<>EPA
United States
Environmental Protection
Agwicy
Office of
PeaicidM and Toxic Subcunca*
WMhinqton CC 2O46C
OctotMr 1981
10,10'-oxy bisphenoxarsine
(OBPA)
Pesticide Registration
Standard
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10, lO'-Oxybis-lOH-phenoxarsine
(OBPA)
Pesticide Registration Standard
Herman Tana Project Manager (SPRD)
Michael F. Branagan Project Support Team (SPRD)
Linda Garczynski Writer/Editor (SPRD)
Bruce A. Kapner Project Support Team (SPRD)
Neil Pelletier Project Support Team (BFHD)
Russ Scarato Project Support Team (BFSD)
Vetcna Williams Project Support Team (RD)
September 30. J9R1
Office of Pesticides and Toxic Substances
Bwircnmental Protection Agency
401 M Street, SW
Washington, D.C. 20460
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- TABI£ OF CONTENTS -
page
Chapter I tfaw to Register under a Registration Standard 1
Chapter II Regulatory Position aid Rationale 9
Chapter III Summary of Data Requirements and Data Gaps 15
Chapter IV Product Chemistry 20
Chapter V Ehvircnmental Fate 22
Chapter VI Toxicology 28
Chapter VII Residue Chemistry 53
Chapter VIII Ecological Effects 54
Bibliography 57
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I. HOW TO REGISTER UNDER A REGISTRATION STANDARD
A. Organization of the Standard
B. Purpose of the Standard
C. Requirement to Reregister Under the Standard
D. "Product Specific" Data aid "Generic" Data
E. Data Compensation Requirements under FIFRA 3(c)(l)(D)
F. Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B)
G. Amendments to the Standard
A. ORGANIZATION OF THE STANDARD
Tnis first chapter explains the purpose of a Registration Standard and
summarizes the legal principles involved in registering or reregistering under
a standard, the second chapter sets forth the requirements that must be met to
obtain or retain registration for products covered by this particular
Registration Standard. In the remaining chapters, the Agency reviews the
available data by scientific discipline, discusses the Agency's concerns with
the identified potential hazards, and logically develops the conditions and
requirements that would reduce those hazards to acceptable levels.
B. PURPOSE OF THE STANDARD
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
provides that "no person in any State may distribute, sell, offer for sale.
hold for sale, ship, deliver for shipment, or receive (and having so received)
deliver or offer to deliver, to any person any pesticide which is not
registered with the Administrator fof EPA1." To approve the registration of a
pesticide, the Administrator must find, pursuant to Section 3(c)(5) that:
"(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply
with the requirements of this Act;
(C) it will perform its intended function without unreasonable adverse
effects en the environment; and
(D) when used in accordance with widespread and commonly recognized
practice it will not generally cause unreasonable adverse effects
on the environment."
In making these findings, the Agency reviews a wide range of data which
registrants are required to submit, and assesses the risks and benefits
associated with the use of the proposed pesticide. But the established
approach to making these findings has been found to be defective on two counts:
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First, EPA and its predecessor agency, the united States Department of
Agriculture (USDA), routinely reviewed registration applications en a "product
by product" basis, evaluating each product specific application somewhat
independently. In the review of products contain ing similar components, there
was little opportunity for a retrospective review of the full range of
pertinent data available in Agency files and in the public literature. Thus the
"product by product" approach was often inefficient and sometimes resulted in
inconsistent or incomplete regulatory judgments.
Second, over the years, as a result of inevitable and continuing advances in
scientific knowledge, methodology, and policy, the data base for many
pesticides came to be considered inadequate by current scientific and
regulatory standards. Given the long history of pesticide regulation in
several agencies, it is even likely that materials may have been lost from the
data files. Mien EPA issued new requirements for registration in 1975 (40 CFR
162) and proposed new guidelines for hazard testing in 1978 (43 FR 29686, July
10, 1978 and 43 FR 37336, August 22, 1978), many products that had already been
registered for years were being sold and used without the same assurances of
human and environmental safety as was being required for new products. Because
of this inconsistency, Congress directed EPA to reregister all previously
registered products, so as to bring their registrations and their data bases
into compliance with current requirements, [See FIFRA Section 3(g)l-
Facing the enormous job of rereviewing and calling-in new data for the
approximately 35,000 current registrations, and realizing the inefficiencies of
the "product by product" approach, the Agency decided that a new, more
effective method of review was needed.
Anew review procedure has been developed. Ihder it, F,PA publishes documents
called Registration Standards, each of which discusses a particular pesticide
active ingredient. Each Registration Standard summarizes all the data
available to the Agency en a particular active ingredient and its current USPS,
and sets forth the Agency's comprehensive position en the conditions and
requirements for registration of all existing and future products which contain
that active ingredient. These conditions and requirements, all of which must
be met to obtain or retain full registration or reregistration under Section
3(c)(5) of FIFRA, include the submission of needed scientific data which the
Agency does not now have, compliance with standards of toxicity, composition .
labeling, and packaging, and satisfaction of the data compensation provisions
of FIFRA Section 3(c)(l)(D).
Ihe standard will also serve as a tool for product classification. As part of
the registration of a pesticide product, EPA may classify each product for
"general use" or "restricted use" fFIFRA Section 3(d)l. A pesticide is
classified for "restricted use" whan seme special regulatory restrict-ion is
needed to ensure against unreasonable adverse effects to man or the
environment. Many such risks of unreasonable adverse effects can be lessened
if expressly-designed label precautions are strictly followed. Thus the special
regulatory restriction for a "restricted use" pesticide is usually a
requirement that it be applied only by, or under the supervision of, an
applicator who has been certified by the State or Federal government as being
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competent to use pesticide safely, responsibly, aid in accordance with label
directions. A restricted-use pesticide can have other regulatory restrictions
[40 CFR 162.11(c)(5)l instead of, or in addition to, the certified applicator
requirement. These other regulatory restrictions may include such acticns as
seasonal or regional limitations on use, or a requirement for the monitoring of
residue levels after use. A pesticide classified for "general use," or not
classified at all, is available for use by any individual who is in compliance
with State or local regulations. The Registration Standard review compares
information about potential adverse effects of specific uses of the pesticide
with risk criteria listed in 40 CFR 162.11(c), and thereby determines whether a
product needs to be classified for "restricted use." If the standard does
classify a pesticide for "restricted use," this determination is stated in the
second chapter.
C. REQUIREMENT TO REREGISTER UNDER THE STANDARD
FIFRA Section 3(g), as amended in 1978, directs EPA to reregister all currently
registered products as expeditiously as possible. Congress also agreed that
reregistraticn should be accomplished by the use of Registration Standards.
Each registrant of a currently registered product to which this standard
applies, and who wishes to continue to sell or distribute his product in
commerce, must apply for reregistration. His application must contain oroposed
labeling that complies with this standard.
EPA will issue a notice of intent to cancel the registration of any currently
registered product to which this standard applies if the registrant fails to
comply with the procedures for reregistration set forth in the Guidance Package
which accompanies this standard.
D. "PRODUCT SPECIFIC" DATA AND "GENERIC" DATA
]h the course of developing this standard, EPA has determined the types of data
needed for evaluation of the properties and effects of products to which the
standard applies, in the disciplinary areas of Product Chemistry, Ehvircnmental
Fate, Toxicology, Residue Chemistry, and Ecological Effects. These
determinations are based primarily on the data Guidelines proposed in 43 FR
29696, July 10, 1978; 43 FR 37336, August 22, 1978; and 45 FR 72948, November
3, 1980, as applied to the use patterns of the products to which this standard
applies. Wiere it appeared that data from a normally applicable Guidelines
requirement were actually unnecessary to evaluate these products, the standard
indicates that the requirement has been waived. Ch the other hand, in some
cases studies not required by the Guidelines may be needed because of the
particular composition or use pattern of products the standard covers; if so,
the standard explains the Agency's reasoning. Data guidelines have not yet
been proposed for the Residue Chemistry discipline, but the requirements for
such data have been in effect for seme time and are, the Agency believes,
relatively familiar to registrants. Data which we have found are needed to
evaluate the registrability of seme products covered by the standard may not be
needed for the evaluation of other products, depending upon the canposition ,
formulation type, and intended uses of the product in question. The standard
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states which data requirements apply to which product categories. (See the
third chapter.) The various kinds of data normally required for registration
of a pesticide product can be divided into two basic groups:
1. Data that are product specific, i.e. data that relates only to the
the properties or effects of a product with a particular composition
(or a group of products with closely similar composition); and
2. Generic data that pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks and benefits of all products containing that ingredient
(or all such products having a certain use pattern), regardless of
any such product's unique composition.
The Agency requires certain "product specific" data for each product to
characterize the product's particular compositicn and physical/chemical
properties (Product Chemistry), and to characterize the product's acute
toxicity (which is a function of its total compositicn). The applicant for
registration or reregistration of any product, whether it is a maiufacturing-
use or end-use product, and without regard to its intended use pattern, must
submit or cite enough of this kind of data to allow EPA to evaluate the
product. For such purposes, "product specific" data on any product other than
the applicant's is irrelevant, unless the other product is closely similar in
compositicn to the applicant's. (Where it has been found practicable to group
similar products for purposes of evaluating, with a single set of tests, all
products in the group, the standard so indicates.) "Product specific" data on
the efficacy of particular end-use products is also required where the exact
formulation may affect efficacy and where failure of efficacy could cause
public health problems.
All other data needed to evaluate pesticide products concerns the properties or
effects of a particular ingredient of products (normally a pesticidally active
ingredient, but in seme cases a pesticidally inactive, or "inert",
ingredient). Some data in this "generic" category are required to evaluate the
properties and effects of all products containing that ingredient fe.g., the
acute LD-50 of the active ingredient in its technical or purer grade; see
proposed 40 CFR 163.Rl-l(a), 43 FR 373551.
Other "generic" data are required to evaluate all products which both contain a
particular ingredient and are intended for certain uses (see, e.g., proposed 40
CFR 163.3"'-I, 43 FR 37363, which requires subchrcnic oral testing of the active
ingredient with respect to certain use patterns only). Where a particular data
requirement is use-pattern dependent, it will apply to each end-use product
which is to be labeled for that use pattern (except where such sid-use product
is formulated fran a registered manufacturing-use product permitting such
formulations) and to each manufacturing-use product with labeling that allows
it to be used to make end-use products with that use pattern. Thus, for
example, a subchrcnic oral dosing study is needed to evaluate the safety of any
manufacturing-use product that legally could be used to make an end-use, food-
crop pesticide. But if an end-use product's label specified it was for use
only in ways that involved no food/feed exposure and no repeated human
exposure, the subchrcnic oral dosing study would not be required to evaluate
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the product's safety; and if a manufacturing-use product's label states that
the product is for use cnly in making end-use products not involving food/feed
use or repeated human exposure, that subchrcnic oral study would not be
relevant to the evaluation of the manufacturing-use product either.
If a registrant of a currently registered manufacturing-use or end-use product
wishes to avoid the costs of data compensation [under FIFRA Section 3(c)(l)(D)l
or data generation [under Section 3(c)(2)(B)l for "generic" data that is
required only with respect to sane use patterns, he may elect to delete those
use patterns from his labeling at the time he reregisters his product, An
applicant for registration of a new product under this standard may similarly
request approval for only certain use patterns.
E. DATA COMPENSATION UNDER FIFRA SECTION 3(O(1)(D)
Lhder FIFRA Section 3(c)(l)(D), an applicant for registration, reregistration,
or amended registration must offer to pay compaisaticn for certain existing
data the Agency has used in developing the Registration Standard. The data for
which compensation must be offered is all data which are described by all the
following criteria:
1. The data were first submitted to EPA (or to its predecessor
agencies, U.S. Department of Agriculture (USDA) or Food and Drug
Administration (FDA), on or after January 1, 1970;
2. The data were submitted to EPA (or USDA or FDA) by some other
applicant or registrant in support of an application for an
experimental use permit, an amendment adding a new use to a
registration, or for registration, or to support or maintain in
effect an existing registration;
3. They are the kind of data which are relevant to the Agency's
decision to register or reregister the applicant's product
under the Registration Standard, taking into account the
applicant's product's composition and intended use pattern(s);
4. The Agency has found the data to be valid and usable in reaching
regulatory conclusions; and
5. They are not data for which the applicant has been exempted by
FIFRA Section 3(c)(2)(D) fron the duty to offer to pay
compensation. (This exemption applies to the "generic" data
concerning the safety of an active ingredient of the applicant's
product, not to "product specific" data. The exemption is
available only to applicants whose product is labeled for end-
uses for which the active ingredient in question is present in
the applicant's product because of his use of another registered
product containing that active ingredient which he purchases from
another producer.)
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An applicant for reregistraticn of an already registered product under this
standard, or for registration of a new product under this standard, accordingly
must determine which of the data used by EPA in developing the standard must be
the subject of an offer to pay compensation , and must submit with his
application the appropriate statements evidencing his compliance with FIFRA
Section 3(c)(l)(D).
An applicant would never be required to offer to pay for "product specific"
data submitted by another firm!3n~~many, if not in most cases, data which
arespecific to another firm's product will not suffice to allow EPA to evaluate
the applicant's product, that is, will not be useful to the Agency in
determining whether the applicant's product is registrable. There may be
cases, however, where because of close similarities between the composition of
two or more products, another firm's data may suffice to allow EPA to evaluate
seme or all of the "product specific" aspects of the applicant's product. In
such a case, tine applicant may choose to cite that data instead of submitting
data from tests on his own product, and if he chooses that option, he would
nave to comply with the offer-to-pay requirements of Section 3(C)(1)(D) for
those data.
Each applicant for registration or reregistraticn of a manufacturing-use
product, and each applicant for registration or reregistraticn of an end-use
product, who is not exempted by FIFRA Section 3{c)(2)(D), must comply with the
Section 3(c)(l)(D) requirements with respect to each item of "generic" data
that relates to his product's intended uses.
A detailed description of the procedures an applicant must follow in applying
for reregistraticn (or new registration) under this standard is found in the
Guidance Package for this standard.
F. OBTAINING DATA TO FILL "DATA GAPS"; FIFRA 3(c)(2)(B)
Some of the kinds of data EPA needs for its evaluation of the properties and
effects of products to which this standard applies have never been submitted to
the Agency (or, if submitted, have been found to have deficiencies rendering
them inadequate for making registrability decisions) and have not been located
in the published literature search that EPA conducted as part of preparing this
standard. Such instances of missing but required data are referred to in the
standard as "data gaps".
FIFRA Section 3(c)(2)(B), added to FIFRA by the Congress in 1978, authorizes
EPA to require registrants to whan a data requirement applies to generate (or
otherwise produce) data to fill such "gaps" and submit those data to EPA. EPA
must allow a reasonably sufficient period for this to be accomplished. If a
registrant fails to take appropriate and timely steps to fill the data gaps
identified by a section 3(c)(2)(B) order, his product's registration may be
suspended until the data are submitted. A mechanism is provided whereby two
ormore registrants may agree to share in the costs of producing data for which
they are both responsible.
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The standard lists, in the third chapter, the "generic" data gaps and notes the
classes of products to which these data gaps pertain. The standard also points
out that to be registrable under the standard, a product must be supported by
certain required "product specific" data. Ii seme cases, the Agency may
possess sufficient "product specific" data en cne currently registered product,
but may lack such data en another. Oily those standards which apply to a very
small number of currently registered products will attempt to state
definitively the "product specific" data gaps en a "product by product" basis.
(Although the standard will in some cases note which data that EPA does possess
would suffice to satisfy certain "product specific" data requirements for a
category of products with closely similar compositicn characteristics.)
As part of the process of reregistering currently registered products, EPA will
issue Section 3(c)(2)(B) directives requiring the registrants to take
appropriate steps to fill all identified data gaps — whether the data in
question are "product specific" or "generic" — in accordance with a
schedule. Persons who wish to obtain registrations for new products under this
standard will be required to submit (or cite) sufficient "product specific"
data before their applications are approved. Upon registration, they will be
required under Section 3(c)(2)(B) to take appropriate steps to submit data
needed to fill "generic" data gaps. (Ws expect they will respond to this
requirement by entering into cost-sharing agreements with other registrants vfao
previously have been told they must furnish the data.) The Guidance Package
for this standard details the steps that must be taken by registrants to comply
with Section 3(c)(2)(B).
Registrants are reminded that Section 6(a)(2) of FIFRA requires you at any
tims to submit factual information raising concerns of possible unreasonable
adverse effects of a pesticide. You should notify the Agency of interim results
of studies in progress if those results show possible adverse effects.
Cl. AMENDMENTS TO THE STANDARD
Applications for registration which propose uses or formulations that are not
presently covered by the standard, or which present product compositions,
product chemistry data, hazard data, toxicity levels, or labeling that do not
meet the requirements of the standard, will automatically be considered by the
Agency to be requests for amaidments to the standard. Ih response to such
applications, the Agency may request additional data to support the proposed
amendment to the standard, or may deny the application for registration on the
grounds that the proposed product would cause unreasonable adverse effects to
the environment. In the former case, when additional data have been
satisfactorily supplied, and providing that the data do not indicate the
potential for unreasonable adverse effects, the Agency will then amend the
standard to cover the new registration.
Each Registration Standard is based upon all data and information available to
the Agency's reviewers on a particular date prior to the publication date.
This "cut-off" date is stated at the beginning of the second chapter. Any
subsequent data submissions and any approved amendments will be incorporated
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into the Registration Standard by means of addenda, which are available for
inspection at EPA in Washington, D.C., or copies of vhich may be requested from
the Agency. When all the present "data gaps" have been filled and the
submitted data have been reviewed, the Agency will revise the Registration
Standard. Thereafter, when the Agency determines that the internally
maintained addenda have significantly altered the conditions for registration
under the Standard, the document will be updated and re-issued.
Mule the Registration Standard discusses oily the uses and hazards of products
containing the designated active ingredient(s), the Agency is also concerned
with the potential hazards of some inert ingredients and impurities.
Independent of the development of any one standard, the Agency has initiated
the evaluation of some inert pesticide ingredients, fchere the Agency has
identified inert ingredients of concern in a specific product to which the
standard applies, these ingredients will be pointed out in the Guidance Package.
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II. REGULATORY POSITION AND RATIONALE
A. Introduction
B. Description of Chemical
C. Regulatory Position
D. Regulatory Rationale
E. Criteria for Registration Under the Standard
F. Acceptable Ranges and Limits
G. Required Labeling
H. Tolerance Reassessment
I. New aid Amended Registrations Ihder This Standard
A. INTRODUCTION
This chapter represents the Agency's regulatory position and rationale based on
an evaluation of all registered products containing 10,10'-oxybis-lOH-
phenoxarsine (OBPA) as the sole active ingredient. After briefly describing
the chemical, this chapter presents the regulatory position aid rationale, and
the criteria for registering products 001 tain ing this chemical. Tnese criteria
include labeling considerations. A summary of data requirements is contained
in Chapter III. Discussions of the data upcn which this regulatory position is
based are presented in each of the disciplinary Chapters, IV through VIII.
10,10'-oxybis-10H-phenoxarsine (OBPA) was originally placed on the Rebuttable
Presumption Against Reregistraticn (RPAR) list because it is an arsenical.
Inorganic arsenicals are suspected oncogens, mutagens and teratoqens. After a
thorough review of the uses of this chemical the Agency concluded that because
the compound did not leach from the treated material, the exposure and, hence
the risk, associated with the uses of this chemical was extremely small (USEPA,
1979, MRID GS044070). The Agency's RPAR decision document concluded that
10,10'-oxybis-10H-phenoxarsine (OBPA) does not exceed any of the toxicology
criteria in 40 CFR 162.11(a)(3). The chemical was subsequently returned to
Registration Division.
B. DESCRIPTION OF CHEMICAL
The acronym OBPA will be used throughout this standard in lieu of other
chemical or trade names. OBPA is an arsenic-containing heterocyclic compound
which is incorporated into flexible vinyl sheeting and extrusions, silicone
caulking compounds, thermoplastic adhesives, polyurethane, latex emulsions (not
including paints, ink bases and textiles) to prevent the growth of
microorganisms. Although the materials themselves are resistant to microbial
attack, the plasticizers and other additives used to produce flexible vinyl
(OBPA is not used in rigid vinyl), caulking and adhesive compounds are subject
to microbial attack resulting in staining and degradation.
All OBPA manufactured in the Ihited States is made by Cordova Chemical Company
of Sacramento. The technical material is sold only to \fentrcn Corporation of
Beverly, Massachusetts, which formulates it in 1.0, 2.0, 3.0, end 5.0 percent
formulations. There are three other end-use registrants: Comark Plastics
Division, Seymour Chemical Association, aid Djracote Corporation.
