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Open for public comment: proposed amendments to the General Rules – closes 17 September 2021.

Human health hazard band B 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. You must always start at hazard band CStep 4.4 tells you when you can stop working through your chemical's human health hazard characteristics and when you need to check each of them - ie C, B and A.

Hazard band B has 9 hazard characteristics you need to consider:

  • High molecular weight polymer that is water absorbing
  • Respiratory sensitisation
  • Corrosive to the respiratory tract
  • Specific target organ toxicity and a single exposure (significant toxicity)
  • Skin corrosion
  • Eye damage
  • Skin sensitisation
  • Acute toxicity (fatal or toxic)
  • Specific target organ toxicity after repeated exposure

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 low or 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 B. 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 B. 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, decide whether you can stop there or continue to human health hazard band A This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 3, continue to human health hazard band A. 

If your introduction is in human health exposure band 4, you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or continue to human health hazard band A.


High molecular weight polymer that is water absorbing

High molecular weight polymer that is water absorbing means that all of the following apply to the industrial chemical: 

  • it is a high molecular weight polymer, and 
  • it has a number average molecular weight that is greater than or equal to 10,000 g/mol, and 
  • it is capable of absorbing its own weight, or more, in water, and 
  • it contains particles with a particle size less than 10 micrometres (microns).

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that is water absorbing 

If the chemical is a high molecular weight polymer, the information required to demonstrate that it does not have the hazard characteristic, high molecular weight polymer that is water absorbing, is at least one of: 

  • molecular weight information that demonstrates the number average molecular weight (NAMW) is less than 10,000 g/mol, or 
  • information that demonstrates that the polymer is not introduced in a particulate form, or 
  • particle size information that demonstrates that the particle size is greater than or equal to 10 micrometres (microns), or
  • information that demonstrates that the polymer does not absorb its own weight or more in water, such as experiments that show that it does not form a gel in water, or that if it does, the gel dissolves upon addition of more water.

Respiratory sensitisation

Respiratory sensitisation means that any of the following apply to the industrial chemical: 

  • the chemical is known or presumed to produce hypersensitivity of the airways in humans, as described in chapter 3.4 of the GHS, with the chemical classified as respiratory sensitisation (category 1), or 
  • the chemical is named: 
    • on the EU SVHC Candidate list for authorisation, based on respiratory sensitising properties (https://echa.europa.eu/candidate-list-table), or 
    • in the Danish EPA (Q)SAR Database as a predicted respiratory sensitiser (http://qsar.food.dtu.dk/), or 
    • the chemical is an enzyme, or 
    • the chemical is a polymer that contains one or more free isocyanate groups, or 
    • an in vivo study on the chemical indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, or 
    • an in vitro study on the chemical: 
      • indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, and 
      • the result of the study has not been negated by in vivo studies conducted on the chemical for hypersensitivity of the airways.

Information required to demonstrate the absence of the hazard characteristic, respiratory sensitisation  

There are no information requirements to demonstrate the absence of the hazard characteristic, respiratory sensitisation. 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.


Corrosive to the respiratory tract

Corrosive to the respiratory tract means that any of the following apply to the industrial chemical: 

  • the chemical is known to cause destruction of the respiratory tract tissue, as described in chapter 3.1 of the GHS, with the chemical classified as corrosive to the respiratory tract (AUH071 - non-GHS hazard statement), or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for acute inhalation toxicity, subacute inhalation toxicity or subchronic inhalation toxicity results in destruction of the respiratory tract, as described in chapter 3.1 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract  

There are no information requirements to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract. 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 (significant toxicity)

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

  • the chemical is known or presumed to produce significant toxicity in humans, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity – single exposure (category 1), 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 less than or equal to 300 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 less than or equal to 1,000 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:
      • gases - less than or equal to 2,500 ppmV/4h, or 
      • vapours -  less than or equal to mg/L/4h, or 
      • for dusts/mists/fumes - less than or equal to 1 mg/L/4h.

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

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (significant toxicity). 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 corrosion

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

  • the chemical is known to produce irreversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin corrosion (category 1), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for skin corrosion results in the prediction of skin corrosion effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS, or 
  • the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS respectively. 

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

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

  • information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
    • anhydride, or
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that contains any of the following reactive functional groups and the polymer has a combined functional group equivalent weight of greater than or equal to 1,000 g/mol: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to skin or has no alerting groups for skin irritation, 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 corrosion, with a non-corrosive prediction, 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 destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS.

