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Final decisions amending, or not amending, the current Poisons Standard, November 2018

Part A - Amendments to the Poisons Standard referred to expert advisory committee

29 November 2018

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2.1. 2-Butoxyethanol

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #19)

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to 2-Butoxyethanol as follows:

Note

New text is shown as green, larger font, with a horizontal line above it.

Schedule 6

2-BUTOXYETHANOL and its ACETATES except:

a) in plant growth regulator preparations containing 20 percent or less of such substances; or

b) in other preparations containing 10 percent or less of such substances.

Index

2-BUTOXYETHANOL

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

Reasons:

The delegate has confirmed that the reasons for the final decision align with those for the interim decision, and are as follows:

  • 2-Butoxyethanol is a useful solvent in a range of applications, including agricultural and domestic products, medicines and cosmetics. It has low to moderate acute toxicity via oral, dermal and inhalation routes, but can produce severe skin and eye irritancy. A Schedule 6 cut-off concentration of 20% is considered to be too high for general consumer use in domestic products.
  • 2-Butoxyethanol is used as a solvent in a range of industrial, trade and domestic cleaning applications, including surface cleaners, floor strippers, paints, laundry detergents, rust removers, and oven and carpet cleaners. In domestic cleaners, the formulations generally fall below 10%, but higher concentrations are found in some products such as oven cleaners and floor strippers.
  • 2-Butoxyethanol is readily absorbed via all routes of exposure (inhalation, dermal, ingestion) with low to moderate acute toxicity via oral, dermal and inhalation routes. Its respiratory, skin and eye irritancy are consistent with Schedule 6 factors of the SPF.
  • The most sensitive toxicological end point is the destruction of red blood cells (haemolysis). Rats[4] are more susceptible to haemolytic effects than humans, but they develop tolerance and show reduced haemolytic effects over time, or on future exposure. Additional toxicities include neurotoxicity (loss of coordination, sluggishness and narcosis) and nephrotoxicity. In-vitro studies show no mutagenicity or genotoxicity.
  • The toxicity of 2-Butoxyethanol is mitigated when formulated as a plant grown regulator, allowing a higher percentage cut off than in products for domestic use. Although the inhalation and skin and eye irritation data of a 20% 2-Butoxyethanol preparation aligns with the Schedule 5 SPF factors, I am satisfied that the mandatory GHS labelling of plant growth regulator preparations as regulated by the APVMA is sufficient to exempt 2-Butoxyethanol from Schedule 6 in such preparations.

On balance, I consider that the perceived benefits of larger pack sizes from a convenience perspective are outweighed by the risks.

Public submissions on the interim decision

No public submissions were received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations.

Interim decision

The interim decision was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS, September 2018 – 2.1 2-Butoxyethanol.

Scheduling proposal

The pre-meeting scheduling proposal for codeine was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.


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