Toxicity study provides a foundation to assess the potential health hazards posed by industrial chemicals including pharmaceutical, agrochemical and other chemicals on human health and safety.

Our laboratory provides integrated services, delivering high quality reliable data to meet the regulatory requirements.

Acute toxicity studies provide information on the potential for health hazards that may arise on result of short term exposure i.e. Single dose on day one and observation upto 14 days.

Determination of acute oral, dermal and inhalation toxicity is the first line of defence to evaluate the toxicity the test item.

Conclusion : LD 50 or LC 50 of the test item.

• Acute Oral Toxicity (OECD 423 / OPPTS 870.1100)
• Acute Dermal Toxicity (OECD 402 / OPPTS 870.1200)
• Acute Inhaltion Toxicity (OECD 403 / OPPTS 870.1300)
• Primary Eye Irritation / Corrosion Toxicity (OECD 405 / OPPTS 870.2400)
• Primary Dermal Irritation Toxicity (OECD 404 / OPPTS 870.2500)
• Dermal Sensitization Toxicity (Maximization and Buehler Test) (OECD 406 / OPPTS 870.2600)

Sub-Acute Toxicity Study

Sub-Acute exposure (14 / 21 / 28 days of exposure)

Sub-Acute studies provide

• Sub-Acute 14 days oral / ip / iv toxicity study (Route of Administration-Oral (OECD 407/408 and OPPTS 870.3050 / 870.3100)
• Sub-Acute 28 days oral / ip / iv toxicity study (Route of Administration-Oral (OECD 407/408 and OPPTS 870.3050 / 870.3100).
• Sub-Acute 21 days dermal toxicity study (OECD 410 /411 and 870.3200 / 870.3250)
• Sub-Acute 28 days inhalation toxicity study

Sub-Chronic Toxicity Study

Sub-Chronic Toxicity Study (90 days / 180 days exposure)

Sub-Chronic studies provide info on health hazard that may result from repeated exposure to test item over a period up to approximately 30% of the life time of a rodent. It also provide information necessary to select proper doses for chronic studies.

Conclusion : NOEL, LOEL, NOAEL and dose range for chronic studies.

• Sub-Chronic 90 days toxicity study
• Sub-Chronic 120 days toxicity study

Chronic Toxicity Study

Information obtained from chronic studies is used to access potential hazard resulting from repeated exposure of test item. Purpose of these studies to observe the test system for the development of neoplastic lesions during life time exposure.

Conclusion : NOEL, LOEL

• Chronic 1 year toxicity study
• Chronic combined 2 year toxicity study

Reproductive Study (Post Natal Toxicity Study)

Multigeneration reproduction studies provide information concerning the effect of test item on overall reproductive capability.

Conclusion : Potential hazards from Parents to next generation and their effects in following generations.

• I / II / III Generation study

Developmental Toxicity Study (Prenatal Toxicity Study)

Development toxicity studies are designed to access the potential of development effects in neonates resulting from exposure of mother to test item during pregnancy.

Conclusion : Potential hazards on the offsprings which are due to exposure to the mother. Basic for post natal study.

• Toxicity study on prenatal development of offsprings (OECD 414 and OPTTS 870.3650)
• Reproduction / Developmental Toxicity Study (OECD 421 and OPTTS 870.3550).
• Combined Repeated Dose Toxicity Study With the Reproduction / Developmental Toxicity Screening Test (OECD 422 and OPTTS 870.3650).
• Reproduction and Fertility Effects (One Generation: OECD 415 and Two Generation 416 / OPTTS 870.3800).

Varity of tests and end points related to efficacy, safety and quality control testing of medical devices and diagnostics.

TOXINDIA is well equipped to provide Analytical Chemistry & Product Chemistry. The laboratories of analytical, and wet chemistry, are adequately spaced and equipped with advanced instruments.

We provide R&D services of international standard Agrochemicals (pesticides, insecticides, herbicides and fertilizers). It is one of the best quality service providers for Analytical & Product Chemistry.

Our Capability Includes:

Product Chemistry

For Technical Grade Active Ingredient:

• Acidity / Alkalinity / pH.
• Boiling Points.
• Color, Physical State, & Odor.
• Density (Liquids and Solids).
• Flammability / Flashpoint / Flame Extension etc.
• Melting Point.
• Moisture Content.
• Partition Coefficient (n-Octanol / Water).
• Solubility (Water and Organic Solvents).
• Surface Tension.
• Vapor Pressure.
• Viscosity.

