Completed
Halquinol (5, 7-dichloro-quinolin-8-ol) is an antimicrobial used as a feed additive for poultry and as a pig growth promotant. It is also used for the control and treatment of non-specified diarrhoea, particularly in pigs.
Work plan
Work plan
Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.
Chemicals
- Halquinol
1. Nomination
1. Nomination
Phase status
CompletedIn July 1993, the National Health and Medical Research Council reconsidered halquinol because of toxicological concerns and the potential risk to human health from dietary residues.
In December 1993, the National Drugs and Poisons Scheduling Committee (NDPSC) of the National Health and Medical Research Council placed halquinol in Appendix M of the Standard for the Uniform Scheduling of Drugs and Poisons, as the toxicological data were outdated and insufficient to establish a no-effect level for halquinol and hence establish an acceptable daily intake.
In August 1994, the NDPSC assessed new halquinol data provided by the registrant, Ciba-Geigy Ltd. The NDPSC concluded that there were insufficient toxicological data to support the continued use of halquinol in veterinary products. The committee recommended that halquinol remain in Appendix M and that the APVMA review the registration of halquinol and the approvals of all products containing it.
In November 1994, the registrant advised that they had voluntarily ceased marketing all products containing halquinol and would phase out all existing stocks. In November 1994, the APVMA conducted a special review of halquinol based on the NDPSC’s recommendation, and formally consolidated all previous regulatory actions.
2. Prioritisation
2. Prioritisation
Phase status
Completed
3. Scoping and work plan
3. Scoping and work plan
Phase status
Completed
4. Notice of reconsideration
4. Notice of reconsideration
Phase status
Completed
5. Assessment
5. Assessment
Phase status
Completed
6. Proposed regulatory decision
6. Proposed regulatory decision
Phase status
Completed
7. Consultation
7. Consultation
Phase status
Completed
8. Final regulatory decision
8. Final regulatory decision
Phase status
CompletedIn March 1996, the APVMA completed the special review of halquinol but did not publish a final report, as the registrant had withdrawn all products before the completion of the review. The APVMA found that there were insufficient toxicological data to support the continued registration of halquinol or the associated maximum residue limits (MRLs).
In the report, the APVMA recommended:
- cancelling the active constituent approval for halquinol, with effect from 31 March 1996
- cancelling the MRLs for halquinol, with effect from 31 March 1996
- cancelling the registrations of all products containing halquinol, with effect from 31 March 1996.
The APVMA’s concerns about halquinol remain, and it will not consider the registration of any product containing halquinol unless all the concerns identified in the review are fully addressed.
No veterinary products containing halquinol are currently registered in Australia for the treatment of food-producing animals.