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Scheduling delegate's final decisions, March 2016

Scheduling medicines and poisons

17 March 2016

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1.5 2,7-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)

1.5 2,7-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 2,7-naphthalenediol in Schedule 6 to include use in hair dyes and eyelash colouring products with an appropriate cut-off.
Scheduling application

In April 2015, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under its Inventory Multi-tiered Assessment and Prioritisation (IMAP) 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 skin sensitiser;
  • the chemical is a severe eye irritant;
  • lack of data on acute or repeated dose dermal and inhalation toxicity; and
  • the overseas restrictions for use of this chemical in hair dyes state that the maximum concentration allowed in an oxidative hair dye substance is 1.0 % after mixing with hydrogen peroxide.

The critical health effect for risk characterisation is skin sensitisation. Given the potential for induction and elicitation of skin sensitisation even below the allowed overseas concentration cut-off, the risk would be better controlled by inclusion of warning statements on the label of preparations containing the chemical below the concentration cut-off. The 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 2,7-napthalenediol (acute toxicity, negative mutagenicity, skin-eye irritancy and sensitisation potential) warrants controls over use in cosmetics and consumer products?
  • What weight should be given to the evidence of moderate skin sensitisation potential? Does the data suggest a suitable cut-off for the sensitisation potential?
  • Does the ACCS consider that including 2,7-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 the same 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?
  • Although there are no notified 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 - 2,7-naphthalendiol or 2,7-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 Inventory Multi-tiered Assessment Prioritisation (IMAP) Human Health Tier II Assessment Report for 2,7-napthalenediol and its related compounds. This report is publically available on the NICNAS website.

Chemical structure of 2,7-naphthalenediol

Figure 4. Chemical structure of 2,7-naphthalenediol

Acute toxicity

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

Toxicity Species 2,7-naphthalenediol SPF* Classification
Acute oral toxicity LD50 (mg/kg bw) Rat 2160 Schedule 5
Acute dermal toxicity LD50 (mg/kg bw) N/A No data N/A
Acute inhalational toxicity LC50 (mg/m3/4h) N/A No data N/A
Skin irritation Rabbit Not an irritant N/A
Eye irritation Rabbit Severe irritant Schedule 6
Skin sensitisation (LLNA) Mouse Skin sensitiser (EC3 = 2.8 %) Schedule 6

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

Skin sensitisation

Based on the available data, the chemical is a moderate to strong skin sensitiser.

In a local lymph node assay (LLNA) conducted according to the Organisation for Economic Co-operation and Development (OECD) Test Guideline, the chemical, in a 4:1 mixture of acetone and olive oil, was applied to the dorsal surface of both ear lobes of female CBA/CaOlaHsd mice (five animals/group) once daily for three consecutive days. The chemical at test concentrations of 0.5, 1, 2.5, 5, 25 or 50 % produced stimulation indices (SIs) of 1.6, 1.8, 1.4, 4.5, 12.4 or 4.2, respectively. The effective concentration needed to produce a three-fold increase in lymphocyte proliferation (EC3) was calculated to be 2.8 %, indicating moderate skin sensitisation potential.

Repeat-dose toxicity

Based on the available data, 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 available data from in vitro and in vivo genotoxicity studies, the chemical is not considered to be genotoxic.

Carcinogenicity

No animal toxicity data are available on the carcinogenicity of the chemical.

Reproduction and developmental toxicity

Based on the limited available data, the chemical is not expected to cause reproductive and developmental toxicity.

Public exposure

The chemical is reported to be used in permanent hair dye preparations in Australia. It has use overseas in both oxidative and non-oxidative preparations.

The Association of South East Asian Nations (ASEAN), European Union (EU) and New Zealand have restricted the use of this chemical in cosmetics. Following a safety evaluation, the Scientific Committee on Consumer Safety concluded that the chemical '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 for using this chemical in cosmetic products. In the absence of any regulatory controls, the characterised critical health effects, particularly skin sensitisation, have the potential to pose an unreasonable risk to the public given the identified uses.

International regulations

The chemical is listed on the following:

  • ASEAN Cosmetic Directive Annex III - Part 1: List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down: '(a) the maximum authorised concentration in the finished cosmetic product as a hair dye substance in non-oxidative hair dye products is 1.0%; and (b) after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0%';
  • EU Regulation (EC) No 344/2013 Annex III - List of substances which cosmetic products must not contain except subject to the restrictions laid down: '(a) the maximum concentration in ready for use preparation is 1.0 %; and (b) after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0 %'; and
  • New Zealand Cosmetic Products Group Standard - Schedule 5: Components cosmetic products must not contain except subject to the restrictions and conditions laid down: '(a) the maximum authorised concentration in the finished cosmetic product as a hair dye substance in non-oxidative hair dye products is 1.0%; and (b) after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0%'.

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

2,7-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 the EU requirements were raised. It was noted however that it is important to maintain "in-use" concentrations for hair dye preps, 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 2,7-naphalenediol as follows:

Schedule 6 - New Entry

2,7-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

2,7-NAPHTHALENEDIOL

Part 1: Standard Statements: A, E1, S1

Appendix F - New Entry

2,7-NAPHTHALENEDIOL

Part 1: Warning Statement: 28

Part 2: Safety Directions: 1, 3

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 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.

The reasons for the recommendation comprised the following:

  • The substance is used in hair dye products
  • The substance is a severe eye irritant and 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 factors5;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is accept the advice of the Committee and create new Schedule 6, with appropriate exemption and cut-off, Appendix E and Appendix F entries for 2,7-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 2,7-naphalenediol 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 severe eye irritation requires warning statements relating to use for dyeing eyebrows and eyelashes.

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

2,7-NAPHTHALENEDIOL except:

  1. in non-oxidative hair dye preparations containing 1 per cent or less of 2,7-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 2,7-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

2,7-NAPHTHALENEDIOL

Part 1: Standard Statements: A, E1, S1

Appendix F - New Entry

2,7-NAPHTHALENEDIOL

Part 1: Warning Statement: 28

Part 2: Safety Directions: 1, 3

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
Schedule 6 - New Entry

2,7-NAPHTHALENEDIOL except:

  1. in non-oxidative hair dye preparations containing 1 per cent or less of 2,7-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 2,7-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 - (Part 2) New Entry

2,7-NAPHTHALENEDIOL

Standard Statements: A, E1, S1

Appendix F - (Part 3) New Entry

2,7-NAPHTHALENEDIOL

Warning Statement: 28

Safety Directions: 1, 3

The proposed implementation date is 1 October 2016.


Footnotes

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

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