0.9% Sodium Chloride Solution & Sesame Oil, NF extracts (Polar & Non-Polar). Includes routine body weights, documentation of feed consumption, haematology, clinical chemistry, gross pathology, organ weights, and histopathology. Sample Requirements: - 56 complete devices, 135cm² (<0 .5mm thickness); - 56 complete devices, 70cm² (>0.5mm thickness); - 28 complete devices, 4 grams (powders/absorbable material only) Estimated Turnaround Time: 14 Weeks
Products specifications
| Subcontracted | Yes |
| Standards | ISO 10993-11:2017 |
| Endpoint | Subacute/Subchronic Systemic Toxicity, Subchronic Systemic Toxicity |
| Turnaround | 10-12 weeks |
| Test system | In vivo — rat (preferred) or mouse, dual route: polar extract by intravenous injection and non-polar extract by intraperitoneal injection, 28-day repeated dose |
| Method | Repeated-Dose Systemic, Dual Route (28-day) |
| Extraction | 2 extracts at 18 mL per extract, one polar and one non-polar per ISO 10993-12, giving at least 56 discrete dose portions — one of each extract on each of the 28 days. Extraction ratio per ISO 10993-12: 6 cm2/mL for material under 0.5 mm thick, 3 cm2/mL at 0.5 mm or thicker, or 0.1-0.2 g/mL where surface area is indeterminate. The polar extract is dosed intravenously and the non-polar extract intraperitoneally, because a non-aqueous vehicle is not suitable for intravenous administration. |
| Acceptance criteria | Per ISO 10993-11, the material passes when there are no toxicologically significant differences between the test and control groups — by either route — in clinical signs, body weight, food consumption, clinical pathology, organ weights, or histopathology over the 28-day repeated-dose period. |
| Deliverable | GLP-compliant final report with raw data, issued in Groenakker’s report template or in your document template on request at no extra cost, under Groenakker’s ISO 13485:2016 certified quality system. |
