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Scheduling delegate's final decisions: ACCS/ACMS, November 2013

Scheduling medicines and poisons

8 November 2013

Book pagination

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

1. Scheduling proposals referred to the July 2013 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#8)

1.1 1,2-Benzenediol (Catechol)

Scheduling proposal

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under the Inventory Multi-tiered Assessment and Prioritisation (IMAP) process, recommended the scheduling delegate consider including cosmetic preparations and domestic preparations containing 1,2-benzenediol in Appendix C and in Schedule 6/7, respectively.

NICNAS indicated that the oral and dermal toxicity, sensitisation and eye irritation potential of this Substance met Schedule 6 factors of the Scheduling Policy Framework (SPF). The potential for carcinogenicity appears to meet the Schedule 7 factors of the SPF. In addition, the risk cannot be mitigated by warnings or packaging, as the potential use in cosmetics involves direct dermal application.

The Chemicals Scheduling Delegate considered a proposal to include 1,2-benzenediol for domestic use in Schedule 6 or Schedule 7 and preparations containing 1,2-benzenediol for cosmetic use in Appendix C. This proposal also includes consideration of appropriate cut-offs for exemption from scheduling.

The delegate considered the NICNAS proposal for a new schedule entry for 1,2-benzenediol in Schedule 7 on the basis of potential carcinogenicity. The delegate noted that the Scheduling Policy Framework (SPF) indicates that proposals for listing in Schedule 7 should be considered by the ACCS. Accordingly, the delegate referred the application to the July 2013 Advisory Committee on Chemicals Scheduling (ACCS) meeting.

The delegate sought the following specific advice from the ACCS:

  • Is the more appropriate listing in Schedule 6, based on acute toxicity, skin/eye irritancy and skin sensitisation potential, or Schedule 7 based on potential carcinogenicity?
  • Is there sufficient basis for establishing a cut-off to a lower schedule for such an entry? While 1,2-benzenediol does not meet the boiling point criterion (<220°C) for the Schedule 6 phenol entry, would the exemption cut-off value (3%) for phenol be appropriate for 1,2-benzenediol?
  • Is listing in Appendix C an appropriate measure for controlling use in cosmetics and personal care products, with a listing cut-off established at X%, and should such listing in Appendix C be additional to any controls imposed under Schedule 6-7 listing?
  • Are there likely to be any unintended consequences of any scheduling recommendation, with inadvertent capture of retail chemical products other than cosmetics and personal care products?
  • Can ACCS advise on appropriate wording for a Schedule 6 and/or Appendix C listing, including whether the substance be listed with its approved chemical name (1,2-benzenediol) and the common name 'catechol'?
Substance details

The chemical appearance of 1,2-benzenediol1 (catechol) is colourless crystals, discolours to brown on exposure to air and light, especially when moist. It has faint characteristic (phenolic) odour and sweet and bitter taste.

1,2-benzenendiol (catechol) has been reported uses such in cosmetic products (i.e. hair dyes, perfumes and essential oils), domestic (surface treatments) and in commercial use (i.e. photographic developer, colouring agents, as ingredient in epoxy coatings and adhesives).

Toxicity 1,2-benzenediol SPF2 Classification
Oral LD50 (mg/kg bw) 300 Moderate to high
Dermal LD50 (mg/kg bw) 600 Moderate to high
Inhalational LC50 (mg/m3/4 h) 2800 Moderate to high
Skin irritation Irritant
Eye irritation Irritant
Skin sensitisation Sensitiser
Observations in humans

An epidemiology study reported exposure of 13 workers in a chemical factory in Japan to catechol (2 to 72 ppm) and phenol (55 to 260 ppm) vapours over 2 years (OECD 2003b). The clinical examinations and physical responses of workers indicated significant cough, sputa, throat and eye irritation.

Repeat dose toxicity

In the only available reliable repeated dose oral toxicity study in rats (Wistar) following the guideline OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), the substance was administered via gavage to 10 animals/sex/dose at 0, 30, 80 and 160 mg/kg bw/day for 4 weeks to males and 7 weeks to females. Mortality was observed at the highest dose in 2 males and 1 female (ECHA 2012). Tremors were observed at the highest dose. At the two highest doses the incidence and severity of squamous hyperplasia in the stomach were increased in animals of both sexes. A no observed adverse effect level (NOAEL) of 30 mg/kg bw/day can be derived based on squamous hyperplasia in the stomach.

Genotoxicity

The genotoxic potential of the chemical is summarised from the conclusion of the OECD (2003a). The chemical appeared to show generally negative results in point mutation studies but uniformly positive result in clastogenicity studies. There is sufficient evidence to classify the chemical as causing possible mutagenic effects.

Carcinogenicity

Classified by the International Agency for Research on Cancer (IARC) as Group 2B (possibly carcinogenic to humans) based on sufficient evidence of carcinogenicity in experimental animals (IARC 1999).

The chemical was tested for carcinogenicity by oral administration in one study in mice and in two studies in rats. No increase in the incidence of malignant tumours was found in mice (IARC 1999). In rats, it induced adenocarcinomas in the glandular stomach in several strains. In one study (ECHA 2012, Environment and Health Canada, 2008) administration of the chemical in the diet in male rats for 34 weeks caused hyperplasia and adenomas of the pyloric gland (glandular hyperplasia) at 141 or 318 mg/kg bw/day. Very weak hyperplasia was noted at 33 and 65 mg/kg bw/day. However, after a 2-year exposure, adenomas and submucosal hyperplasia of the glandular stomach were found in nearly all animals at 33 mg/kg bw/day and higher doses.

Reproductive and developmental toxicity

Any reproductive and developmental effects were only observed secondary to maternal toxicity, so the chemical is not a specific reproductive or developmental toxin.

Scheduling status

1,2-benzenediol is not specifically scheduled.

Scheduling history

1,2-benzenediol (catechol) has not been considered for scheduling before.

Public pre-meeting submissions

One submission was received supporting in principle the internationally aligned risk management of catechol. The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

ACCS advice to delegate

The Committee recommended that preparations containing 1,2-benzenediol be included in Schedule 6 and a cross-reference be added to the Index of the SUSMP.

The Committee also recommended an implementation date of 1 February 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance.