For Formulated Products:

• Appearance.
• Bulk Density.
• CIPAC Formulation Properties.
• Dissociation Constant.
• Emulsion Stability.
• Formulation Storage Stability.
• Partition Co-Efficient.
• Persistent Foaming.
• Solution Stability.
• Surface Tension.
• Suspension Stability.
• Viscosity.
• Wet & Dry Sieve Test.
• Wettability.

Physico-Chemical Studies

• Melting point / Freezing point (OECD 102)
• Boiling temperature (OEED 103)
• Solubility
• pH

Analytical Chemistry

• Method Development & Validation for Impurity Analysis (as Per SANCO Guidelines).
• Additional Analysis – Moisture Content, Inorganic Impurities, Acetone Insoluble etc. (as Per CIPAC Method).
• Validation of Analytical Instrument (as Per OECD Guidelines).

Feed Microbiology

Water Microbiology

Sterility Test

• Acne Model in Rat
• Allergenicity
• Antiasthmatic Studies
• Antibacterial / Antifungal Studies
• Antidiabetic Model in Rat
• Anti-inflammatory Test in Mouse / Rat
• Antimutagenicity (Modulation Study) in Salmonella Typhimurium
• Antiosteoporotic Studies in Rat
• Antipsychotropic - Mouse / Rat
• Antitumerogenicity Model on Balb - C Mouse
• Antitussive Activity in Guinea Pigs
• Antiulcer Activity in Rat
• Cardiovascular Study in Guinea Pigs and Rats
• Cardiovascular Study in Guinea Pigs and Rats
• Energy Booster - Mouse
• Immunogenicity Model in Rabbit
• Immunomodulator - Mouse
• Inflammatory Bowel Disease (IBD) in Mouse / Rat
• In vitro Allergenicity Study (Western Blot Method)
• Neonatal Studies - Rat
• Oral Glucose Tolerance Test (OGTT) in Mouse
• Oral Maltose Tolerance Test (OMTT) in Mouse
• PKa Studies in Rat / Mouse
• Weight Management - Mouse
• Vitiligo Model in Guinea Pigs

Acute studies are short term exposure studies. It includes the other factors such as sex, species, strain, age, diet, nutritional status, general health conditions, animal husbandry, experimental procedure, route of administration, stress, dosage and formulation etc.

Acute studies are conducted for the purpose of determining LD50 of a test substance. But LD50 is not absolute biological constant to be equated.

LD50 : It is the killing power of highly toxic substance and obtain safe dose from lethal.

The adverse effects occurring in a short time of administration of a single dose / multiple doses given within 24 hours.

Types of Acute Testing

• Acute Oral Test.
• Acute Dermal Test.
• Acute Inhalation Test.
• Acute Skin Irritation Test.
• Acute Eye Irritation Test.
• Acute Pre-Neonatal Test.
• Acute Neonatal Test.
• Acute Dermal Contact Sensitization Test.
• Acute Phytotoxicity Test.

Sub-acute studies includes acclimatization, randomization, selection of doses, route of administration, bleeding, observations of clinical signs, urine analysis, haematology, serum biochemistry, necropsy findings, organ weights, histopathology and data analysis.

• 14 - Days Repeated
• 28 - Days Repeated
• 90 - Days Repeated

It is concern with attempting to anticipate where synthetic chemicals go in the environment and what ecological effect they have.

Ecotoxicity test can be carried out at any level in the biological hierarchy of the systems ranging from molecule of the ecosystems (Calow, 1989).

Two Main Views

• To Anticipate Impact Ecological Systems.
• To Access What Changes are Taking Place in Ecological System (Effluents / Emission).

Mainly the Insecticides, Pesticides are Studies in Ecotoxicity. The Organisms on Which the Tests are Carried Out are

• Daphnia
• Earthworm
• Bees
• Fish
• Chicken
• Pigeon
• Quail

These are repeated dose toxicity studies screen potential adverse effects of the chemical on lab animals. Repeated dose studies may vary and termed as follows with respect to their exposure

• 1-4 Weeks :- Short-Term Studies
• 3 months :- Sub-Chronic Studies
• 6-12 months :- Chronic Studies.

Objectives of Short Term Studies

• Determines Adverse Effects at Lowest Conc., Which Allows Max. No. of Survival of Animals.
• Determines Adverse Effects Over Longer Exposure.
• Determines Dose Response to Identify NOAEL.

Objectives of Sub-Chronic Studies

• Determines Adverse Effects not Detected in Short Term Studies.
• Identify Observed Effect of Level & NOAEL.
• Provide Data For Dose Selection for Chronic Toxicity.
• Identify the Target Organ / Site of Action.
• Data Extrapolation to Humans.
• Provide Data for Regulatory Agencies.
• Provide Risk Assessment Data.

