Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, November 2016

Scheduling medicines and poisons

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2 February 2017

1.8 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives

Part A - Interim decisions on matters referred to an expert advisory committee (November 2016)

Advisory Committee on Chemicals Scheduling (ACCS #18)

1.8 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives

Referred scheduling proposal

An application was submitted by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to create a new Schedule 6 entry for 1-deoxy-1-(methylamino)-d-glucitol N-coco acyl derivatives; to consider if an exemption cut-off for rinse-off cosmetics and household cleaning products is appropriate; and to determine whether an Appendix E listing for 1-deoxy-1-(methylamino)-d-Glucitol N-coco acyl derivatives is required.

Scheduling application

General application.

The applicant's proposed amendments to the Poisons Standard are as follows:

Schedule 6 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES in cosmetic and household cleaning preparations except:

  1. in wash-off preparations containing 5 per cent or more of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives, labelled with warning to the follow effect:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

  2. in preparations containing 30 per cent or more of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives.

Appendix E, Part 2 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Standard statement: E1 (if in eyes wash out immediately with water).

The applicant's reasons for the request are:

  • 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives is a severe irritant as tested in vivo with a GHS hazard classification of Category 1 serious eye damage/eye irritation and a hazard statement of H318 – causes serious eye damage;
  • The substance is used as a surfactant in rinse-off cosmetics at a concentration ≤8% and household cleaning products at a concentration ≤10%. Widespread and repeated public exposure is expected. The finished products include cleansing products for skin/hair, laundry, dishwashing and hard surface cleaning;
  • The NICNAS assessment indicates that the hazard and risk characteristics of the substance conform to Scheduling Policy Framework factors for Schedule 6, specifically severe eye irritation (corneal opacity not reversible in 21 days concurrent with conjunctiva redness, chemosis and discharge);
  • Irreversible eye damage or severe eye irritation effects can occur when consumers use the products containing relatively high concentrations of the substance especially hair/skin cleansing products and come into direct contact with the products in eyes; and
  • Reasonable foreseeable harm to users can be reduced through strong label warnings and extensive safety directions. Setting a concentration cut-off for the substance can protect consumers from serious eye damage. Wash-off preparations containing more than 5% of the substance should be labelled and preparations containing more than 30% of the substance should be included in Schedule 6 even when they are labelled.
Current scheduling status and relevant scheduling history

1-Deoxy-1-(methylamino)-D-Glucitol N-coco acyl derivatives are not currently scheduled and have not been previously considered for scheduling; therefore, a scheduling history is not available.

Australian regulatory information

The public exposure to the substance is widespread and repeated. The principal route of exposure is dermal, while ocular exposure is highly possible. Based on current use proposals, the exposure to the substance is up to 8% concentration in rinse-off cosmetics for skin and hair cleansing and at up to 10% concentration in household cleaning products. Without warnings and appropriate directions, use of above consumer products could result in severe eye irritations to users. Setting a concentration cut-off for the substance used in cosmetics and household products, and providing users with labelling and first aid information could protect consumers.

Substance summary

Structure of 1-deoxy-1-(methylamino)-D-Glucitol N-coco acyl derivatives

Figure 1.8: Structure of 1-deoxy-1-(methylamino)-D-Glucitol N-coco acyl derivatives

Table 1.8A: Substance summary
Property 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives
CAS name D-Glucitol, 1-deoxy-1-(methylamino)-, N-coco acyl derivatives
CAS number 1591783-13-9
IUPAC and/or common and/or other names Cocoyl Methyl Glucamaide (INCI Name)

The following toxicology information was extracted from the NICNAS New Chemical assessment report for D-Glucitol, 1-deoxy-1-(methylamino)-, N-coco acyl derivs (Microsoft Word,132kb).

Table 1.8B: Acute toxicity endpoints for 1-deoxy-1-(methylamino)-D-Glucitol N-coco acyl derivatives
Toxicity Species 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives SPF (2015) Classification
Acute oral toxicity LD50 (mg/kg bw) Rat >2,000 Schedule 5
Acute dermal toxicity LD50 (mg/kg bw) Rat >2,000 None
Acute inhalational toxicity LC50 (mg/m3/4h) Not provided Not provided N/A
Skin irritation In vitro Non-irritating None
Eye irritation Rabbit Severely irritating Schedule 6
Skin sensitisation (LLNA / Buehler etc) Guinea pig No evidence of sensitisation None
Acute toxicity

Based on studies provided, the substance is of low acute oral and dermal toxicity. However, 1 of 3 test animals died of the treatment at 2000 mg/kg bw in the acute oral toxicity study.

