Merge branch 'master' of https://github.com/OSEL-DBCMS/CHRIS
Browse files- CHRIS.py +5 -5
- templates/main.html +6 -123
CHRIS.py
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from flask import Flask, render_template
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app = Flask(__name__)
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app.debug =
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from color_module import blueprint
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app.register_blueprint(blueprint)
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from exposure_module import blueprint
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app.register_blueprint(blueprint)
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from efficiency_module import blueprint
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app.register_blueprint(blueprint)
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from flask import Flask, render_template
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app = Flask(__name__)
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app.debug = True
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#from color_module import blueprint
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#app.register_blueprint(blueprint)
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#from exposure_module import blueprint
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#app.register_blueprint(blueprint)
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from efficiency_module import blueprint
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app.register_blueprint(blueprint)
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templates/main.html
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<meta charset="UTF-8">
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<title>CHRIS</title>
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<!-- <script src="https://cdn.jsdelivr.net/npm/jquery@3.5.1/dist/jquery.slim.min.js" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script> -->
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<!-- <script src="https://cdn.jsdelivr.net/npm/popper.js@1.16.1/dist/umd/popper.min.js" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script> -->
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<!-- <script src="https://cdn.jsdelivr.net/npm/bootstrap@4.6.1/dist/js/bootstrap.min.js" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script> -->
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<script src="{{ url_for('static',filename='jquery.slim.min.js') }}" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script>
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<script src="{{ url_for('static',filename='popper.min.js') }}" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script>
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<script src="{{ url_for('static',filename='bootstrap.min.js') }}" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script>
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</head>
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<img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
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<img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
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<br clear="all" />
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<!--
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<img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
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<img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
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<br clear="all" />
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-->
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<header>
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<h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators</h1>
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</header>
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<p>
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The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure
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as part of toxicological risk assessment (TRA) of medical device polymers.
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include Medical Device Development Tools (MDDTs) and Regulatory Science Tools (RSTs). Please click on the information icon for more details about each category.
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<h2>
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• <a href="/
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<p>
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A tool to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components
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that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether
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the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or
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testing to demonstrate acceptable biological risk.
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</p>
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<h2> RST qualified modules <button type=button class="Info_btn" data-toggle="modal" data-target="#RSTModal">ⓘ</button> </h2>
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• <a href="/color2"> Color additives RST (v2) </a>
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An updated version of the color additive module that contains additional features and more robust parameterization of the underlying
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transport model used to estimate patient exposure. Note that this version has not been qualified as an MDDT.
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</p>
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• <a href="/exposure2"> Bulk chemicals (excluding color additives) RST (v2) </a>
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<p>
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the total amount of the chemical is known, e.g. from a certificate of analysis.
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</p>
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• <a href="/efficiency"> Extraction efficiency </a>
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<p>
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This module can be used to estimate the fraction of the total pool or solvent concentration of a bulk chemical that will
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</p>
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<h2> Modules in development <
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• <a href="/color3"> Color additives (v3) </a>
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which can subsequently be used for exposure estimation using the color additives or bulk chemicals modules.
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</p>
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<!--<h2> Future modules <button type=button class="Info_btn" data-toggle="modal" data-target="#FutureModal">ⓘ</button> </h2>
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• Updates to exposure model modules to increase the range of applicable systems <br>
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• New module to address layered materials, e.g. coatings <br>
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• New module to leverage the results of standard device extraction testing for exposure estimation <br>-->
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<!-- Modals -->
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<div id="MDDTModal" class="modal fade" role="dialog">
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<div class="modal-dialog">
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<!-- Modal content-->
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<div class="modal-content">
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<div class="modal-header">
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<h4 class="modal-title">Medical Device Development Tools (MDDTs) </h4>
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</div>
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<div class="modal-body">
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<p> The modules in this category have been qualified as Medical Device Development Tools (MDDTs). This qualification
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means that the output of the tool will be accepted by the FDA without the need to reconfirm the suitability and
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utility of the tool, as long as it is used with the qualified context of use. For more information about MDDTs
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please follow the link <a href="https://www.fda.gov/medical-devices/medical-device-development-tools-mddt"> here</a>.</p>
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</div>
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<div class="modal-footer">
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<button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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</div>
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</div>
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</div>
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<div id="RSTModal" class="modal fade" role="dialog">
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<div class="modal-content">
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<div class="modal-header">
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<h4 class="modal-title">Regulatory Science Tools (RSTs) </h4>
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</div>
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<div class="modal-body">
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<p> The modules in this category have been qualified as Regulatory Science Tools (RSTs). RSTs are tools developed by the FDA
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intended to assist in the design and development of medical devices and test methodologies. RSTs can be
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used to support regulatory submissions, but suitability is assessed on a case-by-case basis. These tools may
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become MDDTs in the future. For more information about RSTs
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please follow the link
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<a href="https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices
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"> here</a>.</p>
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</div>
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<div class="modal-footer">
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<button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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</div>
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</div>
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</div>
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<div id="DevModal" class="modal fade" role="dialog">
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<!-- Modal content-->
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<div class="modal-content">
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<div class="modal-header">
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<h4 class="modal-title">Development modules </h4>
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</div>
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<div class="modal-body">
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<p> The modules in this category are currently under development. While we intend to submit these tools for RST and/or
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MDDT qualification in the future, they have not yet been reviewed in any context by the FDA.</p>
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</div>
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<div class="modal-footer">
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<button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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</div>
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</div>
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<div id="FutureModal" class="modal fade" role="dialog">
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<div class="modal-dialog">
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<!-- Modal content-->
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<div class="modal-content">
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<div class="modal-header">
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<h4 class="modal-title">Future modules </h4>
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</div>
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<div class="modal-body">
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<p> We are actively pursuing generation of the evidence base for the modules and updates listed in this category. Stay tuned
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for future additions to the CHRIS calculators!</p>
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</div>
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<div class="modal-footer">
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<button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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</div>
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</div>
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</body>
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</html>
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<meta charset="UTF-8">
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<title>CHRIS</title>
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<script src="{{ url_for('static',filename='jquery.slim.min.js') }}" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script>
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<script src="{{ url_for('static',filename='popper.min.js') }}" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script>
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<script src="{{ url_for('static',filename='bootstrap.min.js') }}" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script>
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</head>
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<img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
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<img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
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<br clear="all" />
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<header>
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<h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators</h1>
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</header>
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<p>
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The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure
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as part of toxicological risk assessment (TRA) of medical device polymers.
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<h2> CHRIS modules </h2>
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• <a href="/color2"> Color additives RST (v2) </a>
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<p>
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A tool to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components
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that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether
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the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or
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testing to demonstrate acceptable biological risk.
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</p>
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• <a href="/exposure2"> Bulk chemicals (excluding color additives) RST (v2) </a>
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<p>
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the total amount of the chemical is known, e.g. from a certificate of analysis.
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</p>
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• <a href="/efficiency"> Extraction efficiency RST </a>
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<p>
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This module can be used to estimate the fraction of the total pool or solvent concentration of a bulk chemical that will
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</p>
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<h2> Modules in development </h2>
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• <a href="/color3"> Color additives (v3) </a>
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which can subsequently be used for exposure estimation using the color additives or bulk chemicals modules.
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</p>
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</body>
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</html>
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