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Elements of Toxicology and Guidelines
Published in T.S.S. Dikshith, and Safety, 2016
The toxicological evaluations related to human safety of chemical substances is a very complex process. It involves the determination of the intrinsic toxicity and hazard of the test chemical(s). Subsequently, this evaluation leads to determining and establishing a “no observed effect level” (NOEL), the highest dose level tested experimentally that does not produce any adverse effects. This dose level is then divided by a “safety factor” to establish an acceptable daily intake (ADI) of the candidate chemical substance. The ADI value is normally based on current research, long-term studies on species of laboratory animals with several doses including high doses. Subsequently the NOEL is scaled by a safety factor based on judgment, experience, and international convention. Typically, the safety factor ranges between 100 and 1000, depending on the biologic relevance and severity of the observed effect, to extrapolate the differences between test animals and humans. This provides a substantially lower level and thus a large margin of safety for humans.
Nomenclature and Terminology
Published in Jack Daugherty, Assessment of Chemical Exposures, 2020
Two common dose terms in exposure and risk assessments are maximum daily dose (MDD) and lifetime average daily dose (LADD). The MDD is simply the maximum expected dose for any given day. The LADD is a term frequently used in carcinogenicity risk studies. It is the MDD averaged over the fraction of a life span that includes exposure to the chemical of concern (COC), considering factors such as age, sex, state of health, tobacco use, and occupational exposures, among others. Acceptable daily intake (ADI) is a unit of risk based on NOELs and a safety factor based on variation of response in order to protect most people.
Risk Assessment in the Remediation of Hazardous Waste Sites
Published in Donald L. Wise, Debra J. Trantolo, Remediation of Hazardous Waste Contaminated Soils, 2018
Stephen T. Washburn, Jill Warnasch, Robert H. Harris
NOAELs and LOAELs are divided by safety (or uncertainty) factors to obtain an acceptable daily intake (ADI) for the chemical. An ADI represents a dose expected to present no health risk over a specified period of exposure (e.g., a lifetime). Safety factors adjust for limitations and uncertainties in the toxicity data, and for differences between the conditions under which the toxicity data were collected and the conditions of actual human exposure. They also adjust for variability in susceptibility in the human population, and for imprecision in extrapolating from laboratory animals to humans.
Evaluation of greener solvents for solid-phase peptide synthesis
Published in Green Chemistry Letters and Reviews, 2021
Katarzyna Wegner, Danielle Barnes, Kim Manzor, Agnieszka Jardine, Declan Moran
The most reported method for the reduction of hazardous solvents in peptide synthesis involves investigating alternative, greener solvents for peptide synthesis that provide the desired function (solubility and separability) without the undesirable chemical properties that cause environmental, health and safety issues (22–25). Currently, the most commonly used solvent in SPPS is DMF, which due to its highly reprotoxic nature, has been classified as a Substance of Very High Concern (SVHC). This classification has influenced the scientific community to investigate greener solvents to replace hazardous polar aprotic solvents which are still widely used for SPPS today (26). The EPA state that N,N-dimethylformamide has been determined to be a systemic toxicant. An Acceptable Daily Intake (ADI), defined as the amount of a chemical to which humans can be exposed on a daily basis over an extended period of time (usually a lifetime) without suffering a deleterious effect, for N,N-dimethylformamide is 0.096 mg/kg/day for oral exposure (27, 28).