Institute for Industrial Research & Toxicology

Ghaziabad, Uttar Pradesh

Long Term Storage Stability Testing evaluates how the quality, safety, and efficacy of a product change over an extended period under recommended storage conditions. It determines the products shelf life and expiration date.

Subacute toxicity per ISO 10993 Part 11

Subacute toxicity studies evaluate the toxic effects of medical device materials or extracts after repeated exposure over a short-term period, typically up to 28 days. This testing helps to identify adverse effects that may arise from repeated or continuous exposure and supports the safety assessment of medical devices.

Acute Avian Toxicity Test

The Acute Avian Toxicity Test evaluates the toxic effects of chemicals or substances on birds over a short-term exposure. It is important for assessing environmental risks of pesticides, industrial chemicals, and contaminants to wild bird populations

This Test Guideline describes procedures designed to estimate the acute oral toxicity of substances to birds, and it provides three testing options: (1) limit dose test, (2) LD50-slope test, and (3) LD50-only test. The LD50-slope and LD50-only options are sequential testing procedures. The test method selected will depend on whether or not a definitive median dose (LD50) and slope of the dose-response curve are both needed. The limit dose test is the preferred test when toxicity is expected to be low and lethality is unlikely at the limit dose. The limit dose should be adequate for assessment purposes, and it is usually 2000 mg/kg-bwt. Five or ten birds are tested at the limit dose in addition to a control group. 

The LD50-slope test is the preferred test when regulatory or other requirements determine that the slope of the dose-response curve and/or the confidence interval is required in addition to an estimate of the LD50. This is a 3- or 4-stage test with 24 or 34 birds in addition to a control group. The LD50-only test is the preferred test when regulatory or other requirements determine that only the median lethal dose is required but neither the slope of the dose response curve or the confidence interval for the LD50 is required. This may be the appropriate test to estimate a percentile of a species sensitivity distribution of LD50s and to provide information for product labelling purposes. 

The Oral and Contact Toxicity Tests evaluate the effects of chemicals, especially pesticides, on honeybees (Apis mellifera), crucial pollinators in ecosystems. These tests assess the acute toxic effects through oral ingestion and direct contact exposure.

Honey bees (A. mellifera) can be exposed to pesticide residues by indirect contact on plant surfaces, via oral intake with contaminated food or water, or by direct contact during the course of application according to normal farming practice. If the proposed use pattern of pesticides indicates a possible exposure of honey bees, acute contact and oral toxicity studies shall be necessary for the registration of the pesticide in question.

The Terrestrial Plant Toxicity Test assesses the effects of chemicals, such as pesticides, herbicides, or industrial pollutants, on the growth and development of terrestrial plants. This test helps evaluate potential risks to vegetation and ecosystems.

The Acute Toxicity Test in Earthworms evaluates the toxic effects of chemicals or substances on earthworms, which are key soil organisms important for soil health and ecosystem functioning.

Ecological quality of compost and digestate, used as fertilizers for agricultural use, was assessed through an acute ecotoxicological bioassay testing the earthworm Eisenia fetida (Annelida). The test evaluates the earthworms attitude to dig within 15 min into a soil medium constituted by a mixture of a standardized soil and different concentrations of compost/digestate. According to different classes of behavior responses, the sample is classified as good or bad quality (ON/OFF). The validity of this test was confirmed comparing the observations with the results from a standard chronic test developed by OECD (Organisation for Economic Co-operation and Development). Considering samples from different plants and at different stages of degradations, the replicates, the number of tested concentrations and the measured endpoints (ability to dig, mortality, growth, reproduction), a total of 996 observations were analyzed. The chronic test on earthworms uses the same media as in the acute one and measures the endpoints of mortality and growth within 28 days and reproduction within further 28 days. Thus, the test proposed here can be considered a not expensive and quick laboratory test and its implementation in quality assurance (QA) and quality of product (QC) schemes would enhance the protection of soil fauna. This last purpose is very important considering that, concerning the biological indicators of the quality of compost and digestate, the most important studies focused on the use of plants and microorganisms and scarce attention has been paid to soil invertebrates.

