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Scheduling delegate's final decisions: ACCS, August 2014

Scheduling medicines and poisons

7 August 2014

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Part A - Final decisions on matters referred to an expert advisory committee (ACCS) 1.8-1.11

1. Scheduling proposals referred to the March 2014 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#10)

1.8 Hexamine or 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane

Scheduling proposal

On 10 December 2013, the National Industrial Chemicals and Notification Assessment Scheme (NICNAS) under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process, requested that the delegate consider a proposal to include 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane in Schedule 5 with potential low concentration cut-off.

The chemical is not specifically listed. However, specific uses may be included in the following general group entry in Schedule 5 (AMINES for use as curing agents for epoxy resins except when separately specified in these Schedules).

The NICNAS IMAP report recommends that the chemical in cosmetics/personal care products and domestic products should be restricted through poisons scheduling. Exemptions to scheduling may be applicable at low concentrations (up to 0.15 per cent, see Overseas Regulation in the IMAP report).

The IMAP report notes that the matters to be taken into consideration include skin and respiratory sensitisation effects of the chemical (including release of formaldehyde under acidic conditions) and the maximum concentrations authorised in cosmetics overseas.

The delegate's reason for referring this scheduling proposal to the ACCS is that, in accordance with section 4.2 of the Scheduling Policy Framework (SPF), advice is required to be obtained from an expert advisory committee for all rescheduling proposals.

The delegate raised the following specific questions:

  • Does the ACCS support the creation of a Schedule 5 entry for 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane?
  • If so, should the listing name be: 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane, hexamethylene tetramine or methanamine? Note that a related tetramine derivative (hexamethylmelamine) is an anti-cancer drug currently listed in Schedule 4. The structural similarities are not such that the two listings should be confused.
  • Is the purported sensitisation potential sufficient to warrant Schedule 5 scheduling, for a chemical that appears to have minimal acute and repeated dose toxicity?
  • If the ACCS supports scheduling, should the entry be specific for cosmetic use, with a cut-off at 0.15 per cent? Cosmetic-specific scheduling may be needed if there are potential uses (as noted in the NICNAS IMAP report) in AgVet and therapeutic products.
  • Noting the Secretariat's comment that there are generic Appendix E & F statements for 'AMINES for use as curing agents for epoxy resins', or does the ACCS consider that this generic entry already includes 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane, or does its use pattern (as described in the NICNAS IMAP report) and a proposal to schedule only the cosmetic uses of this chemical indicate that these statements are inappropriate?
Substance summary

Please refer to the NICNAS IMAP Human Health Tier II Assessment Report for 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane, which is publically available on the NICNAS website.

Scheduling status

1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane is not specifically scheduled.

Scheduling history

1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane has not been previously considered for scheduling therefore scheduling history is not available.

Pre-meeting public submissions

Two public submissions were received.

One submission indicated that as it did not oppose the scheduling of methenamine in cosmetic preparations on the basis of international harmonisation. Methenamine is used as a camp stove fuel tablet (hexamine tablets). Any scheduling decision should understand the impact on this and other potential sectors.

The other submission indicated that the TGA's e-BS site and the ARTG has hexamine listed in the ARTG ingredient list. Hexamine hippurate is also an active ingredient in an OTC medicine widely used to treat urinary tract infection (hexamine hippurate 1g tablets), and this substance could be regarded as a salt or derivative of hexamine. The submission indicated that the scheduling proposal would therefore capture a TGA registered therapeutic product and requested that the schedule listing of the substance be specifically exempted from scheduling for therapeutic goods.

ACCS advice to the delegate

The ACCS recommended that cosmetic preparations containing more than 0.15 per cent of hexamine be included in Schedule 5. The committee also recommended that there be a cross reference between hexamine and methenamine.

The committee also recommended an implementation date of 1 October 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (c) the toxicity of the substance.

The reasons for the recommendation comprised the following:

  • Toxicity profile (skin sensitisation) warrants cosmetic preparation above 0.15 per cent be included in Schedule 5.
Delegate's interim decision

The delegate accepts the advice of the ACCS to include the substance in Schedules 5. While the chemical has a very low toxicity profile (acute oral/dermal toxicity, no skin/eye irritancy) and this profile is inconsistent with any of the SPF scheduling criteria, its sensitisation potential warrants inclusion of cosmetic products containing it in Schedule 5. The risk is sufficiently ameliorated for cosmetic products containing 0.15 per cent or less, and this is consistent with international cosmetic restrictions.

The schedule 5 entry should be restricted to use in cosmetics, the name is an issue. The IUPAC name is 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane, while other common names are hexamine and hexamethylenetetramine. While the latter names appear to be in common use in Australia, neither appears to have status as an Australian approved name, as outlined in Part 1 of the SUSMP. Accordingly, it is proposed to use the IUPAC name in the listing, with SUSMP index cross-references to hexamine and hexamethylenetetramine.

