Download Advice Summary - Product No. 64371, Application No. 48160

ADVICE SUMMARY
APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:
TEMPRID RESIDUAL INSECTICIDE
Applicant:
BAYER CROPSCIENCE PTY LTD
Product number:
64371
Application number:
48160
Purpose of Application and Description of Use: Registration of a 50 g/L imidacloprid, 25 g/L betacyfluthrin suspension concentrate for use in
and around buildings for the control of various nuisance and public health pests.
Active Constituent(s): BETA-CYFLUTHRIN
IMIDACLOPRID
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. Agricultural products must meet Active Constituents Quality Assurance Requirements
3. Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to Standard Conditions for Applications on the APVMA website.
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Page 1 of 7
KP25S_F39 Version: 2 Issued: 14/08/2007
ADVICE
Australian Government Department Of Health And Ageing, Office Of Chemical Safety
The data package provided in support of the submission comprised twelve acute toxicology studies. Six studies were provided on a 125g/L betacyfluthrin
suspension concentrate formulation as a baseline toxicity benchmark, and six studies were provided on an overseas product similar to that for which
Australian registration is sought containing 200g/L imidacloprid, 100g/L betacyfluthrin.
The acute toxicology studies were conducted in accordance with contemporary test guidelines. The submitted studies were considered to be adequate for
the assessment of the toxicology profile of, and the establishment of Safety Directions for, the product.
Betacyfluthrin is a synthetic Type II cyano-pyrethroid, which consists of two biologically active isomer pairs present in the related compound cyfluthrin.
Betacyfluthrin prolongs the inactivation of sodium channels in insect nervous systems causing paralysis and eventual death. The Acceptable Daily Intake
(ADI) for betacyfluthrin was established in 1990 at 0.01 mg/kg bw/day, based on a No Observed Effect Level (NOEL) of 1.5 mg/kg bw/day from a 13 week
dog study and a 100-fold safety factor. No Acute Reference Dose (ARfD) has been established. Betacyfluthrin is in Schedule 7 of the SUSMP, except for
preparations containing 12.5% or less (which are in Schedule 6), and aqueous preparations containing 2.5% or less or solid preparations containing 8% or
less in a plastic matrix (which are in Schedule 5).
Imidacloprid is a systemic insecticide belonging to the chloronicotinyl group. These insecticides inhibit nicotinergic acetylcholine receptors in insects and
block nervous conduction by neuronal membrane depolarisation. The ADI for imidacloprid was established in 1993 at 0.06 mg/kg bw/day, based on a NOEL
of 6mg/kg bw/day from a 2 year rat study and a 100-fold safety factor. No ARfD has been established. Imidacloprid is in Schedule 6 of the SUSMP, except
in preparations containing 20% or less of imidacloprid (which are in Schedule 5) and in preparations containing 5% or less of imidacloprid which are exempt.
Based upon the findings of the toxicological studies evaluated, Temprid Residual Insecticide (Temprid) is expected to be of low acute oral, dermal and
inhalational toxicity. It is predicted to be a slight skin and eye irritant but not a skin sensitiser. Based upon the acute toxicity profile and the schedule
classification of betacyfluthrin, a Schedule 5 listing is considered appropriate for Temprid.
Taking into consideration of the potential toxicogical hazard, use pattern and likelihood of handler exposure the following First Aid and Safety Directions will
appear on the label:
First Aid
If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126; New Zealand 0800 764 766.
Remove from contaminated area. Apply artificial respiration if not breathing.
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KP25S_F39 Version: 2 Issued: 14/08/2007
Safety Directions
New Entry
Statement Codes
Betacyfluthrin
SC 25g/L or less with
imidacloprid 50g/L or less
160 162 160 164 210 211
279 285 282 290 292c 294c
351 360 361 366
The statement codes translate to the following safety directions:
May irritate the skin. May irritate the eyes. Avoid contact with eyes and skin. When preparing the product for use and using the prepared spray, wear cotton
overalls over normal clothing buttoned to the neck and wrist and elbow-length chemical-resistant gloves. Wash hands after use. After each day’s use wash
gloves and contaminated clothing.
Re-entry
Do not enter treated areas until the spray has dried, unless wearing cotton overalls buttoned to the neck and wrist (or equivalent clothing) and chemicalresistant gloves. Clothing must be laundered after each day’s use.
The Office of Chemical Safety concluded that, when used according to label directions, the product would not be likely to have an effect that is harmful to
human beings and would not be an undue hazard to the safety of people exposed to it during its handling, people using anything containing its residues or
during post-use exposure.
