Toxicological information required in a PCN

What section 1.8 asks for

Section 1.8 is the last of the eight sections making up a PCN dossier, and Annex VIII ties it directly to a document you almost certainly already hold: it asks for the toxicological effects of the mixture or its components, described the same way Section 11 of a safety data sheet already describes them. That means acute toxicity, irritation and corrosion, sensitisation potential, specific target organ effects and any CMR properties, wherever those are relevant to the mixture's own classification. Nothing here is meant to be written fresh for ECHA — it is meant to be carried across from information the SDS already requires you to hold.

Mixture data versus component data

Where the mixture itself has actually been tested as a whole, that is the data to report — it is the most direct answer to what happens on exposure to this specific product. Most formulations are never tested whole, though, and the same convention an SDS relies on applies here: toxicological conclusions built up from what is known about the individual components, using recognised bridging or read-across reasoning rather than a dedicated study on the finished mixture. A dossier should be honest about which of the two is behind the figures it reports, since a poison centre treats a tested result differently from an estimated one.

This distinction also determines what happens later. A mixture whose toxicological picture rests on component data changes as soon as one of those components does — a supplier switch that swaps in a substance with a different toxicological profile can leave section 1.8 describing a product that no longer matches what is actually in the pack, even though nothing about the finished mixture was directly retested. Whoever tracks composition changes for an update needs to know whether the toxicological information behind the dossier depends on a specific component staying exactly what it was.

Where the information comes from

For your own formulation, the starting point is Section 11 of your own safety data sheet — if that section is thorough, most of what section 1.8 needs is already written. Where a component is bought in rather than made, the supplier's SDS for that raw material is usually the source for its toxicological properties, since you rarely hold study data on someone else's substance yourself. For well-characterised substances with an established toxicological profile, published literature and recognised databases fill in what neither SDS covers directly — used as a reference, not copied in without attribution to where it came from.

What is not acceptable

Because this section has to correspond to Section 11 of the SDS for the mixture or its components, a few shortcuts routinely fail: leaving the field blank when the SDS itself has content to draw on, submitting a generic paragraph that could describe almost any product in the same hazard class rather than this one, or carrying over toxicological text written for an earlier version of the formulation that was never revisited after a reformulation. None of these produce a dossier a poison centre can actually act on, even though each one is enough to get the submission through on paper.

A more subtle version of the same failure is toxicological information that technically exists but does not actually support the classification declared elsewhere in the dossier — a mixture classified for serious eye damage, say, with a section 1.8 narrative that never mentions eye effects at all. Validation checks catch missing fields; they do not catch a mismatch between what section 1.8 says and what sections 1.4 and 1.7 already committed to, which is exactly the kind of internal inconsistency a careful review before submission is meant to find.