The delegate agrees with the implementation date being 1 October 2014. An early implementation date is proposed, based on advice that there should be minimal impact on products currently in the Australian market.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: b) the purposes for which a substance is to be used and the extent of use of a substance and c) the toxicity of a substance.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors9;
  • Other relevant information.
Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Schedule entry

Schedule 5 - New entry

1,3,5,7-TETRAAZATRICYLO[3.3.1.13,7] DECANE in cosmetic preparations, except in preparations containing 0.15 per cent or less of 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane.

Index - New entry

HEXAMINE

See 1, 3, 5, 7-TETRAAZATRICYCLO [3.3.1.13,7] DECANE

HEXAMETHYLENETETRAMINE

See 1, 3, 5, 7-TETRAAZATRICYCLO [3.3.1.13,7] DECANE

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1.9 Lambda-cyhalothrin

Scheduling proposal

On 9 November 2013, the Office of Chemicals Safety (OCS) requested that the delegate consider a proposal to amend the Schedule 6 entry for lambda-cyhalothrin to increase the concentration cut-off for (b) other preparations containing lambda-cyhalothrin from 1 per cent or less to 1.5 per cent or less of lambda-cyhalothrin. The OCS’s request is based on an application to the Australian Pesticides and Veterinary Medicines Authority (APVMA) to register a new insecticide product, containing lambda-cyhalothrin and an organophosphate (OP) component. The product is emulsion oil in water (EW) formulation for control of certain pests in wheat, barley, canola, pulses, lucerne and pastures.

The reason for this recommendation is that a product containing lambda-cyhalothrin and OP component has:

  • Moderate acute oral toxicity in rats;
  • Low acute dermal toxicity in rats;
  • Low acute inhalational toxicity in rats;
  • Moderate irritant of the skin in rabbits;
  • Moderate eye irritant in rabbits; and
  • Not a skin sensitiser in mice (local lymph node assay).

The delegate noted that the acute inhalational toxicity values align with the Scheduling Policy Framework (SPF) Schedule 6 factors, i.e. moderate to high toxicity.

The OCS considers that due to the scheduling history for lambda-cyhalothrin and the acute toxicity profile of the product, that amendment of the current Schedule 6 entry for lambda-cyhalothrin would be appropriate.

The OCS recommended to the scheduling delegate that the entries for lambda-cyhalothrin be amended to read:

SCHEDULE 7 entry - no change

SCHEDULE 6 - Amendment

LAMBDA-CYHALOTHRIN - amend entry to read:

LAMBDA-CYHALOTHRIN

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in other preparations containing 1.5 per cent or less of lambda-cyhalothrin

except when included in Schedule 5.

SCHEDULE 5 entry - no change.

The delegate referred this matter to the ACCS. The reason for referring this matter to the ACCS is, although the proposal was a relatively straightforward re-scheduling proposal that may not need advice from the ACCS, the scheduling history of products containing lambda-cyhalothrin is more complex. ACCS advice is therefore requested to ensure that the re-scheduling application incorporates correct wording.

The delegate asked the following questions:

  • The toxicity profile of the product under consideration is clearly consistent with Scheduling Policy Framework (SPF) criteria for Schedule 6. However, the contribution of the organophosphate component masks any potential acute toxicity difference between the 1.5 per cent concentration of lambda-cyhalothrin and the 1 per cent permitted in 'other' preparations in the current Schedule 6 entry.
  • The scheduling is further complicated by the fact that the current Schedule 6 entry permits a concentration of lambda-cyhalothrin up to 25 per cent when in a microencapsulated formulation, while the Schedule 5 entry allows for up to 1 per cent lambda-cyhalothrin in aqueous preparations and up to 2.5 per cent in microencapsulated formulations.
  • The applicant makes a case that the formulation of the product under consideration could be considered to be a form of microencapsulation. If this is the case, amendment of either the Schedule 5 or Schedule 6 entries is not needed to accommodate this product in Schedule 6, where the organophosphate component requires regulation as a Schedule 6 product.
  • Does the ACCS advise that the simple solution to amend clause (b) of the current Schedule 6 entry by extending the limit from 1 to 1.5 per cent, as proposed in the OCS evaluation report, is the more effective re-scheduling approach, or should a more specific clause be added to the current Schedule 6 entry to accommodate this product? The delegate notes that extending the cut-off to 1.5 per cent is insufficient to cover the actual formulation under consideration, and the delegate proposes to make this 1.6 per cent if the ACCS advice supports amendment of the Schedule 6 entry.
  • Would extending the Schedule 6 cut-off from 1 to 1.6 per cent for 'other' preparations have any unintended consequences for lambda-cyhalothrin products currently regulated as Schedule 7 products?
Substance summary

Lambda-cyhalothrin is a synthetic pyrethroid insecticide. It consists of two of the four enantiomers which constitute cyhalothrin. Cyhalothrin comprises approximately 50 per cent lambda-cyhalothrin (cis 1RαS and cis 1SαR enantiomers, enantiomeric pair B) and 50 per cent R157836 (cis 1RαR and cis 1SαS enantiomers, enantiomeric pair A)10. Pyrethroid insecticides disrupt the normal functioning of the nervous system in an organism, which may cause paralysis or death. It is a non-systemic insecticide with contact and stomach action, and repellent properties11.

Figure 4. Structures of lambda-cyhalothrin

Structures of lambda-cyhalothrin

Acute toxicity

The acute toxicity end-points for the chemical are listed in the below table.

Toxicity Species Lambda-cyhalothrin SPF* Classification
Oral LD50 (mg/kg bw) Rats 56 Moderate to high toxicity
Dermal LD50 (mg/kg bw) Rats 632 Moderate to high toxicity
Inhalational LC50 (mg/m3/4h) Rats 65 High to extremely high toxicity
Skin irritation Rabbits Slight irritant
Eye irritation Rabbits Slight irritant
Skin sensitisation (Magnusson and Kligman method) Guinea pigs Not a skin sensitiser

*Scheduling Policy Framework for Medicines and Chemicals (2010)

The OCS report noted that the acute toxicity symptoms in rats were typical of pyrethroid toxicity, consisting of gait abnormalities, decreased activity, salivation, and piloerection.

Repeat-dose toxicity

In a 90 day dietary study in rats with 0, 0.5, 2.5, or 12.5 mg/kg bw/d lambda-cyhalothrin (~10, 50, or 250 ppm), large increases in relative liver weights and aminopyrine demethylase activity were seen in males at 2.5 mg/kg bw/d and in females at 12.5 mg/kg bw/d, but in the absence of accompanying histological changes the effects were considered to be adaptive. The no observed effect level (NOEL) was 2.5 mg/kg bw/d, based on decreased bodyweight gain at 12.5 mg/kg bw/d in both sexes.

Chronic toxicity studies

In a 1-year oral dosing study, dogs in groups of 6/sex/dose received gelatin capsules containing 0.1, 0.5, or 3.5 mg/kg bw/d lambda-cyhalothrin dissolved in corn oil. Slight increases in vomiting in the first weeks of the study were seen at 3.5 mg/kg bw/d, which partially reduced in frequency over the study period. Neurotoxicity symptoms in the form of incoordination (unsteady gait, straddled gait/recumbency), and tremors were seen at 3 to 7 hours post-dosing at 0.5 mg/kg bw/d and above, and were dose dependent. Muscle tremors and convulsions were also seen at 0.5 (2/12 animals) and 3.5 mg/kg bw/d (4/12 animals), but the time of onset and duration was not specified. Most animals recovered from these effects in the intervals between each dosing, and the effects were considered to be non-accumulative. An exception was a male at 3.5 mg/kg bw/d, which developed persistent convulsions and ataxia at week 46 and after two more days was humanely sacrificed in extremis. An incident of ataxia of mild severity was seen in one animal at 0.1 mg/kg bw/d, but was considered to be incidental to treatment.

Decreased food consumption was seen at 3.5 mg/kg bw/d, but bodyweight gain was unaffected. Trends for increased levels of triglycerides, decreased sodium, and (males only) decreased levels of protein and creatine kinase in plasma, were also seen at this dose. Levels of ALP, ALT, and AST in plasma were not measured in the study. Slight but ‘obvious’ increases in the absolute weights of liver and kidney were seen at 3.5 mg/kg bw/d, with trends for increases at lower doses. Necropsy findings, including histopathological, were otherwise unremarkable in all animals. Levels of radiolabel remaining in tissues were not analysed in the study. The NOEL was 0.1 mg/kg bw/d, based on dose-dependent increases in incoordination (unsteady gait, straddled gait/recumbency), muscle tremors and convulsions at 0.5 mg/kg bw/d and above. The OCS (1990) concluded that the neurotoxicity effects of lambda-cyhalothrin could be considered to be short-lasting and reversible. For the purposes of the current assessment, this NOEL can therefore be considered both to be short-term and protective of other effects from long-term exposures.

Mutagenicity

No mutagenic effects were detected using lambda-cyhalothrin in a Salmonella typhimurium reverse mutation assay, with and without metabolic activation.

Genotoxicity

No genotoxic effects were detected.

Carcinogenicity

No information provided.

Reproduction and developmental toxicity

No information provided.

Toxicology of the product

The OCS report noted that the acute toxicity data for lambda-cyhalothrin and an organophosphate (OP) component in the product formulation did not differ markedly from the acute toxicity findings for the product formulation. Therefore, based on a comparison of the acute toxicity profiles of the individual active constituents and the combined product formulation, the information does not appear to indicate the presence of synergism or potentiation resulting from the two active constituents in combination.

The acute toxicity of the product containing OP component and lambda-cyhalothrin are listed in the below table.

