Nanomaterials

For Nanomaterials there are specific requirements for a substance identity profile and a registration dossier according to REACH (Regulation (EU) 2018/1881).

LAUS will be your trusted partner whether you need the characterization of your nanomaterial or experimental endpoints for a full registration.

We offer the evaluation of Nanomaterials regarding EC definition and NanoDefine approach:

Particle Size Distribution
Crystal Structure
Morphology
Boundary of Nanoforms

Definition of Nanomaterials and Nanoforms

Nanomaterials are natural or manufactured substances with 50% or more of particles in the number size distribution containing particle sizes between 1 to 100 nm in at least one dimension. Nanomaterials contain constituent particles in an unbound state, as aggregates, and as agglomerates.

A substance may have one or more different nanoforms, based on differences in size, shape, surface treatment and functionalization as well as specific surface area. These parameters may influence the toxicological or ecotoxicological profile, exposure as well as behavior in the environment. Therefore, all the nanoforms of a substance have to be reported in the registration dossier.

Characterization of Nanomaterials and Nanoforms

LAUS offers the full characterization of your Nanomaterial for a REACH substance identity profile (Sameness).

Determination of Physical-chemical Properties

The following studies are recommended to describe Nanomaterials:

Water solubility (OECD 105)
Water solubility for silica with Tyndall effect
Transformation – Dissolution Study for inorganic Nanomaterials (OECD 29)
Dispersion Stability of Nanomaterials in Simulated Environmental Media (OECD 318)
Particle Size Distribution (PSD), angular laser diffraction for solids, liquids and aerosols
Density: bulk density, tapped density or skeletal density
Dustiness: calculation based on PSD and bulk density
Point of Zero Charge: physical state, when the electrical charge density on a surface is zero
Hydroxy groups acc. SEARS
Determination of Specific Surface Area of Colloidal Silica by titration with sodium hydroxide

Ecotoxicology

Due to the expected long-term effects of nanomaterials, it is recommended to conduct the studies as chronic studies and, if possible, under flow-through conditions:

Aquatic plant studies: Lemna (OECD 221)
Invertebrates studies: Daphnia (OECD 211)
Fish studies (OECD 210, OECD 212, OECD 215)
Lumbriculus studies (OECD 225)

A specific analytical determination for the detection of nanoparticles using DLS (dynamic light scattering) is recommended.

Genotoxicity/Mutagenicity

Since the Ames study (OECD 471) is not recommended for Nanomaterials, Genotoxicity/Mutagenicity shall be evaluated using one or more higher tier in vitro studies on mammalian cells:

OECD 473: In Vitro Mammalian Chromosome Aberration Test
OECD 487: In Vitro Mammalian Cell Micronucleus Test
OECD 490: In Vitro Mammalian Cell Gene Mutation Test: Mouse Lymphoma Assay
OECD 476: Hypoxanthine-guanine phosphoribosyl transferase Test: HPRT Test

A specific analytical determination to monitor the dissolution of nanoparticles using DLS (dynamic light scattering) and to show the cellular uptake using TEM (transmission electron microskopy) is recommended.

Testing of Food/Feed and Cosmetics

Dissolution stability under flow-through conditions acc. efsa guidance
Dissolution testing in body fluids (bioaccessibility) acc. efsa guidance

LAUS could support you with studies simulating physiological conditions in the gastrointestinal tract after food consumption required by EFSA for exposure assessment of nanomaterials via food/feed . A short simulation of mouth conditions, followed by a gastric phase at pH 3 for 2 h and an intestinal phase at pH 7 for 2 h in a static set-up helps to evaluate the degradation rate in food/feed matrix or GI fluids. These bioavailability studies provide information for the “risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” (EFSA Journal 2018;16(7):5327).