You are here

Scheduling delegate's final decisions: ACCS, December 2014

Scheduling medicines and poisons

16 December 2014

Book pagination

Final decisions on matters referred to an expert advisory committee: 1.13-1.17

1.13 N-hydroxy-octanamide

Scheduling decision
  • The delegate has decided not to include this substance in the Poisons Standard.
Scheduling proposal

The ACCS considered the following proposal referred by the delegate for advice:

  • To consider listing N-hydroxy octanamide in an appropriate Schedule with appropriate cut-off to exempt preparations with low concentrations from scheduling.

The committee considered and discussed the resolutions with an implementation date of 1 February/1 June/1 October 2015.

On 13 September 2013, NICNAS, under its New Chemicals programme, requested that the delegate consider a proposal to include the substance in an appropriate schedule. The reason for this request is that the repeat dose toxicity data indicate that the substance presents a moderate hazard from repeated use and a moderate risk of producing irreversible toxicity.

The delegate's reason for referring this scheduling proposal to the ACCS was that advice was needed on whether inclusion in the SUSMP is the most appropriate control measure, given its proposed use in low concentrations as a chelating agent in cosmetic and personal care products.

The delegate asked the ACCS the following questions:

  • Given the relatively minor toxicity profile of this chemical, and the fact that public exposure is only likely to occur through its use in cosmetic and personal care products containing up to 0.3%, does the ACCS consider that listing in the SUSMP is appropriate? If so, in which schedule should it be listed, and can the ACCS recommend a low cut-off concentration to exempt N-hydroxy octanamide from scheduling?
  • If scheduled, what name should be used in the listing - the INCI name of CAPRYLHYDROXAMIC ACID, or the chemical name N-HYDROXY OCTANAMIDE?
  • Noting that the pure chemical has a very low acute toxicity and no evidence of skin/eye irritancy or sensitisation potential, it does not appear to meet any of the factors in the SPF for scheduling. However, the NICNAS report notes that it has the haematological effects expected of a hydroxamic acid derivative in a repeated dose 90-day rat study with a no observed adverse effect level (NOAEL) of 50 mg/kg bw/d. The NICNAS recommendation for scheduling appears to be based on a relatively low estimate of the Margin of Exposure (MoE 42-71), calculated conservatively on an assumption of 100% absorption from dermal exposures.
Substance summary

Please refer to the NICNAS New Chemicals assessment report for octanamide, N-hydroxy- (INCI Name: Caprylhydroxamic acid). This report is publicly available on the NICNAS website:

How to access a word document

Scheduling status

N-hydroxy octanamide is not specifically scheduled.

Scheduling history

N-hydroxy octanamide has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

Two submissions were received. Both submissions indicated that the substance does not require to be scheduled.

Summary of ACCS advice to the delegate

The committee was unable to make a scheduling recommendation due to insufficient toxicological data, particularly repeat-dose studies, for the notified chemical.

Delegate's interim decision

The delegate notes that the ACCS was unable to provide scheduling advice due to the paucity of repeated-dose toxicity data. The toxicological profile (although very limited) includes the potential for hydrolysis to hydroxamic acid and for systemic toxicity (haematotoxicity) to occur on repeated exposure. Hydroxamic acid is also listed as having carcinogenic potential (Class 3; limited evidence). Hydroxamic acid is not listed in any Schedule of the SUSMP. Other aspects of its toxicological profile suggest low toxicity that would not meet SPF criteria for listing in any schedule, nor is it classifiable as Hazardous according to the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)].

The primary reason for the NICNAS recommendation to schedule caprylhydroxamic acid relates to estimates of an unacceptably low MOE associated with its use in cosmetic products. The submissions pointed out that the MOE of 43 was calculated using very conservative assumptions, including 100% dermal bioavailability and exposure via multiple daily product use at the upper level of concentration (0.5%) used in such products. The delegate notes that the NICNAS MOE estimates used methodology recommended in the EU Scientific Committee on Consumer Safety' (SCCS's) Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. The MOE estimate would increase to 71 using the same assumptions, but an upper concentration of 0.3% as indicated by producers of cosmetic products on the Australian market. The submissions also pointed out that there are no international restrictions on the use of caprylhydroxamic acid in cosmetics, despite its wide use.

