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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, June 2014

27 June 2014

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Interim decisions on matters referred to an expert advisory committee: ACCS March 2014: (1.1-1.5)

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

1.1 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)1. 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 properties2.

Figure 1. Structures of lambda-cyhalothrin

Figure 1. 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)

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)

Public pre-meeting 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 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 factors3;
  • Other relevant information.
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.

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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1.2 Oxalic acid

Scheduling proposal

The chemicals scheduling delegate considered a proposal to amend the current Schedule 6 oxalic acid entry to exempt from scheduling preparations containing 8 per cent or less oxalic acid for household and domestic cleaning.

The delegate referred the proposal to the ACCS as the submission sought amendment of the current Schedule 6 entry for oxalic acid, to exempt a specific range of cleaning products containing up to 8 per cent oxalic acid. The Scheduling Policy Framework (SPF) suggests that proposals for re-scheduling require advice from an advisory committee. Furthermore, the history of scheduling of oxalic acid is somewhat obscure and there appears to have been little or no contemporary consideration given to exempting products containing low concentrations of oxalic acid.

The delegate asked the following specific questions to the ACCS:

  • The scheduling history for oxalic acid is not very informative. It was first listed in the (then) schedules Schedule 2 and Schedule 5 in May 1956, when the schedules were first being established. The original wording for these entries was:
    • Schedule 2: Substances which are dangerous to human life if misused or carelessly handled
        OXALIC ACID and metallic oxides, except in laundry blue and polishes.
    • Schedule 5: Domestic poisons
      • OXALIC ACID AND METALLIC OXALATES IN POLISHES.
  • There are no records of when the current Schedule 6 entry was promulgated. The only records of further consideration are in November 1985 when the (then) Schedule 6 entry was amended to clarify the status of sodium salts and in February 1986, when a submission to require child resistant closures was considered, and rejected. It appears that the intent of the original scheduling was to exempt some types of cleaning products, but this appears to have been lost during subsequent re-organisation of the schedules.
  • The current submission seeks to exempt a range of cleaning products containing up to 8 per cent oxalic acid. The submission acknowledges that oxalic acid is systemically toxic, despite being formed as a normal metabolite within the body, with some dietary intake also contributing to oxalate concentrations in the body. Current label warning statement emphasise the corrosive potential associated with high concentrations of oxalic acid.
  • Can the ACCS advise on whether a cut-off clause should be added to the current Schedule 6 entry (to either exempt or to Schedule 5) to address this submission seeking re-scheduling of cleaning products containing up to 8 per cent oxalic acid? If so, what specific wording changes to the current entry are suggested?
  • Current SUSMP Appendix E First Aid statement emphasise the risks of skin, eye and respiratory irritancy. Are these still suitable for cleaning products containing up to 8 per cent oxalic acid?
  • Current SUSMP Appendix F entries for oxalic acid require safety warning statement 2 (corrosive) and safety directions 4 (attacks eyes - protect eyes when using) and 8 (avoid breathing dust (or) vapour (or) spray mist) while the entry for metallic oxalates requires only safety directions 4 and 8. There is no record of when either the Appendix E or F entries were promulgated, and they appear inconsistent with the range of label warning statements used on the applicant’s cleaning products sold overseas. Does the ACCS consider that the current Appendix E and F entries for oxalic acid should be modified, and are there different Appendix entries required if the recommendation is to down-schedule these cleaning products to Schedule 5?
  • Can the ACCS advise on whether there might be inadvertent implications for other types of products containing oxalic acid if scheduling changes are recommended?
Substance details

Oxalic acid is an odourless, colourless powder or granular solid that is slightly soluble in water4. It is present in many plants and vegetables, notably in those of the Oxalis and Rumex families, where it occurs in the cell sap of the plant as the potassium or calcium salt5.

Oxalic acid is endogenously produced in humans and excreted at amounts of about 25 mg daily via urine. Normal concentrations of oxalates in plants were in the range of 5 to 200 000 mg/kg dry weight6.

Figure 2. Structure of oxalic acid

Figure 2. Structure of oxalic acid
Acute toxicity

The summary of acute toxicity studies is shown in the table below.

Toxicity Species Oxalic Acid SPF* Classifaction
Oral LD50 (mg/kg bw) Rat 475 to 375 Moderate to high toxicity
Dermal LD50 (mg/kg bw) Not supplied Low toxicity Unable to assess
Inhalational LC50 (mg/m3/4h) Not supplied Not supplied Unable to assess
Skin irritation Not provided Irritant
Eye irritation Not provided Irritant
Skin sensitisation Not provided Not provided
Skin sensitisation Non-sensitiser Sensitiser

*Scheduling Policy Framework for Medicines and Chemicals (2010)

The US EPA (2005) indicates that acute oral exposure (LD50 = 300 mg/kg in gravid rats and 7500 mg/kg in rats) in rats and dogs causes gastric haemorrhage, central nervous system depression, convulsion, coma and kidney damage in experimental animals.

The US EPA (1992) notes that it is corrosive to the eyes, skin and has been placed in Toxicity Category I (indicating the highest degree of toxicity) for acute eye and skin irritation effects. Moreover, oxalic acid is also highly irritating and damaging to the respiratory system if inhaled. Acute exposure also cause stomach irritation, lowered calcium levels, effects to the nervous system and kidney damage in humans. The Merck Index also indicates that oxalic acid is caustic and corrosive to the human skin and mucous membranes.

Repeat-dose toxicity

In two studies, groups of male and female rats were fed diets supplemented with 0, 25 and 50 g/kg (equivalent to 0, 2000 and 5000 mg/kg bw/day) oxalic acid for 70 days. The high dose levels depressed the growth rate. This was accompanied by renal toxicity (increased water intake, increased kidney weight, abnormal gross appearance of kidneys at necropsy and stone formation) and reduced thyroid function. In a non-invasive screening test for the detection of renal disease, sodium oxalate administrated subcutaneously to rats at 25, 50 and 75 mg/kg bw/day for 2, 3 and 1 weeks respectively, caused mainly haematuria, with increase in the excretion into urine of white blood cells, epithelia and casts. Histopathological examination of kidneys indicated a small number of oxalate deposits in animals treated with sodium oxalate. The report indicated that these effects were indicative of a mild nephrotoxicity due to tubular obstruction following the administration of subcutaneous doses of oxalic acid greater than or equal to 25 mg/kg bw/day, for 5 days a week for 2 weeks.

The US EPA (1992) notes that a subchronic inhalation study in rats showed decreased body weights, restricted growth and disrupted oestrous cycles. At the highest dose, the test animals also had reduced thyroid weights and changes in iodine and hormone levels. Metabolism studies show that excess levels of oxalic acid cause kidney damage in mammals. Chronic oral intake in animals produces kidney damage and disturbances in the metabolism of calcium. A multi-generation mouse reproduction study showed reproductive effects and parental toxicity at the highest dose level.

Mutagenicity

There are no studies which address the mutagenic potential of oxalic acid in vivo. The negative results of the relevant in vitro studies and the data from a chronic toxicity study suggests that oxalic acid has no carcinogenic potential in rats. Therefore further mutagenic studies are not required for a risk assessment of residues of the compound.

Genotoxicity

The results of the various Ames test indicate that oxalic acid is clearly negative in the Salmonella typhimurium assay.

Carcinogenicity

In a carcinogenicity study, male and female rats were administered with 1000, 5000, 8000 and 12 000 ppm (corresponding to 50 to 600 mg/kg bw/day) of oxalic acid for 2 years. There were no effects of the treatment on body weight, body weight gain and food consumption during the first 52 weeks. There was no significant difference between the mortality rate at any dosage level in the treated groups and in the controls. The report indicated that within limitations of the study, which did not meet the criteria of current guidelines, there was no evidence of carcinogenicity in rats given approximately 50 to 600 mg/kg bw/day.

