4. Other information you may need to provide in an assessment certificate application

What’s a similar chemical?

The physico-chemical and toxicological properties must be similar to the primary chemical. This means:

• substructures that might play a critical functional role must be the same
• GHS classifications must be the same
• molecular properties must be the same or you must expect them to be the same
• molecular weight must be similar
• the octanol-water partition coefficient must be within 50-200% of the primary chemical
• the toxicity profile must be unaffected by differences in chemical identity

The following can be similar chemicals:

• salts of the primary chemical
• positional isomers
• stereoisomers.

What’s a similar polymer?

Similar polymers must be 1 of the following:

• contains 1 polymer constituent less than the primary polymer
• contains 1 polymer constituent different to the primary polymer
  • the polymer constituent should be similar to the substituted constituent in the primary polymer
• structurally identical to the primary polymer, but have a different manufacturing method.

Similar polymers must also have:

• the same linkages and functional groups
• water solubility within the range of 50 to 200% of the primary polymer
• no changes in identity that changes toxicity profile.

A multi‑component introduction applies when you are seeking an AICIS assessment certificate to introduce a mixture made up of 2 or more chemicals that are manufactured together. In these cases, there is no single CAS chemical name that adequately covers all the chemical components in the mixture.

An introduction is a multi‑component introduction if all the following criteria are met:

1. Manufactured together – The introduction is a chemical mixture where all component chemicals are manufactured simultaneously.
2. Identifiable components – Each component chemical in the mixture can be uniquely identified.
3. No separation during introduction or use – The component chemicals are not separated at any stage during introduction or use in Australia.
4. No single CAS name – There is no single CAS chemical name available that specifically covers all component chemicals in the mixture.

You should consider the hazard profile and introduction volumes of the chemical mixture when you're working out if the assessment certificate will be health focused, environment focused or both.

Information requirements for designated fluorinated chemicals

If your introduction is of a designated fluorinated chemical, you should provide the following information:

Information requirements for fluorinated degradation products

Test results or scientific justification indicating the identity of the fluorinated degradants and intermediates of the assessed designated fluorinated chemical.

A higher-tiered test such as an inherent biodegradability test report is required. The test should include characterisation of the degradation products and their rate of formation. An inherent biodegradability test is required as there is a greater possibility of degradation occurring in the presence of other nutrients than under the conditions of a ready biodegradability test, where only the test substance is present.  

If it is claimed that no degradation of the assessed designated fluorinated chemical occurs, then a report on the analysis and characterisation of degradation products under relevant degradation conditions must be provided. An inherent biodegradability test does not by itself give information on other degradation modes such as hydrolysis, or on formation of stable degradation products by a mechanism which does not involve mineralisation of a substantial proportion of the chemical or polymer, such as side chain cleavage.  

If literature sources relating to analogue data are provided, then scientific justification on the applicability of the studies to the assessed designated fluorinated chemical must also be included.  

Circumstances in which this information may not be required 

There are some default degradation assumptions contained within the reports on the PFAS chemicals that AICIS has previously assessed. These assumptions can be used to cover the requirements for the degradants for those chemicals that they are applicable to. See our page on previous PFAS chemical assessments.

For all persistent fluorinated degradants and intermediates of the assessed chemical, both 1 and 2:

1. The information required for a standard health and environment-focused certificate application set out above in this page.

   Section 4. Physical and chemical properties – except: Flash point; Auto flammability; Flammability; Explosiveness; and Oxidising properties. 
   Section 5. Environmental fate and pathways
   Section 6. Ecotoxicological information
   Section 7. Toxicological information – except: Acute toxicity; Skin irritation / corrosion; Eye irritation; and Skin sensitisation.

2. Information requirements listed above for an assessed chemical that meets the designated fluorinated chemical definition

Circumstances in which this information may not be required 

If the assessed designated fluorinated chemical is expected to degrade to a PFAS chemical that AICIS has previously assessed, then this chemical assessment can be used to cover the requirements for the degradants. See our page on previous PFAS chemical assessments.

Nanoscale means the particle size range of 1 to 100 nm. An introduction at the nanoscale is a ‘specified class of introduction’ if it: 

• is introduced as a solid or is in a dispersion
• consists of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale 

For details, see categorisation of chemicals at the nanoscale. 

If your chemical is at the nanoscale and is categorised as an assessed introduction, you should give us the following information about the chemical’s identity and physicochemical properties. 

Chemical details

• CAS name and/or IUPAC name
• CAS registry number, if available
• Common or trade name, if available
• Synonyms, if available (for example, chemical identifiers in study reports or test data reports)
• Molecular formula, if defined
• Structural formula, if defined
• Molecular weight or weight range, if defined
• Composition (for example, purity, identity of impurities, details of manufacturing method and batch-to-batch variation if applicable)
• Coated or not coated (if coated, the details of coating)
• Where relevant, information about crystallinity (crystal or amorphous structure). For example, if a chemical has different crystal structures because of the manufacturing technique; then you’ll need to provide the name/s of crystal structure/s and their proportions 

Nanoscale-specific physicochemical properties 

For nanoscale-specific physicochemical properties, multiple techniques may be needed to fully characterise a specific property. The choice of technique will depend on the individual characteristics of the chemical. When there are nano-specific methods available, you must provide justification for using a non-nano-specific method. 

