Section 8(e) Notice User Guide Primary Support Version 3.04 September 10, 2013


CD&

Section 8(e) Notice User Guide -
Primary Support

Environmental Protection Agency
Office of Pollution Prevention and Toxics
Manage Toxic Substances

Delivery Order # GS00Q09BGD0022
Task Order# EP-G11H-00154
Project#TDD 9.21

Version 3.04
September 10, 2013

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Table of Contents

1	Introduction	1

1.1	Overview	1

1.2	Labeling Confidential Information	1

2	System Requirements:	3

2.1	Supported Browsers	3

2.2	Screen Resolution	3

3	Primary Support Functions	4

3.1	Log into Section 8(e) Notice Application	4

3.2	Home Screen Navigation	5

3.2.1	Edit Section 8(e) Notice Submission	6

3.2.2	Section 8(e) Notice Screen Navigation	6

3.2.3	Enter Passphrase Screen	8

3.2.4	Navigation Tree	8

3.2.5	Action Bar	10

3.2.6	Technical Contact Information Screen	11

3.2.7	Submitting on Behalf Of Company Screen	15

3.2.8	Submitting on Behalf of Consortium Screen	16

3.2.9	Chemical Identification Screen	18

3.2.10	Document Management Screen	25

3.2.11	TSCA Health and Safety Filing Substantiation Questions	29

3.2.12	Substantiation Screen	30

3.2.13	Substantiation (continued) Screen	32

4	Validate	36

5	Resources	38

Appendix A. Definitions, Acronyms, and Abbreviations	39

Appendix B. Submission Types, Effects, and Endpoints	40

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List of Exhibits

Exhibit 3-1: Chemical Information Submission System Screen	5

Exhibit 3-2: Section 8(e) Notice Home Screen	6

Exhibit 3-3: Section 8(e) Notice Submission Screen	7

Exhibit 3-4: Enter Passphrase Screen	8

Exhibit 3-5: Navigation Prompt	9

Exhibit 3-6: Navigation Tree	10

Exhibit 3-7: Action Bar - Validate	11

Exhibit 3-8: Action Bar - Save	11

Exhibit 3-9: Action Bar - Preview	11

Exhibit 3-10: Action Bar - Help Links	11

Exhibit 3-11: Technical Contact Information Screen	14

Exhibit 3-12: Submitting on Behalf of Company Screen	16

Exhibit 3-13: Submitting on Behalf of Consortium Screen	18

Exhibit 3-14: Chemical Identification Screen: Submission Is for a Mixture	20

Exhibit 3-15: Chemical Identification Screen: Submission Is Not For a Mixture	21

Exhibit 3-16: Search Substance Registry Services Pop-up Window	22

Exhibit 3-17: Chemical Not Found in Substance Registry Services Pop-up Window	24

Exhibit 3-18 Chemical Identification Screen (Populated with chemical not found in SRS Search)25

Exhibit 3-19: Document Management Screen	26

Exhibit 3-20: Document Management Pop-Up Window	28

Exhibit 3-21: Document Management Screen (Populated)	29

Exhibit 3-22: Substantiation Screen	31

Exhibit 3-23: Substantiation (continued) Screen (Scroll 1)	34

Exhibit 3-24: Substantiation (continued) Screen (Scroll 2)	35

Exhibit 4-1: Section 8(e) Notice Validation Pop-Up Window	37

Exhibit 5-1: Resources Screen	38

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1 Introduction

1.1 Overview

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
'Section 8(e) Notice' application submission process. This document is the user guide for the
Primary Support user of the Section 8(e) Notice tool. As a Primary Support, you can edit a
submission created by the Primary Authorized Official (AO). You are only able to access
submissions to which the Primary AO has granted access.

General information on Section 8(e) Notices is available on the TSCA Section 8(e) website
available at http://www.epa.gov/oppt/tsca8e/. Information on CDX registration, including user
roles that apply to completing a Section 8(e) Notice, is available at
http: //cdx. epa. gov/ Ab out/U serGui de

Toxic Substances Control Act (TSCA) regulations require industry to provide the Environmental
Protection Agency (EPA) with documentation regarding chemical production, manufacture,
distribution, use, disposal, import, and export. As a result, the implementation of TSCA has
generated a large volume of documents submitted to the Agency by the regulated community.

TSCA Section 8(e) requires all United States chemical manufacturers, importers, processors, and
distributors to notify EPA after obtaining information on any of their chemical substances or
mixtures that reasonably supports the conclusion that these substances or mixtures present a
substantial risk of injury to health or to the environment.

Anyone subject to the TSCA Section 8(e) reporting requirement should submit a report to EPA
within thirty calendar days of obtaining said information. This information may be toxicity or
exposure data, full reports, summarized results, limited studies (e.g., range-finding studies),
preliminary results, and draft reports that constitute sufficient evidence for Section 8(e)
reporting.

General information on TSCA Section 8(e) "notice of substantial risk" is available at
http://www.epa.gov/oppt/tsca8e/

For questions concerning TSCA Section 8(e) Notice software requirements, please contact the
Central Data Exchange (CDX) Help Desk at helpdesk@epacdx.net or call 1-888-890-1995
between the hours of 8am - 6pm Eastern Standard Time (EST). For TSCA Section 8(e) Notice
reporting requirements, please contact the TSCA Hotline at TSCA-Hotline@epamail.epa.gov or
call 202-554-1404.

1.2 Labeling Confidential Information

This user guide presents instructions and screenshots for the 'Section 8(e) Notice' electronic
application as if you were logged in as the Primary Support. As the Primary Support you are able
to edit or modify a Section8(e) notice. The user may claim certain information as Confidential
Business Information (CBI). If the data is claimed as CBI, it will be treated in accordance with
Agency confidentiality regulations at 40 CFR part 2, subpart B.

This TSCA Section 8(e) Notice electronic application is optional for the production and
submission of these filings. The paper option for filing will continue to be allowed.

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Potential users may find that the use of this application saves time, burden and, because it is in an
electronic format, provides easy access to reporting forms. Potential users are reminded to
carefully read and follow application instructions. Persons who wish to use this application must
address all provisions in the application, including those relating to indexing information (i.e.,
company name, address, chemical name etc.) and those related to CBI submissions, including the
requirement for the submission of sanitized or redacted filings.

Please note that certain CBI claims will not be accepted if you choose to use this electronic
application for TSCA Section 8(e). For example, chemical name and/or chemical identity, if the
chemical is listed on the public portion of the TSCA Inventory, may not be claimed as CBI in a
submission using this application. Similarly, the user must enter a non-confidential study title,
because it may not be claimed as CBI. EPA does not expect that such information, if evaluated
under procedures at 40 CFR part 2, subpart B, would generally be found entitled to confidential
treatment.

If the user believes that these or other data elements should be treated as CBI, then the user may
use the paper option to file the Section 8(e) Notice and assert CBI claims.

If the user claims the 'Mixture Percent' or an uploaded document as CBI, they are required to
complete the appropriate substantiation questions prior to submitting their Notice to EPA. If the
user claims an uploaded document as CBI, a sanitized document must be provided.

The following fields can be claimed as CBI within the 'Section 8(e) Notice' application:

•	Technical Contact Information

•	Submitting on Behalf of Company information

•	Submitting on Behalf of Consortium information

•	A single chemical substance that is not on the public TSCA Inventory

•	The chemical substances comprising a mixture

•	The percent concentrations of individual chemical substances in a mixture

•	Any document uploaded within the 'Document Management" pop-up window

•	All responses to substantiation questions

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2 System Requirements:

To use the Section 8(e) Notice application the following are required:

•	An e-mail account

•	A supported web browser (see Section Error! Reference source not found, below) with
Java Script enabled.

•	Internet access

•	Adobe Acrobat Reader 5.0 or higher

•	CDX username and password

2.1	Supported Browsers

One of the following supported browsers is required to access the Section 8(e) Notice
application:

•	Internet Explorer 7 or above

-	Go to the following link to download:
http://windows.microsoft.com/en-US/internet-explorer/downloads/ie

•	Mozilla Firefox 3.5 or above

-	Go to the following link to download:
http://www.mozilla.com/en-US/firefox/all-older.html

•	Safari 4 or above

-	Go to the following link to download:
http:// support, apple, com/kb/dl 877

•	Google Chrome

-	Go to the following link to download:
http://www.google.com/chrome

2.2	Screen Resolution

•	Screen resolution should be set to 1024 x 768 or greater.

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3 Primary Support Functions

This section describes how to:

•	Access the application

•	Navigate the Section 8(e) Notice 'Home' screen

•	Complete a Section 8(e) Notice submission

•	Complete an amendment

As a Primary Support, you can edit a submission created by the Primary Authorized Official
(AO). You are only able to access submissions to which the Primary AO has granted access.

