Hazard characterisations
Hazard characterisations are reference exposure values for active substances at the chosen biological target level (external or internal). Hazard characterisations may be specified for specific effects or for the critical effect as defined in hazard characterisation. Hazard characterisations are specified as external values (e.g. human based guidance values, such as ADI or ARfD) or are based on points of departure, such as BMD(L)s from dose-response models or externally specified points of departure (NOAEL, LOAEL, MDS). The computation may involve assessment factors, e.g. for inter-species conversion, intra-species variation or additional sources of uncertainty. The calculation may also use kinetic conversion factors, PBK models or absorption factors to convert external doses to internal concentration/doses or vice versa.
This module has as primary entities: Substances Effects Populations
Output of this module is used by: Active substances Relative potency factors Risks Single value risks
Hazard characterisations as data
Inputs used: AOP networks Active substances Points of departure
Settings used
Calculation of hazard characterisations
Hazard characterisations can be computed from points of departure. The computation may involve assessment factors, e.g. for inter-species conversion, intra-species variation or additional sources of uncertainty. The additional assessment factor can be used to bypass inter- and intra species conversion, or as an additional assessment factor to account for extrapolation for sources where appropriate data or information is scarce or missing (e.g. to implement a mixture assessment factor). The hazard characterisation calculation may also use kinetic conversion factors, PBK models or absorption factors to convert external doses to internal doses/concentrations or vice versa.
Inputs used: Dose response models Effect representations Inter-species conversions Intra species factors Absorption factors Kinetic conversion factors PBK model parametrisations
Settings used
Settings and Tiers
- Hazard characterisations settings
- Hazard characterisations tiers
- Retrospective dietary CRA (EC 2018) - Acute / Tier I
- Retrospective dietary CRA (EC 2018) - Chronic / Tier I
- Retrospective dietary CRA (EC 2018) - Acute / Tier II
- Retrospective dietary CRA (EC 2018) - Chronic / Tier II
- Retrospective dietary CRA (EFSA 2012) - Optimistic
- Retrospective dietary CRA (EFSA 2012) - Acute / Pessimistic
- Retrospective dietary CRA (EFSA 2012) - Chronic / Pessimistic
- Retrospective dietary CRA (EFSA 2022) - Acute / Tier I
- Retrospective dietary CRA (EFSA 2022) - Chronic / Tier I
- Retrospective dietary CRA (EFSA 2022) - Acute / Tier II
- Retrospective dietary CRA (EFSA 2022) - Chronic / Tier II
- Prospective dietary CRA (EFSA 2023) - Acute / Tier II
- Prospective dietary CRA (EFSA 2023) - Chronic / Tier II