Reproduction and developmental toxicity

In a reproductive toxicity study, mice were exposed to dietary doses of 0, 0.05, 0.1 and 0.2 per cent (89, 162 and 275 mg/kg bw/day) oxalic acid. In the F0/F1 generations the number of litters in fertile pairs, live pup weight and prostate gland weight decreased significantly at 0.2 per cent in the diet, while all other parameters were unaffected. In the F1-generation the total number of live pups decreased, and prostate gland weight decreased significantly. Decreased water consumption was induced in the F1 0.1 and 0.2 per cent dose groups. Relative kidney weight of F2 females and the incidence of abnormal sperm in F2 males were increased. The report concluded that oxalic acid is a weak reproductive toxicant in mice at dose of 0.2 per cent in drinking water corresponding to about 275 mg/kg bw/day.

Oxalic acid did not induce overt teratogenic effects or postnatal toxicity. A no observed effect level (NOEL) was not determined since the data from the 0.05 and 0.1 per cent dose level groups were not recorded for the second generation.

Two teratogenicity studies were conducted in rats and sheep. In the rat study 10 females were administered with 0, 159, 205 mg/kg bw/day by gavage from day 7 post conception up to the day of parturition. Higher doses of 227 and 272 mg/kg bw/day had proven fatal within 7 days in a pilot study, while 136 mg/kg bw/day had led to marked vacuolation in cells of proximal tubules and tubular nephrosis in the pups. Neither gross malformation nor tubular nephroses was observed in offspring in the main study.

Observation in humans

Intravenous doses of 25 mg/kg bw oxalic acid inadvertently administered to human patients have led to kidney failure, cardiac arrest and death in spite of intensive care. High oral intake via a diet rich oxalic acid has also occasionally led to severe poisoning and deaths. Oral fatal doses of oxalic acid were reported to range from 3 to 30 g/person. The susceptibility of individuals varies greatly, depending on prior kidney damage, certain intestinal disease states or genetic abnormalities such as primary hperoxaluria.

Determination of individual oxalate intake of 3 volunteers maintaining food records over days suggest high average ingestion (152 ± 83 mg/day, range 44 to 351 mg/day) of normal consumers. On the basis of huge variations of oxalic acid content in the diet it may be assumed that occasional intake may reach and exceed 1 g/day, in particular in vegetarians. The report noted that it is believed, that similar to rodents and ruminants, bacterial decomposition of oxalic acid in the human intestine may largely increase with high prolonged oxalate exposure via diet, leading to reduced bioavailability and consequently lowered toxicity. Therefore adverse reactions are not common in humans in spite of daily intake occasionally reaching potentially dangerous levels.

Public exposure

The US EPA (1992) indicates that the potential for significant eye and dermal exposure exists when homeowners apply bathroom disinfectant products containing oxalic acid and other active and inert ingredients. These products are liquid and granular formulations applied using brushes, swabs or mops. Exposure, especially to the concentrated formulations, can cause chemical burns to the skin and severe to permanent damage to the eyes.

Although they contain only a small amount of oxalic acid and a much greater amount of other active and inert ingredients, oxalic acid products as formulated and registered for use as bathroom disinfectants can be highly irritating and damaging to the eyes, skin and mucous membranes. Exposure to the concentrated formulations can result in chemical burns to the skin and severe to permanent eye damage. However, these risks should be low as long as product label directions and precautions are followed.

International regulations

An internet search regarding international regulation of oxalic acid did not provide comprehensive information. Various Material Safety Data Sheets (MSDS) for products marketed in European Union have relevant label warning statements, such as 'Harmful', 'Harmful in contact with skin and if swallowed', 'Keep out of reach of children' and 'Avoid contact with skin and eyes'. These MSDS also notes: "Classification and labelling have been performed according to EU directives 67/548/EEC, 88/379/EEC".

Scheduling status

Oxalic acid is listed in Schedule 6, Appendices E and F. M.

