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Toxicologic Report
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TO:
The B. F. Goodrich Company Attn: Mr. W,, E McCormick
,November 26 1969
SUBJECT:
Project R-90616 X-1053 Plastic Inflatable Catheters Control
The above material was subjected to Type A Tests I, II and III. The following data were obtained:
1. There was no significant acute toxicity with the eluates.
2. Intracutaneously, there was a mild reaction at 24 hours; reduced to slight at 48 hours; with a trace reaction remaining at 72 hours with the PEG eluate: no reaction with the other eluates.
3. Sections implanted intramuscularly for 72 hours remained free of significant tissue reaction.
4. It is nonpyrogenic.
Respectfully submitted.
Toxicologist ak
T O t> tS 9 0 S
Huntingdon Research Center, Inc.
6
BFG04588
Box 6857
Baltimore, Maryland 21204
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PROJECT R-90616
X-1053 Plastic Inflatable Catheters
Control
November 26, 1969
The following preparations were made:
10 gms 10 gms 10 gms 10 gms
X-1053material -- covered with X-1053material -- covered with X-1053material -- covered with X-1053material -- covered with
50 ml 0.9% saline 50 ml 5% ethyl alcohol in saline 50 ml cottonseed oil (CSO) 50 ml polyethylene glycol (PEG)
All preparations were warmed to 70C for 24 hours along with 50 ml control portions of each menstruum, shaken, and the supernate poured off for testing.
The eluates were clear.
The polyethylene glycol dilutions were mildly turbid.
I A Acute Toxicity Menstruum
Dose
Route
No. Mice
Deaths to 72 hours
Saline 0.9% eluate " control
1.0 ml 1.0 ml
I.V.* I.V.
15 5
0 0
5% ethyl alcohol eluate
tl It
II control
1.0 ml 1.0 ml
I.V. I.V.
15 5
0 0
CSO eluate 11 control
1.0 ml 1.0 ml
I.P.** I.P.
15 5
0 0
PEG eluate It II
8,-000 mg/kg 10,000 mg/kg
I.P. I.P.
10 10
0 0
PEG control II II
8,000 mg/kg 10,000 mg/kg
I.P. I.P.
10 10
0 0
* intravenously
intraperitoneally
The saline, 5% ethyl* alcohol in saline and cottonseed oil elu ates were injected undiluted. The polyethylene glycol 400 eluate and control was diluted as follows:
2.8 ml + 7.2 ml saline ( 8,000 mg/kg) 3.6 ml + 6.4 ml saline (10,000 mg/kg) and 0.025 ml injected per gm of mouse, i.e. 0.5 ml for a 20 gm mouse.
200T690Z
Huntingdon Research Center# Inc.
Box 6857
BFG04589
Baltimore# Maryland 21204
Project R-90616
'
X-1053 Plastic Inflatable Catheters
Control
( age 2 November 26, 1969
B Intracutaneous Reactivity
The 0.9% saline, 5% ethyl alcohol in saline and cottonseed oil were injected undiluted 0.2 ml into each of ten blebs in each of two rabbits, paralleled by ten like control menstruum blebs. The polyethylene glycol 400, eluate and control, was diluted such that the 0.2 ml bleb injection volume contained 24 mgs and two rabbits received ten blebs of each.
Results:
0.9% saline eluate and control: No significant reaction
5% ethyl alcohol in saline eluate and control:
No significant reaction
CSO eluate and control:
No significant reaction
PEG eluate:
There was a mild reaction at 24 hours; reduced to slight at 48 hours; a trace reaction remaining at 72 hrs
PEG control:
No significant tissue reaction
II Intramuscular Tissue Reaction
Acute implants in rabbits
Rabbit 1. Implanted
Four X-1053 sections Four USP controls
No gross reaction to 72 hours
Autopsy:
X-1053:
No significant tissue reaction
Controls: No significant tissue reaction
Rabbit 2. Implanted
Four X-1053 sections Four USP controls
n
Huntingdon Research Center, Inc.
Box 6857
Baltimore, Maryland 21204
r
Project R-90616
X-1053 Plastic Inflatable Catheters Control
. age 3 November 26, 1969
Rabbit 2 (cont'd)
No gross reaction to 72 hours
Autopsy:
X-1053:
No significant tissue reaction
Controls: No significant tissue reaction
III Pyrogenicity
A ten gram portion of the X-1053 material was prepared and covered with 200 ml of pyrogen-free saline and heated to not less than 85C for one hour, cooled to 37C and 10 ml of the eluate in jected per kg of body weight. Body temperatures were recorded to three hours.
Results:
Total rise: 0.10C. It is, therefore, nonpyrogenic.
20691004
B?G0459l
Huntingdon Research Center, Inc.
