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Scheduling delegate's final decisions: ACCS, March 2015

Scheduling medicines and poisons

27 March 2015

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Part A - Final decisions on matters referred to an expert advisory committee (1.1-1.4)

1. Scheduling proposals referred to the November 2014 meeting of the Advisory Committee on Chemicals Scheduling (ACCS #12)

1.1 Summary of final decisions

Substance Final decision
1,2-Benzendicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) and 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP)

New Appendix C/Schedule 10 entry

DI(METHYLOXYETHYL) PHTHALATE for cosmetic use.

New Appendix C/Schedule 10 entry

DIISOBUTYL PHTHALATE for cosmetic use.

Implementation date - 1 June 2015

1,4-Benzenediamine, 2-nitro Pending
Alkoxyethanols (C1-C2) and their acetates

New Schedule 7 entries

2-METHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or less of 2-methoxyethanol.

2-ETHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or less of 2-ethoxyethanol.

New Appendix F, Part 3 entries

2-METHOXYETHANOL - warning statement 77, safety directions 1,4,8

2-ETHOXYETHANOL - warning statement 77, safety directions 1,4,8

Implementation date - 1 June 2015

Benzidine-congener based dyes

New Schedule 7 entry

BENZIDINE-CONGENER (3,3'-disubstituted) AZO DYES.

Implementation date - 1 June 2015

C. I. Acid black 29

Amendment to Schedule 7 entry

BENZIDINE-BASED AZO DYES

add C.I Acid Black 29 to list of substances covered by this entry

Implementation date - 1 June 2015

Fenpyrazamine

New Schedule 5 entry

FENPYRAZAMINE except in preparations containing 40 per cent or less of fenpyrazamine

Implementation date - 1 June 2015

Fluopyram

New Schedule 5 entry

FLUOPYRAM except in preparations containing 50 per cent or less of fluopyram

Implementation date - 1 June 2015

Formaldehyde donors Pending
Methylated spirit(s) Pending
Methyl Ethyl Ketone Oxime

Amendment to Schedule 6 entry

METHYL ETHYL KETONE OXIME except:

  • in viscous silicone adhesives or viscous silicone sealants containing 2.5% or less of methyl ethyl ketone oxime; or
  • in other preparations containing 1 per cent or less of methyl ethyl ketone oxime.

Implementation date - 1 June 2015

1.2 1,2-Benzendicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) and 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP)

Scheduling proposal

The chemicals scheduling delegate (the delegate) referred the following scheduling proposal for consideration by the Advisory Committee on Chemicals Scheduling (ACCS):

  • To create new Schedule entries for 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester (Di(methoxyethyl) phthalate or DMEP) and 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (Diisobutyl phthalate or DiBP) in Appendix C.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/1 October 2015/1 February 2016.

In August 2014, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under its Priority Existing Chemicals (PEC) assessment programme for 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester (Di(methoxyethyl) phthalate or DMEP) and Inventory Multi-tiered Assessment Prioritisation (IMAP) programme for 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (Diisobutyl phthalate or DiBP), referred the following proposal to be considered by the delegate:

  • A proposal to create new entries for 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester (Di (methyoxyethyl) phthalate or DMEP) and 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (Diisobutyl phthalate or DiBP) in Appendix C.

The reasons for the request were:

  • Adverse effects on fertility and development (mediated by testicular toxicity, abnormal spermatogenesis, reduced pup weight, and altered sexual differentiation).
  • The C4-6 transitional phthalate group of chemicals which include 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester can cause anaemia (repeated dose toxicity).
  • 1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester is classified as hazardous under the Hazardous Substances Information System (HSIS) with the risk phrases Repro Cat 2 (R61 'May cause harm to the unborn child'); Repro Cat 3 (R62 'Possible risk of impaired fertility').

NICNAS recommended that the chemicals be listed in Appendix C to limit the potential exposure of the public, including young children, to the chemical from possible use in cosmetics.

Delegate's reasons for referring this to the committee

The delegate's reason for referring this scheduling proposal to the ACCS was that, the NICNAS referral seeks a restrictive scheduling to regulate the use of DMEP and DiMP in cosmetic products. The Scheduling Policy Framework (SPF) recommends that the delegate seek advice from an advisory committee for such restrictive scheduling actions.