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C. REGULATORY POSITION
The Agency has considered the limited anoint of scientific data obtained from
the open literature as of August 14, 1981, the Agency's April 20, 1979,
decision document to remove OBPA from the Rebuttable Presumption Against
Registration (RPAR) list, and the data submitted by the registrants up through
the time of publication of this standard.
Based on the review of this information, the Agency finds that:
1. OBPA, as described in this standard, may be registered for sale,
distribution, reformulation, and use in the United States,
2. The use of closed systems preclude worker exposure and essentially
all of this compound is retained within the treated material,
3. If label directions and precautions are followed, OBPA does not cause
any unreasonable adverse effects to man or the environment. Hence, none
of the risk criteria found in Section 162.11(a) of Title 40 of the U.S.
Code of Federal Regulations were met or exceeded,
4. OBPA products currently registered may be reregistered subject to the
conditions imposed in this standard and with the subsequent submission
of required data. Nsw products may be registered under this standard
and are subject to the same requirements.
D. REGULATORY RATIONALE
1. Manufacturing-Use Products
Tnere are no manufacturing-use products containing OBPA currently registered
with the Agency.
The Agency will consider the registration of manufacturing-use products
containing this compound provided that those product chemistry data listed in
chapter three of this standard are submitted to the Agency.
The toxicology data currently available indicate that OBPA possesses a hiqh
order of acute oral and dermal toxicity, and is very irritating to the lings,
eyes and skin. Toxicology data also indicate that technical OBPA is not
mutagenic, teratogenic, fetotoxic or embryotoxic under the test systems used.
No other chronic data are available on the technical chemical. Since the
current data do not indicate any toxicoloqical concerns and because exposure is
very low, no further testing will be required to support future applications
for registration of manufacturing-use products, provided that (1) this chemical
is used only in closed systems, and (2) no new uses which will significantly
increase human exposure are added to the present list of registered pesticiHal
uses.
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The current fish and wildlife toxicity data indicate that techical OBPA
possesses a high order of acute toxicity to aquatic organisms. However, no
further ecological effects testing will be required of future applications for
registration of manufacturing-use products con tain inq this compound because the
current uses of this compound preclude significant envircnniental exposure.
Since the uses preclude significant environmental exposure, the Agency has
concluded that no environmental fate testing is required of end-use products
containing OBPA. The Agency has concluded that hydrolysis and activated sludge
studies are necessary to understand potential impact of effluents from
manufacturing-use products. However, the Agency has determined that the
requirement for the activated sludge studies will be reserved, pending
development of suitable protocols by the Agency.
In light of the determination of acceptable risk, the Agency will consider the
registration of all manufacturing-use prodj-ts of this compound.
2. Bid-Use Products
The end-use products of OBPA are additives used primarily for preserving
fabrics and plastic materials (vinyls, polyurethane, thermoplastic adhesives,
and siliccne caulking compounds) against attack by fungi and bacteria. Use
rates of OBPA in products are higher if the product will be exposed out of
doors.
The available data on the acute toxicity of the end-use products of OBPA
indicate that the inerts in the product, which are added to facilitate the
manufacture of the treated materials, are the cause of the wide variability in
toxicity levels between products. Because the toxicity of end-use products is
highly variable based on the inerts, it is not possible to readily confirm that
data on any particular product are relevant to any other specific product. The
Agency is able to conclude that the available data taken as a set are
sufficient to provide an understanding of end-use product acute toxicity. Tto
avoid requiring any unnecessary testing, the Agency is prepared to accept a
citing of the existing data and labeling consistent with the most toxic test
conducted to date in lieu of requiring registrants of new products to do the
testing. Applicants choosing to conduct the tests rather than cite the
existing data may do so and will be expected to submit the data, and label thp
product in accordance with the testing.
The 1.0% OBPA solutions in nonvolatile plasticizer carriers showed low to
moderate acute oral, eye irritation and dermal irritation. The 2.n% OBPA
solutions in nonvolatile plasticizer carriers showed low to moderate acute
oral, acute dermal toxicity, and dermal irritation; and showed moderate to
severe eye irritation. The 3.0% OBPA solution in low viscosity carriers showed
low to moderate acute oral, and acute dermal toxicity. The 5.0% solid
pelletized OBPA formulation showed low acute oral and dermal toxicity.
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Based en existing use patterns, the Agency has determined that there is no
significant environmental or fish and wildlife exposure to the end-use products
of OBPA. OBPA is not registered for use on food or feed crops, therefore no
tolerances are required.
The Agency has concluded that it will continue the registration for the active
ingredient 10,10'-oxybis-10H-phenoxarsine (OBPA) for the following reasons:
a) The formulations of OBPA are incorporated into vinyl plastics,
siliccne caulking componds, thermoplastic adhesives, polyurethane and
textiles which chemically and physically retain the active ingredient
during the lifetime of the treated material. Because it is not
released from the treated material, no acute or subacute toxicity to
man, domestic animals, fish and wildlife are expected from OBPA.
b) Based on available data, OBPA has been found to cause no adverse
effects as specified in 40 CFR 162.11.
c) In accordance with the Federal Insecticide, Fungicide, and Rodenticide
Act as amended, (FIFRA) the Agency's policy is not to routinely cancel
or withhold the registration of products merely for lack of data (See
sections 3(c)(2)(B) and 3(c)(7) of FIFRA). Rather, the publication of
this standard provides a mechanism for identifying data needs, and
registration under this standard allows for upgrading of labels while
the required data are being generated. When these data are received
and reviewed, the Agency will reassess the registration of the
chemical.
As the use patterns do not fall within the public health criteria established
under the Agency's efficacy waiver policy, (44 FR 27932, May 11, 1979), a
discussion of the OBPA efficacy data is not required in this standard.
E. CRITERIA FOR REGISTRATION UNDER THE STANDARD
To be subject to this standard, the OBPA products must meet the following
conditions:
- contain 10,10'-oxybis-10H-phenoxarsine (OBPA)
as the sole active ingredient;
- bear required labeling; and
- conform to the acute toxicity limits, product composition and use
pattern requirements stated in this standard.
The applicant for registration or reregistration of products subject to this
standard must comply with all terms and conditions described in this standard.
These include a commitment to fill data gaps on a time schedule specified by
the Agency and, when applicable, offering to pay compensation to the extent
required by 3(c)(l)(D) of the Federal Insecticide, Fungicide and Rodenticide
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Act (FIFRA), as amended, 7 U.S.C. 136a(c)(l)(D). As discussed in Chapter I,
applicants for registration under this standard must contact the Registration
Division for specific instructions, including updated information contained in
the guidance package on data requirements and companies whose data must be
cited and to whom compensation must be offered.
F. ACCEPTABLE RANGES AND LIMITS
1. Man ufacturin g-Use Products
No manufacturing-use products are currently registered. However, based on the
efficacy and use patterns of end-use products, a manufacturing-use product of
any concentration is registrable when labeled according to toxicity categories
determined by the results of appropriate product chemistry and toxicology data.
2. Bid-Use Products
a. Product Composition Standard
Currently the Agency has minimal information on acceptable ranges and limits
for the product composition of end-use products containing OBPA. To be covered
under this standard, registrants of end-use products containing OBPA must
certify ranges and limits for both active and inert ingredients.
b. Acute Tbxicity Limits
The Agency will consider registration of end-use products con tain ing OBPA,
under a general-use classification, regardless of their toxicity category,
provided that they bear appropriate precautionary labeling.
c. Use Pattern Limits
To be registered under this standard, end-use products containing OBPA must be
labeled as a microbicidal (additive) agent.
G. REQUIRED LABELING
To be considered under this standard, end-use products must bear directions for
use as a bacteriostatic and fungistatic agent to be incorporated into one or
more of the following materials: vinyl plastics, siliccne caulking compounds,
polyurethane, thermo-plastic adhesives, and textiles.
Because of the potential for eye and skin irritation , all products containing
OBPA must bear labeling which requires the use of goggles and gloves and the
use of "closed systems" during the manufacturing process. Other then this
labeling, there are no unique precautionary statements which must appear on the
OBPA labeling.
The guidance package will provide an updated list of all precautionary
statements as specified in Title 40, CFR Section 162.10 for this type product.
The Agency may, after review of data submitted under this standard, impose
additional label requirements.
13
-------
H. TOLERANCE REASSESSMENT
These products are not used in food aid feed crops aid are not applied to food
preparation areas. Therefore, the current uses of OBPA products are not
subjected to the requiremaits to obtain a tolerance uider the provisions of the
Federal Food, Drug, and Cosmetic Act as administered by this Agency. No
tolerance reassessment is necessary for this standard.
I. NEW AND AMENDED REGISTRATIONS UNDER THIS STANDARD
Principal among the goals of the Registration Standards process is the
reregistration of currently registered pesticide chemicals. These goals also
include the creation of a mechanism for the registration of new and added uses
of a chemical. Although OBPA bears current registration for use incorporation
into plastics aid fabrics with a limited number of end uses, it may be
anticipated that new sites of application will be sought. While it is
virtually impossible to anticipate future registration actions with any degree
of certainty, it is possible to define the general applicability of this
standard to future uses of this chemical.
The Agency, in its review of the current data base, has determined that OBPA
does not appear to present any unreasonable adverse effects as it is currently
used. The Agency will adopt the results of the standard for all future
registration actions. Additional data will not be required except under those
circumstances in which major alterations in use pattern and formulation might
be sought. Expanding OBPA's use, for example, into non-food uses where
exposure to man and the environment is essentially similar to the present uses
would be deemed covered by this standard. An example of where an alteration to
the standard would be necessary would be the use of OBPA in plastics which will
be in direct, prolonged contact with skin. Should such a registration be
sought, the Agency may seek additional data evaluating any chronic effects as a
result of such exposure. Similarly, the addition or substitution of inert
ingredients into either a manufacturing-use or end-use product, the alteration
of a manufacturing process, or the change of a use pattern might necessitate
the submission of additional data.
14
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III. SUMMARY OF DATA REQUIREMENTS AND DATA GAPS
A. INTRODUCTION
Applicants for registration of end-use OBPA products must cite or submit the
following information on the physical/chemical properties, composition, fate
and toxicity of the proposed product. Data in this standard that satisfy
registration requirements may be cited, if the applicant establishes that the
proposed product is substantially similar to another product for which the
Agency has received acceptable acute toxicity tests. Data may be cited
provided compensation has been offered to the submitters of these studies. The
Agency will consider both active and inert ingredients in the determination of
substantially similar products. (See Chapter I for discussion of substantially
similar products). The sections of the Proposed Guidelines which describe the
types of data and when they are required f43 FR, to. 1332, 29696 of July 10,
1978; and 43 FR, Mo. 163, 37336of August 22, 19781 are listed before each
requirement.
A justification for these requirements is provided in the Guidelines.
Applicants for the reregistration of end-use OBPA must submit all information
identified as data gaps (see charts). A discussion of why data additional to
those already submitted are necessary, or why data normally required are not
necessary for this chemical, are explained in footnotes to the charts. The
footnotes are at the end of all charts. The data requirements specified are
the minimum that will be required. Areas where additional data may he required
as the result of tiered testing, are indicated.
15
-------
Extraction Studies
DATA REQUIREMENTS CHART A
lO.IO'-Oxybls-IQH-phenoxarslne
Generic Data Requirements: ENVIRONMENTAL FATE
Guidelines
Citation
163.161-1
Name or Test
Hydrolysis
Activated Sludge
Hetabolisn
Composition Rres EPA have data Bibliographic
to partially or Citation
totally satisfy
this requirement?
Radlolabeled no
Analytical Grade or
Tech. Grade of A.I.
Tech. Grade of A.I. no
flust additional data
be submitted under
FffHA 1(c)(2)(B)?
If so. due when?
yes/ 4 months
Reserved \l
Each Product
yes
GS04«011,GSOn4056
GS04ll023,Gr,044030
GS044055.GSOU4012
GSOU«02'»
These data requirements are current as of October, 1981. Refer to the guidance package for updated requirements.
1. The activated sludge data will be required, pending development of an acceptable test protcctl.
October. 1981
DATA REQUIREMENTS CHART A
10, KV-Ox ybls-1 CH-phenoxarslne
Generic Data Requirements: TOXICOLOGY
Guidelines
Citation
163.81-1
163.81-3
163.81-3
161.81-4
163.81-5
161.82-1
163.82-4
163.83-3
163.S4-2
through -4
163.85-1
Nane of Test
Acute Oral Tcxiclty
Acute Dermal Tbxlcity
Acute Inhalation Tbxlclty
Primary Eye Irritation
Primary Scln Irritation
Subehronlc Oral Tbxlcity
Subchronic Inhalation
Tbxlcity
Teratogenlclty
Mutageniclty
Metabolism
(Identification of
tfetabolltes)
Composition Does EPA have data Bibliographic
to partially or Citation
totally satisfy
this requirement?
Tech. Grade of A.I. yes
Tech. Grade of A. I. yes
Tech. Grade of A.I. yes
Tech. Grade of A.I. yes
Tech. Grade of A. I. yes
Tech. Grade of A.I. yes
Tech. Grade of A.I. yes
Tech. Grade of A.I. . yes
Tech. Grade of A.I. yes
Radlolabeled, yes
Analytically Pure
Grade of A.I.
00024941,03044002
00024935, 00013591
03015357,0001364?
00034935, 00013547
GS044002,(T:0>i4020
GS044039,GSO«4004
0002*935, CPON4035
05015857,00013591
00024933,00024035
GS044002. 0001 3591
05015R57.00013M3
00024937,00024935
00013591,73015357
00013643,G30«400?
00024936,00024940
GSnH40'l2
00011591,05015857
GS044007
00013644, m013*U7
G304H007
00026092,00024035
00017591, ("3015157
Must additional data
be submitted under
FFRA 3(c)(2XE)?
If so, due when?
no
no
no
no
no
no
no
no
no
no
Tnese data requirements are current as or October, 19H1. Refer Co the guidance package lor updntPd requirements.
October. 1911
16
-------
DATA RECUIRfMBRS CHART B
lO.lO'-Orjbis-lOH-phenoxarsine
Product-specific Knufacturing-Use ffita Requirements: PRCOJCT CHEMISTRY
Guidelines
Citation
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.64-3
Name of Test
Product Mentitiy &
Disclosure of Ingredients
Description of
nnufacturing Process
Discussion on Formulation
of Uiintentional Ingredients
I ;laration & Certification
of Ingredients Limits
Product ftialytical Methods
« Data
Physical & Chemical
Properties
Composition toes Oft have data
to partially or
totally satisfy
this requirement?
EACH Product no
Eoch Piuuuct no
Csch PtxxJuct no
Each Product no
Each Product no
Ttech. Grade of A. I. no
OF Csch Product
Bibliographic Must additional data
Citation be submitted under
FIFRA 3(C)(2)(B)7
If so. due when?
yes/ y
yes/ I/
yes/ I/
yes/ I/
yes/ U
yes/ I/
These data requirements are current as of October, 1981. Refer to the guidance paclnge tor updnted requirements.
1. These requirements must be fulfilled by each applicant. Data from other appplicants may not br cited. Therefore, even
if the requirement has been fulfilled for some products, no references areqiven. These requirements must be fulfilled
at the tine of registration or reregistration.
October, 1981
-------
DATO REOIIREHEmS CHART C
lO.lO'-Qcybis-lffi-phenoxarsine
End-Use Product-Specific CBta Requirements? PRODUCT CHfaiSTRY
Guidelines
Citation
163.61-3
163.61-4
163.61-5
163.61-fi
163.61-7
163.64-3
Name of Tost
Product Mentitiy &
Disclosure of Ingredients
Description of
Manufacturing Process
Discussion en Formulation
of Unintentional Ingredients
Declaration & Certification
of Ingredients Units
Product Analytical ttothods
t Qita
Physical & Chemical
Properties
Conposition Daes EPA have data
to partially or
totally satisfy
this requirement?
Each Product yes
Each Product yes
Each Product no
Eoch Product no
Each Product no
Tech. Grade of A.I. yes
or Each Product
Bibliographic Must additional data
Citation be submitted under
PIFRA 3(C)(2MB)7
If so. due when?
yes/ y
yes/ y
yes/ y
yes/ I/
yes/ y
yes/ y
These data requirements are current as of October, 1981. Refer to the guidance package for updated requirements^.
1. These requirements must be fulfilled by each applicant. Data from other apppllcants nay not he cited. Therefore, even
if the requirement has been fulfilled for some products, no references aregiven. These requirements must be fulfilled
at the time of registration or reregiatraticn.
October. 1981
18
-------
DATA REOUIREMHrrS CHART C
10, lO'-Oxybis-iai-phenoxarslne
Product-Specific End-Use Data Requirements: TOXICOLOGY
Guidelines Name cf Test
Citation
163.81-1 Acute Oral Toxicity
163.81-2 Acute Dermal Toxicity
163.81-3 Acute Inhalation Tcxlcity
163.81-U Primary Eye Irritation
16^.81-5 Primary Skin Irritation
163.1*1-6 Dermal Sensitizatlon
163.B2-2 21-Oay Subchronlc Dermal
Tbxicity
Ccflipositlon Does EPA have data Iliblicgraphic
to partially or Citation
totally satisfy
this requirement?
Each Product yes OOn?«Q53,rsoiU078
GSni|«OT7,tSOllllOS7
00013631 ,nooi36io
GSOMfl025,000233'«i
GSn»il076, 0001 3629
00013630,00013651
00013660,00013661
00013662,000136*3
csou
-------
IV. PRODUCT CHEMISTRY
A. Chemical Identity
B. Manufacturing Process
C. Physical and Chemical Properties
D. Summary of Data Gaps
A. CHEMICAL IDENTITY
OBPA is a common acronym for HMO'-Oxybis-lOH-phenoxarsine, an arsenic-
containing heterocyclic compound. The Chemical Abstracts Registry (CAS) number
for OBPA is 58-36-6, and the EPA Shaughnessy number is 012601.
The structural formula for OBPA is:
c'' V V' \
I II I II
C £
\\ ' \
C As
I
0
I
AS
B. MANUFACTURING PROCESS
One possible synthetic route for technical OBPA is based on U.S. Patent Number
3,701,794 (Wade, 1972, MRID 05016437) and can be summarized as follows: a
reaction between arsenic trichloride and diphenyl ether at (200 C) which
yields 10-chlorophenoxarsine; the latter when heated in an alkaline medium gives
OBPA. The actual synthetic proceedure is considered confidential business
information.
C. PHYSICAL AND CHEMICAL PROPERTIES
The following data are available on the physical and chemical properties of
technical OBPA. Data which are not available but required to be submitted are
listed in the tables in Chapter III. Available data en technical OBPA are as
follows:
1. Color
White (Ventron Corp., 1976, MRID 00013625)
20
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2. Odor
Odorless (Dow Chemical Co., 1965, MRID 00026094)
3. Melting Point
182°C (Dow Chemical Co., 1965, MRID 00026094)
4. Solubility
OBPA is soluble in water at 10 ppm. In nonyl phenyl it is soluble, vhile in
organic solvents it is essentially insoluble (Yeager, 1976, MRID GS04406R).
5. Stability
An assay has shovn that OBPA is stable. There was 99.8 percent present in 1.25-
3.5 years (Ventrcn Corp., 1975, MRID 00013622).
6. fliysical State
OBPA is a crystaline solid (Yeager, 1976, MRID GS044066).
7. Specific Gravity
1.40-1.42 (Yeager, 1976, MRID GS044066).
8. Vapor Pressure
0.05 mm at 20°C (Wade, 1972, MRID 05016437).
9. ]?H
5.55 (Ventrcn, 1981, MRID G3044069).
D. SUMMARY OF DATA GAPS
As applications for new product registrations are submitted, they must provide
information as outlined in the Confidential Statement of Formula, EPA
Form 8570-4.
21
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V. ENVIRONMENTAL FATE
A. Use Suirmary
B. Bivircnmental Fate Profile
C. Exposure Profile - Ehd-Use Products
D. Summary of Bwircnmaital Fate Data Gaps
A. USE SUMMARY
The active ingredient, OBPA, is not currently marketed as a manufacturing-use
product but as formulated products. It is an antimicrobial agent which is
marketed generally in the form of 1-3% OBPA solutions in nonvolatile
plasticizer carriers. Among the plasticizers most commonly used are epoxidized
soybean oil, epoxy compounds and phthalate esters. The OBPA solutions are used
to protect plastic compounds against microbial and fungal attack. OPBA is also
formulated as 1-3% aqueous solutions with various polymers to form solid resin
concentrates. Si this form, OBPA is immobile in the plastic matrix and it
remains physiologically stable.
OBPA is formulated at 5.0%, which is sold as a homogeneous solid in palletized
form. It is used in polyvinyl resins, polyurethane and related polymeric
compositions.
The OBPA formulations are registered for the control of microorganisms on the
following items: flexible vinyl sheeting and extrusions, silicone caulking
compounds, thermoplastic adhesives, polyurethane, latex emulsions (not includig
paints), ink bases and textiles.