Genetic toxicology is sub specialty of toxicology which identifies and analyses the toxicity directed towards the hereditary components of living organisms. These tests detects and access the genetic hazard from agents that are highly specific for nucleic acids and are capable of damaging the genetic material at sub toxic concentrations. These agents are termed as ‘Genotoxic’. The battery of the test system includes–

Ames Salmonella / Microsome Mutagenicity Test

It is a simple and rapid test used to identify chemical carcinogens and mutagens. The test detects these chemicals by means of their mutagenicity and it is about 90% accurate in detecting carcinogens as mutagens. Special strains of Salmonella typhimurium are used for measuring DNA damage and these are combined with liver homogenates from rodents.

In vivo Micronucleus Test in Mice (MNT)

MNT is being increasingly used in this field of chemical mutagenesis. The test serves as a useful indicator of cytogenetic damage and has to date proved to be convenient and rapid method of screening chromosomal damage in vivo in mice.

In vivo Chromosomal Aberration Test (CA)

Chromosomal aberrations are due to lesion in DNA which lead to discontinuities of the DNA double helix. Double strand breaks lead to immediate fixation of the aberrations by misrepair. Depending on the time induction within the cell cycle, the types of aberrations observed at the succeeding metaphase.

In vitro chromosomal Aberration Test in Human Lymphocytes

The studies of CA in cultured lymphocytes offer a good method for dose estimation in persons exposed to chemicals and proved to be useful in screening of potentially mutagenic and carcinogenic agents.

Dominant Lethal Test in Mice

Dominant lethal mutation is a genetic event that kills the individual which carries it in a heterozygous state. Dominant lethal mutations are produced mainly due to induction of structural and numerical chromosomal abnormalities induced in the paternal germ cell.

The beginnings of the science of Embryology in the 17th century literally “open the door” to the science of Teratology.

Birth detects have genetic, maternal and environmental causes. The mechanisms whereby these causes induce aberrant development remain elusive. In modern technology, few animal models for human birth defects which may lead to better understanding of the human condition. They are being adopted to identify cellular and biochemical events in teratogenesis.

Possible Effects of Drug Action on Pregnancy or its Outcome

• Failure of Ovulation
• Prevention of Fertilization
• Interference With Transport
• Abnormal or no Implantation
• Indirect Damage to Embryo
• Direct Damage to Embryo or Fetus

Factors Determining Teratogenicity of Drugs

• Type of Drug
• Level and Duration of Dosage
• Maternal Modulation of Dosage
• Access to the Conceptus
• Developmental Stage at Time of Dosage
• Disposition Within the Conceptus
• Susceptibility of Species and Individual

Cancer is one of the leading causes of death and result from exposure to exogenous chemical.

Long-term testing is to observe test animals for a major portion of these lifespan for the development of neoplasic lesions after and during exposure to various doses of a test substance by an appropriate route.

The main stages of long-term assay for carcinogenicity of test article includes design, contact, analysis and reporting.

It is to determine chemically induced changes, following short and long term exposure. In acute studies dose response and clinical signs are studied which suggests toxicity to the target organs, long term studies are determines target organs to carcinogenic potential of the chemical. Acute exposure involves 4 – 6 hrs exposure while repeated studies involve 14, 28 or 90 days exposure.

The goal of the test is to study irritation of the respiratory tract, behavioral changes, pathological changes to vital organs / tissues, immune system responses, pulmonary function alteration, metabolic disturbance and carcinogenicity.

The mechanism results into developmental toxicities inculcating mitotic interference, alteration in the membrane, transduction, altered energy source, enzyme inhibition, altered nucleic acid synthesis and mutations.

• To Study the Compound Effect on CNS or Peripheral Nervous System.
• Main Affected Organs are Brain, Nerves, Axons, and Synapses.
• Chemically Detection - Blood Cholinesterase Inhibition Estimation.
• Histopath - Nervous Tissues.
• Animal Model used - Birds (Chicken) Rodents (Rat).

Various approaches for BA / BE

• Clinical Trail Approach
• Dermatopharmacokinetic Approach
• Pharmacodynamic Approach
• In vitro Release Approach

Field trial studies are to be carried out on farm animals like Ox, Cows, Buffaloes, Sheep and Goats etc.

Microbial tests are to be carried out for the tests articles such as water, soil, ayurvedic powders, food products, antibiotics etc.