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Removed link to tox profiles

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  1. static/FAQ.html +1 -1
  2. static/FAQ.md +1 -1
static/FAQ.html CHANGED
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  <p>Details regarding the exposure model and underlying assumptions, as well as how the model is parameterized and validated for the additive / polymer combinations listed in CHRIS have been published [1].</p>
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  <p>[1] D.M. Saylor, V. Chandrasekar, D.D. Simon, P. Turner, L.C. Markley, A.M. Hood, Strategies for rapid risk assessment of color additives used in medical devices, Toxicol. Sci. 172 (2019) 201-212. doi:10.1093/toxsci/kfz179.</p>
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  <h3 id="where-do-the-color-additive-tolerable-intake-values-come-from">Where do the color additive tolerable intake values come from?</h3>
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- <p>Provisional tolerable intake values (TIs) were derived for color additives commonly used in polymeric medical device components and implemented into the CHRIS. A TI value is an estimate of the daily intake of the color additive or impurity over a period of time based on body mass and considered to be without appreciable harm to human health. The TI values are expressed in milligrams per kilogram of body mass per day (mg/kg bw/day). They are used to determine the TE value for a patient of particular weight. A comprehensive literature review of studies investigating critical health effects resulting from parenteral exposure to each color additive was reviewed and documented. The quality of the study data was evaluated by the Annapolis Accords [4] principles, and then further analyzed by the Toxicological Data Reliability Assessment Tool (ToxRTool) [5] to determine the critical study for use in derivation of the TI. The point of departure (POD) is the exposure concentration of the color additive reporting the health effect in the critical study typically presented as a no-adverse-effect-level (NOAEL) or bench mark dose (BMD) value, and represents the critical adverse health effect. The POD is extrapolated to humans by calculating a modifying factor (MF) that accounts for uncertainties in the data, such as: intraspecies variability, interspecies differences and quality/completeness of the data. For details on the procedures and data used to derive the TI values, the complete toxicological profiles can be found <a href="ToxProfiles.pdf">here</a>.</p>
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  <p>[4] Gray, G.M., et al., 2008. The Annapolis Accords on the use of Toxicology in risk assessment and decision-making: an Annapolis center workshop report. Toxicol. Method 11, 225e231. http://dx.doi.org/10.1080/105172301316871626.</p>
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  <p>[5] Schneider, K., et al., 2009. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol. Lett. 189, 138e144. http://dx.doi.org/10.1016/j.toxlet.2009.05.013.</p>
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  <h3 id="how-does-chris-deal-with-color-additive-impurities">How does CHRIS deal with color additive impurities?</h3>
 
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  <p>Details regarding the exposure model and underlying assumptions, as well as how the model is parameterized and validated for the additive / polymer combinations listed in CHRIS have been published [1].</p>
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  <p>[1] D.M. Saylor, V. Chandrasekar, D.D. Simon, P. Turner, L.C. Markley, A.M. Hood, Strategies for rapid risk assessment of color additives used in medical devices, Toxicol. Sci. 172 (2019) 201-212. doi:10.1093/toxsci/kfz179.</p>
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  <h3 id="where-do-the-color-additive-tolerable-intake-values-come-from">Where do the color additive tolerable intake values come from?</h3>
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+ <p>Provisional tolerable intake values (TIs) were derived for color additives commonly used in polymeric medical device components and implemented into the CHRIS. A TI value is an estimate of the daily intake of the color additive or impurity over a period of time based on body mass and considered to be without appreciable harm to human health. The TI values are expressed in milligrams per kilogram of body mass per day (mg/kg bw/day). They are used to determine the TE value for a patient of particular weight. A comprehensive literature review of studies investigating critical health effects resulting from parenteral exposure to each color additive was reviewed and documented. The quality of the study data was evaluated by the Annapolis Accords [4] principles, and then further analyzed by the Toxicological Data Reliability Assessment Tool (ToxRTool) [5] to determine the critical study for use in derivation of the TI. The point of departure (POD) is the exposure concentration of the color additive reporting the health effect in the critical study typically presented as a no-adverse-effect-level (NOAEL) or bench mark dose (BMD) value, and represents the critical adverse health effect. The POD is extrapolated to humans by calculating a modifying factor (MF) that accounts for uncertainties in the data, such as: intraspecies variability, interspecies differences and quality/completeness of the data.</p>
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  <p>[4] Gray, G.M., et al., 2008. The Annapolis Accords on the use of Toxicology in risk assessment and decision-making: an Annapolis center workshop report. Toxicol. Method 11, 225e231. http://dx.doi.org/10.1080/105172301316871626.</p>
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  <p>[5] Schneider, K., et al., 2009. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol. Lett. 189, 138e144. http://dx.doi.org/10.1016/j.toxlet.2009.05.013.</p>
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  <h3 id="how-does-chris-deal-with-color-additive-impurities">How does CHRIS deal with color additive impurities?</h3>
static/FAQ.md CHANGED
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  ### Where do the color additive tolerable intake values come from?
