Conditions That Result in a TRS Score < 23, Thereby Allowing for a Baseline Evaluation. This List Does Not Include All the Possible Conditions That Would Produce a Baseline Evaluation Recommendation
| Multiplicative Factors | Additive Factors | Total Risk Score (TRS) | |||
|---|---|---|---|---|---|
| Process Factor RFIV | Final Product Factor RFV | Thermodynamic Factor RFII | Kinetic Factor RFI | Material Factor RFIII | |
| 0.1 (Clearance Step) | 0.1 (Lowest Risk) | 7600a | All Values | All Values | Always ≥23, General or Full Testing |
| 1300b | RFI + RFIII ≥ 1000c | Always ≥23, General or Full Testing | |||
| 1300b | RFI + RFIII < 1000d | Always <23, Baseline Assessment | |||
| 300 or fewere | All Values | All Values | Always <23, Baseline Assessment | ||
| 0.1 (Clearance Step)ii | 0.5 (Low Risk)ii | 7600a | All Values | All Values | Always ≥23, General or Full Testing |
| 1300b | All Values | All Values | Always ≥23, General or Full Testing | ||
| 450f | RFI + RFIII ≥ 10g | Always ≥23, General or Full Testing | |||
| 450f | RFI + RFIII < 10h | Always <23, Baseline assessment | |||
| 243i | RFI + RFIII ≥ 217j | Always ≥23, General or Full Testing | |||
| 243i | RFI + RFIII < 217k | Always <23, Baseline assessment | |||
| 0.5 (Dilution Step) | 0.5 (Low Risk) | 243–7600l | All Values | All Values | Always ≥23, General or Full Testing |
| 81m | RFI + RFIII ≥ 11o | Always ≥23, General or Full Testing | |||
| 81m | RFI + RFIII < 11p | Always <23, Baseline assessment | |||
| 70n | RFI + RFIII ≥ 22nn | Always ≥23, General or Full Testing | |||
| 70n | RFI + RFIII < 22q | Always <23, Baseline assessment | |||
| 0.5 (Dilution Step)jj | 1 (Nominal Risk)jj | 70–7600mm | All Values | All Values | Always ≥23, General or Full Testing |
| 27r | RFI + RFIII ≥ 19t | Always ≥23, General or Full Testing | |||
| 27r | RFI + RFIII < 19u | Always <23, Baseline assessment | |||
| 8s | RFI + RFIII ≥ 3800 | Always ≥23, General or Full Testing | |||
| 8s | RFI + RFIII < 38v | Always <23, Baseline assessment | |||
| 1 (No Special Steps) | 1 (Nominal Risk) | 70–7600mm | All Values | All Values | Always ≥23, General or Full Testing |
| 27–243w | All Values | All Values | Always ≥23, General or Full Testing | ||
| 9x | RFI + RFIII ≥ 14z | Always ≥23, General or Full Testing | |||
| 9x | RFI + RFIII < 14aa | Always <23, Baseline assessment | |||
| 4y | RFI + RFIII ≥ 19pp | Always ≥23, General or Full Testing | |||
| 4y | RFI + RFIII < 19bb | Always <23, Baseline Assessment | |||
| 1 (No Special Steps)kk | 2 (High Risk)kk | 70–7600mm | All Values | All Values | Always ≥23, General or Full Testing |
| 9–243cc | All Values | All Values | Always ≥23, General or Full Testing | ||
| 4y | RFI + RFIII ≥ 7.5dd | Always ≥23, General or Full Testing | |||
| 4y | RFI + RFIII < 7.5ee | Always <23, Baseline assessment | |||
| 2 (Concentrator Step) | 2 (High Risk) | 2–7600ff | All Values | All Values | Always ≥23, General or Full Testing |
| 1gg | RFI + RF III = 4hh | Always <23, Baseline Assessment | |||
Notes:
↵a Solutions with 70% ethanol or higher.
↵b Solutions with 60% ethanol.
↵c For example, materials with 1–10% by weight additives (125), a moderate diffusion coefficient of 5 × 10–10 cm2/sec (40), with processing by heat (50), and with special interest alerts (200) has a RFIII of 415. If the value of RFI was 1000, corresponding to 1 day of storage at 60 °C, then RFI + RFIII = 1415 and TRS = 27.2.
