Annex B 

Spirotetramat 

B.3 Data on application and further information 

Reviewed by: 

AGES, Austria 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3 Data on application and further information 

B.3.1 Data on application relevant to the active substance (Annex IIA 3.1 to 3.6) 

B.3.1.1 Function (Annex IIA 3.1) 

Spirotetramat is an insecticide. 

B.3.1.2 Effects on harmful organisms (Annex IIA 3.2) 

Spirotetramat acts in the target pests mainly after oral ingestion and feeding from the plants. 

B.3.1.2.1 Nature of the effects on harmful organisms (Annex IIA 3.2.1) 

Spirotetramat is very effective against aphids, scales, mealy bugs, psyllids, white flies and selected thrips. It 

has a slow initial but an excellent residual activity and acts mainly against immature stages and requires oral 

ingestion. In many cases it outperforms most of the currently used products, as for example control of the 

Californian red scale (Aonidiella aurantii) on citrus, or control of the sweet potato whitefly (Bemisia tabaci) on 

vegetables. It is an important tool in resistance management, as it has a new mode of action. 

B.3.1.2.2 Translocation in plants (Annex IIA 3.2.2)

Spirotetramat is highly systemic and possesses not only xylem-, but also phloem-mobility. Once taken up by 

the plant, the active substance moves acropetal in the xylem and acropetal and basipetal in the phloem. 

After treatment, even the new shoots or the roots are protected from sap-sucking pests due to this specific 

biological property. 

B.3.1.3 Field of use (Annex IIA 3.3) 

Spirotetramat is intended to be used as an insecticide in agriculture on a range of crops such as citrus, pome 

and stone fruits; tree nuts, grape; strawberries, fruiting and leafy vegetables (indoor and outdoor); brassica 

vegetables, hops but also on tubers vegetables and tropical fruits such as pineapple, mangoes, bananas and 

cotton. It is also considered, to use the product on ornamentals and trees. 

B.3.1.4 Harmful organisms controlled and crops or products protected or treated (Annex 

IIA 3.4) 

The harmful organisms controlled comprise aphids, scales, mealy bugs, psyllids, white flies and selected 

thrips species. 

B.3.1.4.1 Details of existing and intended uses (Annex IIA 3.4.1) 

Spirotetramat is intended to be used especially in top fruit, citrus, grapes, berries, fruiting and leafy 

vegetable, and hops. The details of the intended uses are defined in Document D1. Some examples are 

listed below: 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Citrus (Orange) 

Citrus (Lemon) 

Diaspididae Aonidiella aurantii 

Aspidiotus neri 

Apple, Pear Pemphigidae 

Aphididae 

Psyllidae 

Eriosoma lanigerum 

Aphis pomi 

Dysaphis plantaginea 

Psylla pyri 

Cherries, plums, peaches, 

nectarines, apricots 

Aphididae Aphis pomi 

Dysaphis plantaginea 

Brachycaudus helichrysi 

Myzus cerasi 

Myzus persicae 

Fruiting vegetables Aleyrodidae 

Aphididae 

Bemisia tabaci 

Trialeurodes vaporariorum 

Myzus persicae 

Aphis gossypii 

Cole crops Aphididae Brevicoryne brassicae 

Lettuce Aphididae Nasonovia ribis-nigri

Hop Aphididae Phorodon humuli 

Strawberries Aphididae, Aleyrodidae Bemisia tabaci, Trialeurodes

vaporariorum, Aphis ssp. 

Onions Thripidae Thrips tabaci 

Beans Aphididae, Aleyrodidae Aphis ssp., Trialeurodes vap., 

Bemisia tabaci 

Grapes Pseudococcidae Planococcus ssp. 

B.3.1.4.2 Details of harmful organisms against which protection is afforded (Annex IIA 3.4.2) 

Spirotetramat provides excellent control of a broad number of sucking pests belonging to the Sternorrhyncha 

sub-order (whiteflies; psyllids; scales; mealybugs; aphids). These pests have generally a high reproduction 

potential and a lack of control of them can lead to considerable losses of crop value. Their short life cycle 

can contribute to the development of resistance to insecticides, as for example whiteflies and aphids.

