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Scheduling delegate's final decisions, March 2016

Scheduling medicines and poisons

17 March 2016

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1.2 1,5-Naphthalenediol

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

1. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#15)

1.2 1,5-Naphthalenediol

Scheduling proposal

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

  • To create a new entry for 1,5-naphthalenediol in Schedule 6 to include use in hair dyes and eyelash containing products with an appropriate cut-off.
Scheduling application
  • In August 2015, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under its Inventory Multi-tiered Assessment and Prioritisation (IMAP) assessment programme, referred the proposal to be considered by the delegate for inclusion in the Poisons Standard.

The reasons for the request were:

  • The chemical has reported cosmetic use in permanent hair dye preparations in Australia;
  • The chemical is a moderate to strong skin sensitiser; and
  • The overseas restrictions for use of this chemical in hair dyes (the maximum concentration allowed in an oxidative hair dye substance is 1 % or 0.5 % when used in combination with hydrogen peroxide).
  • The critical health effect for risk characterisation is skin sensitisation. Given the potential for induction and elicitation of sensitisation even below the overseas restriction cut-off, the risk would be better controlled by inclusion of warning statements on the labels of preparations containing the chemical below the concentration cut-off. This chemical has similar use and hazard profiles to a number of chemicals which have been listed in Schedule 6 with reverse scheduling requirements.
Specific issues/questions raised by the delegate

The delegate asked the committee the following questions:

  • Does the ACCS agree that the toxicological profile of 1,5-napthalenediol (acute toxicity, negative mutagenicity and sensitisation potential) warrants controls over use in cosmetics and consumer products?
  • What weight should be given to the evidence of moderate to severe skin sensitisation potential? Does the data suggest a suitable cut-off for the sensitisation potential?
  • Does the ACCS consider that including 1,5-naphthalenediol in Schedules 6 is the best option for controlling its use in consumer products and cosmetics, including hair dyes and eyebrow/eyelash products? Should there be a cut-off to exempt at 1%, as suggested in the NICNAS report? Should this cut-off be adjusted to 0.5% when in combination with hydrogen peroxide?
  • If the ACCS recommends listing in Schedule 6, should exemptions apply when the product is labelled with appropriate warning statements, consistent with other oxidative hair dye ingredients with similar toxicological profiles?
  • Given that there may be some commercial uses other than in cosmetics, should a Schedule 6 listing be specific for use in hair dyes or cosmetic products (as for some other hair dye ingredients)?
  • What name should be used for any schedule entry - 1,5-naphthalendiol or 1,5-dihydroxynaphalene?
  • Is there a need for specific entries in Appendices E & F to manage labelling of scheduled products?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for 1,5-napthalenediol. This report is publicly available on the NICNAS website.

Chemical structure of 1,5-napthalenediol

Figure 2. Chemical structure of 1,5-napthalenediol

Acute toxicity

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

Toxicity Species 1,5-naphthalenediol SPF* Classification
Acute oral toxicity LD50 (mg/kg bw) Rat 660 or >2000 Schedule 5 or 6
Acute dermal toxicity LD50 (mg/kg bw) N/A No data -
Acute inhalational toxicity LC50 (mg/m3/4h) N/A No data -
Skin irritation Rabbit Mild irritant Schedule 5
Eye irritation Rabbit Irritant Schedule 5
Skin sensitisation (local lymph node assay) Mice Moderate to severe skin sensitiser (EC3 = 3.4 %) Schedule 6

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

Sensitisation

A local lymph node assay (LLNA) was performed according to the Organisation of Economic Co-operation and Development test guideline (skin sensitisation) using female CBA/J mice. Various concentrations of 1,5-naphthalenediol were assessed across two experiments. The following stimulation index (SI) values were generated for these concentrations (% / SI): 0.25 / 1.4; 1 / 2.5; 2.5 / 2.8; 5 / 18.4; 25 / 16.7; 50 / 6.1. The estimated concentration required to produce a three-fold increase in lymphocyte proliferation (EC3) was calculated to be 3.4 %. Therefore, under these test conditions, 1,5-naphthalenediol was found to be a moderate to severe skin sensitiser.

Repeat-dose toxicity

Based on the data available, the chemical is not expected to cause serious damage to health from repeated oral exposure. No information was available for repeated dose toxicity by dermal and inhalation routes.

Genotoxicity

Based on the negative results observed in several in vivo genotoxicity studies, the chemical is not expected to be genotoxic.

Carcinogenicity

No data are available.

Reproduction and developmental toxicity

Based on the available data, the chemical is not expected to have developmental toxicity. No data are available on reproductive toxicity.

Public exposure

The chemical is reported to be used in oxidative hair dye preparations in Australia. Internationally, the chemical is reported to be used in oxidative and non-oxidative hair dye preparations.

Following a safety evaluation, the Scientific Committee on Consumer Products (SCCP) (2010) concluded that "1,5-naphthalenediol, as an ingredient in oxidative and non-oxidative hair dye formulations; at a maximum on-head concentration of 1 % does not pose a risk to the health of the consumer, apart from its sensitising potential."

Currently, there are no restrictions in Australia on using this chemical in cosmetics/hair dyes or eyelash colouring products. In the absence of any regulatory controls, the characterised critical health effects (skin sensitisation) have the potential to pose an unreasonable risk to public under the uses identified.