This Test Guideline is a laboratory test method, designed to assess the oral acute toxicity of pesticides and other chemicals, to adult worker honeybees. Adult worker honeybees are exposed to five doses in a geometric series of the test substance dispersed in sucrose solution. A minimum of three replicate test groups, each of ten bees, should be dosed with each test concentration. A toxic standard (usually dimethoate) should be included in the test series. The bees are then fed the same diet, free of the test substance. 

The limit test corresponds to one dose level of 100 ìg active ingredient/bee. Mortality is recorded daily during at least 48 hours and compared with control values. If the mortality rate is increasing between 24 and 48h whilst control mortality remains at an accepted level it is appropriate to extend the duration of the test to a maximum of 96h. The study report should include the amount of diet consumed per group and the observation of all abnormal behavioural. The results are analysed in order to calculate the LD50 at 24h and 48h and, in case the study is prolonged, at 72h and 96h.

Acute Toxicity fish

Acute toxicity testing in fish evaluates the harmful effects of a substance (e.g., chemical leachables, environmental contaminants) on aquatic organisms over a short exposure period. This test helps assess environmental safety and ecological risks.

Acute toxicity study is defined as an assessment that provides information on the adverse health effects of a substance following a large dose administration, evaluating potential lethal doses and identifying target organs for toxicity through biochemical, physiological, and morphological changes.

Acute irritation toxicity studies evaluate whether a substance causes reversible damage to the skin, eyes, or respiratory tract after a single or short-term exposure. These studies are essential for determining the irritation potential of chemicals, drugs, cosmetics, and other consumer products.

Testing of Acute Toxicity '6 Pack' Studies.

• Acute Oral
• Acute Inhalation
• Acute Dermal
• Acute Irritation
• Eye Irritation

Material medicated pyrogenicity per ISO 10993 Part 11

Pyrogenicity testing assesses whether medical device materials or their extracts induce fever-producing substances (pyrogens), mainly bacterial endotoxins, which can cause harmful febrile responses when introduced into the body. ISO 10993-11 includes pyrogenicity as part of systemic toxicity evaluation.

Academic research has not formally defined material-mediated pyrogenicity. That being said, both academically and in the field, material-mediated pyrogenicity is considered to occur due to contamination by a group of pyrogens outside of those comprising endotoxins but within those constituting non-endotoxin pyrogens. More specifically, material-mediated pyrogenicity is thought to derive from surfaces or materials of medical devices as well as contaminations that may have arisen during production or packaging. Material-mediated pyrogenicity is understood to stem from contaminants of mold releases, processing aids, cutting fluids, or cleaning agents among others.

The Acute Toxicity Test in Silkworm evaluates the immediate toxic effects of chemicals, drugs, or substances on silkworms (Bombyx mori). This test is gaining attention as a cost-effective and ethical alternative to mammalian acute toxicity studies.

Fish acute toxicity tests are used to assess potential risk to fish species and for other ecological regulatory needs associated with surface water contaminants. To meet EPA data requirements the test is typically conducted in three different fish species: a cold-water freshwater species, a warm-water freshwater species, and a marine/estuarine species Workgroup is evaluating ecotoxicology methods involving animal testing and what alternatives exist to replace, reduce, or refine animal use in the acute fish toxicity assay. NICEATM is also working with EPA and other partners to explore reducing animal use for fish acute toxicity testing.

Systemic toxicity studies are conducted to evaluate the adverse effects of a substance on the entire body or specific organ systems following its absorption into the bloodstream. These studies help determine how a substance affects various physiological functions and organ health over time. They are a critical component of safety assessments for a wide range of products and substances.

These studies are important for evaluating the safety of:

• Pharmaceuticals – to ensure drugs do not cause harmful effects at therapeutic doses

• Chemicals – including those used in agriculture, industry, or cleaning products

• Food additives – to verify safety for human consumption over time

• Cosmetics – especially products absorbed through the skin

• Industrial compounds – to assess occupational and environmental exposure risks

Systemic toxicity studies provide essential data for regulatory agencies to set exposure limits, labeling requirements, and usage guidelines to protect human and environmental health.

The Abnormal Toxicity Test (ATT) is a historical screening method used in the quality control of biological products, including vaccines, antitoxins, and other injectable formulations. The test aimed to identify unexpected toxic substances that might cause adverse reactions when administered. It involved injecting a sample into laboratory animals (usually mice or guinea pigs) to observe for signs of illness or death, indicating potential contamination.