Sap-sucking pests are responsible for three types of damage: direct damage (feeding on sap, which can 

weaken the plants; cause deformations and reduce the yield); indirect damage (accumulation of honeydew

produced by the insects, which serves as a substrate for the growth of black sooty mold on leaves and fruit), 

transmission of viruses. 

For indoor fruiting vegetables, whiteflies, and among them Bemisia tabaci, are major pests especially for 

Southern Europe countries. They have developed resistance to insecticides from different chemical classes. 

75 g a.i/ha/ m leafwall of spirotetramat, applied with a minimum of 7 days interval in case of multiple 

applications, provide a very high level of control of B. tabaci (including resistant populations) offering at least 

3 weeks of residual efficacy after the last application. These applications will also be able to control aphids 

populations which could infest the crop at the same time. 

The Californian red scale, A. aurantii is a difficult to control space species and is a major pest on citrus 

(orange, mandarine) as infested fruits have a low marketable value for fresh production. One application at 

60 g a.i/ha/m c.h of spirotetramat, targeted against the first generation, at crawlers movement, is able to 

provide a season-long control until maturity of the fruits. Additional spray may be requested however to 

control later occurring pests, such as Aleurothrixus floccosus (Homoptera: Aleyrodidae) at 75 g a.i/ha/ m c.h. 

On apple several aphids species can weaken the growth of the trees (like Eriosoma lanigerum and Aphis 

pomi to a lesser extent). Dysaphis plantaginea can cause direct feeding damage on fruits. The wooly apple 

aphid E. lanigerum is a hard to reach insect as they produce filamentous wax (“wool”) which protect them 

and the full systemicity of spirotetramat contributes greatly to its excellent efficacy against this pest. These 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

aphids species can be effectively controlled by spirotetramat, from 45 g a.i/ha/m c.h (A. pomi; D. 

plantaginea) to 75 g a.i/ha/m c.h (E. lanigerum). It has been also observed that one application against E. 

lanigerum (post-flower, at movement of crawlers) was able to provide sinificative control of later occurring A. 

pomi, infesting new growing shoots, thanks to its longevity and its full systemicity. 

Psylla piri on pear is the major sucking pest on pear; high populations of adults and nymphs feeding on new 

shoots can have a direct effect on the growth of trees; they also produce a vast amount of honeydew, 

damaging the leaves and the fruits. In the majority of situations , one application of spirotetramat at 75 g 

a.i/ha/ m canopy height , targeted against the second generation when eggs are at the yellow stage /first 

larval stage visible is sufficient to provide a high level of control of the pear sucker populations for at least 3 

weeks. 

B.3.1.4.3 Effects achieved (Annex IIA 3.4.3) 

After having ingested spirotetramat, juvenile stages of insects such as aphids, whiteflies cannot mould 

properly and die within 2 to 5 days. The speed of lethal effect is variable, depending on the life stages or on 

external parameters. Spirotetramat can also drastically reduce the number of viable larvae deposited by 

adult aphids. 

B.3.1.5 Mode of action (Annex IIA 3.5) 

The mode of action of Spirotetramat is the suppression of the lipid synthesis. This novel MoA aims at a 

biochemical target and inhibits the proper formation of the ACCase. As a consequence, the total lipids in the 

target pests are significantly decreased and this leads in the end to the death of the insect. 