You can save the submission at any point during the data entry process. The save functionality
will allow you to return to that same submission at any point in the future. You can print the
document at any point; however, the 'Not For Submission' watermark will be placed on the
portable document format (PDF) document each time the submission is printed.

3.1 Log into Section 8(e) Notice Application

After you create an account in CDX and click the 'Primary Support' link under the Chemical
Safety and Pesticide Programs (CSPP) program service, you will be taken to the 'Chemical
Information Submission System' screen.

Note: Information on CDX registration, including user roles that apply to completing a Section
8(e) Notice, is available at http://cdx.epa.gov/About/UserGuide

Exhibit 3-1 shows a screen capture of the 'Chemical Information Submission System' screen:

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Exhibit 3-1: Chemical Information Submission System Screen

CHEMICAL INFORMATION SUBMISSION SYSTEM

TSCA Section Sfet fiotice

TSCA Section S(e i requires all United States chemical manufactures, importers processors, and distributors to notify EPA
after obtaining information on any of their chemical substances or mixtures that reasonably supports the conclusion that
these substances or rrmtures present a substantial risk of Injury to health or to the environment.

This TSCA Section 6(e) electronic application is optional Tor the production and submission of these flings. The paper option
for filing will continue to be allowed

Paperwork Reduction Act Notice

The information collection requirements contained in the information collection request (ICR) have been submitted for OMB
approval under 15 U S C 2607(e) The ICR prepared by EPA identified under EPA ICR No 0794 13 and OMB control
number 2070-0046 is available m the docket for the ICR ICR No 0794 13 addresses the Incremental changes to the
currently approved ICR documents that cover the existing reporting and record keeping programs that are approved under
OMB control number 2070-0046 An agency may not conduct or sponsor and a person is not required to respond to a
collection of information unless It displays a currently valid OMB control number

Authority

The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) provides that, when practicable. Federal organizations
use electronic forms, electronic filings and electronic signatures to conduct official business with the public.

Navigation: Select 'TSCA Section 8(e) Notice' from the drop-down menu and click the 'OK'
button to navigate to the Section 8(e) Notice 'Home' screen.

3.2 Home Screen Navigation

You can access the Section 8(e) Notice 'Home' screen by selecting 'Section 8(e) Notice' from
the 'Chemical Information Submission System' screen drop-down menu and by clicking the
'OK' button.

The Section 8(e) Notice 'Home' screen is the first screen within the Section 8(e) Notice
application. It provides you with links and tabs to access the 'Section 8(e) Notice' submissions,
and 'Resources' screens. To navigate to any of these screens, click the screen link (in blue text),
or click the screen tab (located within the application header). The links and tabs provide the
same functionality.

• Submissions: Click the 'Submissions' link or tab to navigate to the 'Section 8(e) Notice'
submissions screen. You can modify a Section 8(e) Notice submission using the 'Section
8(e) Notice' submissions screen. For additional details about the 'Section 8(e) Notice'
submissions screen, please refer to Section 3.2.1.

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• Resources: Click the 'Resources' link or tab to navigate to the 'Resources' screen. You
can view the Section 8(e) Notice user guide, as well as useful links for further usability
instruction on the 'Resources' screen. For additional details about the 'Resources' screen,
please refer to Section 5.

Exhibit 3-2 shows a screen capture for the Section 8(e) Notice 'Home' screen:

Exhibit 3-2: Section 8(e) Notice Home Screen

Hon* T Suinii.ssia.ra f Headdress

*

HOME

ISubmissionsn

TSCA Section S^i requires that anv person who manu'actures (including importsi processes or distributes
in commerce a chemical substance o' nurture and who obtains information tvhich reasonably supports the
conclusion that such substance or mixture presents a substantial risk of injury to health or the environment
shall immediately inform EPA of such information unless such person has actual Knowledge that the
Administ'ator has been adequately informed of such information

Resources

A helpful guide that describes the Section 8(e) Notice system and provides useful links for further usability
instruction

Support

A Support has the ability to modify any unlocked submission that he/she is assigned to by the Authorizing

Cicial

Navigation: Click the "Submissions" link or lab lo access the 'Section 8(e) Notice" submissions
screen to edit existing submissions.

3.2.1	Edit Section 8(e) Notice Submission

As a Primary Support, you can edit a Section 8(e) Notice submission. You will be able to access
only those submissions for which the Primary AO has assigned you to complete.

3.2.2	Section 8(e) Notice Screen Navigation

You can access the 'Section 8(e) Notice' submissions screen by clicking the 'Submissions' link
from the Section 8(e) Notice 'Home' screen, or by clicking the 'Submissions' tab located within
the application header.

You are only allowed to edit Section 8(e) Notice submissions for which the Primary AO has
granted you access. Each column in the 'Section 8(e) Notice' submission screen can be sorted by
clicking the column headers.

Edit a Submission: To modify an existing Section 8(e) Notice submission, click the
'Submission Alias' link for a submission that has a status of 'In Progress.' You will be required
to enter the passphrase associated with that particular submission in order to access and continue

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editing the submission. Refer to Section 3.2.3 for further instructions on viewing and modifying
a submission that is 'In Progress.'

The 'Section 8(e) Notice' submissions screen displays the following columns:

• Submission Alias: Displays the submission alias provided by the user on the 'Technical
Contact Information' screen. The 'Submission Alias' column will display a time stamp
unless you define a unique submission alias on the 'Technical Contact Information' screen.
The purpose of the submission alias is to help identify each Section 8(e) Notice submission.

• Case Number: Displays the case number for the submission. The case number is
automatically generated upon submission. The 'Case Number' column will display as blank
until the Section 8(e) Notice has been submitted successfully.

• Status: Displays the status of the Section 8(e) Notice submission. The column will display
values as either 'In Progress' or 'Submitted.'

• Modify Date: Displays the date the submission was last modified.

• Submission Date: Displays the date when you complete the submission to EPA. This date
populates only after a Primary AO submits the Section 8(e) Notice submission.

• Export Options: Displays 'CSV,' 'Excel,' 'XML,' and 'PDF' links for you to export the
'Section 8(e) Notice' submissions screen in one of the specified formats as an Excel
spreadsheet, Comma-Separated Values (CSV), Extensible Markup Language (XML), or
Portable Document Format (PDF).

Exhibit 3-3 shows a screen capture of the 'Section 8(e) Notice' submission screen.

Exhibit 3-3: Section 8(e) Notice Submission Screen

SECTION 8(e) NOTICE

To edit an In Progress submission, click the submission alias link in the Submission Alias column in the table below..

Page 1 of 1 « ,

3 items found. Items per page:

HWBSf Bate * SMMn Date «

I Mon Jut 08 09:31:23 EDT2013| 13 In Progress 07/08/2013

T«eJti»D2 10:29:53 EOT2013 li in Progress 07/028013

Tue Jul 02 16:20:12 EDT2013 1 In Progress 07/02/2013

Export options: fl CSV [ Excel | 43 XML | PDF

Navigation: Click the 'Submission Alias' link that has a status of 'In Progress' to navigate to the
'Enter Passphrase' screen.

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3.2.3 Enter Passphrase Screen

To edit a submission, click the 'Submission Alias' link for a submission with a status of 'In
Progress' on the 'Section 8(e) Notice' submissions screen. The 'Enter Passphrase' screen allows
you to enter the passphrase that is associated with the submission.

Enter Passphrase: Enter the passphrase associated with the submission; the passphrase for the
case number you have authority to edit will be given to you by the Primary AO.

Exhibit 3-4 shows a screen capture of the 'Enter Passphrase' screen:

Exhibit 3-4: Enter Passphrase Screen

Us1

ENTER PASSPHRASE

Please enter your user passphrase and click Next

Forgot Your Passphrase?

For security reasons, the system administrator does not have access to your passphrase and cannot retrieve it or reset it to a new one. If you have forgotten

your passphrase you must complete a new Section &;e) Notice.

Cancel

Navigation: Enter the passphrase that was originally created and assigned to you by your AO
and click the 'Next' button to navigate to the 'Technical Contact Information' screen.

3.2.4 Navigation Tree

The navigation tree is located on the left hand side of each screen. You can perform the
following functions using the navigation tree:

• Collapse and Expand folders: Each section of the submission falls under a collapsible
folder within the navigation tree, which allows you to save space or easily view items in the
navigation tree. When a folder is expanded, you can click the minus sign (-), the folder icon
( ), or the folder title link to collapse that section of the navigation tree. When a folder is
collapsed, you can click the plus sign (+), the folder icon ( ), or the folder title link to
expand that section of the navigation tree. When you place your cursor over a folder title
link, it will highlight in red.