The reasons for the recommendation comprised the following:

  • Benefit for industrial use.
Delegate's interim decision

The Delegate accepts the advice tendered by the ACCS and agrees to include a new entry for 1,2-benzenediol in S6, with a cross-reference in the SUSMP index to the common name, catechol.

An implementation date of 1 February 2014 is also agreed, since it appears there may be no products on the Australian market that require re-labelling.

The Delegate notes, and accepts, ACCS advice that the listing of 1,2-benzenediol in Appendix C for cosmetic use is not warranted, in that controls imposed via Schedule 6 listing should limit the use of this chemical in cosmetic products, and achieve appropriate label warnings (Poison signal heading) for any products formulated with this ingredient. This is reinforced by the ACCS recommendation that no scheduling cut-off be implemented.

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

  • The acute and chronic toxicity profile of 1,2-benzenediol is consistent with S6 scheduling criteria in the SPF.
  • The primary objective of this scheduling application was to consider controls over the use of 1,2-benzenediol in cosmetic preparations. However, the schedule entry is also applicable to any other types of products that may be sold to the general public. Scheduling is not intended to replace controls over hazards and information provided to industrial users of the chemical.

The ACCS advice does not include any proposal to develop First Aid (Appendix E) or warning statements/Safety Directions (Appendix F). Although there may not currently be any products in the Australian retail market place, the following proposed entries in Appendices E & F provide for consistency with scheduling of S6 Substances with hazard profiles comparable to that of 1,2-benzenediol.

Delegate's consideration

The delegate considered the following in regards to this proposal:

Submissions on interim decision

No public submissions were received.

Delegates 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 - New entry

1,2-benzenediol.

SUSMP Index - New cross-reference entries

Catechol

See 1,2-benzenediol

Appendix E, Part 2
Poison Standard Statement
1,2-benzenediol (catechol) A,E1,S1
Appendix F, Part 3
Poison Warning Statement Safety Direction
1,2-benzenediol (catechol) 51, 59 1, 4, 8

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1.2 3-Iodo-2-propynyl butyl carbamate (Iodocarb)

Scheduling proposal

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under the Inventory Multi-tiered Assessment and Prioritisation (IMAP) process, recommended the scheduling delegate consider including preparations containing 3-iodo-2-propynyl butyl carbamate (iodocarb) in Appendix C.

The NICNAS's scheduling recommendation noted that the sensitising potential of iodocarb indicates that an appropriate parent schedule is Schedule 6, although a cut-off to unscheduled is warranted. For cosmetic application, relevant cut-offs may be the previous European Union (EU) limit of 0.05% or the United States (US) Cosmetic Ingredient Review CIR recommendation of 0.1%. It may be noted that the International Fragrance Association (IFRA) Quantitative Risk Assessment (QRA) calculations based on EU Cosmetic Directive limits showed that, under the assumptions of this method, the consumer exposure level was less than the acceptable exposure level for the majority of uses.

The Chemicals Scheduling Delegate considered a proposal to amend the current Schedules 5 and 6 iodocarb entries to include cosmetic preparations containing iodocarb in Appendix C. This consideration also includes whether an Appendix C exemption cut-off for cosmetic preparations containing 0.05 per cent or 0.1 per cent iodocarb is appropriate.

The delegate considered the NICNAS proposal for amending the current entries for iodocarb in Schedules 5 and 6 to include cosmetic preparations containing iodocarb in Appendix C. This consideration also includes whether an Appendix C exemption cut-off for cosmetic preparations containing 0.05 per cent or 0.1 per cent iodocarb is appropriate.

The delegate's reasons for referring this to the Advisory Committee on Chemicals Scheduling (ACCS) included:

  • While iodocarb is currently listed in Schedules 5 and 6, with exemptions for aqueous products containing 10% or less, the NICNAS IMAP submission specifically requests consideration of appropriate controls over its use in cosmetics and personal care products, via a possible listing in Appendix C. This type of application requires advice from the ACCS.

Accordingly, the delegate referred the application to the July 2013 ACCS meeting.

The delegate sought ACCS's advice on the following issues:

  • Does the NICNAS IMAP submission warrant an additional entry in Appendix C, to control the use of iodocarb as a preservative in cosmetics and personal care products? If so, should an exemption cut-off of 0.1% or 0.05% be applied?
  • To what extent should any Appendix C entry refer to products that could be aerosolised?
  • If some jurisdictions apply controls consistent with listing in Schedule 7 for Substances listed in Appendix C, is there potential for conflict with the existing S5 and S6 entries?
  • What is the basis for the distinction between the 10% exemption cut-offs in S5 and S6 for aqueous and non-aqueous preparations, and is this distinction still warranted?
  • Is there any need to adjust the current Schedule 5/Schedule 6 listing of iodocarb, or to review the current wording of the Schedule 5 and Schedule 6 entries? If so, what wording is suggested?
Substance details

The chemical appearance of 3-iodo-2-propynyl butyl carbamate4 (iodocarb) is a white or slightly off white crystalline powder with a sharp pungent odour. It is highly soluble in organic solvents and moderately soluble in water.

Iodocarb has been reported uses such in cosmetic products (i.e. preservative in baby wipes) and as an approved constituent in pesticides by the Australian Pesticides and Veterinary Medicines Authority (APVMA).

Toxicity Iodocarb SPF5 Classification
Oral LD50 (mg/kg bw) 1100-1795 Moderate to high
Dermal LD50 (mg/kg bw) >2000 Low
Inhalational LC50 (mg/m3/4 h) 6800 Low
Skin irritation Irritant
Eye irritation Severe irritant
Respiratory irritation Irritant
Skin sensitisation Sensitiser
Observations in humans

The chemical was found to be mildly irritating but not sensitising in clinical study done between 1998 and 2008 by the North American Contact Dermatitis Group (NACDG) using 0.1% iodocarb and/or 0.5% in petrolatum. For iodocarb-positive patients, the most frequent sites of dermatitis were scattered generalised distribution, hands, and arms. The majority (0.5%) of relevant reactions were due to personal care products (Warshaw et al., 2010).

In another clinical study, a 4% cosmetic formulation containing 0.0125% iodocarb was mildly irritating when applied under occlusive patches for 24 hours in a primary irritation study. Erythema without oedema was observed (Lanigan et al., 1998).