In the absence of a clear scheduling recommendation from the ACCS, and taking into consideration the points made above, the interim decision of the delegate is to NOT include caprylhydroxamic acid in any schedule at this time.

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

Delegate's considerations

The delegate considered the following in regards to this proposal:

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

Two submissions were received. Both submissions supported the delegate's interim decision not to schedule N-hydroxy-octanamide.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and 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.

1.14 N-methyl-2-pyrrolidone

Scheduling decision
  • The delegate has decided that the current listing in the Poisons Standard remains appropriate.
Scheduling proposal

The ACCS considered the following proposal referred by the delegate for advice:

  • To amend the N-methyl-2-pyrrolidone Schedule 5 and Schedule 6 entries.

The committee considered and discussed the resolutions with an implementation date of 1 February 2015.

On 23 April 2014, NICNAS, under its IMAP programme, requested that the delegate consider a proposal to amend the current Schedules 5 and 6 N-methyl-2-pyrrolidone (NMP) entries. NICNAS recommended that the concentration of the substance in cosmetics/personal care products and domestic products be restricted. The reason for this request is the toxicity profile at concentrations reported to be in use indicate that N-methyl-2-pyrrolidone be considered for listing in Schedule 6, consistent with the SPF guidelines.

The delegate's reason for referring this scheduling proposal to the ACCS was that the NICNAS IMAP report on N-methyl-2-pyrrolidone draws attention to the developmental toxicity potential of this solvent, and to international actions to limit its concentration in cosmetics and other domestic products. It is noted that its reproductive toxicity potential was considered by the NDPSC during the 1990s, at which time it was considered that the findings were 'inconclusive' and the NDPSC decided to retain N-methyl-2-pyrrolidone in Schedule 6, with cut-offs to 50% for Schedule 5 listing and 25% as exempt, consistent with it also being listed as a designated solvent. There is also a listing in Schedule 5 for a veterinary product containing a high concentration of N-methyl-2-pyrrolidone, but where the pack volume was only 2 ml.

The delegate asked the ACCS the following questions:

  • Does the ACCS consider that the new information on the reproductive toxicity potential of N-methyl-2-pyrrolidone warrants re-consideration of its current scheduling? Does this imply that the stem listing in Schedule 6 remains appropriate, but that adjustments need to be made to the Schedule 5 and exempt cut-offs?
  • Given the advice of the NICNAS IMAP report, reflecting its and international assessments of the safety of using N-methyl-2-pyrrolidone in cosmetic and other domestic products, how does the ACCS advise on using schedule listing to achieve an appropriate restriction on the concentration allowed in such products?
  • What weight should be given to the proposed reclassification proposal under REACH legislation that would lower the specific concentration limit for classification as reproductive toxic category 1B from 5% to 0.3%? If adopted, this will effectively restrict the use of NMP in consumer applications to <0.3%. This would be an effective ban on such products because NMP would have no functionality at this level in present consumer applications.
  • Should N-methyl-2-pyrrolidone be removed from the list of 'designated solvents' or should other adjustments be made to this listing? Does Part 2 Clause 7(k)(iv) need amending?
  • There are currently First Aid statement requirements in Appendix E, but no entry in Appendix F. Is there a need to develop warning statements in Appendix F?
  • What are the likely to be the regulatory impacts on other types of products (consumer, AgVet and therapeutic) that incorporate N-methyl-2-pyrrolidone as a solvent or ingredient?
Substance summary

Please refer to the NICNAS Inventory Multi-tiered Assessment and Prioritisation (IMAP) human health Tier II assessment report for 2-pyrrolidinone, 1-methyl-. This report is publicly available on the NICNAS website: Human health tier II assessment for 2-Pyrrolidinone, 1-methyl-.

Scheduling status

N-methyl-2-pyrrolidone is currently listed in Part 1, Interpretation and Schedule 5, Schedule 6, and Appendix E.

PART 1, INTERPRETATION

"Designated solvent" means the following:

N-methyl-2-pyrrolidone

SCHEDULE 5
  • N-METHYL-2-PYRROLIDONE:
    1. when packed in single use containers having a capacity of 2 mL or less; or
    2. in preparations containing 50 per cent or less of N-methyl-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-methyl-2-pyrrolidone, N-(N-octyl)-2-pyrrolidone or N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.
SCHEDULE 6
  • N-METHYL-2-PYRROLIDONE except:
    1. when included in Schedule 5; or
    2. in preparations containing 25 per cent or less of designated solvents.

