This document summarizes a dermal irritation study conducted according to OECD guidelines using rabbits. It describes procedures for handling, restraining, and housing the rabbits, as well as applying the test chemical to their skin for 4 hours. Observations are made at several time points over 14 days to evaluate the degree of irritation or corrosion and reversibility of any effects. Scoring is based on criteria for erythema, edema, and other reactions. The study aims to safely and humanely evaluate the skin toxicity of chemicals.
Acute eye irritation test as per OECD guidelinesmadhvi Chaubey
toxicological testing studies as per OECD guidline.
Toxicology is the branch of biology, chemistry and medicine concerned with the study of the adverse effects of chemicals on living organisms.
As per OECD test no. 405 : acute eye irritation test should be done as according to the procedure mentioned under guideline's section.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
The presentation is about the dose selection for laboratory animal toxicology drug testing, explaining staged and staggered approach of dose selection.
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
Its a about chrono-pharmacology of diabetes
The accurate and detail information about chrono- pharmacology its not available but this information is sufficient or useful.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
Acute eye irritation test as per OECD guidelinesmadhvi Chaubey
toxicological testing studies as per OECD guidline.
Toxicology is the branch of biology, chemistry and medicine concerned with the study of the adverse effects of chemicals on living organisms.
As per OECD test no. 405 : acute eye irritation test should be done as according to the procedure mentioned under guideline's section.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
The presentation is about the dose selection for laboratory animal toxicology drug testing, explaining staged and staggered approach of dose selection.
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
Its a about chrono-pharmacology of diabetes
The accurate and detail information about chrono- pharmacology its not available but this information is sufficient or useful.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
This presentation provides an in-depth examination of dermal irritation and corrosion, focusing on the principles, testing methods, and safety measures involved. Participants will gain insight into the mechanisms underlying dermal irritation and corrosion, as well as the potential risks posed by various substances. Through a detailed exploration of testing protocols such as the Draize test and in vitro alternatives, attendees will learn how these assessments are conducted to ensure product safety and regulatory compliance. Join us to deepen your understanding of dermal irritation and corrosion, essential for ensuring the safety and well-being of consumers and workers alike.
Medical and Healthcare Professions:
Medical Doctors: Physiology forms the foundation for medical education. It is essential for diagnosing, treating, and preventing diseases. Doctors need a deep understanding of how the body's systems work to provide effective patient care.
Nurses: Nurses rely on physiology to monitor patients' vital signs, administer medications, and provide overall care. Understanding physiology is vital for patient safety.
Pharmacists: Pharmacists require knowledge of physiology to understand drug interactions, mechanisms of action, and potential side effects.
Biomedical Research:
Physiologists and researchers use knowledge of physiology to conduct experiments, develop new therapies, and advance medical science. This research is critical for discovering treatments for diseases.
Sports Science and Exercise Physiology:
Understanding how the body responds to exercise and physical activity is essential in sports science. Coaches, athletes, and fitness professionals rely on this knowledge to optimize training regimens and improve performance.
Nutrition and Dietetics:
Nutritionists and dietitians use physiology to understand how nutrients affect the body's various systems. This knowledge helps in designing diets to manage health conditions and promote overall well-being.
Pharmaceutical and Biotechnology Industries:
Professionals in these industries need to understand the physiological effects of drugs and biotechnological products to develop safe and effective treatments.
Biomechanics:
Physiological principles are fundamental in biomechanics, which is crucial in fields like orthopedics, physical therapy, and engineering to design prosthetics and improve mobility.
Environmental Science:
Environmental scientists study the physiological responses of organisms to changes in their environment, which is essential for understanding the impact of climate change and pollution on ecosystems.
Psychology and Neurobiology:
Understanding the physiological basis of behavior and cognition is critical in psychology and neuroscience. This knowledge helps in researching and treating mental health disorders.
Public Health:
Public health professionals need to comprehend the physiological aspects of disease transmission and prevention, especially in epidemiology and health policy development.
Education and Science Communication:
Educators and science communicators use physiology to teach students and the general public about the importance of health and wellness, disease prevention, and medical advancements.
Personal Well-Being:
Knowledge of physiology helps individuals make informed decisions about their health, leading to a healthier lifestyle, better disease prevention, and improved quality of life.
In summary, the study of physiology is a cornerstone of various disciplines and professions, impacting healthcare, research, sports, nutrition, industry, and more. It equips students with a deep understanding of how the human body functions, en
Skin sensitisation, OECD Test guideline 406 .pptxNikitaBankoti2
Skin Sensitisation: ( allergic contact dermatitis) is an immunologically mediated cutaneous reaction to a substance. In the human, the responses may be characterised by pruritis, erythema, oedema, papules, vesicles or a combination of these. In other species the reactions may differ and only erythema and oedema may be seen.
