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2 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #4, March 2019)
2.1. Interim decision in relation to Polymer in Durazane 1500
Interim decision:
Pursuant to regulation 42ZCZN of the Regulations, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in regards to Polymer in Durazane 1500. The delegate of the Secretary made the decision to use the chemical names, cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, in the Poisons Standard as follows:
Schedule 7 - New Entry
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes except when included in Schedule 6.
Schedule 6 - New Entry
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes when presented in a wipe and when packaged in a container with a child-resistant closure, with chemical resistant gloves and labelled with the words "Do not use without protective gloves. Keep out of eyes".
Appendix E, Part 2 - New Entry
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes
Standard statements: 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]; E2 (If in eyes, hold eyelids apart and flush the eye continuously with running 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.); S1 (If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.)
Appendix F, Part 3 - New Entry
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes
Warning Statements: 2 (Corrosive); 10 (May produce severe burns); 78 (Attacks skin and eyes).
Safety directions: 1 (Avoid contact with eyes); 4 (Avoid contact with skin); 5 (Wear protective gloves when mixing or using.) 35 (Wash gloves thoroughly, immediately after use.).
Index - New Entry
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes
Schedule 7
Schedule 6
Appendix E, Part 2
Appendix F, Part 3
In addition a new listing should be created in Part 2 - Control on medicines and poisons, section 2.4 - child-resistant closures as follows:
cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes when included in Schedule 6, when presented in a wipe
Nominal capacity: All sizes
Proposed date of effect of the proposed amendment: 1 October 2019
Reasons for the interim decision (including findings on material questions of fact):
I agree with the committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the extent of use; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
In my view, the relevant parts of the SPF, 2018 are the Scheduling Factors for Schedules 7 and 6, and the considerations for amending Appendix E and F.
Reasons for interim decision:
I find that it is inappropriate to use the propriety name, Polymer in Durazane 1500, for the Poisons Standard entry as this would be inconsistent with current practice. Having considered the advice of the ACCS#24, I have decided that it is more appropriate to use the chemical name, cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, in the Poisons Standard. The reasoning for my interim decision contained herein will refer to cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, instead of Polymer in Durazane 1500.
I have made the decision to Schedule cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes in Schedules 7 and 6 of the Poisons Standard, below I will set out my reasons. I have taken into account the limited toxicological data on the substance provided by the Applicant and I note that this made performing a risk assessment difficult; there are no data on carcinogenicity, mutagenicity or sensitisation; and the genotoxicity data are insufficient. Nevertheless, based on my reading of the available data, the substance has a GHS of H314 (causes severe skin burns and eye damage) classification, and it is on these grounds, that I have determined the substance meets the Scheduling Factors for Schedule 7 in the SPF, 2018.
It is my view that reasonably foreseeable harm to users can be sufficiently reduced such that a Schedule 6 classification is appropriate for the wipes; while the substance alone presents severe dermal and eye hazards from unprotected use, I have reviewed, among other things, the available information on the packaging and presentation of the commercial product. I find that the dangers of the substance are such that special precautions are required in its handling, use and sufficient labelling to identify the risks before it can be allowed onto the domestic market under, Schedule 6, these include but are not limited to:
- distinctive packaging to distinguish it from other domestic wipes used on a neonate or infant, or a cosmetic product for use on the face.
- inclusion of warning labels that 1) gloves should be used; 2) gloves should be washed following use; and 3) to keep out of eyes; and
- child-resistant packaging of the wipes.
There are a few issues in considering this matter that I took into consideration; I have not been provided with the details of the other product ingredients, the packaging of the commercial product could not be confirmed based on the information provided in the application, no data were provided to explain why nitrile gloves specifically should be used with the product in question, and the concern as to how likely consumers will re-use the protective gloves given that only one pair is supplied, leading to unprotected use for the remaining wipes and a significant risk of toxicity to consumers. On balance, taking into account the special precautions required in its handling, use and labelling I have decided that a Schedule 6 entry would be appropriate for wipes containing cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes.