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
- 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
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)
- Earthworm studies (OECD 222)
- Chironomus studies (OECD 218 and OECD 219)
Since the Ames study (OECD 471) is not recommended for Nanomaterials, Genotoxicity/Mutagenicity shall be evaluated using one or more 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
Testing of Food/Feed and Cosmetics
- Dissolution stability under flow-through conditions acc. efsa guidance
- Dissolution testing in body fluids (bioaccessability) acc. efsa guidance
LAUS can support you with the following studies for the assessment of your substance:
- Estrogen or Androgen Receptor Binding Affinity (YES/YAS Assay)
- Fish Early Life Stage (ELS) Toxicity Test (OECD 210)
- Chironomid Toxicity Test (OECD 218-219)
- Daphnia magna Reproduction Test (OECD 211)
- Earthworm Reproduction Test (OECD 222)
- Sediment Water Lumbriculus Toxicity Test using Spiked Sediment (OECD 225)
- Sediment Water Chironomid Life Cycle Toxicity test (OECD 233)
Please contact us for a customized proposal for Sameness/Substance Identity or an appointment to discuss your test strategy.