Toxicity* Product OP component** Lambda-cyhalothrin
Oral LD50 (mg/kg bw)

114 (females, with deaths)

(99 - 175)

96-475 56
Dermal LD50 (mg/kg bw) >5000 >2000 632
Inhalational LC50 (mg/m3)

>2450 (males, with deaths)

2070 females, with deaths)

>200 65
Skin irritation Moderate irritant Slight irritant Slight irritant
Eye irritation Moderate irritant Slight irritant Slight-irritant
Skin sensitisation Not sensitising Not sensitising Not sensitising

* Oral, dermal and inhalational data from rats; skin and eye irritation data from rabbits; skin sensitisation data from mice or guinea pigs.

** Organophosphate (OP)

Scheduling status

Lambda-cyhalothrin is listed in Schedules 5, 6 and 7.

Other similar substances such as gamma-cyhalothrin is listed in Schedules 5 and 7, and cyhalothrin is listed in Schedule 7.

These three substances differ only in the composition of the stereoisomers present. Cyhalothrin is comprised of 4 stereoisomers (1R, cis, Z-S; 1S, cis, Z-R; 1R, cis, Z-R and 1S, cis, Z-S). Lambda-cyhalothrin is formed from the enantiomer pair (1R, cis, Z-S; 1S, cis, Z-R). Gamma-cyhalothrin has just one isomer (1R, cis, Z-S) which provides almost all the biological activity among the 4 stereoisomers of cyhalothrin.

SCHEDULE 5

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 1 per cent or less of lambda-cyhalothrin; or
  2. in aqueous preparations containing 2.5 per cent or less of microencapsulated lambda-cyhalothrin.

SCHEDULE 6

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in other preparations containing 1 per cent or less lambda-cyhalothrin,

except when included in Schedule 5.

SCHEDULE 7

LAMBDA-CYHALOTHRIN except when included in Schedule 5 or 6.

Scheduling history

In November 1987, the Drugs and Poisons Schedule Committee (DPSC) decided to include first aid and safety directions for lambda-cyhalothrin.

In August 1990, the DPSC decided to include preparations containing 1% or less of lambda-cyhalothrin in Schedule 6 and all other preparations containing lambda-cyhalothrin in Schedule 7, based on the toxicity profile of lambda-cyhalothrin.

In November 1991, the DPSC decided to include aqueous preparations containing 1% or less of lambda-cyhalothrin in Schedule 5. The reason for this decision was that the water-based product containing 1% or less of lambda-cyhalothrin would be used by pest control operators therefore registration mechanism would be applicable.

In November 1994, the NDPSC considered toxicological data on microencapsulated suspensions containing 2.5% or less of lambda-cyhalothrin and decided to include it in Schedule 5.

In August 1999, the NDPSC decided to include microencapsulated preparations containing 25% or less of lambda-cyhalothrin in Schedule 6.

Pre-meeting public submissions

One submission was received.

The submission indicated that as lambda-cyhalothrin was used as an insecticide therefore it would be unlikely that the proposed scheduling amendment would have any impact on therapeutic goods.

ACCS advice to the delegate

The ACCS recommended that the Schedule 6 lambda-cyhalothrin entry be amended to increase the concentration cut-off for (b) other preparations containing lambda-cyhalothrin from 1 per cent or less to 1.6 per cent or less of lambda-cyhalothrin.

The ACCS recommended an implementation date of 1 October 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (c) the toxicity of a substance. The reasons for the recommendation comprised the following:

  • Toxicity profile of the product is consistent with SPF factors for Schedule 6.
Delegate's interim decision

The delegate accepts the advice tendered by the ACCS, and proposes that the lambda-cyhalothrin entry in Schedule 6 be amended to extend exemption clause (b) from 1 to 1.6 per cent. The toxicity profile of the product proposed for registration is consistent with SPF criteria for Schedule 6. The delegate also accepts advice that the product formulation is not microencapsulated and therefore it is not covered by the current Schedule 5 and Schedule 6 entry clauses describing such formulations. Increasing the allowed concentration from 1.5 to 1.6 per cent is ensure that the product formulation, when expressed in grams per 100 millilitre (as per Part I of the SUSMP), is covered by the amended entry.

The delegate agrees with the implementation date being 1 October 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: c) the toxicity of a substance; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors12;
  • Other relevant information.
Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Schedule entry

Schedule 6 - Amendment

LAMBDA-CYHALOTHRIN - Amend entry to read:

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in other preparations containing 1.6 per cent or less of lambda-cyhalothrin

except when included in Schedule 5.

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1.10 Methyl isobutyl ketone or 2-pentanone, 4-methyl

Scheduling proposal

On December 2013, the National Industrial Chemicals and Notification Assessment Scheme (NICNAS) under its Inventory Multi-tiered Assessment Prioritisation (IMAP) process requested that the delegate consider a proposal to delete the current Schedule 5 methyl isobutyl ketone (MIBK) entry and create a new Schedule 6 entry for MIBK.

