Dow Chemical Trial Exhibit Abstracts

NOTE:
The following information is quoted from the cover sheets of the Dow Chemical Trial Exhibit Abstracts
Number
Date
Title

Information

9

00/00/00

JOINT
VENTURE/CORPORATE CONTROL

“Former Dow Chemical Employees Who ‘Transferred’ Or Joined Dow Corning,”

12

00/00/00

ACKNOWLEDGEMENT
OF NEED FOR TESTING COMPLICATIONS: TISSUE REACTION KNOWLEDGE OF SYSTEMIC
DISEASESILICA

W.D. Galloway reports on the “Analysis of Lifetime Carcinogenicity Study
of Silicone Gels” conducted by Dow Corning under GLP regulations using
Sprague-Dawley rats injected with Q7-2159A and MDE-0193 gels.
 Galloway states: Both of the gel-implanted groups showed a
large number of cancers compared to the control group. Particularly
striking was the number of sarcomas (principally fibrosarcomas) which
occurred in the treated group

The only obvious deficiency is that only one dose level was used. Ordinarily,
three doses are used, and five are preferred. Based on the results obtained,
I have little Doubt that NTP would classify these substances as likely
animal carcinogens.

According to Dow Corning, … the tumors were peculiar to rats, the
so called foreign body tumors.

Absent epidemiologic data, and without waiting for the results of additional
lifetime studies, knowledge of the mechanism by which these tumors was
induced is critical to estimate human risks. It is possible that the
tumors were chemically induced, rather than being induced by a physical
mechanism, as Dow suggests. If this is the case, then the argument that
such tumors do not occur in man is untenable. If the tumors were chemically
induced, the active agent is more likely to be one of the several chemicals
which make up the gel, rather than a metabolically produced reactive
intermediate, since the tumors which did occur did not occur selectively
in metabolically active organs such as the liver.

Recent studies have shown that siloxanes may act as estrogen-like substances
and can enhance the growth of tumor cells.

23

00/00/00


RELIANCE ON DOW CHEMICAL SILICONE IS INERT MYTH CHEMICAL TESTING OF SILICONES IN BREAST IMPLANTS

 

Booklet distributed by Dow Corning containing the November 1949 Rowe, Spencer, and Bass article entitled, “Toxicological Studies On Certain Commercial
Silicones,” reprinted from The Journal of Industrial Hygiene and Toxicology,
Vol. 30, No. 6, 332-352.

43

00/00/50

RELIANCE ON DOW CHEMICAL SILICONE IS INERT MYTH

“Toxicological Studies On Certain Commercial Silicones, II. Two-Year Dietary Feeding Of  DC Antifoam A To Rats,” by Rowe, Spencer, and Bass, published in
Archives of Industrial Hygiene and Occupational medicine, Vol. 1, p.
539-544.

78

10/09/57

BIOLOGICAL ACTIVITY OF SILICONES KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning, enclosing
the results of the review of the six Dow Corning silicone compounds.
He informs McGregor that all six compounds depressed the granulocytic
elements of the peripheral (tail) blood of the female rats, and that
the livers of rats fed Z-4141 were significantly heavier than the controls
and demonstrated fatty infiltration or degeneration.

80

11/27/57

BIOLOGICAL ACTIVITY OF SILICONES RELIANCE ON DOW CHEMICAL

Letter from Dr. William Deichmann, University of Miami, to Dr. R.R. McGregor
at Dow Chemical (McGregor was actually at Dow Corning) with a copy to
V.K. Rowe. Deichmann encloses a memo from a pathologist at the University
of Miami. Based on this and a meeting with Dr. Irish, Deichmann decided
to repeat the hematological studies in rats fed Z-4141.