It is also included in Appendix E with the following statements.

APPENDIX E

When included in Schedule 5

Poisons Standard statements
N-methyl-2-pyrrolidone

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

G3 - If swallowed, do NOT induce vomiting.

E1 - If in eyes wash out immediately with water.

When included in Schedule 6

Poisons Standard statements
N-methyl-2-pyrrolidone

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

G3 - If swallowed, do NOT induce vomiting.

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

Other similar substances (namely, N-(n-dodecyl)-2-pyrrolidone and N-(n-octyl)-2-pyrrolidone) are listed in Schedule 5.

Scheduling history

NMP was first listed in Schedules 5 and 6 in November 1997 by the NDPSC. The NDPSC supported the scheduling of NMP in Schedule 6, with a cut-off at 50% to Schedule 5. Exemption from scheduling at a low concentration had not been supported because there had been concerns relating to the teratogenicity of NMP in a rat study which had failed to determine a no effect level for NMP. The NDPSC also noted that literature contained a number of reports indicating that NMP did have reproductive toxicity potential and, therefore, it was difficult to support an exemption at any level for this substance.

In February 1998, the NDPSC agreed that NMP should be included in the list of 'designated solvents' and that a cut-off from Schedule 5 be established for preparations containing 25% or less of designated solvents. It was noted that there was some argument about the interpretation of teratogenicity results, and the committee considered the available data on the reproductive effects of NMP to be inconclusive.

Pre-meeting public submissions

No public submissions were received.

Summary of ACCS advice to the delegate

The ACCS recommended that the current scheduling of N-methyl-2-pyrrolidone remains appropriate.

Delegate's interim decision

The disparity of the advice available to the delegate relating to the potential reproductive and developmental toxicity of N-methyl-2-pyrrolidone makes the scheduling decision difficult. The difficulty for the delegate is compounded by the wide use of N-methyl-2-pyrrolidone across a range of product types and the consequent regulatory impact of any change to its scheduling. The delegate notes that the ACCS has effectively supported previous scheduling consideration by the NDPSC, concluding that the evidence of reproductive toxicity and developmental toxicity (in the presence of significant maternal toxicity) was inconclusive or lacked sufficient detail for an informed evaluation. On the other hand, the NICNAS report cited international regulatory actions under REACH that classifies N-methyl-2-pyrrolidone as 'reprotoxic category 1B' and limits its use in several product types, including in cosmetics. The difficulty for the delegate is further compounded by the fact that the NICNAS recommendations are based primarily on recent (2009 & 2010) OECD and EU reviews, in which some of the critical studies on developmental and reproductive toxicity are 'newer', while others had been available to the NDPSC in its 1997 and 1999 reviews. Noting that the reproductive and developmental toxicities reported in both older and more recent studies occurred at quite high dose rates (oral, dermal and inhalational) and in the presence of significant maternal toxicity, the delegate is inclined to accept the advice of the ACCS, that the current listings of N-methyl-2-pyrrolidone in Schedules 5 and 6 remain appropriate, along with the current entry in Appendix E.

Therefore, the delegate's interim decision is to make no changes to the current entries for N-methyl-2-pyrrolidone in Schedules 5 and 6.

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

Delegate's considerations

The delegate considered the following in regards to this proposal:

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

No public submissions were received.

Delegate's final decision

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

1.15 Nickel, soluble salts

Scheduling decision
  • The delegate has decided not to expand the current Schedule 6 entry in the Poisons Standard for NICKEL SULFATE to include other soluble nickel salts.
Scheduling proposal

The ACCS considered the following proposal referred by the delegate for advice:

  • To amend the current Schedule 6 nickel sulfate entry to read nickel, soluble salts.

The committee discussed and considered the resolutions with an implementation date of 1 February/1 June/1 October 2015.

On 24 April 2014, NICNAS, under its IMAP programme, requested that the delegate consider a proposal to amend the current Schedule 6 nickel sulfate entry to read 'nickel, soluble salts'. This is to include other similar nickel substances such as soluble nickel compounds, nickel chloride and nickel nitrate, and nickel fluoride in Schedule 6 due to their similar toxicological properties (i.e. carcinogenic, genotoxic and developmental toxicity potential.)

