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Fipronil

Fipronil is a broad spectrum phenyl pyrazole insecticide that is used in both agricultural and veterinary situations.  It controls insect pests in a wide range of agricultural crops, it is used as an insecticidal seed dressing, and it is used for the control of termites, cockroaches and ants in residential and commercial buildings.

In veterinary situations, fipronil products are used as spray or concentrated spot-on formulations to control fleas, ticks and other ectoparasites on dogs and cats, and the products are used for the treatment and control of flea allergy dermatitis.

Fipronil review

Status: review in progress - Preliminary Review Findings available for comment until 2 August 2011.

Fipronil was nominated for review following the receipt of a number of reports of adverse experiences in humans and animals.  Reports primarily involved veterinary chemical products and included skin reactions in animals and humans, neurological signs and deaths in target animals (often involving concurrent infestations with paralysis ticks), and deaths following off-label use in domesticated rabbits.

The APVMA commenced the review of fipronil in September 2003.  The review considered concerns over toxicity, primarily related to skin irritation and induction of skin sensitisation, but also the potential of fipronil to form toxic photodegradation products, occupational health and safety issues, animal safety, and the adequacy of label instructions.

The APVMA has completed the assessments of the data provided for this review and has released the Preliminary Review Findings for public comment. The period for public submissions and the submission of additional information closes on 2 August 2011.

In the preliminary review findings, the APVMA recommends that there should be no change to the approval status of fipronil or to the ongoing registration of existing fipronil products in Australia.  However, some amendments are recommended to the first aid instructions and safety directions for most agricultural and veterinary chemical products.  New or revised re-entry intervals are also recommended for many agricultural uses and a rehandling statement is recommended for veterinary spray products.

Additional warnings are recommended when fipronil products are used on dogs and cats.  This includes warnings about the possibility of skin reactions in dogs and cats treated with the spot-on formulations, avoiding applying fipronil products to ‘non-healthy’ skin, and for the spray, treating animals in open areas, and ensuring they are not placed in confined spaces until the spray has dried.

Fipronil is not recommended for use on non-target animals, especially rabbits.  Additional label warnings concerning off-label use on rabbits are recommended due to the severity of reactions (including death) in this species.

The scope of this current review does not include an assessment of the environmental risks.  However, fipronil has been placed on a priority list for environmental review.

The APVMA will issue a final report once the assessment of all available data is completed.

Review Report Date
Fipronil - Preliminary Review Findings Report (PDF, 1.27Mb) | (DOC, 954kb) June 2011
Safety of Fipronil in Dogs and Cats: a review of literature (PDF, 249kb) | (DOC, 344kb) June 2011
A review of Animal Safety Studies for Fipronil in the dog and cat (PDF, 247kb) | (DOC, 109kb) June 2011

Occupational Health and Safety Assessment of Fipronil (PDF, 1.35Mb) | (DOC, 963kb)

June 2011

Review of the Mammalian Toxicology and Metabolism/Toxicokinetics of Fipronil (PDF, 2.60Mb) | (DOC, 2.13Mb)

June 2011

Contact

For more information contact:

Chemical Review

Phone: +61 2 6210 4749

Fax: +61 2 6210 4874

Email: chemicalreview@apvma.gov.au

Product Search

Search the PUBCRIS database for registered products that contain fipronil.
Note: In the Active Constituent 1 field enter fipronil.

APVMA fipronil archive
Title Date
Gazette Notice: reconsideration of approvals and registrations related to fipronil Oct 2003
Fipronil Review Scope Document (PDF. 77kb) Sep 2003