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final report
R O G E R G. P E R K I N S M I N N E S O T A M I N I N G 6. M A N U F A C T U R I N G TOXICOLOGY SERUICES ST. PAUL, MN 55101
COMPANY
SAMPLE: T-4101 NUMBER: T837389-410 753
SAMPLE NUMBER: 70905394 SAMPLE ENTERED: 09/23/07 REPORT PRINTED: 01/17/80
ENCLOSED:
PRIMARY DERMAL IRRITATI ON /C OR ROS IO N ST UD Y IN R A B B I T S (OECD GUIDELINES)
o Key Personnel
o Method o Summary o References o Raw Data Appendix
SIGNED:
3Ifc.ue.ri II.
STUDY DIRECTOR ACUTE TOXICOLOGY
0 0 HAZLETON -- romes
Chemical ft BloMadlcal Sciences Division
3301 K IN S M A N B LV D . P.O. B O X 7545 M A D ISO N , W ISC O N SIN 53707 P H O N E (80S) 341-4471 T L X 703SSS H A Z R A L M D S UO
SAMPLE NUMBER: 70905394 SAMPLE: T-4101
PAGE 2
KEY PERSONNEL
Acute Toxicology
S t e v e n M. G l a z e Study Director
C a l v i n L. H o r t o n Group Leader Support Services
S h a r o n L. H o w e r y Report Coordinator
Quality Assurance
Debra Curley Arndt Manager
Laboratory Animal Ueterinarian
C i n d y J. C a r y , D U M Di pl om a te , A C L A M
HAZLETON
!A/wCPtCA <f\C
3301 K IN S M A N B LV D . P .0 . B O X 7545 M A D ISO N . W ISC O N SIN 53707
Chemical & BloMadlcal Selene Division
P H O N E (60 241-4471 T L X 703956 H A Z R A L M O S UD
S A M P L E N U M B E R ' 7 0 9 0 5 3 9 4 SAMPLE: T-4101
PAGE
OECD DERMAL IRRITATION
Objective: To determine the relative level of primary akin irritation/ corrosion of a test substance on rabbits under semioccluded conditions a c c o r d i n g to the O r g a n i s a t i o n fo r E c o n o m i c C o o p e r a t i o n a n d D a v e l o p m e n t 1s
Guidelines for Testing Chemicals.
Test Material: T-4101 Physical Description: Purity and Stability:
Storage and Retention:
Safety Precautions:
Amber liquid
Sponsor assumes responsibility for
purity and stability dtermint ions .
'
The test materiel was stor ed at ro om temperature.
Any unused material will be discarded according
to H L A S t a n d a r d Op er a t i n g Proced ur e.
Normal handling procedures were used according
to H L A S t a n d a r d O p e r a t i n g Proced ur e.
Test Animal: Young adult rabbits of the New Zeeland Uhite strain were p r o c u r e d , m a i n t a i n e d i n d i v i d u a l l y in s c r e e n - b o t t o m c a g e s in t e m p e r a t u r e e n d h u m i d i t y - c o n t r o l l e d q u a r t e r s , p r o v i d e d a c c e s s to w a t e r ad. 1 i b 1 turn
and a me asured amount of Purina High Fiber Rabbit Chow, and held for an a c c l i m a t i o n period of at least 7 days. Animal h u s b a n d r y and hous in g at H L A c o m p l y w i t h s t a n d a r d s o u t l i n e d in the " G u i d e for the C e r e an d Use
of L a b o r a t o r y A n i m a l s " . If v a r i a t i o n s f r o m the p r e s c r i b e d e n v i r o n m e n t a 1 c o n d i t i o n s existed, they were d o c u m e n t e d and c o n s i d e r e d to have no effect on the s t u d y outcome. No c o n t a m i n a n t s were ex p e c t e d to have been present
in the f e e d or w a t e r w h i c h w o u l d h a v e i n t e r f e r e d w i t h or a f f e c t e d the results of the study.