Although once widely used, ATT has been largely phased out in many countries due to advancements in manufacturing controls, alternative validated methods, and ethical concerns regarding animal use.

Key Points:

• Purpose: Detect unexpected toxic contaminants in injectable biological products.

• Test subjects: Typically mice or guinea pigs.

• Products tested: Vaccines, antitoxins, blood products, and other injectables.

• Outcome: Observation for illness or death post-injection.

• Current status: Largely replaced by modern, validated in vitro methods and improved GMP practices.

Acute oral toxicity studies are conducted to assess the harmful effects of a substance following a single dose or multiple doses within a 24-hour period administered orally. These studies are essential in toxicology and regulatory science as they provide initial information on a substance 's toxicity and potential health risks after short-term exposure.

The primary goal is to determine the LD (lethal dose that kills 50% of test animals) or to estimate an approximate toxic dose. This data is crucial for classifying the toxicity level of chemicals and products and guiding labeling, handling, and safety precautions.

These studies help:

• Identify toxic dose ranges

• Classify chemicals by their acute toxicity level

• Support hazard labeling and risk communication

• Guide dosage selection for further long-term studies

• Ensure safety during development of pharmaceuticals, chemicals, and consumer products

 These studies typically use rodents and follow internationally recognized guidelines such as OECD Test Guideline 420, 423, or 425.

Acute dermal toxicity studies are designed to assess the harmful effects of a single dose of a substance when applied to the skin. These studies are a critical part of toxicological evaluations and help determine the potential risks associated with short-term skin exposure. The data generated supports regulatory decisions, product labeling, and classification under systems like the Globally Harmonized System (GHS).

Key Objectives of Acute Dermal Toxicity Studies:

• Identify immediate toxic effects after skin exposure

• Determine LD values (the dose lethal to 50% of test subjects)

• Assess potential skin absorption and systemic toxicity

• Support chemical safety assessments and risk evaluations

• Aid in GHS hazard classification and labeling

These studies are typically conducted using animal models under strict ethical guidelines. The findings help ensure that substances—such as industrial chemicals, pesticides, or pharmaceuticals—are handled safely in both consumer and occupational settings.

Allergic sensitization studies are designed to evaluate whether a substance can trigger allergic reactions after repeated exposure, particularly through the skin (dermal route) or the respiratory system. These studies are essential for identifying the hypersensitivity potential of various substances and ensuring the safety of products before they reach consumers.

They are commonly conducted for:

• Chemicals – used in industrial and household products

• Pharmaceuticals – especially topical or inhaled drugs

• Cosmetics and personal care products – such as lotions, creams, and fragrances

• Consumer goods – including textiles, cleaning agents, and adhesives

These studies help detect immune system responses, such as skin inflammation, rashes, or respiratory issues like asthma, that can arise from allergen exposure. The results support regulatory decisions, product labeling, and risk assessments to prevent allergic reactions in sensitive individuals and protect public health.

Eye irritation studies are conducted to assess the potential of a substance to cause harmful or reversible effects to the eyes. These studies are crucial for ensuring the safety of chemicals, pharmaceuticals, cosmetics, and various consumer products that may come into direct or accidental contact with the eyes.

Such studies help identify:

• Redness – indicating irritation of the conjunctiva (the eye’s outer membrane)

• Swelling (edema) – showing tissue reaction or inflammation

• Tearing or discharge – signs of discomfort or response to exposure

• Corneal damage – which may affect vision and require medical attention

• Reversibility of effects – determining if damage heals over time or is permanent

Eye irritation tests are used in both regulatory safety assessments and product development. Modern approaches aim to replace or reduce animal testing through validated in vitro alternatives such as reconstructed human corneal models, aligning with ethical and scientific advancements.

Acute inhalation toxicity studies are conducted to evaluate the harmful effects of a single or short-term exposure to a substance through the respiratory system. These studies help determine how toxic a chemical, gas, vapor, aerosol, or dust can be when inhaled, typically within a 24-hour period. The results are essential for risk assessment, safety labeling, and establishing occupational exposure limits.

• Identify toxic effects of airborne substances after short-term exposure

• Determine LC50 values (lethal concentration for 50% of test subjects)

• Assess respiratory irritation or damage to lung tissue

• Support regulatory classification for transportation and workplace safety

• Guide emergency response and first aid measures

These studies are vital for industries that manufacture or handle volatile or airborne chemicals to ensure safe use, handling, and compliance with health regulations.