B.3.1.5.1 Mode of action, mechanism(s) and pathway(s) involved (Annex IIA 3.5.1) 

Reference: Spirodiclofen: Mode of Action and Resistance Risk Assessment in 

Tetranychid Pest Mites 

Author(s), year: Nauen R, 2005 

Report/Doc. number: M-277046-01-1 

Guideline(s): not relevant 

GLP: not relevant 

Spirotetramat is a new insecticide and acaricide particularly effective against a broad range of sucking pests 

of agronomic importance, including aphids and whiteflies. Its mode of action is similar to that of spirodiclofen 

and spiromesifen, i.e. inhibition of lipid biosynthesis by acting on acetyl CoA carboxylase [see reference 

below]. Spirotetramat was shown to strongly reduce the lipid content in aphids feeding on leaves treated with 

the compound. More detailed investigations with 14C-acetate as a radiolabeled precursor of fatty acids

revealed a full inhibition of de novo synthesis of lipids in aphids. Spirotetramat also showed excellent efficacy 

against insecticide resistant pests (including neonicotinoid resistant whiteflies) and will most likely be 

classified within group 23 of the IRAC (Insecticide Resistance Action Committee) mode of action 

classification scheme, i.e. grouped together with spirodiclofen and spiromesifen. Due to the lack of any 

cross-resistance to existing chemical classes of insecticides, spirotetramat will be an invaluable new tool to 

manage insecticide resistance in many crops and pests worldwide. 

Due to its physicochemical properties, spirotetramat effectively acts on a broad spectrum of pests as 

mentioned above, e.g. it shows an excellent efficacy against different aphid species, including Myzus 

persicae, Aphis gossypii and Phorodon humuli. Due to its mode of action as lipid biosynthesis inhibitor 

particularly juvenile stages of aphids are affected by spirotetramat, whereas adults are strongly affected in 

their fecundity, which from an applied point of view will drastically reduce population development under field 

conditions. Spirotetramat applied foliarly exhibited an excellent systemic efficacy against aphids and

whiteflies, whereas its contact efficacy against these pests is rather limited. Once penetrated into the plant 

spirotetramat will be readily hydrolyzed to its enol form. The BYI08330-enol shows a water solubility of 150 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

ppm and is a weak acid (pKa-value 5.2), rendering the compound mobile within the symplast (phloem) of the 

plant according to the “weak acid hypothesis”. Hence it can move acro- and basipetally, and even protects 

the roots when foliarly applied. 

B.3.1.5.2 Details of active metabolites and degradation products (Annex IIA 3.5.2) 

Spirotetramat (BYI08330) is transformed within the plant rapidly to the de-acylated BYI08330-enol. 

BYI08330-enol is the only major metabolite of spirotetramat which exhibits a relevant insecticidal activity. 

Due to its weak acidity (pKa 5.2) BYI08330-enol is responsible for the phloem systemic properties of the 

compound. In spite of this it has some advantages to apply spirotetramat and not directly BYI08330-enol 

since biological trials have shown a higher efficacy of spirotetramat. 

N

H

O

O

O

O

O

N

H

H O

O

O

Spirotetramat BYI08330-enol

B.3.1.5.3 Information relative to the formation of active metabolites and degradation products 

(Annex IIA 3.5.3) 

Please refer to B.3.1.5.2.

B.3.1.6 Information on possible occurrence of the development of resistance (Annex IIA 3.6) 

Introduction – resistance risk analysis spirotetramat 

Resistance in arthropod pest species comprises a change in the genetic composition of a population in 

response to selection by pesticides such that control in the field may be impaired at recommended 

application rates. Selection for resistance in pest populations (including weed, fungi, mites, and insects) due 

to frequent applications of agrochemicals has been one of the major problems in modern agriculture for

many years. 

Spirotetramat (BYI 8330) will be listed together with spirodiclofen and spiromesifen as a member within 

group 23 of the IRAC (Insecticide Resistance Action Committee) mode of action classification scheme 

(www.irac-online.org). It is listed as an inhibitor of lipid biosynthesis and can principally be used in alternation 

with any insecticide of other mode of action classes. Due to the fact that the tetramic acid derivative 

spirotetramat belongs to a completely new chemical class of insecticides, cross-resistance to other 

insecticides is rather unlikely, and this was confirmed by investigations carried out recently (Nauen,

unpublished). The experimental results out of these studies are reported below. 

