Cytotoxicity

Cytotoxicity tests are in-vitro assays used to assess the possibility of a test article to cause cell death or to inhibit cell growth.

Cytotoxicity Testing Services

Cytotoxicity tests are in-vitro assays used to assess the possibility of a test article to cause cell death or to inhibit cell growth. Tests for in vitro cytotoxicity specifies procedures for testing devices by extraction, direct contact, or indirect contact. Extracts of test article devices and materials are tested by exposure to the cell culture medium and is considered the default method of testing.

Testing Methods and Capabilities

  • Agar Diffusion
  • Colony Formation Assay
  • Contact Lens and Lens Solution Testing
  • MEM Direct Contact
  • MEM Elution
  • MTT, NRU, XTT
  • In-Vitro Skin Irritation (Epi-Derm)
  • Epi-Ocular

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Agar Diffusion6 cm² (flat surface) or 1 mL (at least 3 units if 1 unit <1 cm²)2-3 weeks
Agar Diffusion with Extraction12 cm² < 0.5 mm thick, 6 cm² ≥ 0.5 mm thick, or 0.4 g2-3 weeks
L929 MEM Direct Contact6 cm² (flat surface) or 1 mL (at least 3 units if 1 unit <1 cm²)2-3 weeks
L929 MEM Elution120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 0.4 g2-3 weeks
L929 MTT Cytotoxicity (1 & 4 Concentration)30 cm² < 0.5 mm thick, 15 cm² ≥ 0.5 mm thick, or 1 g2-3 weeks
Neutral Red Uptake (NRU) Cytotoxicity (1 & 4 Concentration)30 cm² < 0.5 mm thick, 15 cm² ≥ 0.5 mm thick, or 1 g2-3 weeks
Qualitative Cytotoxicity for Liquid Solution Test Article (1 & 4 Concentration)TBD2-3 weeks
Quantitative Cytotoxicity for Liquid Solution Test Article (1 & 4 Concentration)TBD2-3 weeks