Significant irritation was not reported in 5-and 21-day cumulative irritation studies that tested 0.01 - 0.0125% iodocarb in formulation (Lanigan et al., 1998).

There are several reports available on the sensitisation potential of iodocarb in humans. Recently, it has been described as an emerging contact allergen based on its increasing use in cosmetics (Davies and Johnston, 2011). Although the risk appears to be low at concentrations up to 0.1%, iodocarb -induced contact allergy may increase with increasing availability of iodocarb -containing cosmetic products or at higher concentrations or following longer term exposures (Badreshia and Marks, 2002 and Lanigan, 1998).

The recent available human data supports the findings from the animal studies that iodocarb is a skin sensitiser. Based on the positive results in the human patch tests and the positive animal studies, the chemical is recommended for classification with the risk phrase 'May cause sensitisation by skin contact' (Xi; R43).

Repeat dose toxicity

Based on the available information no hazard classification for repeat dose oral, dermal and inhalation toxicity is recommended, however a hazard classification for respiratory irritation is warranted.

Carcinogenicity

The chemical was not carcinogenic in rats and mice up to and including the highest dose levels (80 and 150 mg/kg bw/d) for rats and mice. In the mouse carcinogenicity study, an increased incidence of hepatocellular adenomas in high dose males (11/50) is not considered to be of biological relevance.

Based on the available study no hazard classification is recommended for carcinogenicity.

Reproductive and developmental toxicity

Overall the chemical is not considered a reproductive or developmental toxin. Based on the available data, no classification is recommended.

Neurotoxicity

Iodocarb was not neurotoxic when administered via the oral route. A NOEL of 300 mg/kg/day was noted based on decreases in locomotor activity (HSBD).

The absence of neurotoxic effects is supported by the repeat dose inhalation study and carcinogenicity studies which all investigated RBC and brain cholinesterase inhibition (ECHA, 2011).

Scheduling status
Schedule 5

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) in preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate except in aqueous preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate.

Schedule 6

 3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) except:

  1. when included in Schedule 5; or
  2. in aqueous preparations containing 10 per cent or less 3-iodo-2-propynyl butyl carbamate.
Scheduling history

In August 1988, the Drugs and Poisons Schedule Committee (DPSC) decided to include iodocarb in Schedule 5. The decision was based on the acute oral toxicity in rats (1470 mg/kg), acute dermal toxicity in rabbits (above 2000 mg/kg) and acute inhalational toxicity in rats (above 6890 mg/m3).

In November 1988, the DPSC agreed to exempt from scheduling aqueous preparations containing 10 per cent or less iodocarb.

In June 2002, the NDPSC decided that the acute toxicity profile of iodocarb warranted inclusion in Schedule 6 with a cut-off to Schedule 5 for preparations containing 10 per cent or less and unscheduled for aqueous preparations containing 10 per cent or less.

Public pre-meeting submissions

One submission was received in support of clarifying the current restrictions on iodocarb. The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

ACCS advice to delegate

The Committee recommended amending the current Schedule 5 and 6 entries for 3-iodo-2-propynyl butyl carbamate to exempt cosmetic and personal care preparations containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.

The Committee also recommended an implementation date of 1 February 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, and (f) any other matters that the Secretary considers necessary to protect public health of a substance.

The following reasons were noted:

  • Low to moderate dermal toxicity in cosmetic and personal care preparations but also noting potential high inhalation toxicity in those products.
  • Common preservative in domestically used products.
  • Existing controls were considered adequate for other uses.
  • Committee suggests that due to potential for high inhalation toxicity may warrant review at a later date.
Delegate's interim decision

The Delegate accepts the advice tendered by the ACCS and agrees to the proposed amendments to the S5 and S6 listings for 3-iodo-2-propynyl butyl carbamate (iodocarb).

An implementation date of 1 February 2014 is also agreed, since the proposed amendments would only affect cosmetic products containing more than 0.1% iodocarb, and the intent of the scheduling change is to restrict such use.

The Delegate notes, and accepts, ACCS advice that the listing of 3-iodo-2-propynyl butyl carbamate (iodocarb) in Appendix C for cosmetic use is not warranted, in that controls imposed via Schedule 5 & 6 listing should limit the use of this chemical in cosmetic products, and achieve appropriate label warnings (CAUTION or Poison signal heading) for any products formulated with this ingredient.

The Delegate also notes advice from a State jurisdictional source that the term 'personal care product' should be deleted from the schedule amendment because it is not defined in State/Territory legislation. This issue may require further advice from the ACCS.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 includes (b) purpose, (c) toxicity and (f) other matters that the Secretary considers necessary to protect public health of a substance:

  • 3-iodo-2-propynyl butyl carbamate (iodocarb) is used as a preservative in a wide range of products and existing schedule entries adequately address these uses. The schedule amendments proposed here address the potential for adverse health effects (skin irritancy and inhalational toxicity) associated with its use in cosmetic and personal care products.
  • At concentrations above 0.1% in products applied to the skin, there is a potential for irritancy and sensitisation. Cosmetic & personal care products intended for aerosolisation during use pose an inhalational irritancy/sensitisation risk.
  • The intent of the scheduling amendments is to align controls over the use of 3-iodo-2-propynyl butyl carbamate (iodocarb) in cosmetic and personal care products with those imposed in US and Europe.

The delegate considered whether imposing restrictions on iodocarb in cosmetic and personal care products without the use of an Appendix C entry meets the NICNAS recommendations that controls be aligned with US (CIR) and European (SCCNFP) regulations. Application of S5/S6 controls does not 'ban' such uses, as achieved in the US and EU regulations, but the ACCS has supported S5/S6 scheduling as an appropriate level of control over use in cosmetics and personal care products.

Delegate's consideration

The delegate considered the following in regards to this proposal:

Submissions on interim decision

One valid public submission was received, tentatively supporting the delegate's interim decision, asking the delegate to clarify the reasons for the Schedule 6 entry and the definition of "personal care". The submission also suggests that the wording of the cosmetic or personal care entry be amended to "preparations containing greater than 0.1 per cent".

The redacted public submissions are available at Public submissions on scheduling matters.