81

12/02/57

BIOLOGICAL ACTIVITY OF SILICONES DOW CHEMICAL TESTING OF DOW CORNING PRODUCTS ATHLETE’S FOOT RELIANCE ON DOW CHEMICAL

Letter from Mark Wolf and checked by D.D. McCollister, Dow Chemical Biochemical Research, to R.R. McGregor of Dow Corning with a copy to J.H. McHard on “Results Of Skin Irritation Tests On XC-4032 [the material is being
considered for treatment of athlete’s foot].” The formulation caused
moderate irritation and damage within 24 hours of contact with covered
skin. “It is recommended that the use of this formulation for Athlete’s
Foot should be approached with caution.” Repeated prolonged contact
caused development of moderate irritation and slight necrosis and slight
exfoliation. The material consists of 43% Dow Corning 200 Fluid, 250
cs. and a Dow Chemical material, Dowicide 2.
Attached
is the data sheet completed by Wolf and McCollister, a toxicology work
sheet, “Request For Applications Testing, “and skin contact – irritation
and patch test – skin test records.NOTE: The document is stamped, “This
Report Is The Property Of The Dow Chemical CompanyNOTE:
Dow Chemical is providing advice and recommendations to Dow Corning
on product applications.

83

12/24/57

BIOLOGICAL ACTIVITY OF SILICONES DOW CHEMICAL TESTING OF DOW CORNING PRODUCTS RELIANCE ON DOW CHEMICAL

Letter from K.J. Olson and checked by D.D. McCollister, Dow Chemical Biochemical Research, to R.R. McGregor of Dow Corning with copies to J.H. McHard and H.H. Gay [Dow Chemical] on “Results Of Range Finding Toxicological Tests On Polymethyl Methylsiloxanes-2-Methylpropionate.” The material has a low acute oral toxicity, the undiluted material may produce slight
pain and slight immediate conjunctivitis, it is irritating to the skin,
and may produce hyperplasia of the hair follicles. “This reaction is
manifested by ‘acneiform’ dermititis [sic] in humans.” There was extensive
lung, liver, and kidney damage along with moderate gastritis in rats
in the acute oral toxicity test.Attached
is a data sheet prepared by Olson and McCollister, a toxicology work
sheet, “Request For Applications Testing”, and acute oral toxicity,
eye contact, skin contact – irritation and single exposure test records.
NOTE: The document is stamped, “This Report Is The Property Of The Dow
Chemical Company.”

84

12/24/57

DOW
CHEMICAL TESTING OF SILICONES IN BREAST IMPLANTS RELIANCE ON DOW CHEMICAL

Letter
from K.J. Olson and checked by D.D. McCollister, Dow Chemical Biochemical
Research, to R.R. McGregor of Dow Corning with copies to J.H. McHard
and H.H. Gay [Dow Chemical] on “Comparison Of 200 Fluid, Treated And
Untreated, Insofar As Eye Contact Irritation Is Concerned.” McGregor
recently submitted 2 samples of 200 Fluid for toxicological evaluation
for eye contact irritation. Neither materials showed any marked irritating
properties when instilled directly into the rabbit eye.
Attached is a data sheet prepared by Olson and McCollister, a toxicology
work sheet, “Request For Applications Testing,” and eye contact test
records. NOTE: The document is stamped, “This Report Is The Property
Of The Dow Chemical Company.”

85

03/28/58

DOW
CHEMICAL TESTING OF SILICONES IN BREAST IMPLANTS KNOWLEDGE OF LIQUID
SILICONE DANGERS RELIANCE ON DOW CHEMICAL

Report
from J.K. Weiler, Dow Corning Analytical Laboratory, to H.J. Horner
with copies to Olson of Dow Chemical, McGregor, File, and Weiler concerning
“Determination of the Amounts of Silicone Fluid Retained by Various
Internal Organs of Rabbits after Intravenous Injection of Material Containing
Silicone Fluid.” Horner writes, “Upon checking with Dr. McGregor I find
this work has been temporarily suspended but not abandoned. Apparently
they have been considering using some labeled 200 fluid. My future work
will again be initiated by Dr. McGregor.”
Attached
is a Dow Chemical “Request For Applications Testing” on DC 710 fluid,
a Dow Chemical “Request For Biological Test” on DC 555 Fluid on human
subjects signed by V.K. Rowe, a Dow Chemical “Request For Applications
Testing” on DC XF-6060, a Dow Chemical “Request For Applications Testing”
on DC XEC-5021, a Dow Chemical “Request For Applications Testing” on
DC XF-371, and a Dow Chemical “Request For Applications Testing” on
DC 555 fluid.
NOTE:
The documents on human testing of DC 555 Fluid by Rowe were
not produced in MDL 926.

