&EPA
United States
Environmental Protection
Agency
Office of Pesticides
and Toxic Substances
Washington, O.C. 20460
EPA 560/11-80-020
July 1980
Toxic Substances
TSCA Chemical
Asessment Series
Chemical Screening:
Initial Evaluations of
Substantial Risk
Notices, Section 8(e)
July 1, 1979 - January 31, 1980
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substantial risk o.f injury to. health o.r the enviroinmeli}t;,,, s;hatJ. ,.;, .,'~\'f'
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EPA 560/11-80-020
July 1980
CHEMICAL SCREENING: I~ITIAL EVALUATIONS OF
SUBSTANTIAL RISK NOTICES, SECTION 8(e)
JULY 1, 1979, TO JANUARY 31, 1980
Volume 2
Office of Testing and Evaluation
Office of Pesticides and Toxic Substances
Washington, DC 20460
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
WASHING'rON, DC 20460
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DisCLaimer
This volume has been reviewed by the Office of Pesticides and
Toxic Substances, u.S. Environmental Protection Agency, and
approved for publication. The status reports published in this
volume present the Agency's preliminary evaluations of the sub-
mitted information; they do not represent final Agency policy or
intent with respect to the submissions or the subject chemicals.
Mention of company names, trade names, or commercial products
does not constitute Agency endorsement or recommendation.
ii
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Foreword
Evaluations of chemical substances prepared by scientists in
EPA's Office of Testing and Evaluation, Office of Pesticides and
Toxic Substances (OPTS), to implement provisions in the Toxic
Substances Control Act (TSCA), will be published periodically and
made available to the public in the TSCA Chemical Assessment
Series. Some of the volumes in the Series will be reports on
single chemicals; others will be compendiums of information
received and evaluated by the Agency about many chemicals. (The
anticipated frequency of publication will vary among titles:
some will be published annually, some semiannually: and others
quarterly. )
Because the chemical assessments published in this Series often
will reflect initial or intermediate steps in EPA's evaluation of
a chemical under TSCA, the Agency welcomes the submission of
additional information for or comments on its evaluations. Such
submissions will be considered either at a subsequent step in the
assessment of the subject chemical or in the decision not to pro-
ceed with further evaluation.
All information for or comments on volumes in the TSCA Chemical
Assessment Series should be submitted to:
Document Control Officer (TS-793)
Office of pesticides and Toxic Substances
u.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Comments on this volume should bear the identifying docket number
OPTS-10004.
The TSCA Chemical Assessment Series is being distributed through
the Industry Assistance Office (IAO) in OPTS. IAO is maintaining
two mailing lists: a subscription list of persons who want to
receive all volumes in the Series and a notification list of per-
sons who want to receive announcements of individual volumes as
they become available. For a place on either IAO list, telephone
IAO (toll-free 800-424-9065 or, in Washington, D.C., 554-1404) or
write to:
Industry Assistance Office (TS-799)
u.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Toll Free: (800-424-9065)
Washington, D.C.: (554-1404)
Generally, five thousand copies of each volume will be printed.
After this supply is exhausted, copies can be purchased from the
National Technical Information Service (NTIS), whose "PB" refer-
ence number can be found in the OPTS "Comprehensive List of
Scientific and Technical Reports," also available from IAO.
iii
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The status reports (evaluations) prepared by OPTS on submissions
received from chemical mancfacturers, processors, and distribu-
tors between July 1, 1979, and January 31, 1980, under Section
8(e) of TSCA (90 Stat. 2029, 15 D.S.C. 2607), are presented in
chronologie order in this volume. Status reports are prepared by
OPTS on all formal submissions received under Section 8(e) and on
other similar types of information received by EPA. All Section
8(e) submissions and the resulting status reports are placed in a
public file (subject to claims of confidentiality made by the
submitter) upon their receipt or completion.
EPA is publishing this volume for two reasons. First, the
collection of status reports in a single volume will make that
information more accessible to the public. Second, the volume
may, by providing specific examples of submitted information and
EPA's evaluation of it, help anyone subject to Section 8(e) to
understand better the types of information that should be
submitted to the EPA.
To date, no information submitted under Section 8(e) has resulted
in immediate regulatory action under TSCA or any other act,
although some submitted information has triggered further data
gathering and evaluation that may lead to proposal of regulations
in the future.
The original submissions, as well as all status reports, can be
viewed at EPA Headquarters (Room 447 East Tower), 401 "M" Street,
S.W., Washington, D.C.
Joseph J. Merenda
Director, Assessment Division
iv
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Contents
Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acknowl edgmen t. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CI . . . . . 0 . . .
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Status Reports 8EHQ-0779-0292 to 8EHQ-0180-0330.............
Supplemental and Follow-up Status Reports...................
Appendix A.
Appendix B.
Appendix C.
Appendix D.
Appendix E.
Statement of Interpretation and Enforcement
Policy; Notification of Substantial Risk
(43 FR 11110, March 16, 1978}..................
List of Status Reports Alphabetized by Chem-
i c a 1 N am e. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of Status Reports Arranged by CAS
Registry Number................ ... . .. .. . .. . . . . .
List of Status Reports Arranged by Study
Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of Status Reports Arranged by Submission
Numbe r. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
v
iii
vii
1
9
90
102
110
115
118
120
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Acknowledgment
In preparing the status reports contained in this volume, staff
of the Office of Pesticides and Toxic Substances (OPTS) have
frequently found it necessary to request further information
about or clarification of the submitted data. OPTS appreciates
the effort and cooperation of those companies and organizations
that have submitted the information evaluated in this volume:
Aerojet-General Corporation
American Cyanamid Company
American Petroleum Institute
Atlantic Richfield Company
Celanese Corporation
Chemical Industry Institute of Toxicology
Ciba-Geigy Corporation
Cincinnati Milacron Chemicals, Inc.
Clorox Company
Diamond Shamrock Corporation
E.l. du Pont de Nemours & Company
Ethyl Corporation
Exxon Company, USA
Exxon Corporation
FMC Corporation
General Electric Company
Gulf Mineral Resources Company
IBM Corporation
International Salt Company
PPG Industries, Inc.
Procter and Gamble Company
Shell oil Company
Sherex Chemical Company, Inc.
Standard Oil Company (Indiana)
Texaco, Inc.
Toms River Chemical Corporation
Union Carbide Corporation
Union oil Company of California
vii
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Introduction
Section 8(e) of TSCA states that "any person who manufactures,
processes, or distributes in commerce a chemical substance or
mixture and who obtains information which reasonably supports the
conclusion that such substance or mixture presents a substantial
risk of injury to health or the environment shall immediately in-
form the Administrator of such information unless such person has
actual knowledge that the Administrator has been adequately in-
formed of such information." Section 8(e) was self-effectuating
and required no implementing rules; therefore, manufacturers,
processors, and distributors of chemicals became subject to
Section 8(e) as of January 1, 1977, the effective date of TSCA.
To provide further guidance to those subject to Section 8(e), on
March 16, 1978, after having received comment on a proposed
statement of policy published earlier in the Federal Register,
EPA published a "Statement of Interpretation and Enforcement
Policy; Notification of Substantial Risk" (43 FR 11110). For
easy referral when using this volume, the March 16, 1978,
statement has been reproduced as Appendix A.
The March 16, 1978, statement expresses the Agency policy that
information subject to Section 8(e) is any information that pro-
vides "reasonable support" for the conclusion that a chemical
presents a substantial risk of injury but need not necessarily
conclusively indicate such risk. A determination of "substantial
risk" does not include evaluation of economic or social benefits
of the use of the chemical and, therefore, is not synonymous with
the term "unreasonable risk" used in other sections of TSCA.
Receipt of information under Section 8(e) of TSCA does not neces-
sarily trigger immediate regulatory action; howeveri information
submitted under Section 8(e) is given priority for evaluation in
order to determine an Agency course of action. An action may,
for example, be further evaluation by EPA or referral to another
agency. To date, no information submitted under Section 8(e) has
resulted in immediate regulatory action under TSCA, although some
submitted information has triggered further data gathering and
evaluation that may lead to proposal of regulations in the
future.
Of the initial submissions received and evaluated by EPA as
Section 8(e) information between January 1, 1977, and June 30,
1979, (Volume 1) approximately 100 were received before the
publication of the March 16, 1978, statement; thus, the sub-
mitters did not have the benefit of that guidance. *
Approximately 25 percent of the initial submissions received were
sent to the Agency with the caveat that the submitter was
* See U.S. Environmental Protection Agency. 1980. ~nemical screen-
ing: initial evaluations of substantial risk notices, section 8(e),
vol. 1. Washington, DC: Office of Pesticides and ~oxic Substances,
U.S. Environmental Protection Agency. EPA 560/11-80-008.
1
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uncertain of the applicability of the information to section
8(e). Some submitters stated that their reports were sent for
information purposes or under other provisions of TSCA, although
EPA believes that some of those reports are appropriate for
submission under Section 8(e). A number of submissions appear to
have been sent out of an abundance of caution, and, considering
their content, did not in EPA's judgment warrant submission under
Section 8(e). Regardless of the nature of the submissions, EPA
has evaluated and prepared a status report for each one.
Figure 1 depicts the Agency's handling procedures for information
received under Section 8(e). Information is first received by
the OPTS Document Control Officer, who is located in the Chemical
Information Division of EPA's Office of Pesticides and Toxic Sub-
stances. The Document Control Officer checks the notice for any
information claimed by the submitter to be confidential and
assigns a Document Control Number. The Document Control Number
is used by the Agency to identify specific submissions and takes
the following form: 8EHQ-0000-0000. Starting from the left, the
first four symbols identify the information as a Section 8(e)
submission received by EPA headquarters; the next four digits
identify the month and year (e.g., -0579-) of receipt of the
information; the final four digits identify the submission's
chronological number. In addition to the basic sequence, charac-
ters may be added to the right end of the Document Control Number
to convey a special status. ~e characters and their meaning
follow:
C:
contains confidential business information; access
is limited to persons with appropriate clearance;
denotes the "sanitized" version of a confidential
document; and
signals that the original document contains the
n~nes or other identification of individuals, the
release of which may violate the Privacy Act (such
documents are sanitized to remove the names or
other identifiers).
S:
P:
The Document Control Officer next enters the information into the
appropriate file: the no~confid~ntial an~ ~anitize~ sub~issions
enter the public file, wh1le cop1es cont~1n1n~ con~1dent1al bus-
iness information are. placed in the conf1dent1al f1le. A letter
acknowledging receipt of the Section 8(e) sUbmission,is prepared
by the Document Control Offic~r.and sen~ to ~he subm1tter. In
the case of submissions conta1n1ng conf:dent1al dat~, the Docu-
ment Control Officer sends a letter ask1ng the subm1tter to
support any confidentiality claims by provid~ng th~ information
requested in an attachment to the letter ent1tled Support
Information for Confidentiality Claims." This att~chment is
reoroduced as Figure 2. The submitter nas,lS work1r:g days from
th~ date of receipt of this letter to prov~de EPA w1t~ the
t d 'nformation. When the Document ~ontrol Off1cer
reques e 1 " f t'\... b' t '
receives the requested support 1nformat10n rom lIe su ffi1 ter, 1t
2
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is forwarded to the EPA Office of General Counsel for review, in
accordance with Agency procedures. No information claimed by the
submitter as confidential will be included in any file to which
the public has access before the Agency's regulations affecting
confidential business information have been complied with
fully- This means that, before any claim for confidentiality is
denied, fair and adequate notice will be given to any person who
has made a claim of confidentiality- If a claimant disagrees
with EPA'S determination on the confidentiality of a piece of
information, that person will have adequate opportunity to
challenge release of the information to the public.
Following receipt of the submission by the Chemical Information
Division, the submitted information is evaluated in OPTS to
determine its significance and to decide what action, if any, is
indicated. Submissions containing confidential data can be
handled only by persons with appropriate clearance. Most Section
8(e) submissions are evaluated by staff in the Chemical Hazard
Identification Branch of the Assessment Division in OPTS, in
consultation with appropriate scientists from that Division
and/or other units of the Office of Testing and Evaluation. The
procedures used in making such evaluations are described below.
In the case of submissions reporting "emergency incidents of
environmental contamination" (see Part V [c] of the March 16,
1978, policy statement), however, the initial evaluation is
performed by staff in the Program Integration Division in OPTS,
with scientific support as necessary from the Office of Testing
and Evaluation.
Upon receipt of a Section 8(e) submission from the OPTS Document
Control Officer, the Section 8(e) coordinator in the Chemical
Hazard Identification Branch scans the information to determine
the type of submission (e.g., mammalian laboratory study, fish
bioaccumulation study, epidemiologic study, etc.) and its
apparent significance. The coordinator next forwards a copy of
the submission to an appropriate scientist in the Office of
Testing and Evaluation, who performs an initial evaluation of the
submission and prepares written comments on it. When the com-
ments are returned to the coordinator, a status report evaluating
the submission is prepared. The basic format of a status report
is shown in Figure 3. The Chief of the Chemical Hazard Identifi-
cation Branch reviews the prepared status report and resolves any
questions with the Section 8(e) coordinator before signing the
report. Next, the Director of the Assessment Division reviews
the status report and either approves the report or asks for
clarification. Following approval of the status report by the
Division Director, follow-up activities on the submission are
initiated. These include delivery of a copy of the status report
to the Chemical Information Division for inclusion in the public
file, transmittal to other EPA offices or Federal agencies, and
preparation of a follow-up letter to the submitter. This letter
transmits a copy of the status report and may ask for clarifica-
tion of or additional information on the submission. Clarifica-
3
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tion is necessary when submissions are incomplete or when the
content of the submission does not appear to "reasonably support"
a conclusion of substantial risk.
Review of notices concerning emergency incidents of environmental
contamination is handled in similar fashion by the Program
Integration Division, with technical support as necessary from
the Office of Testing and Evaluation. The Program Integration
Division has lead responsibility for review of these items to
ensure full and rapid coordination with appropriate EPA regional
office personnel. The Program Integration Division has the
responsibility in OPTS for coordination of headquarters and
regional efforts related to toxic substances.
When reviewing a status report, the reader should remember that
the purpose of EPA's evaluation is to determine the significance
of the submitted information in terms of a need for possible
action by the Agency. This determination involves a critical
analysis of the notice to evaluate the extent to which the
reported hazard is supported by the submitted information.
However, the scope of the initial evaluation generally is limited
to the submitted documents and to any closely related information
known by the reviewer. Neither a literature search to identify
other reported effects nor an in-depth analysis of possible
sources of exposure to the subject chemical is part of the
submission evaluation. Therefore, a status report should be
viewed only as an initial review of the submitted information,
not as a comprehensive assessment of the chemical for which a
Section 8(e) submission has been made.
4
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Figure 1
PROCESSING OF 8(e} NOTICES OF SUBSTANTIAL RISK
~ - - - -- -- - -~
-- -~ - -~ - - - - -- -- -
--------
-____r ---
~--- ----.,
ICIOI I
f,I(';IU
SANITIZED
COPY
I
I
I
I
I
I
I
I
I
I
I
r-------------_J
I
1
1
I
RESPONSE
(15 DAYS)
TSCA CBI PROCEOURES
IN EffECT ONl' AUTHORIZEO
PERSONS INVOl VEO IN PROCESS
DCO (CIDI
DISTRIBUTION
APPAOPRIA TE FILE
CONfIDENTIAL
PUBLIC
AD-ASSESSMENT DIVISION
eBI-CONFIDENTIAl BUSINESS INFORMATION
CHIS-CHEMICAL HAZARD IOENTIF ICATION BRANCH
CIC-CHEMICAL INFORMATION DIVISION
DCD-DOCUMENT CONTROL OFFICER
E.I.E.C.-EMERGENCY INCIDENT OF ENVIRONMENTAL
caNT AIMINA TION
ERD-ENVIRONMENTAL REVIEW DIVISION
HRD-HEALTH REVIEW DIVISION
DE-OFFICE OF ENFORCEMENT
OGC-OFFICE OF GENERAL COUNSEl
PIC-PROGRAM INTEGRATION DIVISION
I-OlLOW UP
lETTER
TO SUBMITTER
EPA
CPSC
FDA
NIOSH
OSHA
OTHERS
5
HC
----
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Figure 2
SUPPORT INFORMATION FOR CONFIDENTIALITY CLAIMS
The Environmental Protection Agency (EPA) has been receiving
many requests for access to notices submitted to EPA under
Section B(e) of TSCA. Accordingly, EPA must make a final confi-
dentiality determination concerning the treatment of the informa-
tion in your submission. In order to make that determination,
EPA needs further information from you. Under EPA's regulations
on the treatment of information claimed as confidential in 40 CFR
Part 2 (41 FR 36902, September 1, 1976), you have an opportunity
to submit comments to substantiate your claim of confidentiality.
To comply with these requirements, you must indicate which
portions of your submission are claimed as confidential. Be
specific as to page, paragraph, or sentence as appropriate. For
those portions that you identify as confidential, you must
address the following questions. In answering the questions, be
as specific as possible, give examples if necessary, and connect
the specific answers to the specific claimed portions.
1. For how long a period do you desire confidential
treatment? May EPA disclose this information after a certain
date or after the occurrence of a specific event?
2. What measures have you taken to guard against undesired
disclosure of this information to others?
3. To what extent have you disclosed this information to
others, and what precautions have you taken in connection with
the disclosures to protect against further disclosure?
4. Have there been any confidentiality determinations made
by EPA, other federal agencies, or courts in connection with this
information? If so, please enclose copies.
5. Do you assert that disclosure of this information would
be likely to result in substantial harm to your competitive
position? If so, what are those harmful effects, and why should
they be regarded as substantial? What is the causal relationship
between the disclosure and the harmful effects?
6
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Figure 2 (cont.)
6. Do you assert that this information was voluntarily
submitted as defined in 40 CFR 2.20l(i)? If so, would the
disclosure of this information tend to lessen the availability to
the Government of similar information in the future? Why?
In making your claims of confidentiality and providing
responses to the above questions, you should keep in mind that,
under Section l4(b) of TSCA, "data from health and safety
studies" are not entitled to confidential treatment, except to
the extent that disclosure of such data would reveal either the
portio, of a mixture comprised of any of the chemical substances
in the mixture or the processes used in manufacturing or
processing a chemical substance or mixture. Any claim of confi-
dentiality for data from health and safety studies that goes
beyond these two types will be denied.
7
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Figure 3
STATUS REPORT FORMAT
Submission Description
The content of the submission and the chemical(s) under discus-
sion are identified in this section.
Submission Evaluation
Depending on the nature of the submission, either an environ-
mental or health scientist will perform the initial evaluation.
Comments generally include remarks on the experimental method,
the significance of the results, points of agreement or disagree-
ment with the conclusions offered, and any recommended actions.
This section can vary in length from a brief paragraph to several
paragraphs.
Current Production and Use
In this section the expected exposure to the chemical(s) is
described, as estimated by production volume and use character-
istics. The production volume information once taken from
secondary literature is now derived from the nonconfidential TSCA
Section 8(b) Chemical Inventory.
Comments/Recommendations
Additional comments that do not
the status report are presented
listing of other submissions on
on the submission in general.
fit into the other sections of
here. Such remarks include a
the same chemical(s) and comments
Recommendations include suggested referrals to other offices or
agencies, the need for follow-up correspondence to the submitter
to clarify a point, and possible EPA actions.
8
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
DATE;
~II\\' "
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8EHQ-0779-0292
Page 1 of 3
:::::::~ ~
Needed
SU8JECT:
Status Report 8EHQ-0779-0292
1~rank D. Kover, Cl1ief
FR<*: Chemical Hazard Identi fication Branch
TO:
Joseph J. Merenda, Director
Assessment Division
Submission Description
An employee of Bell Laboratories reports that an uncured bis-
phenol A-epichlorohydrin resin (EPON 828) is being used in Type
457 PVC telephone cord insulation which is then handled by large
numbers of Bell System and Western Electric personnel. The
submitter also reports that Western Electric industrial hygien-
ists have measured small amounts of epichlorohydrin in the air
surrounding the area where Type 457 PVC insulation is mixed. ~e
submitter also states that recent evidence indicates that Type
457 PVC cord may have caused an allergic skin reaction in a
customer.
In providing this information under TSCA Section 8(e) the sub-
mitter cites several literature references including the NIOSH
documents which address the potential health hazards involved
with exposure to epichlorohydrin and glycidyl ethers. (EPON 828
is the diglycidyl ether of bisphenol A).
Submission Evaluation
The health concerns expressed by the submitter are legitimate.
The many toxicities of epichlorohydrin and glycidyl ethers have
been well documented by NIOSH in its Criteria Documents and
Current Intelligence Bulletins on these specific chemicals.
Current production ano Use
Epichlorohydrin is used as a major raw material for epoxy and
phenoxy resins and is used in the manufacturing of glycerol. It
also has uses in curing propylene-based rubbers, as a solvent for
cellulose esters and ethers, and is used in preparing high wet-
strength resins for the paper industry.
*NOTE: This status report is the result or a preli~inary
staff eva~uation of information submitted to EPA. Statements
made herel~ are n~t to be , regarded as expressing final
Agen~y pollCY or l~tent wlth respect to this particular
chem7cal. ,Any reVlew of the status report should take into
70nslder~tlon the fact that it may be based on incomplete
lnforma tlon.
E~A '0- 1J2I)o.6 (litE". "711
9
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Ojc,HU-U( ('j-UC::'jc.
Page 2 of 3
A review of the production range (including importation volumes)
statistics for epichlorohydrin (CAS No. 106-89-8) which is listed
in the initial TSCA Inventory has shown that between 251 million
and 1.1 billion pounds of this chemical were reported as
produced/ imported in 1977.**/
Bisphenol A-epichlorohydrin based resins are used in molding
powders (e.g. encapsulation of electrical parts). protective
coatings, reinforced plastics, bondings and adhesives, flooring,
paving and other miscellaneous applications.
A review of the production range (includes importation volumes)
statistics for bisphenol A-epichlorohydrin resins (CAS No. 25068-
38-6) which are listed in the initial TSCA Inventory has shown
that between 126 million and 669 million pounds were reported as
produced/imported in 1977.**/
The Type 457 PVC telephone cord cited in this submission is the
electrically insulated coiled cord which provides the connection
between either a standard desk and/or wall telephone and the
standard mouthpiece/earpiece handle. The PVC resin insulation
contains Epon 828 uncured epoxy resin which acts as a non-spewing
stabilizer which does not become tacky on use and performs the
function of scavenging degradation products from polyvinyl
chloride resin should the resin insulation start depolymerizing
during its use life.
Comments/Recommendations
NIOSH has published criteria for recommended standards for the
occupational exposure to glycidyl ethers (June, 1978) and epi-
chlorohydrin (September, 1976). In addition, NIOSH has published
Current Intelligence Bulletins on glycidyl ethers (No. 29.
october 1978) and epichlorohydrin (No. 30, October, 1978).
The Test Rules Development Branch (TRDB/AD). in conjunction with
the Environmental and Health Review Divisions/aTE, is currently
reviewing data received by the EPA pertaining to the Interagency
Testing Committee designated classes "Glycidol and Its
Derivatives" and "Halogenated Alkyl Epoxides."
The Agency has received and evaluated several section 8(e)
submissions on bisphenol A-epichlorohydrin resins (8EHQ-0579-0289
and 8EHQ-0579-0289 Supplement) and epichlorohydrin (8EHQ-1177-
**/
This production range information does not include any
production/importantion data claimed as confidential by the
person(s) reporting for the TSCA Inventory, ,nor does it
include any information which would compromlse Confidential
Business Information. The data submitted for the TSCA
Inventory, including production range information, are
subject to the limitations contained in the Inventory
Reporting Regulations (40 CFR 710).
10
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8EHQ-0779-0292
Page 3 of 3
0016, 8EHO-0878-0230, and 8EHo.-0978-0230 Supplement). The Agency
has also received and evaluated submissions on a number of
glycidyl ethers including n-BGE (n-butyl glycidyl ether; 8EHQ-
0778-0213), t-BGE (t-butyl glycidyl ether; 8EHQ-0579-0285), PGE
(phenyl glycidyl ether; 8EHQ-0279-0274), and n-alkyl glycidyl
ethers with alkyl groups in the C2-C10 range (8EHO-0779-0293).
a)
The Agency should transmit a copy of this submission and
status report to Bell Laboratories. The company should be
requested to provide its rationale as to why the information
provided and concerns expressed by the submitting employee
was not formally submitted by the company pursuant to TSCA
Section 8(e). In addition, Bell Laboratories shouln be
requested to descrihe the actions it has taken in response to
the submitted information to warn workers, customers, and
other companies to reduce or eliminate exposure to the
subject chemicals/materials. The results from monitoring
activities and laboratory studies (e.g. patch tests) on the
subject chemicals/materials should also be requested from the
company.
b)
The EPA has contacted the NIOSH Health Hazard Evaluation
Program in Cincinnati, Ohio, to determine what assistance
their program could provide in cases such as this. A
representative of the progr~n forwarded copies of a NIOSH
booklet which specifies that before NIOSH can act, a request
for a health hazard evaluation must be made by one of the
following: an employer representative; an authorized
representative of the employees for collective bargaining
purposes; an authorized representative of two or more
employees; or one of three or less employees in the work-
place. The booklet which contains a form which can be used
to request a workplace evaluation should he sent to the
submitting employee.
c)
The Agency should transmit copies of this submission and
status report to NIOSH, OSHA, CPSC, and TRDB/AD. In
addition, the Industry Assistance Office (IAO/OPII) should
consider transmitting copies of this submission and status
report to the manufacturers of these types of resins.
11
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~
I ~ITED STATES ENVIRONMENTAL PROTECTIC
8EHQ-Ol79-0293
Page 1 of 3
f C:i::. flp.:H~\ has submitted {:he SUT'1T.3 rized
results from a battery of mutagenicity tests of several n-alkyl
glycidyl ethers. ~he submitter states that this preliminary
j nformation leads to a cc;;c" _,;;;]_on that C2 tl ~~OU(jY Clf') n~alkyl
glycidyl ethers are potential :r.L,'Lc);~en~. Ti:\e su'[,mission a180
cites results from safety studiES performed at an sarlier date
which indicate that a mixtlxe \ c>ii<,sed fTeJominantly of Ce and
CIO n-alkyl glycidyl ethers) can cause testicular lesions ~n
certain animal species at hi0~ dose levels by atypical routes of
administration. The submitter states, however, that these
testicular effects were not corroborat~G in otner studies.
Submission Evaluation
The evidence that glycidyl ethers have effects on testicular
function continues to accumulate. The oral study in monkeys of
the mixture of Cs and CIO glycidyl ethers see~s inappropriate for
what the study was intended to demonstrate. Final copies of the
cited studies on testicular function should be requested for
further evaluation.
The submitter's conclusion regarding the potential mutagenicity
of the n-alkyl (C2-C~O) glycidyl ethers appears valid. However,
without complete cop~es of the protocols, identification of the
chemicals tested, and the actual dat"! from the battery of muta-
genicity tests, a full evaluation of the results as presented in
this submission is not possible at this time.
It is not suprising that the mutagenic potency of the C12 a~kyl
glycidyl ether is lower than that for the shorter chain nomologs.
*NOTE: This status report is the result of a prelimina=v
staff evaluation of information submitted to EPA. State;ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
consideration the fact that it may be based on incomplete
inrorma tion.
E~A '0- IJ~ (litEit'. ~1&)
12
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8EHQ-0779-0293
Page 2 of 3
Current production and Use
A review of the production range (includes i~portation volumes)
statistics for n-alkyl (C8,CIO) qlycidyl ether (CAS No. 68hO~-96-
1) as listed in the initial TSCA Inventory (1977) has shown that
between 1,000 and 10,000 pounds of this che~ical were produced/-
inported in 1977. This production range information does not
include any production/importation data clai~ed as confidential
by the person(s) reporting for the TSCA inventory, nor does it
include any infor~ation which would co~promise Confidential
Business Information. The data submitted for the TSCA Inventory,
including production range infor~ation, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CPR 710).
The submitter states that it has ~anufactured and sold a che~ical
mixture (which is composed predominantly of Cs and CIa qlycidyl
ethers) which is used primarily as a reactive diluent in epoxy
resin syste~s where it nay constitute 10-15% of the final resin.
Comments/Recommendations
Glycidyl ethers have been the subject of several sub~issions
received in the recent past under section 8(e). Phenyl glycidyl
ether (PGE) was found to induce nasal tumors, an uncommon lesion,
at 12 ppm in a two-year rat inhalation study (8FHQ-0279-0274);
tertiary-butyl glycidyl ether (t-BGF) was found genetically
active in several short-term mutagenicity assays (8EHQ-0579-
0285); and n-butyl glycidyl ether (n-BGP) was found to have
genetic activity in several short-term assays and possible
effects on testicular function in rats (8EH0-0279-0213). The
si~ilarity between the data offered in the present submission and
in 8EHQ-0279-02l3 is of interest. In both cases, the initially
available data consisted of evidence of testicular effects in
test animals following exposure to glycidyl ethers. The overall
significance of these initial studies was, however, somewhat
uncertain. However, upon receipt of data evidencing genetic
activity in short-te~ mutagenicity assays, the FPA in its evalu-
ation of 8FHO-0279-0213, and the present submitter in their
evaluation of the data contained in sub~ission 8EHO-0779-029~
separately reached a similar conclusion that reasonable support
for a conclusion of substantial risk was evidenced for the gly-
cidyl ethers examined in the respective cases. The basis for
this conclusion is succinctly described by the present submitter:
"Since our safety information indicates
conditions of exposure this ~ixture (of
be absorbed, become syste~ic, and reach
conclude that the additional results of
battery support the conclusion that the
substantial risk to human health."
that under some
glycidyl ethers) can
gonadal tissue, we
the mutagenicity
~ixture ~ay present
13
-------
b)
8EHQ-0779-0293
Page 3 of 3
a)
The submitter should be requested to send full copies
of the results, including protocols and data, from the
studies cited in this submission.
A copy of this submission and status report should be
transmitted to TRDB, OSHA, NIOSH,CPSC, and OWWM.