Delegates final decision

The delegate has considered the submission received following publication of the interim decision to the proposed amendments to the Schedule 5 and Schedule 6 listings for 3-iodo-2-propynyl butyl carbamate (iodocarb). The submission calls for clarification of the schedule amendments to clearly indicate that all types of cosmetic products containing more than 0.1% would be included in Schedule 6. The submission also requests that reference to 'personal care products' be deleted, in view of the fact that there is no definition of such products in the SUSMP and that the current NICNAS definition of 'cosmetics' adequately covers such products. On the basis of the submission the delegate has agreed to amend the proposed schedule 5 and 6 amendments accordingly.

The delegate accepts that the proposed schedule entries need clarification, in line with the submission received, and now proposes the following amended schedule entries:

Schedule 5 - amendment

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) in preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate except:

  1. in aqueous preparations not for cosmetic use containing 10 per cent or less 3-iodo-2-propynyl butyl carbamate; or
  2. in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.
Schedule 6 - amendment

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) except:

  1. when included in Schedule 5;
  2. in aqueous preparations not for cosmetic use containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate (Iodocarb); or
  3. in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.

The delegate accepts that the 'reverse scheduling' wording used in the Schedule 5 and 6 exemption clauses to differentiate aqueous and non-aqueous preparations containing 10% or less 3-iodo-2-propynyl butyl carbamate (Iodocarb) is potentially confusing. However, there appears to be no other option to give effect to the decision to exclude all cosmetic products containing more than 0.1% 3-iodo-2-propynyl butyl carbamate (Iodocarb) from these exemptions and to include them, by default, in the primary listing in Schedule 6. It should also be clear that the words excluding aerosolised preparations from the exemption clauses, is to result in all aerosolised cosmetic preparations reverting to Schedule 6, irrespective of whether they contain less than 0.1% 3-iodo-2-propynyl butyl carbamate.

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1.3 Cocoyl Glycinate

Scheduling proposal

The NICNAS, under the New Chemicals Program, recommended the scheduling delegate consider including the following three salts of cocoyl glycinate in the SUSMP:

  • glycine, N-coco acyl derivs., sodium salts;
  • glycine, N-coco acyl derivs., potassium salts; and
  • fatty acids, coco, reaction products with glycine, potassium salts.

The NICNAS indicated that these Substances will be used as components of finished cosmetic rinse off and leave on products. Typical rinse-off products include cleansing products for skin and hair, whilst typical leave on products include skin lotions and creams.

The Chemicals Scheduling Delegate considered a proposal to include cocoyl glycinate in Schedule 6 with lower concentration cut-offs for leave-on and rinse-off preparations. This proposal also includes consideration of whether an Appendix E listing is required for cocoyl glycinate.

The delegate's reasons for referring this to the Advisory Committee on Chemicals Scheduling (ACCS) included:

  • The ACCS has the necessary expertise to advice on the types of uses for which this industrial chemical warrants listing in the SUSMP and on the nature of controls to be applied through scheduling.

The delegate sought ACCS's advice on the following issues:

  • Does the ACCS consider that the toxicological profile of cocoyl glycinate warrants inclusion in Schedule 6, as proposed, or in another schedule?
  • What specific wording should be used for any schedule entry? Does the chemical name 'cocoyl glycinate' adequately cover the two specific salts (Na and K) addressed in the NICNAS evaluation report, AND the reaction product with coco fatty acids, glycine and potassium (CAS No. 1170699-63-2)?
  • Does the ACCS support any cut-offs to a lower schedule, and if so, what wording gives effect to such exemption? Should there be different cut-offs for rinse-off and leave-on products, as proposed?
  • Noting that the NICNAS evaluation specifically addresses a scheduling proposal for use of cocoyl glycinate in cosmetic and personal care products, can the ACCS advise whether there could be other uses that could be inadvertently captured by any listing in the SUSMP?
  • To what extent does the current scheduling of related fatty acid esters such as lauryl and laureth sulfates, inform the appropriate scheduling of products containing cocoyl glycine? In particular, are the Appendix E statements for these two surfactants consistent with that proposed for cocoyl glycinate?
Substance details

Potassium cocoyl glycinate is the potassium salt of the amide formed from the reaction of coconut acid chloride and glycine. This Substance is used as a hair conditioning agent and a surfactant-cleaning agent7.

Sodium cocoyl glycinate is the sodium salt of the amide formed from the reaction of coconut acid chloride and glycine. This Substance is used as a hair and skin conditioning agent, and a skin surfactant-cleaning agent8.

Toxicity Substance 1a Substance 1b Substance 2 Substance 3
Oral toxicity (LD50 mg/kg bw) >2000 >2000 >2000 >2000
Dermal toxicity (LD50 mg/kg bw) Not provided >2000** Not provided Not provided
Skin irritation Slightly irritating at 5 per cent concentration Moderately irritating Irritating at 5 per cent concentration Irritating at tested concentration (assumed to be up to 30 %)
Eye irritation Irritating at 5 per cent concentration Irritating Irritating at 5 per cent concentration Irritating at tested concentration
Skin sensitisation No evidence of sensitisation at 5 per cent concentration No evidence of sensitisation No evidence of sensitisation up to 2.5 % concentration No evidence of sensitisation up to 2.5 % concentration

Substance 1a = Glycine, N-coco acyl derivs., potassium salts (INCI name: Potassium Cocoyl Glycinate)

Substance 1b = Glycine, N-coco acyl derivs., sodium salts (INCI name: Sodium Cocoyl Glycinate)

Substance 2 = Glycine, N-coco acyl derivs., potassium salts (INCI name: Potassium Cocoyl Glycinate)

Substance 3 = Fatty acids, coco, reaction products with glycine, potassium salts (INCI name: Potassium Cocoyl Glycinate)

Irritation and sensitisation

Sodium cocoyl glycinate: The Substance caused slight irritation to the skin of rabbits at 5 % concentration. The mean score achieved was 1.83, the substance therefore at 100 % is expected to have severe irritation effects. The NICNAS recommended that the substance should be classified at least as a skin irritant.

The Substance caused slight irritation to the eyes of rabbits at 5 % concentration. Mild redness of the conjunctivae was persistent and was not reversible even after 7 days in 50 % of the animals tested (3/6 animals). The NICNAS recommended that considering the irritant effects observed at 5% concentration, the substance at higher concentrations should be classified as a severe eye irritant.