The reasons for NICNAS' recommendation include:

  • carcinogenicity under conditions of high dose repeated inhalation exposure,
  • acute inhalation toxicity,
  • eye and respiratory irritation,
  • flaking and drying of skin following repeated exposure.

The NICNAS report also notes that, although specific cosmetic and domestic uses have not been identified in Australia, the chemical has reported overseas uses for cosmetic and domestic purposes. Overseas reports have identified concentrations of the chemical up to 12 per cent (aerosol) for use in automotive products at home and a concentration of up to 35 per cent (liquid) for home maintenance uses (US Household Products Database).

The delegate's reason for referring this scheduling proposal to the ACCS is that, the IMAP report recommends re-scheduling MIBK (named as 2-pentanone, 4-methyl in the NICNAS IMAP report) from its current Schedule 5 entry to Schedule 6. This requires advice from the ACCS.

The delegate raised the following specific matters:

  • MIBK is currently listed in Schedule 5, with a cut-off to exempt at 25 per cent. There are relevant entries in Appendices E & F, and it is also listed in Part 1 as a 'designated solvent'. These SUSMP entries are quite old, and it appears that they may have been unchanged since the 1960s - 1970s.
  • The IMAP report draws attention to the recent (2012) IARC classification (2B) of MIBK. The carcinogenicity findings were in liver and kidneys (α-2µ-globulin-induced nephropathy in a recent inhalation toxicity study in rats. The carcinogenicity findings appear to be the primary reason for the NICNAS recommendation to re-schedule MIBK to Schedule 6, although the respiratory and eye irritancy, along with CNS depressant inhalation toxicity could be other reasons.
  • Does the ACCS support the re-scheduling proposal to Schedule 6? If so, is the 25 per cent cut-off to exempt still appropriate? Does a schedule change impact on the designation of MIBK as a 'designated solvent'? Note: some 'designated solvents' have their primary listing in Schedule 6.
  • Can the ACCS identify the potential regulatory impacts on products currently regulated as Schedule 5?
  • Since the NICNAS IMAP report identifies a major overseas use in paints (up to 12 per cent in aerosol form and 35 per cent in liquid form), does the ACCS consider that listing in Appendix I (Uniform Paint Standard) is warranted? If so, in which schedule of the UPS?
Substance summary

Please refer to the NICNAS IMAP Human Health Tier II Assessment Report for MIBK (named as 2-pentanone, 4-methyl- in the IMAP report), which is publically available on the NICNAS website.

Scheduling status

MIBK is currently listed in in Part 1, interpretation (as a 'Designated Solvent'), in Schedule 5 and Appendices E and F.

PART 1, INTERPRETATION

"Designated solvent" means the following:

methyl isobutyl ketone

SCHEDULE 5

Methyl isobutyl ketone except in preparation containing 25 per cent or less of designated solvents.

Appendix E
Poisons Standard statements
Methyl isobutyl ketone

A. For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).

G3. If swallowed, do NOT induce vomiting.

Appendix F
Poisons Warning statements Safety direction
Methyl isobutyl ketone

1. Avoid contact with eyes.

4. Avoid contact with skin.

8. Avoid breathing dust (or) vapour (or) spray mist

Scheduling history

MIBK was first considered by the Poisons Schedule Sub-Committee (PSSC) in February 1971 as a result of a working party addressing the scheduling of solvents. The PSSC decided to include preparations containing more than 25 per cent MIBK when packed in containers of 5 gallons or less in Schedule 5.

In February 1984, the Poisons Schedule (Standing) Committee (PSC) considered amending the Schedule 5 MIBK entry to provide clarity as a result of broader amendments associated with the introduction of warning statements for hazardous substances in bulk distribution. As a consequence of this, the PSC decided to exempt from the Schedule 5 listing for preparations containing 25 per cent or less of ketones and in containers having a capacity of more than 20 litres, provided the containers are marked with the name and proportion of ketones included in Schedule 5.

In February 1986, the Drugs and Poisons Scheduling Committee (DPSC), based on the Working Party on Safety Directions and First Aid Instructions recommendations, decided to include MIBK in Appendix F (Warning Statements) with a statement indicating "Flammable". The DPSC also decided to delete the exemption references for bulk packs.

Pre-meeting public submissions

Two submissions were received.

One submission indicated that it did not support the scheduling proposal. The submission noted that the NICNAS recommendation to up-schedule MIBK appears to be on the basis of the substance's carcinogenic potential. Both the USA and the EU should also be aware of carcinogenicity potential of MIBK and there were no restrictions in the EU or the USA on the use of this substance in cosmetics. The submission further indicated that the NICNAS had not provided any evidence that the current scheduling of MIBK was inadequate therefore there was no need to up-schedule MIBK or to remove the exemption from scheduling.