International regulations

Many countries, including New Zealand, the European Union (EU) and the Association of Southeast Asian Nations (ASEAN) have restricted the use of this chemical in cosmetics.

The chemical is listed on the following:

  • EU Cosmetics Regulation 344/2013 Annex III - List of Substances which cosmetic products must not contain except subject to the restrictions laid down (maximum authorised concentration in the finished cosmetic product is 1.0 % or 0.5 % when used in combination with hydrogen peroxide);
  • New Zealand Cosmetic Products Group Standard - Schedule 5 Components cosmetic products must not contain except subject to the restrictions and conditions laid down; and
  • The ASEAN Cosmetic Directive Annex III - Part 1 List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down.

In the EU, it is mandated that products containing the chemical at any concentration have warning labels indicating that the product can be allergenic.

Scheduling status

N/A

Scheduling history

1,5-naphthalenediol has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

One public submission was received.

No objections to aligning with EU were raised. It was noted in the submission that it is important to maintain "in-use" concentrations for hair dye preparations, due to the mode of use being mixing with an oxidising substance prior to use.

The public submission is available at Public submissions on scheduling matters.

ACCS advice to the delegate

The Committee recommended that new Schedule 6, Appendix E and Appendix F entries be created for 1,5-naphthalenediol with exemptions and cut-offs as follows:

Schedule 6 - New Entry

1,5-NAPHTHALENEDIOL except:

  1. in non-oxidative hair dye preparations containing 1 per cent or less when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height; or

  2. in oxidative hair dye preparations containing 1 per cent or less after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height.

Appendix E - New Entry

1,5-NAPHTHALENEDIOL

Part 1, Standard Statements: A, E1, S1

Appendix F - New Entry

1,5-NAPHTHALENEDIOL

Part 1, Warning Statement: 28

Part 2, Safety Directions: 1

The committee recommended an implementation date of 1 June 2016.

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

The reasons for the recommendations comprised the following:

  • The substance is used in hair dye products
  • The substance is a moderate skin sensitiser and therefore meets the criteria for inclusion in Schedule 6
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors2;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is to create new Schedule 6, with appropriate exemption and cut-off, Appendix E and Appendix F entries for 1,5-naphthalenediol.

Oxidative hair dyes of the aromatic diamine and aminophenolic classes have some common toxicological properties that warrant controls over scheduling. These features are primarily skin-eye irritancy and sensitization potential. These toxicological properties generally align with SPF criteria for listing in Schedule 6. Several of these dyes (e.g. phenylenediamines, toluenediamines; aminophenols) have already been listed in Schedule 6, but previous scheduling policies have allowed for some products to be exempted where there are label statements warning of the potential for skin irritancy and sensitization, and recommending testing for individual susceptibility before use. This approach is commonly called 'reverse scheduling'. Where there is potential mutagenicity, or the need to prevent uses for skin colouration (tattooing) or use to dye eyebrows or eyelashes, some of these substances have been listed in Schedule 10 to prevent such uses.

This is one of six oxidant hair dyes that were referred to the November 2015 meeting of the ACCS for advice to the delegate on scheduling. The key issues were whether their toxicological profiles sufficiently match the SPF criteria for inclusion in Schedule 6 and whether product exemptions based on 'reverse scheduling' could be applied, consistent with labelling provisions applied to other oxidative hair dyes. Given that some products containing oxidative hair dyes require mixing with an oxidant, such as hydrogen peroxide, before application to the hair, consideration was given to appropriate exemption cut-off concentrations that take account of the final concentration applied to the hair.

The delegate notes, and accepts, ACCS advice that 1,5-naphthalenediol should be listed in Schedule 6, with an exemption cut-off at 1%, provided products are labelled with the warning statements about potential skin/eye irritation and sensitisation that have been required for similar oxidative hair dyes. The delegate also notes ACCS advice that the potential for eye irritation requires warning statements relating to use for dyeing eyebrows and eyelashes. The INCI name (1,5-naphthalenediol) is the preferred name for listing in the Schedules.

A later implementation date is proposed to allow for an orderly process of re-labelling of products already on the market.

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

Schedule entry
Schedule 6 - New Entry

1,5-NAPHTHALENEDIOL except:

  1. in non-oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height; or

  2. in oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height.

Appendix E - New Entry

1,5-NAPHTHALENEDIOL

Part 1, Standard Statements: A, E1, S1

Appendix F - New Entry

1,5-NAPHTHALENEDIOL

Part 1, Warning Statement: 28

Part 2, Safety Directions: 1

Public submissions on the interim decision

One submission was received. The submission supported the delegate's interim decision.

Edited versions of public submissions are available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submission 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.

Schedule entry

1,5-NAPHTHALENEDIOL except:

  1. in non-oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height; or

  2. in oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

    Written in letters not less than 1.5 mm in height.

Appendix E - New entry (Part 2)

1,5-NAPHTHALENEDIOL

Standard Statements: A, E1, S1

Appendix F - New Entry (Part 3)

1,5-NAPHTHALENEDIOL

Warning Statement: 28

Safety Directions: 1

The proposed implementation date is 1 October 2016.


Footnotes

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

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