Hazard characterisations data formats

Hazard characterisations provide reference threshold values associated with the hazard of interest. Examples are health-based guidance values such as ADI or ARfD, and points of departure such as BMD or NOAEL.

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Hazard characterisations

Hazard characterisations are specified for combinations of hazard characterisation type, effect, substance, population type, target level, and exposure route (for external) or target organ (for internal). Effects can be specific, but can also be labelled as being the critical effect and used as such if this has been specified in the hazard characterisation settings.

Accepted table names: HazardCharacterisations.

Table 198 Table definition for Hazard characterisations.

Name	Type	Description	Aliases	Required
idHazardCharacterisation	AlphaNumeric (50)	Id of the hazard characterisation.	id, idHazardCharacterisation	Yes
idEffect	AlphaNumeric (50)	Code of the (critical) effect linked to this hazard characterisation.	idEffect, EffectId, Effect, EffectCode	No
idSubstance	AlphaNumeric (50)	The code of the substance.	idSubstance, SubstanceCode, SubstanceId, Substance	Yes
idPopulationType	AlphaNumeric (50)	The code of the population type for which this reference value is defined. If not specified, PS06A, Consumers is assumed.	idPopulationType, PopulationType, PopulationGroup, PopulationSubgroup	No
TargetLevel	TargetLevelType	The target level. I.e., internal or external. If omitted, external is assumed	TargetLevel	No
ExposureRoute	ExposureRouteType	The exposure route (only applicable if target level is external). If not specified, Dietary is assumed.	ExposureRoute	No
Matrix	BiologicalMatrix	The biological matrix or organ (should be specified when target level is internal).	Matrix, BiologicalMatrix	No
Expression type	ExpressionType	The expression type for (internal) hazard characterisations of which the concentrations are not directly specified at the level of the biological matrix. For instance, urinary expressions expressed in terms of the amount excreted per gram of creatinine or blood concentration expressed per gram of lipids.	ExpressionType	No
IsCriticalEffect	Boolean	Specifies whether this value is the value associated with the critical effect. If omitted, No is assumed	IsCriticalEffect	No
ExposureType	ExposureType	The exposure type associated with the hazard characterisation (i.e., chronic or acute).	ExposureType	Yes
HazardCharacterisationType	HazardCharacterisationType	The type of the hazard characterisation (e.g., ARfD, ADI, NOAEL, BMD).	HazardCharacterisationType	Yes
Qualifier	ValueQualifier	Qualifier of the hazard characterisation value, e.g. equal-to (=) or smaller-than (<). If omitted, = is assumed.	QualifierType	No
Value	Numeric	Reference value that characterises the hazard.	Value, HazardCharacterisationValue	Yes
DoseUnit	DoseUnit	Unit of the hazard characterisation value.	DoseUnit, Unit	Yes
idPointOfDeparture	AlphaNumeric (50)	The code of the point of departure from which this hazard characterisation was derived.	idHazardDose, idPod	No
CombinedAssessmentFactor	Numeric	Combined assessment factor (includes, e.g., safety factor, but also other extrapolation factors that may be used to derive the hazard characterisation from the underlying PoD).	CombinedAssessmentFactor, AssessmentFactor, UncertaintyFactor	No
PublicationTitle	AlphaNumeric (250)	Title of the publication of the study in which this hazard characterisation was established.	PublicationTitle, Title	No
PublicationAuthors	AlphaNumeric	Author(s) of the publication of the study in which this hazard characterisation was established.	PublicationAuthors, PublicationAuthor, Author, Authors	No
PublicationYear	Integer	Year of the publication of the study in which this hazard characterisation was established.	PublicationYear, Year	No
PublicationUri	AlphaNumeric	Uniform resource identifier of the reference publication.	URI, URL, PublicationURI, PublicationURL	No
Name	AlphaNumeric (100)	Name of the hazard characterisation.	Name	No
Description	AlphaNumeric (200)	Additional description of the hazard characterisation.	Description	No

Hazard characterisations uncertainty

Often, the hazard characterisations found for a substance are uncertain. This table facilitates in specifying the hazard characterisation uncertainty in the form of a set of uncertainty values that may additionally be specified for a hazard characterisation model - substance combination.

Accepted table names: HazardCharacterisationsUncertain, HazardDoseUncertain, HCUncertain.

Table 199 Table definition for Hazard characterisations uncertainty.

Name	Type	Description	Aliases	Required
idHazardCharacterisation	AlphaNumeric (50)	The hazard characterisation model code (must correspond to values in id column of Hazard characterisations table).	idHazardCharacterisation	Yes
idSubstance	AlphaNumeric (50)	The code of the substance.	idSubstance, SubstanceId, SubstanceCode, Substance	Yes
HazardcharacterisationValue	Numeric	Reference value that characterises the hazard.	HazardCharacterisation, HazardCharacterisationValue	Yes