Toxicity is the science dealing with properties, action, toxicity, fatal dose detection or interpretation of result of toxicological analysis & treatment of poison.
Toxicity studies helps to avoid adverse effect and enhance the safety of drug.
This slide provides the information about toxicity screening on experimental animals.
Dear Friends,
This is my 3rd presentation, which will help you to understand the depth knowledge of acute eye irritation/corrosion (OECD-405) study in rabbit.
the presentation is based on OECD guideline of chemical test on acute eye irritation guideline 403, it also give knowledge about why the guideline was updated and analgesic and anesthetic uses on the albino rabbit eye so to overcome the animal distress, and pain. the presentation explain the full guideline in detail
PREDICTION AND ANALYSIS OF ADMET PROPERTIES OF NEW.pptxMO.SHAHANAWAZ
Detail about PREDICTION AND ANALYSIS OF ADMET PROPERTIES OF NEW MOLECULES AND IT’S IMPORTANCE IN DRUG DISCOVERY, including DESCRIPTORS OF ADMET PREDICTION, DATASETS USED IN ADMET PREDICTION
Detail about PROCESS FOR TECHNICAL NITRATION including INTRODUCTION, BATCH NITRATION,BATCH NITRATION OF HYDROCARBONS,MIXED ACID COMPOSITIONS FOR NITRATION
MOLECULAR DOCKING AND DRUG RECEPTOR INTERACTION AGENT ACTING.pptxMO.SHAHANAWAZ
Point to point M.pharm CADD presentation on MOLECULAR DOCKING AND DRUG RECEPTOR INTERACTION AGENT ACTING, Dihydro Folate reductase Inhibiter (Methotrexate)
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
DERMAL IRRITATION STUDY ACCORDING TO OECD(404) GUIDELINES
1. Dermal irritation study
according to
OECD(404) guidelines
PRESENTED TO
-
Dr. Badruddeen
PRESENTED BY -
MO.Shahanawaz
M.Pharm 1st year 2nd sem.
(Pharmacological and Toxicological
Screening)
2. HANDLING AND
RESTRAINT
Rabbits are
especially
susceptible to
the effects of
stress and
should always
be
approached
in a calm and
confident
manner.
The handler is
restraining the
rabbit firmly by
the scruff with
the other hand
ready to support
the animal’s
hindquarters.
There is no one
correct method of
handling or
restraining
animals, but the
general principle
is that it should
not cause pain or
discomfort to the
animal. It should
also be
comfortable for
the handler.
The methods
shown in the
species-specific
sections are
recommended,
although some
people may feel
more comfortable
using slightly
different ways to
restrain the
animals, which is
also acceptable.
3. INTRODUCTION
• DERMAL IRRITATION is the production of reversible damage of the skin following
the application of a test chemical for up to 4 hours.
• Dermal corrosion is the production of irreversible damage of the skin; namely, visible
necrosis through the epidermis and into the dermis, following the application of a test
chemical for up to four hours.
• Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of
observation at 14 days, by discolouration due to blanching of the skin, complete areas
of alopecia, and scars.
• OECD Guidelines for Testing of Chemicals are periodically reviewed to ensure that
they reflect the best available science.
• In the review of this Guideline, special attention was given to possible improvements in
relation to animal welfare concerns and to the evaluation of all existing information on
the test chemical in order to avoid unnecessary testing in laboratory animals.
4. PRINCIPLE
• The test chemical to be tested is applied in a single dose to the skin of an
experimental animal; untreated skin areas of the test animal serve as the
control.
• The degree of irritation/corrosion is read and scored at specified intervals
and is further described in order to provide a complete evaluation of the
effects.
• The duration of the study should be sufficient to evaluate the reversibility or
irreversibility of the effects observed.
• Animals showing continuing signs of severe distress and/or pain at any stage
of the test should be humanely killed, and the test chemical assessed
accordingly.
• Criteria for making the decision to humanely kill moribund and severely
suffering animals are the subject of a separate Guidance Document.
5. PREPARATION FOR THE IN VIVO TEST
SELECTION OF ANIMAL SPECIES-
• The albino rabbit is the preferable laboratory animal and healthy young adult rabbits
are used.
• A rationale for using other species should be provided.
PREPARATION OF THE ANIMALS-
• Approximately 24 hours before the test, fur should be removed by closely clipping the
dorsal area of the trunk of the animals.
• Care should be taken to avoid abrading the skin, and only animals with healthy, intact
skin should be used.
• Some strains of rabbit have dense patches of hair that are more prominent at certain
times of the year. Such areas of dense hair growth should not be used as test sites.
