Specified conditions for requesting additional data requirements

Minimum requirements

As a minimum requirement, you need to provide particle size information (primary particle size and number-weighted size distribution) where:

  • the chemical is an industrial nanomaterial
  • it can be anticipated or there is uncertainty that the chemical could be a nanomaterial and exposure to human health or the environment is expected based on use scenarios
  • the chemical is introduced as a solid or powder or as a dispersion and is insoluble[1]. and/or known to be biopersistent.[2]

Notes:

  1. If particle size information cannot be supplied for a chemical that meets certain conditions outlined immediately above (other than when declared as a nanomaterial), the chemical will be assumed to be an industrial nanomaterial for risk assessment and recommendation purposes.
  2. These chemicals meet the conditions but may not be subject to additional data requirements.
    1. compounds that dissociate in water to form ions
    2. colloidal polymers
    3. micelles
    4. biological materials.

Contact NICNAS for advice on notification requirements for these chemicals.


Additional requirements

You may also need to provide this additional data under certain circumstances (Figure G5). Specific guidance on physico-chemical characteristics and toxicity testing are provided below.

  • method of production
  • medium identity
  • medium conditions (identity and concentration of stabilizers,  ionic strength and ionic composition)
  • shape
  • crystalline phase
  • agglomeration/aggregation state
  • composition(purity/impurities)
  • surface area
  • surface charge
  • surface chemistry (such as coatings and modifications)
  • toxicity data will be requested case-by-case.

Note:

These additional data requirements will be determined case-by-case and are subject to variation as new knowledge on toxicity of nanomaterials is developed.

[1] for example, water insolubility <1 mg/L); [2] the ability of a substance to remain in the body in spite of physiological clearance mechanisms


Conditions for provision of particle size information and additional data requirements for permit and certificate categories

For an explanation of the options/material presented in this diagram, please call 1800 638 529


Last update 30 November 2016