Categorisation of chemicals in tattoo inks

Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets any terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions. 

Who should read this?

Importers and manufacturers of industrial chemicals (and products that are designed to release industrial chemicals) who are working out if their importation/manufacture (introduction) will be an exempted, reported or assessed introduction. You must read this in conjunction with our categorisation guide.

What is a tattoo ink?

A tattoo ink is a combination of chemicals that contains one or more colouring agents and is applied to the dermal layer of the skin for the purpose of colouring the skin. Examples of chemicals used in tattoo inks include:

• pigments
• dyes
• resins

Tattoo inks can be used as a form of body art or to replicate the effect of cosmetics. Inks used for body art are chosen for permanency, while inks used in semi-permanent tattoos are meant to eventually fade over time.

Introductions of an industrial chemical for an end use in tattoo ink are referred to as a ‘specified class of introduction’. We have an increased level of concern for specified classes of introductions, due to a greater potential for particular hazards or high levels of human or environmental exposure. For this reason, there may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.

Our increased level of concern for introductions of chemicals for an end use in tattoo ink is because these chemicals can persist in the body for many years. Some of these chemicals may produce allergic or irritating skin reactions when exposed to ultraviolet light (such as sunlight or laser irradiation during tattoo removal). The additional or different requirements arising from these concerns are outlined below.

Is this introduction exempted, reported or assessed?

You must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 1-6 of the categorisation guide. If your introduction does not meet the criteria for the exempted or reported category, it will be an assessed introduction.

The additional or different requirements to be aware of when working out your category of introduction are at:

• Step 4.3: Work out your human health exposure band
• Step 4.4: Work out your human health hazard characteristics

What is the human health exposure band? 

Exposure arising from an end use in a tattoo ink is a ‘designated kind of human exposure’. The human health exposure band for the introduction of a chemical for an end use in a tattoo ink is human health exposure band 4. 

Information you need to show that your chemical does not have human health hazard characteristics 

You’ll need additional information to show your chemical doesn’t have the following human health hazard characteristics:

• skin sensitisation – Human health hazard band B
• skin irritation – Human health hazard band A

The information you need for all other human health hazard characteristics is as the same as other chemical introductions.

Skin sensitisation - Human health hazard band B

If your introduction is to be categorised as reported or exempted, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need: 

• the same information that is required for other chemicals in Part 6.14.2 of the Categorisation Guidelines. For example, non-sensitising predictions for the chemical (or suitable read-across information), in studies conducted following acceptable test guidelines for the 1st, 2nd and 3rd key events in skin sensitisation and
• • information to justify why your chemical would not cause skin sensitisation mediated by UV light. This may include one or more of the following:
  • that your 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 skin sensitisation studies where the methods have been modified to include photoactivation

Skin irritation – Human health hazard band A

If your introduction is to be categorised as exempted, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need:

• the same information that is required for other chemicals in Part 6.20.2 of the Categorisation Guidelines. For example, a non-irritant prediction for the chemical (or suitable read-across information), in an in vitro study conducted following an acceptable test guideline for skin irritation and
• information to justify why your chemical would not cause skin irritation mediated by UV light. This may include one or more of the following:
  • that your 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
     

Additional record keeping obligations

There are no unique records that must be kept based on the introduction of a chemical with an end use in a tattoo ink. For record keeping requirements that apply to all chemical introductions see our guidance on reporting and record keeping obligations.