6. HOUSING AND FEEDING CONDITIONS -
• Animals should be individually housed.
• Rabbit at least 12 weeks old and body weight 1.5 kg-3.0 kg.
• The temperature should be 200C (± 30C) for rabbits.
• Relative humidity should be at least 30% and preferably not exceed 70%, other
than during room cleaning; the aim should be 50-60%.
• Lighting should be 12 hours light, 12 hours dark.
• For feeding, conventional laboratory diets may be used with an unrestricted
supply of drinking water.
7. TEST PROCEDURE
APPLICATION OF THE TEST CHEMICAL
• The test chemical should be applied to a dorsal/flank region (approximately 6 cm2) of
skin and covered with a gauze patch, which is held in place with non- irritating tape.
• In cases in which direct application is not possible (e.g., liquids or some pastes), the
test chemical should first be applied to the gauze patch, which is then applied to the
skin.
• The patch should be loosely held in contact with the skin by means of a suitable semi-
occlusive dressing for the duration of the exposure period.
• If the test chemical is applied to the patch, it should be attached to the skin in such a
manner that there is good contact and uniform distribution of the test chemical on the
skin.
8. • Access by the animal to the patch and ingestion or inhalation of the test chemical
should be prevented.
• Liquid test chemicals are generally used undiluted. • When testing solids (which may
be pulverised, if considered necessary), the test chemical should be moistened with
the smallest amount of water (or, where necessary, of another suitable vehicle)
sufficient to ensure good skin contact.
• When vehicles other than water are used, the potential influence of the vehicle on
irritation of the skin by the test chemical should be minimal, if any.
• At the end of the exposure period, which is normally 4 hours, residual test
chemical should be removed, where practicable, using water or an appropriate solvent
without altering the existing response or the integrity of the epidermis.
DOSE LEVEL
• A dose of 0.5 mL of liquid or 0.5 g of solid or paste is applied to the test site.
9.
10. INITIAL TEST (USING ONE ANIMAL)
When a test chemical has been judged to be corrosive, irritant or non-
classified on the basis of a weight of evidence analyses or of previous in
vitro testing, further in vivo testing is normally not necessary.
However, in the cases where additional data are felt warranted, the in vivo
test is performed initially using one animal and applying the following
approach.
Up to three test patches are applied sequentially to the animal.
The first patch is removed after three minutes.
If no serious skin reaction is observed, a second patch is applied at a
different site and removed after one hour.
11. If the observations at this stage indicate that exposure can humanely be
allowed to extend to four hours, a third patch is applied and removed after
four hours, and the response is graded.
If a corrosive effect is observed after any of the three sequential exposures,
the test is immediately terminated.
If a corrosive effect is not observed after the last patch is removed, the
animal is observed for 14 days, unless corrosion develops at an earlier time
point.
In those cases, in which the test chemical is not expected to produce
corrosion but may be irritating, a single patch should be applied to one animal
for four hours.
12. CONFIRMATORY TEST (WITH ADDITIONAL ANIMALS)
If a corrosive effect is not observed in the initial test, the irritant or negative
response should be confirmed using up to two additional animals, each with one patch,
for an exposure period of four hours.
If an irritant effect is observed in the initial test, the confirmatory test may be
conducted in a sequential manner, or by exposing two additional animals simultaneously.
In the exceptional case, in which the initial test is not conducted, two or three
animals may be treated with a single patch, which is removed after four hours.
When two animals are used, if both exhibit the same response, no further testing is
needed. Otherwise, the third animal is also tested.
Equivocal responses may need to be evaluated using additional animals.
13. OBSERVATION PERIOD
The duration of the observation period should be sufficient to evaluate fully
the reversibility of the effects observed.
The experiment should be terminated at any time that the animal shows continuing
signs of severe pain or distress.
To determine the reversibility of effects, the animals should be observed up to 14
days after removal of the patches.
If reversibility is seen before 14 days, the experiment should be terminated
at that time.
14. CLINICAL OBSERVATIONS AND GRADING OF SKIN
REACTIONS
All animals should be examined for signs of erythema and oedema, and the
responses scored at 60 minutes, and then at 24, 48 and 72 hours after patch
removal.
For the initial test in one animal, the test site is also examined immediately after
the patch has been removed.
Dermal reactions are graded and recorded according to the grades in the Table
below.
If there is damage to skin which cannot be identified as irritation or corrosion at
72 hours, observations may be needed until day 14 to determine the reversibility
of the effects.
In addition to the observation of irritation, all local toxic effects, such as
defatting of the skin, and any systemic adverse effects (e.g., effects on clinical
signs of toxicity and body weight), should be fully described and recorded.
Histopathological examination should be considered to clarify equivocal
responses.