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Scheduling delegate's final decisions: ACCS, November 2015

Scheduling medicines and poisons

19 November 2015

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2.4 Cyclopentane, alpha,alpha-dimethylpropanol

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

2. Scheduling proposals referred to the August 2015 ACCS meeting

2.4 Cyclopentane, alpha,alpha-dimethylpropanol

Scheduling proposal

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

  • In April 2015 the delegate received a request to consider creating a new entry for cyclopentanepropanol, alpha,alpha-dimethyl- in Schedule 6 when used in cosmetic and household products, with appropriate concentration cut-offs to exempt from scheduling for preparations with low concentrations.
Scheduling application

The reasons for the request were:

  • The chemical is an eye irritant, consistent with the Schedule 6 factors and skin irritant, consistent with Schedule 5 factors.
  • The NICNAS recommended usage concentrations of 1% in fine fragrances, 0.5% in other cosmetic products and 1% in household products correspond to the maximum proposed usage concentrations by the notifier. The NICNAS assessment determined that there was no unreasonable risk to the public when used at these concentrations.
  • A margin of exposure (MoE) value of ≥ 100 was considered acceptable to account for intra- and inter-species differences. Using an NOAEL of 300 mg/kg bw/day, which was derived from a 28-day, oral repeat dose toxicity study in rats and an estimated exposure value of 1.756 mg/kg bw/day from use of the chemical in cosmetic and household products, a MoE of 171 was estimated.
  • The chemical has been early listed on to the Australian Inventory of Chemical Substances (AICS) at the request of the notifier and is therefore currently available for use by introducers other than the original notifier.
Delegate's reasons for referring this to the committee

The previous ACCS has considered a number of fragrance chemicals referred from NICNAS. For chemicals with a low toxicity profile and likely to be present at quite low concentrations in products in the retail market, the ACCS has advised that there is insufficient public health risk to warrant inclusion in a schedule of the SUSMP. At the November 2014 ACCS, there were five fragrance chemicals that generated such advice. At the November 2013 and July 2014 ACCS meetings, similar advice was offered in relation to two other fragrance ingredients. However, at the July 2014 meeting, ACCS advice in relation and one other fragrance chemical (4,4-dimethyl-1-cyclohexene-1 propanal) was to list it is Schedule 6, with exempt cut-offs at 0.1% to 1% for various cosmetic and other product types. The different ACCS advice appears to be related to the severity of the toxicity potential of the pure compound, with 4,4-dimethyl-1-cyclohexene-1 propanal recommended a Schedule 6 listing because of the severity of the skin/eye irritancy potential and sensitization potential.

The delegate asked the committee the following questions:

  • Does the ACCS consider that the toxicological profile of cyclopentanepropanol, α,α-dimethyl- is sufficiently similar to the seven fragrance chemicals where no scheduling action was recommended, or is it more like 4,4-dimethyl-1-cyclohexene-1 propanal, where listing in Schedule 6 was recommended, along with different product-related exemption cut-offs?
  • If scheduling is recommended, is the chemical name cyclopentanepropanol, alpha,alpha-dimethyl- the preferred name for listing (or some other name)?
  • Does the ACCS support different exempt cut-offs for a Schedule 6 entry for different product types, as proposed in the NICNAS report?
Substance summary

Please refer to the New Chemical assessment report for cyclopentanepropanol, alpha,alpha-dimethyl. This report is publicly available on the NICNAS website:

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Acute toxicity

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

Toxicity Species Cyclopentanepropanol, alpha,alpha-dimethyl- SPF Classification
Acute oral toxicity LD50 (mg/kg bw) Rat > 2,000 None
Acute dermal toxicity LD50 (mg/kg bw) Rat > 2,000 None
Acute inhalational toxicity LC50 (mg/m3/4h) Not provided Not provided -
Skin irritation Rabbit Slight irritant Consistent with Schedule 5
Eye irritation Rabbit Irritant Consistent with Schedule 6
Skin sensitisation (Local lymph node assay) Mouse No evidence of sensitisation None
Repeat dose toxicity

A 28-day repeat dose study by oral gavage was conducted in rats with the notified chemical at dose levels of 30, 300 and 1000 mg/kg/day. Changes in liver weights and body weight gain along with histopathological findings in the high dose group were considered to be adverse and hence the lower dose of 300 mg/kg bw/day was chosen as the No Observed Adverse Effect Level (NOAEL) for systemic toxicity.

Mutagenicity

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

Genotoxicity

The chemical was not clastogenic in an in vitro mammalian chromosome aberration test.

Carcinogenicity

No information was provided.

Reproduction and developmental toxicity

No information was provided.

Observation in humans

No information was provided.

Public exposure

There will be diffuse and repeated exposure of the public to the chemical (at ≤ 1% concentration) through the widespread use of household products and both rinse-off and leave-on cosmetic products. The principal route of exposure will be dermal, while ocular and inhalation exposure is also possible, particularly if products are applied by spray.

International regulations

No information was provided.

Scheduling status

Cyclopentanepropanol, alpha,alpha-dimethyl- is not specifically scheduled.

Scheduling history

Cyclopentanepropanol, alpha,alpha-dimethyl- has not been previously considered for scheduling; therefore, scheduling history is not available. However, for the one fragrance ingredient where the ACCS did recommend scheduling (see delegates reasons for referral below), the wording used in the listing was:

Schedule 6 – New Entry

4,4-DIMETHYL-1-CYCLOHEXENE-1-PROPANAL except:

  1. in leave-on cosmetic preparations containing 0.1 per cent of less of 4,4-dimethyl-1-cyclohexene-1 propanal;
  2. in rinse-off cosmetic preparations containing 0.5 per cent of less of 4,4-dimethyl-1-cyclohexene-1 propanal; or
  3. in other preparations containing 1 per cent of less of 4,4-dimethyl-1-cyclohexene-1 propanal.
Public pre-meeting submissions

No public submission was received.

Summary of ACCS advice to the delegate

The committee recommended a new Schedule 5 entry be created for cyclopentanepropanol, alpha,alpha-dimethyl- except in preparations containing 1% or less.

The committee also recommended changing the name from its original reference of cyclopentane, alpha,alpha-dimethylpropanol is CYCLOPENTANEPROPANOL, ALPHA,ALPHA-DIMETHYL-

The committee recommended an implementation date of 1 February 2016.

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 recommendations comprised the following:

  • Meets the criteria for Schedule 5 as an eye irritant.
Delegate's interim decision

The delegate has decided not to accept ACCS advice on this matter. The delegate has decided not to schedule cyclopentanepropanol, alpha,alpha-dimethyl-.

The reasons for the interim decision comprised the following:

The delegate notes that the ACCS advice to include this fragrance ingredient in Schedule 5 is based primarily on the fact that its acute toxicity and skin/eye irritancy potential is consistent with SPF criteria for listing in Schedule 5, and that a 1% exemption cut-off has been proposed. The delegate also notes that this advice is inconsistent with advice previously given by the ACCS in relation to scheduling fragrance ingredients where there are no strong signals of toxicity at expected use concentrations. The delegate has therefore decided to maintain consistency with previous decisions on fragrance ingredients and not to schedule this 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 factors6;
  • 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.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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