Section 5 Mammalian Toxicology...Section 5 Mammalian Toxicology Juan Parra Morte, PREV Unit TG...
Transcript of Section 5 Mammalian Toxicology...Section 5 Mammalian Toxicology Juan Parra Morte, PREV Unit TG...
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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
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Outline
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Introduction
Revised and new endpoint summaries
Endpoint summaries for Oct 2021 release
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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
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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)
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Endpoint summaries for Oct 2021 release
Toxicokinetics
Genotoxicity including photomutagenicity
Other summaries to be checked
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Thanks for your attention!