Eye damage

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

  • the chemical is known to produce serious eye damage, as described in chapter 3.3 of the GHS, with the chemical classified as eye damage (category 1), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for eye damage results in the prediction of serious eye damage effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS, or 
  • the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS, respectively. 

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

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

  • information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or
  • information that demonstrates that the chemical is a high molecular weight polymer that contains any of the following reactive functional groups with a combined functional group equivalent weight of greater than or equal to 1,000 g/mol: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • 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 eye, 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, which predicts the chemical would not induce serious eye damage 
  • 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 effects on the eye, as described for eye damage in chapter 3.3 of the GHS.

Skin sensitisation 

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

  • the chemical is known to cause an allergic response following skin contact, as described in chapter 3.4 of the GHS, with the chemical classified as skin sensitisation (category 1), or 
  • human testing or epidemiological studies on the chemical result in evidence of an allergic response, as described in chapter 3.4 of the GHS, or 
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
  • an in chemico study on the chemical: 
    • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin sensitisation, results in the induction of an allergic response, as described in chapter 3.4 of the GHS.

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

  • There are no information requirements to demonstrate the absence of the hazard characteristic, skin sensitisation, if the chemical is corrosive to the skin (GHS category 1) as the in vivo tests cannot be conducted 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, skin sensitisation, is at least one of the following:  
    • information that demonstrates that the chemical is a high molecular weight polymer for which at least one of the following: 
      • contains only low concern reactive functional groups, or 
      • contains only low concern reactive functional groups and unsubstituted positions ortho and para to phenolic hydroxyl groups, or  
      • contains only reactive functional groups it contains are unsubstituted positions ortho and para to phenolic hydroxyl groups, or 
      • contains only low and moderate concern reactive functional groups , with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
      • it contains only moderate concern reactive functional groups, with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
      • has a number average molecular weight that is greater than or equal to 10,000 g/mol and both: 
        • less than 2% by mass of molecules with molecular weight that is less than 500 g/mol, and 
        • less than 5% by mass of molecules with molecular weight that is less than 1,000 g/mol, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V, of the REACH Regulation, or 
    • if the human health exposure band is 3 - all of the following: 
      • suitable in silico prediction indicating that the chemical and its metabolites (if any) do not cause skin sensitisation, and 
      • results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a non-sensitising prediction, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction, or 
    • all of the following: 
      • test results from an in chemico test on the chemical or from suitable read-across information, conducted following an acceptable test guideline for the 1st key event in skin sensitisation, with a non-sensitising prediction, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a non-sensitising prediction, and 
      • results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction
    • test results from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for skin sensitisation, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS 
  • in addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter or is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin sensitisation 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 or equal to 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 skin sensitisation studies where the methods have been modified to include photoactivation.

Low concern reactive functional groups - see our polymer of low concern criteria page.

Moderate concern reactive functional groups - see our polymer of low concern criteria page. 


Acute toxicity (fatal or toxic) 

Acute toxicity (fatal or toxic) 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 1 or 2 or 3), or
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute oral toxicity LD50 value of less than or equal to 300 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 less than or equal to 300 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of less than or equal to 1,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of:
      • for gases - less than or equal to 2,500 ppmV/4h, or 
      • for vapours - less than or equal to 10 mg/L/4h, or 
      • for dusts/mists/fumes - less than equal to 1 mg/L/4h , or 
  • evidence in humans of systemic toxicity after eye contact, with the chemical classified with the non-GHS hazard statement – AUH070, or 
  • an in vivo study, conducted following an acceptable test guideline for eye irritation, results in overt signs of systemic toxicity or mortality, which is likely to be attributed to absorption of the chemical through the mucous membranes of the eye, with the chemical classified with the non-GHS hazard statement – AUH070.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic) 

  • there are no information requirements to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic), if the chemical is corrosive to the skin (GHS category 1), or likely to be corrosive to the skin (that is, the chemical is a strong acid (pH less than or equal to 2.0) or base (pH greater than or equal to 11.5), and has high buffering capacity (if relevant)), as the in vivo tests cannot be conducted
  • 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 (fatal or toxic), 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: 
    • for gases -  greater than 2,500 ppmV/4h, or 
    • for vapours - greater than 10 mg/L/4h, or 
    • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (fatal or toxic), 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 for acute toxicity (LD50), conducted following an acceptable test guideline for acute oral toxicity, of greater than 300 mg/kg bw,  or 
    • information that demonstrates that the chemical is a high molecular weight polymer that has:
      • less 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, or 
    • 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 300 mg/kg bw, or
      • conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 1,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute inhalation toxicity, with an LC50: 
        • for gases -  greater than 2,500 ppmV/4h, or
        • for vapours - greater than 10 mg/L/4h, or 
        • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
    • test results from an in vivo study via the oral route 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.

