: The Freund's Comp 1ete 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-3609 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-3609 in 80% ethano 1/disti11ed water in increments to 2.0 ml of Freund's Complete Adjuvant. For the topical induction and challenge application, the test material was administered as a 90% w/v suspension in 80% ethanol/distilled water. All test mixtures were thoroughly stirred during p r e p a r a t i *n9 HAZLETON LABORATORIES AMERICA, INC. Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS4JD SAMPLE HUMBER: 40703984 SAMPLE: T-3609 PAGE 3 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 5% w/v mixture of 80% ethano1/disti11ed water in sterile water was prepared by adding 0.5 g of 80% ethano1/disti1led water into a 30 ml beaker and adding sterile water for injection to a total volume of 10 ml. Solution No. 3: A 5% w/v mixture of 80% ethano1/disti 1led water in Freund's Adjuvant was prepared by adding 1.3 ml of a 10% w/v mixture of 80% ethanol/distilled 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 80% ethanol in distilled water. All vehicle control mixtures were thoroughly stirred during preparation and dosing. Method: A 4.0 x 6.0-cm area was clipped along the midline over the shoulder region. 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 area, one row on each side of the midline as follows per site: 0.05 ml of the prepared Freund's Adjuvant Solution, 0.05 ml of the 5% w/v test mixture, and 0..05 ml of the 5% w/v test material in Freund's Complete Adjuvant 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, the areas of the intradermal injections were pretreated with a 10% w/w sodium lauryl sulfate (SLS) suspension in petrolatum 24 hours prior to topical application. Six days after the intradermal injections the test area was closely shaved and the 10% SLS was massaged into the skin with a glass rod. Twenty-four hours after pretreatment a 2.0 x 4.0-cm patch of Whatman No. 3 filter paper was saturated with a 90% w/v suspension of T-3609 in 80% ethanol/distilled water, placed over the injection sites, then cohered 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 manner usino 80% ethano1/disti1led water only. 0 0 5 2_2 1 HAZLETON &laboratories AMER.CAJNE_____________ Chemical BloMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 2414471 TLX 703956 HAZRAL MDS-UD SAMPLE NUMBER: 40703984 SAMPLE: T-3609 PAGE 4 GUINEA PIG MAXIMIZATION CCONTINUED) Two weeks after topical induction the test and naive control (previously 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% ethano 1/d isti11ed 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 overwrap with Elastoplast tape wound around the trunk. Observations: Twenty-four hours following patch removal the test sites were examined for erythema and edema. The sites were examined again at 48 hour after patch removal to detect any weak, slowly developing reactions. The test sites were shaved 3 hours prior