Box 6857
Baltimore, Maryland 21204
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Toxicologic Report
TO:
The B. F. Goodrich Company Attn: Mr. W. E. McCormick
SUBJECT:
Project R-90616 X-1054 Plastic Inflatable Catheters Discolored
November 26, 1969
The above material was subjected to Type A Tests I, II and III. The following data were obtained:
1. There was no significant acute toxicity with the eluates.
2. Intracutaneously, there was a mild reaction at 24 hours; reduced to slight at 48 hours; with a trace reaction remaining at 72 hours with the PEG eluate; no reaction with the other eluates.
3. Sections implanted intramuscularly for 72 hours remained free of significant tissue reaction.
4. It is nonpyrogenic.
Respectfully submitted.
Toxicologist ak
bFG04593
'0691006
Huntingdon Research Center, Inc.
Box 6857
Baltimore, Maryland 21204
(
PROJECT R--90616
X--1054 Plastic Inflatable Catheters
Discolored
November 26, 1969
The following preparations were made:
10 gms 10 gms 10 gms 10 gms
X-1054 material -- X-1054 material -- X-1054 material -- X-1054 material --
covered with covered with covered with covered with
50 ml 0.9% saline 50 ml 5% ethyl alcohol in saline 50 ml cottonseed oil (CS0) 50 ml polyethylene glycol (PEG)
All preparations were warmed to 70C for 24 hours along with 50 ml control portions of each menstruum, shaken, and the supernate poured off for testing.
The eluates were clear.
The polyethylene glycol dilutions were mildly turbid.
I A Acute Toxicity Menstruum
Dose
Route
No. Mice
Deaths to 72 hours
Saline 0.9% eluate " control
1.0 ml 1.0 ml
I.V.* I.V.
15 5
0 0
5% ethyl alcohol eluate
II II
If control
1.0 ml 1.0 ml
I.V. I.V.
15 5
0 0
CSO eluate " control.
1.0 ml 1.0 ml
I.P.** I.P.
15 5
0 0
PEG eluate II fl
8,000 mg/kg 10,000 mg/kg
I.P. I.P.
10 10
0 1
PEG control II II
8,000 mg/kg 10,000 mg/kg
I.P. I.P.
10 10
0 1
* intravenously ^ intraperitoneally
The saline, 5% ethyl alcohol in saline and cottonseed oil elu ates were injected undiluted. The polyethylene glycol 400 eluate and control was diluted as follows:
2.8 ml + 7.2 ml saline ( 8,000 mg/kg) 3.6 ml + 6.4 ml saline (10,000 mg/kg) and 0.025 ml injected per gm of mouse, i.e. 0.5 ml for a 20 gm mouse.
Huntingdon Research Center, Inc,
Box 6857
4594
Baltimore, Maryland 21204
Project R-90616
(
X-1054 Plastic Inflatable Catheters
Discolored
( ige 2 iNOvember 26, 1969
B Intracutaneous Reactivity
The 09% saline, 5% ethyl alcohol in saline and cottonseed oil were injected undiluted 0.2 ml into each of ten blebs in each of two rabbits, paralleled by ten like control menstruum blebs. The polyethylene glycol 400, eluate and control, was diluted such that the 0.2 ml bleb injection volume contained 24 mgs and two rabbits received ten blebs of each.
Results:
0.9% saline eluate and control: No significant reaction
5% ethyl alcohol in saline eluate and control:
No significant reaction
CS0 eluate and control:
No significant reaction
PEG eluate:
There was a mild reaction at 24 hours; reduced to slight at 48 hours; a trace reaction remaining at 72 hrs.
PEG control:
No significant tissue reaction
II Intramuscular Tissue Reaction
Acute implants in rabbits
Rabbit 1. Implanted:
Four X-1054 sections Four USP controls
No gross reaction to 72 hours
Autopsy:
X-1054:
No significant tissue reaction
Controls: No significant tissue reaction
Rabbit 2. Implanted:
Four X-1054 sections Four USP controls
BFG04595
800TG9(K
Huntingdon Research Center/ Inc.
Box 6857
Baltimore/ Maryland 21204
Project R-90516
*
X-1054 Plastic Inflatable Catheters Discolored
age 3 November 26, 1969
Rabbit 2 (cont'd)
No gross reaction to 72 hours
Autopsy:
X-1054:
No significant tissue reaction
Controls: No significant tissue reaction
III Pyrogenicity
A ten gram portion of the X-1054 material was prepared and covered with 200 ml of pyrogen-free saline and heated to not less than 85C for one hour, cooled to 37C and 10 ml of the eluate in jected per kg of body weight. Body temperatures were recorded to three hours.
Results:
Total rise: 0.20C. It is, therefore, nonpyrogenic.
600TG90:
Huntingdon Research Center, Inc.
BFG04596
Box 6857
Baltimore, Maryland 21204
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(l?910,L0
Baltimore, Maryland 21204
Box 6857,
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