Scheduling history

Oxalic acid was first considered in May 1956 by the Poisons Schedule Committee (PSC) and PSC decided to include oxalic acid and metallic oxalates in Schedule 5.

In November 1985, the PSC decided to amend the Schedule 6 oxalic acid entry to exempt its derivatives and insoluble salts from the Schedule 6 entry.

Public pre-meeting submissions

Four submissions were received.

The first submission requested that consideration of this proposal be broadened in such a way to exclude therapeutic mouthwash preparations containing less than 3 per cent of potassium oxalate.

The second submission noted that it did not object to the delegate's proposal in principle. The submission suggested that the current Schedule 5 listing of the oxalic acid entry should remain the same (i.e. "oxalic acid except its derivatives and insoluble salts") so that it excludes the oxalate salt of some registered medicines, such as escitalopram oxalate (which is in Schedule 4).

The third submission indicated that it supports the delegate's proposal to exempt from scheduling oxalic acid in domestic cleaning preparations containing 8 per cent or less oxalic acid. The submission requested that the ACCS and the delegate consider exempting from scheduling dental products including mouthwashes containing 3 per cent or less of soluble salts of oxalic acid.

The fourth submission requested that mouth wash preparations, intended for use in the symptomatic relief treatment of sensitive teeth, containing up to 3 per cent of oxalic acid's salt potassium oxalate be exempted from scheduling.

ACCS advice to the delegate

The ACCS recommended that the current scheduling of oxalic acid remains appropriate.

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

    the toxicity of a substance. The reasons for the recommendation comprised the following:
  • Insufficient evidence to change the scheduling of the chemical.
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 factors7;
  • Other relevant information.
Delegate's interim decision

The delegate confirms that the toxicity profile of oxalic acid is consistent with SPF Schedule 6 criteria and accepts ACCS advice that the current listing of oxalic acid in Schedule 6 remains appropriate. The label signal heading, First Aid statements (Appendix E), Safety Directions and Warning Statements (Appendix F) remain appropriate for the type of cleaning products in the re-scheduling submission. The delegate also notes ACCS advice that there is insufficient available information to develop an exemption threshold for the Schedule 6 entry at this time. The delegate notes the proposals in public submissions that scheduling therapeutic goods containing oxalates is not appropriate, but concludes that the current entry (excepting derivatives and insoluble salts) should not apply to derivatives used in medicines. The matter of providing an exemption threshold for the use of soluble oxalates in mouthwashes requires further consideration and it will be referred back to a future meeting of the ACCS/ACMS.

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.

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1.3 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 proportions8. 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 3. Structure of ethanol

Figure 3. 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.

Public pre-meeting 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 delegates

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 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.
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.

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1.4 Dibutyl phthalate

Scheduling proposal

On 10 December 2013, the National Industrial Chemicals and Notification Assessment Scheme (NICNAS), under the Priority Existing Chemical (PEC) program, requested that the delegate consider including cosmetic and personal care preparations containing dibutyl phthalate (DBP) in Appendix C.

The reasons for this recommendation are:

  • Estimate of margin of exposure (MoE) for use of DBP in cosmetics indicates that the risk of reproductive toxicity for the general population from the use of cosmetics containing DBP is unacceptable. Repeat-dose toxicity studies on multiple generations of rodents showed testicular toxicity. Both fertility and development are affected in the parents and following generations. The toxicity in male rodents involves overt effects on the reproductive tract organs. DBP also affects testosterone synthesis in male rodents;
  • Reproductive toxicity induced by DBP might have serious long-term health effects and affect the development and reproduction of future populations if the exposure is within a critical window of human health development;
  • A cautious approach to the potential risks associated with DBP is warranted, given the level of uncertainty regarding both the health effects and levels of exposure for different population groups; and
  • Currently there are no restrictions in Australia on the use of DBP in cosmetics and there is a potential for introduction and widespread use of cosmetic products containing DBP.

