Lowest-observed-adverse-effect level

Last updated

The lowest-observed-adverse-effect level (LOAEL), or the lowest-observed-adverse-effect concentration (LOAEC), is the lowest concentration or amount of a substance found by experiment or observation that causes an adverse alteration of morphology, function, capacity, growth, development, or lifespan of a target organism distinguished from normal organisms of the same species under defined conditions of exposure. [1] Federal agencies use the LOAEL during risk assessment to set approval standards below this level. [2]

Hypothetical dose-response showing LOAEL Hypothetical dose-response.png
Hypothetical dose-response showing LOAEL

The United States Environmental Protection Agency defines LOAEL as the 'lowest level of a chemical stressor evaluated in a toxicity test that shows harmful effects on a plant or animal. While LOAELs and LOAECs are similar, they are not interchangeable. A LOAEL refers to a dose of chemical that is ingested, while a LOAEC refers to direct exposure to a chemical (e.g., through gills or the skin). [3]

See also

Related Research Articles

<span class="mw-page-title-main">Toxicology</span> Study of substances harmful to living organisms

Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure, route of exposure, species, age, sex, and environment. Toxicologists are experts on poisons and poisoning. There is a movement for evidence-based toxicology as part of the larger movement towards evidence-based practices. Toxicology is currently contributing to the field of cancer research, since some toxins can be used as drugs for killing tumor cells. One prime example of this is ribosome-inactivating proteins, tested in the treatment of leukemia.

<span class="mw-page-title-main">Toxicity</span> Degree of harmfulness of substances

Toxicity is the degree to which a chemical substance or a particular mixture of substances can damage an organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell (cytotoxicity) or an organ such as the liver (hepatotoxicity). Sometimes the word is more or less synonymous with poisoning in everyday usage.

A reference dose is the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance, "below which no adverse noncancer health effects should result from a lifetime of exposure". Reference doses have been most commonly determined for pesticides. The EPA defines an oral reference dose as:

[A]n estimate, with uncertainty spanning perhaps an order of magnitude, of a daily oral exposure to the human population that is likely to be without an appreciable risk of deleterious effects during a lifetime.

<span class="mw-page-title-main">Aquatic toxicology</span> Study of manufactured products on aquatic organisms

Aquatic toxicology is the study of the effects of manufactured chemicals and other anthropogenic and natural materials and activities on aquatic organisms at various levels of organization, from subcellular through individual organisms to communities and ecosystems. Aquatic toxicology is a multidisciplinary field which integrates toxicology, aquatic ecology and aquatic chemistry.

Acute toxicity describes the adverse effects of a substance that result either from a single exposure or from multiple exposures in a short period of time. To be described as acute toxicity, the adverse effects should occur within 14 days of the administration of the substance.

<span class="mw-page-title-main">Atrazine</span> Herbicide

Atrazine is a chlorinated herbicide of the triazine class. It is used to prevent pre-emergence broadleaf weeds in crops such as maize (corn), soybean and sugarcane and on turf, such as golf courses and residential lawns. Atrazine's primary manufacturer is Syngenta and it is one of the most widely used herbicides in the United States, Canadian, and Australian agriculture. Its use was banned in the European Union in 2004, when the EU found groundwater levels exceeding the limits set by regulators, and Syngenta could not show that this could be prevented nor that these levels were safe.

<span class="mw-page-title-main">Environmental hazard</span> Harmful substance, a condition or an event

Environmental hazards are those hazards that affect biomes or ecosystems. Well known examples include oil spills, water pollution, slash and burn deforestation, air pollution, ground fissures, and build-up of atmospheric carbon dioxide. Physical exposure to environmental hazards is usually involuntary

<span class="mw-page-title-main">Aldrin</span> Chemical compound

Aldrin is an organochlorine insecticide that was widely used until the 1990s, when it was banned in most countries. Aldrin is a member of the so-called "classic organochlorines" (COC) group of pesticides. COCs enjoyed a very sharp rise in popularity during and after World War II. Other noteworthy examples of COCs include dieldrin and DDT. After research showed that organochlorines can be highly toxic to the ecosystem through bioaccumulation, most were banned from use. Before the ban, it was heavily used as a pesticide to treat seed and soil. Aldrin and related "cyclodiene" pesticides became notorious as persistent organic pollutants.

Measures of pollutant concentration are used to determine risk assessment in public health.

Exposure assessment is a branch of environmental science and occupational hygiene that focuses on the processes that take place at the interface between the environment containing the contaminant of interest and the organism being considered. These are the final steps in the path to release an environmental contaminant, through transport to its effect in a biological system. It tries to measure how much of a contaminant can be absorbed by an exposed target organism, in what form, at what rate and how much of the absorbed amount is actually available to produce a biological effect. Although the same general concepts apply to other organisms, the overwhelming majority of applications of exposure assessment are concerned with human health, making it an important tool in public health.

The no-observed-adverse-effect level (NOAEL) denotes the level of exposure of an organism, found by experiment or observation, at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects of the tested protocol. In drug development, the NOAEL of a new drug is assessed in laboratory animals, such as mice, prior to initiation of human trials in order to establish a safe clinical starting dose in humans. The OECD publishes guidelines for Preclinical Safety Assessments, in order to help scientists discover the NOAEL.