• Open and Close the Navigation Tree: To provide more visual form space, a navigation
arrow ("*) that opens and closes the navigation tree is located to the right of the navigation
tree. Click the arrow ( *) to close the navigation tree and increase the space of the form

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content. Likewise, click the arrow (* ) on the closed navigation tree to open the navigation
tree.

• Navigate between screens: You can use the navigation tree to navigate between the
various screens within the application. Each screen of the submission is denoted with a
form icon ( ). You can click the form icon ( ) or the screen title link to navigate to the
selected screen. You must save all information entered on a particular screen before
navigating to the next screen or all entered information will be lost. A prompt will appear
after you click a link in the navigation tree indicating, 'Are you sure you want to leave the
current page? Any unsaved changes will be lost.' If you click the 'OK' button, you will be
taken to the requested screen without saving any of the data in the previous screen. If you
click the 'Cancel' button, the prompt will close and you will not be taken to the requested
screen.

• Add Chemical: You can click the 'Add Chemical' button located at the bottom of the
navigation tree to add another chemical report within a single submission. Clicking the
'Add Chemical' button will generate another chemical report folder containing a 'Chemical
Information' screen and a 'Document Management' screen. The system provides a
'Remove' icon (X) that allows you to remove any unwanted chemical report folders.

Exhibit 3-5 shows a screen capture of the navigation prompt window:

Exhibit 3-5: Navigation Prompt

C , Are you sure you want to leave the current page? Any unsaved changes will be lost.

Cancel

Exhibit 3-6 shows the screen capture of the navigation tree:

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Exhibit 3-6: Navigation Tree

Section 8(e) Notice

Primary Support
E Contact Information

Technical Contact
Information

~"I Chemical Report

Chemical Identification
Document Management
•^Remove
0 Chemical Report

Chemical Identification
|—| {Document Management

	^Remove

3.2.5 Action Bar

The action bar is located at the bottom of each screen. You can perform the following functions
using the action bar:

• Validate: You can click the 'Validate' icon (V ) at any stage of completing a Section 8(e)
Notice submission to check for certain types of errors in a submission. A 'Section 8(e)
Notice Validation' pop-up window is generated when you click the 'Validate' icon
The 'Section 8(e) Notice Validation' pop-up window displays a report of all validation
errors relating to a failed validation. Refer to Section 4 for more information on validating
a submission.

The following exhibits, Exhibit 3-7, Exhibit 3-8, and Exhibit 3-9 show the screen captures for the
action bar:

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Exhibit 3-7: Action Bar-Validate

Validate

Save

Preview

• Save: You can click the 'Save' icon ( ) at any stage of completing a Section 8(e) Notice
submission. After you click the 'Save' icon ( ), the data entered on the screen will save.
The 'Save' function does not validate any entered data.

Exhibit 3-8: Action Bar - Save

Validate

Save

Preview

• Preview: You can click the 'Preview' icon ( ) at any stage of completing a Section 8(e)
Notice submission to preview the submission. After you click the 'Preview' icon ( ), a
watermarked PDF version of the submission will generate.

Exhibit 3-9: Action Bar - Preview

Validate

Save

Preview

• Help Links: You can click any of the 'Help' links, located at the bottom of each screen, at
any stage of completing a Section 8(e) Notice submission.

- If you click the 'CDX Homepage' link, you will be taken to the CDX Homepage.

- If you click the 'MyCDX Homepage' link, you will be taken to the CDX Login screen.

- If you click the 'EPA Homepage' link, you will be taken to the EPA Homepage.

- If you click the 'Terms and Conditions' link, you will be taken to the CDX Terms and
Conditions screen.

- If you click the 'Privacy Notice' link, you will be taken to the CDX Privacy and Security
Notice screen.

Exhibit 3-10 shows the screen capture of the action bar 'Help' links:

Exhibit 3-10: Action Bar - Help Links

3.2.6 Technical Contact Information Screen

You can access the 'Technical Contact Information' screen by clicking the submission alias link
of a form that has a status of 'In Progress' and entering the associated passphrase.

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The 'Technical Contact Information' screen allows you to submit on behalf of another company
or submit on behalf of a consortium. To identify that you are submitting on behalf of another
entity, the system provides the radio button for 'This is a submission on behalf of a consortium.'
To identify that you are submitting on behalf of another company, the system provides the radio
button for 'This is a submission on behalf of another company.' The system will only allow you
to select one radio button per submission.

If you are submitting on behalf of another company, select the 'This is a submission on behalf of
another company' radio button. This functionality has been implemented to accommodate a
company that may use an agent or another individual. If this radio button is selected, you can
enter the contact information for the manufacturing or processing establishment on whose behalf
the submission is being made into the 'Submitting on Behalf Of Company' screen upon clicking
the 'Next' button. If the radio button for 'This is a submission on behalf of a consortium' is
selected, you are taken to the 'Submitting on Behalf of Consortium' screen upon clicking the
'Next' button. If you select the 'N/A' radio button, you are signifying that you are neither
making a submission on behalf of a consortium nor making a submission on behalf of another
company and are taken to the 'Chemical Identification' screen upon clicking the 'Next' button.

The following fields are displayed on the 'Technical Contact Information' screen:

• CBI: Checking this checkbox will claim the technical contact information as CBI.

• Submission Alias: This field is auto-populated with a time stamp and displays on the
'Section 8(e) Notice' submissions screen within the 'Submission Alias' column. This field
is editable should you choose to provide your own submission alias.

• N/A: Selecting the 'N/A' radio button allows you to signify that you are neither making a
submission on behalf of a consortium nor making a submission on behalf of another
company.

• This is a submission on behalf of a consortium: Selecting the 'This is a submission on
behalf of a consortium' radio button allows you to identify yourself as an individual
submitting on behalf of a consortium.

• This is a submission on behalf of another company: Selecting the 'This is a submission
on behalf of another company' radio button allows you to identify yourself as an individual
submitting on behalf of another company.

• Copy CDX Registration: Clicking the 'Copy CDX Registration' button will automatically
populate the fields with your contact information provided during CDX registration.

• Prefix: Displays all optional prefixes. If applicable, select the appropriate prefix. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

• First Name: Enter the technical contact's first name. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

• Middle Initial: Enter the technical contact's middle initial. If you have clicked the 'Copy
CDX Registration' button, the fields populate with information entered during CDX
registration.

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• Last Name: Enter the technical contact's last name. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

• Suffix: Displays all optional suffixes. If applicable, select the appropriate suffix. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

• Company Name: Enter the technical contact's company name. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

• Phone Number: Enter the technical contact's daytime phone number; US or international.
If you have clicked the 'Copy CDX Registration' button, the fields populate with
information entered during CDX registration. This is a required field.

• Email Address: Enter the technical contact's email address. The email address must
follow the standard email address format: iohn.doe@abc.com. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

• Mailing Address 1: Enter the first line of the technical contact's mailing address. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration. This is a required field.

• Mailing Address 2: Enter the second line of the technical contact's mailing address. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

• City: Enter the city of the technical contact's mailing address. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

• State: Enter the state of the technical contact's mailing address. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field if the 'Country' field is 'United States.'

• Postal Code: Enter the postal code of the technical contact's mailing address. If you have
clicked the 'Copy CDX Registration' button, the fields populate with information entered
during CDX registration. This is a required field.

• Country: Displays all available countries. Select the country of the technical contact's
mailing address. If you have clicked the 'Copy CDX Registration' button, the fields
populate with information entered during CDX registration. This is a required field.

Exhibit 3-11: Technical Contact Information Screen shows the screen capture of the 'Technical Contact
Information' screen:

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Exhibit 3-11: Technical Contact Information Screen

Identify the technical contact who is capable of answering questions related to the chemical(s) submitted to EPA within this
submission. Identity if this submission is being submitted on behalf of another company or consortium by selecting the
ch«nvi;ai r-'-.oi appropriate radio button. If submitting on behalf of is not applicable, select the NIA radio button. Click the Copy CDX

Registration button below to Import your CDX registration contact information. The submission alias is an optional field that
changes the submission name on the Submissions Screen. Its purpose is to make it easier to distinguish between multiple
- submissions. If an alias is not selected, the field will default to the date and time It was created. The submission alias may be

.Tharoed at any time

jmission Alias Tue Sep 1011:01:43 EDT 2013

HIA:

This is a submission on behalf of a consortium:

This is a submission on behalf of another company:

Copy CDX Ftegistratjon

CBI: :

Prefix:

First name :

Middle Initial :

Last I lame ;

Suffix:

Company Name

Phone Number :

Email Address:

Mailing Address 1,

Street address, P.O. box, company name, etc

Mailing Address 2:

Apartment, suits, etc.

city:

State: ' -

Postal Code:

Country:

Navigation: If you selected the 'This is a submission on behalf of another company' radio
button, click the 'Next' button to navigate to the ' Submitting on Behalf of Company' screen.
You can also access this screen by clicking the 'Submitting on Behalf of Company' link within
the navigation tree. If you selected the 'This is a submission on behalf of a consortium' radio
button, click the 'Next' button to navigate to the 'Submitting on Behalf of Consortium' screen.
You can also access this screen by clicking the 'Submitting on Behalf of Consortium' link within
the navigation tree. If you have selected the 'N/A' radio button, click the 'Next' button to
navigate to the 'Chemical Identification' screen. You can also access this screen by clicking the
'Chemical Identification' link within the navigation tree.