The delegate referred the proposal to the ACCS. The reason for referring the proposal to the ACCS is that NICNAS recommended specific uses of DBP, i.e. cosmetics and personal care products, be restricted by listing in Appendix C. The Scheduling Policy Framework (SPF) indicates that advice from the ACCS should be sought for such restrictive scheduling. Since the proposal is specific for cosmetic and personal care products, it should have no impact on therapeutic goods regulated by the TGA, so there appears to be no need to refer the matter to a joint meeting of the ACCS-ACMS.

The delegate asked the following questions.

  • Noting the difficulties and uncertainties associated with the assignment of a NOAEL for reproductive toxicity and the exposure estimates, does the ACCS agree that the relatively small margin of exposure (MoE) calculations associated with the uses of DBP in cosmetic and personal care products warrant restrictive scheduling?
  • Based on similar toxicological concerns, previous decisions of the NDPSC and ACCS in relation to restrictions on the use of diethyl phthalate (DEP), dimethyl phthalate (DMP) and diethylhexyl phthalate (DEHP) have resulted in listing in Appendix C for various products deliberately applied to human skin. Does the ACCS support a parallel entry for DBP?
  • The NICNAS exposure calculations indicate that the products contributing most to estimates of DBP systemic exposure would fit the definition of 'cosmetics'. This suggests that a parallel entry for DEHP could act as a template. Is there a need to expand the proposed Appendix C entry to include sunscreens, personal insect repellents and body lotions, with a cut-off at 0.5 per cent, as in the current DMP and DEP entries?
  • None of the phthalate esters currently listed in Appendix C are separately listed in any schedules of the SUSMP. While the NICNAS evaluations only recommend controls on the use of some phthalate esters in cosmetics and personal care products, do other use patterns of the more toxic phthalates suggest a need to consider scheduling to control a broader range of products?
Substance summary

Please refer to the NICNAS PEC assessment report for dibutyl phthalate and its related compounds. This report is publically available on the NICNAS website: Priority Existing Chemical (PEC) Assessments. The report number is PEC/26.

Scheduling status

Dibutyl phthalate is not specifically scheduled. Other phthalates such as diethylhexyl phthalate, diethylphthalate and dimethylphthalate are listed in Appendix C. Diethylhexyl phthalate for cosmetic use is listed in Appendix C and dimethylphthalate and diethylphthalate in sunscreens or personal insect repellents for human use (except in preparations containing 0.5 per cent or less of dimethylphthalate and diethylphthalate) is currently listed in Appendix C.

Appendix C

DIETHYLHEXYL PHTHALATE for cosmetic use.

Appendix C

DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.

Appendix C

DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.

Scheduling history

In June 2011, the chemicals scheduling delegate decided to list cosmetic preparations containing diethylhexyl phthalate in Appendix C.

Public pre-meeting submissions

Two submissions were received.

One submission indicated that dibutyl phthalate is listed in TGA e-BS site with use as an active ingredient restricted to topical prescription preparations, and use allowed as an excipient in registered and listed medicines. The submission requested that only cosmetic preparations containing dibutyl phthalate should be listed in a schedule.

The other submission indicated that cosmetic preparations containing dibutyl phthalate be included in Appendix C. The submission noted that dibutyl phthalate is listed in Annex II (substances banned in cosmetics) of the EU Cosmetics Directive.

ACCS advice to the delegate

The ACCS recommended that cosmetic preparations containing dibutyl phthalate be included in Appendix C.

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:

  1. the toxicity of a substance.

The reasons for the recommendation comprised the following:

  • The potential for irreversible reproductive toxicity warrants banning in cosmetic preparations.
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 factors10;
  • Other relevant information.
Delegate's interim decision

The delegate accepts ACCS advice that a new Appendix C entry be created to restrict dibutylphthalate use in cosmetics. Reproductive toxicity is the toxic effect noted in animal studies that drives the risk assessment and the Margin of Exposure (MoE) estimate for this specific use is considered unacceptable. Inclusion of such products in Appendix C is considered to be the most effective way to prevent the use of dibutylphthalate in cosmetic products, and it is consistent with the listing of other phthalate esters with similar reproductive toxicity potential in Appendix C.

