Pesticide Acute Toxicity Report

1. What this module does

You enter the six acute studies with their results, GLP status and any exceptions, the data confidentiality claim and the sensitisation result.

The tool places each result in a toxicity category, takes the most severe for the product, gives the signal word and POISON statement, and flags missing studies, results it cannot categorise and reports without a GLP statement.

What you get

• A Word or PDF file: acute toxicity summary with the toxicity category and signal word.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The six final study reports (OCSPP 870.1100, 1200, 1300, 2400, 2500, 2600).
• GLP compliance and QA statements.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/pesticide-acute-toxicity.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the test substance

   Give the product, sponsor and testing facility, and choose the data confidentiality claim.

   

2. Enter the studies

   LD50 or LC50 with ">" for a limit test; describe eye and skin findings in words, for example "clearing by day 14" or "slight erythema at 72 h".

3. Read the result

   The headline gives the category and signal word, for example "Toxicity category II · signal word WARNING".

   

4. Resolve alerts and download

   A missing study or a report without a GLP statement is critical. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Product and laboratory

2 · Studies

One row per study. Result: LD50 or LC50 with "> " for a limit test, or the irritation finding in words.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• Toxicity category for each study.
• Signal word and POISON statement.
• Confidentiality, GLP and QA statements.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Summary and labelling. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US only: 40 CFR 156.62 categories. Other systems such as GHS use different cut-offs.

8. Working with other modules

• The studies go in the data matrix of the Pesticide Registration Package package.

9. Common pitfalls

• Treating a limit test (>5000 mg/kg) as an exact LD50.
• Leaving out the GLP statement for a non-GLP study instead of stating how it differs.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Add the GLP statement for the sensitisation study

   Mark CTL-24-0316 as GLP.

   Expected resultCategory II, WARNING, with no critical issue.