All the following results were obtained in collaboration with Biomatech in Chasse sur Rhône – France, according to ISO 10993 standards under GMP conditions.
Official toxicity and biocompatibility tests were carried out with the Globin paste:
- Intracutaneous irritation test by intradermal injection in the rabbit;
- Acute systemic toxicity study in the mouse;
- Sensitization study in the guinea pig (with guinea pig Globin);
- Mouse bone marrow micronucleus study;
- In vitro cytotoxicity study;
- Evaluation of the mutagenicity: Ames test;
- Evaluation of chromosomal aberrations induction in human cells;
- Evaluation of the local tolerance following intradermal injection in the nude rat;
- 13 week subchronic toxicity study in rats following a subcutaneous injection of human Globin;
- Local effects and performance of a rat globin in a subcutaneous injection model in the rat;
- Local effects and performance of a porcine globin in a subcutaneous injection model in the pig.
Bactericidal and fungicidal properties of the globin paste were demonstrated in collaboration with Mycoscience – Willington CT – USA, against Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans.
All the corresponding reports show satisfactory results.