CHemical RISk calculators (CHRIS) - Color additives (v3)

Identity - Select the color additive in the component being evaluated via the pull down list. If the color additive is not explicitly listed, please choose "Other color additive". For the latter case, two additional input fields will be visible. Please select the identifier type and enter the chemical identifier. For example, if the CAS number is known, select CAS from the pull down menu and enter the CAS number in the identifier field. If the CAS number is unknown, CHRIS can identify the molecular structure through the SMILES code, which can be found for many chemicals using PubChem or generated based on the molecular structure using tools such as OSRA. Alternatively, CHRIS can attempt to identify the chemical using a common name for the chemical. If you are evaluating an additive associated with a color additive please select "Other color additive associated compound" and follow the same procedure for "Other color additive".

Amount - Enter the total mass of the substance in the component being evaluated expressed in micrograms or milligrams.

Amount units - Select the appropriate units for the amount, micrograms (µg) or milligrams (mg).

Total impurity concentration - If you have selected a color additive, please enter the combined concentration of all impurities associated with the color additive as a percentage (% mass/mass).

Matrix - Please select your polymer matrix from the list. If your polymer is not listed below, please select "Other polymer". For polymer mixtures/blends, co-polymers, or composites (e.g. glass fiber reinforced matrices), the component or phase that is worst-case for exposure, i.e. the softest or least glassy (lowest T_g) component can be selected if listed (which, in turn, assumes the entire system is composed of the worst-case component or phase). In these scenarios, a justification should be provided for the choice of worst-case component of the polymer system.

Mass - Enter the mass of the polymer matrix in grams.

Density - Enter the estimated density of the polymer matrix in grams per cubic centimeter. Note that a rough estimate (e.g. +/- 10%) is acceptable.

Glass transition temperature - For "Other polymer", optionally enter the T_g of the polymer matrix in degrees Celsius to use a less conservative model. If left blank, a more conservative model is used.

Exposed surface area - Enter the patient contacting surface area of the color additive containing component being evaluated in square centimeters. This includes both direct and indirect patient contact.

Exposure type - Select the appropriate exposure category: > 30 days = long-term, > 24 hours - 30 days = prolonged, ≤ 24 hours = limited. For limited exposures (≤ 24 hours), please enter the maximum exposure duration in hours.

Cumulative exposure duration(s) Check the boxes for the exposure duration(s) to use for cumulative release estimates. 1-day exposure is always calculated. If the "Other duration" box is checked, enter the desired exposure duration in days (e.g., the maximum use duration of the device). Note that this calculation assumes a single device is used for the entire duration. If multiple devices are used concurrently or sequentially (e.g., daily replacement), this should be accounted for during toxicological risk assessment.