Hostapon (containing approximately 25 % of glycine, N-coco acyl derivs., sodium salts): 25 % of the substance was irritating to skin and eyes in tests conducted in rabbits. Irritation effects were also seen in dermal toxicity study at 68.5 %. The NICNAS indicated that the substance at 100 % concentration is expected to have severe eye irritation effects.

Potassium cocoyl glycinate: The Substance caused moderate to severe erythema in the skin of rabbits at 5 % concentration. The symptoms have resolved after 1 week, however, all animals showed scaling by the end of the study period. The NICNAS noted that based on the persistence of skin scaling in all animals tested, the Substance should be classified as irritating to the skin.

In an eye irritation study in rabbits, 5 % of the substance caused iridial inflammation, corneal opacity and signs of conjunctival irritation in all animals tested. Four out of 6 animals continued to show conjunctival redness at the end of the observation period. The NICNAS recommended that based on the persistence of conjunctival redness, the Substance should be classified as a severe eye irritant.

Fatty acids, coco, reaction products with glycine, potassium salts: the Substance caused slight irritation in the skin of rabbits at 5 % concentration. These symptoms had resolved within 1 week, though all the animals showed scaling at day 7. Considering this effect at the tested concentration, the Substance at higher concentration should be classified as at least a skin irritant.

In an eye irritation study in rabbits, 5 % concentration of the substance caused iridial inflammation, corneal opacity and signs of conjunctival irritation in all animals tested. Four out of 6 animals continued to show conjunctival redness at the end of the observation period. The NICNAS recommended that based on the persistence of conjunctival redness, the substance is classified as a severe eye irritant.

Scheduling status

Neither cocoyl glycinate nor its salts are specifically scheduled.

Scheduling history

Neither cocoyl glycinate nor its salts have been considered for scheduling before.

Public pre-meeting submissions

One submission was received suggesting cocoyl glycinate could be included in Appendix B in the SUSMP, based on its extensive use in overseas markets without restriction and that its skin irritancy potential is lower than other similar surfactants. The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

ACCS advice to delegate

The ACCS recommended that a Schedule 6 entry for cosmetic and personal care preparations be created for cocoyl glycinate:

  • for leave-on preparations containing more than 5 per cent of cocoyl glycinate
  • for wash-off preparations containing more than 30 per cent of cocoyl glycinate

The ACCS recommended an implementation date of 1 February 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee include; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, (c) toxicity, and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The following reasons were noted:

  • Risk of eye and skin irritation in cosmetic and personal care preparations.
  • Effective surfactant agent with relatively lower toxicity.
  • Wide personal use, but excluding non-cosmetic/personal care uses.
  • Potentially severe eye and persistent skin irritation.
  • Implementation date to take into account relabelling of imported products.
Delegate's interim decision

The Delegate accepts the advice tendered by the ACCS and agrees to include a new entry for cocoyl glycinate in Schedule 6, with exemptions as stated.

An implementation date of 1 February 2015 is also agreed, to allow sufficient time for any products affected by the scheduling decision to be re-labelled.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 includes: (b) purpose and (c) toxicity of a substance.

  • All surfactants have the potential to cause irritation, particularly if left on the skin for prolonged periods or accidentally taken into the eye. Cocoyl glycinate, its salts and derivatives have somewhat reduced skin/eye irritancy potential, but warrant inclusion in Schedule 6 at high concentrations.
  • The risk of adverse effects (particularly skin-eye irritancy) is sufficiently ameliorated at the cut-off concentrations proposed for exemption from the Schedule 6 entry.

The scheduling proposal referred in the NICNAS report specifically addressed the potential for skin-eye irritancy associated with the use cocoyl glycinate as a surfactant in cosmetic products (leave-on and rinse-off cleansers). Insufficient information was provided on possible use of cocoyl glycinate in other types of products available in the retail market that could also result in a significant exposure potential in the community. Therefore, the schedule entry and exemptions only apply to the use of cocoyl glycinate, its salts and derivatives in cosmetic products.

The ACCS recommendation suggests that a warning of potential eye irritation is not needed for products exempt from Schedule 6 scheduling, except for wash-off products containing between 5 and 30 per cent cocoyl glycinate. This is in contradiction of the recommendation in the NICNAS report, which suggests some potential for skin/eye irritancy associated with products at less than the proposed cut-offs. What is anomalous is that ACCS did not recommend any First Aid statements for products that would be covered by the provisions of Schedule 6 scheduling.

For consistency with other surfactant entries, the Delegate proposes to add an entry for cocoyl glycinate in Appendix E to cover scheduled products. The proposed entry in Appendix E is E1 - If in eyes, wash out immediately with water.

In making an interim decision, the Delegate accepts the implied advice of the ACCS that entries for cocoyl glycinate in Appendix F (Warning Statements and Safety Directions) are not needed, even for scheduled products. However, the Delegate welcomes comment on this matter during the consultation phase on this interim decision, and prior to making a final decision.

Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not available);
  • scheduling proposal;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors9; and
  • other relevant information.
Submissions on interim decision

One valid submission was received, asking the delegate to reconsider the mandatory label statement for wash-off preparations containing greater than 5% cocoyl glycinates. The submission cites that the warning statement does not provide useful first aid guidance, the cost involved in additional labelling for imported fully formulated and packaged products, and that the EU does not require such labelling. The submission also suggests removing the words "personal care".

The redacted public submissions are available at Public submissions on scheduling matters.

Delegates final decision

The delegate accepts that the proposed schedule entry needs amendment, in line with the submission received regarding the use of the words 'personal care', and now proposes the following schedule entry:

Schedule 6 - New entry

COCOYL GLYCINATE in cosmetic preparations except:

  1. in leave-on preparations containing 5 per cent or less of cocoyl glycinate; or
  2. in wash-off preparations containing 30 per cent or less of cocoyl glycinate and, when containing more than 5 per cent of cocoyl glycinate labelled with a warning to the following effect:
    1. If in eyes wash out immediately with water.
Appendix E, Part 2
Poison Standard Statement
Cocoyl glycinate E1

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1.4 Deltamethrin

Scheduling proposal

The OCS recommended the scheduling delegate consider amending the Schedule 5 listings of deltamethrin to include ready-to-use mosquito nets containing 1 per cent or less deltamethrin.