Although flexible vinyls and silicones in themselves are resistant to
microbiological deterioration, the use of OBPA formulations in products made
from these materials is necessary due to microbial susceptibility of
plasticizers, lubricants, and fillers which are added to obtain desirable
physical and chemical properties. In addition, OBPA protects products from
fungi which grow on superficial dust, dirt, or grease on their surfaces.
B. ENVIRONMENTAL FATE PROFILE
The uses of this compound precludes any significant environmental exposure from
end-use products because it is incorporated and bound within plastics and
fabrics. While there is some leaching from newly made plastic during an
initial weathering period, the levels of OBPA found in solvent extracts
indicate that a 50 ppb maximum daily dietary intake of arsenic in drinking
water, recommended by USHEW (1962, MRID GS04405'S)f will not be exceeded. After
the initial period of weathering, end-use products containing OBPA leached, on
the average, far less than the recommended 50 ppb maximum dietary intake
(Hamilton, 1978, MRID GS044024; and Ventron Corp., 1978, MRID GS044056).
22
-------
C. EXPOSURE PROFILE
1. Direct Exposure
The potential for direct human exposure is limited primarily during the
manufacture of products containing OBPA. Formulated products contain only 1.0,
2.0, 3.0 or 5.0% OBPA. Materials incorporating OBPA are produced in "closed
systems" because of the extreme irritating nature of the compound. Two
separate surveys of \fentrcn Corporation reformulation sites for airborne
concentrations of organic arsenic showed exposure readings were 0.18 and 0.002
mg of inorganic arsenic per cubic meter of air (Kugler, 1974, MRID GS044034 and
Weingast, 1976, MRID GS044062). These data, while limited, indicate a very low
exposure to airborne OBPA in the work environment.
After reviewing these data, the Agency has determined that the use of a "closed
system" manufacturing process significantly limits the potential for direct
OBPA exposure to humans.
2. Indirect Exposure
Indirect routes of exposure to OBPA are limited to finished products containing
the compound. Very small amounts of OBPA are used in finished products.
Indoor and outdoor plastics contain 0.03%(w/w) and 0.05% (w/w) of OBPA.
respectively. Caulking compounds contain 0.03% to 0.05% (w/w) OBPA.
Thermoplastic-based adhesives contain 0.03% (w/w) OBPA. Treated textiles
(drapes and matress ticking) contain 0.04% to 0.10% OBPA. These limited
indirect exposure routes consist of: dermal, inhalation and dietary exposure.
a. Dermal Exposure
Dermal exposure cones from vin^" products used in a recreational setting (e.g.
lawn chairs, pool liners, and treated vinyl used in boat seats). In simmer,
exposure is compounded by generally high temperatures, the presence of water or
perspiration, and wearing of swinming attire allowing for maximal skin contact.
Numerous researchers have performed extraction studies of plastics containing
OBPA. Using 10% (v/v) acetic acid, 0.1% (w/v) sodium carbonate or distilled
water for two 24 hour extraction procedures, Cadmus (1973, MRID GS0440U &
GS0044012) extracted less than 20 percent and less than 10 percent of the OBPA
found in heavy and light gauge plastics, respectively.
Ventron (1978, MRID GS044056) extracted OBPA with 10% (v/v) acetic acid, 0.1%
(w/v) sodium carbonate, distilled water or simulated basic sebum for 48 hours
from swinming pool liners prepared in the laboratory. The results of this
study indicate that approximately 10 to 15 percent of the OBPA was extracted
from the pool liner.
In a second study by Ventron (1978, MRID GS044056), commercially prepared heavy
vinyls were extracted for 48 hours using distilled water, simulated acid sebum,
simulated basic sebum, 0.1% (w/v) sodium carbonate, 10% (v/v) acetic acid or
23
-------
stabilized chlorinated pool water. The results of this study indicate that the
amount of OBPA lost from commercially prepared vinyl films does not differ
dramatically frcm the laboratory prepared samples.
Hamilton (1978, MRID GS044023) extracted vinyl films containing 0.026% and
0.04% OBPA at 37 C in distilled water from 5 to 45 days. This study
indicates that approximately 62 and 63 percent leached from plastic initially
containing 0.026% and 0.04% OBPA. No OBPA leached after 25 and 35 days from
plastic containing 0.026% and 0.04% OBPA, respectively.
These studies indicate that small amounts of OBPA can be leached from plastic
used in plastics found in recreational and outdoor settings. These studies
also indicate that the amount of leaching of this compound is limited primarily
to situations of high heat and humidity.
b. Inhalational Exposure
A second route of exposure is through vaporization of OBPA from vinyl-
containing wall coverings, shower curtains, and other treated products.
The vapor pressure of OBPA is less than 1 x 10 mm Hg, the limit of
detectablity of the method (Skinner and Sherman, 1978, MRID GS044068).
Inhalational exposure to OBPA is, therefore, expected to be negligible because
the vapor pressure is negligible.
c. Dietary Exposure
A third exosure possibility is OBPA via water. If caulking compounds are used,
seme OBPA will be leached into appliances which contact food surfaces.
The Consumer Product Safety Commission (CPSC) (Porter, 1973, MRID GS044048)
conducted an extractability study of a silcone caulking compound in an
automatic dishwasher for two hours at 80 C. TVo ml of com oil and 0.2%
(w/v)of dishwashing detergent were added to the water to simulate use
conditions. The results of this study indicate that the 39 percent of the
arsenic extracted from the sealant contributed 28 ppb of arsenic to the wash
water.
The CPSC (Kirkpatrick, 1977, MRID GS044030 and Kirkpatrick, 1977, MRID
GS044031)performed additional extractability studies on two additional siliccne
sealants vhich contained OBPA, one of which was not recommended for use in
dishwashers. The results of this study indicate that neither sealant would
contribute more than 50 ppb to the wash water.
Major Appliances Laboratories (1975, MRID GS044041) conducted two
extractability studies of a silcone sealant in two dishwashers. 50 grams of
citric acid were added to the wash water to simulate aginq conditions of the
appliance. After 28 cycles the arsenic content of the water never exceeded 25
ppb. Analysis of the sealant material indicated that over 70 percent of the
arsenic remained in the sealant after 30 cycles.
24
-------
The above studies indicate that less than 50 ppb arsenic is leached from the
caulking compoinds used in dishwashing appliances. By contrast, up to 50 ppb
arsenic is permitted in public drinking water by the USHEW (1962, MRID
GS044055).
The conclusions of a detailed exposure analysis performed by this Agency (EPA,
1979, MRID GS044070), using the data from the above studies, are summarized in
Table 1.
25
-------
TABLE 1
SUMMARY OF EXPOSURE TO OBPA -'
Amount of OBPA
Primary Route Exposure (ug/kg/hr)
Treated Products/Uses of Exposure 70 kg person 50 kg person
vinyl wall Coverings
Seats & Chairs
Swimming Pool Liners
Food Contact Surface
Ihhalaticnal 4/
Dermal 5/
Dermal 3/
Oral 3/"
Dietary fi/
0.00 2/
7.14 ~
0.91
0.91
o.ni
0.00 2/
10.00 ~
1.27
1.27
0.02
Caulking Material
Shower Curtain & Ihhalaticnal 7_/ 0.00 2/ 0.00 2/
Mattress Cover
1/Ttie references used in tine original exposure analysis include: Cadmus,
1973, MRID GS044012; Kugler, 1974, MRID GS044034; Weingast, l<»7fi,
MRID GS0440062; Uantron Corp., 1978, MRID GS044056; Skinner and Sherman,
1978, MRID GS0440068; Hamilton, 1978, MRID GS044023; and Hamilton, 197R,
MRID GS044024.
2/The estimated exposure to OBPA from inhalation was calculated to be
0.0004 ugAg/hr for a 70 kg person and 0.00056 ugAg/hr for a 50 kg
person. This exposure is low enough that it is reported as 0.00.
3/An oral estimate was not included in the exposure analysis performed by the
Agency in 1979 (USEPA, 1979, MRID GS044070). The calculation of oral
exposure has been estimated to be essentially the same as the dermal
exposure:
Oral Exposure = OBPA cone, in pool water x quantity of water swallowed
Weight of Person
Oral Exposure = 0.02 mg/1 x 0.5 1
70(or 50)kg
2
4/Ihhalational Exposure = (area of 4 walls in a room) x (mg OBPA/M of wall
covering) x (10% OBPA vaporized per yr) x (1M /hr breathing rate/7 hr
day)* (weight of person)
2
5/Dermal Exposure (seats/chairs) = (area of exposed skin) x (nrj OBPA/M
vinyl leached/hr) x (0.5 1 perspiration) * (weight of person)
6/Dietary Exposure = (cone. OBPA in water) x (vol. of water which dries on
plate) * (weight of person)
7/lnhalational Exposure = (area of vinyl surface) x (mq OBPA in vinyl) x
(volume of small room) x (1% OBPA vaporized/ yr) x (1M /hr breathing
rate) *• (weight of person)
26
-------
After a thorough review of the manufacture and use of end-use pesticides and
products the Agency has am eluded that the use "closed systems" and an
extremely small anoint of the material released from plastics treated with this
material will not result in significant human exposure to this compound.
D. SUMMARY OF DATA GAPS
Tfo understand the potential environmental impact from the manufacturing of
OBPA, hydrolysis, and activated sludge metabolism studies are required.
However, the activated sludge study is being delayed intil the Agency completes
development of the protocol.
27
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VI. TOXICOLOGY
A. Toxicology Profile
B. Human and Domestic Animal Hazard Assessment
C. Suirmary of Data Gaps
A. TOXICOLOGY PROFILE
1. Manufacturing-Use OBPA
a. Acute Oral Toxicity
Olsen (1959, MRID 00024941) administered 2.0, 3.^8, 7.95 and 15.8 mgAg to
female rats of an unspecified strain. Four animals per dose were administered
OBPA (unspecified percent A.I.) as a 0.0795 percent com oil suspension. Body
weights and few gross necropsy data are available. No histopathology data are
available. The study indicates that extensive kidney and liver damage were
observed at autopsy. Oily two animals died in the study: at the 3.98 and
15.8 mg/kg doses. No U>50 calculation was performed by the author and hence
the toxicity category of mis product is not knovn.
Si a second study performed by Olsen (1959, MRID 00024941), 15, 31, 63, 125 and
252 mgAg was administered to female rats of an unspecified strain. Two
animals per dose were administered OBPA (unspecified percent A.I.) as a
1.25 percent com oil suspension. Body weight data are available. Some data
are available indicating that the liver and kidney showed extensive damage from
treatment. This study also indicates that mere may have been some
histopathological examination of tissues was made in this test. All but one
animal at me 15 mgAg dose died during the study. While no LD-Q calculation
was performed by the author, the LD,-0 for the test compound could be below
15 mgAg and could place this product: into toxicity category I.
Female rats (unspecified strain) were administered a 0.0795% com oil solution
and a 1.25% com oil suspension of OBPA by Dow (1964, MRID 00024935) by
intubation. Four animals received the 0.0795% solution and two animals per
dose received the 1.25% suspension. The estimated LD-Q is 15 mgAg, placing
this material into toxicity category I.
Male Portcn-Wistar rats and male Duncan-Hartley guinea pigs were administered,
by gavage, technical (unspecified percent A.I.) OBPA by International Paint
Company (1957, MRID 00013591 and Ballantyne, 1978, MRID 05015857). All doses
of the test compound were administered in 0.5% (w/v) Tritcn-X plus 0.5%
(w/v)carboxymethylcellulose. Ten rats per dose were administered 25.0, 29.R,
35.4, 42.0, 50.0, 70.0 and 100.0 mgAg of the test compound. i\=n guinea pigs
per dose were administered 17.7, 21.0, 25.0, 29.8 rngAg and six guinea pigs per
dose were administered 35.4, 50.0, 70.8 and 100.0 mgAg of the test compound.
Survivors showed signs of abdominal tenderness, tenseness, dyspnea, ataxia and
sluggishness. Decedents showed hepatic, lung and kidney involvement. Hepatic
involvement reduced in severity by day 21. Survivors appeared to be normal,
except for a slight increase in portal tract mononuclear cells. The
of the test material for rats and guinea pigs are: 40 mgAg and 23.8
respectively, placing the test material into toxicity category I.
28
-------
Anspach (1977, MRID 00013643) estimated the oral LD5n of technical
(99.9%)OBPA by dosing five male aid five female albino rats (unspecified
strain) per dose level. Animals were administered the test compound as a
0.215% or a 2.0% com oil suspension. Doses of technical OBPA in the 0.215%
suspension were: 2.15, 4.64, 10.0, 21.5 and 46.4 tngAg. Coses of technical
OBPA in the 2.0%suspensicn were: 21.5, 46.4 and 100 rag/kg- The calculated
LD-. of the 0.215%suspensio*t in male and female animals is: 20.0 and 27.1
mg/Kg, respectively. The calculated LD50 of the 2.0% suspension in male and
female animals is: 68.1 and 43.0 mgAg. respectively. Extensive gross necropsy
of all animals briefly showed the following: congested lungs, kidneys and
adrenals, gastro-intestinal tract filled with whitish material and fluid,
depleted fat reserves. Toxic signs include: depression, emaciation, diarrhea
and labored respiration. The results of this test place technical OBPA into
toxicity category I.
Anspach (1977, MRID GS044002) tested the acute toxicity of OBPA by dosing five
male and female Sprague-Dawley rats with the technical material (95.6% A.I.).
The material was administered as a 0.5% (w/v) suspension in com oil at the
following dose levels: 4.64, 10.0, 21.5, 46.4 and 100.0 mgAg. Gross
necropsies were performed on all animals. Tbxic signs included diarrhea,
emaciation and bloody stains around the muscle. Rats exhibited congested
adrenal, kidneys and lungs, irritated gastro-intestinal tracts, and some
animals showed darkened livers and depleted fat stores. The LDc/» for male
and female rats is: 36.9 and 31.6 nrcj/kg, respectively, placing tnis material
into toxicity category I.
After reviewing the above studies for technical OBPA, the Agency has determined
that this material possesses a high order of acute oral toxicity and falls
within toxicity category I.
b. Acute Dermal Toxicity
Dow (1964, MRID 00024935) administered OBPA (unspecified percent A.I.) as a
20 percent suspension in dipropylene glycol methyl ether to the skin rabbits
(unspecified sex and strain) under occlusive wrap. After an exposure of 24
hours the test animals exhibited severe skin bums. TVo animals were used for
each of the following doses: 100, 200 and 500 mgAa. The dermal LD,.^ was
estimated as between 100 and 200 mgAg, placing this chemical into toxicity
category I.
Anspach (1977, MRID 00013643) dosed four rabbits (unspecified strain) per dose
with 100, 215, 464, 1000 and 2150 mgAg for 24 hours. Both abraded and intact
skin was used in this study. The test compound (99.9% technical OBPA) produced
moderate erthyema and edema with diffuse blanching, desquamaticn and
coriaceousness of the exposed skin. Only two animals died from treatment: one
at 100 and one at 2150 mgAg. The LD5Q is estimated as exceeding 2150
mgAg. Extensive gross necropsy revealed effects primarily limited to the
irritative nature of the compound. The results of the test place technical
OBPA into toxicity category III.
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Anspach (1977, MRID GS044002 aid Bgger and Ison, 1976, MRID GS044020) dosed
four male and female albino rabbits (unspecified strain) with 215, 464, 1000
and 2150 mg/kg of technical OBPA (95.6% A.I.). The undiluted material was
applied to both abraded and intact skin for 24 hours under occlusive wrap.
Toxic signs include diarrhea, emaciation, necrosis, edema and blanching of the
test site, labored respiration and bloody discharge from the nose and ears.
Gross necropsy of decedants revealed congested lungs and kidneys, irritated GI
tract and peritoneal walls, depleted fat stores, spotted livers, heammorrhagic
heart. Gross necropsy of survivors was unremarkable. The LD5Q is 414 mgAg,
placing this material into toxicity category II.
Litton Bionetics (1978, MRID GS044039) administered technical OBPA (96.8%
A.I.)to four male Charles River rats per dose. The test material was suspended
in com oil and administered at the following doses: 21.5, 46.4, 100.0, 215.0,
464.0, 1000.0 and 2150.0 mgAg« Toxic signs include nasal and eye discharge,
reduced coordination, activity and tremors. Nscropsy revealed pulmonary,
adrenal, liver and GI tract involvement. The LD^ is 121 mgAg, placing this
material into toxicity category I.
Babish (1978, MRID GS044004) performed a range-finding and final LD,-Q
determination on OBPA (unspecified percent A.I.). Bn the range-finding study,
one male and female Spraque Dawley rat per dose were administered 280, 500,
900, 1600, 2800 and 5000 mg./kg of the test material under occlusive wrap for 24
hours. The dermis of all animals remained intact. One animal died at each of
the three lower doses and all animals died at the other higher doses. Gross
necropsy of the decedents was unremarkable. In the main study, five males and
females were administered 100, 200, 400 and 800 mgAg of the test material in
com oil under occlusive wrap for 24 hours. The dermis of all animals remained
intact. The LDegis 330 mgAg, placing this material into toxicity category
II. Necropsy of all decedents was unremarkable. Ibxic signs for both tests
included: reduced activity, ataxia, urinary incontinence, bloody nasal
discharge and dnromodacryorrhea.
After reviewing the above studies for technical OBPA, the Agency has determined
that this material possesses a high order of acute dermal toxicity and falls
within toxicity category I.
c. Acute Inhalation Toxicity
Dow (1964, MRID 00024935) studied the inhalation toxicity of technical OBPA
(unspecified percent A.I.) by exposing white rats (unspecified sex and strain)
to a saturated atmosphere for seven hours. Two trials were performed with the
test material at either room temperature or at 100 C. Four animals per
trial, ptus one control afimal, were placed in a 19 liter chamber and exposed
to an atmosphere which changed at a rate of one liter per minute. All test
animals in both trials showed mild upper respiratory changes (unspecified)
fromexposure to the test material either during the test or up to two weeks
following exposure. ND analysis of air samples was performed to confirm that
the animals actually were exposed to the test compound.
30
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Lecng (1969, MRID GS044035) exposed eight rats (unspecified sex end strain) to
OBPA (unspecified percent A.I.) to determine the effects of aerosol exposure to
the tissue of the eyes and respiratory tract. A 2% (w/v) solution of OBPA in
polyethylene glycol-200 was dispersed as an aerosol at a ccnonetration of 36.6
lamda per liter. Animals were individually housed in plethyographs with their
heads protruding into a tubular exposure chamber. Respiratory rates of the
animals were measured prior to, during and after the 15 minute exposure. All
animals exhibited eye and nasal irritation and reduction of respiratory rates
and dypsnea. Respiratory rates decreased SO to 60 percent of the control value
for several hours after exposure and subsequently returned to normal with no
latent effects. TVo animals examined immediately after exposure exhibited
slign nasal discharge. Histopathological examination of these animals
revealed a scant amount of mucus and a few polymorphonuclear leukocytes in the
laryngeal lumen. Gross examination of two animals three days after exposure
were unremarkable while histopathological examination of one of these two
animals revealed polymorphonuclear leukocytes in and on the trachea1
epithelium. The histopathology of these animals is compatible with upper
respiratory irritation. NO ocular effects were seen in this study.
International Paint Company (1957, MRID 00013591 and Ballantyne, 1978, MRID
05015857) estimated the LC5Q of technical OBPA (unspecified percent A.I.) by
exposing five male Duncan-Hartley guinea pigs per trial for varying time
periods and dosages. The inhalaticnal exposure dosage was calculated as the
product of the dosage multiplied by the length of exposure. The mean particle
size of the test compound was estimated as between 4 to 5 microns. Air samples
were analyzed to assure that the animals ware exposed to the test material.
Toxic signs included rales, bloody nasal discharge and mild shock. Examination
of the lungs, the only organs necropsied, showed intense pulmonary congestion,
hemorrhaging and edema. The I£,-Q for the test compound is estimated to he
1,279 mg/L, placing this compound into toxicity category IV.
After reviewing the above studies for technical OBPA, the Agency has determined
that this material possesses a low order of acute inhalation t-.oxicity. While
this material is a mild to moderate pulmonary irritant, the results of these
acute toxicity studies place technical OBPA into toxicity category IV.
d. Primary Eye Irritation
Olsen (1959, MRID 00024938 and'Dow, 1964, MRID 00024935) instilled OBPA
(unspecified percent A.I.), both undiluted and as a 10% w/v suspension in
propylene glycol, into the eyes of two female rabbits (unspecified strain).
One eye was washed and the second eye remained unwashed. The washed eye
received a two minute wash within 30 seconds after instillation of the test
material. Instillation of the undiluted material resulted in slight pain and
conjunctival involvement. Washing of the eye reduced these effects. No
effects were seen on the seventh day. Instillation of the 10% solution
resulted in slight pain and moderate comeal and conjunctival involvement.