↵d For example, materials with 1–10% by weight additives (125), a moderate diffusion coefficient of 5 × 10–10 cm2/sec (40), with processing by heat (50), and with special interest alerts (200) has a RFIII of 415. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 515 and TRS = 18.2.
↵e All aqueous solutions over the entire pH range, 40% ethanol or less.
↵f Solutions with 50% ethanol.
↵g For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RF1 + RFIII = 116 and TRS = 28.3.
↵h For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 3. If the value of RFI was 1, corresponding to 1 day of storage at 5°, then RFI + RFIII = 4 and TRS = 22.7.
↵i Aqueous solution with a pH of 1 or lower or 12 or higher.
↵j For example, materials with 0.1% to 1% by weight additives (25), a slow diffusion coefficient of 5 × 10–11 cm2/sec (20), heat processing (50), and a special interest alert (200) has a RFIII of 295. If the value of RFI was 134, corresponding to 180 days of storage at 20°, then RFI + RFIII = 429 and TRS = 33.6.
↵k For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–11 cm2/sec (20), no heat processing (1), and no special interest alert (0) has a RFIII of 46. If the value of RFI was 134, corresponding to 180 days of storage at 20°, then RFI + RFIII = 180 and TRS = 21.2.
↵l Solutions with pH 1 or lower, pH 12 or higher, or 50% ethanol or greater.
↵m Solutions with pH 2 or 11.
↵n Solutions with 40% Ethanol.
↵o For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 3. If the value of RFI was 55, corresponding to 30 days of storage at 20°, then RFI + RFIII = 58 and TRS = 34.8.
↵p For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 3. If the value of RFI was 1.9, corresponding to 365 days of storage at –20°, then RFI + RFIII = 4.9 and TRS = 21.5.
↵q For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 3. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 13 and TRS = 20.8.
↵r Solutions with pH of 3 or 10.
↵s Solutions with 30% ethanol.
↵t For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–13 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 36. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 46 and TRS = 36.5.
↵u For example, materials with 0.01–0.1% by weight additives (5), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 7. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 17 and TRS = 22.
↵v For example, materials with 0.1–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–13 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 26 and TRS = 17.
↵w Solutions with pH 3 or lower or 10 or higher.
↵x Solutions with pH 4 or 9.
↵y Solutions with 20% ethanol.
↵z For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–13 cm2/sec (10), no processing (1), and no special interest alert (0) has a RFIII of 16. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 26 and TRS = 35.
↵aa For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alert (0) has a RFIII of 3. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 13 and TRS = 22.
↵bb For example, materials with 0.01–0.1% by weight additives (5), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alert (0) has a RFIII of 7. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 17 and TRS = 21.
↵cc Solutions with pH 4 or lower or 9 or higher.
↵dd For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alert (0) has a RFIII of 3. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 13 and TRS = 34.
↵ee For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alert (0) has a RFIII of 3. If the value of RFI was 2.7, corresponding to 730 days of storage at –20 °C, then RFI + RFIII = 5.7 and TRS = 19.4.
↵ff All solutions except water with a pH between 5 and 8.
↵gg The only solution that fits this description is water with a pH between 5 and 8.
↵hh The only circumstances that meet this criterion are materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alert (0), which have a RFIII of 3. If the value of RFI was 1, corresponding to 1 day of storage at 5 °C, then RFI + RFIII = 4 and TRS = 20.
↵ii This analysis is also valid for the case of RFIV = 0.5 (dilution step) and RFV = 0.1 (lowest risk).
↵jj This analysis is also valid for the case of RFIV = 1 (no special steps) and RFV = 0.5 (low risk).
↵kk This analysis is also valid for the case of RFIV = 2 (concentrator step) and RFV = 1 (nominal risk).
↵mm Solution with 40% ethanol or greater.
↵nn For example, materials with <0.01% by weight additives (1), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 3. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 58 and TRS = 32.
o For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–13 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 36. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 46 and TRS = 27.
↵pp For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–13 cm2/sec (10), no processing (1), and no special interest alert (0) has a RFIII of 16. If the value of RFI was 10, corresponding to 1 day of storage at 20 °C, then RFI + RFIII = 26 and TRS = 30.