Services at a glance
Testing programs can be designed to support product registration as per National and International requirements described by OECD, US FDA / EPA, EMEA, WHO, ICH, EC, ISO, USP; CDSCO, RCGM-DBT, CIB-RC.
Acute oral, dermal, inhalation toxicity;
dermal & eye irritation/ corrosion;
skin sensitisation (Buehler/GPMT);
in-vitro tests for skin corrosion /eye irritation
Repeated Dose Toxicity (14 day / 28 day / 90 day)
Chronic Toxicity (180 day / 1 year)
Carcinogenicity (18 / 24 months)
Pre-natal Developmental Toxicity (Teratology) studies in Rats/Rabbits
Peri-natal Toxicity studies in Rats
Fertility studies in Rats
Reproduction/Developmental Toxicity Screening test
Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test
Extended One Generation Toxicity Study in Rat
Multi-Generation Reproduction Toxicity studies
Bioassay & Bioanalytical
INTOX offers both in-vivo and in-vitro studies to evaluate genetic toxicity potential of a product.
In Vitro Studies:
Salmonella typhimurium, Reverse Mutation Assay (Ames Test)
Mammalian Cytogenetic (Chromosome
Mammalian Cell Gene Mutation Test
In Vivo Studies:
Mammalian Cytogenetic (Chromosome Aberration) Test
Dominant Lethal Test
Toxicokinetics / Pharmacokinetics in Rodents and Non-rodents, including Non-human Primates & Dogs
Anti-drug Antibody (ADA) Assessment
Immunogenicity of Vaccines
Characterization of vaccines and Gene Therapy products
Biocompatability Studies for Medical Devices
Hemolysis / Hemocompatibility Tests
Skin Sensitization Tests
Regulatory Guidelines -
Pharmacopoeial Tests (USP / BP / IP)
The Aquatic and Environmental toxicology laboratories at INTOX are custom-equipped for respective test systems. The Ecotoxicology studies are supported with dedicated animal housing for avian test systems, and the support of the analytical chemistry laboratories.
Studies on aquatic and terrestrial organisms:
Non-rodents species viz.
- available with collaborating
Routes of Exposure:
Others - Ocular, Otic, Nasal, Vaginal etc.
Physical - chemical studies
Storage Stability (Accelerated storage, Cold storage, Long-term Storage & Corrosion characteristics with metal and metal ions)
Five Batch Analysis / Impurity profile
Method development and validation
Kinetic studies - PK / TK
Safety studies (Explosive properties, Flash point, Auto-ignition, Self-ignition properties)
Soil Micro-organism: Carbon and Nitrogen Transformation Test.
Inhalation toxicology laboratory at Intox, presently capable of testing rodents, is the most advanced in the country.
Apart from the existing inhalation equipment sourced from In-Tox Products (USA), Palash (Germany),
another complete inhalation expsoure system procured from TSE, Germany has been installed in year 2021.
These high precision equipment ensure that the test items, especially the pharmaceuticals are delivered in the most desirable and appropriate manner. The aerosol characterization using automated systems employing validated software provide the much sought robust safety data data.