The second submission indicted that the TGA e-BS website contains an ARTG ingredient listing for MIBK, with the use not specified. The submission therefore requested that the wording of any proposed Schedule 6 entry should be consistent with the existing Schedule 5 entry, i.e. "Methyl isobutyl ketone except in preparations containing 25 per cent or less of designated solvents." This wording would exclude therapeutic goods from Schedule 5 or 6, as per the existing entry.

ACCS advice to the delegate

The ACCS recommended that the current scheduling of methyl isobutyl ketone remains appropriate.

The reasons for the recommendation comprised the following:

  • There are no compelling grounds on the basis of toxicity and carcinogenicity provided to the committee for a change in scheduling.
Delegate's interim decision

The delegate accepts the advice of the ACCS and has decided not to make any change to the current listings of methyl isobutyl ketone (MIBK) in Schedule 5 and Appendices E & F, nor to alter its status as a 'designated solvent' in Part 1 of the SUSMP. The toxicity profile of MIBK is generally consistent with SPF criteria for listing in Schedule 5, but the key issue in the submission seeking re-scheduling to Schedule 6 is its potential for carcinogenicity. The delegate notes the different opinions of the human relevance of carcinogenicity findings in recent inhalation toxicity studies in rats and mice. The ACCS advice downplayed the significance of the findings in rats as possibly related to male rat-specific α-2µ-globulin-induced nephropathy, while the NICNAS report and IARC evaluations have placed less weight on this mechanism and concluded that MIBK is possibly carcinogenic to humans. Findings of non-genotoxicity for MIBK suggest that the carcinogenic findings at high inhalation doses do not appear to be related to a genotoxic mechanism. There is some precedent in that stronger evidence of carcinogenic potential relevant to humans is usually required to support more restrictive scheduling.

The ACCS also noted that, in the absence of information that MIBK is used in any paints on the Australian market, there is no need to amend Appendix I at this time. The delegate accepts this advice.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: c) the toxicity of a substance.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors13;
  • Other relevant information.
Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

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1.11 Methylated spirit(s)

Scheduling proposal

On 15 November 2013, the Australian Competition and Consumer Commission (ACCC) requested the delegate consider including a label warning statement (stated below) alerting consumers regarding the serious burn hazard that methylated spirits may pose when refuelling ethanol burners.

'WARNING: DO NOT attempt to refill methylated spirit burner while it is in use or still warm; it could lead to serious burn injury or death.'

The delegate's reason for referring this scheduling proposal to the ACCS is that the ACCC's proposal to include a mandatory warning statement regarding the risk of burns when used with methylated spirit burners is relatively straightforward. However, the potential regulatory impacts need to be considered by the ACCS and alerted to industry though an appropriate public notice.

The delegate asked the following specific questions:

  • Does the ACCS support the ACCC's recommendation that the proposed warning statement be a mandatory inclusion on labels for products regulated under the Schedule 5 entry for methylated spirit?
  • Would this be best implemented via a sub-clause in the Schedule 5 entry, or by inclusion of a new Warning Statement in Appendix F?
  • In view of the potential regulatory impact, what implementation date does the ACCS recommend for any scheduling action?
  • Since historical aspects of the scheduling of methylated spirit appear to be incomplete, can any member of ACCS shed any light on how the current entry was promulgated, with the earlier exemption for preparations containing <20 per cent changed to exemption of all 'preparations and admixtures'?
Substance summary

Methylated spirit is ethanol denatured with approximately 5 per cent of methanol. Methanol is commonly used additive in denatured ethanol because of its boiling point is close to that of ethanol, its toxicity and it makes ethanol extremely bad tasting to discourage recreational use of denatured alcohol. Methylated sprit, which is also known as denatured ethanol, ethanol, denatured alcohol, is a clear, colourless, mobile liquid. It is miscible with water in all proportions14. Methylated spirit is used as a fuel for spirit burners and camping stoves and also as a solvent for cleaning preparations.

Ethanol is a volatile, flammable, colourless liquid. An ethanol-water solution that contains 40 per cent alcohol by volume will catch fire if heated to about 26°C and if an ignition source is applied to it. The flash point of pure ethanol is 16.60°C, less than average room temperature. Ethanol is a versatile solvent, miscible with water and with many organic solvents, including acetic acid, acetone, benzene, carbon tetrachloride, chloroform, diethyl ether, ethylene glycol, glycerol, nitromethane, pyridine, and toluene. It is also miscible with light aliphatic hydrocarbons, such as pentane and hexane, and with aliphatic chlorides such as trichloroethane and tetrachloroethylene.

Figure 5. Structure of ethanol

Structure of ethanol

Issues raised in the application

Methanol is commonly used as an additive in the methylated spirit because its boiling point is close to that of ethanol.

Methylated spirit is classified as a Schedule 5 poison and the products' label includes the signal word "CAUTION". It is available from supermarkets, hardware stores and camping/outdoors stores.