An occupational exposure limit is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials. It is typically set by competent national authorities and enforced by legislation to protect occupational safety and health. It is an important tool in risk assessment and in the management of activities involving handling of dangerous substances. There are many dangerous substances for which there are no formal occupational exposure limits. In these cases, hazard banding or control banding strategies can be used to ensure safe handling.

<span class="mw-page-title-main">Reproductive toxicity</span> A hazard associated with chemical substances

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. Reproductive toxicants may adversely affect sexual function, ovarian failure, fertility as well as causing developmental toxicity in the offspring. Lowered effective fertility related to reproductive toxicity relates to both male and female effects alike and is reflected in decreased sperm counts, semen quality and ovarian failure.

In analytical chemistry, biomonitoring is the measurement of the body burden of toxic chemical compounds, elements, or their metabolites, in biological substances. Often, these measurements are done in blood and urine. Biomonitoring is performed in both environmental health, and in occupational safety and health as a means of exposure assessment and workplace health surveillance.

The predicted no-effect concentration (PNEC) is the concentration of a chemical which marks the limit at which below no adverse effects of exposure in an ecosystem are measured. PNEC values are intended to be conservative and predict the concentration at which a chemical will likely have no toxic effect. They are not intended to predict the upper limit of concentration of a chemical that has a toxic effect. PNEC values are often used in environmental risk assessment as a tool in ecotoxicology. A PNEC for a chemical can be calculated with acute toxicity or chronic toxicity single-species data, Species Sensitivity Distribution (SSD) multi-species data, field data or model ecosystems data. Depending on the type of data used, an assessment factor is used to account for the confidence of the toxicity data being extrapolated to an entire ecosystem.

Tolerable weekly intake (TWI) estimates the amount per unit body weight of a potentially harmful substance or contaminant in food or water that can be ingested over a lifetime without risk of adverse health effects. TWI is generally preceded by "provisional" to indicate insufficient data exists, increasing uncertainty. The term TWI should be reserved for when there is a well-established and internationally accepted tolerance, backed by sound and uncontested data. Although similar in concept to tolerable daily intake (TDI), which is of the same derivation of acceptable daily intakes (ADIs), TWI accounts for contaminants that do not clear the body quickly and may accumulate within the body over a period of time. An example is heavy metals such as arsenic, cadmium, lead, and mercury. The concept of TWI takes into account daily variations in human consumption patterns.

Occupational toxicology is the application of toxicology to chemical hazards in the workplace. It focuses on substances and conditions that people may be exposed to in workplaces, including inhalation and dermal exposures, which are most prevalent when discussing occupational toxicology. These environmental and individual exposures can impact health, and there is a focus on identifying early adverse affects that are more subtle than those presented in clinical medicine.

<span class="mw-page-title-main">Toxicology of carbon nanomaterials</span> Overview of toxicology of carbon nanomaterials

Toxicology of carbon nanomaterials is the study of toxicity in carbon nanomaterials like fullerenes and carbon nanotubes.

<span class="mw-page-title-main">Occupational exposure banding</span> Process to assign chemicals into categories corresponding to permissible exposure concentrations

Occupational exposure banding, also known as hazard banding, is a process intended to quickly and accurately assign chemicals into specific categories (bands), each corresponding to a range of exposure concentrations designed to protect worker health. These bands are assigned based on a chemical’s toxicological potency and the adverse health effects associated with exposure to the chemical. The output of this process is an occupational exposure band (OEB). Occupational exposure banding has been used by the pharmaceutical sector and by some major chemical companies over the past several decades to establish exposure control limits or ranges for new or existing chemicals that do not have formal OELs. Furthermore, occupational exposure banding has become an important component of the Hierarchy of Occupational Exposure Limits (OELs).

Threshold dose is the minimum dose of drug that triggers minimal detectable biological effect in an animal. At extremely low doses, biological responses are absent for some of the drugs. The increase in dose above threshold dose induces an increase in the percentage of biological responses. Several benchmarks have been established to describe the effects of a particular dose of drug in a particular species, such as NOEL(no-observed-effect-level), NOAEL(no-observed-adverse-effect-level) and LOAEL(lowest-observed-adverse-effect-level). They are established by reviewing the available studies and animal studies. The application of threshold dose in risk assessment safeguards the participants in human clinical trials and evaluates the risks of chronic exposure to certain substances. However, the nature of animal studies also limits the applicability of experimental results in the human population and its significance in evaluating potential risk of certain substances. In toxicology, there are some other safety factors including LD50, LC50 and EC50.

References

  1. "IUPAC glossary of terms used in toxicology - terms starting with L". Environmental Health and Toxicology Specialized Information Services. U.S. Department of Health & Human Services. Retrieved January 9, 2016. based upon Duffus, J. H.; Nordberg, M.; Templeton, D. M. (2007). "Glossary of terms used in toxicology, 2nd edition (IUPAC Recommendations 2007)". Pure and Applied Chemistry. 79 (7): 1153. doi: 10.1351/pac200779071153 .
  2. NIOSH (March 2020). NIOSH Practices in Occupational Risk Assessment. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Publication No. 2020-106. doi:10.26616/NIOSHPUB2020106 . Retrieved 18 July 2024.
  3. Registries, EPA, OEI, SOR, System Of. "Terms & Acronyms".{{cite web}}: CS1 maint: multiple names: authors list (link)