New Active Constituent: Broflanilide

2019-11-08

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, broflanilide. Broflanilide is a meta-diamide insecticide for controlling social insects and non-social solitary or gregarious insects, such as, ants, wasps, termites and cockroaches. Particulars of the Active Constituent

Common name:

Broflanilide

IUPAC name:

<i>N</i>-[2-Bromo-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-6-(trifluoromethyl)phenyl]-2-fluoro-3-(<i>N</i>-methylbenzamido)benzamide

CAS name:

3-(Benzoylmethylamino)-<i>N</i>-[2-bromo-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-6-(trifluoromethyl)phenyl]-2-fluorobenzamide

CAS registry number:

1207727-04-5

Manufacturer?s codes:

MCI-8007 (BAS 450 I)

Minimum purity:

966.8 g/kg

Molecular formula:

C25H14BrF11N2O2

Molecular weight:

663.3 g.mol-1

Structure:

Structure of broflanilide

Summary of the APVMA’s Evaluation of Broflanilide Active Constituent

The APVMA has evaluated the chemistry aspects of broflanilide active constituent (physico-chemical properties, identification, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable. The APVMA has completed a toxicological evaluation of broflanilide. An Acceptable Daily Intake (ADI) and an Acute Reference Dose (ARfD) have not been set noting that the proposed use patterns do not involve uses on food crops. No toxicologically significant impurities have been identified in technical broflanilide.

A delegate to the Secretary of the Department of Health has made an interim decision to amend the Poisons Standard in relation to broflanilide as follows: A new entry will be made to Schedule 6 to include BROFLANILIDE except when included in Schedule 5. A new entry will be made to Schedule 5 to include BROFLANILIDE in preparations containing 0.3 per cent or less of broflanilide. If the above scheduling recommendations are adopted as final, all of the proposed end-use-products would be captured by the Schedule 5 entry. The final decision of the scheduling delegate is to be published on 28 November 2019. On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for broflanilide:

Specification

Level

Broflanilide

Minimum965 g/kg

Other compounds of toxicological significance are not expected to occur in broflanilide technical active constituent. The APVMA is satisfied that the proposed importation and use of broflanilide would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

Further Information

A Public Release Summary (PRS) of the evaluations of the active and seven products is available from the APVMA website’s ‘Public Consultation’ page.

Making a Submission

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether broflanilide should be approved. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based. Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.

APVMA Gazette, 5 November 2019
; http://www.apvma.gov.au