Pharmaceutical ERA•Regulatory Toxicology•PDE / OEL
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PDE / ADE · OEL / OEB

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Acoltremon PDE/ADE, OEL & OEB Assessment Profile

Project-specific health-based exposure limit and occupational toxicology assessment support. The agreed scope may include PDE/ADE derivation, OEL derivation and OEB/OHC banding, based on the exact substance form, available evidence and intended product or workplace context.

CAS Registry Number
68489-09-8
Molecular formula
C18H27NO2
Molecular weight
289.419 g/mol

Chemical identifiers are reproduced from the ToxWriter API catalogue for reference. Confirm the substance identity and relevant form, including any salt, hydrate or isomer, against authoritative source documentation when defining the assessment scope.

View request basketPrefer email? [email protected]
PDE / ADE derivationOEL derivationOEB / OHC banding
Assessment scope

PDE/ADE and occupational toxicology support

ToxWriter provides health-based exposure limit and occupational toxicology assessments for pharmaceutical substances. Depending on the assessment objective, the work may address PDE/ADE, OEL and/or OEB/OHC as separate scientific outputs.

Assessment services may include

  • PDE/ADE derivation using relevant toxicological evidence, critical effects, a justified point of departure and adjustment factors.
  • OEL derivation considering inhalation hazards, exposure duration and workplace context.
  • OEB/OHC banding where requested and supported by the evidence; a band is not itself a numerical OEL.
  • Review of substance form, evidence quality, uncertainty and data gaps.
Assessment considerations

Factors that determine the assessment scope

The required assessment depends on the substance form, intended use, exposure route, manufacturing or workplace conditions and the available toxicological evidence.

  • Exact substance form, route and intended product or manufacturing context.
  • Relevant exposure scenario, duration and workplace conditions.
  • Available toxicology studies and occupational exposure information.
Assessment deliverablesReports document the scientific rationale, source data, assumptions, adjustment factors, uncertainties and limitations relevant to the agreed scope.
PDE/ADE, OEL & OEB/OHC regulatory framework
PDE / ADE background →EMA health-based exposure limits (HBEL) guidelineECHA occupational exposure limits (OELs)NIOSH occupational exposure bandingHSE EH40 workplace exposure limits

The EMA HBEL guideline informs PDE/ADE assessments in relevant shared-facility contexts. ECHA and HSE sources address workplace exposure limits; NIOSH provides occupational exposure-banding guidance. The applicable framework depends on the assessment question and jurisdiction.