Testing per ISO 10993-11:2017. 28-Day, Dual Route for Co-Administration via Intraperitoneal (IP) and Intravenous (IV) Subacute / Subchronic Toxicity Study. Includes organ weights and Tier 1 and Tier 2 histopathology.
Dose Group Route of Administration
Vehicle Control IP and IV (7 Males / 7 Females)
Test Article IP and IV (7 Males / 7 Females)
Species: Rat, Sprague-Dawley
- Dose route/frequency: Test article or extract co-administered by IP (every third day) and IV (daily)
- Body Weight: Weekly
-Food Consumption: To coincide with body weight measurements
-Observations: Mortality/morbidity twice daily; cage-side once daily detailed clinical observations once prior to dosing and weekly thereafter
Clinical Pathology: Blood chemistry, coagulation, and hematology assessed on all animals once
Necropsy: Full necropsy at termination; standard tissues and organs weighed and will be preserved from all animals
Histopathology: Tier 1 tissues/organs (including heart, liver, adrenals, kidneys, skin, spleen, muscle, brain, testes/ovaries, lungs, bronchi,
femur/sternum, bone marrow) and gross lesions of all animals. Found Dead, and humane sacrifices will be evaluated for cause of death or
moribund condition with macroscopic and microscopic examinations.
Histopathology: Tier 2 tissues/organs (Full Tissue List) and gross lesions of all animals. Found Dead, and humane sacrifices will be
evaluated for cause of death or moribund condition with macroscopic and microscopic examinations.
Sample Requirements:
- 56 complete devices, 70cm² (>0.5mm thickness)
- 56 complete devices, 135cm² (<0.5mm thickness);;
- 28 complete devices, 4 grams (powders/absorbable material only)
Estimated Turnaround Time: 16 Weeks
Products specifications
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Subcontracted
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Yes |
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Standards
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ISO 10993-11:2017 |
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Endpoint
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Subacute/Subchronic Systemic Toxicity, Subchronic Systemic Toxicity |
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Turnaround
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10-12 weeks |
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Test system
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In vivo — rat (preferred) or mouse, dual route: polar extract by intravenous injection and non-polar extract by intraperitoneal injection, 28-day repeated dose |
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Method
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Repeated-Dose Systemic, Dual Route (28-day) |
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Extraction
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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. |
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Acceptance criteria
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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. |
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Deliverable
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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. |
