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Toxicology
- In-vitro cytotoxicity assessment via direct exposure (ISO 10993-5:2009 E)
- In-vitro cytotoxicity evaluation through indirect interaction (ISO 10993-5:2009 E)
- Hemocompatibility examination (ISO 10993-4:2009 E)
- Genotoxic potential assessment
- 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
- Hemocompatibility 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)
Studies conducted over an extended period:
- Sub-acute/Sub-chronic investigations
- Repeated Dose studies (14 days/28 days/90 days) for toxicity (Oral/Dermal/Inhalation) following OECD guidelines
- Chronic studies spanning 180 days to 1 year for toxicity (Oral/Dermal/Inhalation) in line with OECD recommendations
- Carcinogenicity Experiments (Rodents/Non-Rodents) as per OECD standards
- Prenatal/Postnatal Developmental Toxicity Assessment adhering to OECD guidelines
- Multigenerational Toxicity examinations as per OECD protocols
- Systemic Toxicity evaluations following ISO-10993 criteria
- Implantation investigations based on ISO-10993-6 (Subcutaneous/Intramuscular/Bone).
The genotoxicity and mutagenicity studies is consistent across the different tests:
- 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)