Work Safe Australia has classified methylated spirit as a hazardous substance. Methylated spirit is also classified as a dangerous good according to the criteria of the Australian Dangerous Goods (ADG) Code. The products' label includes the following information:

  • 'Highly Flammable' symbol and risk phrase;
  • 'Keep out of reach of children', 'Keep container tightly closed'; and
  • 'Keep away from ignition source - No smoking' safety phrases.

Since the introduction of ethanol burners into the Australian market, methylated spirit has also been used as a common fuel for these products. The product is suitable to use as 'burner fuel' and provides instructions of use of filling the product into the burners. However, the labels of other brands do not have this information.

The ACCC noted that from May 2010 until now, it is aware of twenty-seven incidents relating to ethanol burners, in which twenty-two resulted in burn injuries ranging from minor burns and up to serious burns to 55 per cent of the body. Most of the injuries required hospitalisation. Five of the reported incidents resulted in injuries to child and elderly bystanders.

The majority (64 per cent) of burn injuries reported occurred during the refilling of the burner while it was still lit or warm. The number and severity of injuries related to ethanol burners suggest that ethanol burners pose a hazard to the Australian consumers due to the following reasons:

  • Lack of safety warnings on fuel packaging; and
  • Lack of safety warnings on burners and burners’ packaging.
Additional information

On 19 February 2014, the a member of ACCS sent an email directly to the Scheduling Secretariat indicating that it has been alleged that there are products being sold for "eco fuel" spirit burners present in many households, camping trailers/caravans etc. that are ethanol denatured with (only) 0.25 per cent methyl isobutyl ketone. Apparently these are NOT required to be packed and labelled as Schedule 5 poisons, nor controlled under excise legislation, despite being if anything more dangerous than methylated spirits as defined in the SUSMP as they don’t contain a bittering agent but do contain methyl isobutyl ketone which is quite poisonous (and colourless and has a pleasant odour), as noted by the National Industrial Chemicals and Notification Assessment Scheme (NICNAS) in its Inventory Multi-tiered Assessment Prioritisation (IMAP) report. The Excise Act determination indicates that "Denatured Spirits" which are exempted from control under the Excise Act includes ethanol denatured with 0.25% methyl isobutyl ketone only. Should the SUSMP definition of methylated spirit be amended to reflect the Excise Act determination?

Methylated sprit is listed in Schedule 5 and Appendix E. It is also listed in Part 2, Labels and Containers under Child-resistant closures.

Scheduling status

SCHEDULE 5

METHYLATED SPIRIT(S) (being ethanol denatured with denatonium benzoate, methyl isobutyl ketone and fluorescein) except:

  1. when included in preparations or admixtures; or
  2. when packed in containers having a capacity of more than 5 litres.
Appendix E
Poisons Standard statements
Methylated spirit

A - For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).

G3 - If swallowed, do NOT induce vomiting.

Part 2, Labels and containers
Column 1
Name of the poison
Column 2
Nominal capacity
Methylated spirit excluding preparations or admixtures 5 litres or less
Scheduling history

Methylated spirit was first considered in May 1956 by the Poisons Schedules Committee (PSC). The PSC decided to include methylated spirits and all substances containing more than 20 per cent of methylated sprit in Schedule 5.

In July 1963, the PSC decided to amend the methylated spirit entry to exempt 20 per cent or less of methylated spirit which are labelled in accordance with the then Appendix I (prescribed letter weights).

In February 1978, the Poisons Schedule Sub-Committee (PSSC) decided to amend the Schedule 5 methylated spirit entry to exempt containers having capacity of more than 5 litres and preparations containing 75 per cent or less of methylated spirit.

In November 1978, the PSSC decided to amend the Schedule 5 methylated spirit entry to exclude its preparations and admixtures and methylated spirits in containers having a capacity of more than 5 litres.

Pre-meeting public submissions

Six submissions (including one late submission) were received.

One submission indicated that the application sought an amendment to the Schedule 5 entry rather an Appendix F entry (as proposed by the delegate) for methylated spirits. As Appendix F is not adopted across all jurisdictions, the submission requested to consider the best option for achieving nationally adopted consistent warnings for methylated spirits, perhaps for example, via an amendment to Part 2. The submission also argued that as methylated spirit products are marketed to consumers for use as fuel for burners under a range of names including methylated spirits, bio-fuel and bio-ethanol and therefore the proposed warning statement should apply to all such methylated spirit products.

The second submission indicated that it supports the delegate's proposal to include the additional warning statement to the labelling of methylated spirits.

The third submission questioned whether the current flammability warning is not considered effective, and if it is not, why a new warning would be considered to be effective. The submission argued that labelling proposals need to be demonstrated to be effective before they are imposed.