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3.2.7 Submitting on Behalf Of Company Screen

You can access the 'Submitting on Behalf Of Company' screen by selecting the 'This is a
submission on behalf of another company' radio button and clicking the 'Next' button from the
'Technical Contact Information' screen. You can also access this screen by clicking the
' Submitting on Behalf of Company' link within the navigation tree.

The 'Submitting on Behalf Of Company' screen presents you with a list of fields that allow you
to input the contact information for the manufacturing or processing establishment on whose
behalf the submission is being made.

The following fields are displayed on the 'Submitting on Behalf of Company' screen:

• CBI: Checking this checkbox will claim the 'Submitting on Behalf of Company'
information as CBI.

• Prefix: The 'Prefix' drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.

• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This is a required field.

• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.

• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This is a required field.

• Suffix: The 'Suffix' drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.

• Company Name: Enter the company name of the manufacturing or processing
establishment. This is a required field.

• Phone Number: Enter the daytime telephone number of the manufacturing or processing
establishment contact for whom the submission is being made; US or international. This
field does not accept dashes. This is a required field.

• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: iohn.doe@abc.com. This is a required field.

• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This is a required field.

• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.

• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This is a required field.

• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the 'Country' field is defined as 'United
States.'

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• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This is a required field.

• Country: Enter the country of the mailing address of the manufacturing or processing
establishment contact. This is a required field.

Exhibit 3-12 shows the screen capture of the 'Submitting on Behalf of Company' screen:

Exhibit 3-12: Submitting on Behalf of Company Screen

Ohemk a) Report

Chemic.il Report

Fill out the fields below for the manufacturing or processing establishment on whose behalf this submission Is being
made..

CBI: i

Prefix:

Fust Name

Middle Initial: i

Last Name.

Suffix:

Company Name:

Phone Number: s i Ext: ;

Email Address:

Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:

Country:

Previous i Next

Street address, P.O. box, company name, etc.

Apartment, suite,- etc.

Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen. You can
also access this screen by clicking the 'Chemical Identification' link within the navigation tree.

3.2.8 Submitting on Behalf of Consortium Screen

You can access the 'Submitting on Behalf of Consortium' screen by selecting the 'This is a
submission on behalf of a consortium' radio button and by clicking the 'Next' button from the
'Technical Contact Information' screen. You can also access this screen by clicking the
'Submitting on Behalf of Consortium' link within the navigation tree.

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The 'Submitting on Behalf of Consortium' screen allows you to enter contact information for
each consortium member. The system provides you with the ability to identify the consortium
name. The contact information of the logged in user will pre-populate the first consortium field
set. This information is editable. To add a consortium member, click the 'Add' button to display
fields that can be populated and saved. You can click the 'Save' button for each consortium
member added to capture all information entered on the screen. A minimum of two consortium
members must be added to pass validation.

The following fields are displayed on the 'Submitting on Behalf of Consortium' screen:

• CBI: Checking this checkbox will claim the 'Submitting on Behalf of Consortium'
information as CBI.

• Consortium Name: Enter the name of the consortium.

• Prefix: The 'Prefix' drop-down menu displays all optional prefixes and captures the
consortium member contact's prefix. If applicable, select the appropriate prefix.

• First Name: Enter the consortium member contact's first name. This field is required.

• Middle Initial: Enter the consortium member contact's middle initial.

• Last Name: Enter the consortium member contact's last name. This field is required.

• Suffix: The 'Suffix' drop-down menu displays all optional suffixes and captures the
consortium member contact's suffix.

• Company Name: Enter the consortium member contact's company name. This field is
required.

• Phone Number: Enter the consortium member contact's day time telephone number; US
or international. This field does not accept dashes. This field is required.

• Email Address: Enter the consortium member contact's email address. The email address
must follow the standard email address format: iohn.doe@abc.com. This field is required.

• Mailing Address 1: Enter the first line of the consortium member contact's mailing
address. This field is required.

• Mailing Address 2: Enter the second line of the consortium member contact's mailing
address.

• City: Enter the city of the consortium member contact's mailing address. This is a required
field.

• State: Enter the state of the consortium member contact's mailing address. This field is
required only if the country field is set to 'United States.'

• Postal Code: Enter the postal code of the consortium member contact's mailing address.
This field is required.

• Country: Enter the country of the mailing address of the consortium contact. This is a
required field.

Exhibit 3-13 shows the screen capture for the 'Submitting on Behalf of Consortium' screen:

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Exhibit 3-13: Submitting on Behalf of Consortium Screen

KSRRl

Section 8(e) Notice

Primary Support

0 Contact Information

Technical Contact
Information

I Submitting on Behalf
of Consortium

0 Chemical Report

I Chemical
Identification

Document
Management

-•« Logged in as: John Doe, Primary Support

Home ~ Submissions T Resources

SUBMITTING ON BEHALF OF CONSORTIUM

Provide the consortium name and click the Add button to enter member contact information.
Consortium Name:

~ CGI FEDERAL (John Doe)

CBI:	~

Prefix:	|

First Name:

Middle Initial:

Last Name:

Suffix:

Company Name:
Phone Number:

Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

Street address, P.O. box, company name, etc.

Apartment, suite, etc.

Save

Expand All | Collapse All
CBI: N	Edit X

CBU N Cancel

Z]

Ext:

(Do. not en ter any dashes (-) in Phone Number field above.)

Click the Add button to add a new consortium member Add

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: ($88) 590-1995

Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen. You can
also access this screen by clicking the 'Chemical Identification' link within the navigation tree.
3.2.9 Chemical Identification Screen

You can access the 'Chemical Identification' screen by clicking the 'Next' button from the
'Submitting on Behalf Of Company' screen (if you selected the 'This is a submission on behalf
of another company' radio button), by clicking the 'Next' button from the 'Submitting on
Behalf of Consortium' screen (if you selected the 'This is a submission on behalf of a
consortium' radio button), or by clicking the 'Next' button from the 'Technical Contact
Information' screen (if you selected the 'N/A' radio button). You can also access this screen by
clicking the 'Chemical Identification' link within the navigation tree.

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The 'Chemical Identification' screen provides a 'Chemical Alias' field to help distinguish
between chemical reports when there is more than one chemical report. If you provide a
chemical alias, the chemical alias will display within the navigation tree. If you do not provide a
chemical alias, 'Chemical Report' will remain as the title of each chemical report folder.

To access Substance Registry Services (SRS) you will identify if you are reporting for a mixture
by selecting the 'Yes' or 'No' radio button for 'Is this a submission for a mixture?.' If you
identify you are submitting for a mixture, the system provides a 'Please provide the mixture,
compound, or product name' optional text box. The mixture name text box does not appear if
you select 'No' for 'Is this a submission for a mixture?'.

The following fields are displayed on the 'Chemical Identification' screen:

• Chemical Alias: The chemical alias is used to help distinguish between chemical reports
within the navigation tree when there is more than one. A chemical alias can be created for
each chemical report folder. If a chemical alias is not identified, 'Chemical Report' will
remain as the chemical report folder title within the navigation tree.

• This is a submission for a mixture: Selecting the 'Yes' radio button captures if you are
reporting for a mixture.

• Please check this checkbox if the mixture is CBI: Clicking this checkbox will claim the
entire chemical mixture as CBI. Checking the CBI checkbox will disable all individual
chemical CBI checkboxes.

• Please provide the mixture, compound, or product name: Enter the mixture, compound,
or product's name.

• Add: Clicking the 'Add' button will generate a chemical substance field set.

• Search SRS: Clicking the 'Search SRS' button will generate a pop-up window to perform
an SRS search. Refer to Section 3.2.9.1 for further details.

• Chemical Identifying Number: Displays the chemical identifying number for the
specified chemical substance.

• Chemical Name: Displays the chemical name of the specified substance.

