BioTox by Icare offers:

• A preliminary study of your file and guides you in the choice of your testing strategy. 
• Advice and expertise: risk analysis, Biological Risk Assessment, worst-case strategy, evaluation of your file, interpretation of physico-chemical test results according to ISO 10993-17. 

Thanks to their compliance with Good Laboratory Practices (GLP) and current standards, the reports of these studies can also be used for certification (CE, FDA, Japan, etc.).

• Cytotoxicity according to ISO 10993-5 (XTT, Trypan Blue, Neutral Red, etc.) 

Irritation:

• Evaluation of skin irritation on healthy or damaged skin in rabbits according to ISO 10993-23 (single or repeated application) 
• Evaluation of irritant effect on vaginal, anal, nasal and cheek mucous membranes in rabbits according to ISO 10993-23 
• Evaluation of eye irritation in rabbits according to ISO 10993-23 
• Evaluation of intradermal tolerance in rabbits according to ISO 10993-23 
• Evaluation of skin irritation on reconstructed epidermis model according to ISO 10993-23

Sensitisation:

• Skin sensitisation in guinea pigs according to Buehler according to ISO 10993-10 
• Skin sensitisation in guinea pigs according to the Magnusson and Kligman method according to ISO 10993-10 
• Skin sensitisation in mice: lymph node stimulation tests: LLNA-BrdU according to ISO 210993-10  

Evaluation of acute systemic toxicity in rodents:

• Intravenous according to ISO 10993-11  
• Intraperitoneal according to ISO 10993-11  
• Oral according to ISO 10993-11  
• Dermal according to ISO 10993-11  
• Subacute toxicity in rats (4 weeks) according to ISO 10993-11 (OECD 408)
  possibly combined with implantation testing, according to ISO 10993-6 (in accordance with the 3Rs principles)

• Subchronic toxicity in rats (12 weeks) according to ISO 10993-11 (OECD 408)
  possibly combined with implantation testing, according to ISO 10993-6 (in accordance with the 3Rs principles)
• Chronic toxicity in rats (26 weeks, 1 year) according to ISO 10993-11 (OECD 452) 
  possibly combined with implantation testing, according to ISO 10993-6 (in accordance with the 3Rs principles)
• Study of pyrogenic effect in rabbits according to ISO 10993-11 according to USP, European Pharmacopoeia and Japanese Pharmacopoeia.

In vitro haemocompatibility (human blood) according to ISO 10993-4 

• Haemolysis 
• PTT determination 
• Study of complement system activation (SC5b9) 
• Platelet activation test (PF4) 

Mutagenicity and genotoxicity according to ISO 10993-3 and ISO/TR 10993-33 

• Tests for reverse mutations in “Salmonella typhimurium his-” and “Escherichia coli” or Ames test (based on OECD 471) 

• In vitro study of chromosomal aberrations in mammalian cells (human lymphocytes, CHO) (based on OECD 473) 

• In vitro gene mutation tests in mammalian cells  (L5178Y) (based on OECD 490) 

• In vitro micronucleus test in mammalian cells  (CHO) (based on OECD 487) 

Implantation in rats according to ISO 10993-6

• Subcutaneous or intramuscular, (4 weeks) 

• Subcutaneous or intramuscular (12 weeks) 

• Endosteal (12 weeks or 12 months or 18 months) 

• Biodegradation: in vitro and in vivo study according to ISO 10993-9 and ISO 10993-13,-14,-15 (subcontracting) 
• Carcinogenesis in rats according to ISO 10993-3 (OECD 451) (subcontracting) 
• Reproductive and developmental toxicity (OECD 415, OECD 416, OECD 414, OECD 421) (subcontracting)