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					                                                                ADVICE SUMMARY
                                    APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:               PYRIMIDE 3-WAY COMBINATION DRENCH FOR SHEEP
Applicant:                  ARGENTA MANUFACTURING LIMITED
Product number:             62099
Application number:         42334

Purpose of Application and Description of Use: Registration and approval of the associated labels of a 0.8g/L Abamectin, 25.5g/L Levamisole (as
                       levamisole hydrochloride) 20g/L Albendazole, 1.76g/L cobalt (as cobalt EDTA) and 0.4g/l Selenium (as sodium selenate) mineralised
                       antiparasitic drench for use in sheep.


Active Constituent(s):      Abamectin, Levamisole (as levamisole hydrochloride), Albendazole,
                            Cobalt (as cobalt EDTA), and Selenium (as sodium selenate)

Regulatory Decision:
To grant the application subject to the following conditions:

Standard Conditions of Registration/Approval
    1.   Containers must meet AgVet Code Regulation 18
    2.   Shelf Life - Label must contain an expiry date
    3.   Product must not be supplied without meeting GMP Requirements
    4.   Label must contain an Expiry Date and Batch Number
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.

Non-Standard Conditions of Registration/Approval




42334                                                                    Page 1 of 5                                         KP25S_F39 Version: 2 Issued: 14/08/2007
ADVICE

Australian Government Department Of Health And Ageing, Office Of Chemical Safety
   No new toxicological assessments were required. Abamectin, albendazole and levamisole hydrochloride at levels present in the formulation are Schedule 5 Poisons. Each of these
   constituents have established ADIs and NOELs. Abamectin also has an established ARfD (0.005 mk/kg BW/day). Cobalt EDTA, with no established upper safe level, is unscheduled.
   The inclusion of sodium selenite in the formulation, with no ADI or ARfD and an upper safe level of 400 mcg/day, causes the product to labelled as a Schedule 6 POISON.

   New safety Directions were required for levamisole LD 35g/L or less with albendazole 20 g/L or less and abamectin 1 g/L or less. The most likely routes of exposure were considered to be
   dermal (including repeat dose) and ocular (especially in the event of a spill). Abamectin is considered the most toxic inclusion in the formulation with an oral LD50 in rats of 10.6-11.3
   mg/kg. First Aid and Safety Directions have been recommended and included on the label (see below)

   The following two risk statements were recommended in the OCS report (folio 1/65) and appear on the MSDS
        R 61: May cause harm to the unborn child
        R 21: Harmful in contact with skin

   No Re-handling interval was required for an orally administered product. No Warning Statements and General Safety Precautions were recommended.

   Appropriate label First Aid and Safety Directions have been recommended by Office of Chemical Safety to mitigate the risks of handler exposure. These have been incorporated in
   approved labels as follows:

        First Aid Instructions:
        If poisoning occurs, contact a doctor or Poisons Information Centre Phone Australia 131126; New Zealand 0800 764 766
        If skin contact occurs, remove contaminated clothing and wash skin thoroughly

         Safety Directions:
         Harmful if inhaled. Poisonous if swallowed. May irritate eyes and skin. Avoid contact with eyes and skin. When opening and using the product, wear elbow-length chemical
        resistant gloves. Wash hands after use. After each day’s use wash gloves

    It was concluded that use of the product according to label instructions would not be an undue hazard to the safety of people exposed to it during its
    handling or people using anything containing its residues.




42334                                                                                    Page 2 of 5                                                        KP25S_F39 Version: 2 Issued: 14/08/2007
APVMA Chemistry And Residues Program, Residues Team
   The initial residues evaluation provided support for existing residues definitions for the three principal actives and recommended no changes to the associated MRLs. A 14 day WHP for
   meat was also supported. However a minimum re-treatment interval could not be recommended and the proposed milk WHP and proposed 14 day ESI could not be supported.

   Additional residues data was later submitted resulting in an amended report. Evaluation of that data resulted in confirmation of residues definitions, MRLs and a meat WHP of 14 days. A
   retreatment interval of 42 days and an ESI of 42 days were also recommended. Appropriate label statements to cover these recommendations appear on the approved label.

   The initial residues evaluation identified a potential for detectable abamectin residues to unduly prejudice Australia’s export trade in sheep meats and the live sheep trade. Initially an
   appropriate ESI was unable to be recommended. Because there were no abamectin MRLs for sheep meats and offal in South Africa, Taipei, Middle Eastern countries and Codex the “end
   point” in “target tissues” was considered to be the Limit of Quantitation (LOQ). Further residues data was required to address this issue.

   Evaluation of additional residues data concluded that a period of 42 days was required for abamectin residues in liver and fat to fall below LOQ. An ESI of 42 days was then
   recommended.

   It was further concluded that use of the product according to label instructions would not be likely to unduly prejudice Australia’s export trade in sheep meat, sheep offal or live sheep.