• Synonym: Displays the chemical synonym(s) identified by the user. Clicking the 'Add'
icon ( ) will allow you to enter up to three synonyms for the identified chemical
substance. Click the 'Delete" icon (X) to delete a synonym.

• Mixture (%): Enter the percent composition of each chemical within a mixture. This
displays only when you have identified the submission is for a mixture.

• Mixture % CBI: Checking this checkbox will claim all mixture percent information as
CBI.

Exhibit 3-14 shows the screen capture of the 'Chemical Identification' screen for a user reporting
for a mixture:

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Exhibit 3-14: Chemical Identification Screen: Submission Is for a Mixture

ilgiIbE

Home y Submissions y Resources

Section 8(e) Notice ^ _ .. _. . „ „ .... . w , 4!_ ,

* ' < Section 8(e) Notice > Chemical Report > Chemical Identification

Primary Support

CHEMICAL IDENTIFICATION

Logged in as John Doe, Primary Support
Log Out

El L. Contact Information

; " h technical Contact
Information

&L Chemical Report

H |--JW Chemical

Identification

{""Is [Document Management

The chemical alias is an optional field used to help identify each chemical report when there is more than one
chemical per submission. The alias will display in the navigation tree to help distinguish between multiple chemical
reports.

Chemical Alias:

Is this a submission for a mixture?

Please check this checkbox if the mixture is CBI:

@ Yes ONo

Please provide the mixture, compound, or product name:

Expand All | Collapse All

Cancel

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical.

SRS Search

Chemical Identifier:
Chemical Name:
Synonym:

Mixture %:

Mixture % CBI:

Save

Click the Add button to add a new mixture component. Add

Validate

B H

Save Preview

CDX Homepage

| MyCDX Homepage

I EPA Homepage |

| Terms and Conditions | Privacy Notice |

| CDX Help desk: (888) 890-1995

• CBI: Checking the CBI checkbox will claim the chemical as CBI. The CBI checkbox only
appears if the chemical is not found on the TSCA inventory list.

• This is a submission for a mixture: Selecting the 'No' radio button captures that the user
is not reporting for a mixture.

• Search SRS: Clicking the 'Search SRS' button will generate a pop-up window to perform
an SRS search. Refer to Section 3.2.9.1 for further details.

• Chemical Identifier: Displays the chemical identifying number for the specified chemical
substance.

• Chemical Name: Displays the chemical name of the specified substance.

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Exhibit 3-15 shows the screen capture for the 'Chemical Identification' screen for reporting for a
single chemical substance:

Exhibit 3-15: Chemical Identification Screen: Submission Is Not For a Mixture

r nnfart In*--. rn-, -a-i r,n

Chemical Report

The chemical alias is an optional field used to help identify each chemical report when there is more than one
chemical per submission The alias v*ill displav in the navigation tree to help distinguish between multiple chemical

reports.

Chemical Alias:

Is this a submission lor a mixture?

Yes o Mo

Click the button below to search ERA'S Substance Registry Services (SRS) for the desired chemical.

SRS Search

Chemical ldentifier
Chemical Name

Synonym t

Navigation: Click the 'Next' button to navigate to the 'Document Management' screen. You can
also access this screen by clicking the 'Document Management' link within the navigation tree.

3.2.9.1 Search Substance Registry Services

Click the 'Search SRS' button to generate the 'Substance Registry Services' pop-up window.
You can search for the chemical(s) being reported by the 'Chemical Abstract Service Registry
Number (CASRN),' 'CA Index Name or Other Synonym,' 'Accession Number,' or 'Generic
Name.' After you have searched for and selected a chemical and clicked the 'OK' button, the
selected chemical information will populate the 'Chemical Identification' screen. See Section
3.2.9.2 below if you don't know the CAS or Accession Number.

• CASRN: Enter the CASRN of the chemical.

• CA Index Name or Other Synonym: Enter the CA Index Name or Other Synonym of the
chemical. Displays the following search options: 'Contains,' 'Begins With,' and 'Matches
Exactly.'

• Accession Number: Enter the accession number of the chemical. Displays the following
search options: 'Contains,' 'Begins With,' and 'Matches Exactly.'

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• Generic Name: Enter the generic name of the chemical. Displays the following search
options: 'Contains,' 'Begins With,' and 'Matches Exactly.'

Exhibit 3-16 shows the screen capture for the 'Search Substance Registry Services' pop-up
window:

Exhibit 3-16: Search Substance Registry Services Pop-up Window

#"%€S DO

V/Or r

Enter' the specific or partial, currently correct Chemical Abstracts (CA1 index name as listed on the T3CA
Inventory and/or the exact corresponding Chemical Abstract Services Registry Number (CASRfJ) for each
reportable chemical substance at your site Click Search and select the appropriate CA Index name/ CASRN
combination Vom EPA's Substance Registry Services (SRS)

Piease search by CASRN or CA Index Name

1	CASRN	Matches exactiy	|

2	CA Inoex Name or Other Synonym >w:\*z

DR

Enter the specific or partial currently correct Accession Number as listed on the TSCA Inventory and/or the
exact or partial corresponding Generic Name tor each reportable chemical substance at your site Click
Search and select the appropriate Accession Number; Generic Name combination from EPA's Substance
Registry Services (SRS)

Please search by Accession Number andfor Generic Name

1 Accession Number:

2. Generic Name'	;.n;a-h e-

Search

Navigation: Click the 'X' button in the upper-right hand corner of the 'Search SRS' window to
close the 'Substance Registry Services Search' pop-up window and return to the 'Chemical
Identification' screen.

3.2.9.2 Chemical Not Found in Substance Registry Services

You can access the 'Chemical Not Found in Substance Registry Services' screen by entering
known information into the SRS window and performing a search. If there are no results, a
message will be returned stating 'There were no results returned.' If you are sure the chemical
does not exist in SRS, please click the 'Create New Chemical' button to enter the chemical
information. Clicking the 'Create New Chemical' button on the 'Search Substance Registry

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Services' screen takes you to the 'Chemical Not Found in Substance Registry Services' screen.
Click the 'Cancel' button to go back to the 'Search Substance Registry Services' screen. When
entering information into the 'Chemical Not Found in Substance Registry Services' screen at
least one of the following four fields is required; 'Accession Number,' 'CASRN,'
'Premanufacture Notice (PMN) Number,' or 'International Union of Pure and Applied
Chemistry (IUPAC) Name'

If you do not know the accession number, CASRN, PMN number, or IUPAC number, check the
'Unknown' checkbox. Once you check the 'Unknown' checkbox, the above mentioned fields are
disabled and you are only required to enter a chemical name (or descriptor).

• Unknown: Checking the 'Unknown' checkbox disables the 'Accession Number,'
'CASRN,' 'PMN Number,' and 'IUPAC Name' fields and requires you to enter the
chemical name in the 'Chemical Name (descriptor)' field.

• Accession Number: If known, enter the accession number of the chemical.

• CASRN: If known, enter the CASRN of the chemical.

• PMN Number: If known, enter the PMN number of the chemical.

• IUPAC Name: If known, enter the IUPAC name of the chemical.

• Chemical Name (descriptor): Enter the chemical name/descriptor of the chemical being
reported. This is a required field when the 'Unknown' checkbox is checked.

Exhibit 3-17 shows the screen capture for the 'Chemical Not Found in Substance Registry
Services' pop-up window:

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Exhibit 3-17: Chemical Not Found in Substance Registry Services Pop-up Window

¦Q

CSPP

GHEMICAL NOT FOUND IN SUBSTANCE REGISTRY SERVICES

Complete all Known chemical substance information in the below fields. Click the 'OK' button when all known
chemical substance information has been fulfilled.

If you need to go back to the SRS search screen, please click 'Cancel'.

r Chemical ID

Unknown:

Accession Number
CASRN
PMN Number:

IUPAC Name:

Chemical Name (descriptor):

Cancel

Navigation: Click the 'OK' button to populate the entered information and navigate to the
'Chemical Identification' screen. Click the 'Cancel' button to navigate to the 'Search Substance
Registry Services' screen.

The following fields are displayed on the 'Chemical Identification' screen if a chemical is not
found in SRS Search:

• CBI: Checking this checkbox will claim the chemical identity as CBI.

• Chemical Identifier: Displays which identifier you used to label the chemical. The
chemical identifier will vary depending on the data entered in the 'Chemical Not Found In
Substance Registry Services' screen.

• Chemical Name (descriptor): Displays the chemical name (or descriptor) of the chemical
being reported entered in the 'Chemical Not Found In Substance Registry Services' screen.