87

07/31/58

BIOLOGICAL
ACTIVITY OF SILICONES COMPLICATIONS: TISSUE REACTION KNOWLEDGE OF
SYSTEMIC DISEASE RELIANCE ON DOW CHEMICAL

Olson,
Dow Chemical Biochemical Research, letter to McGregor, Dow Corning,
with copies to Gay, Dow Chemical, and McHard regarding the results of
skin irritation, skin absorption, and acute oral feeding tests on Dow
Corning 555 Fluid and Ethylan (a modified lanolin), File No. T2.42-54-1.
In
McGregor’s 06/05/58 letter to Rowe, he indicated that Helen Curtis Industries
had observed untoward systemic effects in rabbits and rats due to absorption
of the material through the skin. Autopsy revealed small yellowish bubbles
and petochone [illegible] on the liver and lungs. Olson applied the
material to the skin of rabbits and fed it to another group for 5 days.
The results for the skin sensitization tests are illegible. There was
questionable to mild kidney disturbance in animals fed DC 555 fluid.

The
conclusions on TDC 6532 state that DC 555 fluid has a low acute oral
toxicity, is essentially non-irritating to the skin upon prolonged repeated
contact, and that there is no indication that the material is absorbed
through the skin in sufficient amounts to produce systemic damage. Attached
is a toxicology work sheet “Request For Screening Or Applications Testing.”
and skin contact absorption and acute oral toxicity test results.

89

09/01/59

BIOLOGICAL
ACTIVITY OF SILICONES COMPLICATIONS: TISSUE REACTION DOW CHEMICAL TESTING
OF SILICONE IN BREAST IMPLANTS LOW MOLECULAR WEIGHT EXTRACTABLES RELIANCE
ON DOW CHEMICAL
Letter
from K.J. Olson and checked by F. Oyen, Dow Chemical Biochemical Research,
to R.R. McGregor with a copy to J.H. McHard on “Comparative Eye Irritation
Of Specially Prepared Dow Corning 200 Fluids.” On the bottom of TDC
6208 there is a handwritten note: “V.K. Rowe says physiological action
of 200 fluid [is] the result of physical forces rather than chemical,
i.e. the eye discomfort may be due to lowering of surface tension.”
The commercial 200 fluid manifested very slight but definite conjunctival
irritation. The dimethyl cyclic tetramer (includes results of D4 studies)
had consistent, slight to moderate irritation in both rabbits which
was significantly worse than the commercial 200 fluid. The dimethyl
linear material and the HO(Me2SiO)H are essentially non-irritating.
NOTE: Dow Chemical
is providing advice and recommendations to Dow Corning.

90

03/10/60

BIOLOGICAL
ACTIVITY OF SILICONES DOW CHEMICAL TESTING OF DOW CORNING PRODUCTS
RELIANCE ON DOW CHEMICAL

Letter
from T.R. Torkelson, Dow Chemical Biochemical Research, to R.R. McGregor
of Dow Corning with copies to J.A. McHard, H.H. Gay [Dow Chemical],
and V.K. Rowe [Dow Chemical] on “The Toxicity To Rats Of Vapors Resulting
From Decomposition Of Three Silicon Rubbers By Heat (A995-46-1, 2, and
3).” Sample 3 was considerably more toxic when decomposed than the other
two. Rats died within 3 days in some tests, in 4 hours in others because
of lung irritation and congestion, and in 2 weeks in another test. Lung,
liver, and kidney pathology were seen at autopsy.