The delegate asked the ACCS the following questions:

  • The related phthalate esters diethylphthalate (DEP) and dimethylphthalate (DMP) are listed in Appendix C to restrict use in sunscreens, personal insect repellents or body lotions, while dibutylphthalate (DBP) and diethylhexyl phthalate (DEHP) listings in Appendix C restrict use in cosmetic products. Are the toxicity profile and risk assessment relating to cosmetic use of DMEP and DiBP sufficiently similar to these other phthalates to warrant a parallel entry for them both in Appendix C? Note that this proposal is pre-emptive, in that there is no evidence that either DiBP or DMEP is currently used in cosmetic products in Australia or overseas.
  • Should the parallel entry specify use in cosmetics, to cover a broader range of products, and is there any basis for setting an exemption cut-off (as for DEP and DMP)?
  • Which names should be used for the proposed listings in Appendix C? The NICNAS IMAP report lists the names diisobutyl phthalate and di-(methoxyethyl) phthalate as possible names for DiBP and DMEP, respectively. This nomenclature may be more consistent with that used for existing Appendix C entries for phthalate esters.
  • Given that the current Appendix C entries for DMP and DEP appear to have been initially developed for personal insect repellents after consideration of their referral from the APVMA registration process, and subsequently extended to sunscreens and body lotions after consideration of a NICNAS evaluation, is there a case for foreshadowing an amendment to the DMP and DEP entries to encompass all cosmetic products?
Substance summary

Please refer to the NICNAS PEC assessment report for Di(methoxyethyl) phthalate (DMEP) and the NICNAS IMAP human health Tier II assessment report for C4-6 side chain transitional phthalates.

The PEC report is publicly available on the NICNAS website Priority Existing Chemical (PEC) Assessments.

The IMAP assessment report is publicly available on the NICNAS website: Human health tier II assessment for C4-6 side chain transitional phthalates.

Scheduling status

1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester (Diisobutyl phthalate or DiBP) and 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester (Di(methyoxyethyl) phthalate or DMEP) are not specifically scheduled.

Scheduling history

Neither 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP) nor 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) have been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

One submission was received that tentatively supports the inclusion of DMEP and DiPB for cosmetic use in Appendix C.

Summary of ACCS advice to the delegate

The committee recommended that a new Appendix C be created for cosmetic preparations containing Di(methoxyethyl) phthalate and Diisobutyl phthalate.

The committee supported the implementation date of 1 June 2015.

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:

  • Systemic and reproductive toxicity consistent with related transitional phthalates warrant restrictions.
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;
  • SPF Scheduling factors;
  • Other relevant information.
Delegate's interim decision

The delegate accepts the advice from the ACCS and agrees to create new entries in Appendix C/Schedule 10 for cosmetic preparations containing Di(methoxyethyl) phthalate and Diisobutyl phthalate. The decision is based on the NICNAS assessment that there is an inadequate safety margin associated with their potential use in cosmetic products and it is consistent with previous scheduling actions to restrict the use of other phthalate esters with comparable reproductive toxicity potential.

The delegate agrees with the implementation date 1 June 2015.

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.

Public submissions on the interim decision

One public submission was received. The submission noted they had previously provided comments on this item, but had no further comment to make in response to the interim decision.

Delegate's final decision

The delegate confirms 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.

The delegate has confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Appendix C/Schedule 10 - New entry

DI(METHYLOXYETHYL) PHTHALATE for cosmetic use.

Appendix C/Schedule 10 - New entry

DIISOBUTYL PHTHALATE for cosmetic use.

1.3 Alkoxyethanols (C1-C2) and their acetates

Scheduling proposal

The delegate referred the following scheduling proposal for consideration by the ACCS:

To develop separate entries for:

  • 2-methoxyethanol (Inventory Multi-tiered Assessment and Prioritisation (IMAP) report for alkoxyethanols (C1-C2) and their acetates),
  • 2-ethoxyethanol (IMAP report for alkoxyethanols (C1-C2) and their acetates),
  • 2-(1-methylethoxy)ethanol (IMAP report for 2-(1-methylethoxy)ethanol and its acetate),
  • 2-butoxyethanol (IMAP report for ethanol, 2-butoxy-, acetate), and
  • 2-propoxyethanol (IMAP report for ethanol, 2-propoxy), along with their acetates.