The fourth (late submission) noted that methylated spirits have multiple uses of which only one is for use in burners. Uses such as disinfecting and cleaning do not result in it being heated. The submission indicated that the proposed warning statement should be applied to the appliance or burner itself, particularly considering such appliances may also have alternate fuel options (which may not contain the proposed warning if such a warning is only applied to methylated spirit containers).

The fifth submission indicated it supports the delegate's proposal to include a warning statement. The submission noted that the appliances themselves have never been referenced as having a 'methylated spirits burner’ and therefore referring to it in this manner may create confusion or inadequately manage the opportunity for change in line with industry standards and the continuing stable growth of the category. It is absolutely beneficial to both consumers and the category to have appropriately and adequately labelled fuel available as opposed to unlabelled methylated spirits bottles.

The sixth submission indicated that as the methylated spirits label already carries information on flammability, that any additional warning statement may be better placed on the burner itself to warn of the dangers of refilling methylated spirit burners when the burner is still warm or still lit. If there is a need for additional warning labels on methylated spirits, sufficient time should be given (at least two years) to amend the label and transition to the newly labelled products.

ACCS advice to the delegate

The ACCS recommended that the delegate refers this matter back to the ACCC on the grounds that the suggested scheduling of methylated spirits will be potentially ineffective in reducing burn injuries. Labelling maybe better considered on the burner devices.

The committee recommends that the delegate consider the current scheduling definition of methylated spirits be based on denaturing chemicals used.

Delegate's interim decision

The delegate notes the advice from the ACCS and the difficulties in achieving, through a schedule entry amendment, the requested outcome of warning consumers of the fire risks associated with using methylated spirits to refill burners while alight or hot. The delegate agrees that there are already appropriate flammability warnings on product labels as seen under current requirement in the SUSMP Part 2, Clause 7(h) and that there are a range of other uses for methylated spirit where the applicant’s proposed warning statements would not be applicable. The delegate agrees with ACCS advice that the ACCC be advised to consider attaching the suggested warning statement to the burners, rather than to the fuel. Accordingly, the delegate does not propose to include the requested warning statements by amending the current Schedule 5 entry for methylated spirit, nor by amending Part 2 Clause 7(h), nor by creating a specific Appendix F entry.

The delegate notes the information relating to possible misalignment of the wording of the current Schedule 5 entry with the definition in the Excise Act. Accordingly, the delegate proposes to refer to a future meeting of the ACCS, with appropriate information sought from industry, the specific matter of whether methylated spirits must contain all three denaturing agents (denatonium benzoate, methylisobutyl ketone and fluorescein) or any combination thereof.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of a substance, b) the purposes for which a substance is to be used and the extent of use of a substance, c) the toxicity of a substance, d) the dosage, formulation, labelling, packaging and presentation of a substance and e) the potential for abuse of a substance.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors15;
  • Other relevant information.
Public submissions on the interim decision

Two submissions were received. One submission supported the delegate's interim decision.

The other submission indicated that the efficacy of warning statement is a key factor in the development of effective and efficient responses to product hazards. The current warning statements do not address a specific hazard and that individuals are being injured though lack of understanding of the nature of the risk. The submission requested that delegate consider amending the current methylated spirit(s) entry to provide a prominent new warning statement as follows:

'WARNING: DO NOT ATTEMPT TO REFILL A METHYLATED SPIRIT BURNER WHILE IT IS IN USE OR STILL WARM; IT COULD LEAD TO SERIOUS BURN INJURY OR DEATH', (or similar)

Edited versions of these submissions are available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and has determined to set aside the interim decision.

The delegate notes the serious nature of burns that have occurred through misuse of fuels that already have prominent flammability warnings and that the ACCC research on the proposed more explicit warning statement suggests the potential for greater awareness of the dangers and possible preventive actions. The delegate intends to seek further information on the practicality of attaching the suggested warning statements to either/both the burners and/or the fuels. The delegate also notes that, under the current schedule 5 entry for METHYLATED SPIRIT(S), some fuels would not be captured even if a warning statement were to be included in the schedule entry (e.g. those in containers containing 5 litres of more and those biofuels not meeting the current specification for methylated spirits).

The delegate had already noted the need to refer back to the ACCS, the matter of which ingredients may be used to denature alcohol, and to better align the methylated spirits definition with current industry practice.

Accordingly, the delegate will refer the matter back to the ACCS for further advice, and also to seek further input from industry and the ACCC. This would include advice on the practicality of limiting the proposed warning statements to methylated spirits in products specifically packaged as biofuels for use in spirit burners and on the need to adjust the schedule entry so that warnings could be applied to the larger containers that are currently exempt from the Schedule 5 listing.

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Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010)
  2. Lambda-cyhalothrin (146) by Christian Sieke (pdf,1.08Mb)
  3. Lambda-cyhalothrin (pdf,68kb).
  4. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010)
  5. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010)
  6. Safe handling and storage of methylated spirit. Department of Transport and Main Roads, Queensland.
  7. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010)

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