Because of the involvement of OE and OGC in 8EHQ-0279-
0213, they, as well as the involved companies, should
also receive copies.
14
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
JAN I 4 ..
SUBJECT: Status Report * 8EHQ-0779-0294
..",,4~;';k D. Kover, Chie f
// ~hemical Hazard Identification
Branch
8EHQ-0779-0294
Page 1 of 2
Approved ~
Revision ~
Needed
CATE: Revised (Hay 28, 1980)
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Sub~ission Description
Texaco, Inc. has submitted preliminary results from several jn
vitro mutagenicity studies of morpholine (CAS No. 110-91-8). The
chemical was found to produce a dose-dependent mutagenic effect
in a mouse fibroblast assay. However, the submitter states that
negative results ohtained from other in vitro assays (mouse lym-
phoma assay and Ames test) indicate that morpholine is not a
mutagen. The submitter also reports that the data from a sister
chromatid exchange assay were inconclusive and that this study
will be repeated.
Ths submitter expresses concern that the positive mouse fibro-
blast assay results may have been influenced by the presence of
nitrites or nitrates in the nutrient, which in combination with
morpholine could lead to the formation of N-nitrosomorpholine.
Submission Evaluation
Without complete copies of the test protocols and data from the
cited studies of morpholine, a full evalation of the submitted
mutagenicity information is not possible at this time.
The submitter's concern regarding the possible presence or in
situ formation of N-nitrosomorpholine is valid and warrantsU1e
planned additional examinations.
Current production and Use
The review of the production range (includes importation volumes)
statistics for morpholine (CAS. No. 110-91-8), which is listed in
the initial TSCA Inventory, has shown that between 100 thousand
and 1 million pounds of this chemical were produced/imported in
1977.**/
*NOTE: This ~tatus ~eport i~ the result of a preliminary
sta:f evaluat10n of 1nformat1on submitted to EPA. Statements
made herein are not to be regarded as expressina final
Agency policy or intent with respect to this pa~ticular
chem~cal. ,Any review of the status report should take-into
~ons1der~t10n the fact that it may be based on incomplete
1nformat1on.
E'-A '0,,", 11~ I"EV. ~111
15
---
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8EHQ-0779-0294
Page 2 of 2
The submitter reports that morpholine is used as a corrosion
inhibitor, especially in steam boiler systems; an emulsifier for
cosmetics, rubless waxes and polishes; separating agent for vola-
tile amines; an intermediate in the manufacture of optical
brighteners, an intermediate for textile lubricants, softening
agents, adjuvants, whitening agents, sizing emulsifiers, rubber
vulcanization accelerators, antioxidants, surface-active agents,
plasticizers, viscosity improvers, insecticides, fumigants, herb-
icides, dyes, catalysts, bactericides, analgesics, anesthe-
tics,and other physioloyically active agents.
Comments/Recommendations
The submitter reports that "in addition to the usual handling
instructions on the material safety data sheets covering
morpholine, there is an added statement, 'Do not use sodium
nitrite or other nitrosating agents in formulations containing
this product. Suspected cancer-causing nitrosamines could be
formed' . "
The existing Chemical Hazard Information Profile (CHIP) on
morpholine has been scheduled for updating.
a)
~he submitting company should be requested to provide
full copies of the test protocols and data from the
studies cited in its submission.
b)
A copy of this sub~ission and status report should be
transmitted to NCI, OSHA, NIOSH, CPSC, OVJWH, and OPP.
**/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
16
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SEP 2 0 1979
8EHQ-0779-0295
Page 1 of 2
DATE:
Revised (May 28, 1980)
Branch
Revision
Needed
SUBJECT, Status Report* 8EHQ-0779-0295
.~r~nk D. Kover, Chief
.~ Chemical Hazard Identification
Approved
TO:
Joseph J. Merenda, Director
Assessment Division, OTE/OTS
Submission Description
The IBM Corporation has submitted the summarized results of a
skin absorption study in rabbits using Direct Black 38 Dye (CAS
No. 1937-37-7) which was radioactively labelled with Carbon 14 in
the biphenyl moiety. The submitter states that the preliminary
data suggest that the dye or a portion of its molecule penetrates
the unbroken skin or experimental animals and appears later in
the urine and feces.
Submission Evaluation
The summarized preliminary results reported in this submission on
Direct Black 38 Dye are very significant and raise definite
concern. The dye, or a portion of the dye molecule, was rapidly
absorbed from the unbroken skin. Thirty percent of the applied
dose was absorbed and excreted within the first 24 hours and by
the sixth day of this study 90% of the applied dose had been
recovered in the urine and feces. The remaining 10% of the
applied dose, if absorbed, may still have been in the body. The
long sojourn in the body suggests binding to blood plasma
proteins and possibly to other tissue proteins. Some benzidine
dyes, used in chemotherapy exhibit this type of prolonged binding
to a variety of blood and tissue proteins. The binding is
unusual in that serum proteins bound to the dye no longer provoke
an anaphylactic reaction in sensitized animals. (An example of a
dye which exhibits this type of prolonged binding is Suramin.
Although it is not technically a benzidine dye, its properities
in vivo so closely resemble benzidine dyes that many pharmaco-
logists have considered it as belonginy to that group.)
*NOTE: This status report is the result of a prelimi~a=v
staff eva~uation of information submitted to EPA. State~er.ts
made here~n are not to be regarded as expressing final
Agen~y policy or i~tent with respect to this particular
chem~cal. . Any rev~ew of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nforma tJ on.
E~A. Ira... -,..m.... ...u --'1&'
17
-------
8EHQ-0779-0295
Page 2 of 2
-2-
The significant metabolite of Direct Black 38 Dye appears to
be benzidine which has been well established as a urinary
bladder carcinogen in humans.
Direct Black 38 Dye (CAS No. 1937-37-7)
Benzidine
#~-N~
Current Production and Use
According to the most recent published data, there is only
one manufacturer of Direct Black 38 Dye in the United States.
It is estimated that 700,000 to 800,000 pounds of this dye
was produced in the U.S. in 1978. The U.S. imported approx-
imately 170,000 pounds of Direct Black 38 Dye in 1978.
Direct Black 38 Dye is used in some textile dyes, aqueous
inks, biological stains, plastics, wood-flour (used as a
resin filler), wood stains, leather goods stain~, and type-
writer ribbons.
Comments/Recommendations
a) The submitter should be requested to provide a full
copy of the final report from this skin absorption study
including test protocols and data. In addition, the sub-
mitting company should be requested to provide information
regarding its uses of Direct Black 38 Dye.
b) It is recommended that Direct Black 38 Dye be
considered a candidate for a Section 8(a) rule.
c) This submission and status report should be trans-
mitted to NIOSH, OSHA, CPSC, FDA, OMvM, lTC, NCI, and CREB.
18
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
ocr I , 1979
SUBJECT: Status Report* 8EHQ-0779-0296
F~'~~ank Kover, Chief
~W~~emical Hazard Identification
Branch
8EHQ-0779-0296
Page 1 of flm-2
Approved
Revision
Needed
DATE: Revised (May 28, 198G)
TO: Joseph J. Merenda, Director
Assessment Division
Submission Description
Cincinnati Mi1acron Chemicals, Inc. has repol~~d the results of
several acute animal toxicity and irritation studies of ethyl-
triphenylphosphonium acid acetate, tetrabutylphosphonium acid
acetate, benzy1triphenylphosphonium chloride, and ethyltriphenyl-
phosphonium iodide.
Submission Evaluation
These aryl and alkyl phosphonium compounds would be expected to
have the typical pharmacological actions of quaternary ammonium
compounds. ~hese effects are mainly cholinergic stiumlations
manifested by: 1) paralysis of skeletal muscle, the most serious
effect involving the muscles of respiration leading to difficulty
in breathing and death: 2) red ("bloody") tears, i.e., chroma-
dacryorrhea: 3) contracation of smooth muscles leading to
diarrhea and an altered urinary pattern: 4) altered blood pres-
sure (usually lowering): 5) altered cardiac rhythm. The
submitted toxicity studies show that the subject chemicals
exhibit at least the first three of these pharmacological
actions.
A more adequate estimation of the relative toxicity of these
compounds would be:
benzyltriphenylphosphonium
chloride
~
1.1 x 10-4M
Relative Toxicity
1
ethyltriphenylphosphonium
iodide
1.9 x 10-4M
0.59 (2/3)
*NOTE: This ~tatus ~eport i~ the result of a preliminary
staff evaluatlon of lnformatlon submitted to EPA. Statements
made herei~ are n~t to be , regarded as expressing final
Agen~y POllCY or l~tent wlth respect to this particular
chem7cal. ,AnY reVlew of the status report should take into
~onslder~tlon the fact that it may be based on incomplete
lnformatlon.
E~A '0- U»6 (~EV. )-711
19
-------
8EHQ~0779-0296
Page 2 of 2
ethyltriphenylphosphonium
acid acetate
~
3. 7 5 x 1 0- 4M
Relative Toxicity
0.31 (1/3)
tetrabutylphosphonium
acid acetate
2.14 x 10-3M
0.05 (1/20)
Cucrent production and Use
A review of production range (includes importation volumes)
statistics for benzyltriphenylphosphonium chloride (CAS No. 1100-
88-5) as listed in the initial TSCA Inventory (1977) has shown
that between 1,000 and 10,000 pounds of this chemical was
reported produced/imported in 1977. This production range
information does not include any production/importation data
claimed as confidential by the person(s) reporting for the TSCA
Inventory, nor does it include any information which would
compromise Confidential Business Information.
A review of production range (includes importation volumes)
statistics for ethyltriphenylphosphonium iodide (CAS No. 4736-60-
1); tetrabutylphosphonium acid acetate (CAS No. 17786-43-5);
ethyltriphenyphosphonium acid acetate (CAS No. 35835-94-0) as
listed in the initial TSCA Inventory (1977) has shown that no
1977 production/importation was reported or that all of the
production range data reported was claimed as confidential by the
manufacturer(s) and importer(s) and cannot be disclosed.
(Section 14(a) of the TSCA, U.S.C. 2613 (a».
The data submitted for the TSCA Inventory, including production
range information, are subject to the limitations contained in
the Inventory Reporting Regulations (40 CFR 710).
According to this 8(e) submission, these chemicals are sold by
the submitter for use as catalysts and stabilizers in quantities
(of all products combined) under 100,000 pounds annually.
Comments/Recommendations
(a) The submitting company states that their customers have been
informed of the reported toxicity and the safe handling
procedures for these chemicals. This submission and status
report should be transmitted to OSHA and NIOSH.
20
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UNITED STATES ~NVIRO~MENTAL PROTECTION AGENCY
OCT 3 I !g'(~
DATE:
Revised (May 28, 1980)
8EHQ-0779-0297
Page 1 of 2
SUBJECT: Status Report* 8EHQ-077S-0297
/11)(---
,t~: Frank D. Kover, Chief
Chemical Hazard Identification Branch
Approved
Revisio
Needed
TO: JC:':"2ph ,j 0 Mer2[',da, Dir:: -t.::-,r
Assessment Division, aTE (TS-792)
Submission De~cription
The Gulf Mineral Resources Company has submitteo a summary of
preliminary results from an ongoing mouse skin painting study of
solvent refined coal (SRC-II) heavy distillate (CAS No. 68410-07-
1). The results indicate that on repeated (three times per week)
dermal exposures to 2.4 mg of SRC II heavy distillate, a 20-25%
incidence of skin tUJ!1ors was observed aft er 247 days. This
incidence is reported to increase to 100% at a dose level of 23.6
mg after 147 days.
The submitter also reports that acetone, which was used as the
sample diluent, has a prof.:::uod effect on the distribution of the
SRC II heavy distillate in the skin, and may therefore affect the
tissue absorption and metabolism of that tested material. The
submitter also states that this "solvent effect obviously would
not be present in usual human exposure routes."
Submission Evaluation
The role 9f the acetone vehicle in the carcinogenic action of
SRC-II heavy distillate can only be surmised until the composi-
tion of the product is known. Does this product contain poly-
nuclear aromatic hydrocarbons? It is doubtful that an adjuvant
action of acetone determines whether SRC-II heavy distillate will
or will not be carcinogenic; however, it may determine the
potency.
Current Production and Use
A review of the production range (includes importation volumes)
statistics for SRC II heavy distillate (CAS No. 68410-07-1) as
listed in the initial TSCA Inventory (1977) has shown that
between 100,000 and 1,000,000 pounds of this chemical were
*NOTE: This status report is the result of a preliminarv
staff evaluation of information submitted to EPA. State;'ents
made herein are not to be regarded as expressing fi~a~
Agency policy or intent with respect to this particular
chem~cal. ,Any review of the status report should take int8
~ons~der~t~on the fact that it may be based on incomplete
~nformat~on .
[~.. ~Q,", IJ~ ("1[". ~7I)
21
-------
8EHQ-0779-0297
Page 2 of 2
produced/imported in 1977. This production range infor~ation
does not include any production/i~portation data claimed as
confidential by the person(s) reporting for the TSCA inventory,
nor does it include any infor~ation which would compromise
Confidential Business Information. The data sub~itted for the
TSCA Inventory, including production range infor~ation, are
subject to the li~itations contained in the Inventory Reporting
Regulations (40 CPR 710).
The submitter states that SRC-II heavy distillate is not envi-
sioned as being produced as a separate ite~ in commerce, but
rather as a component of a fuel oil product.
Comnents/Reco~mendations
( a)
~he submitter should be requested to provide full copies of
the final results fro~ this skin painting study including
test protocols and data. In addition, the sub~itter should
be asked to provide any available data describing the chem-
ical co~position of SRC-II heavy distillate.
(b)
A copy of the sub~ission and
r1itted to OSHA, NIOSH, OWW~1,
report should be trans~itted
submission.
status report should be trans-
and ORD. A copy of the status
to the DOE contact cited in the
22
-------
AUG
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
6 " ,~
;.;;.; .J
DATE:
Revised (May 28, 1980)
8EHQ-0779-029~
Page 1 of 1 / ,,2;:/
Approved . ~ //
;;/
,,/
Revision;F
Needed
SUBJECT:
Status Report* 8EH0-0779-0299
FR~: Walter W. Kovalick, Jr., Director
program Integration Division (~S-793)
TO: Joseph J. Merenda, Director
Assessment Division (TS-792)
Submission Description
On July 10, 1979, an FMC Corporation official reported that
approximately 1,000 pounds of Furadan@ lOG was released by an
"aerial applicator" into the air over a farm pasture in
Harrisonburg, VA. The incident was reported by telephone to
Lynda Young, BPA Region III. BPA headquarters received a follow-
up letter to the telephone incident on July 23, 1979.
Submission Evaluation
Furadan@ lOG is a pesticide registered by EPA (No. 279-2712 AA)
according to the Federal Insecticide, Fungicide and Rodenticide
Act. As was mentioned in the follow-up letter, Furadan@ lOG is
not subject to the reporting requirements of section 8(e),
because it is not a chemical substance as defined by the ~oxic
Suhstances Control Act.
Comments/Recommendations
This incident was referred to the Office of Pesticide Programs
for follow-up.
*NOTE: This status report is the result of a preliminary
staff evaluation of information submitted to EPA. Statemen~s
made herein are not to be regarded as expressina final
Agen~y policy or intent with respect to this pa~ticular
chem~cal. ,Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nforma t~on. ~
E~A 'OIltM 11»-4 f"EV. )-7&\
23
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
,;L;2 2 2 1979
SUIJE CT:
Status Report*
8EHQ-0879-0300
8EHQ-0879-0300
Page I Of~
Approved
Revision
Needed
OA TE:
Revised (May 28, 1980)
~R~: Walter W. Kovalick, Jr., Director
program Integration Division (TS-793)
TO: Joseph J. Merenda, Director
Assessment nivision (TS-792)
Submission Description
Raccoon Valley Truck Stop, Tennessee, Spill of Acrylonitrile
Cincinnati Milacron Chemicals, Inc. reported that on July 23,
1979, 30 to 35 gallons of acrylonitrile were spilled from a truck
enroute from Cincinnati, Ohio to SalisQury, NC. The acryloni-
trile leaked from a damaged drum. The submitter estimates that
most of the spill probably occurred at the Raccoon Valley Truck
stop where the leak was detected. Immediately after the spill, a
hazardous material recovery team, local police, civil defense,
DOT and Cincinnati Milacron employees assisted in the clean-up
and recovery. On July 24, the spill was reported to the National
Response Center which then contacted EPA Region IV, the Coast
Guard's Office of Hazardous MaterialS, the Bureau of Motor
Carrier Safety, and the National Transportation Safety Board.
Submission Evaluation
Acrylonitrile is an extreme irritant to the skin; it is also
toxic when inhaled. However, no injuries or illnesses were
reported to have resulted from this incident.
Comments/Recommendations
Que to the fact that a small quantity of acrylonitrile was
released which was immediately cleaned up, no further action is
indicated either by the State, EPA or other Federal agencies.
*NOT~: This ~tatu~ ~eport is the result of a preliminarv
staf- eva~uat~on o~ ~nformation submitted to EPA. State~ents
made here~n are not to be regarded as expressing flnal
Agen~y POllCY or lntent with respect to this particular
chem~~al. ,Any review of the status report should take into
~o~s~ e:~t~on the fact that it may be based on incomplete
In_orma_lon.
I:~A '0- 11»1 lIltEV. ~11)
24
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
JAN 30 II) 8EHQ-0879-0301
8EHQ-0879-0301 Supplement
DATE: Revised (May 28, 1980)
SUBJECT:
Status Report*
,.~~ D. Kover,
Chemical Hazard
8EHQ-0879-0301
8EHQ-0879-0301
Page 1 of 2~
Approved
Supplement
Revision
Needed
Chief
Identification Branch
TO: Joseph J. Merenda, Director
Assessment Division, aTE
Submission Description
Both the initial and supplemental submissions (provided by the
Union oil Company of California and Texaco, Inc., respectively)
present final results from the same trade-association sponsored
mutagenicity study of Number 2 Home Heating Oil. The submitters
report that the results indicate that this fuel oil had the
ability to produce mutagenic effects in the following test
systems: in vitro mouse lymphoma test (with and without
metabolic activation): in vivo rat bone marrow cytogenetics test
{via oral administration]: and Ames test (with and without
metabolic activation). The conducting laboratory had judged that
the results of the Ames test were equivocal based on the lack of
a dose-related effect: the other test results were judged
positive for mutagenicity.
Submission Evaluation
Number 2 Home Heating oil did evidence mutagenic potential in all
of the performed tests. Both with and without metabolic activa-
tion, this oil was found to increase the mutation frequency in
several bacterial strains used in the Ames test and, in the cul-
tured mammalian cells in the mouse lymphoma assay. Via oral
administration, Number 2 Home Heating oil was found to increase
the number of chromosomal aberrations (e.g. chromatid breaks) in
the in vivo rat bone marrow cytogenetics test.
Current production and Use
According to information provided in the supplemental submission,
Number 2 Home Heating Oil is a mixture of virgin and catalyti-
cally cracked petroleum stocks (CAS Numbers 64741-44-2 and 64741-
*NOTE: This status report is the result of a preliminary
sta£f evaluation of information submitted to EPA. Statements
made herei~ are n~t to be , regarded as expressing final
Agency pol~cy or ~ntent w~th respect to this ?articular
chem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nforma t~on.
r:~A '0- 11»-4 I'-EV. )071)
25
-------
8EHQ-0879-030l
8EHQ-0879-030l Supplement
Page 2 of 2
A review of the production range (includes importation volumes)
statistics for Straight Run f1iddle Distillate (CAS. No. 64741-44-
2) which is listed in the initial TSCA Inventory has shown that
approximately 100 billion pounds of this chemical were
produced/imported in 1977.**/
A review of the production range (includes importation volumes)
statistics for Light Catalytic Cracked Distillate (CAS. No.
64741-59-9) which is listed in the initial TSCA Inventory has
shown that between 53 billion and 90 billion pounds of this
chemical were produced/imported in 1977.**/
Comments/Recommendations
The Agency has previously received and evaluated a section 8(e)
submission which indicated that Num~er 2 Burner Fuel, also
composed of virgin and catalyticall~' cracked stocks, had caused
malisnant skin neoplasms following lifetime dermal application to
mice (8EHQ-0778-0215).
(a) Both submitters should be requested to describe the
actions taken by their companies in light of the
submitted toxicity information to reduce or eli-
minate exposure to this fuel and/or to warn workers
and purchasers of this new toxicity information.
(b) Copies of these submissions and status report ~hould
be transmitted to DOE, OSHA, NIOSH, and OWWM.
**/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
26
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f'\' ':: 0 ItW\
~- .. I '-~ '-.~ ~
DATE:
Revised (May 28, 1980)
8EHQ-0879-0304
Page 1 of 2. ~. b~
//' //
Approved /'/ /
Revision
Needed
SU8JECT: $tatl1s Report* 8EHQ-0879-0304
~~ .
~~ Frank Kover, Chief
, 'Chemical Hazard Identification Branch
Joseph J. Merenda, Director
TO: Assessment Division, aTE
Submission Description
The submission consists of a report from a BF Goodrich Company
employee who states that numerous cases of dermatitis and several
cases of nausea and dizziness have been observed in co-workers
exposed to a number of organic solvents, treated fabrics, and
cements used in the workplace. A company-prepared form entitled
"Toxic Substances Control Act Substantial Risk Report" was used
by the employee in reporting the information to the EPA.
Submission Evaluation
In the absence of more detailed information, it is not possible
at this time to determine which chemical or combination of
chemicals is directly responsible for the observed adverse health
effects. Many organic solvents are known to be irritating to the
skin and can cause dizziness and nausea if inhaled.
The information pertaining to the inadequate safety precautions
taken and the adverse health effects observed following exposure
to chemicals in the workplace would be of interest to OSHA and
NIOSH.
Comments/Recommendations
Accordina to Part V and Part V(a) of the March 16, 1978, section
8(e) pOlicy statement (43 FR 11110) the Agency considers the
effects for which substantial-risk information must be reported
to include: "Any instance of cancer, birth defects, mutagenicity,
*NOTE: This status report is the result of a prelimina=y
staff evaluation of information submitted to EPA. Statements
made herei~ are n~t to be , regarded as expressi~g final
Agency pol~cy or ~ntent w~th respect to this particular
chem~cal. ,Any rev~ew of the,status report should take into
~ons~der~t~on the .act that ~t may be based on incomplete
~nforma t~on.
E~A '0- U- f.""L ~".I
27
-------
8EHQ-0879~0304
rage 2 of 2
death, or serious or prclonged incapacitation, including the loss
of or inability to use a normal bodily function with a consequent
Few) chemicals(s) is strongly implicated."
In general, the Agency does not consider the observation of
certain symptoms (such as dermal ailments or nausea) by
themselves to be reportable under section 8(e) of TSCA. However,
in certain cases there is an obligation to report such effects
under section 8(e) if they are suspected of being precursor
symptoms to more serious human health effects.
Inquiry was made of the NIOSH Health Hazard Evaluation Program,
operating out of Cincinnati, Ohio, to determine what assistance
the program could provide in cases such as this. A representa-
tive of the program forwarded copies of a NIOSH booklet
(attached) which describes the program. The booklet specifies
that before NIOSH can act, a request for a health hazard
evaluation must be made by one of the following: an employer
representative; an authorized representative of the employees for
collective bargaining purposes; an authorized representative of
two or more employees; or one of three or less employees in the
workplace. The booklet also contains a form which can be used to
request a workplace evaluation.
a)
b)
A copy of the booklet on NIOSH's Health Hazard Evaluation
Program and a copy of the March 16, 1978 section 8(e) Policy
statement should be sent to the submitter. The submitter's
employer should also receive a copy of the status report.
Copies of the submission, status report, and followup letter
should be sent to OSHA -and NIOSH. PID should also receive a
copy of this package.
28
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
, t1 1900
8EHQ-0979-030S
8EHQ-I079-030S Supplernen
Page 1 of 3d 0
APprovedpl
Revision
Needed
OATE:
Revised (May 28, 1980)
SUBJECT: Status Report * 8EHQ-0979-030 5
and 8EHQ-I079-0305 (Supplement)
F~~F~ank D. Kover, Chief
~/ Chemical Hazard Identification Branch
TO: Joseph .}. Merenda, Director
Assessment Division, OTE
Submission nescription
The two submitters (the Union Carbide Corporation and the
Celanese Corporation) present somewhat differing assessments of
the results from a preliminary pathologic examination of rats
sacrificed at the termination of a 24-month chronic inhalation
toxicity study of ethylene oxide (CAS No. 75-21-8) at concentra-
tions of 10, 33, and 100 ppm. The study is being co-sponsored by
12 companies. In the initial supmission, Union Carbide states
that "an assessment of the preliminary examination.. .has led to a
suspicion that at the highest concentration (100 ppm) ethylene
oxide may have increased the incidence of [leukemia and] tumors
in certain organs over that seen in similar organs in two control
groups of rats." At a later point in the submission the
incidence of tumors and leukemia in the highest group was charac-
terized as being "statistically significant." The initial
submission also reported a statistically significant increase in
mortality at the 100 ppm level over that seen in controls. In
the supplemental submission, Celanese reported similar findings
for the 100 ppm group but went on to state that "at the mid-
exposure level (33 ppm) a higher incidence of subcutaneous skin
masses or nodules and a higher mortality rate was observed." It
was not stated by the supplemental submi t_ter whether the findings
in the 33 ppm group were statistically significant.
Submission Evaluation
An increased incidence of lesions, particularly neoplasms, over
that which is known to occur spontaneously is always of con-
cern. ~he assumption is that various factors (e.g., chemicals,
*NOTE: This status report is the result of a prelimi~a=v
staff evaluation of information subrnittec to EPA. Sta~e~er.ts
made herein are not to be regarded as expressina flnal
Agency policy or intent with respect to t~is pa~ticular
chem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nformat~on .
E.-A "Q- u.- ,."'''- ..7&1
29
-------
8EHQ-0979-0305
8EHQ-1079-0305 Supplement
Page 2 of 3
viral infections, etc.) can diminish the organism's ability to
control the development of such neoplasms. This lack of control
results in the reappearance in the organism of embryonic and
fetal development processes (e.g., appearance of alpha-feto
protein during tumor development; appearance of placental enzymes
in men and non-pregnant women during development of cancer;
reappearance of fetal liver enzymes in mature rats which have
been administered carcinogens).
On the basis of the preliminary pathologic findings, ethylene
oxide appears to have had oncogenic activity in the study. Final
assessment of this study will have to await the final laboratory
and pathology report. The supplemental submitter's contention
that "33 ppm was a 'minimal effect level' and that 10 ppm was a
no effect level" appears somewhat premature in light of the
preliminary nature of the available data.
Current production and Use
The annual production of ethylene oxide was, according to
secondary sources consulted, greater than 4 billion pounds in
both 1975 and 1976.
A review of the production range (includes importation volume)
statistics for ethylene oxide (CAS No. 75-21-8) which is listed
in the initial TSCA Inventory (1977) has shown that between 1.46
billion and 5.36 billion pounds of this chemical were produced/
imported in 1977. This production range information does not
include any production/importation data claimed as confidential
by the person(s) reporting for the TSCA Inventory, nor does it
include any information which would compromise Confidential
Business Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
Ethylene oxide is used as an intermediate in the production of
ethylene glycol, acrylonitrile, ethanolamine, glycol ether, and
non-ionic surfactants. It is also used as a sterilant and
fumigant.
Comments/Recommendations
The information contained in these submissions is indicative of
the oncogenicity of ethylene oxide but is not sufficiently
complete to assess, at this time, the oncogenic or carcinogenic
potential of ethylene oxide under the conditions of this study.
The initial
examination
conclusions
submission states that the "detailed microscopic
of the tissues, recording of results and drawing of
to the experiment will require an additional year.
30
-------
8EHQ-0979-030S
8EHQ-0979-030S Supplement
Page 3 of 3
The full report will be submitted when it issues."
(a)
The initial submitter states that a copy of his submission
has been sent to NIOSH, OSHA, NCI, and ACGIH. However, in
order to insure completeness, a copy of this status report
and both submissions should he transmitted ~o NIOSH, OSHA,
NCI, ACGIH, CPSC, FDA, lTC, OAQPS, OPP, and TRDB/AD.
31
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
3 0 I9ro
8EHQ-0979-0306
8EHQ_ll79-~3l6
Page 1 of 3
Approved
Revision
Needed
OA TE: Revised (Hay 28, 1980)
SUBJECT: Status Report* REHO-0979-0306
.~ 8EHO-ll79-03l6
P:ROM/fi~~k D. Kover, Chief
Chemical Hazard Identification Branch
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Descriptions
Submissions 8EHO-0979-0306 and 8£HO-ll79-03l6 (received from the
Exxon Corporation and the Exxon Company, U.S.A., respectively)
present summaries of preliminary results from ongoing mouse
dermal carcinogenicity assays of experimental coal-derived fuel
oils. Both submitters state that the preliminary results
indicate that the tested substances (listed below) have caused
tumors in mice "within time periods which indicate high
carcinogenic potency."
In providing these preliminary results under section 8(e) both
submitters report that although the findings are "qualitatively
consistent with the known carcinogenic potential of high-boiling,
coal-derived materials", they have not been able to establish
that the published scientific literature contains specific data
on these particular fractions.
8EHO-0979-0306
1. Experimental pyrolysis fuel oil fraction derived from
~ast Texas lignite (untreated: from test gasification).
2. Experimental pyrolysis fuel oil fraction derived from
Arkansas lignite (untreated: from test pyrolysis).
3.
Illinois bituminous coal-derived heavy fuel oil (from
direct liquefaction tests).
4. Wyoming sub-bituminous coal-derived distillate fuel oil
(from direct liquefaction tests).
8EHQ-ll79-03l6
5. Experimental pyrolysis fuel oil fraction from East Texas
lignite (hydrotreated: from test gasification).
