Toxicity

Toxicity

Introduction

Toxicology is a branch of science that deals with toxins and poisons and their effects and treatment. Toxicological screening is very important for the development of new drugs and for the extension of the therapeutic potential of existing molecules. The US Food and Drug Administration (FDA) states that it is essential to screen new molecules for pharmacological activity and toxicity potential in animals (21CFR Part 314). The toxic effects of chemicals, food substances, pharmaceuticals, etc., have attained great significance in the 21st century.

Toxicity testing of new compounds is essential for drug development process. The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose- specific toxic effects of an investigational product. The toxicity of substances can be observed by (a) studying the accidental exposures to a substance (b) in vitro studies using cells/ cell lines (c) in vivo exposure on experimental animals. The pre-clinical toxicity testing helps to calculate “No Observed Adverse Effect Level” which is needed to initiate the clinical evaluation of investigational products.

Toxicity: The degree to which a substance (a toxin or poison) can harm humans or animals. Acute Subchronic toxicity is the ability of a toxic substance to cause effects for more than one year but less than the lifetime of the exposed organism. Chronic toxicity is the ability of a substance or mixture of substances to cause harmful effects over an extended period, usually upon repeated or continuous exposure, sometimes lasting for the entire life of the exposed organism. ITC Labs Biological Toxicological Testing Offering in Drugs, Agrochemicals, Ayurveda and Herbal Formulations:

  • Biological Assays
  • Efficacy studies for new formulations
  • Toxicological Studies
    Sub Acute Toxicity : It is intended to evaluate the toxicity of the chemical after repeated administration and also to help in establishing doses for the longer-term subchronic studies.
    Chronic Toxicity: adverse effects as a result of long term exposure to a toxin/drug.
    Intravenous & Paravenous studies.
  • Pharmacology Studies etc.
ITC Labs offering testing in Cosmetics Products:
  • Anti-tyrosinase Activity
  • Total Phenolic content
  • Acute Dermal toxicity
  • Sub acute Dermal toxicity
  • Skin irritation study
    in vitro Skin irritation (OECD 439)
    in virto Skin Corrosion (OECD 431)
    Draize test
  • Challenge preservative test
  • Minimum Inhibitory concentration
  • Melanin content
  • SPF (Sun Protection Factor)

Regulations

The above testing offered by us for preclinical, biological and toxicological studies, biological products, new formulations and other test items is as per regulatory guidelines, OECD, GLP, CDSCO etc

 

Bureau of Indian standard (BIS), NABL, AYUSH, EU regulation

Why ITC Labs

With a wide variety of testing equipment, as well as experience in method development and working with complex matrices.We have an expert and dedicated work force for laboratory experiments and for the interpretation of analysis of above test with well equipped laboratory facility both at invivo and invitro levels. The most important part of our team is that it works strictly according to the regulatory guidelines.

  • We offer High Quality Analytical Services viz.,
  • Understand the customer requirements.
  • Identify regulatory requirements.
  • Analyze the products adopting national / internationally approved or validated / client supplied methods.
  • Qualified and calibrated instruments
  • Trained analytical team
  • Maintain traceability of the work done
  • Ensure minimum turn around time