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
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.
Halquinol
1. Nomination
Completed
1. Nomination
Phase status: Completed
In 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halquinol in Appendix M of the Standard for the Uniform Scheduling of Drugs and Poisons, as the toxicological data were outdated and insufficient to establish a no-effect level for halquinol and hence establish an acceptable daily intake.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
Completed
2. Prioritisation
Phase status: Completed
3. Scoping and work plan
Completed
3. Scoping and work plan
Phase status: Completed
4. Notice of reconsideration
Completed
4. Notice of reconsideration
Phase status: Completed
5. Assessment
Completed
5. Assessment
Phase status: Completed
6. Proposed regulatory decision
Completed
6. Proposed regulatory decision
Phase status: Completed
7. Consultation
Completed
7. Consultation
Phase status: Completed
8. Final regulatory decision
Completed
8. Final regulatory decision
Phase status: Completed
In 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.