Lecture 7 Questions Flashcards
What are uncertainty factors used for in toxicology?
To account for variability in human sensitivity and gaps in data when estimating safe exposure levels.
What key concept does a dose-response curve illustrate?
The relationship between the dose of a substance and the severity of its effect.
What is regulatory toxicology?
A subfield of toxicology focused on applying toxicological principles to establish and enforce regulations protecting human health and the environment.
How is Reference Dose (RfD) calculated?
RfD = NOAEL / Uncertainty Factors.
What are the four basic steps in risk assessment?
Hazard identification, dose-response assessment, exposure assessment, and risk characterization.
What is NOAEL?
No Observed Adverse Effect Level – the highest dose at which no adverse effects are observed.
What is LOAEL?
Lowest Observed Adverse Effect Level – the lowest dose at which adverse effects are observed.
What are common exposure pathways for toxic substances?
Inhalation, ingestion, and dermal contact.
What does the REACH regulation aim to do?
Protect human health and the environment from chemical risks by requiring registration, evaluation, and authorization of chemicals in the EU.
What health effects are associated with exposure to Xylochlorine (XC)?
Neurotoxicity, nervous system dysfunction, and developmental delays.
What concentration of Xylochlorine (XC) leads to bioaccumulation in aquatic ecosystems?
5 ppm.
Why is Titanium Dioxide a regulatory concern?
It is classified as possibly carcinogenic to humans (Group 2B by IARC).
What are the three types of hazards in toxicology?
Physical, chemical, and biological hazards.
What are the components of the ICH guidelines?
Harmonized safety standards for pharmaceuticals, including carcinogenicity, genotoxicity, reproductive toxicity, and safety pharmacology.
What is the purpose of the Globally Harmonized System (GHS)?
To standardize hazard classification and labeling of chemicals across countries.
What was the impact of Harvey Wiley’s ‘Poison Squad’?
It led to the 1906 Pure Food and Drug Act and eventually the creation of the FDA.
What are two agencies where regulatory toxicologists might work?
FDA (Food and Drug Administration) and EPA (Environmental Protection Agency).
What are four main roles of regulatory toxicologists?
Risk assessment, compliance & regulations, data review & interpretation, and policy development.
What is the difference between a regulation, a policy, and a guideline?
Regulation has the force of law; a policy is a set of principles; a guideline interprets regulations and offers direction but isn’t legally binding.