Subchronic toxicity studies are scientific investigations designed to evaluate the health effects of repeated exposure to a substance over an intermediate duration, typically lasting 90 days. These studies aim to detect early signs of toxicity, determine the relationship between dose and response, and identify specific organs or systems that may be adversely affected.

They are crucial in the safety assessment of chemicals, pharmaceuticals, food additives, and other products, helping to guide safe exposure levels and predict potential long-term health risks.

• Assess potential toxic effects of repeated dosing

• Identify target organs affected by the substance

• Determine dose-response relationships

• Establish No-Observed-Adverse-Effect Level (NOAEL)

• Support risk assessment and regulatory decisions

Cytotoxicity studies are laboratory tests conducted to assess the harmful effects of a substance on cultured cells. These studies help determine whether a chemical, drug, or other material can damage cells, inhibit their growth, or cause cell death. Cytotoxicity testing is a key step in the early stages of product development, particularly for pharmaceuticals, cosmetics, medical devices, and environmental chemicals.

These studies are essential for:

• Screening new compounds – to identify toxic effects before animal or human testing.

• Evaluating cell viability – measuring the ability of cells to survive after exposure.

• Detecting cell damage – including membrane disruption or organelle injury.

• Assessing dose-response relationships – to determine the concentration at which a substance becomes harmful.

• Ensuring product safety – especially in cosmetics, where human testing may be limited.

Cytotoxicity assays, such as MTT, LDH release, or Trypan Blue exclusion, provide quick, cost-effective, and ethical methods to predict potential toxicity.

Genotoxicity testing is conducted to assess whether materials used in medical devices—or their extracts—have the potential to cause genetic damage. This damage may include gene mutations, chromosomal aberrations, or DNA strand breaks, all of which could lead to serious health effects such as cancer or heritable genetic disorders. These tests are an essential part of the biological safety evaluation of medical devices, especially those intended for long-term or internal use.

The international standard ISO 10993-3 outlines the recommended procedures and requirements for genotoxicity testing as part of a comprehensive risk assessment. It helps ensure that device materials do not pose a genetic hazard to users. Commonly used test methods include the Ames test (for gene mutations), the in vitro chromosomal aberration test, and the micronucleus assay, among others. These evaluations support regulatory submissions and ensure that medical devices meet global safety standards.

Carcinogenicity testing is conducted to evaluate whether the materials used in medical devices—or their chemical extracts—have the potential to cause cancer or lead to tumor formation following long-term exposure. This type of testing is especially important for devices intended for prolonged or permanent contact with the human body, such as implants, catheters, or prosthetics. It helps identify any carcinogenic risks associated with the device’s components, degradation products, or leachables that may interact with body tissues over time.

The evaluation typically involves in vivo studies in animal models over an extended period, allowing observation of any tumor development. Results from carcinogenicity testing play a vital role in regulatory approval and help ensure that medical devices meet strict safety standards before clinical use. Ultimately, this testing protects patients by reducing the risk of long-term adverse health effects, particularly for devices intended for continuous use or implantation.

Reproductive and developmental toxicity studies are conducted to evaluate the potential adverse effects of medical device materials or their chemical extracts on reproductive health and offspring development. These studies assess the impact on fertility, reproductive capability, embryonic and fetal development, as well as the growth and health of offspring.

Such evaluations are essential for medical devices that may come into prolonged or repeated contact with the body, particularly those used during pregnancy or in reproductive health applications. The testing typically involves in vivo studies that monitor key reproductive parameters and developmental milestones across one or more generations.

The data generated from these studies help determine whether a device poses any risk to reproductive function or developmental processes. This information is critical for regulatory approval and for ensuring patient safety, especially for populations that may be more vulnerable, such as pregnant women and children.

Degradation testing is performed to assess how medical device materials break down over time when exposed to physiological conditions, such as those found in the human body. This evaluation is crucial for devices intended for long-term implantation or extended contact with bodily tissues or fluids.

The study focuses on identifying and characterizing chemical, physical, and biological changes that occur in the material during degradation. It also analyzes the nature, quantity, and potential toxicity of the degradation products released. These products may interact with surrounding tissues, and understanding their behavior is vital to ensuring patient safety.