Data relied on to provide the advice
Data No
Data
Source*
39080
S
39090
S
«appl_num»
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
D L Warren, M E Gastner
Acute dermal toxicity study with BAY FCR 4545 125 SC
in rats
28/10/96
Toxicology
Acute Dermal Studies,
Product
Applicant
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Acute dermal toxicity study in rats ? limit test
5/12/07
Toxicology
Acute Dermal Studies,
Product
Applicant
Page 3 of 7
Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data No
Data
Source*
Date
Data Type
Data Sub-type
Authorising
Party
39082
S
J L Ivett
Primary eye irritation study in rabbits with BAY FCR
4545 125 SC
25/11/96
Toxicology
Acute Eye Irritation
Studies, Product
Applicant
39088
S
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Primary eye irritation study in rabbits
5/12/07
Toxicology
Acute Eye Irritation
Studies, Product
Applicant
39085
S
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Acute inhalation toxicity study in rats ? limit test
5/12/07
Toxicology
Acute Inhalation Studies,
Product
Applicant
39081
S
J Pauluhn
FCR 4545 125 SC 002: Study for acute inhalation
toxicity to OECD guideline no. 403
12/11/86
Toxicology
Acute Inhalation Studies,
Product
Applicant
39079
S
D L Warren, A T
Halliburton
Acute oral toxicity study with BAY FCR 4545 125 SC in
rats
1/11/96
Toxicology
Acute Oral Studies,
Product
Applicant
39087
S
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Acute oral toxicity up and down procedure in rats
20/1107
Toxicology
Acute Oral Studies,
Product
Applicant
39089
S
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Dermal sensitization study in guinea pigs (Buehler
method)
5/12/07
Toxicology
Acute Skin Irritation
Studies, Product
Applicant
39083
S
A Wakefield
Acute dermal irritation/corrosivity study in rabbits with
BAY FCR 4545 125 SC
25/11/96
Toxicology
Acute Skin Irritation
Studies, Product
Applicant
39084
S
H-W Vohr
FCR 4545 125 SC 002: Study for the skin sensitization
effect in guinea pigs (Buehler patch test)
2/10/00
Toxicology
Acute Skin Sensitisation
Studies, Product
Applicant
39086
S
J Durando
Temprid SC (21% imidacloprid + 10.5% beta cyfluthrin
SC): Primary skin irritation study in rabbits
5/12/07
Toxicology
Acute Skin Sensitisation
Studies, Product
Applicant
«appl_num»
Author(s)
Title
Page 4 of 7
Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Australian Government Department Of Environment And Heritage
No new environmental fate or ecotoxicological data was submitted with this application. In this assessment the Department of Environment, Water, Heritage
and the Arts (DEWHA) used existing information in its data holdings.
Imidacloprid is hydrolytically stable but photodegrades readily in solution. It is at least moderately persistent in aerobic soils. Laboratory aerobic degradation
studies indicate that metabolism of imidacloprid proceeds more rapidly under vegetation (half-life 7 weeks) than in bare soils (first half-life 27-36 weeks). It
appears that anaerobic conditions favour the reductive pathway (half-life 4 weeks) but that the free base formed is persistent in the absence of oxygen.
Adsorption/desorption tests in five soils indicate that imidacloprid does not bind strongly to soils, and may be considered moderately mobile. Its degree of
sorption is dependent on organic matter content of the soil which increases with increasing organic matter content.
The fate of betacyfluthrin, in common with most synthetic pyrethroids, is influenced principally by strong adsorption to soil and sediment with subsequent
microbial metabolism. Synthetic pyrethroids generally exhibit hydrolytic stability, with abiotic hydrolysis only observed in moderate to highly alkaline
conditions. Studies have indicated that on soil surfaces cyfluthrin is extensively degraded by photolytic processes, while once incorporated, the rate of
metabolism mainly depends on the microbial activity of the soil. Betacyfluthrin undergoes conversion to cyfluthrin four days after application into a body of
water. Photolysis contributes to the elimination of cyfluthrin from water. Adsorption and leaching studies indicate that cyfluthrin and its metabolites have low
mobility. Field dissipation studies have indicated a slight to moderate persisitence of cyfluthrin in soils. The half-life of cyfluthrin was determined to be 4-54
days in the laboratory studies and 0.3-40 days in the field.
Imidacloprid is moderately toxic to mammals and moderately to highly toxic to birds. It is practically nontoxic to adult fish and green algae. It has very high
acute toxicity to mysid shrimp and the fresh water amphipod (Hyalella azteca). It has a systemic mode of action when sprayed on plants or used as a seed
dressing and is therefore selective for sucking insects, and to a lesser extent chewing insects. It is highly toxic to earthworms and honeybees. No significant
effects were observed on soil micro-organisms exposed to imidacloprid.
Environmental toxicology of betacyfluthrin and cyfluthrin is similar. Betacyfluthrin is classified as practically non-toxic to birds and slight to moderately toxic to
mammals. It is very highly toxic to fish, aquatic invertebrates and green algae, but green algae can tolerate relatively higher betacyfluthrin concentrations. It
has slight toxicity to earthworms but high toxicity to honeybees. No significant effects were observed on soil micro-organisms exposed to betacyfluthrin.
