The aim of this procurement procedure is to characterize human variability in TD responses to specific cell stress and cell death pathways in order to map the relevant AOPs in a quantitative way and to use of this knowledge to propose mechanism- and pathway-based uncertainty factors (UF) for TD to refine and reduce the uncertainty in HBGV setting.

Extended TitleCharacterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)
Extended Description

Direct service contract.

Duration 48 months from the kick-off meeting.

Deadline Date2021-09-03
Publication Date2021-06-18
CountryItaly
Procurement StatusActive
TypeOpen procedure
Contract TypeServices
Award CriteriaThe most economic tender
Value1600000.00
OrganisationEuropean Food Safety Authority (EFSA)
AddressVia Carlo Magno 1A
TownParma
Postal Code43126
Class Code73210000
Class DescriptionResearch consultancy services
SourceOffice for Official Publications of the European Communities - Tenders electronic daily (Ted)

Version of 2021-03-22

Characterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)

The setting of health-based guidance values in chemical risk assessment involves the application of uncertainty factors (UFs) to extrapolate animal data to humans and to consider inter-human variability. Inter-human variability consists of the variability in toxicokinetics (TK) and toxicodynamics (TD). While human variability in TK is relatively well characterised, little information is known about TD variability. Attempts to gain insight into the human variability in TD processes have been hampered by the lack of adequate data and the use of transformed or dedifferentiated human cell models.

Extended TitleCharacterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)
Extended Description

The setting of health-based guidance values in chemical risk assessment involves the application of uncertainty factors (UFs) to extrapolate animal data to humans and to consider inter-human variability. Inter-human variability consists of the variability in toxicokinetics (TK) and toxicodynamics (TD). While human variability in TK is relatively well characterised, little information is known about TD variability. Attempts to gain insight into the human variability in TD processes have been hampered by the lack of adequate data and the use of transformed or dedifferentiated human cell models.

The project to be launched by EFSA proposes to use peripheral blood lymphocytes (PBLs) freshly isolated from a cohort of human volunteers. Human variability will assessed through quantitative assessments of the dose-responses to key stress responses known do induce the key pathological reactions and cell death responses observed at the cellular level in chemical-induced toxicity through high-content screening of functional and transcriptomic readouts.

Publication Date2021-03-22
CountryItaly
Procurement StatusFuture
TypeNot applicable
Contract TypeServices
Award CriteriaNot applicable
OrganisationEuropean Food Safety Authority (EFSA)
AddressVia Carlo Magno 1A
TownParma
Postal Code43126
Class Code73000000
Class DescriptionResearch and development services and related consultancy services
SourceOffice for Official Publications of the European Communities - Tenders electronic daily (Ted)

Related Procurements

Deadline: Sep 30, 2021
With this call for tenders, EFSA aims to outsource the development of a platform for the benefit of the EUBP and to enhance standardised data collection and sharing on bees...
View more
There is a need for painting, renovation and finishing works on traditional wall surfaces, metal surfaces and surfaces made of other materials for buildings, installations and objects, and more specifically...
View more
Deadline: Aug 31, 2021
Revamping dell'impianto di selezione e recupero materiali Polo Tecnologico di COGESA S.p.A. – Piattaforma di Tipo “A” e fornitura di una pressa elettromeccanica. Costo dell’opera a base di gara:• Lotto 1:...
View more