Document e71L7662QRmjMxvbyGEp6Q9p
FOR DU FONT USE ONLY
AR226-2922
Copies boa
Haskell
E. I. du Pont de Namours and Company Inc.
Laboratory for Toxicology and Industrial Medicine Elkfon Road, P. 0. Box 50
Newark, Delaware 19714
HASKELL LABORATORY REPORT NO. HLO-97-85
Haskell No. 15.615
Other Codes
Stufiy Initiated/Completed 12/18/84 - 12/24/8A
Submitted b\
temicals and Pigments Department 3ackson Laboratory
DEPARTMENT OF TRANSPORTATION SKIN CORROSION TEST ON RABBITS
Haskell Evaluation; Department of Transportation Regulations 173.1300 Appendix A - Method of Testing Corrosion to Skin [46 FR 49889, October 8, 1981, effective July 1, 1982] was used. Details are given in the appendix (Bio/dynamics Project No. 5444-84).
as applied under occlusion to the skin of six rabbits
_fo_r _f_ou_r_h_o_u_r_s_.All animals had very slight or mild erythema with little or
no edema.
When tested by this n-ocedure,
skin.
is not corrosive to
Contaminants: Composition;
1 -
company Sanitized. Does not contain TSCA CRf
Report by;
Carol S. Auletta/Doma L. Bla^zcak Bio/dynaniics Inc,
Reviewed by!
j A ^ r - t e ^ - Technologist
Gerald L. Kenncuy- m.
Senior Research ToxicoS-ogist
Approved by:
t H ^ David F. Krahn Manager, Toxicology JEH/egg Date Issued: February 22, 1985 AHpapseknedllix Laabtt.acRheepdo:rt N7 op. pH, LBOi-o9/7d-y8n5aniics Project No. 5444-84
Total pages in thig report: 9
2 -
|3%TOanyS^aannin;)'szeda. DUuss nn crt contasn rSCA CBi
Bio/ciynamics Inc.
Division of Biology and Safety Evaluation
PROJECT NO.: 5444-84
DOT SKIN CORROSION TEST IH RABBITS
TEST MATERIAL: 15.615
Submitted to; E.I. duPont de Nemours & Co.
Haskell Laboratory for Toxicology and Industrial Medicine
P.O. Box 50, Elk ton Road Newark, Delaware 19711 Attnl Date: January 30. 1985
Bto/ /dynamo* (nc.
-1-
5444-84
I. INTRODUCTION
This study was conducted for E.I. duPont <fe Ncmours i Co. to evaluate
the dermal corroslvlty produced by 15,615 In rabbits. The study was performed
at 810/dynaffllcs, Inc., Mettlers Road, East Millstone, New Jersey 08873. The
protocol was based on the following guideline: DOT regulation 173.1300 Appendix A - Method of Testing Corrosion to Skin [46 FR 49889. October 8. 1981. effective July 1. 1982].
This report has been reviewed by the Quality Assurance Unit of Bto/dynamics. Inc. to assure Its conformance with the protocol and raw data. All raw data, the original study protocol and final report will be retained on
file In the 81o/dynam1cs Archives.
II. DATES OF STUDY
Animal Receipt:
November 12, 1984
Initiation (Dosing):
December 18, 1984
Termination (Last Observation):
December 20, 1984
III. STUDY PERSONNEL
Study Director:
Laboratory Supervisor:
Technician-1n-Charge:
Study Monitor (Report Preparation);
Donna L. Blaszcak, B.S., AALAS R.L.A.T. Janet Erickson, A.A.S., AALAS L.A.T. Mary Webb. 8.S., AALAS L.A.T.
Ellen C. Levltz, B.S.
IV. MATERIALS
A. Test Animals: Breed:
Albino Rabbits New Zealand White
Reason for' Selection:
Standard laboratory animal for dermal Irritation studies. The New Zealand White breed was used because of Its availability and because of the existing historical data
base for comparative evaluation.
Supplier:
Hazleton-Dutchland, Inc. Denver, Pennsylvania
{CompanySanitized. Does not contain TSCA CW
IV. MATERIALS (cont.)
Number; Age: Weight:
(Pretest) Equilibration Period:
Husbandry:
Housing: Cages: Environmental
Conditions:
Food: Water:
Identification:
RIO/ /liylwmien Inc.
Z" 5444-84
Six (3 males, 3 females)
Young adults
2.7 to 3.0 kilograms
36 days
Currently acceptable practices of good
animal husbandry were followed, e.g.,
Guide for the Care and Use of laboratory Admals: &HEWf>ubHcation No. (HIM) 75-23 Revised 1978.
Individually housed
Suspended, stainless steel.
Temperature: 60-70*F Is considered an acceptable temperature range for rabbits:
room temperature was monitored and recorded
twice daily and maintained within this range to the maximum extent possible.
Humidity: 30-702 Is considered an acceptable humidity range for rabbits; room humidity was monitored and recorded dally and maintained within this range to the maximum extent possible.
Light Cycle: 12 hours light, 12 hours dark (controlled by an automatic timer).
