TOXRA.AI | Co-pilot for Toxicological Risk Assessment

AI-POWERED TOXICOLOGY AND RISK ASSESSMENT

Co-pilot for toxicological risk assessment.

It does the stitching. You make the call.

Search 51 data sources, run rule-based and statistical QSAR side by side, map evidence to six frameworks and generate a source-traced report, with every value open to your judgment. Start free with 5 chemical searches.

Free: 5 chemical searches. No card required.

Name
7,9-Di-tert-butyl-1-oxaspiro[4.5]deca-6,9-diene-2,8-dione
CAS
82304-66-3
FORMULA
C17H24O3
SMILES
CC(C)(C)C1=CC2(CCC(=O)O2)C=C(C1=O)C(C)(C)C
  • 51federated data sources
  • 2independent QSAR engines
  • 6versioned frameworks
  • Every value traced to its source

Built for the toxicologist who signs the assessment.

  • Pharma impurities (ICH M7)
  • Medical devices (E&L)
  • Cosmetics
  • Food contact
  • Tobacco & PMTA
  • CROs & consultancies

THE PROBLEM

The science took an hour. The stitching took three weeks.

IRIS for the reference dose. PubChem for identifiers. ECHA for the REACH dossier. Then ATSDR, IARC, PubMed. Then a spreadsheet named v7_FINAL that is not final.

Two sources disagree on the same endpoint, and nothing on either page tells you which one outranks the other. Three endpoints have no data at all, and the assessment still has to say something about them.

None of that is science.

WHY THIS IS BUILT THE WAY IT IS

A risk assessment is not a report. It is a position someone defends.

When a value is questioned, the question goes to the person who signed the assessment, not to the database it came from. Sometimes years later.

Which is why toxicologists are right to distrust automation. Speed usually arrives by removing the ability to check, and a professional who cannot check cannot sign.

TOXRA.AI is built inside that constraint. Make the stitching disappear. Leave the reasoning visible.

THE INSTRUMENT

Not a better search engine.

Lookup is the cheap half of the problem. The expensive half starts once the data is in front of you: reconciling it, filling what is missing, testing it against a framework, and turning it into something that survives review.

So this is an assessment instrument, not a search product. One chemical context that follows you from first identifier to signed report, with the seams left visible on purpose.

51
FEDERATED DATA SOURCES
6
VERSIONED REGULATORY FRAMEWORKS
1
WORKSPACE, THE WHOLE PIPELINE

INFER

For most chemicals, the study you need was never done.

No amount of searching fixes that. And regulation is moving away from generating it, toward new approach methodologies, which squeezes the assessor from both sides at once: less data, and less licence to go and make more.

What is left is inference from structure. That is legitimate science with one condition attached. A prediction that cannot explain itself is worthless to the person who has to defend it, however accurate it happens to be.

PREDICT · IN SILICO NAMs (QSAR)

ICH M7 does not ask for a prediction. It asks for two.

One expert rule-based, one statistical. Two methods that reason differently, run against the same molecule, with their agreement or disagreement reported. That is not bureaucracy. It is epistemology written into regulation.

Law reached the same split about fourteen hundred years earlier.

7,9-Di-tert-butyl-1-oxaspiro[4.5]deca-6,9-diene-2,8-dione
CAS 82304-66-3FORMULA C17H24O3

PANDECTA

THE RULE-BASED ENGINE

A structural alert is a statute. PANDECTA reads it that way: this substructure, in this context, indicates this concern, for these documented reasons.

The story behind the name

In 533, Justinian's jurists compressed a thousand years of legal opinion into fifty books and named the result from the Greek for all-receiving. Then he forbade commentary on it, because a code anyone may reinterpret is no longer a code.

  • 78 active alerts, authored in a clean room from seven families of primary literature. Not ported from a commercial library, and never fitted to the set used to test them.

  • 0.844 sensitivity at the alert layer against Hansen 2009, out-of-sample for the rule layer.

  • Silence is reported as silence. A structure that fires nothing returns nothing to report inside the domain. It is never returned as safe.

PRECEDENTA

THE STATISTICAL ENGINE

PRECEDENTA holds no rule about mutagenicity at all. It finds the tested chemicals structurally nearest the query and reasons from them.

The story behind the name

Common law worked in reverse. From about 1166 no code came first. Judges decided individual cases, those decisions were reported, and the accumulated record became binding on the next case. It grew stronger as the record grew larger.

  • Trained on curated experimental data. Assays reconciled to a consistent protocol, structures standardised and de-duplicated, contradictory records resolved rather than averaged, and the result held to a defined chemical space. Validation is external, because a model scored against the data it was fitted to will flatter itself.