Degradation testing helps predict the long-term performance and biocompatibility of a device, providing essential data for regulatory submissions and risk assessments. Ultimately, it supports the development of safe, effective medical devices by ensuring that material breakdown does not pose harm to the body over time.

Hemocompatibility testing, as outlined in ISO 10993 Part 4, assesses the interaction between medical device materials and blood to ensure they are safe for use in blood-contacting applications. This testing is essential for devices such as catheters, stents, vascular grafts, and dialysis equipment, which come into direct or indirect contact with circulating blood.

The evaluation focuses on detecting potential adverse effects, including:

• Thrombosis (clot formation)

• Hemolysis (destruction of red blood cells)

• Complement activation (immune response)

• Platelet activation and adhesion

By identifying these risks, hemocompatibility testing helps prevent complications like embolism, anemia, or inflammation. The results guide material selection and design modifications to enhance blood compatibility and ensure patient safety. Compliance with ISO 10993-4 is a key requirement for regulatory approval of blood-contacting medical devices, helping manufacturers meet global safety standards and minimize clinical risks.

Acute toxicity testing in fish is conducted to evaluate the short-term harmful effects of a substance—such as chemical leachables, pharmaceuticals, or environmental contaminants—on aquatic organisms. Typically lasting 96 hours or less, this test assesses the lethal concentration (LC50) that causes death in 50% of the test fish population within the exposure period.

This type of testing is essential for understanding the immediate ecological risks associated with the release or leaching of chemicals into aquatic environments. It provides crucial data for environmental risk assessments, regulatory compliance, and the development of safe discharge limits for industrial or medical substances.

The results help determine whether a substance poses a threat to aquatic life and inform decisions to mitigate environmental impact. Acute toxicity testing is often a preliminary step in broader ecotoxicological evaluations, contributing to the overall assessment of a material 's environmental safety.

The Fish Embryo Toxicity (FET) test is an alternative method to traditional acute fish toxicity tests, utilizing the early life stages—specifically embryos—of fish to evaluate the toxic effects of chemicals or substances. This test is commonly used in environmental risk assessments to determine the potential harm a substance may pose to aquatic ecosystems.

One of the key advantages of the FET test is its ethical benefit, as it significantly reduces the use of live adult fish in toxicity testing. By focusing on embryos, the method aligns with the principles of the 3Rs (Replacement, Reduction, Refinement) in animal testing.

The FET test provides reliable and reproducible data on endpoints such as mortality, developmental abnormalities, and hatching rates, making it a valuable tool for regulatory screening and hazard classification. It is widely accepted for testing a broad range of substances, including industrial chemicals, pharmaceuticals, and environmental pollutants.

Laboratory Testing Services involve a broad spectrum of analytical and bioassay evaluations performed under controlled laboratory conditions to assess the safety, efficacy, quality, and environmental impact of various substances, materials, and products. These services play a crucial role in supporting research and development, regulatory compliance, and quality assurance across multiple industries, including pharmaceuticals, chemicals, medical devices, environmental science, and consumer goods.

Testing may include chemical analysis, microbiological testing, toxicity studies, stability testing, and performance evaluations, depending on the product and its intended use. By generating accurate and reliable data, laboratory testing ensures products meet industry standards, regulatory requirements, and consumer safety expectations.

These services are essential for identifying potential risks, improving product design, and facilitating market approval, ultimately helping companies maintain high standards of safety and quality throughout the product lifecycle.

Long-term storage stability testing is a critical process used to assess how a product’s quality, safety, and efficacy change over an extended period when stored under recommended conditions. This testing helps determine the product’s shelf life and supports the establishment of a scientifically justified expiration date.

By simulating real-time storage environments—such as controlled temperature, humidity, and light exposure—this testing evaluates changes in physical appearance, chemical composition, potency, and microbial stability over time. It ensures that the product remains effective and safe for use throughout its intended lifespan.

Long-term stability data are essential for regulatory submissions, product labeling, and ensuring consistent performance during distribution and storage. This testing is particularly important for pharmaceuticals, medical devices, and biologics, where degradation could affect therapeutic outcomes or patient safety.

