- Reasoning for the suitability of the measurement methods used or any necessary changes made
- Principles for the evaluation of the biocidal products need to be adapted and supplemented by technical guidelines
- shape / form
- aspect ratio
- crystallinity
- secondary structure (assembly structure)
- description of surface functionalisation or treatment
- identification of each agent including IUPAC name and CAS or EC number
- number based particle size distribution
- indication of the number fraction of the constituent particles in the size range 1-100 nm specific surface (volume or mass)
- dissolution rate
- assessment of dispersion as confounding effect
- dispersion stability to be considered when KOW is not applicable
- in vitro gene mutation study in bacteria
- acute toxicity by oral route
- acute toxicity
- short-term repeat dose toxicity
- sub-chronic
- toxicokinetics
- assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information
- short term toxicity in invertebrates
- grow inhibition study on aquatic plants
- short term toxicity testing on fish
- activated sludge respiration inhibition testing
- degradation
- hydrolysis as function of pH
- adsorption desorption screening (further information on adsorption desorption depending on the results of the study required in Annex VIII)
- simulation testing on ultimate degradation in surface water
- bioaccumulation in aquatic species, preferably fish
- effects on terrestrial organisms
- IUPAC name
- descriptors according to Number 2 of the preamble to the Annexes II – VI
- predictable exposition conditions
- IUPAC name
- descriptors according to Number 2 of the preamble to the Annexes II – VI
- particle size
- phys. chem. properties
- quantity estimation
- toxicological profile
- predictable exposition conditions
- special information requirements in the permit application (NFR)
- Labeling with “nano” (ingredients list) (RPFI)
- – in the application for approval –> justification for suitability of the measurement methods used or any necessary changes made need to be stated.
- When NMs are used, the risk of particle skin penetration needs to be reduced
- non signifcant potential for internal exposition → medical device class IIa
- low potential for internal exposition → medical device class IIb
- medium or high potential for internal exposition → medical device class III
- – especially if it’s application is not limited to intact skin –> separate classification rule (No.19) applies
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