to the 24-hour reading. The reactior were scored according to the following 4-point scale: 0 = no reac tion 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. Pathology: At study termination all animals were euthanatized and discarded. Maximization Ratings Sensitization Rate Classification 0% 1% - 9% 10% - 39% 40% - 69% 70% - 100% Not a Skin Sensitizer Weak Sensitizer Mild SensitizerModerate SensitizerStrong Sensitizer 005222 HAZLETON laboratory AMEB.cA.iNc._____________ Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 T U 703956 HAZRAL MDS-UD ~ SAMPLE NUMBER: 40703984 SAMPLE: T-309 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: Test Material: T-3609 09/07/84 Dermal Reactions to Challenge Application Animal Number 24-Hour Score 48-Hour Score Test Group EO-2117 EO-2118 EO-2119 EO-2133 EO-2121 EO-2122 EO-2123 EQ-2124 EO-2123 EO-212 1 1 0 0 0 0 0 1 0 1 1 1 0 0 0 0 0 0 0 1 Average Score 0.4 0.3 EO-2127 EO-2128 EO-2131 EO-2111 age Score Naive Control Group 00 00 00 00 0.0 0.0 00S223 ^ H A Z L E T O N LABORATORIES AMERICA. INC. Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 2414471 TLX 703956 HAZRAL MDS-UD SAMPLE HUMBER: 40703984 SAMPLE: T-3609 PAGE GUINEA PIG MAXIMIZATION (CONTINUED) Uehicle Control (80% Ethanol in Distilled Water) Animal Number 24-Hour Score 48-Hour Score Test Group EO-2030 EO-2027 EG-2051 EO-2052 EO-2053 EO-213 EO-2140 EO-2054 EO-2053 E-2056 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 *aae Score 0.1 0.0 General Behavior and Appearance: All of the guinea pigs used in this study appeared normal throughout the study period with the exception of one test group animal, EO-2133, and one vehicle control group animal, EO-2140, which had diarrhea on day 3 of the study. Normal body weight gains were recorded for all animals during the study with the exception of one vehicle control and two test group animals which exhibited body weight losses of 3--24 g during the first week of the study. During the last week of the study, six test, four naive control and five vehicle control animals exhibited body weight losses of 2-31 g. Skin Reactions to T-3609: Slight dermal reactions were observed in four test group animals 24 hours following the challenge application. None of the naive control animals reacted to the challenge application of the test material. A slight dermal reaction was observed in one vehicle control animal following the challenge application with 80% ethanol/ distilled water. Conclusion: Based on the results obtained, the test material, T-3609, is considered to be a moderate skin sensitizer in guinea pigs. 005224 HAZLETON Chemical & BioMedical Sciences Division 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL M D S -U D " SAMPLE NUMBER: 40703984 SAMPLE: T-309 PAGE 7 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 Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, U.S. Environmental Protection Agency Office of Pesticide and Toxic Substance Series 81-1, pp. 59-62, November 1982. 