• Synonym: Enter the chemical synonym(s).. Clicking the 'Add' icon (*¦ ) will allow you to
enter up to three synonyms for the identified chemical substance. Click the 'Delete' icon
(^ ) to delete a synonym.

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Exhibit 3-18 shows the screen capture for the 'Chemical Identification' screen populated with a
chemical not found in the SRS search:

Exhibit 3-18 Chemical Identification Screen (Populated with chemical not found in SRS

Search)

Submissions

Conlac* Informaii

Chemical Report

:ice > Chemical Report > Chemical Identification

CHEMICAL IDENTIFICATION

meal alias is an optional field used to help identify each chemical report when there is more than one
per submission The alias will display in the navigation tree to help distinguish between multiple chemical

Alias: ]

ubmission for a mixture? Yes » No

. p.' button below to search EPA's Substance Registry Services (SRS) for the desired chemical.
SRS Search

Identifier:

flame (descriptor):

Unknown
Test Chemical

Navigation: Click the 'Next' button to navigate to the 'Document Management' screen.
3.2.10 Document Management Screen

You can access the 'Document Management' screen by clicking the 'Next' button from the
'Chemical Identification' screen. You can also access this screen by clicking the 'Document
Management' link within the navigation tree.

The 'Document Management' screen allows you to upload documents related to Section 8(e)
Notice reporting requirements. To add Section 8(e) Notice documents, click the 'Add Document'
button. Clicking the 'Add Document' button generates the 'Document Management' pop-up
window.

The 'Document Management' pop-up window allows you to attach the submission types: 'Initial
Submission,' 'Follow-up Submission, and 'Final Report Submission.'

The 'Document Management' table displays the 'Report Study Title' of the document, the
document type, the date the document was attached, and the CBI status of the document. The
system allows you to delete unwanted documents by clicking the 'Delete' icon (X) located
under the 'Action' column. Clicking the report study title link generates the 'Document
Management' pop-up window. This allows you to view and edit the attached documents.

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• Add Document: Clicking the 'Add Document' button generates the 'Document
Management' pop-up window.

• Report Study Title: Displays the file name and file extension of the attached file. Clicking
the file name link displays the 'Document Management' pop-up window and allows you to
view and edit the attached document.

• Submission Type: Displays the submission type chosen in the 'Document Management'
pop-up window.

• Attachment Date: Displays the date the document was attached.

• CBI: Displays 'N' or ' Y' depending on if the CBI checkbox was checked.

• Action: Clicking the 'Delete" icon (X) will delete the specified row and all contents
within. A warning message displays to confirm the deletion of the document.

Exhibit 3-19 shows the screen capture of the 'Document Management' screen:

Exhibit 3-19: Document Management Screen

The 'Document Management' pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must enter a report study title and attach one
document. Clicking the 'Browse' button will generate the 'File Upload' window on your hard
drive. Select the document you wish to attach and click the 'Open' button. If a document is
marked as 'CBI' then a sanitized copy of the document must be attached. To save the attached
document to the 'Document Management' screen, click the 'OK' button within the 'Document
Management' pop-up window.

• Report Study Title: Enter the report study title that is unique to this chemical report. This
field is required. This study title must be non-confidential.

• CBI: Checking the 'CBI' checkbox will claim the uploaded document as CBI.

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• Submission Type: Allows you to select the submission type for the attachments. Displays
the following options: 'Initial Submission,' 'Follow-up Submission,' and 'Final
Submission.'

• Original Document: Clicking the 'Browse' button will generate the 'File Upload' window
for you to search for a particular file on your hard drive.

• CBI: Checking the 'CBI' checkbox will claim the uploaded summary/abstract document as
CBI.

• Summary/Abstract: Displays 'Yes' and 'No' radio buttons. If you select the 'Yes' radio
button a document upload will generate. Click the 'Browse' button to generate the 'File
Upload' window for you to search for a particular file on your hard drive.

• Effects: Allows you to select the effect specific to the chemical report. Displays the
following options: 'Health Effects,' 'Environmental Fate,' 'Ecotoxicity,' and'Physical
Chemical Properties.'

• Endpoints: Allows you to select an endpoint that is specific to the chemical report. The
endpoints will be specific to the effect chosen from the 'Effects' drop-down menu. If no
effect is chosen, no endpoints will display.

Refer to Error! Reference source not found, for a complete list of values that are found within
each of the drop-down menus on the 'Document Management' pop-up window. If you have
multiple documents that share the same effects and/or endpoints, you must upload each
individual document separately and select values from the drop-down menus.

Exhibit 3-20 shows the screen capture of the 'Document Management' pop-up window:

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Exhibit 3-20: Document Management Pop-Up Window

4 CSPP

DOCUMENT MANAGEMENT

Select the submission type and browse for the document.

Note: For security purposes, documents are only saved when there are no validation errors.
If there are any validation errors, all documents must be reattached.

Report Study Title







Submission Type

-

CBI

m



Document Upload

Browse

Sanitized Document Upload



Browse

Summary/Abstract:

Yes: ° No:



CBI

m



Document Upload



Browse

Sanitized Document Upload



Browse

OK Cancel

Navigation: Upload all required documentation and click the 'OK' button to save all data to the
'Document Management' table.

Exhibit 3-21 shows the screen capture of the 'Document Management' screen populated with
data:

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Exhibit 3-21: Document Management Screen (Populated)

section o(®J Notice ^ section 8{e} Notice > Chemical Report > Document Management

Ccinia^[ In'crmdtson " s-"!" •• '• I»----

Upload the corresponding Section 8(e) Notice document(s) by clicking on the Add Document button below

Chemical Report I Add Document!

Navigation: Click the 'Next' button to navigate to the 'Substantiation' screen if a chemical or
document was claimed as CBI. If no chemical or document was claimed as CBI click the ' Save'
button located in the bottom action bar.

3.2.11 TSCA Health and Safety Filing Substantiation Questions

Users completing submissions within the Section 8(e) Notice application may claim
confidentiality for information within the TSCA Section 8(e) submission. If you are claiming
CBI within the TSCA Section 8(e) Notice submission, you must complete substantiation
questions and submit detailed written explanations to substantiate all CBI claims. Sanitized
copies of all documents claimed as CBI must be submitted to be placed in the TSCA public
docket.

The system allows you to complete Section 8(e) Notice substantiation for chemicals claimed as
CBI as well as documents claimed as CBI. If you only claim the submitting official information,
or the technical contact information as CBI, the system does not require the submitter to
complete substantiation.

The system takes you to the substantiation sections of the application. Each time you claim an
item as CBI that allows substantiation; the system generates an alert that informs you
substantiation must be completed for items claimed as CBI.

The system will auto-populate substantiation questions for which the information has already
been provided within the Section 8(e) Notice application. The substantiation questions are
logically separated into sections within the application to streamline the substantiation process.
Each question has functionality built into the system dependent upon your responses.

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3.2.12 Substantiation Screen

The 'Substantiation' screen presents you with substantiation questions that pertain to the
chemical substance(s) and document(s) claimed as CBI. The 'Substantiation' screen presents you
with substantiation questions that allow answers to be entered as free text in text fields or by
selecting 'Yes' or 'No' radio buttons.

You can access the 'Substantiation' screen by clicking the 'Next' button from the 'Document
Management' screen if the chemical substance(s) has been claimed as CBI or a document has
been claimed as CBI. You can also access the screen by clicking the 'Substantiation' link within
the navigation tree. All of the fields on the 'Substantiation' screens are required.

Substantiation Question 1:

Is the subject chemical on the TSCA Inventory or otherwise available in commerce in the
United States? If it is a mixture, is the mixture in commerce?

• Yes/No: Allows you to identify if the substance is commercially available.

• CBI: Checking this checkbox will claim the answer as CBI.

Substantiation Question 2:

Is the subject chemical or mixture expected to be subject to TSCA or is it expected to be
used for a non-TSCA purpose?

• Yes/No: Allows you to identify if the substance is expected to be used for a non-
TSCA purpose.

• CBI: Checking this checkbox will claim the answer as CBI.

Substantiation Question 3:

Describe the substantial harmful effects that would result to your competitive position if
the CBI information is made available to the public. In your answer, explain the causal
relationship between disclosure and any resulting substantial harmful effects. Consider in
your answer such constraints as capital and marketing cost, specialized technical
expertise, or unusual processes and your competitor's access to your customers. Address
each piece of information claimed CBI separately.

• CBI: Checking this checkbox will claim the answer as CBI

• A text field is available for you to answer the question.

Substantiation Question 4:

For what period do you assert your claim of confidentiality? If the claim is to extend until
a certain event or point in time, please indicate that event or time period.

• CBI: Checking this checkbox will claim the answer as CBI.