The delegate's reason for referring this scheduling proposal to the ACCS was that the NICNAS IMAP reports on soluble nickel salts raise a number of toxicological issues that warrant scheduling consideration and require advice from the ACCS. The key toxicology issues include acute toxicity, sensitisation, genotoxicity, and carcinogenicity. Nickel sulfate is already listed in Schedule 6, on the basis of actions of the former NDPSC in 1996 when it considered an ingredient of a swimming pool chemical product. The NICNAS IMAP report proposals represent a substantial broadening of the current entry, and may capture a range of products not currently scheduled.

The delegate asked the ACCS the following questions:

  • Are there likely to be any consumer products available for retail sale that contain soluble nickel salts and that may require scheduling? Note the NICNAS IMAP report includes the following summary: 'Given the site-limited uses identified for the chemical, it is unlikely that the public will be exposed to chemicals of this group. Although, the public may come into contact with articles/coated surfaces containing the chemical, it is expected that the chemical will be bound within the article/coated surface and hence will not be bioavailable. Therefore the risk to the public is not considered to be unreasonable.'
  • In framing any scheduling recommendations, is it necessary to consider the REACH regulations addressing the potential for soluble nickel ions to be released from ear rings, ear piercings, necklaces etc?
  • If the current nickel sulfate Schedule 6 entry is to be broadened, is there sufficient information to propose a cut-off to exempt nickel sulfate from scheduling where the health risks do not require control via scheduling?
  • If a generic listing for NICKEL, SOLUBLE SALTS is adopted, is there sufficient definition of the term 'soluble' to enable the specific compounds to be identified?
  • There are currently no entries in Appendices E or F for nickel sulfate. Are such entries needed if the Schedule 6 entry is broadened to include all soluble nickel salts?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment reports for soluble nickel compounds (group 1), nickel chloride, and nickel nitrate and nickel fluoride. These reports are publicly available on the NICNAS website:

Scheduling status

All concentrations and use patterns of nickel sulfate are currently included in Schedule 6.

SCHEDULE 6

NICKEL SULFATE.

Scheduling history

In February 1996, the NDPSC decided to list nickel sulfate in Schedule 6 in view of its acute oral toxicity and skin sensitisation potential.

Pre-meeting public submissions

One submission was received. The submission supported the delegate's proposal.

Summary of ACCS advice to the delegate

The ACCS recommended that soluble nickel compounds such as nickel chloride, and nickel nitrate and nickel fluoride do not require a schedule listing.

Delegate's interim decision

The NICNAS IMAP reports outline the quite significant toxicity potential for nickel and its compounds, including carcinogenicity and respiratory/skin sensitisation potential. The many industrial applications of nickel and its compounds attract stringent regulatory controls, including prohibition under carcinogenicity regulations. There is extensive evidence of sensitising potential associated with the use of nickel metal in jewellery, cutlery and clothing studs, resulting in enhanced regulatory restrictions (EU REACH regulations) on nickel leaching from these uses.

The current Schedule 6 entry for nickel sulfate was listed in 1996 to regulate its specific use in a swimming pool chemical. The delegate notes that neither the NICNAS IMAP report, nor the advice from the ACCS, identified a potential use for any other soluble nickel salts in products that would be available on the domestic retail market. This is a key reason behind the ACCS advice that the Schedule 6 entry for nickel sulfate does not need expansion to capture other soluble nickel salts. The ACCS also advised that it would be inappropriate to use the SUSMP to regulate the use of metallic nickel in jewellery, cutlery etc.

The NICNAS IMAP reports include the following statement about potential public exposures:

Given the site-limited uses identified for the chemical, it is unlikely that the public will be exposed to chemicals of this group. Although, the public may come into contact with articles/coated surfaces containing the chemical, it is expected that the chemical will be bound within the article/coated surface and hence will not be bioavailable. Therefore the risk to the public is not considered to be unreasonable.

Accordingly, the delegate's interim decision is to NOT expand the current Schedule 6 entry for nickel sulfate to include other soluble nickel salts, on the basis that there is no identified public health risk for products available on the retail market, other than the currently registered swimming pool chemical.