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- Provisional tolerable intake values (TIs) were derived for color additives commonly used in polymeric medical device components and implemented into the CHRIS. A TI value is an estimate of the daily intake of the color additive or impurity over a period of time based on body mass and considered to be without appreciable harm to human health. The TI values are expressed in milligrams per kilogram of body mass per day (mg/kg bw/day). They are used to determine the TE value for a patient of particular weight. A comprehensive literature review of studies investigating critical health effects resulting from parenteral exposure to each color additive was reviewed and documented. The quality of the study data was evaluated by the Annapolis Accords [4] principles, and then further analyzed by the Toxicological Data Reliability Assessment Tool (ToxRTool) [5] to determine the critical study for use in derivation of the TI. The point of departure (POD) is the exposure concentration of the color additive reporting the health effect in the critical study typically presented as a no-adverse-effect-level (NOAEL) or bench mark dose (BMD) value, and represents the critical adverse health effect. The POD is extrapolated to humans by calculating a modifying factor (MF) that accounts for uncertainties in the data, such as: intraspecies variability, interspecies differences and quality/completeness of the data. For details on the procedures and data used to derive the TI values, the complete toxicological profiles can be found [here](ToxProfiles.pdf).
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  [4] Gray, G.M., et al., 2008. The Annapolis Accords on the use of Toxicology in risk assessment and decision-making: an Annapolis center workshop report. Toxicol. Method 11, 225e231. http://dx.doi.org/10.1080/105172301316871626.
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  ### Where do the color additive tolerable intake values come from?
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+ Provisional tolerable intake values (TIs) were derived for color additives commonly used in polymeric medical device components and implemented into the CHRIS. A TI value is an estimate of the daily intake of the color additive or impurity over a period of time based on body mass and considered to be without appreciable harm to human health. The TI values are expressed in milligrams per kilogram of body mass per day (mg/kg bw/day). They are used to determine the TE value for a patient of particular weight. A comprehensive literature review of studies investigating critical health effects resulting from parenteral exposure to each color additive was reviewed and documented. The quality of the study data was evaluated by the Annapolis Accords [4] principles, and then further analyzed by the Toxicological Data Reliability Assessment Tool (ToxRTool) [5] to determine the critical study for use in derivation of the TI. The point of departure (POD) is the exposure concentration of the color additive reporting the health effect in the critical study typically presented as a no-adverse-effect-level (NOAEL) or bench mark dose (BMD) value, and represents the critical adverse health effect. The POD is extrapolated to humans by calculating a modifying factor (MF) that accounts for uncertainties in the data, such as: intraspecies variability, interspecies differences and quality/completeness of the data.
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  [4] Gray, G.M., et al., 2008. The Annapolis Accords on the use of Toxicology in risk assessment and decision-making: an Annapolis center workshop report. Toxicol. Method 11, 225e231. http://dx.doi.org/10.1080/105172301316871626.
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