91

09/26/60

BIOLOGICAL
ACTIVITY OF SILICONES DOW CHEMICAL TESTING OF DOW CORNING PRODUCTS
RELIANCE ON DOW CHEMICAL

Letter
from K.J. Olson and checked by F. Oyen, Dow Chemical Biochemical Research,
to R.R. McGregor of Dow Corning with a copy to J.A. McHard on “Results
Of Range Finding Toxicological Tests On Tin Dioctoate (XY-70 Catalyst)
[material is supplied by Nuodex as Silicure T 773 and that it is used
as a 1% concentration to catalyze your Room Temperature Vulcanizing
Silastic. “This silastic in turn is of interest to the medical profession.”].”
The material was fed to rats in 2g/kg body weight and did not produce
any deaths.The material has a low acute oral toxicity. Gross pathology
showed considerable kidney and liver injury along with gastrointestinal
irritation and general congestion. The undiluted catalyst is moderately
to severely irritating to the eye, and slightly irritating to the skin.

94

08/31/61

DOW
CHEMICAL TESTING OF DOW CORNING PRODUCTS – HERBICIDE RELIANCE ON DOW
CHEMICAL

Letter
from K.J. Olson and checked by F. Oyen, Dow Chemical Biochemical Research,
to Jim McHard of Dow Corning on “Results Of Range Finding Toxicological
Tests On Chloromethyl Methyl Siloxane Hydrolysate (Ref: A-1065-94-2).”
The material is said to be a grass killer. The material has a low acute
oral toxicity, is slightly irritating to the eyes, and slightly irritating
to the skin.

96

04/11/62

DOW
CHEMICAL TESTING OF DOW CORNING PRODUCTS – HERBICIDE, DEFOLIANT RELIANCE
ON DOW CHEMICAL

Letter
from Olson, Dow Chemical’s Biochemical Research Laboratory (Bldg. 1701),
to McHard of Dow Corning regarding “Results of Range Finding Toxicological
Tests On Chloromethyl Methyl Dimethoxy Silane.” The material “is generally
effective as an herbicide and specifically effective as a defolient
[sic].” A copy of the letter was sent to K. Leasure, K. Barrons [Dow
Chemical Bioproducts Plt. Sci R and D], and G.E. Lynn [Dow Chemical
Bioproducts Registration Section]. The material has a low acute oral
toxicity and is only slightly irritating to the eye. Direct contact
would likely be somewhat painful and produce slight conjunctival redness.
There is indication from skin irritation and absorption studies conducted
on rabbits that the material possesses a low order of toxicity by absorption
through the skin particularly if abraded. The material also possesses
a relatively high vapor pressure and poses a problem from the viewpoint
of vapor inhalation. Laboratory rats survived 1 hour but did not survive
2 hours. “It is possible under conditions of room temperature to become
exposed to vapors sufficient to result in systemic injury.” On
TDC 7457, there is a note re K. Leasure’s report. “Dow may handle marketing.”
McHard requested the testing. Also, there is a reference to Stage 2
(??) testing; send report to Leasure and Barrons – confidential.

99

07/05/62

BIOLOGICAL
ACTIVITY OF SILICONES COMPLICATIONS: TISSUE REACTION DOW CHEMICAL
TESTING OF SILICONES IN BREAST IMPLANTS RELIANCE ON DOW CHEMICAL

Olson
and Sadek, Dow Chemical Biochemical Research, letter to McHard, Dow
Corning, on “Toxicity By Subcutaneous Injection Of Dow Corning 200 Fluids
And Dow Corning 555 And 550 Fluids.” Dow Corning 200 fluid 10cs. resulted
in a moderate inflammatory response in the subcutis as indicated by
the presence of polymorphonuclear cells and very large mononuclear cells.
“This type of inflammatory reactions is interpreted as due to infection.”
With DC 555 Fluid, all injection sites showed evidence of inflammatory
reaction by the presence by mononuclear cells and polymorphonuclear
cells.

