Services at a glance 

Regulatory Guidelines

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.

General Toxicity

Acute Toxicity

Acute oral, dermal, inhalation    toxicity;

dermal & eye irritation/ corrosion;

skin sensitisation (Buehler/GPMT);

LLNA; 

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)

Reproductive Toxicity

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

Mutagenicity
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

Aberration) Test

Micronucleus Test

Mammalian Cell Gene Mutation Test

 

In Vivo Studies:

 

Mammalian Cytogenetic (Chromosome Aberration) Test

 

Micronucleus Test

Dominant Lethal Test

Toxicokinetics / Pharmacokinetics in Rodents and Non-rodents, including Non-human Primates & Dogs

 

Anti-drug Antibody (ADA) Assessment

Immunogenicity of Vaccines

 

Neutralizing Antibody

Biomarkers

 

Bio-distribution

 

Efficacy/PD Evaluation

Characterization of vaccines and Gene Therapy products

Biocompatability Studies for Medical Devices
Ecotoxicity

Cytotoxicity 

Systemic Toxicity

Implantation

Genotoxicity Tests

Irritation Tests 

Hemolysis / Hemocompatibility Tests

Skin Sensitization Tests

Others 

Regulatory Guidelines -

  • ISO 10993

  • ASTM

  • US FDA

  • CDSCO (DCGI)

  • 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:

  • Algae

  • Daphnia

  • Fish

  • Honey-bee

  • Earthworm

  • Silkworm

  • Chicken

  • Pigeon

  • Quail

Test Systems

Test Species

Rat, Mouse,

Rabbit,

Guinea-Pig,

Hamster

Non-rodents species viz.

Pig, Dog,

Non-Human Primates

    - available with collaborating

      Test Facilities

Routes of Exposure:

Oral,

Dermal,

Inhalation,

Parenteral,

Others - Ocular, Otic, Nasal, Vaginal etc.

Chemistry Services

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

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.