The delegate agrees with the implementation date being 1 October 2014. An early implementation date is warranted since the objective is to remove any such products from the Australian market on safety grounds.

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 and c) the toxicity of a substance and d) the dosage, formulation, labelling, packaging and presentation of a substance.

Schedule entry

Appendix C - New entry

DIBUTYLPHTHALATE for cosmetic use.

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1.5 1-Butanol

Scheduling proposal

On 29 August 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 spray preparations containing 5 per cent or more of 1-butanol in Schedule 5. This proposal was first notified to the delegate in September 2013 at which time it was determined that expert advisory committee advice may not be required for this proposal. However, due to the complexity of the proposal, expert advice on this substance is being sought.

The delegate considered the proposal in the NICNAS IMAP report which focuses on the potential for eye damage and inhalation toxicity associated with the use of 1-butanol in cosmetics and various spray-on products used in a domestic setting. The issues raised have much in common with those in the 1-propanol IMAP report, and they could be considered together. In view of the potential impact on existing products, the delegate considers that advice is needed from the ACCS, with an appropriate public notice alerting the industry to the proposed scheduling action. Since the advice from the TGA is that 1-butanol is used as an excipient (in printing ink only) there is no need to refer the matter to a joint ACCS/ACMS meeting. The inclusion of 1-butanol (as an excipient) in one AgVet product should be considered by the ACCS.

The delegate asked the following specific questions:

  • The principal issue raised by the NICNAS IMAP report is the potential for eye irritancy associated with concentrations of 1-butanol above 5 per cent, with more serious eye damage expected at 10 per cent and above. The Report also notes the potential for skin damage at higher concentrations and effects on the CNS associated with inhalation of vapours. The NICNAS report notes relevant exposure scenarios associated with the use of 1-butanol in cosmetics, domestic cleaners and in particular, spray-on products.
  • The skin-eye toxicity can be attributed to the solvent and de-fatting effects of 1-butanol, and this would be expected of any short-chain alkyl alcohol, including ethanol. It is noted that ethanol is currently included in Appendix B for all uses.
  • Does the ACCS consider that the toxicity potential for 1-butanol and its potential use in the listed products warrants inclusion in Schedule 6, with exemptions to Schedule 5 at x? per cent, and exempt below y? per cent?
  • If scheduling is recommended, should this be limited to certain specific product types in the retail market? If so, what wording is recommended to achieve such limitations?
  • If scheduling is recommended, is the preferred nomenclature 1-butanol, n-butanol or butyl alcohol (consistent with the naming style for ethyl alcohol used in the Appendix B entry)? Should any of these names be cross-referenced in the SUSMP index (as per ethyl alcohol)?
  • What Appendix E & F statements are recommended for any scheduled products?
  • What regulatory impacts on existing products would be expected for any of the above scheduling options, and to what extent should this be considered in setting an implementation date?
Substance summary

Please refer to the NICNAS IMAP Human Health Tier II Assessment Report for 1-butanol. This report is available on the NICNAS website: Human Health Tier II Assessment for 1-Butanol.

Scheduling status

1-Butanol is not specifically scheduled.

Scheduling history

1-Butanol has not been previously considered for scheduling therefore scheduling history is not available.

Public pre-meeting submissions

Four public submissions were received.

The first submission indicated that 1-butanol is listed in the TGA's ARTG ingredient list as n-butyl alcohol BP, indicating that it may have uses in therapeutic goods, although specific uses are not defined. This ingredient may have been used as a propellant in certain aerosol dosage forms for medicines. The submission noted that the delegate's proposal was not limited to cosmetic or industrial preparations containing 1-butanol, and no cut-off is proposed. It is concerned about the possibility that including 1-butanol in a schedule may have some impact on therapeutic goods, and requested that consideration should be given to exempt from scheduling for therapeutic goods containing 1-butanol.

