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. 2017 Mar 16;15(3):e04691. doi: 10.2903/j.efsa.2017.4691

Table 5.

Parts and Modules of the proposed IATA for assessment of nigrostriatal toxicity (adapted from NV/JM/MONO(2014)19)

Part Module Data

Part 1

(Existing information, physicochemical properties and non‐testing methods)

1

2

3

  • Existing information – Existing human epidemiological data

  • Existing guideline studies including nervous system evaluation (OECD TG 424, 452 and 453)

  • In vitro neurotoxicity data

    • 1

      —  Other in vivo and in vitro data with the focus on dopaminergic neurons

4

5

  • ADME data

  • Physicochemical properties e.g. on redox potential
6

  • Non‐testing methods

    • 1

      —  for substances: (Q)SAR, read‐across, grouping and prediction systems;

    • 2

      —  for mixtures: bridging principles and theory of additivity
Part 2 (WoE analysis) 7

  • Phases and elements of WoE approaches

Part 3

(Additional testing, if required)

8

9

10

  • Additional in vitro AOP KE‐based testing

  • Additional in vivo testing

  • Additional data on ADME

OECD: Organisation for Economic Co‐operation and Development; ADME: absorption, distribution, metabolism and excretion; (Q) SAR: quantitative structure–activity relationship; WoE: weight of evidence; AOP: Adverse Outcome Pathways; KE: key event.