Lab Rabbit Chow HP (Purlna ^5326). ad llbituro.
Automatic watering system, ad^ libltum. Municipal wafer supply (Elizabeth town Water Co.)
Each animal was Identified with a monel ear tag bearing a unique number prior to testing.
I^Cifitfi^^sjWi^ r'ue.; r^' cMWi T3CA ''''
ydyswrntof IM. -3-
5444-34
IV. MATERIALS (cont.)
Selection:
Animals were randomly placed in cases
upon receipt ana were placed on study as
available at the time of study Initiation.
Animals considered unsuitable for study
because of poor health, unacceptable skin, or outlying body weights were excluded from
selection.
B. Test Material:
15*615
Description:
Cloudy, pale yellow liquid
Date of Receipt:
November 16, 1984
Received from: Storage:
E.I. duPont de Nemours & Co.
Room temperature
V. METHDDS
A. Preparation of Test Material:
The test material was administered as received; no preparation was
necessary.
B. Preparation of Animals:
On the day before dosing, the hair of each rabbit was closely clipped from the back with an electric clipper, so as to expose the back from
the scapular to the lumbar region. The skin remained Intact, I.e..
no abrasions were made.
C. Administration of Test Material:
There was one test site on the back of each animal. 0.5 ml of the test material was applied to each site beneath a surgical gauze square, T'xl". plac-1 directly on the test site and held In place with tape. Plastic sheeting was then wrapped around the animal and secured with tape to retard evaporation and keep the test substance In contact with the skin without undue pressure. Elizabethan collars were then placed on the animals to prevent disruption of the wrappings and Ingestfon of the test material.
Following approximately 4 hours of exposure, the wrappings and gauze squares were removed and the test sites gently wiped free of excess test material with dry gauze.
Wo/
/dynmm lac.
-4-
5444-84
VI. EXPERIMENTAL EVALUATIO(NIn,-Life) Viability Check: Twice Dally Evaluation of Skin Irritation: 1. Intervals: Approximately 4.5 (30 minutes after removal of wrappings) 24 and 48 hours after administration. 2. Methods: At each Interval alt sites were evaluated for erythema and edema or other evidence of dermal Irritation according to the Draize scoring system (presented In Appendix A). Adjacent areas of untreated skin were used for comparison.
iCpmpany Sanitized. Does nol contain TSCA CC
B*<^
dynamism Inc. 5444-84
VIII. RESULTS AND DISCUSSION Dermal observations are presented In Table I; the scoring system used
is presented In Appendix A. 15,615 was not corrosive. .All animals had very s1<-.,ht (barely
perceptible) or well-defined eryjthema with little or no edema at 4.5 and/or 24 hours. This Irritation persisted In some animals through the 48 hour observa
tion. No evidence of tissue destruction was seen.
^^wcST^^^^ l'^n^w ^^5^erf^^^._______
Donna
ft.LA.T.
Study Director
Assistant Manager, Acute Toxicology
Vsy/vs^ O^T'----
<^^^ Carol S. Auletta^, -B_.A_._. _D_.A_.B_.1
Manager, Acute Toxicology
i/^lvs'
VS^e------
.Company Sanitized. Does not contain TSCA C'
TABLE I'
-6-
5444-84
PRIMARY DERMALIRRITATION STUDY IN RABBITS
TEST MATERIAL: 15,615
INDIVIDUAL DERMAL IRRITATION SCORES6- 4.5, 24 AND 48 HOURS
Time
Interval
Patch Sites i Observation S
;5424F
An froal Numbe r and !Sex
542oP 5431M SCTT 5435N -sissr
4.5 Hours Right Side ER
2
1
1
1
2
2
ED
0
0
0
0
0
0
24 Hours Right Side ER
1
1
i
1
2
1
ED
0
0
0
0
1
0
48 Hours
Right Side ER
1
0
1
0
2
0
ED
0
0
0
0
1
0
Scored using scale presented In Appendix A.
M-Male
F-Female ER-Erythena ED-Edema
iCoinpanySanitized. Does not contain TSCA cr
APPENDIX A
ORAIZE1EVALUATIONOF DERMALIRRITATION
A-l 5444-84
Dermal Observations
.
Erythema and Eschar Formation (Most severely affected area graded):
No erythema..................................................... 0
Very slight erythema (barely perceptible)....................... 1
We!1-defined erythema........................................... 2
Moderate to severe erythema..................................... 3
Severe erythema Eschar
(beet
redness)..................................
4 4E
formation.....*........................................ 4N
Necrosis......................................................
Edema Formation (Most severely affected area graded):
No edema........................................................ 0
Very slight edema (barely perceptible)...........,.............. 1
Slight edema (edges of area well-defined by definite
raising)................................................... 2
Moderate edema (raised approximately 1 mm)...................... 3
Severe edema (raised more than 1 mm and extending
beyond area of exposure)................................... 4
Braize. J.H. 1959. The Appraisal of Chemicals in Foods, Drugs, and Cosmetics, p. 48. Association of Food and Drug Officials of the
United States. Austin. Texas.
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