Concern-Driven Safety Assessment of Nanomaterials - Safety of Nanomaterials along Their Lifecycle - page 368

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Toxicity
domain

Decision-
making process

Test options Toxicity domain Decision-making

process

Test options

- EpiDerm

Local
tolerance

- BCOP and EpiOcular
- in vitro sensitisation strategy
or LLNA
in vitro micronucleus test
and HPRT assay

Judgement

In vitro
genotoxicity

Judgement

- Absorption/dermal
penetration
- Accumulation/persistence
- Barrier crossing

ADCE Judgement

Short-term
toxicity

Short-term toxicity (incl.
inflammation, cytotoxicity)

Judgement

in vivo genotoxicity Judgement

in vivo tests

in vivo repeated toxicity study
incl. kinetics
(absorption, tissue accumulation)
Developmental/fertility testing
incl. kinetics
(absorption, tissue accumulation)

Organ toxicity
(repeated-dose)

Judgement

Reproductive toxicity Judgement

Carcinogenicity Judgement

Establish general concept for NM

Grouping/
waiving

FIGURE 16.4 Integrated approach for the hazard testing and assessment of nanomaterials (NM) addressing speciic concerns for an individual NM.
(Reprinted with permission from Oomen AG et al. (2013), Concern-driven integrated approaches to nanomaterial testing and assessment, Report of the
NanoSafety Cluster Working Group 10, Nanotoxicol 28 May 2013, epub ahead of print.)