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KP25S_F39 Version: 2 Issued: 14/08/2007
Risk Assessment
The label states that the product is applied at the rate of 10mL/L by diluting with 5 and 10L of water/100m2, not exceeding the point of run-off, for non-porous
and porous surfaces respectively.
While no combination toxicity data was provided, the risks to non-target organisms is considered to be acceptable due to the limited exposure resulting from
product application. DEWHA recommended the following Restraint be added to the label particulars:
DO NOT apply spray treatment outdoors if heavy rains are expected to occur within 48 hours of application, or if area is about to be irrigated.
DEWHA recommended that the APVMA be satisfied that the proposed uses of Temprid Residual Insecticide would not be likely to have an effect that is
harmful to animals, plants or things or to the environment if the product is applied according to the recommended use pattern.
State/External Efficacy Reviewer
Data from eight USA trials and one Australian trial were submitted. Trials were conducted on a range of pest species including ants (Argentine ant,
Odourous Ant, Carpenter Ant, Pharoah Ant), bedbugs, cockroach (including both German and American cockroach) and spiders (Cellar Spider, Wolf Spider,
Black Widow and Black House Spider). The methodologies used in these laboratory trials are similar using field or laboratory colonies of insects, 4-20
insects/treatment, 3-5 replicates, sprayed either directly or onto substrates by airbrush or similar application. Various substrates were used (glass, tile, wood,
cement, soil) and spray allowed to dry for two hours before insects were introduced. Efficacy was then monitored by observation for percentage knockdown
and/or percentage mortality at intervals.
Australian trials compared the efficacy of the proposed formulation against an industry standard containing betacyfluthrin at the same rate. USA trials
compared straight imidacloprid and betacyfluthrin formulations with a combined imidacloprid/betacyfluthrin formulation. All rates were equivalent to the
proposed label rates.
Results demonstrated commercial control of pest species and showed high percentage knockdown (generally at 1-4 hours) and high percentage mortality at
24 hours. Results demonstrate that efficacy of Temprid is equivalent or superior to the industry standard formulation when applied at the same rate.
The reviewer concluded that the product will be effective as claimed on the label and would not likely to have an unintended effect that is harmful to the
target sites.
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KP25S_F39 Version: 2 Issued: 14/08/2007
Data relied on to provide the advice
Data No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
39680
S
P. McNally
Efficacy of Temprid 360 SC against crawling insect
pests - Carpenter ant (Camponotus pennsylvanicus)
October 2007
Efficacy and Safety
Efficacy
Applicant
39677
S
E. Snell, W. Sexton & D.
Weiner
Evaluation of 31.5% Temprid, 11.8% Tempo Ultra SC,
and 21.4% Premise 2 SC as residual pesticides when
applied to unpainted wood panels and soils and
exposed to Pharaoh's ant (Monomorium pharaonis)
November
2007
Efficacy and Safety
Efficacy
Applicant
39676
S
R. Cardoza & D. Forey
Laboratory evaluation of Temprid SC, Tempo Ultra, and
Premise 2, applied to various substrates, against the
Argentine ant, odorous house ant, carpenter ant,
oriental cockroach, smokybrown cockroach, field
cricket, house fly, cellar spider, wolf spider, and
centipede
February 2008
Efficacy and Safety
Efficacy
Applicant
39681
S
P. McNally
Efficacy of Temprid 360 SC against crawling insect
pests - Cockroaches (Periplaneta americana, Blattella
germanica)
January 2008
Efficacy and Safety
Efficacy
Applicant
39682
S
Kenneth F. Haynes
Laboratory evaluation of Temprid SC, Tempo Ultra,
Suspend SC and Premise 2 against the bed bug ,
Cimex lectularius
January 2009
Efficacy and Safety
Efficacy
Applicant
39678
S
E. Snell, W. Sexton & D.
Weiner
Evaluation of Temprid 31.5%, Tempo Ultra SC 11.8%,
and Premise 2 SC 21.4% as residual pesticides when
applied to unpainted wood and glass panels and
exposed to black widow spiders (Latrodectus hesperus)
January 2008
Efficacy and Safety
Efficacy
Applicant
39679
S
E. Snell, W. Sexton & D.
Weiner
Evaluation of Temprid 31.5%, Tempo Ultra SC 11.8%,
and Premise 2 SC 21.4% as residual pesticides when
applied to unpainted wood panels and soils and
exposed to house crickets (Acheta domestica)
November
2007
Efficacy and Safety
Efficacy
Applicant
39683
S
I Ridley
A comparison of the knockdown control given by six
overspray treatments, including Temprid Residual
Insecticide against German cockroaches and black
house spiders
22/07/09
Efficacy and Safety
Efficacy
Applicant
Inherited
Application
No.
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
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KP25S_F39 Version: 2 Issued: 14/08/2007