Nanoparticles
Nanoparticles

Chemicals

Nanomaterials

Nanomaterials

Nanomaterial Testing Services

Your Partner for Regulatory Testing of Nanomaterials

LAUS supports you with REACH-compliant nanoform characterization (Sameness), GLP testing, and scientific consulting for nanomaterials following Commission Regulation (EU) 2018/1881.

We provide tailored ecotoxicology and genotoxicity testing approaches and deliver scientifically robust data to support submissions not only for REACH, but also for EFSA and SCCS, etc.

Nanomaterial and Nanoform Characterisation

For a full REACH Substance Identity of your Nanomaterial, we provide comprehensive characterisation of nanomaterials following the European Commission definition of nanomaterials and the NanoDefine approach.

Physicochemical Testing

We offer an extensive portfolio of physicochemical studies for nanomaterials, including:

  • OECD 105 – Water Solubility
  • Water solubility assessment for silica using the Tyndall effect
  • OECD 29 – Transformation/Dissolution of Metals and Metal Compounds
  • Particle size distribution for solids, liquids and aerosols
  • Bulk, tapped and skeletal density
  • Dustiness
  • Point of Zero Charge
  • Zeta Potential
  • Hydroxy groups acc. to SEARS (Specific surface area of colloidal silica)

Ecotoxicology of Nanomaterials

Our experts have comprehensive experience in developing tailored exposure strategies for nanomaterials in accordance with current guidance. We offer:

·Dispersibility pre-testing or

·OECD 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media

·Development of suitable dispersion protocols in accordance with OECD GD 317 – Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials

·Analytical verification of exposure concentrations

·Dynamic Light Scattering (DLS) analyses

Available studies include:

  • OECD 201 – Freshwater Alga and Cyanobacteria, Growth Inhibition Test
  • OECD 202 – Daphnia sp. Acute Immobilisation Test
  • OECD 221 – Lemna sp. Growth Inhibition Test
  • OECD 211 – Daphnia magna Reproduction Test
  • OECD 225 – Lumbriculus variegatus Sediment Toxicity Test

Genotoxicity Testing of Nanomaterials

Nanomaterials present specific challenges for in vitro genotoxicity testing and require additional characterization and study design considerations. Important aspects are:

·Ensuring effective exposure

·Proof of cellular uptake of the nanoparticles

In many cases the uptake of the particles can be demonstrated using transmission electron microscopy (TEM). For an effective exposure to the cells a stable dispersion of the nanomaterial is important. Our experts are very knowledgeable in this field and support you in developing appropriate testing strategies in accordance with current regulatory requirements. Our portfolio includes:

  • OECD 487 – In Vitro Mammalian Cell Micronucleus Test
  • OECD 490 – Mouse Lymphoma Assay
  • OECD 476 – HPRT Gene Mutation Test

EFSA Requirements for Nanomaterials

LAUS can support you with experimental data for feed and food materials for demonstrating that no specific assessment is required based on EFSA’s decision criteria:

  • Water solubility acc. OECD 105 (≥33.3 g/L) or dissolution/degradation rate requirements
  • Particle Size Distribution (if particles ≥500 nm)

Furthermore, we support you regarding a key step for the testing framework for feed and food materials:

  • dissolution/degradation rate of nanomaterials in conditions representative of the human gastrointestinal tract (GIT) for in vitro gastrointestinal digestion assessment

Discuss Your Nanomaterial Project

Whether you require nanoform characterization, physicochemical testing, ecotoxicology, genotoxicity or a complete regulatory testing strategy, our experts are ready to support your project.

Contact us to discuss your testing requirements and receive a customized proposal for your nanomaterial registration program.

Why Choose LAUS?

·      GLP-compliant testing

·      Expertise in nano-specific study design

·      Advanced physicochemical and analytical characterisation

·      Integrated ecotoxicology and genotoxicity services

·      Support for REACH, EFSA and international regulatory submissions

·      Experienced Study Directors and regulatory scientists

·      Tailored testing strategies for complex nanomaterials