101

09/14/62

BIOLOGICAL
ACTIVITY OF SILICONES COMPLICATIONS: TISSUE REACTION DOW CHEMICAL
TESTING OF SILICONES IN BREAST IMPLANTS

Dow
Chemical Texas Division, Agricultural Research, study by F.C. Turner,
K.G. Seymour, and J.B. Jackson on “Topical Application Of Various Solvents
And Solutions To Evaluate Dermal Irritation,” Report No. 210. The report
was circulated to many persons including K.W. McCoy of Dow International;
persons at Bioproducts: Adm., J.E. Johnson; An. Sci. R and D, T.A. Hymas;
Plt. Sci. R and D, K.C. Barrons; Midland BRC Files, L.J. Lippie; Registration
Section, G.E. Lynn; Synthesis Group, W. Reifschneider; and Formulation
Res., J.W. Valkenburg; to V.K. Rowe of Biochemical Research; and to
the following persons at Pitman-Moore: C.W. Hinman, G.R. Burch, and
D.C. Brinkman. Dow Corning 200 fluid – silicone oil with 49% espesol
5 content was administered in 10 cc dosages to shaved strips on the
hide to test for suitable solvents for Ruelene. Dow Chemical hoped to
find a solvent that didn’t damage the hides of cattle when Ruelene was
administered. The DC 200 fluid was rated as bad, which indicated that
the hide had extreme cracking or sloughing at 10 and 16 days after application.

105

10/31/63

GEL
MIGRATION KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr.
Walter Berman writes to Silas Braley, Dow Corning, reporting on his
injection of silicone fluid in mice. Two days after injection, silicone
was found in most organs including the brain, liver, spleen, intestinal
wall, adrenal, and kidney. He also found “evidence of at least radioactivity
and most probably silicone in the brain and all the various other organs…”

253

02/10/72

CONCEALMENT
DOW CHEMICAL TESTING OF SILICONES IN BREAST IMPLANTS FRAUD/MISREPRESENTATION
RELIANCE ON DOW CHEMICAL

“The
Effects of Dow Corning 360 Medical Fluid, 350 CS And Sesame Oil After
Intraperitoneal Or Subcutaneous Administration To Rats,” by E.J. Hobbs,
Dow Corning Toxicology Department. This report is a retyped version
of the 12/02/70 study done by Sparschu and Clashman of Dow Chemical.
The differences in the reports are:
1. In the introductory paragraph,
Hobbs states that this study was initiated to reproduce findings in
a recent publication authorized by Hawthorne, Ballantyne, and Rees entitled,
“Hematological Effects of Dimethlpolysiloxane Fluid in Rats,” J. of
Reticuloendothelial Soc., Vol. 7, 587-593 (1970). The “Hawthorne” study
revealed “an unexpected hematological finding manifested by multiple
vacuoles in red cells of rats following intraperitoneal (I.P.) injection
with massive doses of dimethylpolysiloxane. 2.
On DCC 243000005, Dow Corning refers to “injections” given to the test
animals. In the Dow Chemical report, it states on T 38868 that a single
injection was given.
3.
The table on DCC 243000005 notes that the test animals were reviewed
for 401 days. In the Dow Chemical report, it states on T 38868 that
the animals were reviewed for 481 days.
4.
Dow Corning has deleted the paragraph on T 38869 that Dow Chemical performed
the hematology, urinalysis, clinical chemistry, and gross and histopathology
studies.
NOTE:
This Dow Corning generated cover sheet, which was submitted to the FDA
in 1991 as part of the Dow Corning’s Premarket Approval Application,
claims that this was an “internal Dow Corning study.”

