Points of departure data formats

Points of departure, such as NOAELS and BMDs, describe the critical/reference levels of substance dose in relation to the presence or absence of an effect. If available, the uncertainty of externally specified points of departure can be specified with uncertainty sets (empirical distributions representing possible values) in the points of departure uncertainty table.

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Points of departure

Nominal points of departure should be presented in this table. Each point of departure should be linked to an effect using the effect code (idEffect) and to substances using the substance code (idSubstance).

Table aliases: PointsOfDeparture, PointOfDeparture, HazardDoses, HazardDose.

Table 167 Table definition for Points of departure.
Name Type Description Aliases Required

idModel

AlphaNumeric(50)

The dose response model code.

idDoseResponseModel, idModel, idPod, idPointOfDeparture, Pod, PointOfDeparture

No

idEffect

AlphaNumeric(50)

The effect code.

idEffect, EffectId, Effect

Yes

idSubstance

AlphaNumeric(50)

The code of the substance.

idSubstance, SubstanceId, SubstanceCode, Substance

Yes

Species

AlphaNumeric(50)

The species used to obtain this point of departure.

Species, System

No

Point of departure

Numeric

Point of departure, can be of various types, e.g. NOAEL, LOAEL, BMD, CED

PointOfDeparture, LimitDose, HazardDose, Value, CED

Yes

Point of departure type

PointOfDepartureType

The type of the point of departure: e.g. NOAEL, LOAEL, BMD (default).

PODType, HazardDoseType, LimitDoseType

No

DoseUnit

DoseUnit

The dose unit (if not specified, then mg/kg is assumed).

DoseUnit, UnitDose

No

Benchmark response (BMR)

AlphaNumeric(100)

The effect size.

BenchmarkResponse, CriticalEffectSize, HazardEffectSize

No

ExposureRoute

ExposureRouteType

The route of dose administration used in the study to obtain this point of departure. If not specified exposure route = Dietary is assumed.

ExposureRoute, RouteExposure

No

IsCriticalEffect

Boolean

Specifies whether this value is the value associated with the critical effect. If omitted, No is assumed

IsCriticalEffect

No

Points of departure uncertainty

Often, the PODs found for a substance/effect combination are uncertain. This table facilitates in specifying the POD uncertainty in the form of a set of uncertainty values that may additionally be specified for a substance/effect combination.

Table aliases: PointsOfDepartureUncertain, PointOfDepartureUncertain, HazardDosesUncertain, HazardDoseUncertain.

Table 168 Table definition for Points of departure uncertainty.
Name Type Description Aliases Required

idDoseResponseModel

AlphaNumeric(50)

The dose response model code (must correspond to values in id column of DoseResponseModels table).

idDoseResponseModel

Yes

idUncertaintySet

AlphaNumeric(50)

The identification code of the uncertainty set. During an uncertainty iteration one set will be picked to be the POD value.

idUncertaintySet, UncertaintyId

Yes

idEffect

AlphaNumeric(50)

The effect code.

idEffect, EffectId, Effect

Yes

idSubstance

AlphaNumeric(50)

The code of the substance.

idSubstance, SubstanceId, SubstanceCode, Substance

Yes

Point of departure

Numeric

Point of departure, can be of various types, e.g. NOAEL, LOAEL, BMD, CED

PointOfDeparture, HazardDose, LimitDose, CED

Yes

DoseResponseModelParameterValues

AlphaNumeric(200)

A comma separated list of the values of the parameters of the model, format: a=1.2,b=3.4,c=5.6

DoseResponseModelParameterValues, ParameterValues

No