Toxicological Profiles
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Today’s Topic: Toxicological Profiles
Welcome to the latest edition of our Educational Fridays! The focus this week is on toxicological profiles. Our goal is to empower you with knowledge that enables informed decision-making and promotes a safer and healthier world.
A toxicological risk assessment (TRA) is a scientific process aiming to estimate the level of risk to health adverse effects due to exposure to a chemical or chemical mixture.
It is constituted of 4 stages: Hazard identification, Hazard characterisation, Exposure assessment and Risk characterisation.
Hazard identification and characterisation aim at the identification of the adverse effects of a given ingredient/substance with particular interest in pinpointing at what concentration/dose takes place the most relevant adverse effect for humans.
Commonly, this part of the risk assessment is addressed by building the “toxicological profile” of a substance. It is therefore very convenient for purposes of quality and quick turnaround to have a repository with many robust and QCed toxicological profiles prepared by trained toxicologists. At PCR, we have thousands of toxicological profiles prepared by well-experienced toxicologists.
A thorough toxicological profile must address all toxicological endpoints, typically:
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The evidence for adverse effects must be summarised for all endpoints. However, when screening the scientific evidence, particular attention must be paid on the lowest concentration which produces an adverse effect relevant to humans. This specific concentration is named Lowest Observable Adverse Effect Level (LOAEL). Our interest is in the concentration before the LOAEL which is called Non-Observable Adverse Effect Level (NOAEL).
The NOAEL is the concentration from which we will derive a safety level. Other concentrations can also serve as the point from which the safety level is derived e.g. a NOAEL is selected when there is no LOAEL, a LOAEL is selected when there is no NOAEL. The points from which the safety level is derived are also known as “point of departure” and they are critical for the risk assessment.
Typically, the safety level is derived by dividing the point of departure by 100 although there are variations to this. Such a division is introduced to account for interspecies (animal to human) and intraspecies (between humans) differences. Hence, it is an additional element of conservativity to the several applied during a risk assessment.
Finally, the safety level is compared to the exposure estimates. However, this already belongs to further stages of the risk assessment process.
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Thank you for reading this latest entry! We hope that the information shared has enhanced your understanding of toxicological profiles. We look forward to bringing you more valuable insights in our upcoming newsletter about California Proposition 65!
If you want have any queries about the latest entry, don’t hesitate to contact us at [email protected]. We are here to help!