The OCS has recommended that based on the estimated acute toxicity profile of the net, its physical presentation in polypropylene filaments and potential low level exposure to dislodgeable deltamethrin residues, a Schedule 5 listing for deltamethrin when impregnated in polypropylene net containing 1 per cent or less of deltamethrin is appropriate.

The Chemicals Scheduling Delegate considered a proposal to amend the Schedule 5 deltamethrin entry to include ready-to-use mosquito nets containing 1 per cent or less deltamethrin in Schedule 5 or to create a specific exemption for this product from current deltamethrin schedule entries.

The delegate has considered the OCS evaluation report and the recommendation to include ready-to-use mosquito nets containing 1 per cent or less deltamethrin in Schedule 5 or to create a specific exemption for this product from current deltamethrin schedule entries.

The delegate's reasons for referring this to the Advisory Committee on Chemicals Scheduling (ACCS) include:

  • The history of the scheduling of deltamethrin and its preparations has been complex. While this is an apparently simple request by a sponsor to exempt mosquito nets (polypropylene net) containing up to 8.5 g/kg deltamethrin impregnated in a ready-to-use bed net, the Office of Chemicals Safety (OCS) evaluation report recommends listing in Schedule 5. The product sponsor has not provided any comment on this disparity at this stage. The delegate would therefore value advice from the ACCS on this scheduling submission.

The delegate sought the following specific advice from the ACCS:

  • Does the ACCS support the OCS evaluation report recommendation for a specific entry in Schedule 5 for a ready-to-use mosquito nets containing up to 1 per cent deltamethrin?
  • Alternatively, does the ACCS support unscheduling of this product?
  • Please advise the specific wording to deltamethrin schedule entries to give effect to either of those options.
  • Does the ACCS support the OCS report calculations of the likely exposures and the Margin of Exposure (MoE) estimates for adults and children?
    Please advise the specific wording to deltamethrin schedule entries to give effect to either of those options.
  • If the recommendation is to support Schedule 5 listing, please comment on the feasibility of having Schedule 5 label warnings on a package that will presumably be discarded after opening and use of the net. Note that no Safety Directions or Warning Statements are proposed, but a Schedule 5 product would still need to carry the WARNING signal heading, and the prescribed First Aid Instructions.
Substance details

Deltamethrin is in the chemical class of pyrethroids and is effective against insects via ingestion and direct contact.

Pyrethroids are synthetic chemicals modelled after the pyrethrin components of pyrethrum. Unlike other pyrethroids, deltamethrin consists of one pure compound.

Pyrethroids, in general, interfere with normal production and conduction of nerve signals in the nervous system. Pyrethroids act on nerve membranes by delaying the closing of the activation gate for the sodium ion channel.

There are two classes of pyrethroids based on electrophysiological studies with nerves and symptoms of toxicity. Type II pyrethroids, including deltamethrin, have an α-cyano group that induces "long-lasting" inhibition of the sodium channel activation gate. This results in prolonged permeability of the nerve to sodium and produces a series of repetitive nerve signals in sensory organs, sensory nerves, and muscles. Deltamethrin and other Type II pyrethroids may also affect ion channels in the nervous system other than sodium channels, possibly due to their phosphorylation state.10

Toxicity Deltamethrin SPF11 Classification Mosquito net SPF12 Classification
Oral LD50 (mg/kg bw)

67 (rats)

19 (mice)

300 (dogs)

Moderate to high >3952 Low
Dermal LD50 (mg/kg bw) >2000 Low >2000 Low
Inhalational LC50 (mg/m3/4 h) 600 Moderate to high N/D
Skin irritation Not irritant Not irritant
Eye irritation Mild irritant Not irritant
Skin sensitisation Not sensitiser Not sensitiser

*N/D = not determined

Scheduling status

Deltamethrin is listed in Schedules 5, 6 and 7.

Scheduling history

Decamethrin (also known as deltamethrin) was first considered at the February 1979 Poisons Schedule (Standing) Committee (PSSC) meeting. Based on the toxicology profile of decamethrin, the PSSC decided to list it in Schedule 6.

In May 1979, the PSSC reconsidered the decamethrin's Schedule 6 listing based on a submission requesting that decamethrin be reclassified into Schedule 7. This request was based on the findings that skin prickling and perspiration were observed in persons handling the substance and these symptoms persisted for a week. The PSSC decided to delete the Schedule 6 decamethrin entry and created a new Schedule 7 entry.

In November 1988, the Drugs and Poisons Schedule Committee considered the scheduling of an aqueous suspension formulation and agreed to a Schedule 5 entry for 1 per cent deltamethrin when formulated with no organic solvent other than a glycol.

In February 1993, the Drugs and Poisons Schedule Standing Committee considered the scheduling of a 2.5 per cent deltamethrin formulation and agreed that this should be captured in Schedule 6.

In February 2002, the National Drugs and Poisons Schedule Committee (NDPSC) considered the scheduling of a 25 per cent deltamethrin. The NDPSC agreed that, although the acute toxicity profile of the product was appropriate for a Schedule 5 entry, it remained concerned of the potential for neurotoxicity and the likely flow-on effects for other deltamethrin products. Accordingly, the NDPSC agreed that preparations containing 25 per cent or less should be captured in Schedule 6.

In October 2004, the NDPSC agreed to reschedule 25 per cent deltamethrin when formulated as water dispersible granules, from Schedule 6 to Schedule 5.

In June 2008, the NDPSC decided to expand the Schedule 5 deltamethrin listing for aqueous preparations (when no organic solvent other than a glycol is present) from 1 per cent to 5 per cent.

In February 2010, the NDPSC decided to exempt from scheduling for preparations containing ≤ 0.1 per cent deltamethrin from the requirements of scheduling.

In February 2012, the delegate based on the toxicity profile, decided that deltamethrin, when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin, be rescheduled from Schedule 7 to Schedule 5.

Public pre-meeting submissions

No public submissions were received.

ACCS advice to delegate

The Committee recommended that the Schedules 5 and 6 deltamethrin entries be amended to exempt from scheduling factory prepared mosquito nets containing 1 per cent or less of deltamethrin.

The ACCS recommended an implementation date of 1 February 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • Benefit in reduction of vector borne disease.
  • Formulation as an impregnated net reduces risk of toxicity.
Delegate's interim decision

The Delegate accepts the advice tendered by the ACCS meeting, and proposes that the deltamethrin entries in S5, S6 and S7 be amended to exempt factory-prepared mosquito nets containing 1 per cent or less deltamethrin.