Washing reduced, but did not eliminate, ocular involvement. Effects of the 10%
solution, including comeal involvement, persisted through day 7. The results
of this study place the undiluted material and 10% solution of the test
material into toxicity categories IV and I, respectively.
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Technical (unspecified percent A.I.) OBPA was administered in the eyes of
female New Zealand white rabbits by the International Paint Company (1957, MRID
00013591 and Ballantyne, 1978, MRID 05015857). The 0.1 ml of the test compotnd
was administered with 5% DHSO in PEG 300 solvent. The following mixtures were
administered without washing after instillation into the eyes: PEG 300 solvent
control; a solution containing 0.1%, 0.25% or 0.5% w/v of the test compound
with DMSO/PEG 300 solvent; 0.5% w/v of was administered with 5% DMSO in PEG 300
solvent. The following mixtures were administered without washing after
instillation into the eyes: PEG 300 solvent control; a solution containing
0.1%, 0.25% or 0.5% w/v of the test compound with DMSO/PEG 300 solvent; 0.5%
w/v of the test compound in PEG 300. To determine the effect of eye washinq,
another set of rabbits received a 37 C saline eye wash after instillation of
0.1% w/v of the test compound in DMSO/PEG 300. Intraocular pressure was
measured before and at 10 and 60 minutes after instillation of the test
material.
Instillation of the solvent into the eye of test animals produced very mild
conjunctivitus. The 0.5% w/v solution produced comeal opacity and moderate to
severe conjunctivitus with the iris remaining normal at 14 days. The 0.25%w/v
produced similar but less severe effects. The 0.1% w/v solution produced
transient and mild effects comeal and conjunctivae involvement. Solutions
containing 0.5% w/v with PEG- 300 produced effects similar to the 0.5%
w/vsolution containing both DMSO and PEG 300. Etye washing after instillation
of the test material indicates that the washinq process aggravates the eye,
resulting in increased ocular injury. The results of this study place this
material into toxicity category I.
fr\ eye irritation study was performed by Anspach (1977, MRID 00013643).
Instillation of the technical OBPA (99.9%) into the eyes of six albino rabbits
(unspecified sex and strain) produced comeal opacity, conjunctivitis and
iritis which persisted through 72 hours, the duration of the test. The average
Draize score was 71 out of a possible 110, placing this chemical into toxicity
category I.
Anspach (1977, MRID GS044002) instilled technical OBPA (95.6%) into the eyes of
six rabbits (unspecified sex and strain). The test compound produced
conjunctivitis in all animals and severe comeal opacity in half of the
animals. The primary eye irritation score is 62 out of 110, placing this
material into toxicity category I.
After reviewing the above studies for technical OBPA, the Agency has determined
that the irritating nature of this material to the eye places this material
into toxicity category I.
e. Primary Skin Irritation
Olsen (1959, MRID 00024937 and Dow, 1964, MRID 00024935) tested the dermal
irritation of OBPA (unspecified percent A.I.). The test material was applied
to the ear of one rabbit and abdomen of two rabbits (unspecified sex and
strain). The dermis of the abdcmen was both abraded and intact. The test
material was administered as a 10% w/v solution in dipropylene glycol methvl
12
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ether. Application of the test material to both intact aid abraded skin of the
abdomen and the ear results in hyperemia, edema, necrosis, exfoliation and
formation of a scab and scar tissue through day 21 of observation. Results of
this test place this material into toxicity category I.
A primary skin irritation study was performed by International Paint Company
(1957, MRID 00013591 and Ballantyne, 1978, MRID 05015857). Technical
(unspecified percent A.I.) OBPA was diluted 1:3 in water containing
0.5%carboxymethylcellulose and 0.5% Triton X-100. The diluted test material was
administered as a 0.2 ml dose under occlusive wrap to six male Dun can -Hart ley
guinea pigs for six hours per day for five days. A similar number of animals
were dosed only with the solvent. Treatment produced erythema progressinq to
escherosis with healing commensing five days after the last application. The
results of this test place this material into toxicity category II.
Anspach (1977, MRID 00013643) tested technical OBPA (99.9% A.I.) by placing
0.5 gm of the test substance, under occlusive wrap, on the skin of six albino
rabbits (unspecified sex and strain). Patches of both intact and abraded skin
were used in this test. The test ccmpomd produced blanching of the skin with
slight to severe edema and peripheral and spotted erthyema. The primary
irritation index of this product is 5.79 out of a total possible score of 8.0,
placing technical OBPA into toxicity category II.
Anspach (1977, MRID GS044002) applied OBPA (95.6% A.I.), under occlusive wrap,
to both intact and abraded skin of six albino rabbits for 24 hours. The test
material produced slight erythema and edema and blanching. The primary
irritation index was 3.17 out of eight, placing this compound into toxicity
category III.
After reviewing the above studies for technical OBPA, the Aqency has determined
that the irritating nature of this material to the skin places this material
into toxicity category I.
f. Subchronic Oral
Frantz and Shrader (1959, MRID 00024936 and Oxen, 1959, MRID 00024940)
administered 0, 1, 10, 30, 100 and 300 ppm of OBPA in the diet. The percent
active ingredient was not specified in the report. Tfen rats/sex/dose were used
in this study. Food consumption was measured over 30 days of the 35 day
study. Animals were weighed twice weekly to'day 28 and once per week to day
35. Terminal hematology of five female rats at each of the following doses: 0,
100 and 300 ppm. Lungs, heart, liver, kidneys, spleen, and testes of all
moribund animals and may have been performed on all decedents and sacrificed
animals were removed and weighed. Portions of the pancreas and adrenals were
also examined. Growth of all animals in the 100 and 300 ppm level was
retarded, possibly due to reduced food consumption. The final average liver
weight was significantly increased and there was a significant increase in the
weight of the testes. Histopathological examination reveals proliferation of
the portal portion of the bile duct, an effect which may be expected from
arsenic. Analysis of the liver and kidneys for arsenic content reveals a
significant dose/response accumulation of arsenic in these organs, an effect
vrtuch may be expected from arsenic. The NOEL in this study is 10 ppm.
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McCollister et al. (1969, MRID GS044042) administered OBPA (unspecified percent
A.I.) to ten Sherman rats/sex/dose for 92 days at the following doses: 0, 0.03,
0.1, 0.3, 1.0 and 3.0 mg/kg/day. Hematology was performed at 28, 42 and 84
days into the study. Urinalyses were performed at 7, 32 and 8R days into the
study. SPGT was determined en days 7 and 58. Hair was analyzed for arsenic at
day 88. The following organs were examined and weighed: heart, liver, kirhey,
spleen, testes and brain. Portions of the following organs were examined
microscopically: lung, trachea, urinary bladder, aorta, stomach, colon, small
intestine, esophagus, thyroid, pancreas, skeletal muscle, peripheral nerve,
prostrate, adrenals, seminal vesicle, ovary uterus and thymus. The liver,
kidney and fat were analyzed for arsenic content.
No remarkable toxic signs were observed and there was 100 percent survivalship
in this study. Growth retardation was evident only in the high Hose group,
possibly associated with reduced food consumption. Results of hematological,
urinalysis and clinical chemistry proved unremarkable. Gross necropsy revealed
a significant reduction or absence of fat from the mesentary of high dose
animals. No other abnormalities were noted in necropsy. The only significant
microscopic finding were lesions in the livers of high dose animals and
inflammatory cellular infiltrates in the peripprtal area with bile duct
hyperplasia. Arsenic tended to bioaccumulate in the li-er and kidney at all
doses, in the fat at the 0.3, 1.0 and 3.0 mgAg/day doses and in the hair at
the 1.0 and 3.0 mgAg/day doses. The NOEL in this study is 1.0 mgAg/day.
The results of these studies indicate that the liver, kidney and bile duct are
affected by the test material. Bioaccumulaticn of arsenic occurs in the liver,
kidney and hair at all dose levels, an effect which might be expected from the
consumption of arsenic.
g. Subchrcnic Inhalation
25 male Portcn-Wistar rats and 25 male Duncan Hartley guinea pigs were exposed
by International Paint Company (1957, MRID 00013591 and Ballantyne, 1978, MRID
05015857) to 1 to 2 mg/M' of technical (unspecified percent A.I.) OBPA for
five days per week for 30 days. Air samples were made at 30 minute intervals
to assure that animals were being exposed to the test material. Half of the
control and test animals were sacrificed 48 hours after exposure. The
remaining animals were sacrificed fourmmths after exposure. Gross necropsies
and histopathology was performed on all animals with particular attention to
lung, liver and kidney tissue. The rats and guinea pigs sacrafice^l after ^8
hours demonstrated mild to moderate pulmonary congestion and hemmorhaqinq.
Rats, but not guinea pigs, showed mild to rroderate hepatic involvement.
Animals sacrificed at four months were unremarkable. Only weekly body weiqhts
were recorded. A similar number of animals were used as controls. ft> deaths
were reported in this study.
The results of this study indicate that OBPA produces mild to moderate
pulmonary irritation which is reversible after four months.
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h. Metabolism
In a study by Olsen et al. (1959, MRID 00026092), OBPA was applied to the skin
inder exclusive wrap for 24 hours at 0, 100, 200 or 500 mgAg. Sodium arsenite
was applied in a similar manner to the skin as a positive control. The levels
of sodium arsenite used in this study were: 10 and 40 mgAg. A total of six
rabbits (one female aid five males) of en unspecified strain were used in this
study. All animals died in this study, most within 24 hours. The skin of all
treated animals was severly burned and hyperemic and andemous. The following
items were sampled in this study: liver, blood, feces and urine. The livers
from five animals were analyzed for arsenic content: one control, two 100 mg/kg
test animals, and two sodium arsenite (10 and 40 mgAg) animals. Arsenic is
not concentrated in the livers of animals treated with sodium arsenite, but
accumulates in the livers of animals fed OBPA. Blood levels of arsenic in
sodium arsenite were higher than in those animals treated with OBPA. Arsenic
is excreted primarily in the feces and secondarily in the urine in animals
treated with OBPA. The reverse is true for animals treated with sodium
arsenite. While exact clearance times for arsenic could not be determined
because urine volumes were not available, the report indicates that arsenic
should be eliminated from the body over a two week time period. Because of the
damage observed at autopsy and levels observed upon analysis, the tarqet organs
for arsenic accumulation from OBPA are the liver and kidney.
As an ancillary part of a dermal LD-Q determination, Dow (1964, MRID
00024935) administered OBPA (in spec i tied percent A.I.) as a 20% suspension in
diprppylene glycol methyl ether to the skin rabbits (unspecified sex and
strain) under occlusive wrap. Exposure occurred for 24 hours. Test animals
exhibited severe bums. While the blood, urine, feces and liver tissue were
analyzed for arsenic content, the tabulated data were not presented in the
report. Data are reported to indicate that detectable levels of arsenic are
found in the blood, feces and urine 24 hours after exposure and in the liver 16
days after exosure. An unspecified amount of an aqueous solution of sodium
arsenite was applied to the skin of rabbits (unspecified sex and strain) as a
positive control. "Marginal concentrations" of arsenic are voided in the urine
in "large amounts" within 24 hours after exposure. Liver retention at 16 days
was negligible.
Three Dun can-Hart ley guinea pigs per dose were administered 300 mgAg under
occlusive bandage for six hours by International Paint Company (1957, MRID
00013591 and Ballantyne, 1<>78, MRID 05015857). The test compound, technical
(unspecified percent A.I.) OBPA was administered as a 20% com oil suspension.
The liver, kidneys and blood of test and three untreated control animals were
analyzed for arsenic content. The analytical method used in this study had a
limit of detection of 15 microqrams of arsenic, or 50 micrograms of the test
material. Nb arsenic was found in these tissues.
The results of these studies indicate that OBPA is absorbed rtermally, resulting
also in dramatic skin irritation and necrosis. Because of the damage observed
at autopsy, the target organs for arsenic accumulation are the kidney and the
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liver. Arsenic accumulates in the liver and is cleared from the body after two
weeks. The feces and urine are the primary and secondary routes of excretion,
respectively.
i. Mutagenicity
Brusick and Weir (1976, MRID 00013644) exposed mouse lyphoma L5178Y cells to
technical (99.9%) OBPA. Activated cells were exposed to 0.005, 0.01 and 0.05
ug/ml of active ingredient. Naiactivated cells were exposed to 0.0005, 0.001,
0.005, 0.01 and 0.05 ug/ml of active ingredient. Concentrations greater than
0.1 ug/fal produced cytotoxicity. An initial activation test showed two
increases in mutation frequency at dose levels of 0.001 and 0.01 ug/ml, but
upon retest at slightly higher concentrations, the test substance showed only
slight increases in mutagenicity. The nonactivaticn test was negative. The
results of the initial activation test are considered to be aberrant and the
test compound is not considered to be mutagenic under the test conditions.
in a second mutagen icity study performed by Brusick and Weir (1976, MRID
00013647) S. cere visiae (D-4) and S. typhimurium (TA-98, TA-100, TA-1535, TA-
1537 and TA-1538) were exposed to 0.0005, 0.05, 0.5 and 2.5 uq/ml of technical
(99.9%) OBPA. The 0.0005 ug/ml dose level was added because of toxicity at the
high 2.5 ug/ml dose level. Activated and nonactivated cells were used in this
assay. EMSO was used as the solvent in this assay. The -results of the tests
conducted with both activated and' nonactivated cells indicate that the test
compound is not mutagenic under the test conditions.
As a second part of a teratology study, Beliles and Makris (1973, MRID
GS044007) investigated the mutagen icity of metabolites from Charles River rats
which were orally and dermally exposed to OBPA (95.6%). The test animals were
given a dermal applicatio of zero, 0.3, 3.0 and 30.0 mg/kg of the test
material suspended in com oil. The animals also received an undetermined
amount of OBPA orally because no attempt was made to prevent licking off the
material from the test site. Possibly because of the oral inqestion of the
test material one mid-dose and all high-dose animals died between day ten
through day 14 of gestation. Urine samples were pooled from all dose levels
and evaluated for the mutagenic activity of the metabolites according to the
method of Durston and Ames. There was no indication of mutagenic activity from
either treated or untreated urine in this study.
The results of these studies indicate that technical OBPA is not mutagen ic
under the test conditions.
j. Teratology
Beliles and Makris (1978, MRID GS044007) investigated the effect of dermal
exposure of OBPA (95.6%) on fetuses during the period of organogenesis when
administered to 19 pregnant rats per dose. The test material was administered
in com oil at doses of 0.3, 3.0 and 30.0 mgAg to pregnant female Charles
River rats en days six through 15 of gestation. A vehicle control group was
included in the study. The test solution was applied to the ventral cervical
and thoracic region of the animals. Occlusive wrap or restrainers were not
used during this study. The failure to use this wrap and/or restrain the
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animals resulted in the possible ingestion of the compound by the animals as
evidenced by the fact that one mid-dose and all high dose rats died or were in
moribund condition between days ten and 14 of gestation. Gross necropsy of
treated animals reveal signs of irritation that would be expected with this
compound. The fact that ingestion of this compound occurred during the study
compromises the value of this study as an estimate of the teratogenic potential
of OBPA from dermal exposure. Despite this deficiency, this study can be used
to estimate the teratogenic potential of OBPA. Because each animal may have
ingested differing amounts of the test material, the exact dosage for each
animal can not be estimated in this study.
No evidence of compound-related teratogeicity, variation in sex ratio, or
inhibition of fetal development was revealed in this study. Mule there is
evidence of fetal toxicity in the mid-dose group, the distribution of
resorptions suggest that the test material was not exerting a significant
fetotoxic effect. An NOEL of 0.3 mgAg can be estimated for teratogenicity,
embryotoxicity and fetotoxicity.
2. Bid-Use Products
a. Acute Oral Toxicity
1) Durotex 7599 (2.0% A.I.)
Two male and two female albino rats per dose were administered a 25% w/v
solution of Durotex 7599 in com oil by Kohn et al. (1968, MRID 00024951). The
dose levels in this study were 900, 1350, 2025, end 1038 mq/kg. Gross necropsy
showed the survivors to be unremarkable, while the decedents demonstrated
hyperemic lungs, stomach and intestines. The LD5Q is 1650 mgAg and places
this product into toxicity category III.
2) Durotex 7603 (2.0% A.I.)
Tne oral toxicity of Durotex 7603 was determine by VfcRF (1976, MRID GS044057).
Six male Sprague-Dawley rats were administered, by gavage, a single dose
con tain ing either 1000, 2000, or 5000 mgAg of the test material. The LD5Q
is reported to be between 1000 and 2000 mgAg, placing this material into
toxicity category III.
3) Vinyzene BP-5 (1.0% A.I.)
WARF (1971, MRID 00013631) administered Vinyzane BP-5 at two ctase levels (2,000
and 4,000 mgAg) to six Sprague-Dawley male rats per dose by gavage. No
grosslynecropsy or histopathology was performed on either the survivors or
decedents. The LD-0 for this product is between 2,000 and 4,000 mgAg and
places this product into toxicity category III.
4) Vinyzene BP-5-2 (1.0% A.I.)
In a study performed by W\RF (1973, MRID 00013610), male Sprague-Dawley rats
were administered 1, 2, 5 or 10 ml/kg of BP-5-2 by gavage. Jn a separate study
by WARF (1973) (MRID 00013610), female Sprague-Dawley rats were administered 1,
2 or 5 mlAg of BP-5-2 by gavage. No controls were used in either study and
37
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the reaction to the test material was measured only as number of deaths per
dose. No gross necropsy or histopathology was performed on the animals. The
acute oral LD5Q for BP-5-2 in both male and female test animals is between 1
and 2 mlAg aid places this product into toxicity category I.
5) Vinyzene BP-5-3-STL (unspecified % A.I.)
Six rats per dose were administered 0.5, 1.0, 3.0 or 5.0 ml/kg of the test
compound by W\RF (1974, MRID 00023384). The ID,n of Vinyzene BP-5-3-STL to
male and female Sprague-Dawley albino rats was Between 0.5 to 1.0 ml/kg and
places this product into toxicity category III.
6) Vinyzene SB-1 (5.0% A.I.)
In a study performed by WMIF (1975, MRID 00013629), six male Sprague-Dawley
rats were administered 5, 10 or 20 ml/kg of Vinyzene SB-1 in the feed (1:4).
No controls were used and no gross necropsy or histopathology was performed on
the animals. The acute oral IJD50 for SB-1, as tested, is in excess of 20
ml/kg and places this product into toxicity category IV.
WARF (1976, MRID 00013630) determined the acute oral toxicity of Vinyzene SB-
Iby feeding a single dose of a mixture of the test compound and laboratory chow
(1:3) to six Sprague-Dawley rats. No gross necropsy or histopathology was
performed on any of the test animals. The single dose ID-* of the test
compound is greater than 20 gm/kgr placing this product into toxicity category
IV.
7) Vinyzene SB-5-2-PPG (unspecified % A.I.)
Gordon et al. (1977, MRID 00013651) administered Vinyzene BP-5-2-PPG to Charles
River rats at the following dose levels: 1000, 1470, 2150, 3160, 4640, 6R10 and
10000 mgAg. Four male rats per dose were used in this test. Gross necropsies
showed that the survivors were unremarkable. Decedents showed (1) vascular
constriction in the brain, stomach and ceacum, (2) pale lungs and liver, and
(3) distension of the stomach and intestine by red or yellow viscous material.
The oral LDSO of this product is 1,470 mgAg and places this product into
toxicity category III.
8) Vinyzene SB-8/12.5D (unspecified % A.I.)
In a study performed by V&RF (1977, MRID 00013660), ten male and ten female New
Zealand albino rabbits were administered a single 20 mgAg dose of Formulated
SB-8/12.5D by gelatin capsule. lt> deaths were reported in this study and the
LD-.is reported to be in excess of 20 mgAg* No pharmacologic signs were
noted in any of the animals and gross necropsy revealed no remarkable
alterations. The results of this study place this material into toxicity
category IV.
9) Vinyzene SB-8 (25.0% A.I.)
In another study performed by WARF (1977, MRID 00013661), ten male and ten
female New Zealand albino rabbits were administered a single 20 mgAg dose of
38
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Vinyzene SB-8 (25% A.I.) by gelatin capsule. No deaths were reported in this
study aid the LD5Q is reported to be in excess of 20 mgAg. No pharmacologic
signs were noted in aiy of the animals and gross necropsy revealed no
remarkable alterations. The results of this study place this material into
toxicity category IV.
10) Vinyzene SB-8/25 (unspecified % A.I.)
WARF (1977, MRID 00013662) administered a single 20 mgAg dose of Formulated SB-
8/25 by gelatin capsule to ten male and tan female New Zealand albino rabbits.