005225 Guinea P ig s - Body Weights (g -ams) o '--rest Group: _____________ T - 36.09 P o s it iv e Control Group JA V e h ic le Control Group N aive Control Group MA _____________ MA V e h icle V e h ic le V e h ic le is4iiW / Lca+cir K> Animal Number 2U1 211^ ziiq 2 1 3 3 Z\Z\ 2122 2 _ \ 2 3 Tech n ic ia n Date /PSV 5O Hli* _ 50 60 5S9 6 7 7 i 5*n 1. ' i 515 M C3 553 ((ab? SS v ssi 51 S< C>3l S-V 5 'T f* (aC?3 1 3 MU1 533 S i! 443 VW ra* 373 S15 m u SI-I4 8 --J/ fi* / fan SP ? / f SP V 7 Animal Number cf> -- 2 I 2 4 Z\ 2 3 2 t 2 L Tech n ic ia n Date >9*y 5A* S S (a Sib? (aZS 544 (Ml LU\ m .M NA - Not A p p licab le 51U _ 50? Sbafo /9 01 S c a le Used: \<T ROW 1 3 *4 9 Scale Used: YTCtoh /SO/7 Scale Used: ^TVQlO Scale Used: )<TY?)Y\ /50P? S c a le Used: fCTrOh 5"3-^-? Scale Used: Reviewed by ______ _____________Date rnH 9 - l M r-ai hwt SP. i/f SP *h 1 005226 aeSTCOPY AVAILABLE <r> Guinea Figs - Dally Observations RT No. Yq ? 5 ? 2 Room No. <J Test Group: _________ Positive Control Group Vehicle Control Group ___ Naive Control Group____ fi^ A ajA Vehicle B C fe E fto .tc/ fa s-U /M ' Cafcr- Vehlcle M r t __________ Vehicle M ft Animal Number FO~ 2 H 1 <?nf 311? i/ii Tech nician Date /9SV f f a; fi)- /J /J a J 0 tJ jO. /J f i) /U fit t) A/ D N fi! / j lO t J A/ fU S ' /0 n ) fil AV A S A/ A/ AS aJ fi) AJ AJ k) N) M fi) N fi) M M Ni h) fi) A/ /d /J AJ / O fil f j A J Al /VJ a) AJ M kJ a J / |0 A) h i /V 0 /V n) ri a \ li A rJ M fi) V Af / fil A/ a J A) a J |0 (0 kJ aJ /O f i Al N 1 a J Ai a J _ A L /J a/ _ aL a/ D - -iarrKt-. i f {-!(*-**+ N - No Visible Abnormalities NA - Not Applicable _0_ V AJ AJ AJ A/ aJ aJ // V /Nj aS AS AJ N fiJ to s> fi) fj AJ /v to AO AJ a) M n) fj AJ A) A) /J AJ .J \ L - N A/ A/ a; AJ JT ? /*> gvy ?/r V ,a I AS A/ a! /i/ // ... - - 5/> f - / * / p rv; c& 6 ^r A/ N) a ; AJ rP /S> 0/ aJ aJ NM M AJ aJ |0 k) fJ N AJ /O AJ AJ /u a) ..a J - /T ? 012 rp iff - 09 8/^5 /y9 rs SP SS? SP f 'J X -3 i-: 00522V BEST COPY AVAILABLE f*S Guinea Pigs - Daily Observations RT No. W O J 9 f? Room No. V Test Group: Positive Control Group Vehicle Control Groups Naive Control Group T-3GO?. /Ufl AJ/f Vehicle 'fflfoG'fJvMol/ts tilte d Vehicle /On/i COa-hr Vehicle A ) Animal Number eft- ;UP PIt* Sill ?/3? Q13 M X ?/W M S ' Tech nician Date /?*} nI fj AJ A/ AJ aJ aJ K /t/ ... sib % N hi nI [J li iJ |J nJ iJ K k f\) n) n) l\ fJ l rvl K) h) |\j `SfJU- o i* A/ /J aJ . sf H A A A) a/ - a/ 59 -: (0 a) fj Al a) a) / a ) SP. a ) id V (J / a! a/ a / . a.J SP f - 7 N - No Visible Abnormalities NA - Not Applicable 005228 V* BESTCOPYMMIABLI r` GUINEA FT MATTMTZATTON TEST Tc&r Group Tastt Compound T -.taO ? ax no. 9 0 7 0 3 9 2 V Data Animala Racaivad 7-3V-?V Source riaz le fo n b u U iJa n c / Data of Iatxadaraal Injections Dae* of Topical Application _ r- J / - 2 V Xachnician Tachnician _ Z 1^ /y3 Oaea of Challanga 9 " 9~% V Xachnician ..sP Animal No.. Sax - Si/7 3112 ail9 an3 3121 212% 3133 a/s1/ a/a^ aia(. Tachnician Raeordad By Data 9%^ 24 Boors 48 b o r a Rlahe 1 srgict } o. o o Lafe \ \ . o n i &&* o 1 -Sdo SP Vb \ \ \ r\ Rlahe j Lafe \ 1\ O\ o\ o\ o\ 0 :t o ....A. o 1 fyvt \ \ sf . \ se ...... \ fl \ Scoring Coda: 0 * formal. No Sanction 1 * Scattarad Mild Radnaaa 2 * Moderate and Olffaaa Radnaaa 3 Ineanaa Radnaaa and Swelling REVIEWED BY: ^J,,-DATE: 9 j j S(o <=t2.7'S'- 005229 3$T COPY AVAILABLE r'\ '--^Test Group: P o s it iv e C ontrol Group Guinea P ig s - Body Weights (grams) 'MA N> A- V e h icle V e h ic le Ko. 707039?V Mft ro- V e h ic le Control Group N aive Control Group r o ft T - 3&0? Animal Number eO - Vehicle %0%)hoflo//Os-h/f&J a.'k.r- Z\Z% Z13 l <k SUL _ Tech n ic ia n Date /9SY 500 r-v ? 3? i?o kys G! 2? 5 o 541. 1S 7</V n3 5 29 S%7 UH "# 654 Cito X rort r f .r-2 / /Y7 tf-a? 5^ \ __________X - _ \ - 5P Sp f/7 \ ______ V \ \ .\ Animal Number Tech n ic ia n Date /? ? y Scale Used: Scale Used: Scale Used: frqnkl 134S VCTV/W JlTO /? /5<D/9 rotJ /Y > * - * / rr* \ \ Scale Used: k 'T rc h S ca le Used: yymn 5 3 3R 53 5P_ 9 / i p y ? Scale Used: NA - Not A p p licab le Reviewed by ________________ C y v^ \ Date ^VY-,r mH 0S 230 BEST COPY AVAILAfHF Guinea Pigs - Daily Observations RT No. 7/07039% j Room No. <V Test Group: Positive Control Group Vehlele Control Group _ Naive Control Group - M ____ AJ/?~ a >/9 Animal Number \3171 HP? i?/3l pill ~ V a h ld e Vehlde A-)/) AV9 Vehlde U>akr nTeiccihan Date mi rJ /0 /v/ /O /J /V/ / j N . A/ bl N A/ & tJ / y u AS / J / J iO N) fO M |0 AJ N A> a/ /O (0 A> 0 aJ. a) A; ivi a d N) Ai a/ a/ a/ (0 iJ /O A3 |V/ /vJ nI , Aj (\J 1 _ | '\~S \ \ \ \ \ \ \ \ \ \ V\ \ \ \ r f % 'li n * X -/S zp t-tc. s-/7 ? -r\ Z //*} n * S/j-i f t * %/->/ f r * S/9fr* 1p </L- fr * fr * n* S/ai V r& f'2 ? g -jt /Y> -2 0 SP f b i N - No Visible Abnormalities NA - Not Applicable O Animals o b s e r v e d -h>,e n o m a / o h g/aS/gt/ M t sia en -0f recorded - 005231 BEST COPY AVAILABLE Teat Group: Positive Control Group Vehicle Control Group a Naive Control Group Guinea Pigs - Daily Observations RT No. V 0103 9 2 *} Room No. / roA fi toft T-3GQ9 Vehicle Vehicle AJ/f Vehicle %0?O6rMo/io//0s a ile d LOCrftr- N - No Visible Abnormalities NA - Not Applicable 005232 GUINEA PIG MAXIMIZATION TEST tOO-vOC- G f O J -f* Test Compound Dae* Animal* Received T-died? jv -gy Oaea of ineradarmal Injaction* __ Data of Topical Application . \)fr A2JL Oaea of Challenge _ 9-y-gV bxno. yo7Q3?XV _ Source fa z leJvn O irk b la n d Technician AJ/9~ J/9-Technician a Ti!wi< w Animal No.. Sex 121 nax 213 \ 3111 24 Bonrs Rieht Left o\ o\ o\ o \| 43 Boars Riahe Left .o 0 \ *\ c> \ 0\ * ' Technician Recorded Bv Date SP 1/6 \ <s\ 59 \ sf \ </i .. - , \ Scoring Code: 0 * formal* No Reaction 1 Scattered Mild Eedneee 2 * Moderate and Diffuse Redness 3 Intense Redness and Swelling REVIEWED BY: Q t & u J ) DATS:*?