Section 5

Mammalian Toxicology

Juan Parra Morte, PREV Unit

TG IUCLID PESTICIDE meeting

17-18 June 2020

Chloé De Lentdecker, PREV Unit

Elisa Palmas, Data Unit

Kerstin Hartmann, ECPA

Outline

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Introduction

Revised and new endpoint summaries

Endpoint summaries for Oct 2021 release

The objective for this session is to agree on the revisions needed onendpoint summaries which can be proposed for inclusion in theOctober release of IUCLID (i.e. straight forward and non-controversialamendments), focusing on the endpoints for which comments werereceived during the pilot phase of IUCLID.

Where the tox sub-group agreed a more thorough review of thesummary is required (i.e. deeper review and further discussion needed),these documents were identified and will be analyzed at a later phase inthe project and may be submitted for the next release of IUCLID in Oct2021.

Objective

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Revised and new endpoint summaries (Release Oct 2020)

Acute toxicity: Skin/eye irritation and Skin sensitisation summaries were missing in the TOC -> the

summaries available for Biocides were added

Phototoxicity summary was missing (OHT 66-3 under finalisation at OECD level, will be ready for Oct 2020 release too) -> a simple summary was created

Summary link:https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23315250

Reprotoxicity and Carcinogenicity:

Key changes are the following: Need for adding NOAELs as only one NOAEL could be reported -> addition of endpoints i.e.

reproductive NOAEL, parental NOAEL and offspring NOAEL for the 2-G study; and general toxicity NOAEL and carcinogenic NOAEL for the carcinogenicity study.

Need for adding a second species -> repeatable bock of fields included in the summary

Carcinogenicity summary link: https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23419815

Reprotoxicity summary link:

https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23412967

Dermal absorption: Summary did not exist -> creation of a summary reflecting LoEP entries and based on

EFSA Dermal absorption GD – files can be attached

Summary link:

https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23314328

Non-dietary exposure: Summary did not exist -> creation of a summary reflecting LoEP entries and link to GAP

table (i.e. GAP documents) added – the excel file with calculations or the report provided by the calculator will be attached

Summary link:

https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23413057

Toxicological reference values: Summary did not exist -> creation of a summary fitting with Pesticides TRV.

Summary link:

https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&objid=23421023

Revised and new endpoint summaries (Release Oct 2020)

Endpoint summaries for Oct 2021 release

Toxicokinetics

Genotoxicity including photomutagenicity

Other summaries to be checked

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Thanks for your attention!