  • ROC-AUC 0.897 on a locked internal hold-out (n=1,228). On a genuinely external set the model never saw in training — the EPA CompTox-genetox Ames panel (n=1,048) — sensitivity is 0.849 at 0.981 negative predictive value. The Hansen 2009 set scores higher, but it is 99.6 percent folded into training, so that figure is resubstitution, not external.

  • The threshold is sensitivity-biased on purpose, holding false negatives to 7.9 percent on the internal hold-out. A false alarm is resolved by the next assay in the sequence. A missed mutagen travels forward into development. Those are not comparable errors, and the trade is deliberate.

  • It abstains. Conformal prediction defines a gray zone, and structures falling inside it are returned as inconclusive and routed to expert review rather than classified badly. Within confident calls, specificity is 0.89 to 0.91.

  • It shows its neighbours. The analogues that drove the result arrive with their measured outcomes and their structural similarity, so the reasoning can be read the way a lawyer reads the cases a judgment rests on.

When they agree, and when they do not.

Pandect and precedent. Rome in 533, England from 1166. Deduction from a code, induction from decided cases. The two traditions were rivals rather than a designed pair, and we are borrowing the contrast rather than claiming otherwise. What neither could do is run both methods against the same molecule and hand you the reconciliation.

Concordance is a strong position and ICH M7 treats it as one. Divergence is the more valuable output, because it identifies the exact compound where judgment is required and shows why. Here is the rule that fired. Here are the analogues that disagree with it.

PANDECTA · RULE-BASEDPOSITIVE

2 alerts fired

alpha,beta-Unsaturated carbonyl (generic Michael acceptor)
grade probable
alpha,beta-Unsaturated ketone (enone)
grade plausible
PRECEDENTA · STATISTICALNEGATIVE
P(positive)11.7% · threshold 0.190
nearest analoguesim 0.421 · AD 0.350
conformal reliabilityconfident
CONCORDANCE: DISCORDANT NEGATIVE CONCLUSION SUPPORTED: NO EXPERT REVIEW REQUIRED: YES ICH M7 CLASS 3
FIVE NEAREST TESTED ANALOGUES TO CAS 82304-66-3, BY STRUCTURAL SIMILARITY
SIMILARITY ANALOGUE CAS EXPERIMENTAL
0.4212,6-Di-tert-butyl-4-methyl-4-tert-butylperoxy-2,5-cyclohexadienone13154-57-9Ames −
0.3333,3',5,5'-Tetrabis(tert-butyl)stilbenequinone809-73-4Ames −
0.3032,5-Di-tert-butylbenzoquinone2460-77-7Ames −
0.302Dihydrojasmone lactone7011-83-8Ames −
0.2973,3'-Di-tert-butylbiphenyldiquinone-(2,5,2',5')14160-38-4Ames +

Four of the five nearest tested compounds came back negative, which is why the statistical leg said negative. The enone is why the rule leg said positive. Both are visible, and the assessor decides.

Read-across. Precedent applied deliberately rather than statistically. Analogues named, justification built, the grouping yours to accept or reject. Read-across holds up when the rationale is documented, so the rationale is the deliverable.

Carcinogenicity weight of evidence. Never one number. Classifications from multiple authorities, genotoxicity findings, mechanistic evidence and structural concerns, assembled as strands you can weigh rather than collapsed into a verdict.

EVALUATE · ASSESSMENTS AND FRAMEWORKS

Knowing the framework is not the same as mapping your evidence to it.

The work is walking the clause list and showing, for each clause, what evidence satisfies it and where the record is thin.

TOXRA.AI evaluates against six versioned frameworks at clause level and reports data sufficiency per clause. A populated field is not evidence. TOXRA.AI shows, clause by clause, what evidence sits where and where the record is thin.

Exposure is modelled with EPA standard scenarios feeding straight into chronic daily intake. The calculators are the ones already in use: ELCR, MOE, MOS, RfD and TTC, with dose unit conversion handled rather than done twice by hand. Every figure keeps its audit trail, and every assessment records which version of the framework judged it.

AUTHOR · ASSESSMENTS AND REPORTS

Save the time. Keep the pen.

COMING SOON

The objection is never whether it is fast. It is what happens to your judgment. A tool that produces something plausible by means you cannot inspect costs you time, because you redo the work by hand before you put your name on it.

Assessments, coming soon: one way to work, and you are in charge of all of it.

Every assessment will arrive as a draft that is already built: subheads, values and sources in place. You delete what is excess, add what is missing and write your narrative underneath. Then you accept it, page by page.

