Feedback from VCI

German Chemical Industry Association (VCI)

Posted on: March 30, 2007

Introduction

Environmental Defence and DuPont drafted a framework for manufactures to support responsible production and use of nanomaterials. The "Nano Risk Framework" is based on well established elements of Risk Assessment, e.g. assessment of substance hazards (toxic/ecotoxic and physico-chemical hazards), exposure scenarios and LCA.

The "Nano Risk Framework" differentiates between substances with high production volumes and substances that are still in development. It allows to use assumptions if data gathering is still in progress (e.g. for R&D substances) and allows cross reading and waiving. The selection of tests has to reflect likely exposure. If exposure is not likely, this fact has to be documented.

The "Nano Risk Framework" requires i.a.

• Data on physico-chemical properties
• A base set of health hazard data and ecotoxicological data and additional data on an “as needed” basis
• Data on exposure
• Data on life cycle profile in alignment with the use of the product
• Risk evaluation
• Measures for Risk Management.

VCI Comments

1. VCI appreciates the "Nano Risk Framework" of Environmental Defence and DuPont from February 26, 2007 as a comprehensive document for responsible production and use of nanomaterials.
2. VCI appreciates that the "Nano Risk Framework" regards the established elements of Risk Assessment as suitable for nanomaterials.
3. The "Nano Risk Framework" reflects the VCI position in many aspects as it differentiates between commercialised and R&D substances at different development stages, as it takes into account production volume and exposure, and allows for using existing data.
4. The "Nano Risk Framework" has many elements similar to the Chemical Safety Report under the European REACH system.
5. Base for any Risk Assessment are the data to be gathered. The data requirements proposed by the "Nano Risk Framework" and the "Foundation Data Set" of the German Chemical Industry Association (VCI) are quite similar with some differences in detail (synopsis in annex 1). These two proposals should be carefully reviewed and refined by the OECD Working Party on Manufactured Nanomaterials (Steering Groups 2 and 3) to finally come up with one worldwide accepted data set for nanomaterials.
6. Specific Risk Management measures, e.g. in occupational health and safety, environmental safety and consumer safety, must be aligned with national regulations.
7. It should be noted that individual companies may wish to use their own well established documentary formats to ensure safe production and use of nanomaterials.

Annex 1

Synopsis of the data requirements of the "Nano Risk Framework" of Environmental Defence and DuPont, February 26, 2007 and the VCI proposal for a "Foundation Data Set", September 19, 2006

Physico-chemical Properties
Nano Risk Framework	VCI proposal
Chemical Composition (including surface coatings)	Chemical composition Impurity profile
Particle Size and Size Distribution	Particle size diameter Particle size distribution
Crystal Phase/Molecular Structure Physical Form/Shape	Shape Surface structure, roughness/morphology
Agglomeration/Aggregation State	Tendency to agglomerate
Solubility	Solubility in water
	State of substance (at 20° C and 101.3 kPa) melting/freezing point boiling point
Particle Density Bulk Density Porosity	relative density
Base Set of Safety Hazard Data (Flammability, Explosivity, Incompatibility, Reactivity, Corrosivity)	Flash-point, flammability, explosive properties, self-ignition temperature, oxidizing properties
Surface Area	Specific surface area
Surface Charge
Toxicological Data
Basic
Nano Risk Framework	VCI proposal
Short-term Toxicity: Pulmonary toxicity, Oral toxicity.	Acute toxicity: By oral route. If the dermal route or the inhalation route is the likely route of exposure, the acute toxicity of the dermal route or of the inhalation route has to be considered
Skin sensitization/irritation Skin penetration	Skin irritation or skin corrosion Skin sensitization
	Eye irritation
Genotoxicity: Gene mutation in prokaryotic cells, Chromosomal aberration	Mutagenicity: In vitro gene mutation study in bacteria
Additional data on an “as needed” basis
Nano Risk Framework	VCI proposal
Chronic inhalation studies Chronic oral studies Chronic dermal irritation/sensitization studies	Repeated dose toxicity: Short-term repeated dose toxicity study (28 days) or sub-chronic toxicity study (90 days)
Neurotoxicity Studies
Focused toxicity studies
More extensive genotoxicity studies	Appropriate mutagenicity tests
Reproductive and developmental toxicity	Appropriate reproductive toxicity
	Carcinogenicity study in very special cases
	Toxicokinetics: Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from relevant available information
Ecotoxicological Data
Basic
Nano Risk Framework	VCI proposal
Aquatic Toxicity: Fish (fathead minnow or trout), Invertebrate (Daphnia), Aquatic Plant (algae)	Aquatic toxicity: Short-term toxicity testing on invertebrates (preferred species Daphnia)
Terrestrial Toxicity (if significant release to terrestrial environments), Earthworms, Plants
Environmental Fate Data: Water Solubility, Vapor Pressure, Adsorption/Desorption Coefficients in Release Medium (Soil/Sludge) Persistence potential screen Bioaccumulation potential screen	Degradation: Biotic: Ready biodegradability (where appropriate)
Additional data on an “as needed” basis
Nano Risk Framework	VCI proposal
Biological fate and behaviour	Fate and behaviour in the environment: Adsorption/desorption
Persistence potential in relevant media
	Bioaccumulation in aquatic species (preferably fish)
ADME studies on aquatic organisms	Appropriate long term aquatic toxicity
More extensive genotoxicity studies Focused toxicity studies Population/ecosystem level studies
Micro-organism toxicity Chronic toxicity to soil micro-organisms and sediment- and soil dwelling organisms Further testing for terrestrial toxicity Avian Toxicity
Activated sludge respiration inhibition
Potential for transformations via oxidation-reduction reactions