Three a c c l i m a t e d animals, w e i g h i n g from 2240 to 23 9 7 g, we re chosen at r a n d o m for the test, tr eated, an d m a i n t a i n e d d u r i n g the o b s e r v a t i o n period as specified for the acclimation period. Test animals were
identified by animal number and corr es po nd in g ear tag. A p p r o x i m a t e l y twenty-four hours before treatment the hair was clipped from the back of each animal.
Reason for Species Selection: Historically, the New Zealand Uhite albino rabbit has been the animal of choice for evaluating the effect
of chemicals on the skin.
Preparation and Administration of Test Material: The sample was dosed as received. The pH was d e t e r m i n e d to be 12.9.
HAZL5TOM
3301 K IN S M A N SLV D . P O. B O X 7545 M A D ISO N . W ISC O N SIN 53707
Chemical & BioMedleal Sciences Division
P H O N E (60S) 341.4471 T L X 703656 H A Z R A L M D S UD
SAMPLE NUMBER: 70905394 SAMPLE: T-4101
PAGE 4
OECD DERMAL IRRITATION
(CONTINUED)
Treatment: The test material mas ap p l i e d to the intact skin of ea ch r a b b i t in t b e a m o u n t of 0. 5 ml. T h e t r e a t e d a r e a w a s c o v e r e d w i t h a 2.5 x 2.5-cm gauze patch secured with paper tape and overwrapped with
S a r a n Lirap a n d E l a s t o p l a s t t a p e to p r o v i d e a s e m i o c c l u s i v e d r e s s i n g . Coll ar s were a p p l i e d to restrain the test a n im al s for the 4 - h o u r ex p o s u r e per iod.
Reason for Route of Administrat ion: Historically, the route of choice based on the method of Draize.
b se rv at io ns: After the exposure period, the patches were removed. The test sites were washed using lukewarm tap water and disposable paper
towels. The test material was removed from the test sites as thoroughly
as possible without irritating the skin. Thirty minutes following removal of the teat material, the degree of erythema and edema was read
ac co rd in g to the Draize technique. Su bs e q u e n t e x a m i n a t i o n s were made at 24, 48 and 72 hours after patch removal.
Individual b o d y w e ig ht s were taken just prio r to s t u d y initiation.
Pathology: At s t u d y termination all a n i m a l s were e u t h a n a t i z e d and d iscarded.
Statistical Methods: Other than average skin irritation scores, no other statistical method was performed.
Location of Raw Data and Final Report: The raw data and a copy of the final report will be r e t a i n e d in the a r c h i v e s of HLA.
HAZLETOn
kKWBtCJx rsC
Chemical & BloMtdlcal Scianeas Divisin
3301 K IN S M A N B LV D . P .0 . B O X 7S4S M A D ISO N . W ISC O N SIN 53707 P H O N E (BOB) 241-4471 T U 70395B H A Z R A L M D S UD
SAMPLE NUMBER: 70905394 SAMPLE: T-4101
PAGE 5
OECD DERMAL IRRITATION
(CONTINUED)
SUMMARY
Test Animal: Albino Rabbits - New Zealand Uhite Source: Hazleton Research Products, Inc., Denver PA Date Animals Received: 10/20/87
Date Test Started: 11/02/87
Date Test Completed:
11/05/87
Animal Numbe r Sex
F20312 F20313 F20331
M M F
Mean
IN D IU I D U A L D E R M A L I R R I T A T I O N S C O R E S
Erythema
Edema
________H o u r s _______ 4 24 48 72
________H o u r s 4 24 48
011 0 0000 000 0
000 00 0 000
0.0 0.3 0.3 0.0
0.0 0.0 0.0
72
0 0 0
0.0
PRIMARY DERMAL IRRITATION SCORES *
Observation Period
3 Rabbit Mean
4 Hours :
24 Hours:
48 Hours: 72 Hours :
0.0
0.3
0.3 0.0
* T h e P r i m a r y D e r m a l I r r i t a t i o n S c o r e is the to ta l d e r m a l i r r i t a t i o n s c o r e for all the animals (erythema and edema) divided by the number of test sites (3) at each ob se rv at io n period.
Comment: The right hind foot of Animal No. P20312 appeared injured 24 hours following patch removal.