Every model output will be a proposal, not a verdict. A QSAR call, a hazard classification, an ICH M7 class, a risk tier: override any of them, at any point. Nothing is locked, and every change you make is recorded.

Already use other prediction tools? You will be able to bring their outputs in. They sit inside the assessment as a distinct, clearly labelled evidence class, next to TOXRA.AI's own.

For triage, take the draft as it stands: twelve candidate impurities, find the one that matters in minutes. For the compound you will defend, work every page.

Until then, report generation works now: one chemical in, a source-traced draft report out.

The assessment ends when you can defend every line.

Built from the assessment, not retyped into it. Everything assembled and every decision made carries through into a source-traced document. The report is not a summary of the work. It is the work, formatted.

Pluck it out, plug it in. Not every assessment is going to live inside TOXRA.AI, and pretending otherwise would be a fiction. Sponsors have templates. Consultants have house formats. Submissions have prescribed structures. So any element lifts out into the document you are actually writing, with its traceability travelling along: a value with its provenance, a QSAR result with its analogues, a clause finding with its justification.

The audit trail. Every figure traceable to its source and version. Every override recorded with its reasoning. Every calculation reproducible, years later, when someone asks.

Export the finished assessment as a PDF.

Draft completeness check. Missing sections and thin evidence are flagged while you write, so you catch them before anyone else does.

TOXRA.AI does not sign assessments.*

It does not replace a qualified toxicologist and it is not built to. Every prediction carries an applicability domain, and the platform says when a query falls outside it. Every automated evaluation is a draft position for a professional to accept, amend or reject. Features in active development are labelled as such rather than presented as finished.

USE CASES

Different frameworks. The same three weeks of stitching.

  • Pharmaceutical impurity assessment

    ICH M7 across a candidate list, not one compound at a time.
  • Medical devices

    ISO 10993 extractables and leachables, at the scale an extractables study actually returns.
  • Cosmetics and personal care

    Safety assessment without new animal data.
  • Food contact and ingredients

    Migration and dietary exposure, with the sources reconciled.
  • Tobacco and PMTA

    FDA CTP tiering across long constituent lists.
  • CROs and consultancies

    Someone else's deadline on top of your own.

PLANS

Start free. Upgrade when the work is real.

Free

Try it on a compound you already know.

  • 5 chemical searches
  • No card required

Search & Literature

For the retrieval and evidence-gathering half of the job: every value found, every paper accounted for.

  • Chemical Search: one profile from 51 sources, with every value traced to its origin, conflicts flagged and gaps named.
  • Literature Extractor: pulls the relevant study details out of toxicology papers into a structured, source-linked form.
  • Systematic Review: runs a structured literature review, recording what was searched, screened and included, so the evidence base is documented.

In Silico

For chemicals where the study you need was never done: predictions that explain themselves.

  • QSAR (PANDECTA + PRECEDENTA): rule-based and statistical mutagenicity predictions run side by side, with agreement or disagreement reported.
  • Read-across: analogues named, justification built, grouping yours to accept or reject.

Assessments: COMING SOON

FAQ

Questions toxicologists ask us

Does TOXRA.AI replace a toxicologist?

No. It does the retrieval, reconciliation and drafting. A qualified toxicologist reviews, decides and signs.

Where does the data come from?

51 federated sources including EPA IRIS, PubChem, ECHA, ATSDR, IARC and PubMed, with every value traced to its source and version.

How are the QSAR models validated?

PANDECTA: 78 active alerts, 0.844 sensitivity at the alert layer against Hansen 2009, out-of-sample for the rule layer.

PRECEDENTA: ROC-AUC 0.897 on a locked internal hold-out (n=1,228); on the external EPA CompTox-genetox Ames panel (n=1,048), sensitivity 0.849 at 0.981 negative predictive value. The Hansen 2009 set scores higher, but it is 99.6 percent folded into training, so that figure is resubstitution, not external.

Can I override a prediction or classification? COMING SOON

Coming with Assessments: yes, any of them, at any point, with every change recorded.

Can I add predictions from other tools I already use? COMING SOON

Coming with Assessments: yes, as a separate, labelled evidence class.

What happens when the two QSAR engines disagree?

The result is flagged as discordant, both reasoning chains are shown and expert review is requested.

What does the free plan include?

5 chemical searches, no card required. Two packages, Search & Literature and In Silico, unlock the full toolset for each part of the work.

What can I export?

A PDF of the finished assessment; individual elements can be lifted into your own documents with their sources attached.

Who signs the assessment?

You do. TOXRA.AI does not sign assessments.

The science was never the slow part. Now the rest of it is not either.

One workspace, one traced chain of evidence, one document that holds up. Bring a compound you already know the answer to, which is the only demo worth sitting through.