The proposed wording of the schedule amendments is accepted.

The proposed implementation date of 1 February 2014 is agreed. This should enable sufficient time for the schedule amendment to be implemented before APVMA registration of the product.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 includes: (a) the risk and benefits, (c) toxicity and (d) dosage, formulation, labelling, packaging and presentation of a substance.

  • Use of the product may have public health benefits through reduction of vector-borne diseases and the risks associated with such use are negligible.
  • The low concentration of deltamethrin impregnated into the nets and the low potential for it to be dislodged during use suggest that exposure potential and toxicity risk is negligible and does not require control through scheduling.
  • While an original package could have an attached label containing scheduling information (signal heading etc) if needed, such labels may not be practical for the unpacked product when in use. There is insufficient need for such warning labelling to warrant inclusion in a Schedule.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling proposal;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors13; and
  • other relevant information.
Submissions on interim decision

No public submissions were received.

Delegates 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 - Amendment

DELTAMETHRIN:

  1. when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin;
  2. in aqueous preparations containing 5 per cent or less of deltamethrin when no organic solvent other than a glycol is present;
  3. in wettable granular preparations containing 25 per cent or less of deltamethrin when packed in child-resistant packaging each containing 3 grams or less of the formulation;
  4. in water-dispersible tablets each containing 500 mg or less of deltamethrin in child-resistant packaging; or
  5. in other preparations containing 0.5 per cent or less of deltamethrin,

except:

  1. in factory prepared mosquito nets containing 1 per cent or less deltamethrin; or
  2. in preparations containing 0.1 per cent or less of deltamethrin.
Schedule 6 - Amendment

DELTAMETHRIN:

  1. in aqueous preparations containing 25 per cent or less of deltamethrin, when no organic solvent, other than 10 per cent or less of a glycol, is present;
  2. in wettable granular preparations containing 25 per cent or less of deltamethrin;
  3. in water-dispersible tablets each containing 500 mg or less of deltamethrin;
  4. in emulsifiable concentrates containing 11 per cent or less of deltamethrin in a solvent containing 40 per cent or less of acetophenone and 45 per cent or less of liquid hydrocarbons; or
  5. in other preparations containing 3 per cent or less of deltamethrin,

except:

  1. when included in Schedule 5;
  2. in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or
  3. in preparations containing 0.1 per cent or less of deltamethrin.
Schedule 7 - Amendment

DELTAMETHRIN: except

  1. when included in Schedules 5 or 6; or
  2. in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or
  3. in preparations containing 0.1 per cent or less of deltamethrin.

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1.5 Ethanol, 2-(Hexyloxy) - (Hexyloxyethanol)

Scheduling proposal

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under the Inventory Multi-tiered Assessment and Prioritisation (IMAP) process, recommended the scheduling delegate consider including the substance in Schedule 6.

The critical health effect of hexyloxyethanol is corrosivity, with delayed skin effects occurring post dose. This effect is consistent with the Schedule 6 of the Scheduling Policy Framework (SPF) factors. Although the current schedule listing for this chemical is correct, consideration should be given to creation of a new entry within Schedule 6 so that the associated Warning Statements can be better targeted to the corrosive effect.

The Chemicals Scheduling Delegate considered a proposal to create a separate Schedule 6 entry for hexyloxyethanol to complement the generic entry for ethylene glycol monoalkyl ethers. This consideration includes whether Appendices E, F and I entries are required for hexyloxyethanol.

The delegate considered a NICNAS proposal for a new schedule entry for hexyloxyethanol in Schedule 6.

The delegate's reasons for referring this to the Advisory Committee on Chemicals Scheduling (ACCS) include:

  • This submission is relatively straightforward since it proposes a specific listing of hexyloxyethanol in Schedule 6, to complement the existing generic entry for ethylene glycol monoalkyl ethers. The primary purpose of the submission is to suggest more explicit Warning Statements to address the potential for corrosivity. The advice of the ACCS would be useful in making such amendments.

The delegate sought the following specific advice from the ACCS:

  • Does the current scheduling of hexyloxyethanol in S6 remain appropriate and is there a need for a separate specific entry for hexyloxyethanol in S6 to complement the generic entry for ethylene glycol monoalkyl ethers?
  • The current Safety Directions for the generic S6 entry are rather mild
    (1. Avoid contact with eyes; 4. Avoid contact with skin; 8. Avoid breathing dust (or) vapour (or) spray mist). Is there a case for stronger warnings against corrosivity when captured by the S6 entry - e.g., Warning Statement 2 corrosive
  • Is there a need to also make separate entries for hexyloxyethanol in Appendices E (First Aid instructions) and I (Uniform paint standard), as well as in Appendix F (Warning Statements and safety directions)?
  • Is the ACCS satisfied that products containing 10% or less hexyloxyethanol remain exempt from scheduling, and that no safety directions or Warning Statements would be applied?
Substance details

The chemical appearance of ethanol, 2-(hexyloxy)- (hexyloxyethanol)14 is a water-white, odourless liquid.

Hexyloxyethanol has been reported in domestic uses (i.e. a range of cleaning products), commercial and site-limited uses (i.e. coalescing agent in latex paints and cleaners, colouring agent and in cleaning/washing agents).

Toxicity Hexyloxyethanol SPF15 Classification
Oral LD50 (mg/kg bw) 738 Moderate to high
Dermal LD50 (mg/kg bw) 721 Moderate to high
Inhalational LC50 (ppm) 85 Moderate to high
Skin irritation Corrosive potential
Eye irritation Corrosive potential
Skin sensitisation N/D
Repeat dose toxicity

Based on the acute toxicity findings and repeat dose inhalation study, the chemical is not considered to be as potent a haemolytic agent as other monoethylene glycol ethers such as 2-butoxyethanol (CAS no 111-76-2).

Genotoxicity

In general, monoethylene glycol ethers are not genotoxic (OECD, 2006; NICNAS, 1996). The negative data available from several in vitro genotoxicity studies for the chemical supports this (OECD, 2006; REACH, 2011).

Carcinogenicity

There are no valid carcinogenicity studies available.