*NOTE: This status report is the result of a Prelimina~y
t ~~ 1 . ~. f -
s a_- eva.uat~on o~ ~n ormation submitted to EPA. Statements
made here~~ are n~t to be regarded as expressing final
Agen~y pol~cy or lntent with respect to this particular
chem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
lnforrnat~on .
r;~A 1'0""" IJ~ '1'1£"'. ..111
32
-------
8EHQ-0979-0306
8EHQ-1179-0316
Page 2 of 3
Submission Evaluation
In the absence of submitted chemical analyses, it could be
presumed that all of the tested coal-derived fractions contain
polynuclear aromatic hydrocarbons and triterpanes. Triterpanes,
which are structurally similar to important human steroid
hormones (e.g. pregnanes), may also exhibit certain biological
activities.
Of the samples tested, the untreated pyrolysis fuel oil fraction
derived from East Texas lignite (sample 1. above) appears to be
the most potent oncogen. The other samples, although less
potent, do exhibit oncogenic activities in these ongoing studies.
Current Production and Use
A search of the master inventory file has shown that these
experimental coal-derived fuel oils are not listed on the intial
TSCA Inventory. There are relatively few entries on the TSCA
Inventory which are "coal-specific" and those that are listed,
are non-specific with regard to the geographical source of the
coal.
It is assumed that these experimental coal-derived fractions are
intended for use as feedstocks for subsequent distillation and
treatment in a refining plant. The end-uses of the resulting
refinery products (i.e. synthetic natural gas, gasoline,
solvents, etc.) are expected to be similar to those for petroleum
oil products.
Comments/Recommendations
Status reports have been prepared for a number of section 8(e)
submissions received on synthetic and petroleum fuels: 8EHQ-0029,
0030, 0044, 0082, 0083, 0117, 0148, 0212, 0215, 0216, 0217, 0238,
0240, 0247, 0252, 0253, 0297, and 0301. (These numbers represent
the last four digits of the Document Control Officer assigned
numbers.)
a) Both submitters report that the studies are continuing and
that the Agency will be advised of the outcome. However, at
this time, the submitters should be requested to provide full
copies of the reported interim results including test proto-
cols and any available pathology data from these ongoing
mouse dermal carcinogenicity studies. In addition, the
submitters should be requested to provide the CAS numbers (if
known) and any available data from chemical analyses of these
coal-derived fractions.
33
-------
8EHQ-0979-0306
8EHQ-1179-0316
Page 3 of 3
b) The submitters should also be requested to describe any
actions taken by their companies, in light of this toxicity
information, to reduce or eliminate exposure to these
chemicals and/or to warn workers and purchasers of this new
toxicity information.
c) Copies of these submissions and status report should be
transmitted to DOE, OSHA, NIOSH, OWWM, and ORD.
d) CHIS will review the additional data requested, revise this
Status Report as appropriate, and recommend further followup
assessment if warranted.
34
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
3(00)
DATE:
Revised (May 28, 1980)
8EHQ-0979-03l0
Page 1 Of~
Approved
Revision
Needed
SU8JECT: Status Report* 8EHO-0979-03l0
'R~k D. Kover, Chief
Chemical Hazaro Identification Branch
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Description
The Aerojet-General Corporation reports that eleven chlorinated
organic chemicals have been identified as groundwater
contaminants at a site outside Sacramento, California. The
submitted chemical analyses show that tricl1loroethylene, 1,1,1-
trichloroethane, chloroform, carbon tetrachloride, trans-l,2-
dichloroethene (incorrectly spelled in the submitted table),
tetrachloroethylene, l,l-dichloroethane, l,l-dichloroethylene,
l,2-dichloroethane, chlorobenzene, and 1,1,2-trichloroethane are
present in varying concentrations in several different domestic
and industrial well water samples and test borings. The
submitter states that"the adverse effects and the extent of the
risk involved are unknown." In addition, the submission reports
that evic'!ence that the submitter and/or a near-by company are the
source of this groundwater c0ntamination has not been shown.
Submission Evaluation
With one exception (chlorobenzene) the contaminating chemicals
are chlorinated derivatives of methane, ethane, and ethylene.
Several of these are carcinogens. All of the reported chemicals,
including chlorobenzene, cause liver injury. Most of the
chemicals also cause kidney injury. Such closely related
chemical compounds may have the potential for synergism.
Current Production and Use
Based on the nature of this submission, a review of the current
production and uses of the subject chemicals is not necessary at
this time.
*NOTE: This status report is the result of a prelimina=y
staff evaluation of information submitted to EPA. Statements
made he=ein are not to be regarded as expressing final
Agen~y policy or intent with respect to this particular
chem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nformat~on .
E,." '0""" 11»-4 (~EV. ~7iJ
35
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8ERQ,-0979.,-.0310
Page 2 of 2
Comments/Recommendations
Region IX has placed this site of contamination on the list of
Uncontrolled Hazardous Waste Sites. It is the concensus of
Region IX and the State of California that this site presents a
potential hazard to human health and the environment.
A report (FRL-756-4) on the human effects caused by exposure to
chemical contaminants in drinking water has been prepared by the
National Academy of Sciences in accordance with the Safe Drinking
Water Act (P.L. 93-523).
EPA has recently published (november 29, 1979) a final rule which
establishes a maximum contaminant level for total trihalomethanes
(THMs), including chloroform, in drinking water of 100 ppb (40
CPR 68624). This requirement will apply in two years to water
systems serving communities of 75,000 or more and to systems
serving 10,000-75,000 in four years.
( a )
Follow-up activities by state and local agencies concerning
this reported contamination will be monitored by Region
IX. CHIB has requested to be informed of any future devel-
opments by way of status reports prepared by the Hazardous
Materials Branch, Region IX.
(b)
A copy of this status report should be transmitted to the
Region IX Office (Hazardous ~laterials Branch). A copy of
the original submission was transmitted previously to that
branch by CHIB.
( c)
Copies of the submission and status report should be
transmitted to OWWr1, SAD/OPII, PID/OPII, CREB, and TRDB.
3F
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SUBJECT: Status Report * 8E1},>.0979-03l1
~;(F~ank D. Kover, Chief
,.~ Chemical Hazard Identification
Branch
8EHQ-0979-0311
kcrov:;ge;p! 0z/~
Revisionpi'
Needed
DATE:
Joseph J. Merenda, Director
TO: Assessment Division, OTE
Submission Description
In a letter dated January 15, 1980, the submitting company
withdrew its claims of confidentiality for this notice.
PPG Industries, Inc. has reported that a chemical mixture (see
Table I below), when applied to the eyes of rabbits, caused a
clouding of the corneas within 20 seconds. Subsequent water
rinsing of the affected eyes for one minute Jid not alleviate the
condition; cloudiness and several ulcers of the corneas were
still evident 14 days following application of the mixture. In
addition, the submitter reports that two previous laboratory
studies have demonstrated that diallyl diglycol carbonate alone
does not cause demonstrable eye irritation or other abnormality.
with regard to the nature and extent of the risk involved the
submitting company states:
"Based upon the information reported..., the nature
of the risk is immediate and irreversible changes
(opacity and ulceration) to the corneas of rabbits.
These lesions would be expected to indicate a par-
tial or total loss of visual function of the eye.
The extent of the risk is limited by the fact that
this mixture was in PPG Industries, Inc., research,
was not manufactured and, to the best of the [sub-
mitter's] knowledge, has not been distributed."
TABLE I
Chemical Mixture Components
75%
20%
5%
100 ppm
Diallyl diglycol carbonate
Maleic anhydride
Tungsten hexacarbonyl
Hydroquinone monomethyl ether
CAS no.
CAS No.
CAS No.
CAS No.
142-22-3
108-31-6
14040-11-0
150-76-5
*NOTE: This status report is the resul t of a prelimina=';
staff eva~uation of information submitted to EPA. State~ents
made here~~ are n~t to be , regarded as exp~essing final
Agen~y pol~cy or ~ntent wlth respec~ to t~is par~icular
chem~cal. ,Any review of the status report should take intc
7ons~der~t~on the fact that it may be based on incompl t
lnformat~on. . e e
E~A '0"" IJ~ I"EV. ..,11
37
-------
SEHQ-0979-0311
Page 2 of 3
Submission Evaluation
Maleic anhydride is the most likely substance in the mixture to
produce rapid corneal opacity and ulceration. The Merck Index
points out that maleic anhydride is a powerful irritant that can
cause burns. The 1 minute post-application wash reported was
inadequate (the Merck Index recommends at least a 15 minute
wash). However, there is a possibility that the observed effects
were due to a combination of two or more of the components in the
tested mixture. Further studies would have to be conducted to
better define the observed toxicity. The diallyl diglycol
carhonate and tungsten hexacarbonyl alone might be somewhat
irritating but they are not likely to be corrosive. Hydroquinone
monomethyl ether is one of several monoalkyl ethers of hydro-
quinone that are used as antiseptics. A concentration of 100 ppm
would not be likely to produce the observed rapid corneal
opacity.
Current Production and Use
A review of the production ranges (includes importation volumes),
for those mixture components which are listed in the initial T8CA
Inventory, has shown the following amounts reported as
produceo/imported in 1977:
Chemical Name
Approx. Prod./Import.Range **j
Diallyl diglycol carbonate
(CAS No. 142-22-3)
Maleic anhydride
(CAS No. 108-31-6)
Hydroquinone monomethyl ether
(CAS No. 150-76-5)
1 million to 10 million lbs.
100 million to 457 million lbs.
100 thousand to 1 million lbs.
A search of the master inventory file for tungsten hexacarbonyl
(CAS No.14040-ll-0) has shown that this chemical is not listed on
the TSCA Inventory. Information on the production/importation
volumes for this chemical could not be located in the secondary
literature sources consulted.
Information on the actual/proposed uses of the chemical mixture
was not provided in the submission. The mixture is apparently
still in R & D.
**/ This production range information does not include any production/
importation data claimed as confidential by the person (s) reporting
for the TSCA Inventory, nor does it include any information which
would compromise Confidential Business Information. The data sub-
mitted for the TSCA Inventory, including production range information,
are subject to the limitations contained in the Inventory Reporting
Regulations (40 CFR 710).
38
-------
BEHQ-0979-0311
Page 3 of 3
(a)
Comments/Recommendations
(b)
The submitting company should be requested to describe
the actions it has taken, in light of the reported toxic-
ity information, to warn workers and/or to reduce or
eliminate exposure to the subject chemical mixture and
its components.
The Agency should transmit a copy of this submission and
status report to OSHA and NIOSH. Because tungsten hexa-
carbonyl was not located on the master TSCA Inventory,
the Premanufacturing Review Division/OCC should also
rpceive copies of this information.
39
-------
: ~',
.ir ~
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
2 1900
SUBJECT: Status Report*
~-Frank D. Kover,
a~: Chemical Hazard
8EHQ-I079-0312
8EHQ-I079-0312
Page I of 2 //~~
Approved ~~~/ (
0... TE:
Revised (May 28, 1980)
Chief
Identification Pranch
Revis ion /
Needed
Joseph J. Merenda, Director
TO: Assessment Division, OTE
Submission Description
The Exxon Company, U.S.A. has submitted a summary of the final
results from a 12-week inhalation toxicity study of ISOPAR C and
VARSOL 40 solvents in male and female rats. Evidence of kidney
damage is reported for male rats exposed to the solvents.
Submission Evaluation
Both ISOPAR C and VARSOL 40 appear to produce typical toxic
nephrosis (degeneration of the epithelial cells of the kidney
tubules without damage to the basement membrane). Mercury,
dichromate, uranium, chloroform, carbon tetrachloride, dioxane,
and many other chemicals produce similar lesions in the kidney.
Current Production and Use
The submitter states that ISOPAR C is an isoparaffinic
hydrocarbon solvent (CAS No. 64741-66-8).
A review of the production range (includes importation)
statistics for CAS No. 64741-66-8 (naptha (petroleum) light
alkylate) which is listed in the initial TSCA Inventory (1979)
has shown that between 8.7 billion and 27.3 billion pounds of
this chemical were produced/imported in 1977.**
"ISOPAR" is a trademark for a group of high-purity paraffinic
materials. These materials are used as odorless solvents,and
reaction diluents, and are permitted under a number of FDA
regulations for food-related applications.
The submitter states that VARSOL 40 (a mixture of aromatic,
paraffinic, and napthenic hydrocarbons,) is not marketed in the
u.S. However, VARSOL 40 is similar to VARSOL 1 which is
distributed in commerce domestically. VARSOL 1, like VARSOL 40,
*NO;E: This ~tatus ~eport is the result of a prelimina~y
sta_f evaluatlon of lnformation submitted to EPA. Statements
made herei~ are not to be regarded as expressing final
Agen~y POllCY or intent with respect to this particular
chem~cal. . Any review of the status report should take into
~onslder~tlon the fact that it may be based on incomplete
lnforma tlon.
1:"" '0- 1J~ ("1['0'. ~111
40
-------
8EHQ-1079-01l2
P. age- 2 0,[ 2
" '
is a mixture. The CAS No. of the petroleum hydrocarbon portion
of VARSO~ 1, exclusive of additives is 64742-88-7.
A review of the production range (includes
statistics for CAS No. 64742-88-7 (solvent
medium aliphatic) as listed in the initial
has shown that between 1.5 billion and 4.1
chemical were produced/imported in 1977.**
importation volumes)
naptha(petroleum) ,
TSCA Inventory (1979)
billion pounds of this
"VARSOL" is a trademark for straight petroleum aliphatic solvents
used as paint and varnish thinners, for dry cleaning, and for
general plant machinery cleaning.
Comments/Recommendations
a)
The submitter should be requested to provide a full copy
of the final results including test protocols and data
from the recently concluded l2-week inhalation toxicity
studies of ISOPAR C and VARSOL 40 in rats.
b)
The submitter should be requested to describe the
actions taken by his firm based on this information to
control exposure to the chemicals and/or to warn workers
or purchasers of this new toxicity information.
c)
Copies of this submission and status report should be
transmitted to FDA, OSHA, NIOSH, CPSC, OANR,
OCC/CAD, and OWWM.
**This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to
limitations contained in the Inventory Reporting Regulatio~s (40
CFR 710).
41
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
rer 158
8EHQ-1079-0314
Page 1 of 3
I
rrR~~;ank D. Kover, Chief.. .
Cnemical Hazard Identlflcatlon
Revision
Needed
~
OA TE:
Revised (July 30, 1980)
SUBJ E C:T:
Status Report* 8EHQ-l079-0314
Approved
Branch
TO:
Joseph J. Merenda, Director
Assessment Division
Submission Description
The Chemical Industry Institute of Toxicology (CIIT) and
several chemical manufacturers have provided the same
sU~TIary report of interim sacrifice pathology results from a
24-month innalation toxicity study of formaldehyde (CAS No.
50-00-0) in mice and rats. It is reported that nasal
squamous cell carcinomas have been detected in three (3) of
the rats sacrificed at the highest dose tested (15 parts per
million). No squamous cell carcinomas of the nasal cavity
have been observed by the performing laboratory in the
exposeu or control mice, nor in 480 control rats in this
study. One other case of squamous cell carcinoma was
observed in rats exposed to 6 parts per million. The
summary report states, however, that this particular lesion
differs from those reported at 15 ppm in that it appears to
have arisen from the spindle-cell layer of the skin which
makes the relationship of this neoplasm to formaldehyde
exposure less clear.
Submission Evaluation
The reported findings of nasal squamous cell carcinomas in
Fischer 344 rats appear to be highly significant as this
particular type of lesion is not frequently observed. As
the provided summary pathology reports note:
"In two recently completed inhalation studies involving
a total of 1920 Fischer 344 rats purchased from the
same supplier, no similar cancer was observed. The
same is true in two feeding studies involving 1680
*NOTE: This status report is the result of a preliminary
sta!f evaluation of information submitted to E~A. State~ents
made here~n are not to be regarded as expressing final
Asency pol~cy or ~ntent with respect to this particular
c:Jem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
lnforma t~on.
I:~A "0'-111 1J~ ('-EV. ..711
42
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8EHQ-1079-03l4
Page 2 of 3
rats. A survey of spontaneous lesions in 3,548 aging
Fischer 344 rats of both sexes (Goodman et al.,
Toxicol. Appl. Pharmacol. 48:237-248, 1979)~ails to
mention squamous cell carcinoma originating from the
nasal respiratory epithelium."
A description of the experimental protocols and complete
copies of any interim sacrifice pathology data, at a
minimum, would be necessary to permit further evaluation of
the findings summarized by these submissions.
Current Production and Use
A review of the production range (includes importation
volumes) statistics for formaldehyde (CAS. No. 50-00-0)
which is listed in the initial TSCA Inventory, has shown
that between 2 billion and 7.9 billion pounds of this
chemical were reported as produced/imported in 1977.**/
Formaldehyde has uses in: urea and melamine resins;
polyacetal resins; phenolic resins; ethylene glycol;
pentaerythritol; hexamethylenetetramine; fertilizer dyes,
medicine (disinfectant, germicide); embalming fluidsi
preservative; hardening agent; reducing agent, as in
recovery of gold and silveri corrosion inhibitor in oil
wells; durable-press treatment of textile fabrics; possible
condensation to sugars and other carbohydrates for food use
(experimental); industrial sterilant; treatment of grain
smut.
Comments/Recommendations
(a)
The Agency should request complete copies of the
experimental protocols and full pathology data from
all interim sacrifices to date from this inhalation
toxicity study of formaldehyde in rats and mice.
**/ This production range information does not include any
-- production/importation data claimed as confidential by
the person(s) reporting for the TSCA Inventory, nor does
it include any information which would compromise
Confidential Business Information. The data submitted
for the TSCA Inventory, including production range
information, are subject to the limitations contained in
the Inventory Reporting Regulations (40 CFR 710).
43
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8EHO-I079-0314
Page 3 of 3
(b) The Agency should transmit a copy of these
summarized interim pathology results and EPA status
report to OSHA, NIOSH, FDA, CPSC, NCI, HUD, DOE, and
the interagency formaldehyde workgroup.
44
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
0" T E;
8EHQ-I079-0315
Page 1 o~
Approved
(/
Revision
Needed
1/;7/10
SUBJECT:
Status Report* 8EHQ-1079-03l5
. I F/~r'-a nk D .
Kover, Chief
FR~: Chemical Hazard Identification Branch
Joseph J. Merenda, Director
TO: A t D. . .
ssessmen lV1Slon
Submission Description
The Standard Oil Company (Indiana) reports that an employee in
its liquid polymerization unit had complained of "severe throat
irritation and an alarming shortness of breath, with chest pain
on occasion" from inhaling the combined vapors of (1) tri [mixed
mono- and dinonylphenyl] phosphite and (2) thiodipropionate ester
complex. The submitter also states that the employee claiming
"substantial risk", had neither sought any medical attention from
the company's medical department at the time of the alleged
exposure, nor complains of any lasting effects.
In addition, the submitter reports that, although the above mate-
rials have been handled since before 1968, to the company's know-
ledge there have he en no previous complaints other than "simple
respiratory irritation." The suhmitter does state however, that
if "any information that verifies any evidence of substantial
risk" is received, the Agency will be informed immediately.
Submission Evaluation
Inhalation of irritants can lead to a constriction of the smooth
muscle of the airways which would account for the reported diffi-
culty in breathing, shortness of breath, and c~estpain. Such nar-
rowing of the airways would be caused by histamine, acetylcholine
or norepinephrine. Respiratory tract irritants could cause the
release of one or more of these substances from nerve endings or
mast cells present in the tracheobronchial smooth muscle.
Current Production and Use
Due to the nature of the information contained in this submis-
sion, a review of the current production of the subject chemicals
does not appear to be necessary at this time.
The chemicals are apparently used as stabilizers/inhibitors in
certain rubber and/or plastic polymerization processes.
*NOTE: This status report is the result of a preliminary
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this par~icular
chemical. Any review of the status report should take into
consideration the fact that it may be based on incomplete
informa tion.
I[~A '0"" U2D-f, I~£V. 1-151
45
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~EHQ-1079-03l5
Page 2 of 3
Comments/Recommendations
It is the Agency's preliminary determination that the acute
toxicity information, as presented in this submission, did not
warrant being reported under section 8(e) of TSCA. The rationale
for this preliminary determination is as follows:
According to Part V of the March 16, 1978 "Statement of
Interpretation and Enforcement Policy; Notification of
Substantial Risk" (43 FR 11110), a substantial risk of
injury to health is a risk of considerable concern be-
cause of (a) the seriousness of the effect... and (b)
the fact or probability of its occurence." With regard
to the seriousness of the effect, the Agency considers
the human health effects for which substantial risk
information must be reported to include "any instance
of cancer, birth defects, mutagenicity, death or seri-
ous or prolonged incapacitation, including the loss of
or inability to use a normal bodily function with a
consequent relatively serious impairment of normal ac-
tivities...." In addition, Part VI(2) further states
that it is possible that effects less serious than
those described above may be preliminary manifestations
of those more serious effects and together with another
triggering piece of information, constitute reportable
information.
Therefore, because the human health effects reported in this sub-
mission do not appear to be serious and die not produce a pro-
longed incapacitation or serious impairment of normal activities,
the Agency believes that the provided acute human toxicity infor-
mation, when considered alone, did not warrant reporting under
section 8(e) of TSCA.
With regard to the submitter's statement which concerns the
reporting of obtained "information that verifies any evidence of
substantial risk", the Agency believes that the following
clarification is needed. The submitter should note that section
8(e) states that the information required for reporting is any
information which reasonably supports ~ conclusion that a chem-
ical substance or mixture presents a substantial risk of injury
to health or the environment. The Agency considers that reason-
able support of a conclusion of substantial risk is not identical
to the conlusion itself. The former typically occurs, and must
be reported at an earlier stage. In addition, Part VI of the
section 8(e) policy statement specifies that a "person is not to
46
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8EHQ-1079-0315
Page 3 of 3
delay reporting until he obtains conclusive information that a
substantial risk exists, but is to immediately report any evi-
dence which 'reasonably supports' that conclusion. Such evidence
will generally not be conclusive as to the substantiality of the
risk... ."
The Test Rules Development Branch/AD, with support from the
Chemical Review and Evaluation Branch/AD and the Environmental
and Health Review Divisions, is currently reviewing data received
by the Agency pertaining to the Interagency Testing Committee
(ITC) designated category "Aryl Phosphates." One of the chemi-
cals described in this 8(e) submission is a tri[mono- and dinonyl
phenyl]phosphite which can, by way of an oxidative pathway be
converted to the phosphate. Therefore, aninformation copy of
this status report and submission should be sent to TRDB/AD for
possible consideration in the ongoing review of data on aryl
phosphates.
a)
The submitting company should be reques.ted to describe
any actions taken, in light of the submitted toxicity
information, to warn workers and/or to reduce or elimi-
nate exposure to the subject chemicals.
b)
The Agency should transmit a copy of this submission and
status report to OSHA and NIOSH.
47
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
;'f' ~Otnon
.j: ,.,'i \.J t:KJU
SUIJECT: Status Report* 8EHQ-0979-0306
, (1- 8EHQ-1179-0316
'~rank D. Kover, Chief
I Chemical Hazard Identification
Branch
8EHQ-ll79-03l6
8EHQ-0979-0f!2!L306
Page 1 of 3
Approved
Revision
Needed
DA TE: Revised (May 28, 1980)
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Descriptions
Submissi~ns 8EHQ-0979-0306 and 8EHQ-1179-0316 (received from the
Exxon Corporation and the Exxon Company, U.S.A., respectively)
present summaries of preliminary results from ongoing mouse
dermal carcinogenicity assays of experimental coal-derived fuel
oils. Both submitters state that the preliminary results
indicate that the tested substances (listed below) have caused
tumors in mice "within time periods which indicate high
carcinogenic potency."
In providing these preliminary results under section 8(e) both
submitters report that although the findings are "qualitatively
consistent with the known carcinogenic potential of high-boiling,
coal-derived materials", they have not been able to establish
that the published scientific literature contains specific data
on these particular fractions.
8EHQ-0979-0306
1. Experimental pyrolysis fuel oil fraction derived from
East Texas lignite (untreated7 from test gasification).
2. Experimental pyrolysis fuel oil fraction derived from
Arkansas lignite (untreated7 from test pyrolysis).
3
Illinois bituminous coal-derived heavy fuel oil (from
direct liquefaction tests).
4. Wyoming sub-bituminous coal-derived distillate fuel oil
(from direct liquefaction tests).
8EHQ-1179-0316
5. Experimental pyrolysis fuel oil fraction from'East Texas
lignite (hydrotreated7 from test gasification).
*~O~E: This ~tatus ~eport i~ the result of a prelimina=y
s~a~f eva~uat~on of ~nformat~on submitted to EPA. Statements
made here~~ are n~t to be regarded as expressing final
Agency pol~cy or ~ntent with respect to this particular
chem~cal. . Any review of the status report should take into
~ons~der~t~on the fact that it may be based on incomplete
~nforma t~on.
E,." '0- 11»-6 (~!:v. ..711
48
-------
8EHQ-ll79-0316
8EHQ-0979-0306
Page 2 of 3
Submission Evaluation
In the absence of submitted chemical analyses, it could be
presumed that all of the tested coal-derived fractions contain
polynuclear aromatic hydrocarbons and triterpanes. Triterpanes,
which are structurally similar to important human steroid
hormones (e.g. pregnanes), may also exhibit certain biological
activities.
Of the samples tested, the untreated pyrolysis fuel oil fraction
derived from East Texas lignite (sample 1. above) appears to be
the most potent oncogen. The other samples, although less
potent, do exhibit oncogenic activities in these ongoing studies.
Current Production and Use
A search of the master inventory file has shown that these
experimental coal-derived fuel oils are not listed on the intial
TSCA Inventory. There are relatively few entries on the TSCA
Inventory which are "coal-specific" and those that are listed,
are non-specific with regard to the geographical source of the
coal.
It is assumed that these experimental coal-derived fractions are
intended for use as feedstocks for subsequent distillation and
treatment in a refining plant. The end-uses of the resulting
refinery products (i.e. synthetic natural gas, gasoline,
solvents, etc.) are expected to be similar to those for petroleum
oil products.
Comments/Recommendations
Status reports have been prepared for a number of section 8(e)
submissions received on synthetic and petroleum fuels: 8EHQ-0029,
0030, 0044, 0082, 0083, 0117, 0148, 0212, 0215, 0216, 0217, 0238,
0240, 0247, 0252, 0253, 0297, and 0301. (These numbers represent
the last four digits of the Document Control Officer assigned
numbers. )
a) Both submitters report that the studies are continuing and
that the Agency will be advised of the outcome. However, at
this time, the submitters should be requested to provide full
copies of the reported interim results including test proto-
cols and any available pathology data from these ongoing
mouse dermal carcinogenicity studies. In addition, the
submitters should be requested to provide the CAS numbers (if
known) and any available data from chemical analyses of these
coal-derived fractions.
49
-------
8EHQ-ll79-0316
8EHQ-0979-0306
Page 3 of 3
b) The submitters should also be requested to describe any
actions taken by their companies, in light of this toxicity
information, to reduce or eliminate exposure to these
chemicals and/or to warn workers and purchasers of this new
toxicity information.
c) Copies of these submissions and status report should be
transmitted to DOE, OSHA, NIOSH, OWWM, and ORD.
d) CHIB will review the additional data requested, revise this
Status Report as appropriate, and recommend further followup
assessment if warranted.
50
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
'I ,
8EHQ-1179-03l7
Page 1 of 3
Approved ~ ~//fl
Revision/
Needed
DATE:
SU8JECT: Status Report* 8
EHQ-1179-03l7
. '/ --
I~rank D. Kover, Chief
fRo..: Chemical Hazard Identification Branch
Joseph J. Merenda, Director
TO: Assessment Division/OTE
Submission Description
The FMC Corporation has determined that the n-octanol/water
partition coefficients for certain aryl phosphates are in excess
of 25,000 (see Table 1 below). According to Part V(b)(2) of the
March 16, 1978, TSCA Section 8(e) policy statement (43 FR 11110),
the finding of an n-octanol/water partition coefficient greater
than 25,000 is to be reported to EPA when the subject chemical
has potential for widespread exposure and can cause any non-
trivial adverse effect. In submitting this type of physi-
cal/chemical information under section 8(e), the company states:
"Because there may be a 'potential for widespread
exposure', and because there exists possibility of
'non-trivial adverse effects' (e.g., toxicity to fish}
this information may constitute 'substantial risk' informa-
tion as that term is interpreted by the Agency in Part
V(b) (2) of the Policy Statement.
Table I.
n-Octanol/Water Partition Coefficients of
Several Aryl Phosphates
Chemical CAS Number Partition Coefficient
Kronitex (R) 50 None Assigned (8.5 + 1. 5) x 104
- x 105
Kronitex (R) 100 None Assigned (1. 5 + 0.1)
Kronitex (R) 200 None Assigned (1.2 + 0.3) x 105
Trixylyl phosphate 25155-23-1 (5.1 + 0.3) x 105
Tricresyl phosphate 1330-78-5 (8.6 + 4.0) x 105
Kronitex (R) 200B None Assigned (1. 2 + 0.4) x 105
Kronitex (R) 50, 100, and 200 are mixtures of triphenyl phosphate
and isopropylphenyl phenyl phosphates. FMC formerly manufactured
Kronitex (R) 200B, which is a mixture of triphenyl phosphate and
t-butylphenyl phenyl phosphates.
*NOTE: This status report is the result of a prelimina=v
staff evaluation of information submitted to EPA. State~ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. . Any review of the status report should take into
7ons~der~t~on the fact that it may be based on incomplete
~nforma t~on.
E~... 'or--- u- ~ .--.. ~-..,
51
-------
8EHQ-1l79-0317
Page 2 of 3
Submission Evaluation
The n-octanol/water partition coefficients reported for these
aryl phosphates indicate that they will be fat-soluble and have
the potential for bioaccumulation.
In addition to the toxicity to aquatic species noted by the
submitter, aryl phosphates are known to be toxic to mammals,
including humans. Partly due to their lipid solubility, these
esters can be absorbed via all routes of exposure and certain of
the aryl phosphates can, in sufficient amounts, produce a delayed
neurotoxicity (e.g. axonal neuropathy).