Irritation

An in vitro study on eye irritation using bovine corneal opacity and permeability test method indicated that the substance may have potential for eye irritation. Subsequent eye irritation study in rabbits demonstrated that the substance is severely irritating to the eyes. A single ocular application of the substance produced severe irritation effects. These effects included corneal opacity, conjunctiva redness, chemosis and discharge that were not reversible within 21 days after the application in 2 of 3 test animals. The results warranted following classification of the substance under GHS:

Hazard classification Hazard statement
Serious eye damage/eye irritation (Category 1) H318 - Causes serious eye damage
Sensitisation

Guinea pig maximisation test on the substance at up to 5% concentration did not reveal evidence of skin sensitisation.

Repeat-dose toxicity

In a 28 day repeated dose oral toxicity study on the substance, no treatment-related adverse effects were observed in the test animals at any dose tested.

Mutagenicity

The substance tested negative in bacterial reverse mutation assay and in vitro mammalian cell gene mutation tests.

Genotoxicity

The substance tested negative in an in vivo mouse bone marrow micronucleus test via the oral route.

Public exposure

The substance is used as a surfactant-cleaning agent in consumer products with widespread and repeated public exposure. The finished products include cleansing products for skin/hair, laundry, dishwashing and hard surface cleaning.

Pre-meeting public submissions

One (1) pre-meeting submission was received which opposed the scheduling proposal. The main points are in relation to the toxicity and risks of 1-deoxy-1-(methylamino)-D-glucitol N-coco-acyl derivatives; and the scheduling inconsistencies and international regulations of similar surfactants.

Summary of ACCS advice to the delegate

The committee advised that a new Schedule 6 entry be created for 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives with exemptions and cut-offs as follows:

Schedule 6 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES except:

  1. in cosmetic rinse-off preparations containing 8 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER, or

  2. in household cleaning preparations, other than those intended to be sprayed, containing 10 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled with the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER.

The committee also advised appendix and index entries as follows:

Appendix E, Part 2 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Standard statement: E1 (if in eyes wash out immediately with water).

Appendix F, Part 3 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Warning statement: 79 (Will irritate eyes).

Safety direction: 1 (Avoid contact with eyes).

Index - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES
cross reference: cocoyl methyl glucamaide

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The committee recommended an implementation date of 1 June 2017.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; and(d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the advice comprised the following:

  • 1-Deoxy-1-(methylamino)-d-glucitol N-coco acyl derivatives is used as a surfactant.
  • 1-Deoxy-1-(methylamino)-d-glucitol N-coco acyl derivatives is a severe eye irritant, which can be managed by labelling at low concentrations in rinse-off products.
  • The risk of spray products containing 1-deoxy-1-(methylamino)-d-glucitol N-coco acyl derivatives entering the eye is high.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal
  • ACCS advice
  • Public Submissions received
  • Section 52E of the Therapeutic Goods Act 1989
  • Scheduling Policy Framework (SPF 2015)
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is to create a new Schedule 6 entry for 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives with exemptions and cut-offs in cosmetic rinse-off preparations and household cleaning preparations.

The proposed Schedule entry is as follows:

Schedule 6 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES except:

  1. in cosmetic rinse-off preparations containing 8 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER, or

  2. in household cleaning preparations, other than those intended to be sprayed, containing 10 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled with the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER.

Appendix E, Part 2 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Standard statement: E1 (if in eyes wash out immediately with water).

Appendix F, Part 3 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Warning statement: 79 (Will irritate eyes).

Safety direction: 1 (Avoid contact with eyes).

Index - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES
cross reference: cocoyl methyl glucamaide

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

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; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • The delegate acknowledges the committee's advice.
  • 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives is used as a surfactant.
  • 1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives is a severe eye irritant, which can be managed by labelling at low concentrations in rinse-off products.
  • The risk of spray products containing 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives entering the eye is high.
  • Earliest possible implementation date.

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