/*?so 005233 Guinea Pigs - Body Weights (grans) Hoiosr-T ETNo. 22l2 2 L </0 7 0 3 9 t ov-^Iaat Group: Positiva Control Group K5V Mft _. Vehicle Vehicle Vahlcla Control Group * 0 % E ik a n o l / P i s U W e A - l i ^ o k r Nalva Control Group ___________ i t _______ ________ Vehicle Aninal Number 30- 203G zozn : 205\ 2.135 2.mo to n MA nTeicchian J9WDate 52T 51 5"9% s& o (alai t>ar L 30 3.<r 544 SXI (a(a uh U<f 5 \n ... 553 m i u n s y ?.... S ?J tTMt/tir $?<z> Ln9 (ota ln(a^ . 5 2 6<57 ?7 _.c7 MW a-m /* Z-2 />* tfat ?-i 7> 9-7 ti Animal Number ~0-- 2054 2055 t o s u 4*13 520 T o t* ^c/tsTtaTfl* 53^ 51( .ov 57</ 31 , CrW 41U " T3C? 5*vn feu t Scale Usad: UTttfM 13AS Scale Usad: K.TtO\ 1 ^ 0 1 9 i Scale Usad: }Troi/i / S 'O l.9 ' Scale Usad: f T C c d SA^-% Scale sed: jC ry m 5 " ^ ? Scale aed: Tech nician Date /9 SV tAW _ t - W r * f-/ ./ ? * sP 3*TM. L S? 7-7 1 NA - Not App11cabla Reviewed by L Date Enb-jj <Lrrav-\ ry * ? - 3 / - f y 005234 *** BEST COPY AVAILABLE Guinea Pig - Daily Observation* V070Sr/*Sj) Un .*f0 R X 140 loo* No. Tt Group: MA Vahdo . . /? Positive Control Group AlAr Vahdo A JA Vehicle Control Group G&onol / b)zhllcd la4cr Salva Control Group t A)A Vahlde ___ M AnlnalNuabar eo- Tech- Data J7_ff/ 30$^ J/3S"?no SO$1 OS, /9?y A> Ai1 N /O /J /U 1^ /j fj / Ai ;/v/ `ft/ fSl: f/ a) p a> a* aJ //. 'fiJ ^ 'V fS M V /C/ A / /</ // AjT M /V AJ Ai... i\l M AiAJ aJ A> /t/ flJ A' A J ,a / r r s-/y t P ?-/j' <>P -T-/ r P X'l? rt *?/& r//? aJ // a/ /S /!/ aJ A/ V A/ A/ SP */sl N M |Sl |sJ KA IV * 'M M 1 aj a) fsf aj /S H (M N /V A) ,AJ fl* Af rJ r r s^- |V) A) fO /M AJ Aj Ai f f 9Si N | (j aj Ai fi AJ Ai AJ W tJ' n| M n! >1 Fi fi n) VBt |vJ aJ a) AJ M" KJ r # /J /v/ W Ai aJ Ai r f fJ M r4 M A) (0 |0 /VT (V) /P> &?9 O lO M lO IS/ A) M M ... Ai kA /O r P M Aj |\[ _j L M flL-_M_ _jL ..fl/.., SP J k 0 *! Diin+tA 'M S - So Visible Abnorualitla* NA - Noe Applicable 005235 BEST COPY AVAILABLE Guinea Pigs - Dally Observations t/070S`/Y$' 90703929 RT No. 907-03?*' Soot No. V ^ Tost Group: ........... ._ . frlA Vahid* 'Positiv* Control Group MA Vahicl# Vahleia Control Group 9i> Gfhaooi/ChVW UfrA lOoA<r~ Naiv* Control Group ! \Jffr Vahid* tOfi fsjA A Jj9 030 can 30& Anlnal Nuubar -- i Tech- ?53 Q I3 /fO <PO&f 9 0 3 S POSo nielaa D.C. / y f l i s f J tl 'A id a/ A *1 K a / >U aJ hi |J *) e tc h .O rL h X fi N ftf- h fl a! (a . O A/ A/ A/ V /i/ a/ A/' 'a/ Ai a/ aJ i j A) a/ /l/ aJ a/ SP <?-4 S P f-vf fj *} k5 sS as J cj-lo a/ V a/ v a! A/ t j f * A/ a/ 1/ 9 -1 ! , N - No Vlslbl* Abnornalltias KA * Noe Appliesbla \ 005236 BEST COPY AVAIl AR! r / GimrgA. pi MATTMT74HQB test Oeluck. Group Tase Coapound V010Z9SY KO% Eilranolf Dl s - ^ i ^ A O a k r *** -ftfPtf&SL___ pB Rssule Sponsor Ho. AJ/3 Does ini-- 1 Bsesiysd 7 -jV -g V Ose of lacradaraal Injections g-/yf v Soares ffaiie4vn riukkioHct Technician Osee of Topical ippllcacioa Tactalclan Dae of ChaHongo . Tocfanician in ia a l H b .. Sox /9s7 24 H oars B ich e L o fe 48 B o ars B ia h e lo f t o Ao 3021 90S ! o ......... o V _O KO o a o S Jt O: V O 70S 3 O h O su r am O fo O \ is % `o 3 0 S4 o kO Jo ss ' O 0O o se* T e ch n icia n O . *sc> )O A> S P Bseordod By 2s s _______ .s p s ip S P 9/ , j ________ Scoring Cods: 0 Hotnal, Ho Bsacelon 1 Scaeearod Mild Sadsaoa 2 * Moderate and Olffaso Badness 3 * Iaeonaa Redness ***** Swelling O E/vhrQ <rror~ /^ 2> ge**** gWorr Sp 9-1-H aB7IEBED ** f&fc PATZ: tfldfa 005237 EST COPV AVAILABLE Q o s e Ran) e Guinea Pigs - Body Weights (grams) RT No. VOIQZ <?