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. Hazard characterisations may be dependent on e.g. age (or gender not implemented yet)

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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 275 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

ExposureRoute

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, HazardCharacterisationsUncertai, HazardDoseUncertain, HCUncertain.

Table 276 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

Hazard characterisations subgroups

Hazard characterisations are dependent on e.g. age.

Accepted table names: HCSubgroups, HCSubgroup.

Table 277 Table definition for Hazard characterisations subgroups.
Name Type Description Aliases Required

idSubgroup

AlphaNumeric (50)

The id of the subgroup.

idSubgroup

Yes

idHazardCharacterisation

AlphaNumeric (50)

Id of the hazard characterisation.

idHazardCharacterisation

Yes

idSubstance

AlphaNumeric (50)

The code of the substance.

idSubstance, SubstanceId, SubstanceCode, Substance

Yes

AgeLower

Numeric (50)

Specifies the lower bound of the age interval (in years) of the hazard characterisation subgroup. Individuals belong to a subgroup when the age of the individual is equal or greater than the specified lower bound and smaller than the specified lower age of the next subgroup.

AgeLower, LowerAge

No

Gender

GenderType

The gender of the subgroup.

Gender

No

Value

AlphaNumeric (50)

The hazard characterisation of the subgroup.

Value

Yes

Hazard characterisations subgroups uncertainty sets

Hazard characterisations are dependent on e.g. age and may be uncertain.

Accepted table names: HCSubgroupsUncertain, HCSubgroupUncertain.

Table 278 Table definition for Hazard characterisations subgroups uncertainty sets.
Name Type Description Aliases Required

idSubgroup

AlphaNumeric (50)

The id of the subgroup.

idSubgroup

Yes

idHazardCharacterisation

AlphaNumeric (50)

Id of the hazard characterisation.

idHazardCharacterisation

Yes

idUncertaintySet

AlphaNumeric (50)

The id of the ucertainty set.

idUncertaintySet, idUncertaintySet, idUncertainty

Yes

Value

AlphaNumeric (50)

The uncertain hazard characterisation of the subgroup.

Value

Yes