HAZLETON
Chemical ft BloMadical Scianca Olvialon
3301 K IN S M A N BLVD. P.O. B O X 7545 M A D ISO N , W ISC O N SIN 53707 P H O N E (BOB) 241-4471 T U 703B5B H A Z R A L M D S UD
SAMPLE NUMBER: 70905394 SAMPLE: T-4101
OECD DERMAL IRRITATION
(CONTINUED)
PAGE
1. O r g a n i s a t i o n for E c o n o m i c C o o p e r a t i o n a n d D e v e l o p m e n t ' s G u i d e l i n e s for Testing of Chemicals, Section 404, Acute Dermal Irritation/ Corrosion, adopted May 12, 1981.
2. O E C D ' s P r i n c i p l e s of G o o d L a b o r a t o r y P r a c t i c e , A n n e x 2, C C 8 D 3 0 (F inal).
3. D r a i z e , J . H . , " A p p r a i s a l of the S a f e t y of C h e m i c a l s in F o o d s , D r u g s , and Cosmetics - Dermal Toxicity", Association of Food and Drug Officials of the U.5., pp. 46-59 (1975).
4. N I H P u b l i c a t i o n No. 8 6 - 2 3 ( r e v i s e d 1985).
Personnel Signature Sheet Acute Toxicology
h u 0 . 1 0 9 C S 2 Q Q
Maae
Jrt Tltli
Becky Beckwith
Sr. Lab. Anlaal Asst.
Steve Beloungy
Lab. Anlaal Asst.
Ken Bridges Pat Crary
Sr. Lab. Anlaal Asst. Sr. Lab. Anlaal Asst.
Shane Elth
Lab Anlaal Asst.
Shawn Frazier
Lab Anlaal Asst.
Steven N. Glaza
6roup Leader
Nolly Hahn
Adarin. Clerk '
Kevin Heal1ton
Lab. Anlaal Asst.
Jeff Hicks
Sr. Lab. Anlaal Asst.
Calvin Horton
Group Leader
Sheren L. Howery Adarlnlstratlve Asst.
Gregory Johnson
Lab. Anlaal Tech.
Paul Krebs
Lab. Anlaal Asst.
Mayne IMIson
Section Supervisor
Scott NcConnell
Lab. Anlaal Tech.
Shelley NcConnell Dawn Conant
Lab. Anlaal Tech. Sr. Lab. Anlaal Asst.
Don Navis
Lab. Anlaal Asst.
Robin Olson
Lab. Anlaal Asst.
Patricia Padghaa Joseph J. Daun
Teas Leader Lab. Anlaal Asst.
Nlchael Patzfca
Lab. Anlaal Asst.
John Paulson Jane Polnow
Sr. Lab. Anlaal Asst. Lab. Anlaal Tech.
Dennis B. Steiner Lab. Anlaal Tech.
Nlchael Thesing
Lab. Anlaal Asst.
Paula 6. Vangen
Adarlnlstratlve Asst.
Albert Olson
Manpower
Jin Jlrschele
LTE
Ben Haley
Sr. Lab Animal Asst.
Eileen M. McConnell Admin. Clerk
Annette R. Turner Manpower
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HLA:
PRIMARY DERMAL IRRITATION SCORING SCALE (ORAIZE1 TECHNIQUE)
(1) Erytheem and Eschar Formation
No erythema Vary slight erythema (baraly parcaptlbla)
Mell-deflned erythema
Modarata to severe erythema Savara arythaaa (baat radnass) to slight aschar
formation (Injuries 1n dapth)
Highest possible erythema score
(2) Edema Formation
No adeem Vary slight adama (baraly parcaptlbla) Slight adama (edges of area m e 11-defined by
definite raising) Modarata adama (raised approximately 1 am) Savara adama (raised more than 1 me and
extending beyond area of exposure)
.
Highest possible adeem score
0 1 2 3 __ i
4
0 l 2
3 1
4
1 Dralze, J. H., `Appraisal of the Safety of Chemicals 1n Foods, Drugs, and Cosmetics - Dermal-Toxicity.* Association of Food and Drug and Drug Officials of the U.S., pp. 46-59 (1975).
(00261/vmt)
