1. MEM Elution Cytotoxicity Test (GLP)
ISO 10993-5 / USP <87>
Study 1216816-S01 | Nelson Laboratories | September 2019
| Item | Value |
|---|---|
| Test Article | Ag 181109-103 (13.5 ppm silver nanoparticles, light yellow liquid) |
| Sponsor | EVOQ (Attostat, Inc.) |
| Study Number | 1216816-S01 |
| Study Received | 27 Aug 2019 |
| Testing Laboratory | Nelson Laboratories, LLC, Salt Lake City, UT |
| Study Director | McKenna Wild |
| Standard | ISO 10993-5:2009, USP <87>, GLP (21 CFR Part 58) |
| Cell Line | L-929 mouse fibroblasts (ATCC CCL-1) |
| Incubation | 48 ± 3 h at 37 ± 1 °C with 5 ± 1 % CO₂ |
| Deviations | None |
Test Article Results – Dilution Series
| Dilution | Pass/Fail | #1 | #2 | #3 | Average |
|---|---|---|---|---|---|
| Neat | Fail | 4 | 4 | 4 | 4 |
| 1:2 | Fail | 4 | 4 | 4 | 4 |
| 1:4 | Pass | 0 | 0 | 0 | 0 |
| 1:8 | Pass | 0 | 0 | 0 | 0 |
| 1:16 | Pass | 0 | 0 | 0 | 0 |
Controls
| Identification | #1 | #2 | #3 | Average | Extraction Ratio | Amount Tested / Extraction Solvent |
|---|---|---|---|---|---|---|
| Negative Control – Polypropylene Pellets | 0 | 0 | 0 | 0 | 0.2 g/mL | 4 g / 20 mL |
| Media Control | 0 | 0 | 0 | 0 | N/A | N/A |
| Positive Control – Latex Natural Rubber | 4 | 4 | 4 | 4 | 0.2 g/mL | 4 g / 20 mL |
Reactivity Grading Scale
| Grade | Reactivity | Conditions of All Cultures |
|---|---|---|
| 0 | None | No cell lysis, intracytoplasmic granules. |
| 1 | Slight | Less than or equal to 20% rounding, occasional lysed cells. |
| 2 | Mild | Greater than 20% to less than or equal to 50% rounding, no extensive cell lysis. |
| 3 | Moderate | Greater than 50% to less than 70% rounding and lysed cells. |
| 4 | Severe | Nearly complete destruction of the cell layers. |
Conclusion: No cytotoxicity at 1:4 dilution (Grade 0).
All controls valid & Test accepted.