ED criteria assessment under the ECHA-EFSA-JRC joint guidance (2018), weight-of-evidence reasoning that holds under peer review, and mode-of-action analysis for the endocrine designation.
An ED file built for evaluator scrutiny.
An ED assessment is judged on three things: whether each line of evidence has been read correctly, whether the WoE integration holds across modalities, and whether the conclusion would survive the alternative reading a reviewing authority could construct from the same dataset. Our work is structured around those three judgements — with lines of evidence, AOP key events and in vivo apical outcomes integrated into a single defensible position, not parallel files.
EATS modalities, AOP key events, in vivo apical outcomes — integrated into a single defensible position, not parallel files.
Across the ED lifecycle, from early screening through to formal commenting rounds — concrete points where senior endocrine input shapes the file.
From (Q)SAR screening to EFSA peer review — the same MoA reasoning, applied at every stage.
An open screening tool built on the same OECD Conceptual Framework we use in formal assessments — for portfolio-level visibility before deeper work is commissioned.
Active substance registrants preparing ED assessment for approval or renewal under BPR or PPP. Biocide consortia where a co-formulant has been flagged as an ED suspect. REACH registrants requiring CLP ED hazard classification assessment under the new ED HH and ED ENV hazard classes. REACH registrants on a CoRAP list where ED is one of the concerns raised.
An active substance under BPR renewal carried isolated mechanistic signals across two EATS modalities, with apical findings in repeated-dose studies that the previous dossier had framed as endocrine-mediated. The client needed a defensible EATS WoE before peer review, with the MoA position re-examined against current ECHA-EFSA criteria.
The substance had positive in vitro receptor interaction findings on the estrogenic axis and a thyroid signal in subchronic studies. Apical reproductive and thyroid-weight findings had been argued in the existing dossier as endocrine-mediated adverse outcomes. Closer reading of the dataset suggested the apical findings were consequential to oxidative stress at systemically toxic doses, but the existing WoE had not separated activity from adversity at the depth required under the 2018 ECHA-EFSA guidance. Peer-review feedback was anticipated to challenge the ED conclusion as under-evidenced in either direction.
Outcome. A full EATS WoE dossier concluding that the substance did not meet the ED criteria, with the conclusion supported by modality-by-modality reasoning, structured MoA analysis and documentation of the alternative oxidative stress pathway. The dossier was structured to anticipate peer-review questions on each pillar, with responses tied to specific lines of evidence rather than narrative restatement.
Most ED conversations start in one of these five places. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.
When the data show an adverse effect, an endocrine mode of action, and a biologically plausible link between them — with the adversity considered population-relevant. The dossier needs explicit reasoning on each of those three pillars, per modality. Our role is to make sure each pillar is argued at the depth the evaluating authority will read it at.
We anchor the MoA to a defined AOP where one is available, apply the IPCS-ILSI human-relevance framework, and develop species-specific reasoning on the kinetic and metabolic determinants — UDP-glucuronosyltransferase activity, half-life and binding-globulin profile being the typical decision points. The strength of the argument depends on the underlying data; our role is to make sure the available evidence is integrated in a way that holds.
Yes. We screen co-formulants under CG-50-2022-05 AP 16.6 and the CA-March21-Doc.4.3 flowchart, using (Q)SAR predictions, available in vitro data and read-across. Where the co-formulant is also a REACH-registered substance, the screening leverages existing REACH data with documented justification of relevance. The output is a structured screening report suitable for regulatory submission.
We review the comment against the original WoE, identify the modality and pillar under question, and reinforce the argument with mechanistic, kinetic or species-relevance evidence. The response is structured within the procedural commenting clock and tied directly to lines of evidence in the original dossier.
Yes. We deliver the full EATS WoE dossier under the ECHA-EFSA 2018 guidance — structured per modality, with explicit reasoning on adversity, endocrine activity and biological plausibility, and Appendix E prepared for inclusion in the dRAR.
Tell us the substance, the modality and the regulatory clock. We'll come back with an initial scope and a fit assessment.
