T9: Risk assessment
19 important questions on T9: Risk assessment
What is the difference between risk and hazard?
Hazard: Potential danger of a compound or process
Risk assessment: the process by wich hazard, exposure and risk are determined.
How is the Estimated daily intake (EDI) calculated?
More advanced intake: probabilistic intake assessment.
Not all products have got the same concentration, so you can have a normal distribution of the concentration and also from the consumption and tis will give a normal ditribution of the intake., this is where you can calculate further.
What principle is used to determine what amount of exposure to an avoidable genotoxic (carcinogenic) contaminant will be allowed?
What principle is used to determine the amount of exposure to an unavoidable genotoxic (carcinogenic) contaminant will be allowed?
Unavoidable genotoxic contaminant: ALARA principle = make the exposure As Low As Reasonably Achievable
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How is risk asseszment done for the non-genotoxic compounds?
1/10 is sometimes a bit overdone, but risk assessment is a really strickt thing so it needs to be totally save.
What is done to make a risk assessment for non-genotoxic chemicals?
- BMD graph (Bench Mark Dose method)
- Calculate ADI or TDI
What is stated for risk characterization?
Margin of safety (MOS) =
ADI/EDI --> should be > 1
or
NOAEL or BMDL/ EDI --> should be > 100
Which items play a role in the process of toxicological risk assessment?
-risk characterization
-margin of safety approach
What is the difference between genotoxic and non-genotoxic?
What is zero tolerance?
For unavoidable contaminants there is an ALARA: as low as reasonably achievable.
Also there is a Virtual safe dose (VSD): Define dose with acceptable cancer risk per 10^6 consumers
And a MOE: margin of exposure
How do you extrapolate from the high dose of testing to the low dose of 1 per million?
Now, the following is done:
the MOE is calculated. This is done by BMDL10/EDI(human)
MOE: used by risk managers to set priorities
MOE > 10000 low priority for risk management.
When the risk assessment for a non-genotoxic compound is made, a risk characterization can also be made: the Margin Of Safety MOS, which expresses how close the human exposure levels are to the risk assessment levels. In what 2 ways is this calculated?
- Acceptable daily intake ADI / Estimated daily intake EDI
- NOAEL or BMDL / Estimated daily intake EDI
How do we calculate in vitro data to in vivo data?
The PBK model is used reverse.
In order for a non-genotoxic chemical to be deemed (?) according to the Margin of safety MOS, the outcomes of either calculation method
- ADI / EDI
- NOAEL or BMDL / EDI
should be equal to or higher than ... ?
- ADI / EDI > 1
- NOAEL or BMDL / EDI > 100
What types of risk assessment are used for unavoidable genotoxic chemicals?
- Virtual Safe Dose VSD: define dose with acceptable cancer risk, which is 1 in a million
- Margin of Exposure MOE: sets priority of risk management for cancer risks
- ALARA: As Low As Reasonably Achievable principle
What is reverse dosimetry?
Forward dosimetry: relate external toxic dose level to ctritical internal concentrations
Reverse dosimetry: Translate toxic in vitro concentrations to external toxic dose levels.
How do you calculate the Margin of Exposure to make a risk assessment for an unavoidable genotoxic chemical?
What value does the MOE have if the priority for risk management is NOT high?
MOE > 10000 --> low priority
MOE < 10000 --> higher priority
What is the difference between a MOS and a MOE?
MOE: for genotoxic carcinogenic compounds
How do you calculate the Estimated Daily Intake EDI of a chemical within products?
Most products use different concentrations of a chemical and there are different consumption rates for them. The EDI can only be estimated for certain points, but a more advanced assessment can be used to make a normal distribution that integrates the concentration x the consumption of a chemical. What is this assessment?
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