These proposals require consideration of changes to the exemption cut-offs for the Schedule 6 entries, and the need for separate entries in Appendices E, F and I.

There is currently a generic entry in Schedule 6 for ETHYLENE GLYCOL MONOALKYL ETHERS and their ACETATES. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) IMAP programme has reviewed a number of chemicals in this class and recommended that separate entries be created for selected chemicals in this class. In November 2013, the delegate decided to separately list a similar substance namely 2-hexyloxyethanol. This decision was based on an outcome of the July 2013 ACCS meeting.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/1 October 2015/1 February 2016.

In August 2014, NICNAS, under its IMAP programme, referred the following proposal to be considered by the delegate:

  • To separately list 2-methoxyethanol, 2-ethoxyethanol, 2-(1-methylethoxy)ethanol, 2-butoxyethanol and 2-propoxyethanol and their acetates in Schedule 6.

NICNAS suggested that any review of the substance entry in the Poisons Standard should form a part of a review of the entries for all ethylene glycol monoalkyl ethers and their acetates.

The reasons for the request were:

  • At present, the chemicals fall within the scope of the listing of ethylene glycol monoalkyl ethers in Schedule 6 of the SUSMP for preparations containing more than 10 % of glycol ether. However, the health effects of the members in this class of chemicals vary significantly and a separate listing for the chemicals in this group might be more appropriate.
  • Whilst the chemicals meet the criteria for Schedule 6, given the critical health effects identified, a lower concentration cut-off (than the current 10%) might be appropriate for some substances, and a higher concentration cut-off level may be more appropriate for others.
  • Physiologically based pharmacokinetic (PBPK) modelling suggests that humans could experience toxic effects at concentration levels lower than those observed in animals.
Delegate's reasons for referring this to the committee

The delegate's reason for referring this scheduling proposal to the ACCS was that the SPF suggests that all re-scheduling proposals be referred to the relevant advisory committee.

The delegate asked the ACCS the following questions:

  • The current generic Schedule 6 entry ETHYLENE GLYCOL MONOALKYL ETHERS and their ACETATES would cover the five chemicals referred by NICNAS for consideration of replacement with specific entries. Are there sufficient similarities or differences in their toxicity profiles that they could warrant separate Schedule 6 entries and concentration cut-off levels to exempt (currently 10%) from scheduling?
  • Is there a need to develop separate entries in Schedule 6, as well as Appendices E, F and I as the delegate recommended at the July 2013 meeting for 2-hexyloxyethanol, with different concentration cut-off levels to exempt from scheduling for each substance?
  • Note that the NICNAS IMAP reports for 2-butoxyethanol, 2-propoxyethanol and 2- methylethyloxyethanol suggest that concentrations higher than 10% can be used safely, is this a justification for separate Schedule 6 entries with higher cut-off levels?
  • What weight should be given to the claim in the NICNAS report for 2-methoxyethanol and 2-ethoxyethanol that physiologically based pharmacokinetic (PBPK) modelling suggests that humans could experience toxic effects at concentration levels lower than those observed in animals?
  • Does the more recent toxicity data on 2-methoxyethanol and 2-ethoxyethanol reviewed in the NICNAS report suggest that a cut-off at 10% is no longer appropriate, and that a lower concentration cut-off level to exempt from scheduling should be considered for these two chemicals?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report on alkoxyethanols (C1-C2) and their acetates, 2-(1-methylethoxy)ethanol and its acetate, ethanol, 2-butoxy and ethanol, 2-propoxy.

These reports are publicly available on the NICNAS website:

Scheduling status

2-Methoxyethanol, 2-ethoxyethanol, 2-(1-methylethoxy)ethanol, 2-butoxyethanol and 2-propoxyethanol and their acetates are not specifically scheduled.

These substances belong to the chemical class of ethylene glycol monoalkyl ethers. Ethylene glycol monoalkyl ethers and their acetates are listed in Schedule 6 and Appendices E, F and I.

Another similar substance, namely hexyloxyethanol or 2-hexyloxyethanol is listed in Schedule 6 and Appendices E, F and I.