Current Production and Use
A review of the production ranges (includes importation volumes)
for the subject chemicals, which are listed on the initial TSCA
Inventory, has shown that the following amounts were reported as
being produced/imported in 1977.
Chemical Name
CAS Number
Approximate Production/
Importation Range **/
Trixylyl phosphate
25155-23-1
2 thousand to 20
thousand lbs
Tricresyl phosphate
1330-78-5
100 thousand to 1
million lbs.
Triphenyl phosphate
115-86-6
2 million to 20
million lbs.
Phenol, isopropylated,
phosphate (3:1)
68937-41-7
10 million to 50
million lbs.
Phenol, isobutylenated, 68937-40-6
phosphate (3:1)
o
Organophosphate esters, specifically triaryl and trialkyl/aryl
phosphate esters, are widely used in many consumer and industrial
products where flame retardance or fire resistance are desirable
properties or mandatory requirements. The major uses of organo-
**/This production range information does not include any produc-
tion/importation data claimed as confidential by the person(s)
reporting for the TSCA Inventory, nor does it include any infor-
mation which would compromise Confidential Business Informa-
tion. The data submitted for the TSCA Inventory, inluding
production range information, are subject to the limitations
contained in the Inventory Reporting Regulations (40 CFR 710).
52
-------
8EHQ-1179-03l7
Page 3 of 3
phospha-:::.e tsters are as flame retardant plasticizers in polyvinyl
chloride (PVC) plastic materials and as industrial fire resistant
hydraulic fluids. Because of their flame retardant use in plas-
tics, these esters are found in numerous consumer products. The
use of or=?an'--,p"jo:.-:phate este:s az fir2 [;2.sistant hydraulic fluids
has led to wlaespread use in industrles maintaining hydraulic
systems close to high temperature sources. The organophosphate
esters have also been used in wood preservation and as additives
to lubricants and adhesives.
Comments/Recommendations
The Test Rules Development Branch/AD, with support from the
Chemical Review and Evaluation Branch/AD and the Environmental
and Health Review Divisions, is currently reviewing data received
by the Agency pertaining to the Interagency Testing Committee's
designated category: "Aryl Phosphates." Therefore, an infor-
mation copy of this statu~ report and submission should be sent
to TRDB/AD for possible consideration in the ongoing review of
data on the aryl phosphates. A copy of this submission and
status report should also be transmitted to OWWM.
a) The FMC Corporation should be requested to describe any
company actiuns taken, in light of t.he reported data on
phosphates, ~0 warn workers/customers, or to reduce or
eliminate exposure to the subject chemical substances.
aryl
53
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
1 4 1900
SUBJECT: Status Report* 8EHQ-1179-0318
~-Frank D. Kover, Chief
'FROM: Chemical Hazard Identification
Branch
8EHQ-1179-0318
Page 1 of 3 ~~
Approved ~;V / I
',/
Revis iorv/
Needed
0. TE:
Revised (May 28, 1980)
Joseph J. Merenda, Director
TO: As sessment Di vi sion, OTE
Submission Description
The CIBA-GEIGY Corporation has provided interim results from an
implantation study of strontium chromate (SrCr047 CAS No. 7789-
06-2) in rats. Stainless steel mesh pellets, containing strontium
chromate suspended in an equal weight of cholesterol, were
surgically implanted in the left inferior bronchiolus of
anesthetized rats. The submitter reports that after I year,
29/100 SrCr04 exposed animals had died. The submitter states
that "lesions consistent with the appearance of squamous cell
carcinomas were observed grossly in the left lung of 21 of the
dead animals." In questioning the relevance of these reported
data, the submitter raises the following points:
1 )
The diagnosis of squamous cell carcinomas has not yet
been confirmed histologicallY7
2 )
The exposure level to the test substance has not been
quantified7
3 )
The method of administering the substance is
extraordinarY7 and
4)
The test material submitted for the the study has not
been analyzed for purity or residual substances.
In addition, the submitter states that "the carcinogenicity of
strontium chromate in experimental animals has been known since
1961. Tne compound is currently listed in this regard in Table 2
of EPA's Support Document, Test Data Development Standards:
Chronic Health Effects, Toxic Substances Control Act, Section 4;
(EPA-560/l1-79-001) ."
*NOTE: This status report is the result of a preliminarv
staff evaluation of information submitted to EPA. State~ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. ,Any review of the status report should take into
cons~derat~on the fact that it may be based on incomplete
information.
£.-.. "0- 1J~ 1"£'1. ~7')
54
-------
8EHQ~1179~0318
Page 2 of 3
Submission Evaluation
The interim results from this implantation study are in support
of previous findings that strontium chromate is carcinogenic in
experimental animals.
With regard to the points raised by the submitter concerning the
relevance of the reported data:
1)
The laboratory scientists conducting
study in rats appear to be confident
examination will confirm their gross
squamous cell carcinomas.
this implantation
that microscopic
observations of
2, 3)
The "not quantified" exposure level of the strontium
chromate and the method of administration being
extraordinary cannot change the fact that the tested
substance is carcinogenic.
4 )
It is hoped that the tested substance would be
representative of the strontiu~ chromate being produced.
Current Production and Use
A review of the production range (includes importation volumes)
statistics for strontium chromate (CAS. No. 7789-06-2), which is
listed in the initial TSCA Inventory (1977), has shown that
between 123 thousand and 1.2 million pounds of this chemical were
produced/imported in 1977.~
The submitter states that strontium chromate is used as a
corrosion resistant agent in industrial primer coating
applications. Strontium chromate is also used in pyrotechnics
and in polyvinylchloride resins to produce pastel primrose
yellows.
Comments/Recommendations
The submitting company reports that the previous owner of the
(submitter's) Srcr04 production facilities notified its strontium
chromate customers By letter in 1976 of the "potential lung
cancer hazard from prolonged excessive inhalation of chromate
pigment dust." The submitting company also reports that it plans
to review and revise its Material Safety Data Sheet and
*/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does ot include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CPR 710).
55
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8EHQ-1179-0318
Page 3 of 3
precautionary labelling, if necessary, to ensure that its workers
and customers are aware of potential dangers.
NIOSH has developed criteria documents on both chromic acid and
chromium (VI).
a)
The submitter should be requested to provide a full copy of
the final results from this implantation study of strontium
chromate when that report becomes available.
b)
A copy of this submission and status report should be
transmitted to NIOSII, OSHA, NCI, and CPSC.
56
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
DEC 2 6 1979
'R~: Walter W. Kovalick, Jr., Director
program Integration Division (TS-793)
8EHQ-1179-03l9
Page 1 Of~2
Approved
Revision
Needed
OATE: Revised (May 28, 1980)
SUBJECT: Status Report* 8EHQ-1179-03l9
TO: Joseph J. Merenda, Director
Assessment Division (TS-792)
Submission Description: Avery Island Mine and Refinery Avery
Island, Louisiana: Spill of PCBs
On October 19, 1979, three General Electric 250 KVA transformers
were overturned during blasting of salt at the Avery Island Mine
of International Salt Company (ISC) at the 880 foot level.
Investigation discloseo that the resulting spill of PCBs (into
salt in the vicinity of the blast) amounted to approximately
thirteen gallons. The spill area was roped off and the
tranformers were removed to the surface of the mine and are
located on concrete pads at the shaft house. The presence of
PCBs (trade name: Inerteen, produced by Westinghouse) has been
confirmed in the fluid of all three tranformers at the following
levels: twenty percent in the first two and fifteen percent in
the third. The incident was reported to EPA Headquarters on
November 9, 1979. EPA Region Six was notified on November 20,
1979. Several phone conversations with International Salt
Company were necessary in order to gather all the details of this
incident.
Submission Evaluation
Available data indicate that PCBs may cause several adverse
health effects in humans, mammals, birds, and aquatic organisms
at extremely low concentrations. EPA has adopted the view that
"safe" or threshold levels cannot be established given the
present state of scientific knowledge. The first symptoms to
develop after human exposure to PCBs are skin rashes (such as
chloracne) and impaired liver function, both of which manifest
themselves approximately one week after exposure. Later,
neurological effects occur, particularly with regard to
peripheral nerves in the brain.
*NOTE: This status report is the result of a preliminary
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
consideration the fact that it may be based on incomplete
information.
E~A '0,"" UZ1>6 1111[\1. )-711
57
-------
8EHQ-1179-0319
Page' 2 of 2
Tests conducted by International Salt Company have shown no trace
of PCBs in production salt to the one-half part-per-million
level; ISC plans to test to five parts-per-billion. No employees
came into contact with the contaminated transformer fluid, but
sow~ testing personnel did; the fluid was immediately washed off
lheir hands and no skir. .Lashes have been reported. ISC shovelled
the contaminated material into plastics bags and placed them on
the floor of the mine; employees involved in the cleanup wore
closed respirators and plastics boots. ~he salt floor underneath
the spill, while relatively imp0rme~ble, will be chipped away
down to one foot and removed. Pleliminary testing of this salt
0Y ISC has indicated a PCR level of 800 to 1000 ppm.
Comments/Recommendations
This incident appears to warrant reporting as an 8(e). Even
though the spill was immediately cleaned up, any spill of PCB
requires careful follow-up to ensure that no adverse health
effects occur, that exposure is minimized, and that the chemical
is properly disposed of. Specifically, analysis of the rate of
diffusion of the transformer fluid in the salt will have to be
undertaken. In addition, hecause continued storage of
contaminated material in plastic bags is unsafe and possibly
illegal, the PCB-contaminated materials should be placed in metal
containers. ISC has indicated that they need assistance in
disposing of the contaminated materials and in monitoring for any
additional diffusing transformer fluid. The Toxic Substances
staff in EPA Region VI has agreed to provide assistance as
needed.
TCDD analyses will have to be undertaken to determine if there is
any dioxin impurity in the transformer fluid. EPA Headquarters
will arrange this. In addition, International Salt should hire a
dermatologist, with expertise in chloracne and associated skin
rashes, to examine the testing personnel who came in contact with
the fluid.
EPA Headquarters will contact FDA headquarters, and EPA Region VI
will contact FDA's appropriate Regional Office, since the spill
occurred near the salt (table) production area.
In summary, EPA Headquarters and EPA Region VI will follow up on
this incident as needed and maintain a complete record.
58
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I 4 19fI)
SU8JECT: Status Report* 8EHQ-1179-0320
?1~~an~ D. Kover, Chief
~t~: Chemlcal Hazard Identification
Branch
8EHQ-1179-0320
Page 1 Of~
Approved
/
Revision
Needed
DATE; Revised (May 28, 1980)
Joseph J. Merenda, Director
TO: Assessment Division, aTE
Submission Description
The Sherex Chemical Company, Inc. reports that certain of its
ethoxylated products have been found to contain significant
amounts of 1,4-dioxane (CAS No. 123-91-1) as determined by gas-
liquid chromotography (see Table 1 below). The submitter states
that:
Since 1,4-dioxane has been reported in an NCI study to be
carcinogenic when administered to rats via drinking water, we
are reporting our findings under the provisions of TSCA.
Although the analysis must be confirmed by mass spec., the
probability of the presence of 1,4-dioxane is sufficiently
high to merit this notification.
The submitter expresses concern about the potential risks to
workers involved in the production and handling of the undiluted
ethoxylated materials containing 1,4-dioxane where there is the
possibility of dermal and inhalation exposure. The submitter
reports that these ethoxylated materials are used in the formu-
lation of detergents, shampoos, and textile auxiliaries. It is
the submitterDs belief, that the concentrations of 1,4-dioxane
present in the final formulated products are "at such a low level
as not to pose a substantial risk. "Quantitative support for this
statement, however, was not presented.
TABLE 1 - Concentrations of 1,4-Dioxane in Various Ethoxylated
Products
RANGE (PPM)*
PRODUCT
ethoxylated fatty amines, (standard processing)
ethoxylated fatty amines (special processing)
quanternaries from ethoxylated fatty amines
ethoxylated monoglycerides
ethoxylated alcohol, phosphate ester
ethoxylated amide
(*10 ppm lower
<10 to 450
3400 to 6800
<10 to 1000
40 to 1300
290
830
detection limit)
*NOTE: This status report is the result 0: a prelimina='1
staff evaluation of information submitted to EPA. State~ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report shoul= take into
consideration the fact that it may be based on incomplete
information.
IE~A '0- ..-.... /...v ....,..,
59
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8EHQ-1179-0320
Page :2 of 3
SubMission Evaluation
Like many polyethylene glycols, 1,4-dioxane (an anhydride of
diethylene glycol) can produce toxic effects in the kidney and
liver (in humans). A characteristic nephrosis of the kidney
tuhules (hydr0p~c degeneratio~) wit~ associated liver cell
necrOS1S can occur regardless of the route of 1,4-dioxane
exposure (inhalation, oral ingestion, and/or skin application).
Because of this, there is definite concern about human exposure
to any product or material containing significant amounts of 1,4-
dioxane.
The submitter should be asked to quantitate the amounts of 1,4-
dioxane expected in the final formulated products and also to
provide the basis for any quantification; i.e., is it based on a
knowledge of the dilution rate (or some other factor) character-
istically employed in the formulation of final products, or has
actual quantitative chemical analysis been undertaken? In any
case, the submitter should be requested to provide a "worst case"
estimate of the amount of l,4-dioxane present in final products.
Current Production and Use
The 1,4-dioxane-contaminated compounds (listed in Table 1) which
are reportedly used in the formulation of shampoos, detergents,
textile auxilaries, and similar products, are not described in
sufficient detail to permit a review of their TSCA Inventory
production ranges. The submitter should be requested to provide
CAS numbers for the ethoxylated compounds. A description of the
process(es), particularly the "ethoxylation step", used in the
manufacture of these compounds, as well as a description of
"standard" versus "special" processing should also be requested.
A review of the production range (includes importation volumes)
statistics for 1,4-dioxane (CAS. No. 123-91-1) which is listed in
the initial TSCA Inventory has shown that between 2 million and
15 million pounds of this chemical were produced/imported in
1977.**/
**/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
60
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8EHQ-1179-0320
Page 3 of 3
Comments/Recommendations
The submitting cornpany reports that its customers and employees
are being notified of the finoing of significant amounts of 1,4-
dioxane in its ethoxylated products.
In 1974, OSHA set the current occupational standard for 1,4-
dioxane exposure at an A hr. time-weighteo average (TWA) of 100
ppm in air (39 CFR 23540). An evaluation of the carcinogenic
risk of 1,4-dioxane to man has been prepared by the International
Agency for Research on Cancer (IARC Monograph, Vol. 11, 1976).
In 1977, NIOSH recommended that the occupational exposure to 1,4-
dioxane be controlled so that workers are not exposeo at airborne
concentrations greater than 1 ppm (3.6 mg/cu m) based on a 30-
minute sampling period (DHEW (NIOSH) Puhlication No. 77-226).
Based on the results of its bioassay of 1,4-dioxane for possible
carcinogenicity, the National Cancer Institute (1978) has
concluded that:
"Under the conditions of this bioassay, 1,4-dioxane induced
hepatocellular adenomas in female Osborne-Mendel rats. 1,4-
Dioxane was carcinogenic in both sexes of rats, producing
squamous-cell carcinomas of the nasal turbinates, and in both
sexes of B6C3Fl mice, producing hepatocellular carcinomas."
(DHEW (NIH) Publication No. 78-1330)
A Chemical Hazard Information Profile (CHIP) on l,4-dioxane is
now in preparation.
a)
The submitter should be requested to quantitate the
amounts of l,4-dioxane expected in the final formulated
products and also to provide the basis for any
quantitation.
b)
The submitter should also be requested to provide CAS
numbers for the compounds identified in Table 1 of the
submission and to describe the processes used in the
manufacture of these compounds.
c)
A copy of this submissiqn ana status report should be
transmitted to CPSC, NIOSH, OSHA, FDA, and OWWM.
61
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FEB
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
6 1900
SUBJECT: Status Report *
;21111 ~
( ~Frank D. Kover,
~~: Chemical Hazard
8EHQ-1179-0321
8EHQ-1179-0321
Page 1 Of~
Approved
Revision
Needed
DATE:
Revised (May 28, 1980)
Chief
Identification Pranch
Joseph J. Merenda, Director
TO: Assessment Division, OTE
Submission Description
The Toms River Chemical Corporation has submitted the summarized
final results from a number of in vitro and in vivo mutagenicity
assays of Color Index Disperse Blue 7 Dye (CAS No. 3179-90-6).
The submitter reports that although the results from several in
vitro tests indicate that this material can inouce point
mutations, the results from in vivo testing indicate that it does
not produce chromosomal aberrations.
The suhmitting company reports that it han previously notified
the Agency (July, 1977) that in vitro Ames and mouse lymphoma
test results had been ohtaine~which supported the conclusion
that one or more of the specific components of Color Index Dis-
perse Blue 7 was a possible mutagen. At that time the company
stated that additional testing was to be conducted and signifi-
cant results reported to the Agency. Those additional test
results are the subject of the present section 8(e) submission.
Submission Evaluation
As presented, the final results from several of the in vitro
tests do indicate a mutagenic potential for C.I. Disperse Blue 7
Dye. However, without complete copies of the test protocols and
data from all of the studies cited in this submission, a full
evaluation of the mutagenic potential of this dye is not possible
at this time.
Current Production and Use
A review of the production range (includes importation volumes)
statistics for C.I. Disperse Blue 7 (Cas. No. 3179-90-6), which
is listed in the initial TSCA Inventory, has shown that no 1977
production/importation was reported or that all of the production
range data reported were claimed as confidential by the manu-
facturer(s) and importer(s) ann cannot be disclosed. (Section
14(a) of the TSCA, U.S.C. 2613 (a».**/
*NOTE: This status report is the result of a prelimina=v
staff evaluation of information submitted to EPA. State~ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. ,Any review of the status report should take into
cons~derat~on the fact that it may be based on incomplete
inrorma tion.
E~'" '0- IJ~ I~E"". )0711
62
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8EHQ-1179-0321
Page :2 of 2
C.I. Disperse Blue 7 is used mostly in printing processes and the
dying of synthetic fibers, wool sheepskins, and furs. It also
has uses in the surface dying of thermoplastics.
Comments/Recommendation
The submitting company reports that its customers have been
notified of this new tox~c0~ogical info~ffiat_uil. In addition, the
submitter reports that the warning label, developed in response
to the mutagenic findings reported in 1977, will continue to be
affixed to all containers of Disperse Blue 7.
a)
The submitting company should be requested to provide
complete copies of the final results, including test
protocols and data, from the studies cited in its
submission.
b)
A copy of this submission and status report should be
transmi t ted to OSHA, NIOSH, CPSC, NCI, and O~1WH.
c)
CRIB will review the additional information requested,
revise this Status Report as appropriate, and
recommend further followup assessment if warranted.
**/The data submitted for the TSCA Inventory including production
range information, are subject to the limitations contained in
the Inventory Reporting Regulations (40 CFR 710).
63
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FEB I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
1900
SUBJECT:
Status Report* 8EHQ-1279-0322
8EHQ-12 7 9-03 2. 2.~
Page 1 of 2 ,/,-
Approved h--
DATe: Revised (May 29, 1980)
'R~: Walter W. Kovalick, Jr., Director
Program Integration Division (TS-793)
., /
Rev~s~on
Needed l
TO: Joseph J. Merenda, Director
Assessment Division (TS-792)
Submission Description: The Clorox Company Plant, Oakland,
California: accidental release of chlorine gas
On November 16, 1979, at 7:00 a.m., an accidental release of
chlorine gas occurred at the Oakland plant of the Clorox
Company. The cause of this release was equipment failure in
piping which connected a tank car containing the gas to permanent
plant facilities.
Submission Evaluation
Chlorine gas is a serious irritant. Inhalation may cause
bronchitis, bronchopneumonia, tachycardia, and pulmonary edema.
Chlorine gas is also an eye irritant and a mucous membrane
irritant. These effects manifest themselves within forty-eight
hours after exposure.
Comments/Recommendations
This incident does not appear to warrant reporting as an 8(e).
Fourteen Clorox employees were taken to either the Oakland
hospital or the California Industrial Medical Clinic for
examination and treatment. Two employees were retained in the
hospital - one for three days and the other for five days. The
diagnosis was lung irritation and the prognosis was full recovery
with no complications. Thirty-five people from areas surrounding
the release site were examined at various hospitals and were
subsequently released.
*NOTE: This status report is the result of a prelimina=y
sta:f evaluation of information submitted to EPA. Statemer.ts
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
consideration the fact that it may be based on incomplete
inrorma tion.
E.-A '0- U»-6 ("EV. 1-711
64
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8EHQ~l279-0322
Page 2 of 2
An investigation has been initiated by appropriate personnel at
the Oakland plant to analyze the actions taken and to make
recommendations for improvements. Clorox expects these
recommendations to be implemented.
The letter and accompanying report submitted by Clorox were
lacking in the detail necessary for a thorough review of the
incident. There was no estimate of the amount of chemical
release, duration of release and exposure periods, no specific
medical examination report, and no indication of historical
use. However, this information is being forwarded to EPA by
Clorox, and should not significantly affect the status of the
incident.
The release was investigated by EPA Region IX, California OSHA,
and local fire and police departments. Following an
investigation, California OSHA informed Clorox that there were no
violations and that it does not intend to issue a citation.
EPA Headquarters and Region IX will follow up on this incident
and will maintain a complete record.
65
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
DJ. TE:
8EHQ-1279-032
~l of 2
Approved ~
Revisio
Needed
SUBJECT: Status Report* BEHO-1279-0323
1 (.-
Frank D. Kover, Chief
FR~: Chemical Hazard Identification Branch
Joseph J. Merenda, Director
TO: Assessment Division/OTE
Submission Description
The Atlantic Richfield Company has provided a complete copy of
the final results from a number of in vitro and in vivo mutagen-
icity studies of Jet Fuel A, which is a complex petroleum mix-
ture. The submitter reports that this fuel did not exhibit a
positive response in the Ames test either with or without meta-
bolic activation. However, Jet Fuel A was found to induce muta-
tions in the in vitro mouse lymphoma assay (in the presence of
metabolic activation), and found to produce bone marrow cell
mutations in an in vivo cytogenetic study.
In reporting these mutagenicity data under Section 8(e) the
submitting company states that it does "not interpret these
findings as an indication of significant human health risk.
Mutagenicity test methods only recently have been developed and
therefore lack the history to verify their reproducibility. In
addition, tne meaning of mutagenic test results is subject to
serious scientific questions."
Submission Evaluation
No increase in the incidence of mutation was observed with Jet
Fuel A in the Ames Salmonella test in the presence or absence of
the S-9 metabolic activation system. However, Jet Fuel A did
induce a dose dependent increase in mutation frequency in the
mouse lymphoma L5178Y assay in the presence of S-9 activation.
Similarly, Jet Fuel A (via inhalation) induced significant
increases in chromosomal aberrations in the bone marrow cells of
rats.
*NOTE: This status report is the result of a preliminary
s~a:f evaluation of in:o=ma~ion submitted to EPA. Stateme~ts
~ade herein are not to be regarded as expressing final
Age~cy policy or inten~ with respect to this particular
che~iccl. ~~y review of the status report should take into
c~~sideration the fact that it may be based on i~comDlete
. ~ . .
]..;J - orma tlon .
EPA F'ORW 1J~ (REV. ""I
66
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8EHQ-1279-0323
Page 2 of 2
Current Production and Use
The submitter reports that Jet Fuel A is a complex petroleum
product which is sold to airline companies for use as jet
airplane fuel. Although there is no one CAS number used to
identify the possible availahle mixtures and treatment processes
for this product, the submitter did provide the results of a mass
spectrometry analysis. Jet Fuel A, as such, is not listed in the
initial TSCA Inventory.
Comments/Recommendations
Contrary to the company's comment with regard to the significance
of mutagenic test results, the Agency believes that mutagenicity
test systems provide valuable data that can aid in assessing
possible risks of injury to health and/or the environment posed
by chemicals.
Status reports have been prepared for a numher of section 8(e)
submissions received on synthetic and petroleum fuels: 8EH0-00?9,
0030, 0044, 0082, 0083, 0117, 0148, 0212, 0215, 0216, 0217, 0238,
0240, 0247, 0252, 0253, 0297, 0301, 0306, and 0316. (These
numbers represent the last four digits of the Document Control
Officer assigned numbers.)
The National Cancer Institute/NIB is currently studying the
chronic toxicity (skin-painting with mice and oral gavage with
rats) of Navy Fuel JP-5, which is also a kerosene-based jet fuel.
a)
The submitting company should be requested to describe
any actions taken, in light of this toxicity information,
to reduce or eliminate exposure to Jet Fuel A and/or to
warn workers and purchasers of this submitted toxicity
information.
b)
Copies of this submission and status report should be
transmitted to DOE, OSHA, OWWM, and ORD.
67
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UNITED 5T A TES ENVIRONMENTAL PROTECTION AGENCY
0,," TE:
I.. 'j\ ,', - ,,'
--" '~J .~'....,,".,J
8EHQ-0180-0324
Page 1 of 3
Approved ~~~
Revision ~
Needed
SU8JECT:
Status Report* 8EHQ-0180-0324
J I' Frank D. Kover, Chief
FR~: Chemical Hazard Identification Branch
TO:
Joseph J. Merenda, Director
Assessment Division/OTE
Submission Description
The Diamond Shamrock Corporation (in a submission sent directly
to the EPA Administrator) has reported that due to an industrial
accident in its methylene chloride and chloroform production
facility in Belle, West Virginia, two employees were exposed to
an airborne mixture of chemicals which may have included bis-
(chloromethyl)ether (BCME; CAS No. 542-88-1). The suhmitting
company states that RCME is not normally present in its pro-
cesses. Diamond Shamrock reports that since restarting the
production processes, BCME has not been detected. The company
states that it will continue its analytical investigation of this
situation and will conduct continuing medical examinations of all
known or potentially exposed individuals.
Submission Evaluation
The workers have apparently recovered from the acute exposure to
the chemical mixture as none had developed any pulmonary signs or
symptoms. The planned continuing medical examinations appear to
be appropriate as both the irritating and carcinogenic properties
of BCME are well known.
It would be of interest to know the levels of BCME detected and
the sensitivity of the analytical methods used in that detection.
Current Production and Use
A review of the production ranges (includes importation volumes)
for the subject chemical(s), listed on the initial TSCA
Inventory, has shown that the following amounts were reported as
being produced/imported in 1977:
*NOT:: This ~tatu~ ~e~ort i~ the re~ult of a preliminary
sta£~ evaluat~on o~ lnrormatlon submltted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. ,Any review of the. status report should take into
conslderatlon the fact that lt may be based on incomDlete
in forma tion . ~
~~A "0- IJ~ I.-£V. ~711
68
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8EHQ-Ol80-0324
Page 2 of 3
Chemical N-3.me
C""~ j\Jur--::-- "'x
App~ox~mate Production/
~~--_c ortation Ra?ge ** /
- - - -~ .--,-----.-. --
Methylene chloride
75-09-2
350 mill~on to 1.4
billion Ibs.
Chloroform
67-66-3
93 million to 350
million lbs.
Bis{chloromethyl}-
ether
542-88-1
100 thousand to 1
million lbs.
Methylene chloride has uses in paint removers; propellants for
aerosol sprays; blowing agents in foam; plastics processing; and
solvent degreasing and extraction procedures.
Chloroform has uses as a solvent; fumiqant; insecticide; fluoro-
carbon refrigerant and ~~~pella~t; and-is used in certain
fluorocarbon plastic processes.
Bis{chloromethyl)ether is used as a laboratory reagent and as an
interm~diate for ion-exchange resins.
Comments/Recommendations
Diamond Shamrock reports that annual medical examinations are
provided for its employees and that a computer tracking and
surveillance system {COHESS} is maintained- which provides a rapid
assessment of medical status. In adnition, the submitter states
that any newly developed information which may inpact on the
reported situation will be provided to the EPA.
In this particular case, the Diamond Shamrock Corporation's
submission of section 8{e} information to the EPA Administrator's
office did not unduly burden the Agency's processing of the
notice. However, it should be brought to the submitter's atten-
tion that the substantial risk information reporting requirements
{Part IX of the March 16, 1978, "Statement of Interpretation and
Enforcement Policy; Notification of Substantial Risk" (43 FR
11110}) clearly specify that TSCA section 8{e} notices are to be
sent to the Document Control Officer, Chemical Information
Division, Office of Pesticides and Toxic Substances (WH-557),
Environmental Protection Agency, 401 M Street S.W., Washington,
D.C. 20460. A copy of the March 16, 1978, policy statement
should be sent to the submitter.
**/This production range information does not include any
production/importation data claimed as confidential by the
person{s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are suhject to the
limitations contained in the Inventory Reporting Regulations {40
CFR 710}.
69
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8EHQ-0180-0324
Page 3 of 3
An evaluation of the carcinogenic risk of bis(chloromethyl)ether
to man has been prepared by the International Agency for Research
on Cancer (IARC Monograph: Vol. ~, 1974).
NIOSH has prepared criteria documents on both chloroform (1974)
and methylene chloride (1976).
The Test Rules Development Branch/AD, in conjunction with the
Environmental and Health Review Divisions, is currently reviewing
data received by the Agency pertaining to the Interagency Testing
Committee designated chemical: "Methylene Chloride." The
Chemical Review and Evaluation Branch/AD is presently developing
the Phase I Assessment on Chloroform.
a)
Diamond Shamrock should be requested to provide informa-
tion on the levels of BCME detected at the time of the
upset situation and the sensitivity of the analytical
method(s) used in that detection.
b)
The Agency should transmit a copy of this submission and
status report to NIOSH, OSHA, CREB/AD, and TRDB/AD: the
Industry Assistance Office (IAO/OPII) should consider
sending this information to the producers of methylene
chloride and chloroform.
70
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
MAR ;
,- ." 'r-.
~,j ,''''~~(!