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

Delegate's considerations

The delegate considered the following in regards to this proposal:

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

No public submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.1.16 Phenol, 2-amino or o-aminophenol

1.16 Phenol, 2-amino or o-aminophenol

Scheduling decision
  • The delegate has decided not to include this substance in the Poisons Standard.
Scheduling proposal

The ACCS considered the following proposal referred by the delegate for advice:

  • To add restrictions for domestic use and to include phenol, 2-amino in Appendix C for cosmetic use.

The committee considered and discussed the resolutions with an implementation date of 1 February/1 June/1 October 2015.

On 23 April 2014, NICNAS, under its IMAP programme, requested that the delegate consider a proposal to include cosmetic preparations and/or domestic preparations containing phenol, 2-amino- in Appendix C.

The delegate's reason for referring this scheduling proposal to the ACCS was that o-aminophenol is a hair dye ingredient with the following toxicological issues: acute toxicity, mutagenicity and sensitisation potential. The NICNAS recommendation was for scheduling controls to restrict use in hair dye and other cosmetic preparations. Its use in cosmetics is restricted in various overseas regulations. ACCS advice was needed to determine the optimal scheduling actions to achieve the requested controls.

The delegate asked the ACCS the following questions:

  • Noting that the toxicological data on o-aminophenol is limited, and the NICNAS assessment is based on read-across from available data on the isomers p- and m-aminophenol, does the ACCS support the contention that the mutagenic potential warrants stringent controls over use in cosmetics and consumer products?
  • What weight should be given to the equivocal evidence of sensitisation potential?
  • In the light of insufficient information on carcinogenicity, what weight should be given to the range of positive and negative studies on genotoxicity?
  • Does the ACCS consider that including o-aminophenol in Schedule 6 or 7, or a specific entry in Appendix C is the best option for controlling its use in consumer products and cosmetics, including hair dyes?
  • What name should be used for any schedule entry - 2-hydroxyaniline, o-aminophenol, or 1-hydroxy-2-aminophenol?
  • Is there a need for specific entries in Appendices E & F?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for phenol, 2-amino. This report is publicly available on the NICNAS website: Human health tier II assessment for phenol, 2-amino-.

Scheduling status

Phenol, 2-amino is not specifically scheduled.

Scheduling history

Phenol, 2-amino has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

One submission was received. The submission indicated that the substance is being phasing out of use in Australia, most likely due to the inclusion of the substance in the EU banned list.

Summary of ACCS advice to the delegate

The ACCS recommended that phenol, 2-amino- does not require a schedule listing.

Delegate's interim decision

The delegate notes the advice from the ACCS that the toxicity profile of o-aminophenol is partly based on 'read-across' from other isomers. It has a HSIS Cat 3 mutagenicity categorisation (in vitro positive but negative in vivo) supporting the ACCS advice that evidence of its potential mutagenicity is too weak to support any scheduling actions. The delegate notes that there are some international restrictions on its use in cosmetic products but that ACCS advice is that such use is unlikely in Australia. Based on the use pattern and toxicity profile the substance, the ACCS considered there were no public health issues to be addressed via scheduling. The delegate therefore accepts the ACCS advice that a schedule listing of o-aminophenol in the SUSMP is not required.

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

Delegate's considerations

The delegate considered the following in regards to this proposal:

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

One submission was received which supported the delegate's interim decision not to schedule phenol, 2-amino.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and 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.

1.17 Tetrahydro-4-methyl-2-phenyl-2H-pyran

Scheduling decision
  • The delegate has decided not to include this substance in the Poisons Standard.
Scheduling proposal

The ACCS considered the following proposal referred by the delegate for advice:

  • To create new Schedule 6 and Appendix F entries for tetrahydro-4-methyl-2-phenyl 2H-pyran with appropriate cut-off to exempt from scheduling.

The committee considered and discussed the resolutions with an implementation date of 1 February/1 June/1 October 2015.

On 13 September 2013, an application was received requesting that the delegate consider a proposal to create new Schedule 6 and Appendix F entries for tetrahydro-4-methyl-2-phenyl 2H-pyran.