Microbiological testing of water is essential for evaluating its safety and quality by identifying the presence of harmful microorganisms. This testing focuses primarily on detecting bacteria, viruses, protozoa, and fungi that can pose significant health risks if consumed or used. It plays a vital role in preventing waterborne diseases and ensuring compliance with public health standards.

Microbiological analysis is widely applied in various sectors, including:

• Drinking water testing – to ensure safe consumption

• Wastewater treatment – to monitor and control microbial contamination before discharge

• Environmental monitoring – for assessing water bodies like rivers, lakes, and reservoirs

• Industrial applications – such as food and beverage processing, where water purity is crucial

Regular microbiological testing helps in the early detection of contamination and supports effective water treatment processes, making it a critical component of public health and environmental safety strategies.

Medical device microbiological testing is a vital process to ensure that medical devices are safe for use and meet strict regulatory standards. This testing is essential for both sterile and non-sterile devices, as it helps detect and control microbial contamination that could pose risks to patient health.

Key microbiological tests include:

• Sterility testing – confirms that sterile devices are free from viable microorganisms.

• Bioburden assessment – measures the number of microorganisms present on a device before sterilization.

• Endotoxin testing – detects bacterial endotoxins that can cause fever or toxic reactions, especially in devices that contact blood or cerebrospinal fluid.

• Cleanliness evaluation – ensures devices are free from residual contaminants, including organic and inorganic matter.

These evaluations are crucial for maintaining product safety, performance, and regulatory compliance, particularly for devices intended for invasive or long-term use.

Surgical testing encompasses a range of procedures and evaluations designed to ensure the sterility, cleanliness, and overall safety of surgical instruments, environments, personnel, and products used during surgical procedures. The primary goal of these tests is to prevent surgical site infections (SSIs) and to support compliance with established healthcare regulations and safety standards.

Key aspects of surgical testing include microbial testing, sterility validation, residue analysis, and equipment performance checks. These assessments are conducted on surgical tools, sterile drapes, gloves, implantable devices, and the operating room environment to confirm that they meet safety and hygiene requirements.

Routine surgical testing helps identify and eliminate contamination risks, ensuring patient safety and successful surgical outcomes. It also supports hospital infection control programs and promotes adherence to protocols set by organizations such as the FDA, ISO, and WHO.

Herbal and AYUSH products (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) are gaining widespread popularity in the health and wellness sector due to their natural and holistic approach. However, their natural origin makes them highly susceptible to microbial contamination, which can compromise product safety and efficacy.

Microbiological testing plays a vital role in ensuring these products are safe for human consumption and meet established regulatory quality standards. This testing involves the detection and quantification of harmful microorganisms such as bacteria, yeast, mold, and specific pathogens like E. coli, Salmonella, and Staphylococcus aureus.

By identifying microbial contamination early, manufacturers can take corrective actions to maintain product integrity, protect public health, and ensure compliance with national and international guidelines. Regular microbiological testing is essential for building consumer trust and promoting the safe use of herbal and AYUSH-based health products in the market.

Sanitary product testing is a vital process that ensures personal hygiene products—such as sanitary napkins, tampons, diapers, baby wipes, adult incontinence products, and similar items—are safe, non-toxic, and free from harmful microorganisms. Given that these products come into direct or prolonged contact with the skin or mucosal surfaces, maintaining high microbial safety standards is essential to prevent potential infections, skin irritations, and allergic reactions.

Testing typically involves evaluating the microbial load, detecting pathogenic organisms, and ensuring the materials used do not release harmful substances upon contact. It also assesses parameters such as absorbency, pH levels, skin compatibility, and material integrity under normal use conditions.

By conducting thorough sanitary product testing, manufacturers can meet regulatory and quality standards, safeguard public health, and build consumer trust in the safety and reliability of their hygiene products.

The Microbial Limit Test is a vital microbiological assay used to evaluate the quantity and type of microorganisms present in non-sterile products such as pharmaceuticals, cosmetics, food, and raw materials. This test helps determine whether the microbial content of a product falls within the acceptable safety limits defined by regulatory standards.

The assessment includes both quantitative and qualitative analysis, targeting:

• Total aerobic microbial count (TAMC)

• Total yeast and mold count (TYMC)

• Absence of specific pathogens, such as Escherichia coli, Salmonella spp., Staphylococcus aureus, and Pseudomonas aeruginosa

The purpose of the Microbial Limit Test is to ensure product safety, quality, and compliance by detecting microbial contamination that could pose health risks to consumers. This testing is crucial during product development, manufacturing, and quality control stages to prevent the release of contaminated products into the market.