'- ./ ,'. ..:
DAT£:
Revised (May 28, 1980)
8EHQ-1279-0325
Page 1 of 4
SU8JECT: Status Report* 8EHQ-1279-0325
~Y'-
I y~ Frank D. Kover, Chief
, ~: Chemical Hazard Identification
Branch
Revisio
Needed
Joseph J. Merenda, Director
TO: Assessment Division, GTE
Submission Description:
The American Cyanamid Company has provided a summary of the final
resul~s from two short-term (30 day) feeding studies of the
symme~rical form of trithiocyanuric acid (TTCA~ 1,3,5-triazine-
2,4,6-(lH, 3R, 5H)-trithione~ CAS No. 638-16-4) at concentrations
of 625, 2500~ and 5000 ppm in the diet of rats. The submitter
reports that during the first study (performed June-July 1977),
the rats at the two highest dose levels developed discoloration
and eventual necrosis of the di~tal one-third of the tail and
discoloration of the external ear. Although none of the animals
at the highest dose survived to the 30th day, the lowest dose
group showed no apparent effects. The second feeding study
(performed April-May 1978). which reportedly confirmed the
observations of the first study, included a microscopic
examination of the tails and ears. The pathological findings are
reported to include vascular congestion, edema, and necrosis in
the tail~ the ear tip was found to have a moderate infiltrate of
scavenging white cells and localized necrosis.
The submitting company
toxicological findings
"because the substance
(less than 1000 lb has
the possibility of any
be negligible."
states that it did not report these
to Lhe Agency at the time (1977, 1978)
was, and has been, only in test marketing
been manufactured to date) and we consider
injury to health under those conditions to
In reporting these toxicological findings under section 8(e) at
this time, the submitting company states that it intends to in-
crease TTCA production/distribution to 100,000 lb/year. However,
the submitter reports that this increase will not take place un-
til a more safe, dust-free form of TTCA can be developed. It is
the submitter's judgement that the "commercial introduction of
the substance does not create conditions under which one could
conclude reasonably that it presents a suhstantial risk of injury
to heal th . "
*N~TE: This status report is the result of a prelimina=v
staff evaluation of information submittec to EPA. State;e~ts
mace herein are not to be regarded as expressing :inal
Agency policy or intent with respect to this partic~lar
chemical. Any review of the status report should take into
7onsideration the fact tha~ it may be based on incomplete
~nformation .
[~A '0.-.. IJ~ ("[V. 1-111
71
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8EHQ-l279-0325
Page 2 of 4
Submission Evaluation
By the oral route, this symmetrical isomer of TTCA is absorbed
and apparently acts on the peripheral arteries to ultimately
cause congestion and stasis (stoppage) of the blood in the distal
terminal vasculature, possibly resulting in gangrene.
Inhalation of dusts of this chemical may lead to similar effects
on the blood vessels of the nasal passages and lungs. These
effects could be caused by simple local action without
necessitating systemic absorption of the chemical.
Current Production and use
A review of the production range (includes importation volumes)
statistics for both tautomeric forms of trithiocyanuric acid
(CAS. No. 638-16-4) which are listed in the initial TSCA
Inventory (1977) has shown that between 0 and 1500 pounds of
these chemicals were produced/imported in 1977.**/
The submitter anticipates the commercial use of TTCA to be as a
curative agent in acrylic rubber, in which it would be incorpo-
rated at a concentration of less than one percent. It is the
submitter's belief that the chemical will lose its identity by
becoming part of the polymeric structure of the rubber. It is
not clear that chemical analysis of the final product provides
the basis for this belief; quantitative support was not presented
in the submission.
Comments/Recommendations
Following a review of the provided information on TTCA, it is the
Agency's preliminary determination that the submitter should
have, at an earlier date, immediately informed the EPA of these
toxicological findings under Section 8(e) of TSCA. The basis for
this determination is as follows:
According to Section 8(e) of the Toxic Substances
Control Act (TSCA) (90 Stat. 2029, 15 D.S.C. 2607), a
person who obtains substantial risk information "must
immediately inform the Administrator...." The preface
to Part V of the March 16, 1978, "Statement of Interpre-
tation and Enforcement Policy; Notification of Substan-
tial Risk" (43 FR 11110) states that a substantial risk
of injury to health or the environment is a risk of
considerable concern because of (a) the seriousness of
the effect... and (b) the fact or probability of its
occurrence." With regard to the seriousness of the ef-
fect, Part V further explains that the Agency considers
the health effects for which substantial risk informa-
tion must be reported to include "any pattern of effects
or evidence which reasonably supports the conclusion
that the chemical substance or mixture can produce....
72
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8EHQ-1279-0325
Page 3 of 4
toxic effects resulting in death, or serious or prolong-
ed incapacitation." The information respecting these
effects can be obtained directly or inferred from de-
signed studies (e.g. in vivo experiments and tests as
described in Part VI of the policy statement). with re-
gard to the "fact or probability of its occurrence" cri-
terion, Part V also provides that certain health effects
are so serious that relatively little weight should be
given to a chemical's exposure in determining whether a
risk is substantial. The mere fact that an implicated
chemical is in commerce constitutes sufficient evidence
of exposure. In addition, Part I of the policy state-
ment clearly specifies that the reporting requirements
for TSCA Section 8(e) include test market chemicals in
the definition of the manufacturing or processing of
chemical substances or mixtures for commercial purposes.
Therefore, because the pattern and nature of the observed in vivo
toxicological effects could produce gangrene, which is a serious
and prolonged incapacitation, and the fact that 'J'TCA was in test
marketing and therefore in commerce, the Agency believes that the
submitting company should have provided this substantial risk
information to the EPA at an earlier date under Section 8(e) of
TSCA.
The following Agency comments concern the submitter's statement
that commercial introduction of TTCA "does not create concH tions
under which one could conclude reasonably that it presents a
substantial risk of injury to health." Section 8(e) of TSCA
clearly states that the information required for reporting is any
information which reasonably supports a conclusion that a chemical
substance or mixture presents a substantial risk of injury to
health or the environment. The Agency considers that reasonable
support of a conclusion of substantial risk is not identical to the
conclusion itself. The former typically occurs, and must be re-
ported at an earlier stage. In addition, Part VI of the Section
8(e) policy statement specifies that a "person is not to delay
reporting until he obtains conclusive information that a substan-
tial risk exists, but is to immediately report any evidence which
'reasonably supports' that conclusive. Such evidence will gener-
ally not be conclusive as to the substantiality of the risl<...."
a)
The submitting company should be requested to provide
complete copies of the final results, including test
protocols and all data (including pathology reports)
obtained from the cited feeding studies of TTCA in rats.
In addition, the submitter should be requested to provide
quantitative information concerning the actual amounts of
TTCA ingested during these feeding studies. The submitter
should also be requested to provide available chemical
data with regard to residual TTCA in final products.
73
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8EHQ-1279-0325
Page 4 of 4
b)
The submitting company should also be requested to
describe any additional studies it has performed and/or
planned for further defining the toxicity of TTCA. The
Agency would be particularly interested in the results
from any inhalation toxicity studies.
c)
The submitting company should be requested to describe the
actions it has taken, in light of this submitted toxicity
information, to reduce or eliminate exposure to TTCA and
to warn workers and purchasers of this reported toxicity
information.
d)
CHIB will review the additional information requested,
revise this status report as appropriate, and recommend
further followup assessment if warranted.
e)
A copy of this submission and status report should be
transmitted to OSHA, NIOSH, FDA and CPSC.
**/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory, includ-
ing production range information, are subject to the limitations
contained in the Inventory Reporting Regulations (40 CPR 710).
74
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
DA TE:
I'.:-_! ! ":' ! -'..'
r., 1\ J J,,~ :-~"
&EHQ-0979-0326S
8EHQ-0180-0326 Suppl. A
Page 1 of 4
Approved ~ ~~
A o. ,
RevJ.sJ.on
Needed
SU&JECT:
Status Report* 8EHQ-0979-0326S
8EHQ-0180-0326 Supplement
oj / -
'R~: Frank D. Kover, Chief
Chemical Hazard Identification Branch
TO:
~oseph J. Merenda, Director
Assessment Division, aTE
Submission Description
In its initial submission (8EHQ-0979-0326S), the Shell oil
Company reported that two specific products, the sodium and
ammonium salts of alcohol ethoxysulfates, were found to contain
between 130 and 2500 ppm of l,4-dioxane (CAS No. 123-91-1). The
submitter also stated that 1,4-dioxane forms during the
conversion of alcohol ethoxylate to the alcohol ethoxysulfate
salts. Although supporting quantitative evidence was not
provided, the submitter reported that dioxane is not present in
the starting alcohol ethoxylated materials.
In providing the initial information under Section 8(e), the
submitter stated that IIl,4-dioxane was shown in an NCI study to
be carcinogenic when given to rats at 5,000 and 10,000 ppm in
drinking water" and expressed concern about the potential risks
posed to the health of workers involved with the sulfation
process, and the further product handling, where there is the
possibility of dermal and/or inhalation exposure. The submitter
also reported that the alcohol ethoxysulfate salts are used in
the formulation of detergents, shampoos, and similar products
requiring high foaming and surface-active properties.
In the supplemental submission (8EHQ-0180-0326 Supplement A),
Shell reports that as soon as it became aware of the potential
risks involved with the handling of 1,4-dioxane-containing
materials, monitoring activities were initiated for the personnel
and work area in the sulfation step, several product streams, and
the contents of several tanks and tank trucks. The submitter
states that the analytical results (provided in the supplement)
show that the atmospheric levels for 1,4-dioxane were no more
than 0.1 ppm for an 8-hour time-weighted average (TWA) which, as
the submitter points out, is below the current OSHA standard of
*NOTE: This status report is the result of a prelimi~a=y
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
7onsideration the fact that it may be based on incomplete
J.nforma tion.
tJ8A 'Q.-.. 1J~ (IIItV. )-111
75
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8EH~,-0979-0326S
8EHQ-Ol80-0326 Suppl. A
Page 2 of 4
100 ppm (TWA) and the ACGIH TLV of 50 ppm. However, the
submitter does report that the concentrations of 1,4-dioxane in
liquid ethoxysulfate were found to vary between 220 and 3,160
ppm.
Based on this recently developed exposure information the submit-
ter states that "we are now of the opinion that the presence of
1,4-dioxane does not constitute a substantial risk situation to
people involved in the sulfation process or in the formulation
process, particularly if our suggested safe handling procedures
are followed." The submitter further states that "it is O"Jr con-
firmed belief that after formulation, concentrations of the diox-
ane are lowered sufficiently that the final products do not pose
a substantial risk for those who are exposed to them." The quan-
titative $upport for this statement; however, was not provided by
the company in either the initial or supplemental submissions.
Submission Evaluation
Like many polyethylene glycols, 1, 4-diexi:.' ne (an anhyd ride of
diethylene glycol) can produce toxic effects in the kidney and
liver (in humans). A characteristic nephrosis of the kidney
tubules (hydropic degeneration) with associated liver cell necro-
sis can occur regardless of the route of 1,4-dioxane exposure
(inhalation, oral ingestion, and/or skin application). B~cause
of this, there is definite concern about human exposure to any
product or material containing significant amounts of 1,4-dioxane.
As reported, the inhalation exposure to 1,4-dioxane does appear
to be negligible (i.e. 1 ppm). However, the 3000 ppm dioxane
detected in several of the liquid materials does indicate a
significant dermal exposure which can lead to serious healtn
effects in unprotected/uninformed workers.
The submitter should be asked to quantitate the amounts of 1,4-
dioxane expected in the final formulated products and also to
provide the basis for any quantification; i.e., is it based on a
knowledge of the dilution rate (or some other factor) character-
istically employed in the formulation of final products, or has
actual quantitative chemical analysis been undertaken? In any
case, the submitter should be requested to provide a "worst case"
estimate of the amount of 1,4-dioxane present in final products.
Current Production and Use
Neither the starting alcohol ethoxylated material nor the 1,4-
dioxane-contaminated compounds (which are reported by the submit-
ter to be used in the formulation of shampoos, detergents, and
similar products) are described in sufficient detail in these
submissions to permit a review of their TSCA Inventory production
ranges.
76
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8EHQ-0979-0326S
8EHQ-0180-0326 Suppl. A
Page 3 of 4
A review of the production range (includes importation volumes)
statistics for 1,4-dioxane (CAS. No. 123-91-1) which is listed in
the initial TSCA Inventory has shown that between 2 million and
15 million pounds of this chemical were produced/imported in
1977.**/
Comments/Recommendations
The submitting company reports that its customers, its two toll
producers, and OSHA have been notified that 1,4-dioxane has been
detected in these alcohol ethoxysulfate products.
In 1974, OSHA set the current occupational standard for 1,4-dioxane
exposure at an 8 hr. time-weighted average (TWA) of 100 ppm in air
(39 CFR 23540). An evaluation of the carcinogenic risk of 1,4-
dioxane to man has been prepared by the International Agency for
Research on Cancer (IARC Monograph, Vol. 11, 1976). In 1977, NIOSH
recommended that the occupational exposure~o 1,4-dioxane be con-
trolled so that workers are not exposed at airborne concentrations
greater than 1 ppm (3.6 mg/cu m) based on a 30-minute sampling
period (DHEW (NIOSH) Publication No. 77-226).
Based on the results of its bioassay of 1,4-dioxane for possible
carcinogenicity, the National Cancer Institute (1978) has concluded
that:
"Under the conditions of this bioassay, 1,4-dioxane induced
hepatocellular adenomas in female Osborne-Mendel rats. 1,4-
Dioxane was carcinogenic in both sexes of rats, producing
squamous-cell carcinomas of the nasal turbinates, and in both
sexes of B6C3Fl mice, producing hepatocellular carcinomas."
(DHEW (NIH) Publication No. 78-1330)
The Agency has recently received two additional 8(e) submissions
(8EHQ-1179-0320 and 8EHQ-0280-0331) which also reported the detec-
tion of 1,4-dioxane in other ethoxylated products.
A Chemical Hazard Information Profile (CHIP) on 1,4-dioxane has been
prepared by the Chemical Hazard Identification Branch/AD. The
Chemical Review and Evaluation Branch/AD is now preparing an in-
depth source and health effects assessment (Phase I) for 1,4-
dioxane.
a)
The submitting company should be requested to provide the
data which were the basis for its statement that no dioxane
is present in the starting alcohol ethoxylated materials.
In addition, the submitter should be requested to ~uanti-
tate the amounts of 1,4-dioxane expected in the final
formulated products and also to provide the basis for any
quantitation.
b)
The submitting company should also be requested to provide
any available data on the actual chemical compositions
(including amounts and CAS numbers of components where
77
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BEHQ-0979-0326S
BEHQ-01BO-0326 Suppl. A
Page 4 of 4
available) of the starting alcohol ethoxylated materials and
the alcohol ethoxysulfate salt compounds identified in its
submission. In addition, the submitter should be requested
to provide, if 'available, any additional information on the
processes by which l.4-dioxane is formed during the conver-
sion of the alcohol ethoxylates to the alcohol ethoxysulfate
salts.
c)
Copies of these submissions and the status report should be
transmitted to CPSC, NIOSH, OSHA, FDA, OWWM, and CREB/AD.
**/This production range information does not include any pro-
duction/importation data claimed as confidential by the person(s)
reporting for the TSCA Inventory, nor does it include any informa-
tion which would compromise Confidential Business Information.
The data submitted for the TSCA Inventory, including production
range information, are subject to the limitations contained in the
Inventory Reporting Regulations (40 CFR 710).
78
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SU8JECT:
Status Report* 8EHQ-0180-0327
Approved
8EHQ-0180-03:
Page 1 of 2
~#~
/'
D.+. TE:
" .. ~ .', I")
J-,I I \ I:j 1::1(..(;
)/
'.oW:
Frank D. Kover, Chief
Chemical Hazard Identification Branch
Revision
Needed
TO:
Joseph Merenda, Director
Assessment Divisjnn, aTE
Submission Description
The Atlantic Richfield Company reports that preliminary resul,ts
from a planned 80-week skin-painting study show that each of two
tested materials (ARCa LB-7979 and Provalent 4A) had produced
skin tumors when applied twice weekly to the shaven skin of
mice. The submitter states that all tumors observed thus far
have been characterized as benign by the performing laboratory.
The incidence of tumors in each test group (50 mice) is presente0
in Table I below.
Atlantic Richfield states that it had initiated this study of
ARca LB-7979 and Provalent 4A in response to an earlier section
8(e) submission from the Standard ail Company (Indiana) (8EHQ-
0579-0283). In that submission Standard ail reported that one of
its developmental products (Wellaid PG-IOO) had been shown to be
carcinogenic in a mouse skin-painting study. The ARCa LB-7979
product is a chemical component of Wellaid PG-IOO and Provalent
4A is purchased by Atlantic Richfield from the Mobil ail
corporation for use in the formulation of ARca LB-7979.
Table I.
Tumor Incidence (l/Animal) at 17 Weeks
Chemical Name
No. of Tumors
Percentage
Average 'La tent
Period - Weeks
ARca LB-7979
Provalent 4A
Benzo(a)pyrene
(positive control)
2
16
3
4
32
6
14.0
15.8
10.0
Atlantic Richfield states that the incidence of apparently benign
skin tumors observed at this stage of this study does not indi-
cate a substantial health risk to humans. The submitter also
states that subsequent results will be provided periodically to
the EPA.
*NOTE: This status report is the result of a preliminary
staff evaluation of information submitted to EPA. Sta~eme~ts
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this ~articular
chemical. Any review of the status report should take intc
~onsideration the fact that it may be based on incomplete
lnrorma tion.
I!~.. 'Q- IJ~ IIU:V. -..711
79
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8EHQ-0180-0327
Page 2 of 2
Submission Evaluation
Both ARC a LB-7979 and Provalent 4A have produced benign skin
tumors in mice at approximately 16 weeks. In this respect, these
preliminary results are similar to those previously reported for
Wellaid PG-IOO (8EHQ-0579-0283). Wellaid PC-IOO was shown to
produce benign skin papillomas at the application site at about
16 weeks. In addition, Wellaid PG-IOO produced malignant skin
tumors after the 26th week. Although the results from the 26th
week of the current study of ARCO LB-7979 and Provalent 4A are
not yet available for determining their possible carcinogenicity,
the oncogenic capability of both products has been established.
Current Production and Use
Neither the ARCO LB-7979 product nor the Provalent 4A product are
described in sufficient detail to permit a review of TSCA
Inventory production ranges. CAS numbers should be requested for
all chemical components of these products.
According to the submitter, the purchased Provalent 4A is used in
the formulation of ARCO LB-7979 and other specialty chemicals for
industrial applications. To the submitter's knowledge, none of
these specialty chemicals are used in consumer products.
Comments/Recommendations
The Atlantic Richfield Company reports that their employees,
their customers, and the supplier of Provalent 4A (Mobil oil
corporation) are being notified of these interim test results and
of precautionary measures to be taken in handling products con-
taining Provalent 4A.
a)
The Atlantic Richfield Company should be requested to
provide the CAS numbers of the chemical components of the
ARCO LB-7979 product. The Mobil Oil Corporation should be
requested to provide the CAS numbers of the components in
its Provalent 4A product.
b)
The Agency should transmit a copy of this submission and
status report to the Mobil Oil Corporation, the Standard
Oil Company (Indiana), NIOSH, OSHA, DOE, DOT, and OWWM.
80
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SUIJECT: Status Report* 8EHQ-OI80-0328S
..~Frank D. Kover, Chief
,~: Chemical Hazard Identification
Branch
8EHQ-0180-0328S
Page l~ 5'hk,
Approved t///( /~iJ'-
R .. /
eV~s~on
Needed
DATE:
APR 2 2 /980
Joseph J. Merenda, Director
TO: Assessment Division
Submission Description
The CIBA-GEIGY Corporation has reported that gross observations
made after the 24th month of a lifetime mouse skin-painting study
indicate that an imported developmental "dimethylhydantoin -
derived epoxy resin" (XB-2793) had produced skin "tumors" at the
site of application. The histopathological examination of the
test animals is reported to be underway at the performing labora-
tory in Switzerland. The submitting company also provided a
summary of mutagenicity data from several in vitro tests of XB-
2793 and another product (XB-2826), each with and without
metabolic activation. The exact chemical identities of the XB-
2793 and the XB-2826 products have been claimed as confidential
by the submitting company. In its submission to the EPA, the
company states:
"Although we are reporting the preliminary dermal car-
cinogenicity assay information under TSCA Section 8(e),
no conclusion has been made as to whether this informa-
tion or the mutagenicity test results constitute a
substantial risk since:
1.
The dermal carcinogenicity study is incomplete
and final results are not yet available.
2 .
The description of the initial gross observa-
tions indicates the lesions are limited to the
site of application. Histopathology of all
tissues and suspected lesions are now underway.
3 .
The in vitro mutagenicity results are inconclu-
sive-Since inconsistencies exist between
batches and test systems."
*NOTE: This status report is the result of a prelimina=y
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agen~y policy or intent with respect to this particular
chem~cal. ,Any review of the status report should take into
~ons~derat~on the fact that it may be based on incomplete
~nformation .
E~A 'QIIIII 11»4 (~EV. ~711
81
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8EHQ-0180-0328S
Page 2 of 3
CIBA-GEIGY also reports that a more complete summary of the prelimi-
nary data from the skin-painting study of XB-2793 is now in prepara-
tion and, in addition, a final report is to be prepared after comple-
tion and evaluation of the histopathology. The submitter states that
copies of each report will be forwarded to the EPA.
Submission Evaluation
The diaryl, the monoaryl-monoalkyl, and the dialkyl substituted
hydantoins have been associated with a variety of serious toxicities
including lymph adenopathy (which resembles Hodgekin's Disease) and
malignant lymphoma. Hydantoins have also been associated with
aplastic anemia of bone marrow origin and have been reported to
produce fatal hepatic necrosis and lupus erythematosus (via an effect
on the adrenal cortex). Supstituted hydantoins have been used exten-
sively in medicine (e.g. diphenlylhydantoin which is used in the
treatment of epilepsy). Replacing the aromatic substituents with
alkyl groups can alter the central nervous system effects toward
depression.
Although XB-2793 has not been demonstrated histopathologically to be
carcinogenic, the summarized preliminary results provided in the
submission do indicate that this product is oncogenic (i.e. produces
tumors) in mice via skin-painting.
With regard to the submitter's statement that the in vitro
mutagenicity results are inconsistent and inconclusive, it should be
noted that while neither XB-2793 nor XB-2826 were shown to be muta-
genic in the Saccharomyces Cerevisiae D4 (yeast) assays, mutagenic
activities were demonstrated for both XB-2793 and XB-2826 in almost
all of the performed Salmonella Typhimurium bacterial assays with and
without metabolic activation. In addition, the XB-2793 product was
shown to be positive (with and without activation) in an in vitro
mouse lymphoma assay. (The XB-2826 was apparently not tested in this
particular assay.) It should also be noted that the negative results
obtained in the yeast assay may have been due to the low permeability
of the yeast cell wall for certain types of chemical molecules.
Current Production and Use
Because the chemical identities of XB-2793 and XB-2826 have been held
as confidential by the submitter, a full report of the non-confiden-
tial production/importation range information from the initial TSCA
Inventory (1977) will not appear in this status report. **/ However,
the submitter does report non-confidentially that the combined annual
volume of XB-2793 and XB-2826 imported by the ClBA-GEIGY Corporation
falls within the inventory production range 2 (10,000 to 100,000
pounds) .
**/The data submitted for the TSCA Inventory, including
production range information, are subject to the limitations
contained in the Inventory Reporting Regulations (40 CPR 710).
~?
-------
8EHQ-0180-0328S
Page 3 of 3
The submitter states that both XB-2793 and XB-2826 are sampled or
sold for industrial use only and reports that there is no
consumer exposure because these materials are fully reacted to
inert polymeric products prior to reaching consumers. The
submitter did not, however, provide any quantitative data in the
submission to support this contention.
Comments/Recommendations
CIBA-GEIGY reports that it is reviewing the adequacy of the XB-
2793 and XB-2826 current lahelling and Material Safety Data
sheets in light of the new submitted information and will inform
the Agency of any company decisions regarding these reviews and
of any customer/employee notifications.
a)
The submitting company should be requested to provide the
analytical data which were the basis for its contention
that there is no exposure to residual XB-2793 and/or XB-
2826 in polymeric end-products.
b)
The submitter should also be requested at this time to
provide full copies of the protocols and data obtained
from the mutagenicity studies cited in this submission.
c)
The Chemical Hazard Identification Branch (CHIB/AD) will
review the additional data requested and/or provided,
revise this Status Report as appropriate, and recommend
further followup assessment if warranted.
d)
The Agency should transmit a copy of the non-confidential
submission and status report to NIOSH, OSHA, and NCI.
83
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
9
. ~'I"')
~ ....J
SUBJECT:
Status Report*
8EHQ-1279-0329
8EHQ_1279-0~329
Page 1 of 1
Approved
Revision
Needed
OA TE;
Revised (May 28, 1980)
FR~: Walter W. Kovalick, Jr., Director
Program Integration Division (TS-793)
TO: Joseph Herenda, Director
Assessment Division (TS-792)
Submission Description:
Tennessee:
du Pont plant at New Johnsonville,
accidental release of chlorine gas
On Tuesday, December 4, 1979, chlorine gas was released into the
atmosphere at a loading dock of the du Pont plant at New
Johnsonville, Tennessee. The release occurred when a flange
split on a chlorine barge unloading line; within twelve minutes
the flange was valved off.
Submission Evaluation
Chlorine gas is a serious irritant. Human exposure can result in
tachycardia, bronchopneumonia, and pulmonary endema. Chlorine
gas is also a serious mucous membrane and eye irritant.
ComnentsjRecommendations
This incident does not appear to warrant reporting as an 8(e).
Ou Pont estimated that the amount of chlorine released may have
been about .5 to 1.5 tons. An insignificant chlorine odor was
detected but no significant chlorine fumes. A du Pont
investigation found no evidence of any damage to humans or the
surrounding environment, and no evidence of damage to surrounding
biota.
Ou Pont concluded that "the pattern, extent, and amount of
chlorine in this incident did not result in an 'emergency
incident of environmental contamination' under section 8(e) of
'rSCA." This appears to be the correct decision.
EPA Region IV and Headquarters will follow-up and maintain a
complete record of this incident.
*NOTE: This status report is the result of a prelimina=v
s~af: eva~uaticn of information submitted to EPA. Statements
made herel~ are not to be , regarded as expressing final
A~en~y POllCY or 1~tent_w1th respect to this partic~lar
cnem1cal. Any reV1ew or the status report should take' t
' d . h - 1n 0
conS1 erat10n t e zact that it may be based on incompl t
. ~ . e e
1D-ormatlon.
!:~... '0- 11»-4 (~£V. )"11
84
-------
UNITED STA TES ENVIRONMENTAL PROTECTION AGENCY
01. if;
APf.(
7 1980
8EHQ-0180-0330
Page 1 of ~ ~'i/p-,...,
Approved '7/' ( ~ //0 L/
/
SUBJECT:
Sta~us R9port~ 8EHQ-CI80-0330
Frank D. Kover, Cnief CJn~Jlt~ /1
Cnemical Hazard Identitl;~ti~ Bran~
Revision
Needed
I'ROM:
TO:
Josep~T. M€r~~da, Director
Asse;;'6'ddlt Div~s~J);-., CTE
Submission Description
In a section 8(e) submission to the EPA's Region I Office
(Boston, Massacnusetts), tne General Electric Company reports
that it nas been conducting a study of possible industrial
pollution of groundwater at several locations in the vicinity of
its Pittsfield (Mass.) manufacturing complex. ~ne submitter
reports that mineral oil containing PCBs (polychlorinated
biphenyls) in the part:.s per million (ppm) range nad been detecteo
at the groundwater surface in certain areas. At one particular
location (a sump in the basement of a nearby residence) an
estimated gallon 0f oil had accumulated which was found to
contain approximately 200-300 ppm PCBs. It is this circumstance
which prompted tne company to submit this information under ~SCA
section 8 (e) .
In addition, the company reports that [mono]chlorobenzene, at
concentrations of 5 mg/1 and 30 mg/l, had been detected in the
water from 2 of 21 observation wells installed at depths up to 50
feet at varying distances from the manufacturing site. The
submitter states that all of the wells are now being analyzed for
all priority pollutants.
In addition to having notified EPA's Region I Office, General
Electric also reports that this study "has been and continues
under review by personnel of the Massachusetts Division of Water
Pollution and the Massachusetts Department of Environmental
Quality Engineering."
Submission Evaluation
PCBs are among the most stable chemicals known. Once released
into the environment, they decompose very slowly over a period of
several decades. Due to this stability, they remain in the
*NOTE: This status report is the result of a preliminary
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
consideration the fact that it may be based on incom~lete
information. ~
E~, ~o- 1:1- ,."V- a.7&1
85
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8EHQ-0180-0330
Page 2 of 5
environment and are taken up and accumulated in fatty tissues.
This accumulation in organisms is significant because PCBs are
hazardous to health at extremely low levels. Specifically. PCBs
have been shown to cause chronic toxic effects in many species at
less than 10 parts per million (ppm). ~here are well documented
tests on laboratory animals which show that PCBs can cause
reproductive failures, gastric disorders, skin lesions, tumors,
and other effects of concern.
In man, PCBs can enter the body through the lungs, the gastroin-
testinal tract, and the skin. After absorption, PCBs are circu-
lated in the blood throughout the body and are stored in fatty
tissue and a variety of organs, including the liver, kidneys,
lungs, adrenal glands, brain, heart, and skin.
Therefore, the submitter's finding of one gallon of oil contain-
ing 200-300 ppm PCB indicates an opportunity for significant
exposure with a resultant health and environmental hazard.
In addition, there is concern with regard to the [mono]chloro-
benzene concentrations of 5 mg and 30 mg per liter of water in
the observation wells. If these concentrations of chlorobenzene
have access to drinking water, long term consumption/use could
possibly lead to the following human health effects: eye and skin
irritation, liver and kidney damage, and possible blood
disorders.