No deaths were reported in this study and the LD5nis reported to be in excess
of 20 mgAg« No pharmacologic signs were noted in any of the animals and gross
necropsy revealed no remarkable alterations. The results of this study place
this material into toxicity category IV.
11) Vinyzene SB-8/25D (unspecified % A.I.)
5i another study performed by VC\RF (1977, MRID 00013663), tan male and ten
female New Zealand albino rabbits were administered a single 20 mgAg dose of
Formulated Product SB-B/25 D by gelatin capsule. No deaths were reported in
this study and the LDu- is reported to be in excess of 20 mgAg. Mo
pharmacologic signs wire noted in any of the animals and gross necropsy
revealed no remarkable alterations. The results of this study place this
material into toxicity category IV.
12) Vinyzene SB-1 (40 Mesh) (5.0% A.I.)
WARF (1977, MRID GS044060) dosed six male Sprague Dawley rats per dose with
5000 and 10,000 iigAg by gavage. The test material (Vinylzanz SB-1, 40 mesh)
was administered as a 25% com oil solution. Gross necropsies were
in remarkable except for one low dose animal which had abcessed lobes of the
lung. The LD5_ is reported as 10,000 mgAg, placing this material into
toxicity category IV.
13) Fungicidal Additive (5.0% OBPA)
Hobbs (19??, MRID GS044075) administered 0.1, 1.0 and 10.0 mlAg of a
fungicidal additive containing 5% OBPA to two rats (unspecified sex and strain 1
per dose. No deaths occurred at the low dose and all animals died at the 1.0
and 10.0 mlAg dose. Decedents exhibited necrosis of ths gastrointestinal
tract, moderate kidney pathology (unspecified), depression, diarrhea and
diuresis. The LD-Q is between 0.1 and 1.0 mlAg, placing this material into
toxicity category III.
In another study to determine the toxicity of a Dow Coming bathtub caulking
compound containing 1% OBPA, Hobbs (19??, MRID GS044076) administered the test
substance to 2 rats (unspecified sex and strain) for pach of the following
doses: 0.5, 1.0, 2.0 and 4.0 mlAg. No deaths occurred and survivors exhibited
initial depression and weight loss. All animals recovered after two -.^eeks.
The LD__ is in excess of 4.0 mlAg, placing the test substance into toxicity
category III.
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14) Miscellaneous
Powers (1968, MRID 00023386) administered 5,000 and 10,000 mgAg of Test
Material 2473-353-008-8 (unspecified percent A.I.) to male and female Charles
River rats (unspecified number of animals per dose). The test material was
administered in Karo syrup over a 24 to 48 hour test period. No deaths or
toxic sign were reported. Body weights were apparently recorded but not
reported. No remarkable findings were reported at gross necropsy. The maximum
tolerated dose was reported to be greater than 10,000 mqAg of the test
material.
Hobbs (19??, MRID (S044025) administered an experimental bathtub caulking
compoind, containing a ftngicidal additive with BO ppm arsenic, to rats
(unspecified sex aid strain). Two animals per dose were administered 1000 or
10,000 mgAg of the test material. Oily one high dose animal died from
inqestion of the test material. The LD,^ is estimated to be between 1000 and
10,000 mgAg, placing this material into toxicity category IV.
Hobbs (19??, MRID GS044077) attempted to determine the oral toxicity of a
caulking compound. An experimental bathtub caulking compound, containing a
ftngicidal additive at doses of 5000 and 10,000 mqAg, was administered to cne
male and cne female rat (unspecified strain) per dose. The test material
contained 80 ppm arsenic. No animals died from the test material. No
necropsies or histopathology was performed en the animals. The LD5Q was
determined to be in excess of 10,000 mgAg, placing this material Into toxicity
category IV.
In a study to determine the toxicity of Dow Coming 780 Building Sealant
(unspecified % A.I.), Hobbs (19??, MRID GS044078) administered the test
material to two male and two female rats per dose (unspecified strain). The
test material, which contained 80 ppm of arsenic derived from the fingicidal
additive, was administered at 5000 and 10,000 mqAg. Two high dose animals
died from the test material and none died in the low dose group. The LD_n is
probably greater than or equal to 10,000 mgAq» placinq this material into
toxicity category IV.
15) Summary of Acute Oral Toxicology for End-Use Products
Formulated products containing OBPA generally possess a low order of toxicity,
ranging from Toxicity category IV to III. Chly Vinyzene BP-5-2 possesses a
high order of acute oral LD_0 of between 1 and 2 ml/kg, placing this material
into toxicity category I.
b. Acute Dermal Toxicity
1) Durotex 7599 (2.0% A.I.)
Two male and two female albino rats per dose were administered Durotex 7599
under occlusive wrap for 24 hours by Kchn et al. (1968, MRID 00024953). The
dose levels in this study were 2025, 3038, 4556, and 6834 mqAg. The skin of
all animals was unabraded during the test. Reactions by all animals included
40
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erythema, edema, anorexia, generalized weakness and drying of the skin at the
site of application. Decedents also exhibited hyperemic lings, enlarged spleen
and thickening of the skin at the application site. The dermal LD,0 is 4560
mgAg and places this product into toxicity category III.
2) Durotex 7603 (2.0% A.I.)
WARF (1976, MRID GS044057) determined the dermal toxicity of Durotex 7fi03 by
dosing six male rabbits (unspecified strain) to 4000 and 3000 mg/kg under
occlusive wrap for 24 hours. TVo of the high dose animals died within four
days after application. The application site of the surviving high dose animal
was defatted and crusty in appearance. The IA-« was estimated to be between
4000 to 8000 mgAg» placing this compound in toxicity category III.
3) Vinyzene BP-5 (1.0% A.I.)
Six male rabbits (unspecified strain) per dose were administered 4, 8. and 12
ml/kg of Vinyzene BP-5 by WARF (1971, MRID 00013631). Ife gross necropsy or
histopathology was performed en either the decedents or survivors. The dermal
LD5Q for this product is between 4 and 8 mlAg and places this product into
toxicity category III.
WARF (1973, MRID 00013610) administered 2, 4 or 8 mlAg of BP-5-2 under
occlusive wrap to six male rabbits (unknovn strain). *b controls were used in
this study and the reaction to the test material was measured only as number of
deaths per dose. Na gross necropsy or histopathology was performed on the
animals. The dermal LD-0 for BP-5-2 in male test animals is between 2 and 8
mlAg. placing this product into toxicity category III.
4) Vinyzene BP-5-3-STL (unspecified % A.I.)
Two male rabbits per dose (strain unspecified) were administered doses of 1, 2
or 4 ml Ag of Vinyzene BP-5-3-STL under occlusive wrap for 24 hours. The skin
of all animals was dry, hard and wrinkled after administration of the test
material. The acute dermal lAr/jin this study, performed by WARF (1974, MRID
00023384), was between 1.0 and 2.0 mlAg. placing this compound into toxicity
category III.
5) Vinyzene SB-1 (5.0% A.I.)
WARF (1975, MRID 00013629) administered 2000, 4000 or 8000 mgAg of Vinyzene SB-
1 under occlusive bandage to six male rabbits (unknown strain). Ho controls
were used in this study and the reaction to the test material was measured only
as number of deaths per dose. M> gross necropsy or histopathology was performed
on the animals. The acute dermal LD5Q for Vinyzene SB-1 in male test animals
is greater than 8000 mgAg and places this product into toxicity category III.
WARF (1975, MRID 00013636) performed a single dose determination of the dermal
toxicity of Vinyzene SB-1. 20.5 mq of the test compound was applied to the
skin of three male and three female New Zealand white rabbits under an
occlusive bandage for 24 hours. The test material was applied to patches of
skin which were either abraded and intact. ND irritation was produced at 24
41
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aid 72 hours after application and gross necropsy showed no remarkable changes
in the animals. Che death occurred 11 days after application of the test
compound. The LD-Q for this compound is greater than 20.5 mg/kg and places
this product into toxicity category IV.
WARF (1976, MRID 00013630) administered a single dose of 8000 mg/kg of Vinyzene
SB-1 to four rabbits (unspecified sex and strain) under occlusive bandage for
24 hours. No gross necropsy or histopathology was performed. The LD-0 was
determined to be greater than 8000 rag/kg, placing this compound into toxicity
category III.
6) Vinyzene SB-5-2-PPG (unspecified * A.I.)
Two New Zealand albino rabbits per dose were administered 1,000 or 2,000 mg/kg
of Vinyzene BP-5-2-PPG under occlusive wrap for 24 hours by Gordon et al.
(1977, MRID 00013652). The test material was applied to patches of both
abraded and intact skin. ND gross necropsy or histopathology was performed in
this test. The dermal LD,._ in this study is greater than 2,000 mq/kq and
places this product into toxicity category III.
7) Vinyzene SB-8/12.5D (unspecified % A.I.)
Four male and four female New Zealand albino rabbits were exposed to a single
20,000 mgAg dose under occlusive wrap by fcftRF (1978, MRID 00013660).
Exposureto Formulated SB-8/12.5 D resulted in no pharmacological signs.
Necropsy of the test animals revealed kidneys with mild petechial
hemmorrhaging. The dermal LD-Q is estimated to be in excess of 20,000 mqAg,
placing this compound into toxicity category IV.
8) Vinyzene SB-8 (25.0% A.I.)
Three male and three female Nsw Zealand albino rabbits were exposed to a single
20,000 mgAg dose under occlusive wrap by WARF (1978, MRID 00013661). Exposure
to Vinyzene SB-8 (25% A.I.) resulted in no pharmacological signs. Necropsy of
the test animals revealed kidneys with mild petechial hemorrhaqing and lungs
which were red in color. The dermal LD5Q is estimated to be in excess of
20000 mgAg, placing this compound into toxicity category IV.
9) Vinyzene SB-8/25 (unspecified % A.I.)
Four male and four female New Zealand albino rabbits were exposed to a single
2C 000 mqAg dose under occlusive wrap by W\RF (1978, MRID 00013662). Exposure
to the formulated product SB-8/25 resulted in no pharmacological signs.
Necropsy of the best animals revealed kidneys with extensive petechial
hemorrhaging and lungs vhich were red in color. The dermal LD^g is estimated
to be in excess of 20,000 mq/kq, placing this compound into toxicity category
IV.
10) Vinyzene SB-8/25D (unspecified % A.I.)
Four male and four female New Zealand albino rabbits were exposed to a single
20000 mgAg dose under occlusive wrap by WARF (1978, MRID 00013663). Exposure
42
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to the formulated product SB-8/25 D resulted in no pharmacological sicns.
Necropsy of the test animals revealed kidneys with extensive petechial
hemorrhaging and lings which were red in color. The dermal LD^-j is estimated
to be in excess of 20,000 mg/kg, placing this compound into tofcicity category
IV.
11) Fmgicidal Additive (5.0% OBPA)
Hobbs (19??, MRID GS044075) administered 2000 mgAq of a finqicidal additive
containing 5% OBPA to two rabbits (undetermined sex and strain). The test
compound was possibly administered under occlusive wrap, possibly for 24
hours. No notes were made en the one decedent, but the surviving animal showed
significant weight loss and CMS depression. The results of this study possibly
place this compound into toxicity category II.
12) Miscellaneous
In another study by Hobbs (19??, MRID GS044077) six rabbits (unspecified sex
and strain) were dosed with 2000 mg/kg of an experimental bathtub caulking
compound. This compound contained a fungicidal additive with 80 ppm of
arsenic. Three animals had intact skin and three had abraded skin. All
animals survived treatment. No necropsy or histopatholoqy was performed on any
animal. No animals died from the treatment and the results of this study place
this compound into toxicity category III.
in another study performed by Hobbs (19??, MRID GS044078), Dow Cominq 790
Building Sealant (unspecified % A.I.) was administered to six Tiale animals,
possibly rabbits (unspecified sex), at a rate of 2000 mgAg- Three animals had
abraded and three intact skin . No deaths resulted from treatment with the
material. The ID™ is estimated to be in excess of 2000 mqAg, placing this
material into toxicity category III.
13) Summary of Acute Dermal Tbxicity of Bid-Use Products
Formulated products containing OBPA generally possess a low order of toxicity,
falling within toxicity categories II to III. The Fungicidal Additive with
5.0% OBPA differs fron the other formulated products in that it possesses a
moderate order of toxicity, falling within toxicity category II.
c. Acute Inhalation Toxicity
Data on the acute inhalation toxicity of end-use products con tain inq OBPA are
available for only one end-use product, a fungicidal additive containing 5.0%
OBPA.
Hobbs (19??, MRID GS044075) exposed five rats (unspecified sex and strain) to
asaturated atmosphere containing 6.82 mg/L of a fuigicidal additive containing
5% OBPA. No information on the test conditions, except for an exposure time of
7 hours, was available. No animals died from exposure to the test material ;nd
only heavy salivation was the only toxic sign during exposure. The LC^g is
jn excess of 6.82 mg/L, placing this compound into toxicity category III.
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d. Primary Eye Irritation
1) Durotex 7599 (2.0% A.I.)
Kchn et al. (1968, MRID 00024956) tested the eye irritation potential of
Durotex 7599 by instilling 0.1 ml into the eyes of five N»w Zealand albino
rabbits. The study does not mantion whether the oompound was washed from any
of the eyes. Instillation of the test compound resulted in comeal opacity and
a 72 hour Draize score of 57.4, placing this product into toxicity category I.
WARF (1976, MRID 00013630) instilled 0.1 ml of Durotex 7599 into the eyes of
five New Zealand albino rabbits (unspecified sex). The study did not employ an
eye wash. Exposure to the test compound resulted in irritation of the cornea,
iris and conjunctivae with a Draize score of 55.4 out a total possible score of
110 at 7 days. The results of this study place this material into toxicity
category I.
2) Durotex 7603 (2.0% A.I.)
The eye irritation potential of Durotex 7603 was determined by l-P\RF (1976, MRID
GS044057). Durotex 7603 is a fabric containing 100(1 ppm OBPA. The eyes of six
New Zealand albino rabbits were instilled with n.l gn of the test material.
The test material produced comeal opacity and redness, chemosis and
discharge. The primary eye irritation score is 32.0 out of 110, placing this
material into the toxicity category I.
3) Vinyzene BP-5 (1.0% A.I.)
WARF (1975, MRID 00013632) studied the eye irritation potential of Vinyzene BP-
5by placing 0.1 ml of the test compound into the eyes of six albino rabbits
(unspecified sex). The rabbit eyes were not washed in this study. Exposure to
the test compound resulted in Draize score of zero out of a total possible
score of 110 at 72 hours, placing this product into toxicity category IV.
This test is considered to be invalid because the results conflict with the
known corrosiveness of OBPA to the eye and, more importantly, the results of
the primary skin irritation test (see below).
4) Vinyzene BP-5-2 (1.0% A.I.)
WARF (1975, MRID 00013636) studied the eye irritation potential of Vinyzene BP-
5-2 by placing 0.1 ml of the test compound into the eyes of six albino rabbits
(unspecified sex). The study does not mention whether the compound was washed
fron any of the eyes. Exposure to the test compound resulted in Draize score
of 4.0 out of a total possible score of 110 at 72 hours, placing this product
into toxicity category III.
This test is considered to be invalid because the results conflict with the
known corrosiveness of OBPA to the eye and, more importantly, the results of
the primary skin irritation test (see below).
44
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5) Vinyzene SB-5-2-PPG (unspecified % A.I.)
WARF (1977, MRID 00013653) instilled 0.1 ml of Vinyzene BP-5-2-PPG into the
eyes of six white New Zealand rabbits (unspecified sex). The study doss not
mention whether the compound was washed fron any of the eyes. Exposure to the
test oomooind resulted in a Draize score of 5.33 out of a total possible score
of 110 at 72 hours, placing this product into toxicity cateqory III.
This test is considered to be invalid because the results conflict with the
known corrosiveness of OBPA to the eye and, more importantly, the results of
the primary skin irritation test (see below).
6) Fungicidal Additive (5.0% OBPA)
Hobbs (19??, MRID GS044075) administered an undetermined amount of a funqicidal
additive containing 5% OBPA into the eyes of rabbits (unspecified sex, strain
and number). Washed and unwashed eyes exhibited severe conjunctivitis and
moderate comeal response with essentially no pain. The effects of the
material subsided within 7 days. The results of this study place this material
into toxicity category II.
7) Bathtub Caulk (1.0% OBPA)
In another study by Hobbs (19??, MRID (5044076), a Dow Cominq experimental
bathtub caulking compound containing 1% OBPA was instilled into the eye of an
undetermined number of rabbits (unspecified sex and strain). Eyes washed after
instillation of the test material exhibited moderate conjunctivitis and iritis
which subsided within 7 days. Ihwashed eyes showed similar effects, but also
exhibited a comeal response (unspecified) which subsided within two we^ks.
The results of this study place the material into toxicity category TI.
8) Miscellaneous
Hobbs (19??, MRID (50*4025) studied the eye irritation potential of an
experimental bathtub caulking material. An undetermined amount of the test
material containing a fungicidal additive with 80 ppm arsenic was instilled in
the eyes of an undetermined number of rabbits (unspecified sex and strain).
Both washed and unwashed eyes exhibited severe pain with slight ccnjunctival
and comeal response (unspecified). The washed eye and unwashed eyes recovered
within 2 and 7 days, respectively. The results of this test place the test
material into toxicity category IV.
Hobbs (19??, MRID GS044077) instilled an undetermined amount of a bathtub
caulking compound containing a fugicidal additive (unspecified % A.I.) into tho
eyes of six rabbits (unspecified sex and strain). The test material contained
80 ppm of arsenic. Comeal, irital and ccnjunctival irritation of a minor
nature was produced by me test substance. Minor comeal irritation of an
unspecified nature persisted through the seventh day. The results of this
study place the test material into toxicity category II.
45
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Dow Coming 780 Building Sealant containing 80 ppm of arsenic from a
fingicidal additive was tested for eye irritation potential by Habbs (19??, MRID
GS044078). Ihsillaticn of a uidetermined anoint of the test material into the
eye of six rabbits (unspecified sex and strain) produced mild chemosis and
redness of the conjunctiva of three animals and mild reaction of the the iris
(unspecified). All effects subsided by the seventh day. The results of this
study place the material into toxicity category III.
9) Summary of Primary Eye Irritation of Bid-Use Products
Formulated products containing OBPA are moderate to severe irritants (e.g.
toxicity categories IV through I). It is not possible to generalize on the eye
irritation potential of end-use products because the inert ingredients in these
formulations cause the individual products to vary markedly.
e. Primary Skin Irritation
1) Durotex 7599 (2.0% A.I.)
Kohn et al. (1968, MRID 00024953) tested the skin irritation potential of
Durotex 7599 by placing 0.5 ml of the test compound, under occlusive wrap, onto
the skin of six New Zealand albino rabbits (unspecified sex) for 24 hours. The
primary irritation score is 4.98 out of a total possible score of R, placing
this product into toxicity category II.
Kohn et al. (1968, MRID GS044079) tested the irritating properties of a piece
of fabric containing Durotex 7599. The test material contained 1,000 ppm of
OBPA. The tost material was applied to patches of both intact and abraded skin
of six New Zealand albino rabbits (unspecified sex) under occlusive wrap for 24
hours. The test material produced no irritation, placing this product into
toxicity category IV.
2) Durotex 7603 (2.0% A.I.)
In another study performed by Kohn et al. (1968, MRID GS044033), Durotex 7603
was applied to patches of both intact and abraded skin of six ifew Zealand
albino rabbits (unspecified sex) for 24 hours. The test material is a piece of
fabric which contains 1,000 ppm of OBPA. The test material produced no
irritation, placing Durotex 7608 into toxicity category IV.
3) Vinyzene SB-1 (40 Mesh) (5.0% A.I.)
WARF (1977, MRID GS044061) administered 0.5 ml of Vinyzene SB-1 (40 mesh) to
six albino Nsw Zealand rabbits under occlusive wrap. The test material
produced a primary irritation score of 0.5 after 24 hours. The results of this
test place this material into toxicity category IV.
4) Vinyzene BP-5 (1.0% A.I.)
WARF (1975, MRID 00013632) studied the skin irritation potential of Vinyzene BP-
5 by placing 0.5 ml of the test compound, under occlusive wrap, onto the skin
46
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of six albino rabbits (unspecified sex) for 24 hours. Exposure to the test
compoind resulted in primary irritation score of 6.13 out of a total possible
soore of 8.0, placinq this product into toxicity category I.
5) Vinyzene BP-5-2 (1.0% A.I.)
WARF (1975, MRID 00013636) studied the skin irritation potential of Vinyzene BP-
5-2 by placing 0.5 ml of the test compoind, under occlusive wrap, onto the skin
of six albino rabbits (unspecified sex) for 24 hours. Exposure to the test
compoind resulted in primary irritation score of 7.0 out of a total possible
score of 3.0, placinq this product into toxicity category I.