The second submission indicated that it did not support scheduling of 1-butanol. If, however, 1-butanol is considered for inclusion in a schedule, it should be considered by the joint ACMS & ACCS consideration to ensure that therapeutic use of 1-butanol is not inadvertently affected. The submission asserted the CIR found that that cosmetic preparations containing 1- butanol are safe therefore cosmetics preparations containing 1-butanol be exempted from scheduling.

The third submission noted that 1-butanol is currently used in therapeutic and cosmetic products, therefore the proposal should be considered by the joint ACCS & ACMS. The submission asserted that it is not aware of any issues using 1-butanol in aerosol products intended for cosmetic or therapeutic use. Based on the Cosmetic Ingredient Review (CIR) Ingredient Status Report and publically available data, 1-butanol has been classified as safe for use in various cosmetic products. These types of products therefore should be exempted from the proposed Schedule 5 and/or 6 entry/s.

The fourth submission noted that 1-butanol is also used in therapeutic goods therefore the scheduling proposal should be considered by the joint ACCS and ACMS. The submission indicated that publically available data has shown that 1-butanol is recognized as safe for use in cosmetic products. If a Schedule 5 and/or Schedule 6 entry is considered appropriate, the entry should exempt from scheduling for cosmetic and therapeutic products containing 1-butanol. If a concentration cut-off is applied, the cut-off should be set at a concentration where current cosmetic and therapeutic products in the market will not be impacted.

ACCS advice to the delegate

The ACCS recommended that preparations containing 1-butanol at concentrations greater than 10 per cent be included in Schedule 6 except when in Schedule 5 and except for preparations containing 5 per cent or less of 1-butanol. Cosmetics and therapeutics to be exempted. The committee also recommends appropriate Appendix E and F statements for 1-butanol.

The ACCS recommended an implementation date of 12 months.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee included:

  1. the toxicity of the substance.

The reasons for the recommendation comprised the following:

  • Potential for moderate to severe eye damage or respiratory irritation consistent with the SPF factors for Schedule 5 or Schedule 6 depending on concentration and use.
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 factors11;
  • Other relevant information.
Delegate's interim decision

The delegate accepts the advice of the ACCS to include 1-butanol in Schedules 5 and 6. The critical toxicological endpoints driving this categorisation (potential for inhalation toxicity, skin irritancy and severe eye irritancy) are consistent with SPF criteria for listing in Schedule 6, with the public health risk sufficiently ameliorated for products between 5 and 10 per cent to be included in Schedule 5, and to be exempt from scheduling when less than 5 per cent. The delegate notes, but does not accept, the ACCS recommendation that cosmetics and therapeutic products be specifically exempted. There appear to be no therapeutic goods or cosmetics where the concentration of 1-butanol would be likely to exceed the 5 per cent cut-off to exempt, and if there are any such products, the warnings associated with the proposed schedule entries would be applicable and suitable.

The delegate agrees with the implementation date being 1 July 2015. The ACCS suggested that at least twelve months may be needed to implement the required label changes.

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.

Schedule entry

Schedule 6 - New entry

1-BUTANOL except

  1. when included in Schedule 5; or
  2. in preparations containing 5 per cent or less of 1-butanol.

Schedule 5 - New entry

1-BUTANOL in preparations containing 10 per cent of less of 1-butanol except for preparations containing 5 per cent or less of 1-butanol.

Appendix E, Part 2 - New entry
Poison Standard Statement
1-butanol 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).
When in Schedule 6

E2 - If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes.

S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin with running water.

When in Schedule 5

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).

E1 - If in eye, wash out immediately with water.

Appendix F, Part 3 - New entry
Poison Warning Statement Standard Statement
1-butanol 5. Irritant.

1. Avoid contact with eyes.

4. Avoid contact with skin.

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

9. Use only in well ventilated area.

Footnotes

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