Data relied on to provide the advice
                                                                                                                                                                                                  Inherited
Data     Data               Author(s)                                  Title                                Date          Data Type                Data Sub-type              Authorising        Application
No       Source*                                                                                                                                                                Party                No.
18459    S          M. ChambersB.              Determination of the Tissue Residues of                    Apr-07   Residues                   Animal Commodity             Applicant
                    CurtinD. Chandler          Abamectin in Sheep Following Oral                                                              Residues Direct
                                               Administration of TRITON-A, a Sheep Drench                                                     Application
                                               Containing Three Anthelmintic Actives
25366    S          B. Chick. M                A tissue residue study to confrim appropriate              Apr-08   Residues                   Other Information            Applicant
                    Chambers. J.               with-holding periods and export slaughter
                    Carnevale.                 intervals for Triton-A; a sheep drench containing
                                               three athelmintic actives. Addendum Report




42334                                                                                       Page 3 of 5                                                            KP25S_F39 Version: 2 Issued: 14/08/2007
State/External Efficacy Reviewer
   Efficacy of the product was evaluated by an external (state based) reviewer. The trials were considered to be well conducted and that their analysis was appropriate. A total of nine studies
   were submitted and relied upon. It was concluded that the submitted data collectively demonstrated that Pyrimide 3-way Combination Drench for Sheep was equivalent to the reference
   product Triton Multiphase Liquid for Sheep. Broad Spectrum Oral Antiparasitic with Selenium and Cobalt, in terms of efficacy against a range of common nematodes infecting sheep
   (including in the presence of known resistance to one or more of the principle active constituents). The observed efficacy conclusions have been translated to appropriate label claims.

   No new data in respect to the inclusion of selenium and cobalt in this product were included in the submission.

   Target animal safety was also evaluated by an external (state based) reviewer. One study was submitted and relied upon. That study was considered to be well conducted and analysed
   appropriately. The trial included data on double dosing of young lambs (3-6 weeks old and weighing 10-15 kg). Relatively small numbers of lambs were included. No adverse clinical
   affects were observed. The reference product label currently shows a Restraint against the use of the product in lambs under 6 weeks of age. The applicant has agreed to include a similar
   limitation referring to young/low weight lambs as a Precaution on the product label.

   It was concluded that use of the product according to label instructions would be effective and not be likely to have an unintended effect to the target animals.

Data relied on to provide the advice
                                                                                                                                                                                                  Inherited
Data     Data               Author(s)                                  Title                                Date          Data Type                Data Sub-type              Authorising        Application
No       Source*                                                                                                                                                                Party                No.
18464    S          D. RendellD.               Investigation of the relative performance in a             Nov-06   Efficacy and Safety        Efficacy                     Applicant
                    Chandler                   (Faecal) worm egg count reduction test
                                               (WECRT) of multiple-active drenches
                                               containing abamectin and ivermectin
18465    S          D. RendellD.               A field investigation of the relative performance          Nov-06   Efficacy and Safety        Efficacy                     Applicant
                    Chandler                   in a (faecal) worm egg count reduction test
                                               (WECRT) of multiple-active drenches
                                               containing abamectin or ivermectin
18460    S          D. RendellD.               Investigation of the relative persistence of               Oct-05   Efficacy and Safety        Efficacy                     Applicant
                    Chandler                   abamectin and ivermectin in combination
                                               drenches
18466    S          D. RendellD.               Investigation of the relative efficacies in a              Nov-06   Efficacy and Safety        Efficacy                     Applicant
                    Chandler                   (faecal) worm count reduction test (WECRT) of
                                               multiple-active drenches containing abamectin
                                               or ivermectin, with and without praziquantel




42334                                                                                       Page 4 of 5                                                            KP25S_F39 Version: 2 Issued: 14/08/2007
18462   S        M. VenningD.          Efficacy of triple active formulations on                 Sept-06   Efficacy and Safety   Efficacy                 Applicant
                 Chandler              gastrointestinal parasites in sheep
18467   S        C. CooperM.           Investigation of the relative efficacy of                 Apr-07    Efficacy and Safety   Efficacy                 Applicant
                 ChambersD. Chandler   abamectin and ivermectin- containing versions of
                                       TRITON
18461   S        M. VenningD.          Efficacy of triple active anthelmintic                    Aug-06    Efficacy and Safety   Efficacy                 Applicant
                 Chandler              formulations in the treatment of gastrointestinal
                                       parasites of sheep
18463   S        D. ChandlerS. Moran   Field evaluation of two multiple-active oral              Nov-06    Efficacy and Safety   Efficacy                 Applicant
                                       anthelmintics for sheep by WECRT
18468   S        M. VenningA           A field study to evaluate the tolerance and safety        Nov-06    Efficacy and Safety   Target Animal Safety     Applicant
                 Familton              of two prototype oral triple active combination                                           Studies
                                       anthelmintic formulations in suckling (pre-
                                       ruminant) lambs




* S = Data submitted with the application
  I = Data inherited (that is, referenced) from another application




42334                                                                              Page 5 of 5                                                    KP25S_F39 Version: 2 Issued: 14/08/2007

				
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