Table 1.
Biocompatibility Test Results for 1,4-Butanediol Diglycidyl Ether–Containing Products
| Biocompatibility Test Objective | Test Standard | Results |
|---|---|---|
| Tests for in vitro cytotoxicity | ISO 10993–5 | No evidence of cytotoxicity |
| Tests for irritation and delayed-type hypersensitivity | ISO 10993–10 | No evidence of skin irritation (erythema, edema, necrosis) or delayed dermal contact sensitization |
| Tests for acute systemic toxicity | ISO 10993–11 | No evidence of systemic toxicity for up to 4 days after implantation |
| Tests for subchronic toxicity | ISO 10993–11 | No evidence of toxicity or signs of irritation or inflammation for up to 3 months after implantation |
| Tests for local effects after implantation | ISO 10993–6 | No evidence of irritation and minor local tissue reaction for up to 4 weeks and 12 weeks after muscle implantation |
| Tests for genotoxicity: Ames test | ISO 10993–3 | No evidence of genotoxicity |
| Tests for genotoxicity: Micronucleus Test | ISO 10993–3 | No evidence of genotoxicity |
| Tests for genotoxicity: Chromosomal Aberration Test | ISO 10993–3 | No evidence of genotoxicity |
| Test for chronic toxicity: 12-month study, multiple injections | ISO 10993–11 | No evidence of systemic toxicity or local irritation for up to 12 months after implantation |
ISO, International Standards Organization.
These data, from multiple regulatory agency-mandated preclinical tests, demonstrate that this BDDE-containing range of products has a favorable safety profile. The products used in all of these tests were from the Juvéderm range.