Scheduling status of ethylene glycol monoalkyl ethers
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 statements
Ethylene glycol monoalkyl ethers and their acetates except when separately specified A,G3,E2,S1
Appendix F, Part 3
Poison Warning statements Safety directions
Ethylene glycol monoalkyl ethers and their acetates except when separately specified 1,4,8
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 status of hexyloxyethanol
Schedule 6

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
Appendix I

The Second Schedule

Substance Proportion
Hexyloxyethanol 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.

In November 2013, the delegate, based on the ACCS advice, decided to create a separate schedule entry for hexyloxyethanol with a cut-off level to exempt from scheduling for preparations containing 10 per cent of less of hexyloxyethanol. The delegate also decided to create new Appendices E, F and I entries specifically for hexyloxyethanol. The delegate's decision was based on the fact that hexyloxyethanol's toxicity profile was different from the chemical class ethylene glycol monoalkyl ethers.

Pre-meeting public submissions

Two submissions were received.

One submission noted that this schedule entry applies to a wide range of chemicals that, while chemically related (i.e. derivatives, chemically speaking), are not toxicologically similar (i.e. should not be considered derivatives for toxicological purposes). The submission requested that the ACCS consider limiting the schedule 6 entry to short alkyl chain glycol ethers, and also consider limiting the schedule entry to compounds with 1 mole alkyl ethers i.e. ethylene glycol monoalkyl ethers, excluding derivatives.

The second submission noted that methoxyethanol and ethoxyethanol are used in a number of topical cosmetic products at low concentrations with no reported safety issues they are aware of. The submission requested that if a Schedule 6 entry is adopted, the committee and delegate exempt cosmetic products containing methoxyethanol and ethoxyethanol in low concentrations from scheduling.

Summary of ACCS advice to the delegate

The committee recommended that 2-methoxyethanol and its acetates and 2-ethoxyethanol and its acetates, based on their reproductive toxicity potential, be listed in Schedule 7.

The committee recommended that 2-(1-methylethoxy) ethanol, 2-propoxyethanol and their acetates do not require a separate schedule listing.

The committee supported the implementation date of 1 June 2015.

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:

  • reproductive toxicity potential.
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;
  • SPF scheduling factors;
  • Other relevant information.
Delegate's interim decision

For some time, the scheduling of this group of alkoxyethanols has been covered by the generic Schedule 6 entry for ethylene glycol monoalkyl ethers and their acetates. More recently, as a results of NICNAS IMAP evaluations, some individual members have been referred for consideration of whether separate entries (with possibly different exemption cut-offs) would be more appropriate for some members of this class of compound, given the differences in their toxicity profile as the alkyl side chain is lengthened. The separate listing of butoxyethanol and hexyloxyethanol in Schedule 6 (with the same 10% exemption cut-off) is an example of these more recent scheduling reconsiderations.

The current advice from the ACCS is that the toxicity profiles of 2-butoxyethanol, 2-propoxyethanol and 2- methylethyloxyethanol are consistent with the listing in Schedule 6 and that they are adequately covered by the current generic entry (noting that butoxyethanol already has a separate listing in Schedule 6). Despite some evidence in the NICNAS IMAP reports suggesting that, for these specific alkoxyethanols, concentrations higher than 10% can be used safely, the ACCS did not recommend raising the current 10% cut-off to exempt. The delegate accepts the ACCS advice and makes no recommendation for a separate listing in Schedule 6 for 2-propoxyethanol and 2-methylethyloxyethanol.

In the case of methoxyethanol and ethoxyethanol (and their acetates), the ACCS made a different recommendation. On the basis of their reproductive and developmental toxicity potential, and NICNAS assessment that product concentrations below 10% could result in unacceptable Margin of Safety estimates, the ACCS recommended that both be listed in Schedule 7, with no cut-off to exempt or to a lower Schedule. Given the serious nature of their toxicity profile and the fact that both substances are listed by the European Chemicals Agency (ECHA) as 'substances of very high concern', the delegate accepts that a primary listing in Schedule 7 is more appropriate than the existing coverage by the generic Schedule 6 entry. However, the delegate has concerns that the ACCS did not recommend any cut-off to exempt or to a lower schedule. This could have significant regulatory impact on existing products. While the NICNAS report suggests there are no known uses of methoxyethanol, ethoxyethanol or their acetates in Australia, an industry submission noted the potential for them to be present at very low concentrations (or as impurities?) in some cosmetic products. In the absence of any definitive advice from the ACCS on a suitable cut-off from the proposed Schedule 7 listing (substances in Schedule 7 are not eligible for the generic 10 ppm exemption in Part 1 of the SUSMP), the delegate proposes to include an exemption clause in the Schedule 7 entry at the REACH maximum of 0.5%.