255

04/07/72

GEL
MIGRATION

Dimethylpolysiloxane
Fluid C (Dow Corning 360 Medical Fluid C) Distribution and Disposition
In Rats Following Subcutaneous Injection.” by LeBeau and Gorzinski of
the Bioscience Research Department of DC. A copy was sent to Ryan, Bennett,
Braley, Hunter, Isquith, Frye, LeVier, Speier, Stark, Boley, and others.
DC 360 fluid was administered subcutaneously to rats to measure the
distribution of the fluid in expired air, urine, and feces at 8, 30,
60, and 90 days. The highest percentage (>94%) was detected at the
original injection site. Less than 10 percent (<10%) was detected
in urine and feces. “There was a ubiquitous distribution of low concentrations
of radioactivity in the tissues and organs (<.02%). However, lymphatic
tissue near the injection site had a higher (ten-fold) concentration
of radioactivity of all tissues and organs examined suggesting migration
via lymphatic routes.”
Rodents
receiving massive subcutaneous doses of silicone fluid were examined
histopathologically. Droplets of vacuoles were found throughout the
reticuloendothelia systems including the regional lymph nodes and extending
to the liver, spleen, kidneys, and adrenals. Definite proof of silicone
fluid in the droplets was not demonstrated but the authors assumed it
was silicone fluid.
NOTE:
Le Beau later joined Dow Chemical to head up its toxicology
department.

256

05/14/82

COMPLICATIONS:
TISSUE REACTION GEL MIGRATION IMMUNOLOGY KNOWLEDGE OF SYSTEMIC DISEASE
RECKLESS/CONSCIOUS DISREGARD SHELL DEGRADATION

Dr.
Robert Parsons, Professor of Surgery at the University of Chicago,
writes a letter to Gene Jakubczak at Dow Corning informing them of
their research on implanted silicone prostheses. “Our data suggest
strongly that the fibrosis and capsular contracture seen clinically
may be an immunologically mediated phenomenon.” Dr. Parsons states
that macrophages aggregate and adhere to the surface and actively
erode the silicone envelope after implantation; macrophages ingest
and process silicone; macrophage-lymphocyte communication occurs by
intracellular bridging in the lymph nodes and have identified silicone
containing microvacuoles in both the macrophage and lymphocyte ends
of the bridges; and significant inhibition of macrophage migration
by silicone sensitized lymphocytes in vitro has been shown. Dr. Parsons,
Dr. Heggers, and their research assistant, Nir Kossovsky, suggest
that their work may enable them to develop a method of screening patients
for “hypersensitivity to silicone” before they are implanted.

The
research team found that the body’s reaction to silicone created giant
cells called macrophages that erode the silicone envelope and can
migrate to the lymph nodes. Dr. Parsons believes that the body’s immune
reaction could be causing such problems as capsular contracture. Requests
for funding from Dow Corning to further research to better understand
this immune response were denied by the company.

577

00/00/83

RELIANCE
ON DOW CHEMICAL SILICONE IS INERT MYTH

“Technology
of Silicones in Biomedical Applications.” Chapter 8 in Biomaterials
in Reconstructive Surgery, by Eldon Frisch of Dow Corning. Frisch cites
the November 1948 Rowe, Spencer, Bass article.

624

08/01/84

CONCEALMENT-
SECRECY AGREEMENT INSECTICIDES JOINT VENTURE/CORPORATE CONTROL

Joint
Research Agreement For Identification Of Agricultural Chemicals between
Dow Corning (signed by Weyenberg) and Dow Chemical (signed by P. Gehring).
Dow Chemical produces and sells pesticides, herbicides, insecticides,
acaricides, nematocides, and fungicides and has developed expertise
in perceiving structural-activity relationships in non-organosilicon
compounds. Dow Corning has expertise in the synthesis and manufacture
of organosilicon compounds referred to as silicones. The parties will
work together to “identify commercially salable organosilicon compounds
and formulations thereof with biological activity as pesticides in the
agricultural chemical field…” (DCC 2001173) Dow Corning appoints Dr.
John Ryan as its representative; Dow Chemical appoints Dr. Yulan Tong.
The
Joint Research Program will begin with one or more meetings between
the designated representatives. Dow Chemical will disclose the type
of pesticides it seeks to develop and the kinds of chemical structural
groups that DOW believes impart desired agricultural chemical properties.
The parties may select compounds for screen tests by Dow Chemical. The
designated representatives shall generate a plan for conduct of the
Joint Research Program. The information developed under this program
shall be kept confidential for 10 years.

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