Toxicology

In-Vitro Toxicity

  • In-vitro cytotoxicity test by direct contact (ISO 10993-5:2009 E)
  • In-vitro cytotoxicity test by indirect contact (ISO 10993-5:2009 E)
  • Hemocompatibility testing (ISO 10993-4:2009E)
  • Genotoxicity
  • Reverse Mutation Assay(Salmonella typhimurium)AMES TEST – ISO 10993-3:2014
  • In Vitro Mammalian Chromosomal Aberration Test) – ISO 10993-3:2014
  • Qualitative In Vitro Cytotoxicity Direct Contact Test – ISO 10993-5:2009
  • Qualitative In Vitro Cytotoxicity Elution Test – ISO 10993-5:2009
  • Quantitative In Vitro Cytotoxicity Test – ISO 10993-5:2009
  • Haemocompatibility Test – ISO 10993-4:2017

In-vivo Toxicology Services

Acute Toxicity Studies

 

  • Acute oral toxicity in rats (OECD)
  • Acute oral toxicity in mice (OECD)
  • Acute dermal in rats (OECD)
  • Acute Inhalation (OECD)
  • Acute dermal corrosion/Primary skin irritation (OECD, ISO-10993, Indian standards)
  • Guinea Pigs Maximization test (GPMT)/ Skin sensitization (OECD, ISO-10993)
  • Acute eye irritation test (OECD, ISO-10993)
  • Intracutaneous test (ISO-10993)
  • Systemic I.V, I.P, Oral tests (ISO-10993, USP-39)
  • Muscle implantation in rats in rabbits (ISO-10993, USP-39)
  • Bone implantation in rabbits (ISO-10993, USP-39)
  • Subcutaneous implantation in rabbits and rats (ISO-10993, USP-39)
  • Intravenous test in rats
  • Abnormal toxicity tests/ Undue toxicity
  • Acute Pathogenicity tests (EPA)
  • Erythropoietin test
  • Insulin bio identity test/ Insulin potency test (USP 121)
  • Pyrogenicity Test (ISO-10993, USP-39)

Sub-acute/Sub-chronic studies/long term studies

 
  • Repeated Dose 14 Day/28 day/90 day toxicity study (Oral/Dermal/Inhalation) (OECD)
  • Chronic 180 days to 1 year toxicity study (Oral/Dermal/Inhalation) (OECD)
  • Carcinogenicity Studies (Rodents/ Non-Rodents) (OECD)
  • Prenatal/Postnatal Developmental Toxicity Study (OECD)
  • Multigenerational Toxicity studies (OECD)
  • Systemic Toxicity as per ISO-10993
  • Implantation studies as per ISO-10993-6 (Subcutaneous/Intramuscular/Bone)

Genotoxicity and Mutagenicity Studies

 
  • Bacterial Reverse Mutation Test (OECD 471/ISO 10993-3)
  • In-vitro Mammalian Chromosomal Aberration Test (OECD 473/ISO 10993-3)
  • In-vivo Mammalian Chromosomal Aberration Test (OECD 475)
  • In-vitro Mammalian Cell Gene Mutation Test (OECD 476/ISO 10993-3)