Reproduction and developmental toxicity

No developmental effects were noted (even at concentrations that produced maternal toxicity) in rabbits and rats exposed to the chemical by inhalation (OECD, 2006).

Although certain short chain monoethylene glycol ethers such as 2-ethoxyethanol (110-80-5) are known reproductive toxicants, the ability of the glycol ethers to cause testicular toxicity decreases with increasing chain length (OECD, 2006). As 2-butoxyethanol (111-76-2), which has a shorter chain than the chemical, has been shown not to be a reproductive toxicant (OECD, 2006; NICNAS, 1996) the chemical is also considered not to be toxic to the reproductive system.

Scheduling status

Ethylene glycol monoalkyl ethers and their acetate are listed in Schedule 6 and Appendices E, F and I.

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Schedule 6

ETHYLENE GLYCOL MONOALKYL ETHERS and their ACETATES, except:

  1. when separately specified in these Schedules; or
  2. in preparations containing 10 per cent or less of such Substances.
Appendix E, Part 2
Poison Standard Statement
Ethylene glycol monoalkyl ethers and their acetates except when separately specified A,G3,E2,S1
Appendix F, Part 3
Poison Warning Statement Safety Direction
Ethylene glycol monoalkyl ethers and their acetates except when separately specified 1, 4, 8

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Appendix I

The second schedule
Substance Proportion
Ethylene glycol monoalkyl ethers and their acetates except when separately specified more than 10 per cent by vol
Scheduling history

In November 1984, the Poisons Schedule (Standing) Committee (PSC) considered scheduling of ethylene glycol monoalkyl ethers and their acetates. The PSC noted that ethylene glycol monomethyl- and monoethyl ethers were the most toxic of the series which demonstrated significant testicular effects, reproductive toxicity, haematological effects and were toxic at inhalation levels at the TLV. The PSC also noted that other alkyl ethers of demonstrated haematological effects which increased with chain lengths. The PSC therefore decided to include preparations containing 5 per cent or more ethylene glycol monoalkyl ethers and their acetates in Schedule 6.

In February 1985, the PSC reconsidered the November 1984 decision and decided to raise the Schedule 6 ethylene glycol monoalkyl ethers and their acetates exemption cut-off from 5 per cent to 10 per cent.

Public pre-meeting submissions

One submission was received in support of the internationally aligned risk management of hexyloxyethanol. The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

ACCS advice to delegate

The Committee recommended that a new Schedule 6 entry be created specifically for hexyloxyethanol with a cut-off level for products containing 10 per cent of less of hexyloxyethanol remain exempt from scheduling. The Committee also supported that a new Appendix E and I entries be created specifically for hexyloxyethanol. Further, the Committee supported that an Appendix F entry be created specifically for hexyloxyethanol including a Warning Statement 2 Corrosive.

The ACCS recommended an implementation date of 1 February 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 following reasons were noted:

  • Recognising that this Substance has a different toxicity profile from the class entry ethylene glycol monoalkyl ethers.
Delegate's interim decision

The Delegate accepts the advice tendered by the ACCS meeting, and proposes that a new S6 entry be created for hexylethoxyethanol, to complement the generic entry for ethylene glycol monoalkyl ethers, with the same concentration cut-off for exemption from scheduling.

The proposed wording of the schedule amendments is accepted, including those for the new Appendix E, I and F entries,

The proposed implementation date of 1 February 2014 is agreed. There should be no implications for industry since the proposed schedule entries for hexylethoxyethanol mirror the existing generic entries for ethylene glycol monoalkyl ethers.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 includes: (c) the toxicity of a Substance.

  • While the toxicity profile of hexyloxyethanol is slightly different from that of the generic class entry for ethylene glycol monoalkyl ethers, it still fits with the criteria for S6 scheduling in the SPF.
Delegate's consideration

The delegate considered the following in regards to this proposal:

Submissions on interim decision

No public submissions were received.

Delegates 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 - New entry

HEXYLOXYETHANOL except in preparations containing 10 per cent or less of hexyloxyethanol.

Appendix E, Part 2
Poison Standard Statement
Hexyloxyethanol A,G3,E2,S1
Appendix F, Part 3
Poison Warning Statement Safety Direction
Hexyloxyethanol 2 1, 4, 8

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Appendix I

The second schedule
Substance Proportion
Hexyloxyethanol more than 10 per cent by vol

Footnotes

  1. NICNAS (2013): Inventory Multi-tiered Assessment and Prioritisation (IMAP). Human Health Tier II Assessment for 1,2-benzenediol.
  2. Scheduling Policy Framework for Medicines and Chemicals (2010)
  3. Scheduling Policy Framework for Medicines and Chemicals (2010)
  4. NICNAS (2013): Inventory Multi-tiered Assessment and Prioritisation (IMAP). Human Health Tier II Assessment for Carbamic acid, butyl-, 3-iodo-2-propynyl ester.
  5. Scheduling Policy Framework for Medicines and Chemicals (2010)
  6. Scheduling Policy Framework for Medicines and Chemicals (2010)
  7. NICNAS (2010): Full Public Report File No: EX/130 (LTD/1306) - Glycine, N-coco acyl derivs., sodium salts (Sodium Cocoyl Glycinate) <http://www.nicnas.gov.au/__data/assets/word_doc/0008/6668/EX130FR.docx>
  8. Safety Assessment of Amino Acid Alkyl Amides as Used in Cosmetics. Cosmetic Ingredient Review. Available at < http://www.cir-safety.org/sites/default/files/aaaamd022013slr.pdf>
  9. Scheduling Policy Framework for Medicines and Chemicals (2010)
  10. Deltamethrin Technical Factsheet, National Pesticide Information Centre. Available at <http://npic.orst.edu/factsheets/Deltatech.pdf>
  11. Scheduling Policy Framework for Medicines and Chemicals (2010)
  12. Scheduling Policy Framework for Medicines and Chemicals (2010)
  13. Scheduling Policy Framework for Medicines and Chemicals (2010)
  14. NICNAS (2013): Inventory Multi-tiered Assessment and Prioritisation (IMAP). Human Health Tier II Assessment for Ethanol, 2-(hexyloxy)-.
  15. Scheduling Policy Framework for Medicines and Chemicals (2010)
  16. Scheduling Policy Framework for Medicines and Chemicals (2010)

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