6) Vinyzene SB-5-2-PPG (unspecified % A.I.)
In a second part of an earlier dermal toxicity study by Gordon et al. (1977,
MRID 00013652), two tew Zealand albino rabbits exposed to 1,000 or 2,000 mq/kg
of Vinyzene BP-5-2-PPG under occlusive wrap for 24 hours were graded for
primary skin irritation. The test compound produced moderate to severe edema
at both doses and moderate erythema at the high dose. The primary skin
irritation index of this product is 5.4 out of a total possible score of 8.0,
placing this product into toxicity category II.
WARF (1977, MRID 00013653) exposed six white New Zealand rabbits (unspecified
sex) to 0.5 ml of Vinyzene BP-5-2-PPG under occlusive wrap for 24 hours. The
primary irritation index of this product is 5.58 out of a total possible score
of 8.0, placing this product into toxicity category II.
7) Vinyzene SR-8/12.5D (unspecified % A.I.)
In a study performed by VftRF (1978, MRID 00013660), six New Zealand albino
rabbits (unspecified sex) were exposed to 0.5 gm of formulated SB-8/12.5D under
occlusive wrap. The test material was applied to patches of both abraded and
intact skin. The primary irritation index was 0.5 out of a total of eiqht,
placing this compound into toxicity category IV.
8) Vinyzene SB-8 (25.0% A.I.)
In a study performed by WKRF (1978, MRID 00013661), six New Zealand albino
rabbits (unspecified sex) were exposed to 0.5 gm of Vinyzene SB-8 (25*
A.I.)under occlusive wrap. The test material was applied to patches of both
abraded and intact skin. Ihe primary irritation index was zero out of a total
of eight, placing this compoind into toxicity category IV.
Jn another study performed by WARF (1978, MRID 00013663), six tew Zealand
albino rabbits (unspecified sex) were exposed to 0.5 gm of Vinyzene SB-8 (25%
A.I.) under occlusive wrap. Ihe test material was applied to patches of both
abraded and intact skin. The primary irritation index was 2.62 out of a total
of eight, placing this compound into toxicity category III.
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9) Vinyzene SB-8/25 (unspecified % A.I.)
WARF (1978, MRID 00013662) exposed six New Zealand albino rabbits (unspecified
sex) to 0.5 gm of Formulated Product SB-8/25 under occlusive wrap. The skin
had patches both abraded aid intact. The primary irritation index was 1.92 out
of a total of eight, placing this compound into toxicity category III.
10) Ftngicidal Additive (5.0% OBPA)
Hbbbs (19??, MRID GS044075) administered an undiluted fingicidal additive
containing 5% OBPA to patches of abraded and intact skin and the ear of rabbits
(unspecified sex, strain and number). The compound remained in contact with
the skin, possibly under occlusive wrap, for 15 minutes, 1, 2, 4 and 24 hours.
Effects rapidly progressed as a function of time from none at 15 minutes, to
slight to severe erythema and edema with necrosis, regardless of the initial
condition of the skin. The results of this study place the test material into
toxicity category I.
11) Bathtub Caulk (1.0% OBPA)
In another study by Hobbs (19??, MRID GS044076), Dow Coming bathtub caulking
with 1% OBPA was placed, possibly under occlusive wrap, on the intact and
abraded skin and on the ear of rabbits (unspecified sex, strain and number).
All test site demonstrated moderate erythema, edema and necrosis. The length of
exposure to the material is not mantioned in the report. The results of this
study place the test material into toxicity category II.
12) Miscellaneous
Gabriel (1970, MRID 00013603) exposed six albino rabbits (unspecified sex and
strain) to 0.5 ml of 3M Sample T-220 (NOMAD Surfacing Material, unspecified
percent A.I.) for 24 hours under occlusive wrap. The skin of the test animals
was both abraded and intact. Ho reaction to the compound was observed in this
test, placing this material into toxicity category IV.
3M Company (1970, MRID 00013601) exposed six albino rabbits (unspecified
strain) to 0.5 ml of 3M Sample T-220 (NOMAD Surfacing Material, unspecified
percent A.I.) for 8 hours per day, five days per week for three weeks. The
test material was kept in contact with both abraded and intact skin under
occlusive wrap. No reaction to the compound was observed in this test, placing
this material into toxicity category IV.
Hobbs (19??, MRID GS044025) tested the dermal irritation potential of an
experimetal bathtub caulking compound containing an fingicidal additive with 30
ppm arsenic. This compound was repeatedly placed on patches of intact end
abraded skin , possibly under occlusive wrap, and the ear of an undetermined
number of rabbits (unspecified sex and strain). Three applications of the test
material to the ear and two applications to patches of abraded and intact skin
resulted in moderate erythema and necrosis followed by formation of a scab.
The results of this study place this test material into at least toxicity
category III.
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Hobbs (19??, MRID GS044077) estimated the dermal irritability of a bathtub
caulking compound with a fingicidal additive which contained 80 ppm arsenic.
An undetermined number of rabbits (unspecified sex and strain) were exposed to
the test material, possibly under occlusive wrap. Administration of the
material resulted in a primary irritation score of 2.6 out of a possible score
of eight, placing this compound into toxicity category III.
In a study performed by Hobbs (19??, MRID GS044078) en Dow Coming 780 Building
Sealant (unspecified percent A.I.), the test mat rial was placed on patches of
intact and abraded skin, possibly under occlusive wrap, of rabbits (unspecified
sex, strain and number). The test material produced mild erythema and edema to
intact and abraded skin. The primary irritation score was 2.1 out of fl,
placing this material into toxicity category III.
13) Summary of Primary Skin Irritation of Bid-Use Products
Formulated products containing OBPA possess a broad range of dermal irritation
abilities (e.g. toxicity categories IV through I). It is, therefore, not
possible to generalize on the skin irritation potential of end-use products
because the inert ingredients in these formulations cause the individual
products to vary markedly.
f. Skin Sensitization
1) Durotex 7603 (2.0% A.I.)
Bgger and Ison (1976, MRID GS044020) tested Durotex 7603 for its ability to
sensitize skin. Durotex 7603 is a fabric containing 1,000 ppm of OBPA. 63
male and female panelists, 58 of whom completed the study, were exposed to
Durotex 7603 for 24 hours. A challenge, made 14 days after the initial
application, resulted in no reactions. The test material is not considered to
be a sensitizing agent.
2) Vinyzene BP-10 (unspecified % A.I.)
WARF (1974, MRID 00023377) tested Vinyzene BP-10 for skin sensitization
potential by subcutaneously injecting 0.1 ml of the test compound into ten
white male guinea pigs for ten consecutive days. No skin sensitization was
observed when the test animals were later challenged with 0.05 ml of the test
compound after a two week rest period.
3) Vinyzene SB-1 (5.0% A.I.)
WARF (1976, MRID 00013630) tested Vinyzene SB-1 for skin sensitization
potential by injecting 0.1 ml of the test compound subcutaneous ly into ten male
guinea pigs for ten days. The test material was diluted as a 0.01% saline
solution. After a two week rest period, the animals were challenged with a
0.05 ml dose of the test compound. No sensitizaticn to the test compound was
observed, but slight erythema was present at the test site.
49
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4) Miscellaneous
21 human infants were tested for sensitizaticn to Blue CGT 7*730-118-1 and Blue
CGT 7730-118-2 (unspecified percent A.I.) by Guillaume et al. (1966, MRID
00024946). Impregnated plastic containing the test compound was applied twice
within 24 hours to the skin of infants less than one year old during a one week
period. After a one week rest period, the test subjects were challenqed with
the same test material. There was a minor incidence of mild erythema and
slight glazing of the application site. No sensitizaticn was observed.
5) Summary of Skin Sensitizaticn of End-Use Products
Current data indicate that none of the current formulations of OBPA, which were
tested, are dermally sensitizing.
h. Subchronic Dermal Tbxicity
1) Vinyzene BP-5 (1.0% A.I.)
Cox and Stevens (1979, MRID GS044017) performed a 21 day subdnronic dermal
study using Vinyzene BP-5. Male and female New Zealand white rabbits were
dosed at 0.1, 0.5 or 1.0/0.75 gAg of body weight. Because of high mortality,
the 1.0 g/kq dose was reduced to 0.75 gAg en the llth day of this study. A
vehicle control group was dosed at 1.0 gAq of body weight. No other control
groups, using either the technical grade of the active ingredient or 0 gAq of
Vinyzene BP-5, were used in this study.
Dermal application of Vinyzene BP-5 over a 21 day period produced toxicity
typical of an arsenical (eg. ulcerative dermatitis, capillary fragmentation and
muscle degeneration). The test material and treatment conditions fplacinq
animals in stocks) caused dose related deaths, increases in adrenal weights and
decreases in body weights which are typical of stress-related reactions. A
decrease in spermatogenesis seen in the high dose group is considered to be a
stress-related effect of the test material and the testing conditions. This
study is not sufficient to determine the hazard associated with Vinyzene BP-5
because of the lack of proper control groups. While this study does not meet
the Agency's current testing requirements, a NOEL can be estimated as 0.1 gAg
of body weight for Vinyzene BP-5.
2) Vinyzene BP-10 (unspecified % A.I.)
In a second subdnronic dermal study performed with Vinyzene BP-1H, WARF (1974,
MRID 00023377) administered the test compound in distilled water to New Zealand
white rabbits as a 10% and 20% solution. Tween BO, a surfactant, was added to
the test mixture to enhance the solubility of the test compound. Except for
reduced food consumption aid body weights in the high dose female test animals,
food consumption and body weight determinations were unremarkable. Organ
weights for all test animals were unremarkable, except for the reduced size of
high dose females. The results of hematological tests performed prior to
initiating the study and at the termination of the study were unremarkable.
Gross necropsy of the animals showned compound related exfoliation, thickening
50
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and erythema of the epidermis. Histopathological examination of control and
treatedmales revealed small, atrophic, degenerated testes. The researcher
determined that the testicular effect was not compound related.
3) Summary of Subchronic Dermal Toxicity of End-Use Products
Continued dermal application produced irritation consistent with the corrosive
nature of this material, and toxicity typical of an arsenical.
B. HUMAN HA2ARD ASSESSMENT
The use of OBPA is limited to incorporation of formulated OBPA into impregnated
materials such as plastics and caulking material to protect the treated
materials from microbial attack.
Potential exposure to OBPA is limited to 1) The manufacture of technical or
formulated OBPA or OBPA treated materials and 2) the use of the treated
materials.
1. Hazard From Manufacture and Use of_ OBPA
a. Summary of Toxic Effects
1) Acute Effects
a) Manufacturing-Use OBPA
Currently available data indicate that technical OBPA is acutely toxic by the
oral and dermal routes. While not acutely toxic by the inhalation route, OBPA
possesses sufficient irritating properties which preclude prolonged human
exposure. The available data indicate that the technical material is not
dermally sensitizing. Technical OBPA is very irritating to both the eyes and
the skin. The Agency has determined that the use of goggles and gloves and the
use of "closed systems" during the manufacturing process are sufficient to
eliminate irritation from future manufacturing-use products containing this
chemical.
b) End-Use OBPA
Currently available data on formulated products containing OBPA generally
indicate these products possess a low order of acute toxicity by the oral and
dermal routes. Little information is available on the acute inhalation
toxicity of formulated products. Formulated products are generally very
irritating to the eye, are a minor skin irritant and are not dermally
sensitizing. The Agency has determined that the use of goggles and gloves and
the use of "closed systems" during the manufacturing process are sufficient to
eliminate irritation and irritation hazard from registered end-use products
containing this chemical.
51
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2) Chronic Effects
The limited data available to assess the effects of chronic exposure to CBPA
indicate that (1) this material and its metabolites are not mutagenic, (2) this
material possesses a subchronic toxicity and metabolism somewhat similar to
arsenic which also indicates a high margin of safety to the user of products
containing this chemical, and (3) that this material is not teratogenic,
fetotoxic or embryotoxic. Ns other chronic toxicity data are available.
b. Summary of Exposure
Production of CBPA technical, formulated products, and impregnated materials is
presently performed in closed systems by virtually all registrants because of
the nature of CBPA as an eye irritant. Hence, there is little to no exposure
toCBPA during the manufacturing process.
c. Hazard Assessment
Pased on the extremely low potential for exposure, no human hazard is expected
from the production and use of CBPA if goggles and gloves are used during a
"closed system" manufacturing process.
2. Hazard From Exposure ^o CBPA Treated Materials
Based on the low exposure to CBPA, leaching frcm treated materials in relation
to the levels at which acute toxic effects ware identified in formulated
products, no acute toxic effects are expected frcm exposure to currently
registered CBPA treated materials. The lack of mutagenic, teratogenic,
fetotoxic or embryotoxic effects for the formulated product indicate that such
effects are not likely frcm materials treated with CBPA. Therefore, no human
hazard is expected to result frcm the exposure to finished products treated
with CBPA.
C. SUftt'ARY OF DATA GAPS
No additional toxicology data are reouired to support the existing uses of
COPA. If new uses are proposed that might result in significant increases in
human exposure, detailed exposure data and/or chronic toxicity testing may be
required.
52
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VII. RESIDUE CHEMISTRY
A-i allowable residue level (tolerance) for specific chemicals is determined by
the Agency for the commodities en vhich they may occur. Since no 10,10'-oxybis-
lOH-phenoxarsine (OBPA) product is registered for use en food or feed crops,
its use should not result in such residues. Therefore, there are no residue
chemistry data for this chemical.
53
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VIII. ECOLOGICAL EFFECTS
A. Ecological Effects Profile
B. Ecological Effects Hazard Assessment
C. Sumnary of Data Gaps
A. ECOLOGICAL EFFECTS PROFILE
The aid-use products of OBPA are additives used primarily for preserving
fabrics and plastic materials against attack by fungi and bacteria. These
products are not associated with uses which would effect non target organisms.
Therefore, fish and wildlife toxicity data are not required to be submitted or
cited. The Agency has, however, reviewed some ecological effects data on
OBPA. The results are presented in Table 2.
B. ECOLOGICAL EFFECTS HAZARD ASSESSMENT
The above data indicate that manufacturing-use products are very highly toxic
and end-use products are only slightly less toxic to aquatic organisms. The
tested end-use product possesses a very low order of toxicity to avian
species. Despite this toxicity, the uses of this compound preclude release
into the environment. Therefore, no hazard to fish and wildlife is expected
from the existing uses of OBPA.
C. SUMMARY OF DATA GAPS
No further fish and wildlife toxicity data are required.
54
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Table 2
ECOLOGICAL EFFECTS DATA
Species
Daptmia
Grass Shrimp
Bluegill
Rainbow Trout
Sheepshead
Minnow
Bluegill
Rainbow Trout
BobvAiite
Quail
Mallard Duck
Bluegill
Test
48-hr LC5Q
96-hr LC5Q
96-hr LC5Q
96-hr LCSQ
96-hr LC5Q
96-hr LC5()
96^r LC5Q
Acute LC5Q
Acute LD50
96-hr LC50
Formula
Techn ical
99.0%
Active OBPA
Technical
95.6%
Active OBPA
Technical
95.6%
Active OBPA
Technical
95.fi%
Active OBPA
Technical
95.6%
Active OBPA
Formulation
5.0%
Active OBPA
Formulation
5.0%
Active OBPA
Formulation
5.0%
Active OBPA
Formulation
5.0%
Active OBPA
Formulation
3.0%
Active OBPA
Results Citation
4.8 ppb Browne, 1930,
MRID 00030657
50 ppb Heitrouller, 1979,
MRID 00030656
8.0 ppb Buccafusco, 1977,
MRID GS044009
3.5 ppb Buccafusco, 1977,
MRID GS044009
8.0 ppb Ifeitmuller, 1980,
MRID 00030558
1800 pom Bentley, 1976,
MRID 00013641
560 ppm Bentley, 1976,
MRID 00013641
>10,000 ppm Fink, 1976,
MRID 00013648
>10,000 mgAq Fink, 1976,
MRID 00013649
0.210 ppm Lse and Regel, 1974,
MRID GS044067
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Table 2,continued
ECOLOGICAL EFFECTS DATA
species
Test
Formula
Results
Citation
Rainbow Trout 96-hr LC
50
Bluegill
96-hr LC,
50
Rainbow Trout 96-hr LC,
50
Formulation 0.125 ppm
3.0%
Active OBPA
Formulation
2.0%
Active OBPA
Formulation
2.0%
Active OBPA
0.350 ppm
0.200 ppm
Lse and Regel, 1974,
MRID GS044067
WARF, 1973,
MRID 00013611
WARF, 1973,
MRID 00013611
56
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IX. CASE BIBLIOGRAPHY
Guide to Use of This Bibliography
A. CmrENT OF BIBLIOGRAPHY
This bibliography contains citations of all the studies reviewed by EPA in
arriving at the positions and conclusions stated elsewhere in this standard.
The bibliography is divided into two sections: (1) citations in alphabetical
order that contributed information useful to the review of the chemical and are
considered to be part of the data base supporting registration under the
standard, (2) citations in alphabetical order judged to be inadequate or not
relevant to support registration and therefore not considered part of the data
base for this standard. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor agencies in support
of past regulatory decisions, and the published technical literature.
B. UNITS OF ENTRY
The in it of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. M the case of
unpublished materials submitted to the Aqency, the Agency has sought to
identify documents at a level parallel to a published article from within the
typically larger volumes in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single subject), can stand alone
for purposes of review, and can be described with a conventional biblioqraphic
citation. The Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
C. IDENTIFICATION OF EITTRIES
The a-itries in this bibliography are sorted by author, date of the document.
and title. Each entry bears, to the left of the citation proper, an eight-
digit numeric identifier. This number is unique to the citations and should be
used at any time specific reference is required. This number is called the
"Master Record Identifier" or "MRID". It is not related to the six-^igit
"Accession Number", which has been used to identify volumes of submitted data;
see paragraph D(4)(d) below for a further explanation. In a few cases, entries
added to the bibliography late in the review may be preceded by an eight-
character temporary identifier. This is also to be used whenever a specific
reference is needed.
57
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D. FORM OF THE ENTRY
In addition to the Master Record Identifier (MRID), each entry consists of a
bibliographic citation containing standard elements followed, in the case of
materials submitted to EPA, by a description of the earliest known submission.
The bibliographic conventions used reflect the standards of the American
National Standards Institute (ANSI), expended to provide for certain special
needs. Seme explanatory notes of specific elements follow:
1. Author. Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. When no individual was
identified, the Agency has shown an identifiable laboratory or testing
facility as author. As a last resort, the Agency has shown the first
known submitter as author.
2. Document Date. When the date appears as four digits with no
question marks, the Agency took it directly from the document. When a
four-digit date is followed by a question mark, the bibliographer
deduced the date from evidence in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of
the document.
3. Title. This is the third element in the citation. In scree cases it
has been necessary for Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between
square brackets.
4. Trailing Parentheses. For studies submitted to us in the past, the
trailing parentheses include (in addition to any self-explanatory
text) the following elements describing the earliest known
submissions:
(a) Submission Date. Immediately following the word 'received'
appears the date of the earliest knovn submission, at the time
that particular document was processed into the Pesticide
Document Management System.
(b) Administrative Number. The next element, immediately following
the word 'under1, is the registration number, experimental permit
number, petition number, or other administrative number
associated with the earliest known submission, at the time that
particular document was processed into the Pesticide Document
Management System.
(c) Submitter. The third element is the submitter, following the
phrase 'submitted by'. When authorship is defaulted to the
submitter, this eleirant is omitted.
-------
(d) Volume Identification. The final element in the trailing
parenthesis identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-
digit accession number follows the symbol 'CDL', standing for
"Company Data Library". This accession number is in turn
followed by an alphabetic suffix which shows the relative
position of the study within the volume. For example, within
accession number 123456, the first study would be 123456-A; the
second, 123456-B; the 26th, 123456-Z; and the 27th,123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD ALPHABETICAL BIBLIOGRAPHY
Section I: Citations Considered to be Part of the Data Base
Supporting Reqistrations Under the Standard
MIRD CITATION
GS044002 Anspach, P.S. (1977) Acute Toxicity and Irritation Studies of
OBPA (95.6%). (Unpublished study prepared by Hill Top- Toxic-
ology Division of Hill Too Testing Services, Inc.)
00013643 Anspach, P.S. (1977) Acute Toxicity and Irritation Studies of
99.9% lO/lO'-Oxybisphenoxarsine: 76-990-21. (Unpublished study
received Feb 16, 1977 under 2829-115; proparcd by International
Bio-Research, Inc., submitted by Ventron Corp., Beverly, Mass.;
CDL.-228087-B)
GS044004
05015857
GS044007
00013641
00030657
0001364^
Babish, J.G. (1978) The Acute Demal Toxicity (LD-p) of OBPA
with Sprague-DawJey Rats. (Unpublished study prepared by
Food and Drug Research Laboratories, Inc.)