The ACCS considered the need for Appendix F warning Statements for products covered by the Schedule 7 listing, but ultimately did not put a recommendation. Nor did the ACCS address the need to an entry in Appendix J. The delegate proposes that, in addition to the standard Warning Statements 1,4 and 8 applied to all ethylene glycol monoalkyl ethers, there is a need to also specify WS 77 (WARNING - may cause birth defects) for any products captured by the Schedule 7 entry.

The delegate agrees with the implementation date 1 June 2015.

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

Public submissions on the interim decision

One public submission was received. The submission noted they had previously provided comments on this item, but had no further comment to make in response to the interim decision.

Delegate's final decision

The delegate confirms 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.

The delegate has confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Schedule 7 - New entries

2-METHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or less of 2-methoxyethanol.

2-ETHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or less of 2-ethoxyethanol.

Appendix F, Part 3 - New entries
Poison Warning statements Safety direction
2-METHOXYETHANOL and its acetates 77 1,4,8
2-ETHOXYETHANOL and its acetates 77 1,4,8

1.4 Benzidine-congener based dyes

Scheduling proposal

The delegate referred the following scheduling proposal for consideration by the ACCS:

  • To insert a new entry for benzidine-congener-based dyes in the SUSMP, to prohibit their sale, supply and use in dyes for home use.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/1 October 2015/1 February 2016.

In August 2014, NICNAS, under its IMAP programme, referred the following proposal to be considered by the delegate:

  • A proposal to insert a new entry to the SUSMP for various benzidine-congener-based dyes to prohibit their sale, supply and use in dyes for home use.

The reasons for the request were:

  • The chemicals are both genotoxic and carcinogenic in animals. The benzidine-congener metabolites are reasonably anticipated to be potent human carcinogens; this is also considered to be the case for the non-metalised dyes given that:
    • the incidence of malignant tumours observed following exposure to Acid Red 114 and Direct Blue 15 was also similar to that observed following exposure to 3,3'-DMB and 3,3'-DMOB; and
    • the amount of free benzidine-congener detected in animals was equivalent to that observed following an equimolar dose of benzidine-congener.
  • Whilst metal chelation appears to render the chemicals more inert towards metabolism, based on data for C.I. Direct Blue 218, this does not completely eliminate the azo reduction and carcinogenicity potential of the chemicals.

NICNAS recommended that the chemicals be scheduled to prohibit their sale, supply and use in dyes for home use.

Delegate's reasons for referring this to the committee

The delegate's reason for referring this scheduling proposal to the ACCS was that, advice was requested from the ACCS to determine whether a Schedule 7 entry for benzidine-congener-based dyes should be added to the current Schedule 7 entry for BENZIDINE-BASED AZO DYES, or a new separate entry be created in Schedule 7.

The NICNAS IMAP programme has reviewed a number of diazotized benzidine derivatives likely to be a component of dyes and stains and found that the toxicological profile of these benzidine-based azo dyes is consistent with the SPF criteria for listing in Schedule 7 (based on their mutagenicity and carcinogenicity profile and ability to be metabolised to benzidine, a known human carcinogen). Scheduling recommendations from the November 2013 ACCS meeting resulted in eleven of these substances being listed in Schedule 7.

The Delegate asked the ACCS the following questions.

