Skip to main content

Draft AICIS Cost Recovery Implementation Statement (CRIS) 2021-22 – read the CRIS and have your say. Comments close on 14 May 2021.

Human health hazard band A hazard characteristics

This page accompanies step 4.4 Work out your human health hazard characteristics.

 

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

Hazard band A has 6 hazard characteristics you need to consider:

  • High molecular weight polymer that has lung overloading potential
  • Aspiration hazard
  • Specific target organ toxicity after a single exposure (harmful or transient effects)
  • Skin irritation
  • Eye irritation
  • Acute toxcity (harmful)

Instructions

You must always start at hazard band C. You only need to work through the hazard characteristics on this page if your introduction is in: 

  • human health exposure band 3, and you are trying to get to an outcome of very low indicative human health risk or 
  • human health exposure band 4, and you are trying to get to an outcome of very low indicative human health risk.

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have. 

If it does meet the hazard characteristic definition, stop there - your introduction's human health hazard band is A.

Move on to the next step - step 4.5 Work out your human health risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s human health hazard band is A.

Move onto the next step – step 4.5 Work out your human health risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, go to step 4.5 to work out your human health risk for categorisation).


High molecular weight polymer that has lung overloading potential

High molecular weight polymer that has lung overloading potential means that all of the following apply to the industrial chemical: 

  • it is a polymer, and 
  • it has a number average molecular weight that is greater than 70,000 g/mol, and 
  • it has a solubility in water of less than 0.1 mg/L, and 
  • it becomes aerosolised during end use.

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that has lung overloading potential  

If the chemical is a polymer, the information required to demonstrate that a chemical does not have the hazard characteristic, high molecular weight polymer that has lung overloading potential, is at least one of the following: 

  • molecular weight information that demonstrates that the number average molecular weight is less than or equal to 70,000 g/mol, or 
  • information that demonstrates that the polymer has a solubility in water that is greater than or equal to 0.1 mg/L measured following an acceptable test guideline for water solubility, or 
  • information that demonstrates that the polymer does not become aerosolised during end use

Aspiration hazard

Aspiration hazard means that any of the following apply to the industrial chemical:

  • the chemical is known or presumed to cause aspiration toxicity, as described in chapter 3.10 of the GHS, with the chemical classified as may be fatal if swallowed and enters airways (category 1), or 
  • the chemical is a hydrocarbon that has a kinematic viscosity less than or equal to 20.5 mm2/s, measured at 40°C.

Information required to demonstrate the absence of the hazard characteristic, aspiration hazard  

  • If the chemical is a hydrocarbon, the information required to demonstrate the absence of the hazard characteristic, aspiration hazard, is a measured kinematic viscosity greater than a20.5 mm2/s, at 40°C 
  • Otherwise, there are no information requirements to demonstrate the absence of the hazard characteristic, aspiration hazard. If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.

Specific target organ toxicity after a single exposure (harmful or transient effects)

Specific target organ toxicity after a single exposure (harmful or transient effects) means that any of the following apply to the industrial chemical: 

  • the chemical is known or presumed to be harmful to humans or to cause transient target organ effects, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity-single exposure (category 2 or 3), or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 300 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at: 
      • for gases -  greater than 2,500 but less than or equal to 20,000 ppmV/4h, or 
      • for vapours -  greater than 10 but less than or equal to 20 mg/L/4h, or 
      • for dusts/mists/fumes -  greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects)  

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects). If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation. 


Skin irritation 

Skin irritation means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce reversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin irritation (category 2), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for skin irritation results in the prediction of skin irritation effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, skin irritation  

The information required to demonstrate that a chemical does not have the hazard characteristic, skin irritation, is at least one of the following: 

  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the skin, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in skin reactions, as described for skin irritation in chapter 3.2 of the GHS, or 
  • test results from an in vivo study on the chemical or from suitable read across information conducted following an acceptable test guideline for acute dermal toxicity, that when tested at 2,000 mg/kg bw/day is not irritating to the skin.

In addition, if the chemical is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin irritation mediated by UV light. This may include one or more of the following: 

  • the chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
  • results from in vitro phototoxicity studies, or  
  • results from in vitro or in vivo irritation studies where the methods have been modified to include photoactivation.

Eye irritation

Eye irritation means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce changes in the eye, as described in chapter 3.3 of the GHS, with the chemical classified as eye irritation (category 2), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for eye irritation results in the prediction of eye irritation effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in changes in the eye, as described for eye irritation in chapter 3.3 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, eye irritation  

The information required to demonstrate that a chemical does not have the hazard characteristic, eye irritation, is at least one of the following: 

  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the eyes, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye damage or eye irritation with a non-irritant prediction, or 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye irritation, which does not result in changes in the eyes, as described for eye irritation (category 2) in chapter 3.3 of the GHS. 

Acute toxicity (harmful) 

Acute toxicity (harmful) means that any of the following apply to the industrial chemical: 

  • the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as acute toxicity (category 4), or 
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute toxicity LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for acute toxicity, or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in an acute oral LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of: 
      • for gases -  greater than 2500 but less than or equal to 20,000 ppmV/4h, or 
      • for vapours - greater than 10 but less than or equal to 20 mg/L/4h, or 
      • for dusts/mists/fumes - greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (harmful)  

  • if the chemical is for end use in a personal vaporiser - the information required to demonstrate that the chemical does not have the hazard characteristic, acute toxicity (harmful), is a test result from at least one in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for acute inhalation toxicity with an LC50 of: 
    • for gases - greater than 20,000 ppmV/4h, or 
    • for vapours - greater than 20 mg/L/4h, or 
    • for dusts/mists/fumes - greater than 5 mg/L/4h, or 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (harmful), is at least one of the following: 
    • if the human health exposure band for the introduction is 3 -  both of the following: 
      • a suitable in silico prediction for acute toxicity (LD50) of the chemical of greater than 2,000 mg/kg bw/day, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for acute oral toxicity, with a predicted LD50 of greater than 2,000 mg/kg bw, or 
    • information that demonstrates that the chemical is a high molecular weight polymer that has: 
      • less than than 5% by mass of molecules with molecular weight less than 1,000 g/mol, and 
      • less than 2% by mass of molecules with molecular weight less than 500 g/mol 
    • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available): 
      • conducted following an acceptable test guideline for acute oral toxicity with an LD50  greater than 2,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute dermal toxicity with an LD50  greater than 2,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute inhalation toxicity with an LC50: 
        • for gases - greater than 20,000 ppmV/4h, or 
        • for vapours - greater than 20 mg/L/4h, or 
        • for dusts/mists/fumes - greater than 5 mg/L/4h, or
    • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL greater than or equal to 1,000 mg/kg bw/day.

Contents

Was this page helpful?
For broken links or technical issues, please provide as much detail as possible. Do not include your name, email address and other personal or commercially sensitive information.

Keep informed with updates