SED · MoS · Evidence
Calculate SED and MoS. Review the basis.
Connect your formula, product use and raw material evidence. Calculate suitable exposure and MoS values and identify gaps for safety assessment.
One calculation path. A visible basis.
The software brings suitable inputs together. This schematic example connects exposure, the toxicological basis and the professional review that follows.
Calculation with traceable evidence
Schematic workflow without invented dose values
Formula and use
Current formula, substance fraction and intended product use.
Exposure and absorption basis
Suitable product use data and dermal absorption: evidence or an explicitly labelled assumption.
SED: systemic exposure dose
Product exposure × substance fraction × absorbed fraction
Simplified relationship with compatible inputs and units. Depending on the data, a value, range or upper bound; missing information remains visible.
Suitable systemic PoD
A suitable toxicological starting point with its endpoint, route, unit and source. Any required systemic derivation must remain traceable.
MoS: Margin of Safety
MoS = suitable systemic PoD ÷ SED
With a suitable basis and compatible units. SED may be available while MoS remains open without an appropriate PoD.
Prepare the professional review
Review sources, assumptions and outstanding questions together. A calculation alone does not confirm product safety or market clearance.
From formula to traceable preparation
Connect the formula and product use
Start with the current formula and intended use. Systemic exposure relates to the product as used; it is not a fixed property of a raw material.
Review suitable raw material evidence
Use suitable confirmed profiles and available references. Identity, material form, scope, study context and original sources must match the actual use.
Review exposure and dermal absorption
Review product use, substance fraction and the absorption basis. Your own entries, source values and labelled model assumptions remain distinguishable.
Calculate SED and, where possible, MoS
INCIkit shows calculable exposure values and suitable MoS results. Ranges, upper bounds and missing information remain visible. Without a suitable systemic PoD, SED may be available while MoS remains open.
Work through gaps and documentation
Add missing evidence and review sources and assumptions. Save edited information and available evidence through the relevant workflow. The final professional safety assessment remains a separate step.
Work with traceable inputs
See where values come from
Trace available study values and calculation inputs to their sources. A suitable NOAEL or BMDL retains its endpoint, route and any systemic derivation.
Recognise information gaps
Incomplete information is not hidden behind one result. Values, ranges, upper bounds and missing prerequisites remain distinct.
Distinguish assumptions from measurements
See whether an absorption basis comes from suitable evidence or a labelled assumption. Reference assumptions have their own scope of application.
Review changes deliberately
Current formula and product inputs are compared in the relevant reading and saving workflows. Outdated references can be identified while historical versions remain intact.
What the calculation prepares
SED is the estimated systemic exposure dose. MoS compares it with a suitable systemic Point of Departure, or PoD. The connected dermal calculation path uses suitable NOAEL or BMDL evidence. An LD50 value or an inhalation concentration is not an automatic substitute.
Route, unit and systemic basis must match. A value that is already systemic is not corrected again. The applicability of a dermal absorption assumption depends on market, material form, target population and application site. A conservative assumption does not resolve conflicting evidence.
The software prepares calculations and documentation. A result is neither a signed safety assessment nor market clearance. Sources, assumptions, gaps and suitability for the actual product still require professional judgement.
Calculation, editing and file output are separate services. Changes require the appropriate team role and active write access. In regular paid plans, CPSR PDFs require Professional or Enterprise; PIF PDFs are included from Starter. Document type and export limits still apply.
SED and MoS preparation questions
Does INCIkit complete the safety assessment?
INCIkit calculates suitable SED and MoS values and organises evidence, assumptions and gaps. It does not replace the required final assessment by a qualified professional. An unremarkable MoS alone does not clear a product.
Can SED be calculated without MoS?
Yes, when the exposure inputs are sufficient. If a suitable systemic PoD is missing, SED can still be calculable while MoS remains open. The software distinguishes these cases.
Which toxicological starting points are supported?
The connected dermal path supports suitable NOAEL and BMDL evidence with an appropriate route, unit and systemic derivation. Other endpoints are not simply renamed. Source values must be suitable for the substance and use.
Are absorption assumptions measured values?
No. Evidence and assumptions remain distinct. The published SCCS dermal absorption default is connected to the EU/Northern Ireland context with a suitable standard material form, target population and application site. Explicit conservative full absorption can only be used without genuine conflicting evidence. This does not create blanket clearance for other markets.
What happens after a formula changes?
Current inputs and references are compared during the relevant reading, saving or document workflow. Review outdated evidence and continue with suitable current information. Earlier versions are not silently overwritten; continuous background updating is not assumed.
Which plan do I need?
Automatic SED/MoS preparation and available references in the safety workflow are available on all paid plans. Editing and saving require the appropriate write role and active write access. Regular CPSR PDF output requires Professional or Enterprise; an effective Professional trial has its own access and limits. PIF PDFs are included from Starter. The existing EU PIF/CPSR preparation template is currently German; the English website does not automatically translate documents.