The reasons for the request were:

  • Skin irritation data indicate tetrahydro-4-methyl-2-phenyl 2H-pyran is a moderate to severe irritant and meets the SPF factors for Schedule 6;
  • Skin sensitisation data indicate tetrahydro-4-methyl-2-phenyl 2H-pyran is a moderate skin sensitiser and meets the factors of the SPF for Schedule 6; and
  • Based on the available data, the chemical is classified as hazardous according to the Safe Work Australia's Approved Criteria for Classifying Hazardous Substances. The classification and labelling details are: 'Irritating to skin'and 'May cause sensitisation by skin contact'.

The delegate's reason for referring this scheduling proposal to the ACCS was that ACCS advice was needed on whether inclusion in the SUSMP is the most appropriate control measure, given its proposed use in low concentrations in fragrances, cosmetics and household cleaners.

The delegate asked the ACCS the following questions:

  • Given the relatively moderate toxicity profile of this chemical, and the fact that public exposure is only likely to occur through its use as a fragrance in cosmetic and household cleaning products containing up to 0.1%, does the ACCS consider that listing in the SUSMP is appropriate? If so, in which schedule should it be listed, and can the ACCS recommend a low cut-off concentration to exempt? Are different cut-offs required for different product categories?
  • Noting that the pure chemical is a slight-moderate skin/eye irritant and a potential sensitiser, but there is limited information on these toxicities at the low concentrations proposed for consumer products, is this toxicity potential sufficient to warrant inclusion of the substance in Schedule 6, or is it more consistent with SPF criteria for listing in Schedule 5? Are Appendix E & F statements required?
Substance summary

Tetrahydro-4-methyl-2-phenyl 2H-pyran will be used as a component of fragrances for a variety of cosmetic and household products, including fine fragrances, cosmetics and household cleaning products at concentrations up to 0.1%.

Acute toxicity

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

Toxicity species Tetrahydro-4-methyl-2-phenyl 2H-pyran SPF Classification
Acute oral toxicity LD50 (mg/kg bw) Rat >2000 Low toxicity
Acute dermal toxicity LD50 (mg/kg bw) Rat >2000 Low toxicity
Acute inhalational toxicity LC50 (mg/m3/4h) Not provided Not provided Unable to assess
Skin irritation Rabbit Irritant
Eye irritation Not provided Not provided
Skin sensitisation Guinea pig Sensitiser
Repeated dose toxicity

No information was provided.

Mutagenicity

The chemical was not mutagenic in a bacterial reverse mutation study.

Genotoxicity

No information was provided.

Neurotoxicity

No information was provided.

Carcinogenicity

No information was provided.

Reproduction and developmental toxicity

No information was provided.

Observation in humans

No information was provided.

Public exposure

Members of the public may experience repeated exposure to the chemical through use of fine fragrances, cosmetics and household cleaning products at concentrations up to ≤ 0.1%. The repeated dose toxicity effects of the chemical have not been determined; however, based on the low concentration of chemical in end-use products, exposure to the chemical is expected to be limited. In addition, based on the low concentration, the risk of skin and eye irritation is not considered to be unreasonable.

International regulations

No information was provided.

Scheduling status

Tetrahydro-4-methyl-2-phenyl-2H-pyran is not specifically scheduled.

Scheduling history

Tetrahydro-4-methyl-2-phenyl-2H-pyran has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

One submission was received. The submission indicated that the substance does not require a schedule listing.

Summary of ACCS advice to the delegate

The ACCS recommended that tetrahydro-4-methyl-2-phenyl-2H-pyran does not require a schedule listing.

Delegate's interim decision

The delegate accepts ACCS advice that the fragrance ingredient tetrahydro-4-methyl-2-phenyl 2H-pyran does not require scheduling. The delegate notes that sensitisation potential is the toxicological finding that could justify inclusion in the schedules, and that the ACCS has made recommendations at this and previous meetings that it is not necessary to use the scheduling process to regulate fragrance chemicals when there is no evidence of a significant public health hazard associated with the low concentrations likely to be found in consumer products in Australia. There were no other toxicological factors that would justify scheduling. Accordingly, the interim decision of the delegate is to NOT include this chemical in the SUSMP.

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

Delegate's considerations

The delegate considered the following in regards to this proposal:

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

One submission was received which supported the delegate's interim decision not to schedule tetrahydro-4-methyl-2-phenyl-2H-pyran.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and 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.

Book pagination