Current Production and Use
Polychlorinated biphenyls (PCBS7 no designated CAS number) are
members of a broad family of organic chemicals known as chlori-
nated hydrocarbons. Although PCBs may be produced naturally in
the environment, almost all PCBs in existence today have been
synthetically manufactured.
Primary uses of PCBs were, and continue to be, electrical trans-
former cooling liquids and capacitor dielectric fluids. Most of
the PCBs marketed in the United States are still in service in
these applications. However, PCBs have also been used in a vari-
ety of other applications such as heat transfer systems and
hydraulic fluids7 dye carriers in carbonless copy paper; plasti-
cizers in paints, adhesives, and caulking compounds; fillers in
investment casting waX7 and as dust control agents, sealants, and
coatings on roads.
PCBs have a heavy liquid, oil-like consistency, have high boiling
points, and weigh 10-12 pounds per gallon. Other important pro-
perties include: a high degree of chemical stability, low solu-
bility in water, high solubility in fat, low flammability, and
low electrical conductivity. These physical/chemical properties
have made PCBs commercially attractive.
86
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8EHQ-Ol80-0330
Page 3 of 5
Current EPA PCB Regulations
A report by the President's Council on Environmental Quality in
May 1972, recommended that Congress enact the Toxic Suhstances
control Act (TSCA) to provide the regulatory authority required
to deal with PCBs and other chemicals. Before the Toxic Sub-
stances Control Act, EPA could only regulate facilities that
discharged PCBs into naviagable waterways. On July 23, 1976 (41
FR 30468), EPA proposed to ban the discharge of PCBs by electri-
cal transformer and capacitor manufacturers. A final rule was
promulgated under Section 307(a) of the Federal Water Pollution
Control Act on February 2, 1977 (42 FR 6532).
In 1976, Congress passed the Toxic Substances Control Act. At
that time there was widespread recognition and concern regarding
the serious, adverse effects PCBs have on the environment and
human health. Congress responded to this problem by including a
special section in TSCA, Section 6(e), prohiblting future manu-
facturing, processing, distribution in commerce, and use of PCBs
and providing for adequate marking and disposal of the PCBs still
in use.
Since then, EPA has implemented the provisions under Section 6(e)
of TSCA. The following is a summary of these actions:
On February 17, 1978, EPA promulgated the PCB Marking and Disposal
Rule (40 CFR 761). In this rule, EPA established specific require-
ments for the marking and disposal of PCBs according to the nature
and concentration of the PCBs in question.
On May 31, 1979, EPA promulgated the PCBs Manufacturing, Processing,
Distribution in Commerce, and Use Prohibitions (PCB Ban Rule) (40
CFR 761). Specifically, this rule:
1 )
Prohibits all manufacturing of PCBs after July 2,
1979, unless specifically exempted by EPAi
2)
Prohibits the processing, distribution in commerce,
and use of PCBs, except rn a totally enclosed manner
after July 2, 1979, unless specifically authorized by
EPAi
3 )
Authorizes certain processing, distribution in
commerce, and use of PCBs in a non-totally enclosed
manneri
4)
Prohibits all processing and distribution in commerce
of PCBs after July 1, 1979, unless specifically
exempted by EPA.
87
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8EHQ-Ol80-0330
Page 4 of 5
The regulatory scheme developed in the PCB Marking and Disposal Rule
and the PCB Ban Rule was designed to minimize exposure to humans and
the environment while allowing the continued use of those PCBs which
are totally enclosed or have been granted authorizations or exemp-
tions. "Totally enclosed manner" was defined by Congress in TSCA to
mean a manner which will ensure no significant exposure of the human
beings or the environment to PCBs, as determined by EPA by rule
(Section 6(e)(2)(C)). The final ban rule provides that human or
environmental exposure to any detectable quantities of PCBs shall be
deemed significant.
The use of intact, non-leaking PCB transformers, PCB-contaminated
tranformers, electromagnets, and PCB capacitors and equipment con-
taining such capacitors is considered a "totally enclosed"
activity- However, servicing of such equipment is not considered a
totally enclosed activity.
Congress provided a mechanism to allow exceptions to the statutory
ban of non-totally enclosed activities (Section 6(e)) by permitting
EPA to authorize some activities which are not totally enclosed. In
order to authorize an activity, EPA must find that continuation of
the activity does not present an unreasonable risk of injury to
human health or to the environment.
The following non-totally enclosed activities have been granted
authorizations until July I, 1984: the servicing of PCB-containing
transformers; the use of PCBs in heat transfer systems; the use of
PCBs in hydraulic systems; the servicing of PCB electromagnets; the
use of small quantities of PCBS for research and development; and
the use of PCBs as a microscopy mounting medium. The use of PCBs in
natural gas pipeline compressors is authorized until May 1, 1980.
Authorizations until January 1, 1982, have been granted for the use
of PCBs in mining equipment, the servicing of mining equipment, and
the use of PCBs in pigments. Finally, because of the significant
quantities of carbonless copy paper that contains small amounts of
PCBs in government, industry, and personal files, the rule
authorizes continued maintenance of such paper.
Exceptions may also be made to the manufacturing ban or to the ban
on PCB processing and distribution in commerce. ~hese exceptions
are referred to in TSCA as exemptions (Section 6{e){3)(B)). Before
an exemption can be granted, there must be a determination that an
unreasonable risk is not present and that good faith efforts have
been made to develop substitutes for the PCBs.
Although PCBs remain in use, EPA carefully considers the circum-
stances and conditions of each remaining use. Most of the remaining
PCBs are in totally enclosed electrical equipment which will be
replaced in the next few years as this equipment is serviced or
retired. Most importantly, EPA has strict servicing, storage and
disposal requirements to protect against escape of the PCBs into the
environment. Further, authorization of each remaining use will
88
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8EHQ-0180-0330
Page 5 of 5
continue to be reviewed on a regular basis to ensure that they do
not present an unreasonable risk to human health and the
environment.
comments/Recommendations
In this particular case, the General Electric Company's submission
of this section 8(e) information to the Region I Office did not
unduly burden the EPA's processing of the notice. However, it
should be brought to the submitter's attention that the substantial
risk information reporting requirements (Part IX of the March 16,
1978, "Statement of Interpretation and Enforcement Policy; Notifi-
cation of Substantial Risk" (43 FR 11110» clearly specify that TSCA
section 8(e) notices are to be sent to the Document Control Officer,
Chemical Information Division, Office of Toxic Substances (WH-557),
Environmental Protection Agency, 401 M Street S.W., Washington,
D.C. 20460. A copy of the March 16, 1978, policy statement should
be sent to the submitter.
Region I (EPA) has recommended that this site of groundwater
contamination be placed on the list of Uncontrolled Hazardous Waste
Sites.
A report (FRL-756-4) on the human effects caused by exposure to
chemical contaminants in drinking water has been prepared by the
National Academy of Sciences in accordance with the Safe Drinking
Water Act (P.L. 93-523).
The Test Rules Development Branch/AD, in conjunction with the
Environmental and Health Review Divisions, is currently reviewing
data received by the Agency pertaining to the Interagency Testing
Committee's designated category: "Mono- and Di-Ch1orinated
Benzenes."
a)
The EPA Region I Office is monitoring company and state/
local agency actions and will continue with necessary
follow-up activities involving this reported groundwater
contamination.
b)
A copy of this status report should be transmitted to the
EPA Region I Office (Hazardous Waste Task Group/Enforcement
Division) .
c)
Copies of the submission and status report should be
transmitted to OWWM, SAD/OPII, TRDB/AD, and PCB Team/CAD/
OCC.
89
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U HITED STATES ENVIRONMENTAL PROTECTION AGENCY
OCT 2 5 1979
8 Eli Q - 0 7 7 9 - 0 0 10
Followup Respons
Page 1 of 2
Branch
Revisio
Needed
DATE: Revised (May 28, 1980)
SU8JECT: Status Report* 8EHO-0779-0010
Followup Response
,.~l:ank D. Kover, Chief
~ Chemical Hazard Identification
Approved
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Description
The American Petroleum Institute has submitted information
relating to the physical, chemical, and compositional properties
of "rubber solvent," "60 solvent," and "high aromatic solvent."
Information is included on the current availability of these
solvents in commerce. This additional information, sent in
response to an EPA request, is supplemental to a previous submis-
sion (8EHQ-1077-0010), which reported the possible mutagenic
activity of these three solvents.
Submission Evaluation
The chemical analyses show that the tested "rubber solvent" con-
tained 1.5% benzene by volume. The concern is 4-fold:
(1)
benzene can cause aplastic anemia. The bone marrow becomes
lncapahle of producing mature red blood cells. This failure
of hone marrow activity may also involve white blood cells
and blood platelets.
( 2 )
( 3 )
aplastic anemia may progress to leukemia.
exposure to benzene increases the risk for developing
lymphoid cancers.
( 4)
exposure to benzene increases the risk five-fold for
developing all types of cancer.
The chemical analyses also show that the tested "high aromatic
solvent" contained polynuclear aromatic hydrocarbons. Their
presence raises the question of carcinogenicity.
*NOTE: This status report is the result of a prelimina=v
staf: eva~uation of information submitted to EPA. State~ents
mace hereln are n~t to be,regarded as expressing final
Agency POllCY or lntent wlth respect to this particular
chem~cal. . Any review of the. status report should take into
~onslder~tlon the fact that lt may be based on incomplete
lnformatlon.
I:~" "Q- IJ~ II'IEV. ..711
90
-------
8EHQ-0779-0010
Followup Response
Page 2 of 2
Current Production and Use
The submitter states that the "rubber solvent" and "high aromatic
solvent" petroleum products currently available in commerce ("60
solvent" appears to be no longer available commercially as such)
can be variable blends of several different Petroleu~ Refinery
Process Streams (TSCA Generic Terms) all of which are listed in
the TSCA Inventory. No other information on the current
production volumes or uses of the solvents was located in the
secondary sources consulted.
Comment/Recommendations
Copies of the original submission (8EHQ-1077-0010), the followup
submission (8EHQ-0879-0010 Followup), and their respective status
reports should be transmitted to NIOSH, OSHA, OWWM, CPSC, OPP,
and CREB.
91
-------
FE8
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
600
8EHQ-1179-0028
Supplement
P:;;r~v:: 2 /?J7J
Revision ~
Needed
DATE: Revised (May 28, 1980)
SUBJECT:
Status Reports*
8EHQ-1179-0028
Supplement
,. ~;:nk D. Kover, Chief
ctJ~~emical Hazard Identification Branch
TO: Joseph J. Merenda, nirector
Assessment Division, OTE
Submission Description
This supplemental submission by the Union Carbide Corporation
presents the final results from a co-sponsored mouse skin
painting study designed to determine the carcinogenic potential
of neopentylglycol diacrylate (NPGDA; CAS No. 2223-82-7). The
report indicates that upon repeated NPGDA application (3 times
per week) over the lifetime of the animals, 8/37 mice developed
neoplastic skin lesions. Of those lesions, 5 squamous cell
papillomas and 3 squamous cell carcinomas were confirmed by
histopathology. The submission also reports that a squamous cell
carcinoma (cause undetermined) of the skin had developed near the
right eye of one control mouse treated with the acetone vehicle.
The original submission (8FHQ-0178-0028) which reported the
preliminary results from this dermal carcinogenesis study was
reviewed previously by the Agency. A status report was prepared
at that time.
Submission Evaluation
The earlier suspicion, raised by the interim results (8EHQ-0178-
0028), that NPGDA is a carcinogen is strongly supported by the
data presented in this final report.
There is some concern, however, about the cause of the skin
carcinoma observed in the acetone control group. Is there a
possibility that the test animals were exposed to some other
carcinogen or is this tumor type being considered "spontaneous"
as observed in historical controls.
*NOTE: This status report is the result of a prelimina~y
staff eva~uation of information submitted to EPA. Statements
made here1~ are n~t to be , regarded as expressing final
Agen~y po11cy or l~tent wlth respect to this particular
chem7cal. ,Any reV1ew of the, status report should take into
7ons1der~t10n the fact that lt may be based on incomplete
1nformat1on.
E~A '0- 1121)... ("!:Y. to "I
92
-------
8EHQ-l179-0028
Supplement
Page 2 of 2
Current Production and Use
A review of the production range (includes importation volumes)
statistics for neopentylglycol diacrylate (CAS. No. 2223-82-7)
which is listed in the initial TSCA Inventory (1977) has shown
that between 1 thousand and 8.6 thousand pounds of this chemical
were produced/imported in 1977.**/
As stated in the original status report, NPGDA appears to have
certain uses in UV-curable coatings, adhesives, and inks.
Comments/Recommendations
The submitting company stated in the original submission that its
employees, customers, suppliers, and another producer had been
notified of the preliminary results showing tumorigenic activity
of NPGDA and the need for precautions against exposure.
The Agency has previously received and evaluated section 8(e)
submissions on several other acrylates: ethyl acrylate (8EHQ-
0978-0250); 2-ethylhexyl acrylate (8EHQ-1278-0262); glycidyl
acrylate [GA] and glycidyl methacrylate [GMA] (8EHQ-0179-0270).
Chemical Hazard Information Profiles (CHIP) for ethyl acrylate,
2-ethylhexyl acrylate and NPGDA are now in preparation.
a)
According to the original submission, the final results
of this mouse dermal study of NPGDA will be made
available to those people known to have potential
exposure to this chemical. It is not clear in the
cover-letter to the present submission if this action
has been taken. This point should be clarified with the
submitter.
b)
NPGDA should be considered as a candidate for inclusion
in the 8(a) use rule.
c)
A copy of the original and supplemental submissions and
the respective status reports should be transmitted to
NIOSH,OSHA, CPSC, NCI, and TRDB.
**/This production range information does not include any
production/importation data claimed as confidential by the
person(s) reporting for the TSCA Inventory, nor does it include
any information which would compromise Confidential Business
Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
93
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
FEB 2 6 1900
8EHQ-I079-0211
Followup Respon~~
Page 1 of 3 / ;f7-Y1
Approved C~// /' / /
Revision V
Needed
DATE: Revised (May 28, 1980)
SUIJEC:T: Status Report * 8EHQ-l079-02ll
,~.., FOl~OW Up Response "B"
'R~~rank D. Kover, Chlef
Chemical Hazard Identification Branch
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Description
Per the Agency"s request in a follow-up letter, the Ethyl
Corporation has provided the full final results of a teratology
study of methylcyclopentadienyl manganese tricarbonyl (MMT; CAS
No. 12108-13-3) in rats.
The submitting company, in its initial submission on MMT (8EH0-
0778-0211) stated that it had obtained preliminary information
which if found to be reliable, could reasonably support the con-
clusion that MMT was teratogenic in laboratory rats. However,
the submitter expressed "grave reservations" about the data and
indicated that further study and an audit of the information was
underway. After completion of these activities, the submitter
forwarded a follow-up report to the Agency.
In that follow-up report (8EHQ-I078-02ll Follow-up Response A),
the submitter provided a summary of the teratology results and
stated that based upon his audit, the "data does not support a
conclusion that MMT is a teratogen." The submitter further con-
cluded that, in this instance, his company "does not possess
information which reasonably supports the conclusion that MMT
presents a substantial risk of injury to health or the environ-
ment." The Agency in its evaluation of the information, however,
concluded that the data as presented could not be used to support
the contention that ~MT was not a teratogen. It was therefore
the Agency's preliminary determination that the toxicological
information as submitted appeared to offer reasonable support for
a conclusion of substantial risk.
In its follow-up to Response A the Agency requested that the
submitter provide a complete copy of the final results, including
test protocols and data, obtained from the teratology study. Per
the Agency's request, the submitter forwarded the final report;
that information (Response B) comprises the subject of this
status report.
*NOTE: This ~tatus ~eport i~ the re~ult of a prelimina=y
staff eva~uatl0n of lnformatlon submltted to EPA. Statements
mace hereln are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. . Any review of the status report should take into
7ons1der~tl0n the fact that it may be based on incomplete
lnrorrna tlon.
E~A '-OIltM 11»-6 ("tv. ..111
94
-------
8EHQ-1079-02ll
Followup Response
Page 2 of 3
In Response B, the submitter also states that based on concerns
about the quality and reliability of the data, the teratology
study has been repeated. According to the submitter, the results
obtained from the second study appear to substantiate his earlier
conclusion that the "data does not support a conclusion that MMT
is a teratogen." The data from this new teratology study were
not, however, included in the present submission.
Submission Evaluation
The final report of the initial teratology study will not ade-
quately support a contention that MMT is not a teratogen. The
significance of 5/5 litters with an increased incidence of ocular
and vertebral malformations cannot be minimized by speculation
concerning the high maternal toxicity observed, the group sizes
being too small for statistical analysis, or the origin of the
rats used for the study. Abnormal events affecting the fetuses
occurred during this study and MMT appears to have been responsi-
ble for those events.
Therefore, based on the data provided thus far by the submitter,
it is strongly suspected that MMT is a potential teratogen.
Current Production and Use
A review of the production range (includes importation volumes)
statistics for MMT (CAS No. 12108-13-3) which is listed in the
initial TSCA Inventory (1977) has shown that no 1977 production/
importation was reported or that all of the production range data
reported were claimed as confidential by the manufacturer(s) and
importer(s) and cannot be disclosed. [Section 14(a) of the TSCA,
U.S.C. 2613 (a)].**-1
MMT is currently used in some leaded gasolines as an anti-knock
agent. provisions of the 1977 Amendments to the Clean Air Act
resulted in a ban on the use of MMT in unleaded gasoline sold in
the U.S. after September 15, 1978. However, on May 31, 1979, EPA
suspended enforcement of the ban on MMT in unleaded gasoline
until October 1, 1979. This EPA action was taken in order to
increase the summer supply of unleaded gasolines and therefore
decrease the need for consumers to switch to the leaded fuels
which would have resulted in severe damage to pollution-control
catalysts in many of the newer automobiles.
** /The data submitted for the TSCA Inventory including
production range information, are subject to the limitations
contained in the Inventory Reporting Regulations (40 CFR 710).
95
-------
8EHQ-I079-0211
Fol1owup Response
Page 3 of 3
Comments/Recommendations
a)
The submitter should be requested to provide, when available,
a complete copy of the final results, including test proto-
cols and data, from the second teratology study of MMT in
rats.
b)
CHIB will review the additional information requested, revise
this Status Report as appropriate, and recommend further
follow-up assessment if warranted.
c)
A copy of this submission and status report should be trans-
mitted to OSHA, NIOSH, OAQPS, OMSAPC, and ORD.
96
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OCT 3 I 1979
SU8JECT: Status Report*8EH0-0879-0250
,~./ Followup Response (A)
,.~~rank D. Kover, Chief
Chemical Hazard Identification
Brandl,
8 EB Q - 0 8 7 9 - 0 2 5 0
Followup Response
Page 1 of 2~
Approved, ~v t
/ /
Revisiorf/
Needed
DATE: Revised (~ay 28, 1980)
TO: Joseph J. Merenda, Director
Assessment Division
Submission Description
The Celanese Corporation has submitted the final results from
several interim sacrifices from a co-sponsored two-year inhala-
tion toxicity study of ethyl acrylate (CAS No. 140-88-5) in mice
and rats. These final results, including test protocols and
data, were submitted in response to an EPA request for additional
information which was hased on its evaluation of the summarized
preliminary sacrifice results presented in the original suhmis-
sion (8BHQ-I078-0250).
Submission Evaluation
This followup information does not significantly alter the
Agency's preliminary evaluation of the summarized results pre-
sented in the original suhmission.
The final results from the six-month ethyl acrylate exposure to
mice do indicate that the chemical is a volatile irritant capahle
of provoking histoloqical changes in the nasal mucosa. The
significance of the metaplasia will probahly emerge from this
two-year study.
The final results from the six-month exposure of ethyl acrylate
to rats, however, is of greater concern. Fyperplasia was
observed in addition to the metaplasia. Whether the hyperplasia
is related to neoplasia will be determined from future results
obtained from this two-year study.
Current Production and. Use
A review of the production range (includes importation volumes)
statistics for ethyl acrylate (CAS No. 140-88-5) as listen in t~e
*NOTE: This status report is the result of a prelimina=y
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respec~ to this particula=
chemical. Any review of the status report should take into
7onsideration the fact that it may be based on incomp~ete
l.nf"orma tion .
I:~A '0,"" 11»-40 lIitEV. "'.1
97
-------
8EHQ-0879-0250
Followup Response
Page 2 of 2
initial TSCA Inventory (1977) has shown that between 70 ~illion
and 200 ~illion pounds of this chemical was producedji~ported in
1977. This production range infor~ation does not include any
production/importation data claimed as confidential by the per-
son(s) reporting for the TSCA Inventory, nor does it include any
information which would co~pro~ise Confidential Business Informa-
tion. The data sub~itted for the TSCA Inventory, including
production range information, are subject to the limitations
contained in the Inventory Reporting Regulations (40 CFR 710).
This che~ical is used in the manufacture of acrylic paints and
polymers, and as a chemical intermediate.
Conmen t s/RecoPlI'ienda t ions
A production and use profile (PUP) and literature search have
been initiated as prelininary steps in considering ethyl acrylate
a candidate for a Chemical Hazard Infor~ation Profile (CHIP).
( a )
The two-year inhalation toxicity studies were initiated in
December 1977 and should, therefore, be scheduled for com-
pletion in Decenber 1979. The submitter should be requested
to provide full copies of the pathology results including
test data from the l2-month sacrifices which were scheduled
for December 1978 and any subsequent sacrifices from these
24-nonth inhalation toxicity studies on ethyl acrylate.
(b)
Cor LoS of ',e original submission (8F.HQ-I078-0250), the
followup supplemental submission (8FHQ-0879-0250 Followup
Response A) and their respective status reports should be
transmitted to OSHA, NIOSH, CPSC, FDA, NCI, and FIBjOWWM.
98
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SE.P '9 (-I -r-j
! .~ '~
SUIJECT: Status Report* 8EHQ-0879-0251
~~ Supplement
,.t..!}Frank D. Kover, Acting Chief
Chemical Hazard Identification
Branch
8ERQ-0879-0251
Supplement
Page 1 o~
Approved
Revisio
Needed
DATE:
Revised (May 28, 1980)
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Description
This supplemental submission by the Union Carbide Corporation,
contains the final report of a life-time skin-painting study with
2' ,2'-di(sec-butoxy) acetophenone (DBAP; CAS No. 68109-57-9) in
mice. The original submission (8F.HQ-l078-0251) which summarized
this study was received earlier by the Agency and a status report
was prepared at that time. Both the original and supplemental
submissions state that DBAP had been shown to have a weak
tumorigenic activity in mice.
Submission Evaluation
The supplemental information does not alter the impression that
DBAP is a weak carcinogen. Because this chemical is photosensi-
tive, there is also a concern for non-cancerous skin lesions in
humans.
Current Production and Use
DBAP was developed as a photoinitiator in acrylate-based photo-
cure coating systems. The submitter has previously stated that
they have withdrawn from the photocure chemical coatings market.
No additional information on current production or other uses for
this chemical was located in the secondary sources consulted.
However, DBAP is listed in the TSCA Inventory.
Comments/Recommendations
A production and use profile (PUP) and a literature search have
been initiated as preliminary steps in considering DBAP a candi-
date for a Chemical Hazard Information Profile (CHIP).
A copy of this submission and status report should be transmitted
to NIOSH, OSHA, CPSC, OWWM.
*NOTE: This status report is the result of a prelimina~y
staff evaluation of information submitted to EPA. Statements
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chemical. Any review of the status report should take into
7onsider~tion the fact that it may be based on incomplete
lnforma tlon.
...... .....-... ..------.. ,-.~ --..,
99
-------
NOV
UNITED STATES ENVIRONMENTAL PROTECT!ON AGENCY
I 3 :~}I''J 8EHQ-I079-0262
Followup Response
Page 1 of ~ ~
Approved ~
Revision ~
Needed
OAT!:
Revised (May 28, 1980)
SUBJECT: Status Report* 8EH(\-1079-0262
Follow up Response
,.~~k D. Kover, Chief
. Chemical Hazard Identification
Branch
TO: Joseph J. Merenda, Director
Assessment Division, OTE
Submission Description
The Union Carbide Corporation has provided final results from a
mouse life-time skin painting study designed to evaluate the
carcinogenic potential of 2-ethylhexyl acrylate (CAS No. 103-11-
7). The results indicate that upon repeated (3 times per week)
paintings of 2-ethlyhexyl acrylate (75% w/v dilution in acetone)
6/40 mice developed neoplastic skin lesions in the treated
area. Histological examination revealed that 4 of the lesions
were squamous cell papillomas and 2 were squamous cell
carcinomas. It is also reported that a squamous cell carcinoma
had developed near the right eye of one of the control mice
treated with undiluted acetone. The SUbMission reports that this
lesion mayor may not have been due to the acetone treatment.
The original submission (8EHQ-1278-0262) had reported that, after
21 months of 2-ethylhexyl acrylate treatment, 31 of 40 treated
mice had died, of which 3 were observed to have developed squa-
mous cell papillomas in the treated area. The submitter
concluded at that time that the preliminary results indicated a
weak tumorigenic activity for 2-ethylhexyl acrylate in mice.
However, the submitter also concluded that these preliminary
"results, of themselves do not indicate that similar effects
would result in humans or necessarily present evidence of a
substantial risk to human health."
Submission Evaluation
The final pathology results from this life-time skin-painting
study in mice demonstrate that 2-ethylhexyl acrylate is an animal
carcinogen.
*NOTE: This status report is the result of a prelimina=v
staff evaluation of information submitted to EPA. State~ents
made herein are not to be regarded as expressing final
Agency policy or intent with respect to this particular
chem~cal. . Any review of the status report should take into
cons~derat~on the fact that it may be based on incomDlete
information. .
E~A '0,", U»1 I"EV. ~7'1
100
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8EHQ-I079-0262
Followup Response
Page 2 of 2
Current Production and Use
A review of the production range (includes importation volumes)
statistics for 2-ethylhexyl acrylate (CAS No. 103-11-7) as listed
in the initial TSCA Inventory (1977) has shown that between 21
million and 110 million pounds of this chemical were produced/
imported in 1977. This production range information does not
include any production/importation data claimed as confidential
by the person(s) reporting for the TSCA Inventory, nor does it
include any information which would compromise Confidential
Business Information. The data submitted for the TSCA Inventory,
including production range information, are subject to the
limitations contained in the Inventory Reporting Regulations (40
CFR 710).
2-Ethylhexyl acrylate is used as a monomer for plastics,
protective coatings, and in paper treatment. It also has uses in
water-based paints.
Comments/Recommendations
A Chemical Hazard Information Profile (CHIP) on 2-ethylhexyl
acrylate is being prepared by the Chemical Hazard Identification
Branch.
Copies of the original submission, the followup submission and
the respective status reports should be transmitted to OSHA,
NIOSH, NCI, CPSC, FDA, OWWM, and TRDB.
101
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APffNIllX A
THURSDAY, MARCH 16, 1978
PART V
ENVIRONMENT AL
PROTECTION
AGENCY
.
TOXIC SUBSTANCES
CONTROL ACT
Statement of Interpretation and
Enforcement Policy; Notification
of Substantial Risk
102
-------
11110
[6560-01]
ENVIRONMENTAL PROTECTION
AGENCY
[FRL 849-2]
TOXIC SUBSTANCES CONTROL ACT
Notification 0' Subltantial Rllk Under
Sedlon BCe)
AGENCY: Environmental Protection
Agency.
ACTION: Statement of interpretation
and enforcement policy.
SUMMARY: This action states EPA's
Interpretation of, and enforcement
policy concerning, section B(e) of the
Toxic Substances Control Act (TSCA)
(90 Stat. 2029, 15 U.S.C. 2607). The
provisions of that section went into
effect on January 1, 1977.
Section B(e) states that "any person
who manufactures, processes, or dis-
tributes in commerce a chemical sub-
stance or mixture and who obtains in-
formation which reasonably supports
the conclusion that such substance or
mixture presents. a substantial risk of
Injury to health or the environment
shall immediately inform the Adminis-
trator of such information unless such
person has actual knowledge that the
Administrator has been adequately in-
formed of such information."
DATES: The policy expressed in this
document is in effect as of the date of
publication.
FOR FURTHER INFORMATION
CONTACT:
Frank D. Kover, Assessment Divi-
sion, Office of Toxic Substances
(WH-557), Environmental Protec-
tion Agency, 401 M Street SW.,
Washington, D.C. 20460, 202-755-
2110.
SUPPLEMENTARY INFORMATION:
On September 9,1977, the Agency pro-
posed guidance (42 FR 45362) on its in-
terpretation of and policy concerning
the provisions of section B(e). Al-
though the proposed "guidance" was
an Interpretive rule and statement of
policy exempt from the notice and
public comment provisions of the Ad-
ministrative Procedure Act (5 U.S.C.
553), the Agency solicited comments
on several issues to make more in-
formed decisions. On October 11, the
comment period was extended from
October 15 to October 31, 1'977 (42 FR
54857). On November 4, 1977, a supple-
mental notice to the proposed guid-
ance was published (42 FR 57744), de-
leting the November 15 date for re-
porting certain information obtained
before 1977 and stating that a new
date would be established in the final
guidance.
In developing this policy statement,
two meetings have been held (FE:.bru-
NOTICES
ary 1, 1977, and October 26, 1977> with
selected representatives of industry
and environmental and other inter-
ested groups. Comments submitted
pursuant to the February 1 meeting
were addressed in the preamble to the
September 9 proposal. Over 100 writ-
ten comments have been submitted
pursuant to the September 9 proposal
from trade associations, businesses, en-
vironmental groups, labor unions,
State and Federal agencies, and other
interested parties. Appendix B de-
scribes significant issues raised in
these comments and the Agency's re-
sponse to them.
The major modifications to the Sep-
tember 9 proposal are summarized in
points 1 through 7 below.
(1) Pursuant to some question over
the definition and nature of "guid-
ance," this document is now described
more accurately as a "policy state-
ment." It is exempt from the notice
and public comment provisions of the
Administrative Procedure Act, as well
as provisions concerning delayed effec-
tive dates.
