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Scheduling delegate's final decisions, June 2016
Scheduling of medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
4. Agriculture and veterinary chemicals
Delegate's Scheduling proposal
In April 2016 the Office of Chemical Safety (OCS), based on an application made to the Australian Pesticides and Veterinary Medicines Authority (APVMA), referred the following scheduling proposal to be considered by the delegate:
- A proposal to consider a positive listing of cyclaniliprole in Appendix B of the SUSMP for agricultural use, based on the low toxicity of the substance.
The applicant, as part of an application to the APVMA, submitted a data package seeking approval of the new active constituent cyclaniliprole and registration of a new product ISK Cyclaniliprole 50 SL Insecticide, containing 50 g/L cyclaniliprole in a soluble concentrate formulation. Cyclaniliprole is a ryanodine receptor modulator and part of the anthranilic diamide class of chemicals. As a new chemical for AgVet use, it will require consideration by the Delegate/ACCS for SUSMP listing prior to final registration of products containing this active constituent. The applicant for registration of the product did not propose a schedule for cyclaniliprole as part of the application.
The proposed product ISK Cyclaniliprole 50 SL Insecticide is intended to be used as an insecticide for the control of codling moth in apples.
Figure 14: Chemical structure of cyclaniliprole
|Acute oral toxicity LD50 (mg/kg bw)||Rat and mice||LD50 > 2000 (no deaths)||Appendix B|
|Acute dermal toxicity LD50 (mg/kg bw)||Rat||LD50 > 2000 (no deaths)||Appendix B|
|Acute inhalational toxicity LC50 (mg/m3/4h)||Rat||LC50 > 4620 (no deaths)||Appendix B|
|Skin irritation||Rabbit||Non-irritant||Appendix B|
|Eye irritation||Rabbit||Non-irritant||Appendix B|
|Skin sensitisation||Guinea pig (GPMT)
*Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)
|Toxicity||Species||ISK Cyclaniliprole 50 SL Insecticide|
|Acute oral toxicity LD50 (mg/kg bw)||Rat||LD50 > 2000 (no deaths)|
|Acute dermal toxicity LD50 (mg/kg bw)||Rat||LD50 > 2000 (no deaths)|
|Acute inhalational toxicity LC50 (mg/m3/4h)||Rat||LC50 > 5050 (no deaths)|
|Eye irritation||Rabbit||Slight irritant|
|Skin sensitisation||Guinea pig (Buehler)
The change in eye irritation potential for ISK Cyclaniliprole 50 SL Insecticide is likely due to the product excipients rather than the active constituent.
Low systemic toxicity effects were observed with cyclaniliprole in all dietary studies in rats and mice. Dogs appeared to be the more sensitive species compared to rodents, with relatively low NOAELs (~4 mg/kg bw/d) based on toxicologically significant changes in liver weights and clinical chemistry (notably ALP and albumin levels) at higher dose levels.
No treatment related adverse effects were seen in a short-term rat dermal study at the limit dose.
Genotoxicity and mutagenicity
There was no evidence of a mutagenic/genotoxic potential in vitro with and without metabolic activation, or a genotoxic potential in vivo.
No increased incidence was seen in any tumour type in male or female mice in a 78-week dietary study or in male or female rats in a 2-year dietary study.
Reproduction and developmental toxicity
There was no evidence of reproductive or developmental toxicity in the two-generation reproduction study in rats, or in the developmental studies in rats and rabbits.
Neurotoxicity and immunotoxicity
No evidence of an acute neurotoxic effect was observed in functional observation battery or motor activity assessment in the acute and repeat dose neurotoxicity studies at or up to limit dose of cyclaniliprole.
Cyclaniliprole was not immunotoxic in female mice.
Observation in humans
No information was provided.
No information was provided.
Cyclaniliprole is currently under consideration by EFSA, US EPA and Health Canada. No published regulatory decisions from these agencies have been found as of the preparation of this paper, though EFSA has undertaken a public comment process in 2015 on a draft assessment report for cyclaniliprole.
CYCLANILIPROLE is not specifically scheduled.
CYCLANILIPROLE has not been previously considered for scheduling; therefore, scheduling history is not available.
Delegate's interim decision
The delegate's interim decision is to create a new Appendix B entry for cyclaniliprole as follows:
Appendix B - New Entry
Reason for listing: a (low toxicity)
Area of use: 1.2 (Insecticide)
The proposed implementation date is 1 October 2016.
The reasons for the interim decision comprised the following:
- The OCS evaluation suggests a low toxicity profile for the specific product that does not meet any of the SPF criteria for listing in the Schedules.
- It meets criteria for a positive listing in Appendix B of the SUSMP for agricultural use, based on its low toxicity.
The delegate considered the relevant matters under subsection 52E (1) of the Therapeutic Goods Act 1989: (a) the 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 of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
The delegate considered the following in regards to this proposal:
- Scheduling proposal;
- OCS evaluation report
- Section 52E of the Therapeutic Goods Act 1989;
- Scheduling factors24;
- Other relevant information.
Submissions on the interim decision
The applicant had no objections to the Delegate's interim decision.
Delegate's final decision
The delegate notes the submission from the applicant supporting the interim 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. The implementation date is 1 October 2016.