The Bacterial Endotoxins Test (BET), commonly known as the Limulus Amebocyte Lysate (LAL) test, is a vital microbiological assay used to detect and measure endotoxins—harmful substances found in the outer membrane of Gram-negative bacteria. These endotoxins can trigger serious inflammatory reactions, including fever, shock, or even organ failure when introduced into the human body.

BET is routinely performed on pharmaceutical products, biologicals, and medical devices, especially those intended for injection or direct contact with blood or internal tissues. The test uses the blood cells of the horseshoe crab (Limulus polyphemus), which react in the presence of endotoxins, allowing accurate detection and quantification.

Controlling endotoxin levels is critical to ensure patient safety and regulatory compliance. The BET is recognized by pharmacopeias worldwide (e.g., USP, EP, JP) and is an essential step in quality control to prevent contamination and ensure the sterility and safety of healthcare products.

PPE kit testing is a crucial process to ensure that personal protective equipment—including masks, gloves, gowns, face shields, and coveralls—meets required safety, performance, and regulatory standards. This testing verifies the effectiveness of each component in providing protection against chemical, biological, and physical hazards that workers may encounter in healthcare, industrial, or emergency settings.

The evaluation includes testing for factors such as filtration efficiency, fluid resistance, tear and puncture strength, breathability, and fit and comfort. For example, masks are tested for bacterial and particulate filtration efficiency, while gowns and coveralls are assessed for barrier performance and seam integrity.

PPE kit testing ensures compliance with standards set by organizations like ISO, ASTM, and NIOSH, helping manufacturers deliver reliable products that safeguard users. Ultimately, this process is essential for minimizing health risks and enhancing the safety and confidence of individuals relying on PPE in hazardous environments.

Face mask testing is a vital process to ensure that various types of face masks—such as surgical masks, N95 respirators, and cloth masks—meet established performance, safety, and regulatory standards. This testing evaluates the mask’s ability to protect against airborne particles, bacteria, fluids, and pathogens, ensuring effective filtration and user safety.

Key parameters tested include bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), fluid resistance, breathability (differential pressure), and fit or seal integrity, particularly for respirators like N95s. These tests help determine whether a mask is suitable for medical, industrial, or general public use.

Face mask testing is essential for regulatory compliance with standards such as ASTM, EN, or NIOSH, depending on the region and mask type. It ensures that only safe and effective products reach consumers and healthcare professionals, especially during public health emergencies where protective equipment is critical.

Fabric and textile testing is a vital process used to evaluate the physical, mechanical, chemical, and biological properties of textiles to ensure their quality, safety, durability, and compliance with industry regulations. This comprehensive analysis helps manufacturers confirm that fabrics meet specific standards for performance and consumer safety.

Key tests may assess strength, colorfastness, flammability, pH levels, antimicrobial activity, and resistance to wear and environmental factors. These evaluations are essential across a wide range of industries, including:

• Apparel and fashion – to ensure comfort, color retention, and longevity

• Medical textiles – for sterility, biocompatibility, and hygiene

• Personal protective equipment (PPE) – for safety, durability, and barrier protection

• Upholstery and home furnishings – for strength, appearance, and fire resistance

• Automotive and industrial textiles – for performance under stress and environmental exposure

Through standardized testing, fabric and textile products can meet both customer expectations and regulatory requirements.

Agrochemicals and Industrial Chemicals are broad categories of substances widely used in agriculture and various industries, respectively. Testing and evaluation of these chemicals are crucial to ensure their efficacy, safety, environmental impact, and regulatory compliance.

Acute irritation toxicity studies are conducted to assess whether a substance causes reversible damage to the skin, eyes, or respiratory tract after a single or short-term exposure. These studies are crucial in evaluating the safety of chemicals, pharmaceuticals, cosmetics, and various consumer products.

They help determine the irritation potential, which guides product labeling, handling precautions, and regulatory classification.