Specific target organ toxicity after repeated exposure

Specific target organ toxicity after repeated exposure means that any of the following apply to the industrial chemical:

  • the chemical is known to exhibit significant toxicity or be potentially harmful to human health following repeated exposure, as described in chapter 3.9 of the GHS, with the chemical classified as specific target organ toxicity – repeated exposure (category 1 or 2), or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for subacute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) value of less than 300 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subchronic oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) of less than 100 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subacute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) value of less than 600 mg/kg bw/day, or
    • conducted following an acceptable test guideline for subchronic dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) of less than 200 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subacute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of: 
      • for gases - less than 750 ppmV/6 h/day, or
      • for vapours - less than 3 mg/L/6 h/day, or 
      • for dusts/mists/fumes less than 0.6 mg/L/6 h/day, or 
    • conducted following an acceptable test guideline for subchronic inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of: 
      • for gases - less than 250 ppmV/6 h/day, or 
      • for vapours - less than 1 mg/L/6 h/day, or
      • for dusts/mists/fumes less than 0.2 mg/L/6 h/day.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure  

Information is required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure, if: 

  • the human health exposure band for the introduction is 4, and 
  • you are seeking to demonstrate that the introduction meets the criteria for low risk or very low risk 

and any of the following apply: 

  1. the human health categorisation volume for the introduction is greater than 100 kg and the chemical is introduced for end use in any of the following types of articles: 
    • food contact, or
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth, or 
  2. the human health categorisation volume for the introduction is greater than 1000 kg and the chemical is not introduced for end use in any of the following types of articles: 
    • food contact, or 
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth, or

3.    the chemical is for end use in a personal vaporiser.

See extra guidance on categorisation of chemicals:

If 1 or 2 apply, the information required to demonstrate that a chemical does not have the hazard characteristic, specific target organ toxicity after repeated exposure, is at least one of the following: 

  • 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 
  • information that demonstrates that the chemical is a high molecular weight polymer that does not have the hazard characteristic, skin corrosion, 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 subacute oral toxicity, in which the NOAEL (oral) is greater than or equal to 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subchronic oral toxicity, in which the NOAEL (oral) is greater than or equal to 100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subacute dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subchronic dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 200 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is: 
      • for gases - greater than or equal to 750 ppmV/6 h/day, or 
      • for vapours - greater than or equal to 3 mg/L/6 h/day, or 
      • for dusts/mists/fumes - greater than or equal to 0.6 mg/L/6 h/day , or 
    • conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is: 
      • for gases - greater than or equal to 250 ppmV/6 h/day, or 
      • for vapours - greater than or equal to 1 mg/L/6 h/day, or 
      • for dusts/mists/fumes - greater than or equal to 0.2 mg/L/6 h/day.

If 3 applies (the chemical is for end use in a personal vaporiser), the information required to demonstrate that the chemical does not have the hazard characteristic, specific target organ toxicity after repeated exposure, is a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below: 

  • conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, or the NOAEC (inhalation) is: 
    • for gases - greater than or equal to 750 ppmV/6 h/day, or 
    • for vapours - greater than or equal to 3 mg/L/6 h/day, or 
    • for dusts/mists/fumes - ≥ 0.6 mg/L/6 h/day, or
  • conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, or the NOAEC (inhalation) is: 
    • for gases - greater than or equal to 250 ppmV/6 h/day, or 
    • for vapours - greater than or equal to 1 mg/L/6 h/day, or 
    • for dusts/mists/fumes - greater than or equal to 0.2 mg/L/6 h/day.

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure, if: 

  • the human health exposure band for the introduction is 4, and 
  • you are seeking to demonstrate that the introduction meets the criteria for low risk or very low risk, 

and any of the following apply: 

  • the human health categorisation volume for the introduction is less than or equal to 100 kg and the chemical is introduced for end use in any of the following types of articles: 
    • food contact, or
    • children’s toys that can be placed in the mouth, or
    • children’s care products that can be placed in the mouth, or 
  • the human health categorisation volume for the introduction is less than or equal to 1,000 kg and the chemical is not introduced for end use in any of the following types of articles:
    • food contact, or 
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth

In these circumstances, 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.

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