%<{ r\ -- Test Group: -r-?,o 9 Positive Control Group MA Vehicle S^haAp//07s h/feJ coater Vehicle ______ A J _______ Vehicle Control Group _ Naive Control Group ajA AlR Vehicle roA \ Animal Number Tech nician Date NA - Not Applicable Scale Used: \CTrova ^'""^'"'"'"^Seale Used: IS iQ St* Scale''use3>^ \ Scale Used: Scale Used: Scale Used: Reviewed by ____________ O^tbc^J Date ( P frtcoyzAiVuj ^inro<' Sf ? -'S-5^ 005238 S-Sr-gv V RT No. <-/0 7 0 3 9 2 V 0 Dose Range. " * - Guinea Pigs - Dally Observations Test Group: -x --* (o 0 9 Positive Control Group lOft Vehicle Control Group Naive Control Group /OA Vehicle %D?0 tta*olA>\^{\<A lOcx4cr Vehicle ___ f O # _____ Vehicle 30C& 2002 2 0 /0 \Atiimai Number G O /?*? 1 Tech nician fJ iO N) /O- f! / / y A/ A / AJ a J \ rr aa Tf v i nJ 1^1 V ml \\ \ \ \ \ \ \ \ \\ \\ \ \ \ \ \ ' \ \v \ \ \ N Date m V- *k t/r V /o e N - No Visible Abnormalities 005239 o Oo s e Ran^e. 'C GUINEA. PIS MAXIMIZATION TEST Test Compound ~T ~ 3 6? 0 9 One Animals Received One of Intrsdernal Injections OA Date of Topical Application MA Data of Challenge ^ hi no. 9 0 1 0 3 9 8 9 Source H az-le\oo boAs&UQMgl Technician Mft Technician mi OA /y9 Animal No.. Sex so- 300? aoo9 3010 199a 24 Hours U7*' Hlsht 90^ O W lM tt O3 S ?o so% 0 S0? O 75# <0 48 Hours Right O' O' 0 (\ t Left n 0 ..... . 0 . . . o Technician Recorded Bv Date /9 8*~f fj^ M fy(0 Gho "lx. 1H V Scoring Code: 0 Normal, No Reaction 1 Scattered Mild Hedneaa 2 * Moderate and Diffuse Hedneaa 3 Intense Redness and Swelling SUl f-u REVIEWED BY: _____ DATE: 9~(9- 005240 H A Z L E T O N LABORATORIES AMERICA. INC. 3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, Wl 53707 (608) 241-4471 TLX 703956 HAZRAL MDS UD ">-, Guinea Pig Maximization Sample: T-3609 Study No. 40703984 MAY 151385 3 oORm# / ,i.u7 Sponsor Minnesota Mining & Manufacturing Toxicology Services St. Paul MN 55101 Sponsor's Representative W. C. McCormick Contractor Hazleton Laboratories America, Inc. Life Sciences Division 3301 Kinsman Boulevard Madison WI 53704 Study Director Steven M. Glaza Amendment No. 1 to the Final Report Effective May 13, 1985 This amendment modifies the following portion of the report. Page 6, Conclusion. To correctly identify the degree of skin sensitization, substitute the underlined for "moderate". Based on the results obtained, the test material, T-3609, is considered to be a mild skin sensitizer in guinea pigs. Steven M. Glaza $ Study Director, Acute Toxicology Hazleton Laboratories America, Inc. (0701t/cja) Date 005241 Chemical & BioMedical Sciences Division