Ballantyne, B. (1978) The comparative short-term mammalian
toxicology of phenarsazine oxide and phenoxarsine oxide.
Toxicology 10(4): 341-461.
Beliles, R.P.; Makris, S.L. (1978) Teratology Study in Rats.
10-10 '-Oxybisphenoxarsine: LET Project No. 20R16. (Unpublish-
ed study prepared by Litton Bionetics, Inc. )
Bentley, R.E. (1976) Acute Toxicity of Vinyzene [sicl SB-1 to Blue-
gill (Lepomis macrochirus) and Rainbow Trout (Salmo
gairdneri ) . (Unpublished study received Feb 5, 1976 under
2829-115; prepared by EG&G, Bionomics, submitted by Ventron
Corp., Beverly, Mass".; CDL:226171-V)
Brown, A.M.; (1980) The Acute Toxicity of 10, 10 '-Oxybisphenoxarsine
to the Water Flea Daphnia Magna Straus: UCES Project Mo. 115H7-
57-02. (Unpublished study received May 29, 1980 under uaknown
admin. No.; prepared by Union Carbide Corp., submitted by
Thiokol Corp., Ventron Div. , Dnnvers, Mass., CDL:242904-D)
Rrusick, D.; Weir, R.J. (1976) Mutagenicity Evaluation of 10,10'-
Oxybisphenoxarsine (Technical): Final Report: LBI Project
No. 2547. (Unpublished study received Jul 15, 1976 under 2829-
115; prepared by Litton Bionetics, Inc., submitted by Ventron
Corp., Beverly, Mass.; CDL: 22809 1-A)
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MRID CITATION
00013644 Brusick, D.J.; Weir, R.J. (1976) Mouse Lymphoma Mutagenicity Eval-
uation of 10,10'-0xybisphenoxarsine: Final Report: LBI Project
No. 2548. (Unpublished study received Nov 9, 1976 under 2829-
115; prepared by Litton Bionetics, Inc., submitted by Ventron
Corp., Beverly, Mass.; CDL:228088-A)
GS044009 Buccafusco, R.J. (1977) Acute Toxicity of OBPA to Bluegill and
Rainbow Trout. (Unpublished study prepared by EG and G
Bionomics)
GS044011 Cadmus, E.L. (1973a) Extractability of Vinyzene BP-5, Laboratory
Report submitted by Ventron Corporation, Beverly, f1A, Mar 30.
GS044012 Cadmus, E.L. (1973b) Extractability of Vinyzene BP-10 from Light-
gauge Plasticized Vinyl Film used as Baby Pants' Material,
Laboratory Report submitted by Ventron Corporation, Beverly,
MA, Oct 1.
GS044017 Cox, G.E.; Stevens, K.R. (1979) Dermal and Systemic Toxicity
Study of Vinyzene BP-5 Following Repetitive Dermal Application
over a 21-Day Period to the Intact and Abraded Skin of New
Zealand Albino Rabbits. Report No. 5801 of Food and Drug
Research Lab, Inc., Jan 5.
00024935 Dow Chemical Company (1964) Toxicological Properties of 10,10'-
Oxybisphenoxarsine. (Unpublished study received Nov 2, 1964
under unknown admin. No.; submitted by ?; CDL:121914-A)
00026094 Dow Chemical Company, U.S.A. (1965) Chemical and Physical
Properties of Dow Fungicide SA-546. (Unpublished study received
Feb 17, 1965 under unknown admin. No.; CDL:119577-A)
GS044020
00013649
Egger, D.; Ison, A. (1976) Reported Insult Pafh Test of Two
Fabric Samples. (Unpublished study received ? under an un-
known admin, no.; prepared by Hill Top Research, Div. of Hill
Top Testing Services, Inc.)
Fink, R. (1976) Final Report: Acute Oral LD5Q—Mallard Duck:
Project No. 121-107. (Unpublished study received on uaknown
date under 2829-115; prepared by Truslow Farms, Inc. in coopera-
tion with Maryland, Dept. of Agriculture, Div. of Inspection and
Regulation, submitted by Ventron Corp., Beverly, Mass.; CDL:
228092-B)
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MRID CITATION
00013648 Fink, R. (1976) Final Report: Eight-Day Dietary LC5n~Bobwhite
Quail: Project No. 121-105. (Unpublished study received on un-
known date under 2829-115; prepared by Truslow Farms, Inc. in
cooperation with Maryland, Dept. of Agriculture, Div. of Inspec-
tion and Regulation, submitted by Ventron Corp., Beverly, Mass.;
CDL:228092-A)
00024936 Frantz, G.C.; Shrader, S.A. (1959) Results of a 35-day Dietary Feed-
ing Study of 10,10'-0xybisphenoxarsine to Rats. (Unpublished
study received Nov 2, 1964 under unknown admin. Mo.; prepared
by Dow Chemical Co. in cooperation with Biochemical Research
Laboratory, submitted by ?; CDL:121914-B)
00013603 Gabriel, K.L. (1970) Primary Skin Irritation Study. (Unpublished
study received Nov 15, 1971 under 10350-3; prepared by Bio-
search, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:
230572-D)
00013652 Gordon, E.B.; Rene, A.A.; Weir, R.J. (1977) Final Report: Acute
Dermal Toxicity Study in Rabbits: LBI Project No. 2773. (Unpub-
lished study received Jun 12, 1977 under 2829-96; prepared by
Litton Bionetics, Inc., submitted by Ventron Corp., Beverly,
Mass.; CDL:230703-B)
00013651 Gordon, E.B.; Rene, A.A.; Weir, R.J. (1977) Final Report: Acute
Oral Toxicity in Rats: LBI Project >D. 2772. (Unpublished study
received Jun 12, 1977 under 2329-96; prepared by Litton Bio-
netics, Inc., submitted by Ventron Corp., Beverly, Mass.; CDL:
230703-A)
00024946 Guillaume, R.O.; Elsea, J.R.; Ede, M. (1966) Patch Test of Films
Blue CGT Production, 7730-11B-2, and 7730-118 I in Infants:
Q-316. (Unpublished study received Sep 15, 1969 under 8730-1;
prepared by Hill Top Research, Inc., submitted by Herculite
Products, Inc., New York, N.Y.; CDL:100580-A)
GS044023 Hamilton, N.F. (1978) Laboratory Report Evaluating the Diffusive
Properties of Mew Biocides ATV-129, C-10545, and RH-893 in
Three Polymer Systems Compart to OBPA. Test 78-49 Part 1.
(Unpublished study received ? under an unknown admin, no.;
prepared by Ventron Corp., Beverley, MA)
GS044024 Hamilton, N.F. (1978) Efficacy Study of PVC Films Containig <"IRPA:
Test 78-49 Part IB. (Unpublished study received ? under an
unknown admin, no.; prepared by Ventron Corp., Revorley, MA)
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MRID CITATION
00030656 Heitmuller, T. (1979) Acute Toxicity of 10,10'-Oxybisphenoxarsine
(OBPA) to Grass Shrimp (Palaemonetesougro): Report No. RP-79-U-
167. (Unpublished study received May 29, 1980 under unknown
admin. No.; prepared by EG&G, Bionomics, submitted by Thiokol
Corp., Ventron Div., Danvers, Mass.; CDL:242904-A)
00030658 Heitmuller, T. (1980) Acute Toxicity of OBPA (10,10'-
Oxybisphenoxarsine) to Sheepshead Minnows (Cyprinodon
variegatus); Report No. BP-80-2-30. (Unpublished study
received May 29, 1980 under unknown admin. No.; prepared by
EG&G, Bionomics, submitted by Thiokol Corp., Vontron Div.,
Danvers, Mass.; CDL:242904-E)
GS044025 Hobbs, E. (1977) Acute Toxicoloqic Properties of EXP Bathtub
Caulk. (Unpublished study received ? under an3 uaknown admin.
no.; prepared by Dow Corning Corp.)
GS044075 Hobbs, E. (19??) Acute Toxicological Properties and Industrial
Handling Hazards of Dm* Corninq® Funqicidal Additive. (Unpub-
lished study received ? under an unknown admin, no.; prepared by
Da* Corning Corp.)
GS044076 Hobbs, E. (19??) Acute Toxicoloqical Properties and Industrial
Hazards of Experimental Dow Corning^ Fungicidal Additive, an
Anti-Microbial Agent. (Unpublished study received ' under an
unknown admin, no.; prepared by Dow Corning Corp.)
GS044077 Hobbs, E. (19??) Acute Toxicological Studies with Regard to the FHSA
on a Potential Consumer Sealant, Dow Corning*3 Bathtub Caulk
Containing Dow Corning® Funqicidal Additive. (Unpublished study
received ? under an unknown admin, no.; prepared by Dow Corninq
Corp.)
CS044078 Hobbs, E. (19??) Acute Toxicoloqical Studies with Regard to the FHSA
on Experimental Buildinq Sealant with Arsenic Fungicide. (Unpub-
lished study received ? under an unknown admin, no.; prepared by
Dow Corning Corp.)
00013591 International Paint Company (1957?) Report on the ComDarative "ox-
icology of Phenarsazine oxide and Phenoxarsine oxi^e with Addi-
tional Data for the Inhalation Toxicity of DM. (Unpublished
study received Sep 8, 1970 under 2693-21; CDL:105318-A)
GS044030 Kirkpatrick, D. (1977a) Laboratory report on Silicone Sealant,
sample no. D805-3082. (Unpublished report recoi"ed ? under in
unkown admin. No.; prepared by the Consumer Protection Safety
Commission; submitted by ?)
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MRID CITATION
GS044031 Kirkpatrick, D. (1977b) Laboratory report on Silicone Sealant,
sample no. D805-3083. (Unpublished report received •* under an
unkown admin. Mo.; prepared by the Consumer Protection Safety
Commission; submitted by ?)
GS044033' Kohn, F.E.; Kay, D.L.; Stahoviak, E.F. (1968) Skin Irritation
Study on Treated Fabric (Durotex 7603). (Unpublished study
received ? under an unknown admin. No.; submitted by ?}
GS044(P9 Kohn, F.E.; Kay, D.L.: Stahoviak, E.F. (1968) Skin Irritation Study
on Treated Fabric (Durotex 7599). (Unpublished study received '
under an unknown admin. No.; prepared by Lifestream Laboratories;
submitted by Ventron Corp., Beverly, Mass.)
00024953 Kohn, F.E.; Kay, D.L.; Vega, S.M.; (1968) Acute Toxicity
Studies on Durotex #7599. Sunmary of studies 025525-E throuqh
025525-H. (Unpublished study received Mar 6, 1968 under 2829-
89; preoared by Lifestream Laboratories, Inc.; submitted by
Thiokol Corp., Ventron Div., Danvers, Mass.; CDL:025525-G)
00024956 Kohn, F.E.; Kay, D.L.; Vega, S.M.; (1968) Eye Irritation
Study—Albino Rabbits. (Unpublished study received Mar 6, 19P8
under 2829-89; prepared by Lifestream Laboratories, Inc.;
submitted by Thiokol Corp., Ventron Div., Danvors, Mass.;
CDL:025525-G)
GS044034 Kuqler, D.J. (1974) Arsenic Survey at Ventron Corp.
GS044067 Lee, T. and Reqel, L. (1974) Fish Toxicity. Testing Report of V7ARF
Institute, Mo. 3121308.
GS044035 Leong, B.H.J. (1969) Result of a Respiratory Function Study and a
Limited Histoloqical Examination of Rats Exposed to OBPA.
(Unpublished study received ? under an unknown admin. Mo.;
prepared by Biochemical Research Laboratory, Dow Chemical Co.,
submitted by ?)
GS044039 Litton Bionetics, Incorporated (1978b) Acute Dermal Toxicity
Study in Rats- 10-10'-oxybisphenoxarsine Final Report. Project
No. 20936. (Unpublished study received ? under an unknown
admin. No., submitted by Ventron Corp., Beverley, MA)
GS044041 Major Appliance Lab (1975) Physical Sciences Lab Report No. Ca-
75-130 of Apr 1, 1971 to Howard Lester (Lester, Schwab, Katz,
and Dwyer) on Darnell Case.
-------
MRID CITATION
GS044042 McCollister, S.B.; Sparschu, G.L.; Spencer, H.C. (1969) Results
of 92-Day Dietary Feeding Studies on OBPA in Rats. (Unpublish
ed study received ? under an unknown admin. No.; prepared by
Biochemical Research Laboratory, Dow Chemical Co., submittod
by ?)
00024941 Olson, K.J. (1959) Acute Oral Toxicity. (Unpublished study
received Nbv 2, 1964 under unknown admin. No.; prepared by Bio-
chemical Research Laboratory, submitted by ?; CDL:i21914-H)
00024938 Olson, K.J. (1959) Eye Contact Test. (Unpublished study received
Nov 2, 1964 under unknown admin. No.;, prepared by Biochemical
Research Laboratory, submitted by ?; CDL:121914-D)
00024937 Olson, K.J. (1959) Skin Contact—Irritation. (Unpublished study
received Nov 2, 1964 under unknown admin. No.; prepared by
Biochemical Research Laboratory, submitted by ?; CDL:121914-C)
00026092 Olson, K.J.; Nunemaker, R.B.; Shrader, S.Al; et al. (1959) Skin
Contact Absorption.. (Unpublished study received Nov 2, 1964
under unknown admin. No.; prepared by Biochemical Research
Laboratory in cooperation with Dow Chemical Co., submitted by ?;
CDL:121914-F)
00024940 Oxen, F. (1959) Summary of Pathology on Male & Female Rats Fed 10,
lO'-Oxybisphenoxarsine in the Diet for 30 days. (Unpublished
study received Sep 2, 1965 under unknown admin . No.; submitted
by ?; CDL:121914-G)
GS044048 Porter, W.K. (1973) U.S. Consumer Product Safety Commission's
Analyst Worksheet on G.E. Silicons sealer white, Nov 11.
00023386 Powers, M.B. (1968) Acute Oral Toxicity—Rats: Final Report:
Project No. 349-163. (Unpublished study received Feb 22, 1974
under 2829-105; prepared by Hazelton Laboratories, Inc.;
submitted by Thiokol Corp., Ventron Div., Danvers, Mass.;
CDL:025537-F)
GS044068 Skinner and Sherman, Inc. (1968) Technical Report: Vapor Presure.
Ventron Chemicals Division. Case No. 9837.
GS044055 United States Department of Health, Education, and Welfare (1962)
Public Health Service Drinking Water Standards, 1962. Public
Health Service Publication No. 956, Washington, DC, U.S. Gov-
ernment Printing Office.
-------
MRID CITATION
GS044070 United States Environmental Protection Agency (EPA) (1979) Removal
of OBPA from Rebuttable Presumption Against Registration.
Decision Document prepared by Herman Gibb, Project Manager.
00013622 Ventron Corporation (1975) Analytical Laboratory Report: Stability
Data for OBPA and Solid Biocides Containing OBPA. (Unpublished
study received Mar 22, 1976 under 2829-115; CDL:226170-A)
00013625 Ventron Corporation (1976) Process: Description of Manufacturing
Process. (Unpublished study received Mar 22, 1976 under
2829-115; CDL:226170-D)
GS044056 Ventron Corporation (1978) Extraction of 10,10'-
Oxybisphenoxarsine from Plasticized Vinyl Films.
GS044069 Ventron Corporation (1981) pH of Technical ORPA.
05016437 Wade, R.C., inventor; Ventron Corp., assignee (1972) Method for
preparing 10-chlorophenoxarsine. U.S. patent 3,701,794. Oct
31. 2 p. Int. Cl. C 07d 105/06; U.S. Cl. 260-440.
00013631 WARF Institute, Incorporated (1971) Report: WARF Mo. 1030508.
(Unpublished study received Feb 5, 1976 under 2829-115; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:226l7l-H)
00013611 WARF Institute, Incorporated (1973) Report: WARF No. 3031960.
(Unpublished study received May 31, 1973 under 2829-96; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:006984-D)
00013610 WARF Institute, Incorporated (1973) Report: WARF Mo. 3031«60.
(Unpublished study received May 31, 1973 under 2829-96; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:006984-C)
00023384 WARF Institute, Incorporated (1974) Report: WARF No. 3121308.
(Unpublished study received Feb 22, 1974 under 2829-105;
submitted by Thiokol Corp., Ventron Div., Danvers, Mass.;
• CDL:025537-D)
00023377 WARF Institute, Incorporated (1974) Report: WARF No. 4041382.
(Unpublished study received Jun 14, 1974 under 2829-93; sub-
mitted by Thiokol Corp., Vontron Div., Danvers, Mass.;
CDL:221989-A)
00013632 WARF Institute, Incorporated (1975) Report: WARF No. 5062466.
(Unpublished study received Feb 5, 1976 under 2829-115; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:2261'71-I)
-------
MRID
CITATION
00013636 WARF Institute, Incorporated (1975) Report: WARF No. 5062467.
(Unpublished study received Feb 5, 1976 under 2829-115; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:226171-N)
00013629
00013630
GS044057
00013653
GS044060
GS044061
00013661
00013662
00013663
00013660
WARF Institute, Incorporated (1975) Report: WARF Ho. 5103842. (Un-
published study received Feb 5, 1976 under 2829-115; submitted
by Ventron Corp., Beverly, M.'GS.; CDL:226171-F)
WARF Institute, Incorporated (1976) Report: WARF No. 5121270. (Un-
published study ^-eceived Feb 5, 1976 under 2829-115; submitted
by Ventron Corp., Beverly, Mass.; CDL:226171-C)
WARF Institute, Incorporated (1976a) Report: WARF No. 6013715,
Acute Oral LD,- and Acute Dermal LDe/Durotex 7603.
,-g
eg
WARF Institute, Incorporated (1977) Report: WARF Institute
No. 7033536. (Unpublished study received Jun 12, 1977 under
2829-96; submitted by Ventron Corp., Beverly, Mass.; CDL:
230703-C)
WARF Institute, Incorporated (1977b) Report: WARF No. 6112742,
Acute Oral LD5Q, Vinyzene SB-1.
WARF Institute, Incorporated (1977c) Report: WARF No. 6112742,
Skin Irritation, Vinyzene SB-1.
WARF Institute, Incorporated (1978) Report: WARF Institute
No. 7116139. (Unpublished study received Jan 27, 1978 under
2829-117; submitted by Ventron Corp., Beverly, Mass.; CDL:
232999-B)
WARF Institute, Incorporated (1978) Report: WARF Institute
No. 7117217. (Unpublished study received Jan 27, 1978 under
2829-117; submitted by Ventron Corp., Beverly, Mass.; CDL:
232999-C)
WARF Institute, Incornorated (1978) Report: WARF Institute
No. 7117218. (Unpublished study received Jan 27, 197R under
2829-117; submitted by Ventron Corp., Beverly, Mass.; CDL:
232999-D)
WARF Institute, Incorporated (1978) Report: WARF Institute
No. 7117219. (Unpublished study received Jan 27, 1978 under
2829-117; submitted by Ventron Corp., Beverly, Mass.; CDL:
232999-A)
-------
MRID CITATION
GS044062 Weingast, J. (1976) Arsenic Survey at Ventron Corp.
GS044066 Yeager, C.C. (1976) Physical Properties of OBPA. (Unpublished study
submitted by Ventron Corporation)
00013601 3M Company (1970) Summary: Toxicological Data. Summary of studies
230572-C through 230572-F. (Unpublished study received Nov 15,
1971 under 10350-3; CDL:230572-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD ALPHABETICAL BIBLIOGRAPHY
Section 2: Citations Considered Not Part of the Data Base
Supporting Registration Under the Standard
MIRD CITATION
05018655 Akagane, K.; Allan, G.G. (1973) Choki boosei no keakyu.
(Dai-5-po). Tashu no dokubutsu yorinaru A/F kobunshishu no
kassei dokubutsu-kan no sogo sayo. [Studies on long term
protection. V. Mutual interactions of active toxicants in
antifouling polymers consisting of mu Iticomponent toxicants.!
Shikizai Kyokaishi. [Journal of the Japan Society of Color
Materials.! 46(8):437-442.
05018510 Akagane, K.; Matsuura, K. (1972) [Long-term protection. I.
Effects of toxic polymers on long-term protection.! Shikizai
Kyokaishi. [Journal of the Japan Society of Color Materials.!
45(2):69-74.
05015858 Alarie, Y.; Lin, C.K.; Geary, D.L. (1974) Sensory irritation
evoked by plastic decomposition products. American Industrial
Hygiene Association Journal 35(10):654-661.
GS044080 Aldous, K.M. (1977) Analysis of Silicone Cauking Compounds for
Arsenic Content. (Unpublished study prepared by the N.Y.
