Toxicity studies are performed using up to date research techniques. They are conducted in compliance with GLP and OECD guidelines for the testing of chemicals.

Testing for risk factors of drugs and chemical agents:

Tests offered according to Directives 1999/12/EC, 92/69 EEC, 96/54/EC, 2001/59/EC, 88/302/EEC and OECD Test Guidelines:

• Acute toxicity (oral) fixed dose method
• Acute toxicity (oral) – Acute toxic class method
• Acute toxicity (dermal)
• Acute toxicity (skin irritation)
• Acute toxicity (eye irritation)
• Skin sensitization
• Repeated dose (28 days) toxicity (oral)
• Repeated dose (28 days) toxicity (dermal)
• Sub-chronic oral toxicity test. Repeated dose 90 – day oral toxicity study in rodents
• Sub-chronic oral toxicity test. Repeated dose 90 – day oral toxicity study in non-rodents
• Sub-chronic dermal toxicity test : 90 – day repeated dermal dose study using rodent species
• Chronic toxicity test
• Carcinogenicity test
• Combined chronic toxicity/carcinogenicity test
  
  For more information about in vivo tests, please contact Dr. Mojmír Mach: mojmir.mach@savba.sk

In vitro toxicology tests according to OECD, ISO a ICH :

• Skin corrosion test in 3D reconstructed human tissue model – OECD TG 431
• Skin irritation test in 3D reconstructed human tissue model – OECD TG 439
• Eye irritation test in 3D reconstructed human tissue model – OECD TG 492
• Phototoxicity studies in human skin fibroblasts – OECD TG 432
• Phototoxicity studies in 3D reconstructed human cornea-like model – OECD TG 498
• Biocompatibility of medical devices – cytotoxicity – ISO 10993:5
• Biocompatibility of medical devices – skin irritation – ISO 10993:23 and modifications thereof for other epithelial models
• In vitro tests of skin and eye tolerance for cosmetic and pharmaceutical raw materials and final formulations
  
  For more information about in vitro tests, please contact Dr. Helena Kandarova: helena.kandarova@savba.sk