• Event: Allows you to enter the appropriate information to complete the question.

• Date: Provides a calendar widget for you to specify the date to which the claim of
confidentiality extends.

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If you answered 'Yes' to any of the questions above indicate why in the text box
below. Indicate below where the information appears and explain why it should
nevertheless be treated as confidential:

• A text box is displayed and allows you to enter any text.

Exhibit 3-22 shows the screen captures for the 'Chemical Substantiation' screen:

Exhibit 3-22: Substantiation Screen



Section 8{e> Notice

Primary Support

Contact Information

Technical Contact
Information

Chemical tdentincaDon
Document M snags rnent

Nutislrtntiwtioii

Sufistanaiasi&fl
(contenued)

i jonnooe Primary Support

Home y Submissions y User Management J Resources

* Section 8|e) Notice > Cta«mc*t R»pon Substantiation

SUBSTANTIATION

1	Is the subject chemical on the TSCA inventory or otherwise available in commerce'? If it cs a mixture is the mixture in
commerce?

COL 17

C Yes r No

2	Is the subject chemical or mixture expected to be subject to TSCA or is d expected to be used for a non-TSCA purpose?
CBfP

a Yes r No

3	Describe the substantial harmful effects that would result to your competitive position if the CBi information is made
available to the public In your answer exp-ain the causal relationship between disclosure and any resulting substantial
harmful effects Consider in your answer such constraints as capital and marketing cost specialized technical expertise or
unusual processes and your competitor's access to your customers Address each piece of information claimed CBI
separately

CBI P

4 For what penod do you assert your claim of confidentiality'' If the claim is to extend until a certain event or point in time
please indicate that event or time period
CBI &

Event

Date 12/31/2013 _J

If you answered Yes'to any of the questions above indicate in the text box below. Indicate below where the
information appears and explain why it should nevertheless be treated as confidential:

Previous	Next







>/

¦



m









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Save



Preview



COX Homepage

I MyCOX Horn*040

o I EPA*

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: and Conditions

1 PflvS

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Navigation: Answer all substantiation questions and click the 'Next' button to navigate to the
'Substantiation (continued)' screen.

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3.2.13 Substantiation (continued) Screen

The 'Substantiation (continued)' screen presents you with substantiation questions that require
answers to be entered as free text in text fields or by selecting 'Yes' or 'No' radio buttons.

You can access the 'Substantiation (continued)' screen by clicking the 'Next' button from the
'Substantiation'. All of the fields on the 'Substantiation (continued)' screen are required.

Substantiation Question 5A:

Do you assert that disclosure of this information you are claiming CBI would reveal any
of the following?

Confidential processes used in manufacturing the substance?

Clicking the 'Yes' radio button will bring up another question:

•	CBI: Checking this checkbox will claim the answer as CBI.

Substantiation Question 5B:

Do you assert that disclosure of this information you are claiming CBI would reveal any
of the following?

If a mixture, the actual portions of the substance in the mixture?

Clicking the 'Yes' radio button will bring up another question:

•	CBI: Checking this checkbox will claim the answer as CBI.

Substantiation Question 5C:

Do you assert that disclosure of this information you are claiming CBI would reveal any
of the following?

Information unrelated to the effects of the substance on human health or the
environment?

Clicking the 'Yes' radio button will bring up another question:

•	CBI: Checking this checkbox will claim the answer as CBI.

Substantiation Question 6A:

Does the information claimed as confidential appear or is it referred to in any of the
following:

Advertising or promotional material for the chemical substance or the resulting end
product?

Clicking the 'Yes' radio button brings up another set of questions:

•	CBI: Checking this checkbox will claim the answer as CBI.

•	Browse for the document(s) containing the materials as indicated above:

Browse for the specified document and click the 'Upload' button.

Substantiation Question 6B:

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Does the information claimed as confidential appear or is it referred to in any of the
following:

Non-confidential material safety data sheets or other similar materials (such as technical
data sheets) for the substance or resulting end product (include copies of this information
as it appears when accompanying the substance and/or product at the time of transfer or
sale)?

Clicking the 'Yes' radio button brings up another set of questions:

•	CBI: Checking this checkbox will claim the answer as CBI.

•	Browse for the document(s) containing the materials as indicated above:

Browse for the specified document and click the 'Upload' button.

Substantiation Question 6C:

Does the information claimed as confidential appear or is it referred to in any of the
following:

Professional or trade publications?

Clicking the 'Yes' radio button brings up another set of questions:

•	CBI: Checking this checkbox will claim the answer as CBI.

•	Browse for the document(s) containing the materials as indicated above:

Browse for the specified document and click the 'Upload' button.

Substantiation Question 6D:

Does the information claimed as confidential appear or is it referred to in any of the
following:

Any other media or publications available to the public or to your competitors?

Clicking the 'Yes' radio button brings up another set of questions:

•	CBI: Checking this checkbox will claim the answer as CBI.

•	Browse for the document(s) containing the materials as indicated above:

Browse for the specified document and click the 'Upload' button.

Substantiation Question 7:

Has EPA, another federal agency, or court made any confidentiality determination
regarding information associated with this substance?

Clicking the 'Yes' radio button brings up another question:

•	CBI: Checking this checkbox will claim the answer as CBI.

•	Browse for the document(s) containing the materials as indicated above:

Browse for the specified document and click the 'Upload' button.

•	If you answered 'Yes' to any of the questions above indicate in the text box
below. Indicate below where the information appears and explain why it

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should nevertheless be treated as confidential: Displays a text field for you to
enter the appropriate information to complete the question.

Exhibit 3-23 and Exhibi t 3-24 Error! Reference source not found, show the screen capture for the
'Substantiation (continued)' screen.

Exhibit 3-23: Substantiation (continued) Screen (Scroll 1)

rf

Section 8(9) Notice
Primary Support

Contact information

Technical Contact
Information

Chemical Report

^ iChemical Identification

Document Management

-J Substantiation

Substantiation
(continued)

1 L	i-. -Joftn Doe Primary Support

Home y Submissions y User Management * Resources

^ Section 8(e) Notice > Chemical Report > Substantiation (continued)

SUBSTANTIATION (CONTINUED)

5	Do you assert that disclosure of this information you are claiming CBI would reveal any of the following?

a Confidential processes used in manufacturing the substance?

CBI. R

Yes r No

b If a mixture, the actual portions of the substance in the mixture?

CBLP

^ Yes f No

c. Information unrelated to the effects of the substance on human health or the environment?

CBI: P

Yes r No

6	Does the information claimed as confidential appear or is it referred to in any of the following

a Advertising or promotional material for the chemical substance or the resulting end product?

CBI W

^ Yes No
Confidential Advertising/Promotional Material

Browse for the documents} containing the materials as indicated above.

Browse Upload

File Name	Action

b Non-confidential materia] safety data sheets or other similar materials (such as technical data sheets) for the substance
or resulting end product (include copies of this information as it appears when accompanying the substance and/or
product at the time of transfer or sale)?

CBI. W

<* Yes No
Confidential Data Sheets

Browse for the documerrt(s) containing the materials as indicated above
Browse Upload

File Name	Action

c Professional or trade publications?

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Exhibit 3-24: Substantiation (continued) Screen (Scroll 2)

c Professional or trade publications?

CBI R

Yes r No

Confidential Professional/Trade Publication

Browse for the document(s) containing the matenals as indicated above

Browse Upload

File Nam*	Action

d. Any other media or publications available to the public or to your competitors7
CBI P

Yes r No

Confidential Media'Publication*

Browse for the document(s) containing The materials as indicated above
Browse Upload

FHft Nam#	Action

7 Has EPA another federal agency or court made any confidentiality determination regarding information associated with
this substance?

CBI P

Yes r No

Confidentiality Documents

Browse for the document(s) containing the materials as indicated above
Browse Upload

File Name	Action

If you answered 'Yes' to any of the questions above indicate in the text box below. Indicate below where the
information appears and explain why it should nevertheless be treated as confidential:

Previous



s n

Validate	Save	Preview

CO*	| MyCOX Humecxigo 6PA Homepage | Tiwrris and Conxion? | Privacy Naiicn | COX H#lp
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CDX,

4 Validate

You can click the 'Validate' icon () at any stage of completing a Section 8(e) Notice. The
'Section 8(e) Notice Validation' pop-up window is displayed when you click the 'Validate' icon
( ) in the action bar. The 'Section 8(e) Notice Validation' pop-up window displays a report of
all validation errors. During the validation process, the application validates each screen of the
Section 8(e) Notice to find missing and invalid data. For example, if a document is claimed as
CBI a sanitized version of the document must be uploaded. If a sanitized version if not uploaded,
you will be unable to complete the submission.