(2) Many commenters expressed the
view that to apply these requirements
to officers and employees of a business
organization would result in ill-consid-
ered, premature reports and would un-
fairly subject employees to conflicting
responsibilities as individual respon-
dents and as corporate agents. Other
commenters expressed support for the
view that certain employees have a re-
sponsibility to report pertinent infor-
mation, and felt that the phrase "ca-
pable of appreciating pertinent infor-
mation" appropriately described those
employees.
The September 9 proposal would
have applied section B(e) requirements
to commercial establishments as well
as to employees capable of appreciat-
ing pertinent information, but stipu-
lated enforcement priorities intended
to encourage corporate processing and
centralized reporting of such informa-
tion (42 FR 45363). The intent was to
ensure that pertinent information ob-
tained by employees is promptly and
appropriately considered, while mini-
mizing duplicative or ill-considered
submissions.
The Agency now feels that these ob-
jectives would best be served by allow-
ing commercial establishments-under
certain conditions designed to ensure
full disclosure-to assume exclusive re-
sponsibility for reporting to EPA any
substantial-risk information obtained
by individual officers or employees.
Accordingly, this policy statement
stipulates that individual officers and
employees will have fully discharged
their section B(e) obligations once they
have notified the designated responsi-
ble company supervisor or official of
pertinent information, provided, that
the employing company or firm has
established, internally publicizes, and
affirmatively implements procedures
governing such notifications. These
procedures, at a minimum, must: (1)
Specify the information that must be
reported; (2) indicate how the notifica-
tions are to be prepared and submit-
ted; (3) note the Federal penalties for
failing to report; and (4) provide a
mechanism for promptly notifying of-
ficers and employees who have submit-
ted reports of the company's disposi-
tion of those reports, including wheth-
er or not they were submitted to EPA
(and if not, informing employees of
their right to report to EPA, as pro-
tected by TSCA section 23). EPA be-
lieves these four criteria will ensure
prompt and appropriate processing of
pertinent information.
Establishment of such proc/;'dures
notwithstanding, all officials responsi-
ble and having authority for the orga-
nization's execution of its section B(e)
obligations retain personal liability for
ensuring that substantial-risk informa.
tion is reported to EP A.
(3) The September 9 proposal stated,
in Part III. that a person obtains in-
formation when he is aware that it
"may suggest" substantial risk. Nu-
merous commenters questioned the
Administrator's authority to compel
the reporting of information which
"may suggest" substantial risk. The
Administrator agrees that section B(e)
addresses information that "reason-
ably supports the conclusion" of sub-
stantial risk and has deleted the "may
suggest" provision. but emphasizes
that "reasonably supports the conclu-
sion" of substantial risk is not identi-
cal to a conclusive demonstration of
substantial risk. The former typically
occurs, and must be reported, at an
earlier stage. Part VI in this policy
statement provides Agency interpreta-
tion of the types of information that
"reasonably support" such a conclu-
sion.
(4) Numerous commeI'1ters requested
clarification of different aspects of
Part V of the September 9 proposal
("Information Which Reasonably Sup-
ports a Conclusion of Substantial
Risk"), particularly concerning envi-
ronmental effects, and suggested dif-
ferent interpretations of what consti-
tutes a "substantial risk". The Agency
continues to focus in this policy state-
ment on the effects set forth in the
September 9 proposal, but clarifies
that the substantiality of a risk is a
function of both the seriousness of the
effect and the probability of its occur-
rence (see Part V).
(5) Numerous commenters main-
tained that section B( e) only applies
prospectively to information obtained
after January 1, 1977. The Agency dis-
agrees, as explained in the preamble
to the September 9 proposal. This
policy statement continues to apply
section B(e) to information obtained
before 1977 of which a person has
FEDERAL REGISTER, VOL 43, NO. 52-THURSDAY, MARCH 16, 1978
103
-------
been aware since January I, 1977. In
response to requests for clarification,
the statement defines what constitutes
such awareness. In this manner, EPA
intends to limit the need for searches
of historical records and files.
(6) This policy statement now pro-
vides that any information published
in scientific literature, In any Ian.
guage, is exempt if it is referred to in
abstracts published by specified ab-
stracting services.
(7) This policy statement describes
in a new Part X how to submit claims
of confidentiality.
Accordingly. the Administrator's in-
terpretation of and policy towards sec-
tion 8(1') is set forth below.
Dated: February 24, 1978.
DOUGLAS COSTLE
Administrator.
I. DEFINITIONS
The definitions set forth in TSCA
section 3 apply to these requirements.
In addition. the fOllowing definitions
are provided for purposes of this
policy statement:
The term "manufacture or process
'for commercial purposes' " means to
manufacture or process: (1) For distri-
bution in commerce, Including for test
marketing purposes, (2) for use as a
catalyst or an intermediate. (3) for the
exclusive use by the manufacturer or
processor, or (4) for product research
and development.
The term "person" includes any nat-
ural person, corporation, firm, com-
pany, joint-venture, partnership, sole
proprietorship, lk"Sociation, or any
other business entity, any State or po-
Utical subdivision thereof, any municl-
paUty, any Interstate body and any de-
partment, agency. or Instrumentality
of the Federal Go\ernment.
The term "substantial-risk Informa-
tion" means Information which rea.
sonably supports the conclusion that a
chemical substance or mixture pre-
sents a substantial risk of injury to
healtll or the environment.
II. PERSONS SUBJECT TO THE
REQUIREMENT
Persons subject to section 8( e) reo
quirements Include both natural per-
sons and business entities engaged in
manufacturing, processing, or distrib-
uting in commerce a chemical sub-
stance or mixture. In the case of busi-
ness entities, the president, chief ex-
ecutive officer, and any other officers
responsible and having authority for
the organization's execution of its sec-
tion 8(1') obligations must ensure that
the organization reports substantial-
risk Information to EP A. The business
organization is considered to have ob-
tained any information which any of-
ficer or employee capable of appreciat-
ing the significance of that informa-
tion has obtained. It is therefore in.
NOTICES
cumbent upon business organizations
to establish procedures for expedi-
tiously processing pertinent informa-
tion in order to comply with the
schedule set forth in Part IV.
Those officers and employees of
business organizations who are capa-
ble of appreciating the significance of
pertinent information are also subject
to these reporting requirements. An
employing organization may relieve its
individual officers and employees of
any responsibility for reporting sub-
stantial-risk information directly to
EPA by establishing, internally publi-
cizing, and affirmatively implementing
procedures for employee submission
and corporate processing of pertinent
information. These procedures, at a
minimum, must: (1) Specify the infor-
mation that officers and employees
must submit; (2) indicate how such
submissions are to be prepared and
the company official to whom they are
to be submitted; (3) note the Federal
penalties for failing to report; and (4)
provide a mechanism for promptly ad-
vising officers aJ1d employees In writ-
Ing of the company's disposition of the
report, including whether or not the
report was submitted to EPA (and if
not informing employees of their right
to report to EP A, as protected by
TSCA section 23). An employee of any
company that has established and
publicized such procedures, who has
internally submitted pertinent infor-
mation In accordance with them, shall
have discharged his section 8(1') obli-
gation. Establishment of such proce-
dures notwithstanding, all officials re-
sponsible and having authority for the
organization's execution of its section
8(1') obligations retain personal liabil-
Ity for ensuring that the appropriate
substantial-risk Information is report-
ed to EPA.
Business organizations that do not
establish such procedures cannot re-
lieve their individual officers and em.
ployees of the responsibllty for ensur-
Ing that substantial-risk information
they obtain is reported to EP A. While
officers and employees of such organi-
zations may also elect to submit sub-
stantial-risk Information to their supe-
riors for corporate processing and reo
porting, rather than to EPA directly,
they have not discharged their individ-
ual section 8(1') obligation until EPA
has received the information.
NOTE.-IlTespective of a business organlza.
tion's decision to establish and publicize the
procedures descrlbt-:! above. it is responsible
for becoming cognizant of any substantial-
risk information obtained by its officers and
employees, and for ensuring that such infor-
mation is reported to EPA within 15 work-
ing days.
III. WHEN A PERSON WILL BE REGARDED
AS HAVING OBTAINED INFORMATION
A person obtains substantial-risk in-
formation at the time he first comes
11111
into possession of or knows of such in-
formation.
NOTE.-This includes Information of
which a prudent person similarly situated
could reasonably be expected to possess or
have knowledge.
An establishment obtains informa-
tion at the time any officer or em-
ployee capable of appreciating the sig-
nificance of such information obtains
it.
IV. REQUIREMENT THAT A PERSON "IM-
MEDIATELY INFORM" THE ADMINISTRA-
TOR
With the exception of information
on emergency incidents of environ-
mental contamination [see Part V(C)]
a person has "immediately informed"
the Administrator if Information is re-
ceived by EPA not later than the 15th
working day after the date the person
obtained such information. Supple-
mentary information generated after a
section 8(1') notification should, if ap-
propriate, be immediately reported.
For emergency incidents of environ-
mental contamination, a person shall
report the Incident to the Administra-
tor by telephone as soon as he has
knowledge of the incident (see Part IX
for appropriate telephone contacts).
The report should contain as much of
the information required by Part IX
as possible. A written report in accor-
dance with Part IX (a) through (f) is
to be submitted within 15 days.
Information currently In the posses-
sion of a person who is subject to re-
porting must be reported within 60
days of pUblication of this policy state-
ment.
V. WHAT CONSTITUTES SUBSTANTIAL
RISKS
A "substantial risk of Injury to
health or the environment" is a risk of
considerable concern because of (a)
the seriousness of the effect [see Sub-
parts (a). , and (c) below for an il-
lustrative list of effects of concern],
and (b) the fact or probability of its
occurrence. (Economic or social bene-
fits of use, or costs of restricting use,
are not to be considered In determin-
ing whether a risk is "substantial".)
These two criteria are differentially
weighted for different types of effects.
The human health effects listed In
Subpart (a> below, for example, are 80
serious that relatively little weight is
given to exposure; the mere fact the
implicated chemical is In commerce
constitutes sufficient evidence of expo-
sure. In contrast, the remaining ef-
fects listed In Subparts (b) and (c)
below must Involve, or be accompanied
by the potential for, significant levels
of exposure (because of general pro-
duction levels, persistence, typical
uses, common means of disposal, or
other pertinent factors).
Note that: (i) The effects outlined
below should not be reported if the re-
fEDEItAL REGISTER, VOL 43, NO. 52-THURSDAY, MARCH 16, 1978
104
-------
11112
spondent has actual knowledge that
the Administrator is already informed
of them.
(ii) Information respecting these ef-
fects can be obtained either directly,
by observation of their occurrence, or
inferred from designed studies as dis-
cussed in Part VI.
The Agency considers effects for
which substantial.risk information
must be reported to include the fol.
lowing:
(a) Human' health effects-(l) Any
instance of cancer, birth defects, mu-
tagenicity, death, or serious or pro-
longed incapacitation, including the
loss 01 or inabllity to use a normal
bodily function with a consequent rel-
atively serious impairment of normal
activities, if one (or a few) chemical(s)
is strongly implicated.
(2) Any pattern of effects or evi-
dence which reasonably supports the
conclusion that the chemical sub-
stance or mixture can produce cancer,
mutation, birth defects or toxic effects
resulting in death, or serious or pro-
longed incapacitation.
(b) Environmental effects-(1) Wide-
spread and previously unsuspected dis-
tribution in environmental media, as
Indicated in studies (excluding materi-
als contained within appropriate dis.
posal facllities).
(2) Pronounced bioaccumulation.
Measurements and indicators of pro-
nounced bioaccumulation heretofore
unknown to the Administrator (includ-
Ing bioaccumulation in fish beyond
5,000 times water concentration in a
30.day exposure or having an n-oc-
tanol/water partition coefficient
greater than 25,000) should be report-
ed when coupled with potential for
widespread exposure and any non-triv-
ial adverse effect.
(3) Any non-trivial adverse effect,
heretofore unknown to the Admiuis-
trator, associated with a chemical
known to have bioaccumulated to a
pronounced degree or to be wide-
spread in environmental media.
(4) Ecologically significant changes
In species' interrelationships; that is,
changes in population behavior,
growth, survival, etc. that in turn
affect other species' behavior, growth,
or survival.
Examples include: (i) Excessive stim-
ulation of primary producers (algae,
macrophytes) in aquatic ecosystems,
e.g" resulting in nutrient enrichment,
or eutrophication, of aquatic ecosys.
tems.
(ii) Interference with critical biogeo-
chemical cycles, such as the nitrogen
cycle.
(5) Facile transformation or degra-
dation to a chemical having an unac.
ceptable risk as defined above.
(c) Emergency incidents of environ-
mental contamination-Any environ-
mental contamination by a chemical
substance or mixture to which any of
NOTICES
the above adverse effects has been as.
cribed and which because of the pat-
tern, extent, and amount of contami-
nation (1) seriously threatens humans
with cancer, birth defects, mutation,
death, or serious or prolonged inca-
pacitation, or (2) seriously threatens
non-human organisms with large-scale
or ecologically significant population
destruction.
VI. NATURE AND SOURCES OF INFORMA-
TION WHICH "REASONABLY SUPPORTS
THE CONCLUSION" OF SUBSTANTIAL
RISK
Information attributing any of the
effects described in Part V above to a
chemical substance or mixture is to be
reported if it is one of the types listed
below and if it is not exempt from the
reporting requirement by reason of
Part VII of this policy statement. A
person is not to delay reporting until
he obtains conclusive information that
a substantial risk exists, but is to im-
mediately report any evidence which
"reasonably supports" that conclusion.
Such evidence will generally not be
conclusive as to the substantiality of
the risk; it should, however, reliably
ascribe the effect to the chemical.
Information from the following
sources concerning the effects de-
scribed in Part V will often "reason-
ably support" a conclusion of substan-
tial risk. Consideration of corrobora-
tive information before reporting can
only occur where it is indicated below.
( 1) Designed, controlled studies. In
assessing the quality of information,
the respondent is to consider whether
it contains reliable evidence ascribing
the effect to the chemical. Not only
should final results from such studies
be reported, but also preliminary re-
sults from incomplete studies where
appropriate. Designed, controlled stud-
ies include:
(i) In vivo experiments and tests.
(Ii) In vitro experiments and tests.
Consideration may be given to the ex-
istence of corroborative information, if
necessary to reasonably support the
conclusion that a chemical presents a
substantial risk.
Reports concerning and evi-
dence of effects in consumers, w.orkers,
or the environment.
VII. INFORMATION WHICH NEED NOT BE
REPORTED
Information need not be reported if
it:
(a) Has been published by EPA in re-
o ports;
(b) Has been submitted in writing to
EPA pursuant to mandatory reporting
requirements under TSCA or any
other authority administered by EPA
(including the Federal Insecticide,
Fungicide and Rodenticide Act, the
Clean Air Act, the Federal Water Pol-
lution Control Act, the Marine Protec-
tion, Research, and Sanctuaries Act,
the Safe Drinking Water Act, and the
Resource Conservation and Recovery
Act), provided that the information:
( 1) Encompasses that required by Part
IX (c) through (I>; and (2) is from now
on submitted within the time con-
straints set forth in Part IV and iden-
tified as a section 8( e) notice in accor.
dance with Part IX(b);
(c) Has been published in the scien-
tific literature and referenced by the
following abstract services: (1) Agric-
ola, (2) Biological Abstracts, (3)
Chemical Abstracts, (4) Dissertation
Abstracts, (5) Index Medicus, (6) Na-
tional Technical Information Service.
(d) Is corroborative of well-estab-
lished adverse effects already docu-
mented in the scientific literature and
referenced as described in (c) above,
unless such information concerns
emergency incidents of environmental
contamination as described in Part
V(c), or
(e) Is contained in notification of
spills under section 311
-------
(b) Any Inlonnation the contents of
which a person has been alerted to by
date received after January 1, 1977, in-
cluding any infonnation concerning a
chemical for which the person is pres-
ently assessing health and environ-
mental effects;
(c) Any other infonnation of which
the person has actual knowledge.
IX. REPORTING REQUIREMENTS
Notices shall be delivered to the
Document Control Officer, Chemical
Infonnation Division, Office of Toxic
Substances (WH-557), Environmental
Protection Agency, 401 M Street SW.,
Washington, D.C. 20460.
A notice should:
(a) Be sent by certified mail, or in
any other way permitting verification
of its receipt by the Agency,
(b) State that it is being submitted
in accordance with section 8(e),
(c) Contain the job title, name, ad-
dress, telephone number, and signa-
ture of the person reporting and the
name and address of the manufactur-
ing, processing, or distributing estab-
lishment with which he is associated,
(d) Identify.the chemical substance
or mixture (including, if known, the
CAS Registry Number),
(e) Summarize the adverse effects
being reported, describing the nature
and the extent of the risk involved,
and
(0 Contain the specific source of the
infonnation together with a summary
and the source of any available sup-
porting technical data.
For emergency incidents of environ-
mental contamination (see Part V(c»,
a person shall report the incident to
the Administrator by telephone as
soon as he has knowledge of the inci-
dent (see below for appropriate tele-
phone contacts). The report should
contain as much of the infonnation re-
quired by instructions (b) through (f)
above as possible. A written report, in
accordance with instructions (a)
through (f) above, is to be submitted
within 15 days. Twenty-four hour
emergency telephone numbers are:
Region I (Maine, Rhode Island. Connecti-
cut, Vermont, Massachusetts, New Hamp-
shire), 617-223-7265. .
Region II (New York. New Jersey, Puerto
Rico. Virgin Islands), 201-548-8730.
Region III (Pennsylv1illia, West Virginia.
Virginia, Maryland, Delaware, District of
Columbia),215-597-9898.
Region IV (Kentucky, Tennessee, North
Carolina, South Carolina, Georgia, Ala-
bama, M!s.s!s.sippl, Florida), 404-881-4062.
Region V (Wisconsin, mlnois, Indiana,
Michigan, Ohio, Minnesota), 312-353-
2318.
Region VI (New Mexico, Texas, Oklahoma,
Arkansas, Louisiana), 214-749-3840.
Region VII (Nebraska, Iowa, M!s.souri,
Kansas), 816-374-3778.
Region VIII (Colorado, Utah, Wyoming.
Montana, North Dakota, South Dakota),
303-837 -3880.
Region IX (California, Nevada, Arizona,
Hawaii, Guam). 415-556-6254.
NOTICES
Region X (Washington. Oregon, Idaho,
Alaska), 206-442-1200.
X. CONFIDENTIALITY CLAIMS
(a) Any person submitting a notice
to EPA under section 8(e) of TSCA
may assert a business confidentiality
claim covering all or part of the infor-
mation contained in the notice. Any
information covered by a claim will be
disclosed by EP A only to the extent,
and by means of the procedures, set
forth in 40 CFR Part 2 (41 FR 36902,
September 1. 1976).
(b) If no claim accompanies the
notice at the time it is submitted to
EPA, the notice will be placed in an
open file to be available to the public
without further notice to the submit-
ter.
(c) To assert a claim of confidential-
ity for infonnation contained in a
notice, the submitter must submit two
copies of the notice.
(1) One copy must be complete. In
that copy the submitter must indicate
what infonnation, if any, is claimed as
confidential by marking the specified
infonnation on each page with a label
such as "confidential," "proprietary,"
or "trade secret."
(2) If some infonnation in the notice
is claimed as confidential, the submit-
ter must submit a second copy. The
second copy must be complete except
that all infonnation claimed as confi-
dential in the first copy must be de-
leted. .
(3) The first copy of the notice will
be disclosed by EP A only to the
extent, and by means of the proce-
dures, set forth in 40 CFR Part 2. The
second copy will be placed in an open
file to be available to the public.
(d) Any person submitting a notice
containing infonnation for which they
are asserting a confidentiality claim
should send the notice in a double
envelope.
(1) The outside envelope should bear
the same address outlined in section
IX of this policy statement.
(2) The inside envelope should be
clearly marked "To be opened only by
the OTS Document Control Officer."
XI. FAILURE To REPORT INFORMATION
Section 15(3) of TSCA makes it un-
lawful for any person to fail or refuse
to submit infonnation required under
section 8(e). Section 16 provides that a
violation of section 15 rendels a
person liable to the United States for
a civil penalty and possible criminal
pro:secution. Pursuant to section 17,
the Government may seek judicial
relief to compel submittal of section
8(e) information and to otherwise re-
strain any violation of section 8(e).
11113
APPENDIX A.-QUICK REFERENCE SUMMARY
FOR EMERGENCY INCIDENTS OF ENvIRONM!:1f-
TAL CONTAJIIINATION
A. WHAT SHOULD BE REPORTED AS AN
EMERGENCY INCIDENT
An emergency incident of environmental
contamination is "any environmental con-
tamination by a chemical substance or mix-
ture . . . which, because of the pattern.
extent and amount of contamination, (1) Se-
riously threatens humans with cancer, birth
defects, mutation. death, or serious or pro-
longed Incapacitation, or (2) seriously
threatens non-human organisms with large
scale or ecologically significant population
destruction". (See Part V(c) for complete
description. )
B. WHAT NEED NOT BE REPORTED AS Alf
EMERGENCY INCIDENT
Information contained in notification of
spills under section 311
-------
11114
Response: The Agency considers that dif-
ferent sections of TSCA, having different
purposes, are appropriately directed to dif-
ferent respondents. In the case of section
B(e), officers and employees who are capable
of appreciating the significance of informa-
tion have a legitimate responsibility to be
alert to and report substantial-risk informa-
tion. The guidance has been modified so
that natural persons and business entities
can fulflll their section 8( e) obligations In
different ways. Most ofllcers and employees
can discharge their section 8(e) obligations
by submitting pertinent Information to cor-
porate superiors, provided that the com-
pany has established the risk-evaluation
procedures characterized In Part II. In the
case of a business organization. Its presi-
dent, chief executive officer, and other offi-
cials responsible and having authority for
the business organization's execution of Its
section 8(e) obligations must ensure that
the organization reports substantial-risk in-
formation to EPA.
Comment 2: Even If employees can be held
subject to these requirements, they should
not be. To do so would force employees and
employers Into conflicting positions, inviting
Internal corporate dissension and over- re-
porting, Further, individuals often do not
have the overview necessary to reach con-
sidered, well-supported decisions. Corporate
reporting by designated officials will pro-
vide EPA with more reliable data.
Response: The Agency considers that em-
ployees have a legitimate role In risk report-
Ing; it Is imperative that risk Information
obtained by employees be appropriately
considered. Officers and employees can ful-
fill their role In the reporting of substantlal-
risk Information, without the disadvantages
described above, by reporting Information
to superiors for corporate consideration,
and, having done so, will have discharged
their obligation to EPA. This Is contingent
upon the establishment by the business or-
ganization of certain procedures for risk-
evaluation, thereby assuring the appropri-
ate consideration of such reports. Those of-
ficers responsible and having authority for
the organization's execution of Its section
B(e) obligations must ensure that the orga-
nization reports substantial-risk informa-
tion to EP A.
Comment 3: Clarify which employees are
covered, and the extent of their obligation.
Are employees "capable of appreciating per-
tinent information" by virtue of rank, or
knowledge? Are rank and file employees
subject to these requirements. or just super-
visory and managerial personnel, company
toxicologists, etc.? Is an employee absolved
of further responsibility If he reports to his
supervisor?
Response: The Agency considers that the
phrase "capable of appreciating the signifi-
cance of pertinent information" appropri-
ately describes those officers and employees
who have a responsibility to be alert to and
report substantial-risk Information. includ-
Ing not only relatively senior corporate offi-
cers but also many corporate employees.
The policy statement modifies the Septem-
ber 9 proposal, In response to the concerns
expressed, In Comments 2 and 3, to permit
most officers and employees to discharge
their obligation by submitting Information
to corporate superiors, subject to the condi-
tions described In Part II.
Comment 4: Consultants and Independent
labs should not be subject to these require-
ments.
Response: Contractors and Independent
labs are not responsible for reporting infor-
NOTICES
matlon they have obtained directly to EPA;
rather. their client manufacturers, proces-
sors and distributors are responsible for
reporting such information.
B. THE "OBTAINING" OF INPORJl(ATION
Comment 5: The "may suggest" criterion
In Part III of the proposal serves to compel
further examination of information that by
Itself Is not subject to section 8(e) require-
ments. The statutory language calling for
"reasonable support" does not support this.
Further. risk assessment often requires any-
where from months to several years of
study after preliminary results "suggest"
risk. far exceeding the 15-daY compliance
period.
Ruponse: The Agency does not Intend to
compel under section 8(e) examination of
information that by Itself Is not subject to
section 8(e) requirements and has deleted
the "may suggest" provision. providing Its
Interpretation of what' constitutes evidence
that "reasonably supports the conclusion"
of substantial risk In a new Part VI.
Comment 6: Section 8(e) obligations are
Incurred upon obtaining conclusory substan-
tial-risk Information.
Response: The Agency disagrees, and con-
siders that "reasonable support" of a con-
clusion of substantial risk Is not Identical to
the conclusion Itself. The former typically
occurs, and must be reported, at an earlier
stage.
Comment 7: The statement, In Part III of
the proposal that a person has obtained in-
formation If he ". . . should know of the ex-
Istence of such Information not In his pos-
session but which would be delivered to him
on request:' tends to compel an active
search for substantial-risk information
rather than the reporting of substantial-risk
information a person "obtains." This Is of
particular concern to Importers with limited
access to Information possessed by their
suppliers.
Rupome: The Agency considers that sec-
tion 8(e) applies to Information which a
person possesses or of which he knows. It Is
not Intended to compel searches for infor-
mation or extraordinary efforts to acquire
information. The Agency further considers.
however, that "known" information in-
cludes Information which a prudent person
similarly situated could reasonably be ex-
pected to know. Negligence or intentional
avoidance of information does not absolve a
person of his section 8(e) obligation. Part
III has been modified to express these in-
tentions.
Comment B: Circumstances can exist when
coming "Into possession" of risk informa-
tion does not correspond to an understand-
Ing of the implications of the information;
"obtains" should be defined In terms of pos-
session of information and awareness of Its
import.
Rupome: The "obtaining" of information
occurs via persons who are "capable of ap-
preciating the significance of pertinent in-
formation." There will likely be circum-
stances In which the evaluation of informa-
tion clarifies Its full Import; the establish-
ment of corporate procedures for processing
risk-information prescribed In Part II will
expedite this.
C. TIME ALLOWED POR COMPLIANCE
Comment 9: Fifteen calendar days Is insuf-
ficient to determine whether information
which "may suggest" substantial risk should
be reported; It Is even insufficient to &CC?m-
modate normal procedural time constramts
(corporate processing, mailing. holidays.
etc.).
Re8pome: The Agency has changed the
compliance period to 15 business days. It is
imperative that procedures be established to
expedite the reporting of substantial-risk in-
formation. not that reporting conform to
existing procedures.
Comment 10: Allow from 30 to 90 days for
the second phase of reporting; alternatively.
do not prescribe a time limit for additional
reporting.
Re,ponse: Having deleted the "may sug-
gest" criterion, the Agency sees no need to
provide a second phase to the reporting
period. Supplemental information that Is
generated after a section 8(e) notification
should. If appropriate. be Immediately re-
ported.
Comment 11: Allow from 30 to 120 days to
report pre-1977 information; this period
should commence: (a) upon final publica-
tion, (b) January 1. 1978. (c) following the
Inventory reporting period since many of
the same corporate personnel will be imple-
menting both requirements.
Re,ponse: The policy statement prescribes
a 60 day reporting period. commencing im-
mediately upon publication. Section 8(e) has
been In effect since January 1, 1977; post-
ponement In reporting substantial-risk In-
formation Is not warranted.
D. EPTECTS AND INFORMATION T;RAT MUST BE
REPORTED
Comment 12: The reporting of "any in-
stance" of cancer, birth defects, etc., In
humans Is too broad and such Infonnatlon
will be of little use; chemical workers, like
the general population, develop cancers and
other ailments of uncertain etiology.
Relpome: This policy statement clarifies
that the reporting of single occurrences of
human cancer or other serious effects will
depend upon evidence strongly implicating
one (or a few) chemical(s).
Comment 13: Dermal ailments and nausea
are poorly chosen examples of precursor
Symptoms. Deleting these examples will
avoid unduly emphasizing them when other
Symptoms may be more Important. yet will
not eliminate the obligation to report them
If they are suspected precursors.
Re8pome: The Agency agrees.
Comment 14: How are reportable data dis-
tinguished from routine tests including
range tests such as LDoo's?
Relpome: This policy statement directs
the reporting of specified effects when un-
known to the Administrator. Many routine
tests are based on a knowledge of toxicity
associated with a chemical; unknown effects
occurring during such a range test may have
to be reported If they are those of concern
to the Agency and If the information meets
the criteria set forth In Parts V and VI.
Comment 15: The most widespread "in
vitro" test Is the Ames test, which Is subject
to considerable debate. Clarify the circum-
stances under which positive results of In
vitro tests must be reported.
Ruponse: Part VI clarifies that the re-
porting of In vitro tests will depend upon
the existence of corroborative Information
If necessary to reasonably SUppolt the con-
clusion of substantial risk.
Comment 16: The description of "extreme
persistence" as a substantial risk Is an exam-
ple of the need to redefine Part V(c) ("Envi-
ronmental Effects"). Persistence and blo-
accumulation should be considered risks
only when coupled with toxicity and signifi-
cant exposure.
FEDERAL REGISTER. VOL 43, NO. 52-THURSDAY, MARCH 16, 1978
107
-------
Re3p01l$e: Part V now clarifies those ef-
fects for which reporting depends upon a
s1gnlflcant exposure potential. Persistence
by itseIf Is no longer Itemized as a report-
able effect but rather Is considered to be a
component of exposure potential; It m;w
also underlie the measurements described in
Part V(b)(l). Laboratory indicators of pro-
nounced bloaccumulation are to be reported
when coupled with potential for widespread
exposure and any non-trivial adverse effect.