State Department of Health)
GS044001 Anspach, P.S. (1977) Acute Toxicity and Irritation Studies of 99.9%
lOjlO'-Oxybisphenoxarsine. (Unpublished study prepared by
International Bio-Research, Inc., Cincinnati, OH, Feb. ])
GS044003 Aldous, K.M. (1977) Analysis of Silicone Caukinq Compounds for
Arsenic Content. (Unpublished study prepared by the N.Y.
State Department of Health)
GS044005 Bailey, E.M.; Zimgaro, R.A. (1978) Toxicologic and Mutagenic
Properties of OBPA and its Formulations.
GSO44006 Biesemeier, J.A. (1975) Vinyzene SB-1: Acute Oral LD5n; Acute
Dermal LDc-. Testing report of W\RF Institute, Inc.,
Madison, wl, Nov 19.
GS044008 Biochemical Research Laboratory, Dow Chemical Company (1960)
Results of a 35-Day Dietary Feeding Study of OBPA to Rats.
05017159 Brown, F.L.; Gcoch, R.M. (1968) 10,10'-Oxybisphenoxarsine—a
candidate wood preservative. Wood Science l(l):41-46
-------
MRID
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Cadmus, E.L. (19??) The Biological Stability of Polymers. (Unpub-
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Cadmus, E.L. (1972) Laboratory Report: Extractability of Vinyzene
BP-10: Test No. 12269. (Unpublished study received Jan 23, 1973
under 2829-93; submitted by Ventron Corp., Beverly, Mass.; CDL:
240463-A)
Cadmus, E.L. (1973) Laboratory Report: Extractability of Vinyzene
BP-5 and Vinyzene BP-10 from Light-Gauge Plasticized Vinyl Film
Used as Baby Pants Material: Test No.: 12690-1. (Unpublished
study received Oct 9, 1973 under 2829-82; submitted by Ventron
Corp., Beverly, Mass.; CDL:101720-A)
Cadmus, E.L. (1973) Laboratory Report: Extractability of Vinyzene
BP-5: Test No: 12424. (Unpublished study received Apr 5, 1973
under 2829-82; submitted by Ventron Corp., Beverly, Mass.; CDL:
101719-A)
Cadmus, E.L. (1974) Laboratory Report: Test No. 12864. (Unpub-
lished study including supplementary report, received Apr 24,
1974 under 2829-110; submitted by Ventron Corp., Beverly, Mass.;
CDL:025538-A)
Cadmus, E.L. (1974) Laboratory Report: Test No. 12952. (Unpub-
lished study received Apr 24, 1974 under 2829-109; submitted by
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Cadmus, E.L.. (1974) Laboratory Report: Test No. 13325. (Unpub-
lished study received Nov 15, 1974 under 2829-105; submitted by
Ventron Corp., Beverly, Mass.; CDL:n09750-A)
Cadmus, E.L. (1975) Laboratory Report: Test Mo. 13325-11. (Unpub-
lished study received Feb 19, 1975 under 2829-105; submitted by
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Cadmus, E.L. (1976) Laboratory Report: Test No. 14113. (Unpub-
lished study including test nos. 13843 and 13995, received Feb
13, 1976 under 2829-115; submitted by Ventron Corp., Beverly,
Mass.; CDL:228093-A)
-------
MRID
05017990
GS044013
00013592
00014468
GS044014
CITATION
Chadaeva, N.A.; Kami, G.K.; Mamakov, K.A. (1966)
Serusoderzhashchie organicheskie soedineniya mysh'yaka: III.
Sintez i svoistva nekotorykh tioefirov
5,10-diqidrofenarsazinistoi kisloty. fSulfur-containing
organic compounds of arsenic: III. Synthesis and properties of
some thioesters of 5,10-dinydrophenarsazinous acid.l Zhurnal
Obshchei Khimii. [Journal of General Chemistry.1
XXXVI(5):916-920.
Chitlik, L.D. (1979) Memo sent to Herman Gibb (FPA) dated Feh 5,
1979. [Rabbit 21-day dermal toxicity study on Vinyzene BP-5
for RPAR review on 10,10'-oxybisphenoxarsine (OBPA)l
Coberly, R.D. (1970) 10,10'-Oxybisphenarsazine or Phennrsazine
oxide. (Unpublished study received Nov 3, 1970 under 2693-21;
submitted by International Paint Co., Union, N.J.; CDL:105339-A)
Coleman, W.; Yeager, C.C. (1968) [Testing Procedure for Pink
Staining in Polyvinyl chloridel. (Unpublished study including
test nos. 6468, 6468-1, 9610 and 22168, received Jun 6-, 1968
under 2829-10; submitted by Ventron Corp., Beverly, Mass.; CDL:
025526-A)
Coon, F.B. (1976a) Vinyzene SB-1: Acute Oral LD_Q (1 level);
Acute Dermal LD_0 (1 level); Skin Sensitization. Test
report of WARF institute. Inc., Madison, WI, Jan 26.
GS044015 Coon, F.B. (1976b) Durotex: Acute Oral LD5Q and Acute Dermal
LD . Test report of WARF Institute, Inc., Madison, WI,
Mar 11.
GS044016 Coon, F.B. (1976c) Vinyzene SB-1: Acute Derma] LD5f). Test
report of WARF Institute, Inc., Madison, WI, Dec 22.
GS044018 Day, H.R. (1979) Memo sent to Herman Gibb (EPA) dated Jan 18,1979
[Determination of OBPA (10-10'-oxybisphenoxarsine) in dish-
washer water!
GS044019 Demko, P.R. (1978) Analysis of Diffusion Study Films for Polymer
Bound OBPA. (Unpublished study prepared by Ventron Corpora-
tion, Beverley, MA.)
00013639 DiBenedetto, J.L. (1975) Laboratory Report: Test Mo. 13P90 Part 1.
(Unpublished study received Feb 5, 19^6 under 2829-115; sub-
mitted by Ventron Corp., Beverly, Mass.; CDL:226171-S)
-------
MRID CITATION
00013599 Dow Chemical U.S.A. (19??) [Dow Fungicide SA-546]. (Unpublished
study received Nov 12, 1965 under 464-346; CDL:107339-A)
00007407 Dow Chemical U.S.A. (1968) Wood Preservation—1968 Field Test.
(Unpublished study received Apr 1, 1970 under 464-79; CDL:
008926-B)
05016438 Dunbar, J;E., inventor; Dow Chemical Co., assiqnee (197-1)
Phenoxarsinyl ethers of polymeric polyhydroxy compounds and
preparation. U.S. patent 3,624,062. Nov 30. 4 p. Int. Cl. C
08f 3/34; U.S. Cl. 260/91.3 VA.
05015866 Earley, R.A.; Gallagher, H.J. (1970) Mass spectra of
5,10-dihydrophenarsazines, 5,10-dihydrophenarsazine and
phenophosphazine oxides, and related heterocycles. Organic
Mass Spectrometry 3(10):1287-1291.
05015867 Earley, R.A.; Gallagher, M.J. (1970) The mass spectra of
5,10-dihydro-5-10-o-benzenophenarsazine (azarsatriptycene) and
its oxide. Organic Mass Spectrometry 3(10):1283-1286.
GS044020 Egger, D.; Ison, A. (1976) Reported Insult Patch Test of Two
Fabric Samples. (Unpublished study received ? under an un-
known admin, no.; prepared by Hill Top Research, Div. of Hill
Top Testing Services, Inc.)
GS044021 EG&G Bionomics Aquatic Toxicology Laboratory (1977) Acute Tox-
icity of OBPA to Bluegill and Rainbow Trout. (Unpublished
study received ? under an unknown admin, no.; submitted by ?)
00013596 Exxon Chemical Company U.S.A. (1969) Effectiveness: fOBPAl. (Un-
published study received Oct 7, 1969 under unknown admin, no.;
CDL:127660-A)
GS044022 Food and Drug Research Laboratories, Incorporated (1979) Dermal K
Systemic Toxicity Study of Vinyzene BP-5. (Unpublished study
received January 19, 1979 under an unknown admin, no.; submit-
ted by Ventron Corp., Beverley, MA)
05015865 Freedman, L.D.; Styles, V.L. (1975) Some observations on the
interaction of diaryJamines and arsenic trichloride. Journal
of Organic Chemistry 40(18):2684-2686.
00013602 Gabriel, K.L. (1970) Repeated Dermal Irritation Study. (Unpub-
lished study received Nov 15, 1971 under 10350-3; prepared by
Biosearch, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:
230572-C)
-------
MRID
05017989
05017987
05017988
00013638
00013654
00013595
00013594
00013598
CITATIOH
Gavrilov, V.I.; Batina, L.A.; Chernokal'skii, B.D.; Kamai, G.K.
(1971) Vzaimodeistvie okisei tretichnykh arsinov ryada
digidrofenarsazina s kislotami. [Reactions of tertiary arsine
oxides of the 5,10-^ihydrophenarsazine series with acids. 1
Zhurnal Obshchei Khimii. fJourna] of General Chemistry.!
41(3): 564-567.
Gavrilov, V.I.; Gavrilova, G.R.; Chernokal'skii, B.D.
Sintez nekotorykh okisei 10-alkil(ari1 )fenoksarsinov i iz
adduktov s kislotami. [Synthesis of some 10-alky]- and
10-aryl-phenoxarsine 10-oxides and their adducts with acids. 1
Zhurnal Obshchei Khimii. [Journal of General Chemistry. 1
46(1): 72-75.
Gavrilov, V.I.; Khlebnikov, V.N.; Gavrilova, G.R.; Chernokal'skii,
B.D. (1972) Sintez 10-alkylfenoksarsinov. [Synthesis of
10-alkylphenoxarsines.l Zhurnal nbshchei Khimii. [Journal of
General Chemistry.] 42(9): 1963-1966.
Guillaume, R.O.; Elsea, J.R.; Ede, M. (1966) Patch Test of Films
Blue CGT Production, 7730-118-2, and 7730-118-1 in Infants:
0-316. (Unpublished study received Feb 5, 1976 under 2329-115;
prepared by Hill Top Research, Inc. for Scientific Chemicals,
Inc., submitted by Ventron Corp., Beverly, Mass.; CDL:226171-R)
Hamilton, M.F.; Moy, F.S.; Cadmus, E.L. (1977) Laboratory Report:
Test Mo. 77-218. (Unpublished study received Jun 21, 1977 under
2829-96; submitted by Ventron Corp., Beverly, Mass.; CDL:
230704-A)
Hanus, J.G. (1973) Report of Plant Biology Laboratory, Corvallis,
Oregon: ID 101027. (Unpublished study received on unknown date
under 2693-35; submitted by International Paint Co., Union,
N.J.; CDL:025385-B)
Hanus, J.G. (1973) Report of Plant Biology Laboratory, Corvallis,
Oregon: ID 101161. (Unpublished study received on unknown date
under 2693-35; submitted by International Paint Co., Union,
N.J.; CDL.-025385-A)
Herculite Protective Fabrics Corporation (19??) Confidential Formu-
la. (Unpublished study received Oct 30, 1967 under 8730-1;
CDL:107336-A)
-------
MRID CITATION
05015864 Holliday, R.J.; Broach, R.W.; Handy, L.B.; Cordes, A.W.; Thomas,
L. (1972) The molecular structure of an adduct of
10-phenoxarsine chloride: C19H0OAsC10SbClc. Inorqanic
Chemistry 11(8):1849-1851. 1Z H 5
05014120 Hcogeveeri, A.P.J. (1940) The detection of .small quantities of war
gases (Dijkstra's method). Chemistry and Industry
1940:550-556.
GS044026 Hoover, M.F. (1978a) Letter sent to Richard Mountfort dated Jan
26, 1978 [Vinyzene BP-5 and alternate formulae (EPA reg. no.
2829-82), Vinyzene BP-5-2 and alternate formulae (EPA reg. no.
2829-96), Vinyzene BP-5-DOP (EPA reg. no. 2829-104), and
Vinyzene BP-5-DIDP (EPA reg. no. 2829-102) request for amended
labeling]
GS044027 Hoover, M.F. (1978b) Letter sent to John Lee dated Jan 26, 1978
[Vinyzene SB-1 (EPA reg. no. 2829-115) request for amended
labeling]
00013590 Industrial Bio-Test Laboratories, Incorporated (19??) Report to
Scientific Chemicals Inc.: Human Repeated Insult Patch Test on
Two Vinyl Films (Control Vinyl Film and Film Containing Vinyzene
BP-5). (Unpublished study received on unknown date under un-
known admin, no.; submitted by Scientific Chemicals, Inc., Chi-
cago, 111.; CDL:107342-E)
GS044028 Industrial Bio-Test Laboratories, Incorporated (1976) <>0-Day
Subacute Oral Toxicity with Vinyzene SB-1 in Albino Rats:
IBT No. 8560-08838. (Unpublished report received ? under an
unknown admin, no.; submitted by Ventron Corp., Beverley, MA)
00013607 Johnson, G.D. (1970) Water Extractable Vinyzene BP-5 in Polyvinyl
chloride Matting (Nomad): Report No. 5465. (Unpublished study
including letter dated Hov 10, 1971 from G.L. Olson to R.F.
Heine, received Nov 15, 1971 under 10350-3; submitted by 3M Co.,
St. Paul, Minn.; CDL:230572-H)
GS044029 Johnson, C.D.; McMurray, P.A. (1978) Acute Dermal Toxicity Study
in Rats- 10-10'-Oxyvisphenoxarsine: LBI Project Ho. 20936.
(Unpublished study received ? under an unknown' admin, no.
prepared by Litton Bionetics, Inc.; submitted by ?)
i* r
05016440 Josephs, M.J.; Hardy, J.L., inventors; Dow Chenical Co., assignee
(1962) Methods for the control of the growth of plants and
plant parts. U.S. patent 3,069,252. Dec 18. 6 p. U.S. Cl.
71-2.5.
-------
MRID CITATION
05017986 Kami, G.K.; Gavrilov, V.I.; Chemokal'skii, B.D. (1972)
Osnovnost1 okisei para-zameshchennykh
10-aril-5,in-difidrofenarsazinov. [Basicities of
10-(p-X-pheny1)-5,10-dihydrophenarsazine 10-oxides.l Zhurnal
Obshchei Khimii. [Journal of General Chemistry.]
42(7):1530-1534.
00249039 Kary, T. (1964) Single Vapor Exposure Record. (Unpublished study
received Nov 2, 1964 under unknown admin. Mo.; prepared by Rio-
chemical Research Laboratory, submitted by ?; CDL:121914-E)
00013606 Kaye, S.; Shapiro, R.L.; Yeager, C.C. (1970) Summary of Microbio-
logical Reports. (Unpublished study including test nos. 10871,
11085, 11174..., received Nov 15, 1971 under 10350-3; prepared
by Ventron Corp. in cooperation with WARF Institute, Inc. and
Hudson Laboratories, Inc., submitted by 3M Co., St. Paul, 'linn.;
CDL:230572-G)
00023383 Kaye, S. (1970) Laboratory Report: Test No. 11039. '(Unpublished
study received Feb 22, 1974 under 2829-105; submitted by Thiokol
Corp., Ventron Div., Danvers, Mass.; CDL:025537-C)
00023382 Kaye, S. (1940) Laboratory Report: Test No. 11040. (Unpublished
study received Fob 22, 1974 under 2829-105; submitted by Thiokol
Corp., Ventron Div., Danvers, Mass.; CDL:025537-B)
00013637 Kohn, F.E. (1965) Report to Scientific Chemicals Incorporated:
Determination of Arsenic in Vinyl Film Extracts. (Unpublished
study received Feb 5, 1976 under 2829-115; prepared by Industri-
al Bio-Test Laboratories, Inc.; submitted by Ventron Corn.,
Beverly, Mass.; CDL:226171-Q)
00013633 Kohn, F.E. (1965) Report to Scientific Chemicals, Inc.: A Study of
the Extractability of Vinyzene BP-5 from Vinyl Film into Simu-
lated Human Sudor and Sebum. (Unpublished study received Feb 5,
1976 under 2829-115; prepared by Industrial Rio-Test Labora-
tories, Inc., submitted hy Ventron Corp., Beverly, Mass.; CDL:
226171-J)
GS044032 Kohn, F.E. (1968) Report to Scientific Chemicals, Incorporated:
Acute Toxicity Studies on Durotex «7599. (Unpublished study
received ? under an unknown admin. Mo.; prepared by Lifestream
Laboratories, Inc., submitted by ?)
-------
MRID
CITATION
00024955
00024924
00024957
00023380
GS044036
GS044037
GS044038
GSO44040
00013624
Kohn, F.E.; Kay, D.L.; Vega, S.M.; (1968) Acute Dermal
Toxicity—Albino Rabbits. (Unpublished study received Mar 6,
1968 under 2829-89; prepared by Lifestream Laboratories, Inc.,
submitted by Thiokol Corp., Ventron Div., Danvers, Mass.;
CDL:025525-F)
Kohn, F.E.; Kay, D.L.; Veqa, S.M.; (1968) Procedures and
Results. (Unpublished study received Mar 6, 1968 under 2829-89;
prepared by Lifestream Laboratories, Inc.; submitted by Thiokol
Corp., Ventron Div., Danvers, Mass.; CDL:025525-E)
Kohn, F.E.; Kay, D.L.; Vega, S.M.; (1968) Skin Irritation
Study—Albino Rabits. (Unpublished study received Mar 6, 1968
under 2829-89; prepared by Lifestream Laboratories, Inc.,
submitted by Thiokol Corp., Ventron Div., Danvers, Mass.,
CDL:025525-H)
Lifestream Laboratories, Incorporated (1962) Acute "Ysxicity Studies
on Durotex *7599. (Unpublished study received Mar 6, .1968 under
2829-91; submitted by Thiokol Corp., Ventron Div., Danvers,
Mass.; CDL:050468-A)
Litton Bionetics, Incorporated (1976a) Mutagenicity Evaluation of
10,10'-oxybisphenoxarsine (technical) Final Report.
(Unpublished study received ? under an unknown admin. Mo., sub
mitted by Ventron Corp., Beverley, MA)
Litton Bionetics, Incorporated (1976b) Mouse Lymphoma Mutagenici-
ty evaluation of 10-10'-oxybisphenoxarsine (technical) Final
Report. Project Mo. (Unpublished study received ? under an
unknown admin. No., submitted by Ventron Corp., Bevorley, MA)
Litton Bionetics, Incorporated (1978a) Teratology Study in Rats:
10-10'-oxybisphenoxarsine (technical) FinaJ Report. Project
No. 20816. (Unpublished study received ? under an unknown
admin. No., submitted by Ventron Corp., Beverley, MA)
Maeda, J. (1971) New Organo-Arsenic Antimicrobial Agents.
Biniiru To Pokima 11(2):11-26 (Japan)
Enka
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f-IRID
00013604
GS044043
05016439
00013655
00013665
00024950
GS044044
GS044045
00013646
00023381
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[Voluntary cancellation of Vinyzene BP-101
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MRID CITATION
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[Extractability of Vinyzene BP-5- analytical techniques!
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MRID CITATION
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MRID CITATION
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MRID CITATION
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cides Containing OBPA by Atomic Absorption Spectrcohotometry.
Method dated Mar 19, 1975. (Unpublished study received Mar 22,
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MRID CITATION
00013642 WARF Institute, Incorporated (1976) Report: WARF Institute
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GS044058 WARF Institute, Incorporated (1976b) Report: WARF No. 6013735,
Eye Irritation/Durotex 7603.
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Skin Irritation, Eye Irritation for 10,lO'-Oxybisphenoxarsine.
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Skin Irritation, Vinyzene SB-1.
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05017985 Yaroshevskii, A.B.; Khlebnikov, V.M.; Gavrilov, V.I.;
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study received May 31, 1973 under 2829-96; submitted by Ventron
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-------
MRID CITATION
GS044063 Yeager, C.C. (1976) Memo to Daniel Cirelli (EPA) dated Dec 10,
1976, [Record of telephone call on 10,10'-Oxybisphenoxarsinel
00013659 Yeager, C.C. (1976) Toxicology on OBPA Formulations. (Unpublished
study received Sep 16, 1977 under 2829-96; submitted by Ventron
Corp., Beverly, Mass.; CDL:231822-E)
GS044064 Yeager, C.C. (1977a) Merro to Hernvan Gibb (EPA) dated May 16, 1977
[Meeting on 10,10'-oxybisphenoxarsinel
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fRPAR review, 10,10'-oxybisphenoxarsinel
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00026093 3M Company (19??) Formulation—Nomad Brand Surfacing Material.
(Unpublished study received Oct 22^ 1970 under 10350-3;
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00013600 3M Company (19??) Formulation—Nomad Brand Surfacing Material.
(Unpublished study received Nov 15, 1971 under 10350-3; CDL:
230572-A)
00014467 '3M Company (1971) Introductory Data: Nomad Brand Surfacing Mate-
rial. (Unpublished study received Nov 15, 1971 under'10350-3;
CDL:230572-K)
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