Validation Errors: Errors are denoted by an 'Error' icon (©) and can be fixed by clicking the
error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the
associated error. For example, if you claimed an uploaded document as CBI and have not
attached a sanitized copy prior to validation, the system would display a validation error similar
to 'Document Management: You have uploaded a CBI document. A sanitized copy is
required.' After you click a link, the main application screen will display the screen where the
error occurred so you can easily fix the error. Once you have fixed the error(s), click the
'Validate' icon ( ) again to refresh the 'Section 8(e) Notice Validation' pop-up window. If the
information you fixed passes validation, the error will be removed from the ' Section 8(e) Notice
Validation' pop-up window. You must fix all validation errors to successfully submit to EPA via
CDX.

Warning Messages: Warnings are denoted by a 'Warning' icon ( ) and can be fixed by
clicking the warning link. The links will display the Screen Title and the associated warning.
After you click a link, the main application screen will display the section where the warning
occurred so you can easily fix the warning. Once you have fixed the warning(s), click the
'Validate' icon ( ) again to refresh the ' Section 8(e) Notice Validation' pop-up window. If the
information you fixed passes validation, the warning will be removed from the ' Section 8(e)
Notice Validation' pop-up window. You can pass validation and continue to submit a form to
CDX with active warning messages.

You can close the 'Section 8(e) Notice Validation' pop-up window by clicking the 'X' button
located at the top right of the 'Section 8(e) Notice Validation' pop-up window.

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Exhibit 4-1 shows the screen captures for the 'Section 8(e) Notice Validation' pop-up window:
Exhibit 4-1: Section 8(e) Notice Validation Pop-Up Window

* U&PP
Section 8(e) Notice Validation

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5 Resources

You can access the 'Resources' screen by clicking the 'Resources' link on the Section 8(e)
Notice 'Home' screen or by clicking the 'Resources' tab located in the application header. The
'Resources' screen provides you with a link to the Section 8(e) Notice user guide as well as
additional helpful links. Click the 'User Guide' link to access the Section 8(e) Notice user guide
document.

Toxic Substances Control Act (TSCA) Section 8(e) Notices and Section 8(e) Notice
Submissions: If you click this link, a new internet browser window will generate displaying
EPA's TSCA Section 8(e) Notices screen.

CDX Home: If you click this link, a new internet browser window will generate displaying the
CDX Homepage.

TSCA Chemical Substances Inventory: If you click this link, a new internet browser window
will generate displaying the TSCA Chemical Substances Inventory screen.

Exhibit 5-1 shows the screen capture of the 'Resources' screen:

Exhibit 5-1: Resources Screen

^ hi t l t

I

RESOURCES
Section 8(e) Notice User Guide

This guide describes each screen of the Section 8(e) Notice application sofhrai e and provides information on how to use the system to complete a Section 8(e)
Notice submission. The guide also contains Instructions for registering with CD \ submitting a Section 8(e) Notice submission, and amending a previous

submission. You can download and punt the guide tor quick reference.

Use:

Helpful Web Links

Click the link provided below to access additional Information related to Section 8(e) Notices.

Toxic Substances Control Act (TSCA) Section 8f

Click the link provided below to access additional information related to Genital Data Exchange (CDX).

CDX Home

Click the link provided below to access additional information related to the Toxic Substances Control Act (TSCA)

TSCA Cfiemi&ii Sti&steices Inventory
If you need assistance, please call (202) 564-3011 or e-mail the TSCA Hotline at TSCA-Hoffine@epamail.epa.gov.

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Appendix A. Definitions, Acronyms, and Abbreviations

The following table displays all the definitions, acronyms, and abbreviations used in this
document and their full name.

Definitions, Acronyms, and Abbreviations

Acronym	Full Name

AO

Authorized Official

CA

Chemical Abstract

CASRN

Chemical Abstract Service Registry Number

CBI

Confidential Business Information

CDX

Central Data Exchange

CSPP

Submissions for Chemical Safety and Pesticide Programs

CSV

Comma-Separated Values

EPA

Environmental Protection Agency

EST

Eastern Standard Time

IUPAC

International Union of Pure and Applied Chemistry

OPPT

Office of Pollution Prevention and Toxics

PDF

Portable Document Format

PMN

Premanufacture Notice

SRS

Substance Registry Services

TSCA

Toxic Substances Control Act

UVCB

Unknown or Variable Composition or Complex Reaction product or Biological Material

XML

Extensible Markup Language

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Appendix B. Submission Types, Effects, and Endpoints

The following appendix displays all possible options within each drop-down menu on the
'Document Management' pop-up window.

First Dropdown:

•	Title: Submission Type

•	Contains the following values

o Initial Submission
o Follow-Up Submission
o Final Submission

Second Dropdown

•	Title: Summary/Abstract Submission

•	Contains the following values

o Yes

o No

Third Dropdown

•	Title: Effects

•	Contains the following values

o Health Effect
o Ecotoxicity
o Environmental Fate
o Physical-Chemical Properties

Fourth Dropdown

•	Title: Endpoints

•	Contains the following values

o For Health Effect (shows when Health Effect is selected from third dropdown)

¦	Basic Toxic kinetics

¦	Dermal Absorption

¦	Acute Toxicity: oral

¦	Acute Toxicity: inhalation

¦	Acute Toxicity: dermal

¦	Acute Toxicity: other routes

¦	Skin irritation/corrosion

¦	Eye irritation

¦	Skin sensitization

¦	Respiratory sensitization

¦	Repeated Dose toxicity: oral

¦	Repeated Dose toxicity: inhalation

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¦	Repeated Dose Toxicity: dermal

¦	Repeated Dose Toxicity: other routes

¦	Genetic Toxicity in vitro

¦	Genetic Toxicity in vivo

¦	Carcinogenicity

¦	Toxi city to Reproducti on

¦	Developmental Toxicity/teratogenicity

¦	Toxicity to reproduction: other studies

¦	Neurotoxicity

¦	Immunotoxicity

¦	Specific investigations: other studies

¦	Health surveillance data

¦	Epidemiological data

¦	Direct observations: clinical cases, poisoning incidents and other

¦	Sensitization data (humans)

¦	Exposure related observations in humans: other data

¦	Toxic effects on livestock and pets

¦	Additional toxicological information

¦	Other

o For Ecotoxicity (shows when Ecotoxicity is selected from third dropdown)

¦	Short-term toxicity to fish

¦	Long-term toxicity to fish

¦	Short-term toxicity to aquatic invertebrates

¦	Long-term toxicity to aquatic invertebrates

¦	Toxicity to aquatic algae and cyanobacteria

¦	Toxicity to aquatic plants other than algae

¦	Toxicity to microorganisms

¦	Toxicity to other aquatic organisms

¦	Sediment toxicity

¦	Toxicity to soil macroorganisms except arthropods

¦	Toxicity to terrestrial arthropods

¦	Toxicity to terrestrial plants

¦	Toxicity to soil microorganisms

¦	Toxicity to birds

¦	Toxicity to other above-ground organisms

¦	Biological effects monitoring

¦	Biotransformation and kinetics

¦	Additional ecotoxicological information

¦	Other

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o For Environmental Fate (shows when Environmental Fate is selected from third
dropdown)

¦	Photo transformation in air

¦	Hydrolysis

¦	Photo transformation in water

¦	Photo transformation in soil

¦	Biodegradation in water: screening test

¦	Biodegradation in water and sediment: simulation tests

¦	Biodegradation in soil

¦	Mode of degradation in actual use

¦	Bioaccumulation: aquatic/sediment

¦	Bioaccumulation: terrestrial

¦	Adsorption/desorption

¦	Henry's Law constant

¦	Distribution Modeling

¦	Other Di stributi on D ata

¦	Monitoring Data

¦	Field Studies

¦	Additional Information on Environmental Fate and Behavior

¦	Other

o For Physical-Chemical Properties (shows when Physical-Chemical Properties is
selected from third dropdown)

¦	Appearance/Physical

¦	Melting Point

¦	Boiling Point

¦	Density

¦	Particle size distribution

¦	Vapor Pressure

¦	Partition Coefficient

¦	Water Solubility

¦	Solubility in Organic Solvent

¦	Surface Tension

¦	Flash Point

¦	Auto Flammability

¦	Flammability

¦	Explosiveness

¦	Oxidizing Properties

¦	Oxidation Reduction Potential

¦	Stability in organic solvents and identity of relevant degradation products

¦	Storage stability and reactivity towards container material

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¦	Stability: thermal, sunlight, metals

¦	pH

¦	Dissociation constant

¦	Viscosity

¦	Additional physic-chemical information

¦	Other

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