The details of testing methods and important issues of risk assessment are available for nanoscale materials in the Organisation for Economic Cooperation Development’s Publications in the Series on the Safety of Manufactured Nanomaterials. 

Shape of the particle 

• Description of the particle shape (for example, a qualitative or semi-quantitative geometrical description of the extremities of the particle, and/or particles, agglomerate or aggregate that make up the chemical).
• Image analysis (electron micrograph using transmission electron microscopes and/or scanning electron microscope).
• Morphology descriptors - see the International Organization for Standardization’s ISO 9276-6:2008: Representation of results of particle size analysis – Part 6: Descriptive and quantitative representation of particle shape and morphology. 

For carbon nanotubes (CNT), you also need to provide the number of walls in the CNT. 

For graphene, you also need to provide the number of plates in the particle. 

Particle size and particle size distribution (PSD)  

• Particle size and PSD with percentages of different particle sizes in a batch.
• Variation between batches, if applicable.
• Aspect ratio (length/diameter) is required for elongated and platelet shapes. For example, carbon nanotubes to indicate whether the aspect ratio is over 3. 

For nano tubes and plates, you must provide all dimensions of the particle.  
For details of the methods to be used, see the OECD’s test guideline publication TG 125 - Nanomaterial particle size and size distribution of nanomaterials.

Volume specific surface area 

For details of the methods to be used, see OECD TG 124: Determination of the volume specific surface area of manufactured nanomaterials. 

Another useful reference is ISO/TR 14187:2020: Surface chemical analysis – Characterization of nanostructured materials. 

Surface chemistry – the chemical nature of the surface of a particle 

The description must include whether the particles have been surface-treated. 

If surface treated: 

• the chemical identity of the surface treatment agents (CAS and/or IUPAC name of the chemicals) and the amount (% w/w) applied on the particle, if applicable
• the chemistry imparted to the surface, for example, an agent may be used to graft new functional groups to the surface, or to oxidize/reduce existing functional groups
• a schematic representation of the particle surface may be provided to illustrate the surface chemistry. 

Surface charge 

You need to provide measured data on the zeta potential of the chemical. 

You may also submit isoelectric point and/or electrophoretic mobility as an indirect measurement of zeta potential. 

Measured data describing dispersibility (if relevant and information is available) 

• The degree of dispersion refers to the relative number or mass of particles in a suspending medium and relates to the stability, aggregation and agglomeration of the chemical in relevant media (for example, water).
• Measured data on particle concentration.
• Measurement methods include (but are not limited to) light-scattering methods, single particle ICP-MS, and scanning mobility particle sizer (OECD TG 318).

Measured data describing dustiness 

This data is only required if inhalation exposure is likely to occur. 

Measured data or suitable alternatives describing the Biological (re)activity 

This includes oxidising properties, conditions causing instability, decomposition products. 

Data on photoreactivity (if relevant) 

This requirement applies where the chemical absorbs light between 200-750 nm wavelength (UV/visible light). 

The following OECD test guidelines are available for testing the photoreactivity of chemicals (these are not specific to nanoscale chemicals or particles):  

• OECD TG 432: In Vitro 3T3 NRU Phototoxicity Test, OECD TG 498: In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method
• OECD TG 495: Reactive Oxygen Species (ROS) Assay for Photoreactivity. 

Human health hazards 

• Measured data or suitable alternative data/information describing the potential human health hazards consistent with the minimum data requirements for chemical assessments and any other hazard information available to the introducer. For details, see step 4 of our Categorisation Guide.
• If dermal and/or inhalation exposure is expected to occur, then you must submit information on dermal and/or inhalation toxicity (acute or repeated dose). If you can’t give us this information, you must provide a justification. 

If other routes of exposure are expected, then you should provide toxicity data on those hazard end points. 

All OECD TG available for testing human health toxicity end points are considered applicable in the absence of equivalent testing guidelines for nanoscale chemicals. For details, see OECD guidelines for the testing of chemicals: health effects. 

Information to consider when providing toxicity data 

1. When experimental data for the nanoscale chemical are not available or limited, you may use the read-across approach using existing data from one or more analogous nanoscale chemicals. The read-across from a nanoscale material or a bulk substance requires strong evidence and justification for their suitability to the assessed chemical. You can follow grouping of chemicals when assessing the validity of an analogue. For details, see working out your hazards using read-across information.
2. Information on genetic toxicity – the Ames test (OECD TG 471) is not considered to be a reliable test to confirm negative results for mutagenicity of nanoscale particles.  
    

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