• Skin irritation – redness, swelling, or damage to the skin surface

• Eye irritation – tearing, redness, corneal damage, or visual impairment

• Respiratory irritation – coughing, wheezing, or discomfort in the nose and throat

These studies are typically performed using in vitro or in vivo models, depending on regulatory requirements. Results play a vital role in ensuring user safety and complying with global safety regulations before a product is approved for market use.

This Test Guideline includes two methods: a paper contact toxicity test and an artificial soil test. The recommended specie is Eisenia foetida (Michaelsen).

The initial screening test (filter paper contact test) involves exposing earthworms to test substances on moist filter paper in order to identify potentially toxic chemicals to earthworms in soil. Five or more treatment levels in a geometric series and, at least, ten replicates (one worm per vial) for each treatment should be used. Tests are done in the dark and for a period of 48 hours. The artificial soil test gives toxicity data more representative of natural exposure of earthworms to chemicals. It involves keeping earthworms in samples of a precisely defined artificial soil. Five concentrations, in a geometric series, of the test substance have been applied. One concentration resulting in no mortality and one resulting in total mortality should be used. Four replicates for each treatment are recommended. Mortality is assessed 7 and 14 days after application.

This Test Guideline is designed to be used for assessing the effects of chemicals in soil on the reproductive output (and other sub-lethal end points) of the earthworm species Eisenia fetida or Eisenia andrei.  Adult worms are exposed to a range of concentrations of the test substance either mixed into the soil or applied to the soil surface. The range of test concentrations is selected to encompass those likely to cause both sub-lethal and lethal effects over a period of eight weeks. The limit test corresponds to one dose level of 1000 mg/kg. 

This study includes the observation of unusual behaviour and morphology, the counting and weighing of the adult worms after the four primary weeks, the number of juveniles hatched at the end of the second 4-week period. The reproductive output of the worms exposed to the test substance is compared to that of the control(s) in order to determine the no observed effect concentration (NOEC) and/or ECx by using a regression model to estimate the concentration that would cause a x % reduction in reproductive output. The test concentrations should bracket the ECx so that the ECx then comes from interpolation rather than extrapolation.

This Test Guideline is a laboratory test method, designed to assess the acute contact toxicity of pesticides and other chemicals to adult worker honeybees. Anaesthetized adult worker honeybees are exposed to five doses in a geometric series of the test substance dissolved in appropriate carrier (in total a volume of 1 ml), by direct application to the thorax (droplets). A minimum of three replicate test groups, each of ten bees, should be dosed with each test concentration. A toxic standard (usually dimethoate) should be included in the test series. 

The limit test corresponds to one dose level of 100 ìg active ingredient/bee. The test duration is 48h. Mortality is recorded daily during at least 48 hours and compared with control values. If the mortality rate is increasing between 24 and 48h whilst control mortality remains at an accepted level, it is appropriate to extend the duration of the test to a maximum of 96h. The results are analysed in order to calculate the LD50 at 24h and 48h and, in case the study is prolonged, at 72h and 96h.

Cosmetic testing is an essential process in the cosmetic industry aimed at ensuring product safety and quality. It focuses on verifying that cosmetics are free from harmful microorganisms and safe for consumer use. This testing involves the detection, identification, and quantification of microbial contaminants in various stages of production, including raw materials, in-process samples, and finished products.

Common microbial tests check for the presence of bacteria, yeast, and mold, as well as specific pathogens like Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli, which can pose serious health risks.

Routine cosmetic testing ensures compliance with regulatory standards and helps maintain product stability, shelf life, and consumer trust. By identifying contamination risks early in the manufacturing process, companies can take corrective actions, reduce product recalls, and ensure the safety and effectiveness of their cosmetic products before they reach the market.

Sterility testing is a vital microbiological quality control procedure used to ensure that sterile pharmaceutical products, medical devices, and other sterile preparations are completely free from viable microorganisms. This test is especially crucial for products intended for injection, ophthalmic use, implantation, or surgical procedures, where any microbial contamination could lead to serious health risks.

The process involves incubating product samples in nutrient-rich media under controlled conditions to promote the growth of any contaminating microbes. If no growth is detected after the incubation period, the product is considered sterile.

Sterility testing is required by regulatory authorities and follows stringent protocols, such as those outlined in pharmacopeial standards (e.g., USP, EP, or JP). It plays a critical role in safeguarding patient health by verifying that products meet strict sterility requirements before they are released to the market or used in clinical settings.