What is reproductive toxicity test?
Reproductive toxicity tests
Reproductive toxicity testing is based on the measurement of reproductive functional and structural defects caused by toxic agents in both males and females. The toxicity endpoints most frequently studied in reproductive in vivo testing are summarized in Table 5.3.
What are DART studies?
Development and reproductive toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. Their goal is to detect any effects of a drug within a complete reproductive cycle as relevant to humans — from initial conception to reproductive capacity in the next generation.
What is female reproductive toxicity?
Reproductive toxicity refers to the potential risk from a given chemical, physical or biologic agent to adversely affect both male and female fertility as well as offspring development.
What is developmental and reproductive toxicity?
Reproductive toxicity is defined as adverse effects of a chemical substance on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. Developmental toxicity pertains to adverse toxic effects to the developing embryo or fetus.
What causes reproductive toxicity?
Reproductive toxicity results when a chemical has an adverse impact on the normal function and development of male or female reproductive tissues or reproductive behavior resulting in reduced fertility.
What is teratogenicity study?
Abstract. The principal source of evidence for adverse effects on fetal development that are recognized at term is teratogenicity studies in experimental animals. The design of these studies should be appropriate for the intended purpose, and their conduct should conform to high standards.
Which of the following is a developmental toxins?
Typical factors causing developmental toxicity are radiation, infections (e.g. rubella), maternal metabolic imbalances (e.g. alcoholism, diabetes, folic acid deficiency), drugs (e.g. anticancer drugs, tetracyclines, many hormones, thalidomide), and environmental chemicals (e.g. mercury, lead, dioxins, PBDEs, HBCD.
What is Category 2 reproductive toxicity?
Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the …
What type of hazard is reproductive toxicity?
Reproductive toxicity refers to adverse effects of a chemical substance/mixture on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. Developmental toxicity pertains to adverse toxic effects to the developing embryo or fetus.
Is reproductive toxicity a health hazard?
Reproductive toxicity encompasses adverse reproductive health outcomes in both men and women caused by exposure to such agents. Changes in reproductive systems, fertility, and adverse pregnancy outcomes can be caused by reproductive toxicity [2].
Which drugs cause teratogenicity?
Teratogenic drugs and birth defects
- ACE (angiotensin converting enzyme) inhibitors.
- angiotensin II antagonist.
- isotretinoin (an acne drug)
- alcohol.
- cocaine.
- high doses of vitamin A.
- lithium.
- male hormones.
What is teratogenicity with example?
A teratogen is any agent that causes an abnormality following fetal exposure during pregnancy. Teratogens are usually discovered after an increased prevalence of a particular birth defect. For example, in the early 1960’s, a drug known as thalidomide was used to treat morning sickness.
How long do toxic chemicals stay in the body?
Experiments have shown they affect a number of organs and systems. Once dioxins enter the body, they last a long time because of their chemical stability and their ability to be absorbed by fat tissue, where they are then stored in the body. Their half-life in the body is estimated to be 7 to 11 years.
What are the 4 hazard categories?
4 Types of Workplace Hazards
- Physical Hazards. Physical hazards are the most common type of workplace hazards.
- Biological Hazards.
- Ergonomic Hazards.
- Chemical Hazards.
What are 5 types of teratogens?
Teratogenic agents include infectious agents (rubella, cytomegalovirus, varicella, herpes simplex, toxoplasma, syphilis, etc.); physical agents (ionizing agents, hyperthermia); maternal health factors (diabetes, maternal PKU); environmental chemicals (organic mercury compounds, polychlorinated biphenyl or PCB.
What are 4 teratogens?
Teratogens are classified into four types: physical agents, metabolic conditions, infection, and finally, drugs and chemicals.
What are the 4 types of teratogens?
Additionally, teratogens may also affect pregnancies and cause complications such as preterm labors, spontaneous abortions, or miscarriages. Teratogens are classified into four types: physical agents, metabolic conditions, infection, and finally, drugs and chemicals.
What are the 3 types of toxicity?
Types of toxicity
There are generally three types of toxic entities; chemical, biological, and physical. Chemicals include inorganic substances such as lead, hydrofluoric acid, and chlorine gas, organic compounds such as methyl alcohol, most medications, and poisons from living things.
How do you test for toxicity in the body?
The only way in which toxins can be checked in the blood is through blood tests. Heavy metal toxicity can result in damage to the vital organs, neurological and muscular degeneration, cancer, allergies and even death.
What is the symbol for acute toxicity?
Skull and Crossbones
Skull and Crossbones: Substances, such as poisons and highly concentrated acids, which have an immediate and severe toxic effect (acute toxicity).
What are 2 common teratogens?
Common teratogens include some medications, recreational drugs, tobacco products, chemicals, alcohol, certain infections, and in some cases, uncontrolled health problems in the birthing parent. Alcohol is a well-known teratogen that can cause harmful effects on the fetus after exposure at any time during pregnancy.
What drugs cause teratogenic effects?
What is the most common teratogen?
What birth defects can teratogens cause?
During this time, teratogens can cause neural tube defects such as spina bifida. Some organs are sensitive to teratogens during the whole pregnancy. This includes the baby’s brain and spinal cord. Alcohol affects the brain and spinal cord, so it can cause harm at any time during pregnancy.
What chemicals are teratogens?
Known teratogens include alcohol, smoking, toxic chemicals, radiation, viruses, some maternal health conditions, and certain prescription drugs. Amount: The amount of harm to a fetus increases the more the pregnant person consumes or is exposed to a teratogen.