Comment 17: The n-octanol/water parti-
tion coefficient addresses a physico-chemi-
cal property, not biological effects. and Is
not alone an indicator of substantial risk;
further, the values stated for the coefficient
and the bloaccumulatlon factor in fish do
not correspond.
RUPo1l$e: The Agency acknowledges the
numerical error and has amended the values
to correspond. This policy statement now
directs the reporting of an experimental
measurement of bloaccumulation when
coupled with an adverse effect and potential
for widespread exposure.
Comment 18: The requirement that Infor-
mation which "links" an effect to a chemi-
cal be reported Is too broad and contradicts
the statutory language of "reasonably
supports".
Re3ponse: The Agency has provided In a
new Part VI Its interpretation of "reason-
ablY supports".
Comment 19: A determination that infor-
mation "reasonably supports the conclu-
sion" of substantial risk cannot be made in-
dependently of considerations of use since
the method and manner of using a chemical
may Influence the occurrence of an effect;
In particular, the criteria should reflect a
distinction between normal and abnormal
uses of chemicals.
Re3P01l$e: The Agency considers that the
appropriate components of a "substantial
risk" with respect to a chemical are (a) the
seriousness of the effect. and (b) total expo-
sure potential. The method and manner of
usiI)g a chemical Is one of several factors de-
termining its exposure potential. As de-
scribed in Part V, the Importance of expo-
sure potential as a component of "substan-
tial risk" depends upon the kind of effect of
concern. Thus. the effects described In Part
V(a) are so serious that relatively little
weight Is given to exposure; the effects de-
scribed in Parts V (b) and (c) Involve a sig-
nlflcant exposure or exposure potential.
The Agency further considers that a defi-
nition of "normal" use for a particular
chemical will often depend upon a knowl-
edge of the risks associated with the
chemical.
E. INJI'ORMATION THAT NEED NOT BE REPORTED
Comment 20: Information published in
scientific literature in languages other than
English should be exempted if published In
summary form by abstracting services. Can
the accuracy of English language abstracts
and commercial translations of foreign lit-
erature be assumed?
Re3ponse: This policy statement now pro-
vides that Information published in scien-
tIfic literature. whether In English or an-
other language. Is exempt from reporting If
published In summary form by certain
specified abstract services.
Comment 21: Information exchange sys-
tems with other Federal agencies should be
Immediately established so that respondents
need not report to EPA information already
reported to other Agencies. and vice versa.
Such duplicative reports are unduly burden-
wme.
NOTICES
Response: EP A Is coordinating this pro-
gram with other agencies now. When this
coordination is successfully completed. the
policy statement will be amended to exempt
from the reporting requirement information
that has been submitted to other specified
agencies. In the meantime. substantial-risk
information must be reported directly to
EPA; such a report does not discharge any
reporting obligation to other agencies.
F. INFORMATION FIRST RECEIVED PRIOR TO THE
EFFEcriVE DATE OF TSCA
Comment 22: The tense of the verb "ob-
tains" reveals that section 8(e) was intended
to be applied prospectively to Information
newly acquired after January I, 1977. Utilize
section 8(d) or other rules to acquire infor-
mation obtained before then.
Response: As discussed in the preamble to
the September 9 proposal, the Agency con-
siders section 8(e) to apply to risk informa-
tion possessed by or known to a person
before, on, or after January I, 1977. Con-
cerning Information first obtained before
1977. this polley statement continues to re-
quire reporting of information received If a
person has been aware of it since January 1.
1977. for the reasons discussed In the Sep-
tember 9 preamble.
Comment 23: The term "aware" is too
vague to be of any help in responding to
these requirements. Since many corporate
employees are potentially subject to these
requirements. and given uncertainty over
the extent to which they ought to be awar'e
of pre-1977 information, this provision tends
to compel the very file search It was intend-
ed to avoid. The term "aware" should be
further defined, possibly in terms of actual
knowledge.
ResPo1l$e: The Agency In Part VIII of this
policy statement now defines the pre-1977
information of which a person Is considered
to be aware.
G. CONFIDENTIAL INFORMATIO~
Comment 24: EPA should delay guidance
until procedures are published governing
the treatment of confidential submissions.
Comment 25: EPA should treat all submis-
sions as confidential until the information Is
verified.
Comment 26: EPA should automatically
publish section 8(e) notices.
Response to Comments 24 through 26:
EPA has included a new Part X which de-
scribes how to submit a claim of confiden-
tiality and states that any or all of the in-
formation submitted may be claimed as con-
fidential. Such information will be disclosed
by EPA only to the extent, and by means of
the procedures. set forth in 40 CFR Part 2.
H. MISCELLANEOUS
Comment 27: What Is the statutory basis
or need for guidance? What Is its exact
status under the Administrative Procedure
Act?
Response: This policy statement sets forth
EPA's interpretation of and policy concern-
Ing TSCA section 8(e). As an interpretive
rule and statement of policy it Is not subject
to the comment period and delayed effec-
tive date provisions of the Administrative
Procedure Act (5 U.S.C. 553). Although
TSCA does not mandate a policy statement.
the Agency of necessity must develop the
criteria which will govern enforcement ac-
tivities. Trade associations and businesses
were among those who previously expressed
interest In such a statement to guide their
compliance,
11115
Comment 28: Clarify whether these re-
quirements apply to chemicals previously
but no longer manufactured, processed. or
distributed in commerce by a person.
Response: Information obtained before
1977 must be reported If the person has
been aware of it since January I, 1977, as
prescribed by Part VIII. Concerning chemi-
cals which a person has discontinued manu-
facturing. processing, or distributing since
January I, 1977, information obtained
before the time of discontinuation Is subject
to these requirements. It Is expected that
the acquisition of information after that
time will be minimal; however. should addi-
tional information be acquired, It may trig-
ger the reporting described in Part VIII.
Comment 29: Clarify the meaning of "sub-
stantial risk" relative to other risks ad-
dressed by TSCA.
Response: A substantial risk Is defined in
Part V(a) of this policy statement as a risk
of considerable concern because of (a) the
seriousness of the effect, and (b) the fact or
probability of Its occurrence. As opposed to
other risks addressed by TSCA. economic or
social benefits of use. or costs of restricting
use. are not to be considered in determining
whether a risk Is "substantial".
Comment 30: To what extent are "users"
of chemicals subject to these requirements?
ResPo1l$e: The Agency considers that
many industrial uses of chemicals actually
fall within the scope of "processing" chemi-
cals. A manufacturer, processor, or distribu-
tor who obtains substantial-risk information
concerning chemicals he handles should be
alert to the possibility he may have to
report It.
Comment 31: Are chemicals manufac-
tured, processed and 'dlstributed In com-
merce In small quantities solely for purposes
of research and development subject to
these requirements?
Response: In general. the Agency consid-
ers that much manufacturing, processing.
and distribution In commerce of chemicals
In small quantities sOlely for purposes of re-
search and development Is conducteli for
"commercial purposes". Such purposes
would include the sale and distribution of
such materials. as well as their use by the
manufacturer or processor In activities (for
example. product research and development
and studies assessing the feasibility and
safety of using chemicals) preceding his or a
cllent.s commercial use of such materials or
others on a larger scale.
As described In Part V, the Agency consid-
ers that "substantial risks" depend in part
upon an exposure potential. Thus. the oc-
currence of the effects described in Part
V(a) presuppose exposure to the chemical
and must be reported; reporting of the
other effects will depend upon a potential
for significant levels of exposure.
Comment 32: Are raw materials. interme-
diates, and Inert ingredients produced or
used in the manufacture of a pesticide sub-
Ject to TSCA?
Response: The Administrator considers
that raw materials, intermediates and Inert
Ingredients produced or used in the manu-
facture of a pesticide are substances or mix-
tures which can be regulated under TSCA.
In order to be considered a pesticide, a
substance must be intended for use as a pes-
ticide. Raw materials, intermediates. and
inert ingredients produced or used in the
manufacture of a pesticide are not them-
selves regulated under FIFRA (unless they
happen to be pesticides themselves) and.
therefore. are subject to TSCA. The pestl-
fEDERAL REGISTER, VOL. 43, NO. 52-THURSDAY, MARCH 16, 1978
108
-------
11116
ctde regulations at 40 CFR 162.4 are consis-
tent with this view.
Comment 33: Are Intermediates and cata-
lysts Intended solely for use In the produc-
tion of a food. food additive, drug, cosmetic.
or device subject to TSCA?
Response: The Administrator considers
that intermediates and catalysts Intended
solely for use In the production of a food,
food additive. drug, cosmetic. or device are
excluded from regulation under TSCA. The
definitions of the FFDCA provide that
chemical substances which are Intended for
use as a component of a food, food additive,
drug, cosmetic, or device are encompassed
within the meaning of such terms, respec-
tively. The FDA considers Intermediates
and catalysts to be such components. There-
fore. they are subject to regulation under
the FFDCA. Any such substance is excluded
from regulation under TSCA insofar as it is
actually manufactured, processed, or dis-
tributed In commerce solely for use In the
NOTICES
production of a food. food additive, drug.
cosmetic. or device.
Comment 34: Employees should have the
option to submit reports anonymously.
Response: EPA considers that any person
may report Information to EPA under
TSCA. Those who are required to do so
under section 8(e) are persons who manu-
facture, process, or distribute In commerce
chemical substances or mixtures, Including
not only business entitles but also such em-
ployees as described In Part II. In order to
establish that such persons have discharged
their obligations. and In order to encourage
responsible review of the quality of informa-
tion and the substantiality of risks. EPA be-
lieves that notlflers should identify them-
selves. Section 23 will adequately protect
employees from discrimination pursuant to
notifications they have made under section
8(e).
[FR Doc. 78-7064 Filed 3-15-78; 8:45 am]
FEDERAL REGISTER, VOL 43, NO. 52-THURSDAY, MARCH 16, 1978
109
-------
APPENDIX B. STATUS REPORTS BY CHEMICAL NAME
CHEMICAL NAME
SUBMISSION NO.
I I
ACETOPHENONE, 2 ,2 -DI(SEC-BUTOXY)-
08790251 SUPPLEMENT
ACRYLATE, NEOPENTYLGLYCOL DI-
11790028 SUPPLEMENT
ACR~LIC ACID, ETHYL ESTER
08790250 FOLLOW UP RESPONSE
ACR~LIC ACID, 2-ETHYL HEXYL ESTER
10790262 FOLLOW UP RESPONSE
ACRyLONITRILE
08790300
ALCOHOL ETHOXYSULFATE (AMMONIUM SALT)
09790326
ALCOHOL ETHOXYSULFATE (SODIUM SALT)
09790326
I-'
I-'
o
ARCO LB-7979
01800327
ARGUS Q-328 (MARK-328)
10790315
*
ARYL PHOSPHATES
10790317
BENZENE, CHLORO-
09790310
01800330
BENZYLTRIPHENYLPHOSPHONIUM CHLORIDE
07790296
BIS~HENOL A-EPICHLOROHYDRIN RESINS
07790292
C. I. DISPERSE BLUE 7 DYE
10790321
CARBOFURAN
07790299
*
CARBON TETRACHLORIDE
09790310
-------
APPENDIX B. STATUS REPORTS BY CHEMICAL NAME (contd.)
CHEMICAL NAME
SUBMISSION NO.
DIOXANE,
1,4-
12790322 *
12790329 *
09790310
01800324
09790306
10790316
09790311
01800328S
10790320
09790326
07790295
07790292
09790310
09790310
09790310
09790310
09790310
01800324
10790320
CHLORINE
CHLOROFORM
COAL DERIVED FUEL OIL FRACTIONS (EXPERIMENTAL)
DIALLYL DIGLYCOL CARBONATE
DIMETHYLHYDANTOIN - DERIVED EPOXY RESIN (DEVELOPMENTAL)
I-'
I-'
I-'
DIRECT BLACK 38 DYE
EPICHLOROHYDRIN
ETHANE, 1,1-DICHLORO-
ETHANE, 1,1,1-TRICHLORO-
ETHANE, 1,1,2-TRICHLORO-
ETHANE, 1,2-DICHLORO-
ETHENE, 1,2-DICHLORO-, (E)
ETHER, BIS(CHLOROMETHYL)
ETHOXYLATED PRODUCTS
-------
APPENDIX B. STATUS REPORTS BY CHEMICAL NAME (contd.)
CHEMICAL NAME SUBMISSION NO.
ETHYLENE OXIDE 09790305
ETHYLENE, TETRACHLORO- 09790310
ETHYLENE, TRICHLORO- 09790310
ETHYLENE, l,l-DICHLORO- 09790310
ETHYLTRIPHENYLPHOSPHONIUM ACID ACETATE 07790296
ETHYLTRIPHENYLPHOSPHONIUM IODIDE 07790296
FORMALDEHYDE 10790314
FURADAN 10 -G (lO% GRAJ'.TULAR) 07790299 *
i-'
i-' HOME HEATING OIL (NO.2) 08790301
I'V
HYDROQUINONE MONOMETHYL ETHER 09790311
ISOPAR C 10790312
JET FUEL A 12790323
KRONITEX (R) 100 10790317
KRONITEX (R) 200 10790317
KRONITEX (R) 200B 10790317
KRONITEX (R) 50 10790317
MALEIC ANHYDRIDE 09790311
-------
APPENDIX B. STATUS REPORTS BY CHEMICAL NAME (contd.)
CHEMICAL NAME
SUBMISSION NO.
01800324
07790294
07790293
10790312
08790304 *
07790010 FOLLOW UP RESPONSE
08790301
08790301
10790317
10790317
10790317
07790296
10790317
10790317
01800330
10790319
10790315 *
01800327
METHANE, DICHLORO-
MORPHOLINE
N-ALKYL GLYCIDYL ETHERS (C2-C10)
NAPHTHA (PETROLEUM), LIGHT ALKYLATE
ORGANIC SOLVENTS
PETROLEUM DISTILLATE (LIGHT CATALYTIC CRACKED)
PETROLEUM DISTILLATE (STRAIGHT RUN MIDDLE)
f-'
f-'
W
PHENOL, DIMETHYL-, PHOSPHATE (3:1)
PHENOL, ISOBUTYLENATED, PHOSPHATE (3:1)
PHENOL, ISOPROPYLATED, PHOSPHATE (3:1)
PHOSPHONIUM ACID COMPOUNDS
PHOSPHORIC ACID, TRIPHENYL ESTER
PHOSPHORIC ACID, TRITOLYL ESTER
POLYCHLORINATED BIPHENYLS
POLYGARD
PROVALENT 4A
-------
f-'
f-'
.J::>.
APPENDIX B. STATUS REPORTS BY CHEMICAL NAME (contd.)
CHEMICAL NAME
SUBMISSION NO.
SRC-II HEAVY DISTILLATE
07790297
STRONTIUM CHROMATE
10790318
TETRABUTYLPHOSPHONIUM ACID ACETATE
07790296
THIODIPROPIONATE ESTER COMPLEX
10790315
*
s-TRIAZINE-2,4,6-TRITHIOL
12790325
TRI (MIXED MONO AND DINONYLPHENYL) PHOSPHITE
10790315
*
TRICARBONY1J, METHYLCYCLOPENTADIENYL MANGANESE-
10790211 FOLLOW UP RESPONSE
TUNGSTEN HEXACARBONYL
09790311
VARSOL 40
10790312
*
Based on a preliminary evaluation, the EPA believes that the information in
this submission does not warrant being reported under Section 8(e). In some
instances, a submitting company has been requested to provide the basis for
its contention that the information reported shows reasonable support for a
conclusion of substantial risk.
-------
APPENDIX C. STATUS REPORTS BY CAS REGISTRY NUMBER
CAS NUMBER SUBMISSION NO.
50-00-0 10790314
56-23-5 09790310
67-66-3 09790310
01800324
71-55-6 09790310
75-09-2 01800324
75-21-8 09790305
75-34-3 09790310
75-35-4 09790310
t-' 79-00-5 09790310
t-'
U1
79-01-6 09790310
103-11-7 10790262 FOLLOW UP RESPONSE
106-89-8 07790292
107-06-2 09790310
107-13-1 08790300
108-31-6 09790311
108-90-7 09790310
01800330
110-91-8 07790294
115-86-6 10790317
-------
APPENDIX C. STATUS REPORTS BY CAS REGISTRY NUMBER (contd.)
CAS NUMBER SUBMISSION NO.
123-91-1 10790320
09790326
127-18-4 09790310
140-88-5 08790250 FOLLOW UP RESPONSE
142-22-3 09790311
150-76-5 09790311
156-60-5 09790310
542-88-1 01800324
638-16-4 12790325
f-'
f-'
(j\ 1100-88-5 07790296
1330-78-5 10790317
1336-36-3 10790319
01800330
1563-66-2 07790299 *
1937-37-7 07790295
2223-82-7 11790028 SUPPLEMENT
3179-90-6 10790321
4736-60-1 07790296
7782-50-5 12790322 *
12790329 *
-------
APPENDIX C. STATUS REPORTS BY CAS REGISTRY NUMBER (con td . )
CAS NUMBER SUBMISSION NO.
7789-06-2 10790318
12108-13-3 10790211 FOLLOW UP RESPONSE
14040-11-0 09790311
17786-43-5 07790296
25068-38-6 07790292
25155-23-1 10790317
35835-94-0 07790296
64741-44-2 08790301
I-' 64741-59-9 08790301
I-'
-..J
64741-66-8 10790312
68109-57-9 08790251 SUPPLEMENT
68410-07-1 07790297
68937-40-6 10790317
68937-41-7 10790317
*
Based on a preliminary evaluation, the EPA believes that the information in
this submission does not warrant being reported under Section 8(e). In some
instances, a submitting company has been requested to provide the basis for
its contention that the information reported shows reasonable support for a
conclusion of substantial risk.
-------
APPENDIX D.
STATUS REPORTS BY STUDY TYPE
STUDY TYPE
SUBMISSION NO.
ACUTE/SUBCHRONIC TOXICI'ry - ANIMAL STUDY
07790295
07790296
09790311
10790312
12790325
CARCINOGENICITY - ANIMAL STUDY
07790297
09790305
09790306
10790314
11790316
11790318
01800327
01800328S
11790028 SUPPLEMENT
08790250 FOLLOW UP RESPONSE
08790251 SUPPLEMENT
10790262 FOLLOW UP RESPONSE
I-'
I-'
00
CHEMICAL/PHYSICAL PROPERTIES
07790294
11790317
07790010 FOLLOW UP RESPONSE
ENVIRONMENTAL EXPOSURE/RELEASE/FATE
07790299
08790300
09790310
11790319
12790322
01800324
12790329
01800330
*
*
*
-------
APPENDIX D. STATUS REPORTS BY STUDY TYPE (contd.)
STUDY TYPE
SUBMISSION NO.
EXPOSURE INFORMATION - POTENTIAL HAZARDOUS USE
07790292
11790320
09790326
HUMAN TOXICITY
07790292
08790304
10790315
*
*
MUTAGENICITY STUDY
07790293
07790294
08790301
11790321
12790323
01800328S
i-'
i-'
'"
REPRODUCTIVE SYSTEM/TERATOGENICITY - ANIMAL STUDY
07790293
10790211 FOLLOW UP RESPONSE
*
Based on a preliminary evaluation, EPA believes that the information
in this submission does not warrant being reported under Section 8(e).
In some instances, a submitting company has been requested to provide
the basis for its contention that the information reported shows
reasonable support for a conclusion of substantial risk.
-------
SUBMISSION NO.
07790292
07790293
07790294
07790295
07790296
t-'
N
o
07790297
07790299
08790300
08790301
08790304
09790305
APPENDIX E. STATUS REPORTS BY SUBMISSION NUMBER
CHEMICAL(S)
BISPHENOL A-EPICHLOROHYDRIN RESINS
EPICHLOROHYDRIN
N-ALKYL GLYCIDYL ETHERS (C2-C10)
MORPHOLINE
DIRECT BLACK 38
BENZYLTRIPHENYLPHOSPHONIUM CHLORIDE
ETHYLTRIPHENYLPHOSPHONIUM ACID ACETATE
ETHYLTRIPHENYLPHOSPHONIUM IODIDE
PHOSPHONIUM ACID COMPOUNDS
TETRABUTYLPHOSPHONIUM ACID ACETATE
SRC-II HEAVY DISTILLATE
*
CARBOFURAN
FURADAN 10-G (10% GRANULAR)
ACRYLONITRILE
HOME HEATING OIL (NO.2)
PETROLEUM DISTILLATE (LIGHT CATALYTIC CRACKED)
PETROLEUM DISTILI~TE (STRAIGHT RUN MIDDLE)
*
ORGANIC SOLVENTS
ETHYLENE OXIDE
SUBMITTING COMPANY
EMPLOYEE SUBMISSION
PROCTER & GAMBLE COMPANY
TEXl-"O INC.
IBM CORPORATION
CINCINNATI MILACRON CHEMICALS INC.
GULF MINERAL RESOURCES CO.
FMC CORPORATION
CINCINNATI MILACRON CHEMICALS INC.
UNION OIL COMPANY OF CALIFORNIA
EMPLOYEE SUBMISSION
UNION CARBIDE CORPORATION
-------
SUBMISSION NO.
09790306
09790310
to-'
~
to-'
09790311
10790312
10790314
10790315
10790316
APPENDIX E. STATUS REPORTS BY SUBMISSION NUMBER (contd.)
CHEMICAL(S)
SUBMITTING COMPANY
COAL DERIVED FUEL OIL FRACTIONS (EXPERIMENTAL)
EXXON CORPORATION
BENZENE, CHLORO-
CARBON TETRACHLORIDE
CHLOROFORM
ETHANE, l,l-DICHLORO-
ETHANE, l,l,l-TRICHLORO-
ETHANE, 1,1,2-TRICHOLRO-
ETHANE, 1,2-DICHLORO-
ETHENE, 1,2-DICHLORO-, (E)
ETHYLENE, TETRACHLORO-
ETHYLENE, TRICHLORO-
ETHYLENE, l,l-DICHLORO-
AEROJET-GENERAL CORPORATION
DIALLYL DIGLYCOL CARBONATE
HYDROQUINONE MONOMETHYL ETHER
MALEIC ANHYDRIDE
TUNGSTEN HEXACARBONYL
PPG INDUSTRIES, INC.
NAPHTHA (PETROLEUM), LIGHT ALKYLATE
ISOPAR C
VARSOL 40
EXXON COMPANY, U.S.A.
FORMALDEHYDE
CIIT
*
ARGUS Q-328 (MARK-328)
POLYGARD
THIODIPROPIONATE ESTER COMPLEX
TRI (MIXED MONO AND DINONYLPHENYL)
PHOSPHITE
STANDARD OIL COMPANY (INDIANA)
COAL DERIVED FUEL OIL FRACTION (EXPERIMENTAL)
EXXON COMPANY, U.S.A.
-------
SUBMISSION NO.
10790317
10790318
I-' 10790319
N
N
10790320
10790321
12790322
12790323
01800324
12790325
APPENDIX E. STATUS REPORTS BY SUBMISSION NUMBER (contd.)
CHEMICAL(S)
SUBMITTING COMPANY
ARYL PHOSPHATES
KRONITEX (R) 50
KRONITEX (R) 100
KRONITEX (R) 200
KRONITEX (R) 200B
PHENOL, DIMETHYL-, PHOSPHATE (3:1)
PHENOL, ISOBUTYLENATED, PHOSPHATE (3:1)
PHENOL, ISOPROPYLATED, PHOSPHATE (3:1)
PHOSPHORIC ACID, TRIPHENYL ESTER
PHOSPHORIC ACID, TRITOLYL ESTER
FMC CORPORATION
STRONTIUM CHROMATE
CIBA-GEIGY CORPORATION
POLYCHLORINATED BIPHENYLS
INTERNATIONAL SALT COMPANY
DIOXANE, 1,4-
ETHOXYLATED PRODUCTS
SHEREX CHEMICAL COMPANY INC.
C. I. DISPERSE BLUE 7 DYE
TOMS RIVER CHEMICAL CORPORATION
*
CLOROX COMPANY
CHLORINE
JET FUEL A
ATLANTIC RICHFIELD COMPANY
CHLOROFORM
ETHER, BIS(CHLOROMETHYL)
METHANE, DICHLORO-
DIAMOND SHAMROCK CORPORATION
s-TRIAZINE-2,4,6-TRITHIOL
AMERICAN CYANAMID COMPANY
-------
SUBMISSION NO.
09790326
01800327
01800328S
12790329
01800330
r-o
N
w
07790010
FOLLOWUP
RESPONSE
11790028
SUPPLEMENT
10790211
FOLLOWUP
RESPONSE
08790250
FOLLOWUP
RESPONSE
APPENDIX E. STATUS REPORTS BY SUBMISSION NUMBER (contd.)
CHEMICALS
SUBMITTING COMPANY
ALCOHOL ETHOXYSULFATE (AMMONIUM SALT)
ALCOHOL ETHOXYSULFATE (SODIUM SALT)
DIOXANE, 1,4-
SHELL OIL COMPANY
ARCO LB-7979
PROVALENT 4A
ATLANTIC RICHFIELD COMPANY
DIMETHYLHYDANTOIN - DERIVED EPOXY RESIN
(DEVELOPMENTAL)
CIBA-GEIGY CORPORATION
* CHLORINE
E. I. DUPONT DE NEMOURS & COMPANY
BENZENE, CHLORO-
POLYCHLORINATED BIPHENYLS
GENERAL ELECTRIC COMPANY
ORGANIC SOLVENTS
AMERICAN PETROLEUM INSTITUTE
NEOPENTYLGLYCOL DIACRYLATE
UNION CARBIDE CORPORATION
METHYLCYCLOPENTADIENYL MANGANESE TRICARBONYL
ETHYL CORPORATION
ACRYLIC ACID, ETHYL ESTER
CELANESE CORPORATION
-------
SUBMISSION NO.
08790251
SUPPLEMENT
10790262
FOLLOWUP
RESPONSE
I--'
IV
.1>0
NOTE:
CHFMICAL(S)
SUBMITTING COMPANY
ACETOPHENONE, 2' ,2'-DI(SEC-BUTOXY)
UNION CARBIDE CORPORATION
ACRYLIC ACID, 2-ETHYLHEXYL ESTER
UNION CARBIDE CORPORATION
* Based on a preliminary evaluation, the EPA believes that the information
in this submission does not warrant being reported under Section 8(e).
In some instances, a submitting company has been requested to provide the
basis for its contention that the information reported shows reasonable
support for a conclusion of substantial risk.
The following document control numbers are considered VOID due to
clerical errors made during the EPA logging of Section 8(e) documents.
8EHQ-XXXX-0298
8EHQ-XXXX-0302
8EHQ-XXXX-0303
8EHO-XXXX-0307
8EHQ-XXXX-0308
8EHQ-XXXX-0309
8EHQ-XXXX-03l3
-------
TECHNICAL REPORT DATA
(Please read Inwuetions on the rererse before completing)
1. REPORT NO. 12. 3. RECI PI ENT'S ACCESSIOr+ NO'
4. TITLE AND SUBTITLE 5. REPORT DATE
CHEMICAL SCREENING: INITIAL EVALUATIONS OF
SUBSTANTIAL RISK NOTICES, SECTION 8 (e), JULY 1, 1979 6. PERFORMING ORGANIZATION CODE
to JANUARY 31, 1980
7. AUTHOR(S) 8. PERFORMING ORGANIZATION REPORT NO.
Chemical Hazard Identification Branch
Assessment Division/OTE/OPTS/EPA
9. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS 13. TYPE OF REPORT AND PERIOD COVERED
Office of Pesticides and Toxic Substances TS-792 7-01-79 to 1-31-80
u.S. Environmental Protection Agency 14. SPONSORING AGENCY CODE
401 M Street, s.w.
~lashinqton, D.C. 20460
15. SUPPLEMENTARY NOTES
16. ABSTRACT
This collection of Status Reports ( initial evaluations) was prepared by scientists
in the EPA Office of Pesticides and Toxic Substances (OPTS) on submissions received
between July 1, 1979 and January 31, 1980 from chemical manufacturers, processors,
and distributors under Section 8 (e) of the Toxic Substances Control Act (TSCA).
The volume 1S being published for two reasons. First, the collection of status
reports in a single volume will make that information more accessible to the public.
Second, the '.colume may, by providing specific examples of submitted information
and EPA's evaluation of it, help anyone subject to Section 8(e) to understand
better the types of information that should be submitted to the Agency.
To date, no information submitted under Section 8(e) has resulted 1n immediate
regulatory action under TSCA or any other act, although some submitted information
has triggered further data gathering and evaluation that may lead to proposal of
regulations in the future.
17. KEY WORDS AND DOCUMENT ANAL YSIS
a. DESCRIPTORS b.IDENTIFIERS/OPEN ENDED TERMS
c. COSATI Field/Group
Section 8(e)
Substantlal Risk
Toxic Substances Control Act
TSCA
18. DISTRIBUTION STATEMENT 19. SECURITY CLASS (This Report) 21. NO. OF PAGES
20. SECURITY CLASS (This page) 22. PRICE
EPA Form 2220-1 (9-73)
125
-------
INSTRUCTIONS
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2-
3.
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4.
TITLE AND SUBTITLE
Title should indicate clearly and briefly the subject coverage of the report, and be displayed prominently. Set subtitle, if used, in smaller
type or otherwise subordinate it to main title. When a report is prepared in more than one volume, repeat the primary title, add volume
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concept of the research and are sufficiently specific and precise to be used as index entries for cataloging.
(b) IDENTIFIERS AND OPEN-ENDED TERMS - Use identifiers for project names, code names, equipment designators, etc. Use open-
ended terms written in descriptor form for those subjects for which no descriptor exists.
(c) COSATI FIELD GROUP - Field and group assignments are to be taken from the 1965 COSATI Subject Category List. Since the ma.
jority of documents are multidisciplinary in nature, the Primary Field/Group assignment(s) will be specIfic discipline, area of human
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the primary posting(s).
18. DISTRIBUTION STATEMENT
Denote releasability to the public or limitation for reasons other than security for example "Release Unlimited." Cite any avaIlability t
-------
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