  • The toxicological profile of the 66 dyes listed in the NICNAS IMAP report is based on read-across from a few related dyes, and the assumption that all will be metabolised in vivo to benzidine or its congeners. Is there sufficient evidence to conclude that they represent the same hazard profile as other benzidine-based azo dyes currently listed in Schedule 7, and therefore warrant addition to that entry?
  • Should all 66 of the listed benzidine-congener-based azo dyes (and their CAS numbers) be simply added to the list of dyes currently captured by the generic Schedule 7 entry for BENZIDINE-BASED AZO DYES, or should they be listed under a separate schedule entry?
  • What weight should be given to 'the reasonably anticipated to be human carcinogens' classification for the three congeners expected to be their metabolites (3,3’-DCB, 3,3’-DMOB and 3,3’-DMB) for the NICNAS assessment report for these chemicals), as opposed to the 'known human carcinogen' classification for benzidine?
  • What weight should be given to the disclosure in the NICNAS IMAP report that these dyes are being phased out internationally and that there may be no current uses in Australia, other than the possibility that some of them might be present in imported textiles and fabrics? Are there likely to be other products available in the retail market that may contain these dyes?
  • Should the schedule 7 wording be limited to dyes available to the general public for home use, or should there be blanket coverage of all products where the dyes have been used?
  • Is the regulatory impact of adding these benzidine-congener-based dyes to Schedule 7 likely to be similar, or greater than, the effects on products covered by the current Schedule 7 listing of benzidine-based azo dyes?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for Selected Benzidine-Congener-Based Dyes. This report is publicly available on the NICNAS website: Human health tier II assessment for Selected Benzidine-Congener-Based Dyes.

Scheduling status

Benzidine-congener-based dyes are not specifically scheduled.

Benzidine based azo dyes are listed in Schedule 7.

Schedule 7

BENZIDINE-BASED AZO DYES being:

  • 2,2'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[N-(4-chlorophenyl)-3-oxobutanamide], CAS No. 94249-03-3
  • Acid Red 85 (Acid Fast Red A). 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-, disodium salt. CAS No. 3567-65-5
  • Direct Black 38. 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt. CAS No. 1937-37-7
  • Direct Blue 2. 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt. CAS No. 2429-73-4
  • Direct Blue 6. 2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt. CAS No. 2602-46-2
  • Direct Brown 2. 5-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxy- benzoic acid disodium salt. CAS No. 2429-82-5
  • Direct Brown 95. Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt
    CAS No. 16071-86-6
  • Direct Green 1. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt. CAS No. 3626-28-6
  • Direct Green 6. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt. CAS No. 4335-09-5
  • Direct Red 28 (Congo Red). 1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[4-amino-, disodium salt. CAS No. 573-58-0
  • Direct Red 37. 1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-ethoxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt. CAS No. 3530-19-6
Scheduling history

Benzidine-congener-based dyes are not specifically scheduled.

The following is the scheduling history of benzedine-based azo dyes.

In April 2014, the delegate, based on ACCS advice, made a decision to list 11 benzidine-based dyes in Schedule 7. The delegate indicated that inclusion of benzidine-based dyes in Appendix C is not the most appropriate way of regulating the use of these substances. The delegate also noted that some of the dyes may have use as laboratory and analytical reagents. While there are stringent existing controls under Model Work Health and Safety legislation, and industry advises that they have been largely phased out of many uses, their carcinogenic potential, via conversion to benzidine (a known human carcinogen), indicates they should not be used in products available in the domestic market.

Pre-meeting public submissions

No submissions were received.

Summary of ACCS advice to the delegate

The committee recommended that a new Schedule 7 entry be created for benzidine-congener (3,3'-disubstituted) azo dyes.

The committee supported the implementation date of 1 June 2015.

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:

  • Concerns about the potential carcinogenic and reproductive affects.
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;
  • SPF scheduling factors;
  • Other relevant information.
Delegate's interim decision

The delegate accepts ACCS advice that a new Schedule 7 generic entry be created for benzidine-congener (3,3'-disubstituted) azo dyes. The scheduling proposal complements previous decisions to list in Schedule 7 some azo dyes that can be metabolized to benzidine, a known human carcinogen. While the three congeners expected to be their metabolites (3,3'-DCB, 3,3'-DMOB and 3,3'-DMB) are classified as 'reasonably anticipated to be human carcinogens', rather than the 'known human carcinogen' classification for benzidine, the ACCS considers that their carcinogenic potential warrants similar restrictive scheduling. The delegate notes that the NICNAS report lists 66 substances that fit the generic description. Rather than list these substances individually by name (as in the current Schedule 7 listing for BENZIDINE-BASED AZO DYES), the delegate notes that there is precedent for a generic entry to capture a group of substances with similar hazard characteristics and that this is a more pragmatic approach than listing the 66 individual substances included in the NICNAS report.

The delegate agrees with the implementation date 1 June 2015.

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.

Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

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

The delegate has confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Schedule 7 - New entry

BENZIDINE-CONGENER (3,3'-disubstituted) AZO DYES.

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