Vinclozolin chemical review

In January 1996, the APVMA (then the NRA) began a review of vinclozolin because of concerns about its potential to cause adverse reproductive and developmental effects.

In August 1995, the registrant (BASF) withdrew its products containing vinclozolin from sale in Australia under a voluntary suspension of sales notice. In September 1995, the registrant provided additional toxicological data on vinclozolin to the APVMA for urgent assessment. This followed regulatory concerns in Germany about its endocrine-disrupting effects.

In animal tests, vinclozolin has been found to cause feminisation of developing male rat fetuses in utero by acting on certain hormone receptors (specifically, by acting to block androgen receptors).

In January 1997, the APVMA released the Vinclozolin review final report. The review was based on information obtained from a variety of sources, including scientific studies and other information submitted by the registrant. During the review, the APVMA made no specific requests for submissions but took into consideration submissions received from interested members of the public and organisations.

Following the review of the toxicological data, the APVMA was not satisfied that the existing vinclozolin products could be used safely, concluding that there were potential health risks associated with the use of these products.

In the final report, the APVMA recommended:

• cancelling the registration of all products containing vinclozolin and associated product label approvals, effective 31 December 1996
• withdrawing all maximum residue limits (MRLs) for vinclozolin, with effect from March 1997.