The efficacy of spirotetramat against several sucking pest species was tested with laboratory strains 

resistant and susceptible to conventional insecticides, e.g. organophosphates, carbamates, pyrethroids, 

chlorinated hydrocarbons and neonicotinoids. Baseline susceptibility and resistance monitoring studies have 

been performed for those species considered as high risk organisms and targeted by the active ingredient 

mentioned above, and are mentioned below. The studies were performed according to EPPO Guideline PP 

1/213 (see Heimbach et al., 2000; OEPP/EPPO, 1999) whereever necessary. Species tested included the 

green peach aphid (Myzus persicae), the cotton aphid (Aphis gossypii), the damson hop aphid (Phorodon 

humuli), the cotton whitefly (Bemisia tabaci) and the greenhouse whitefly (Trialeurodes vaporariorum). 

Spirotetramat was particularly tested against biochemically characterized, multi-resistant strains of B. tabaci

derived from vegetables from different parts in the world incl. European areas such as southern Spain 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

(Rauch & Nauen, 2003). The cotton whitefly was considered to be one of the most important pest species

due to its pronounced multi-resistance to numerous insecticides including neonicotinoids. Several of the 

neonicotinoid resistant strains show high monooxygenase activity, elevated esterase and glutathione Stransferase levels, and target-site mutations leading to acetylcholinesterase insensitivity and kdr (knock 

down resistance) (Nauen and Denholm, 2005). 

Spirotetramat turned out to be highly active in both insecticide susceptible and resistant strains of several 

sucking pest species, and showed no cross-resistance to other chemical classes of insecticides tested in 

these strains. Our studies using for example B. tabaci, T. vaporariourum and M. persicae (as aphid 

representative most prone to resistance development) revealed that spirotetramat is a new chemical option 

with a new mode of action for example in aphids to control multi-resistant sucking pests. It is an excellent 

partner of many known chemical classes of insecticides in resistance management strategies 

Materials and methods 

Insecticides 

All reference insecticides (technical material) used were either obtained in-house or purchased from 

Ehrenstorfer (Augsburg, Germany) and Riedel de Haen (Seelze, Germany), respectively. All technical 

insecticides used were of analytical grade (purity >97%). 

Insects 

Aphids

Myzus persicae (strains NS, JR and F04-01) and Aphis gossypii (strain HS) were maintained on cabbage 

and cotton plants, respectively under the following conditions: day temperature 24°C, night temperature 

20°C, 18 : 6 h light : dark and 65% RH. For all experiments aphids (nymphs) from synchronized populations 

were used.

In order to obtain synchronized populations, leaf discs (30 mm in diameter) were cut from Chinese cabbage 

and placed on a bed of agar (10 g litre-1; 2 mL per well) in six-well tissue culture plates (Greiner Bio-One 

GmbH, Frickenhausen, Germany). Fifteen to 20 adult apterous aphids were placed in each well before the

plates were covered with a ventilated lid. The plates were stored upside down in the laboratory at 22°C and 

an ambient photoperiod. The aphids produced nymphs and after 24 h adult aphids were removed and 

nymphs within a similar age class were obtained. The leaf discs with the nymphs were placed onto a 

Chinese cabbage plant and maintained until they reached the stage which was needed for the respective 

test. Synchronised nymphs were kept in the greenhouse at a day temperature of 24°C, a night temperature 

of 20°C, 18 h : 6 h light : dark and 65% RH. Cotton aphids (A. gossypii) were synchronized in a similar 

manner, but using cotton leaf discs instead of cabbage leaf discs. 

Whiteflies

All strains were maintained on cotton plants (Gossypium hirsutum) at 25 ± 1°C, 60% RH and a photoperiod 

of L:D 16h:8h. Table 1 lists all different strains of B. tabaci and T. vaporariorum used throughout the study. 

Strains CRE04-01, ISR-02 and ESP-00 are highly resistant to neonicotinoid insecticides as well as to other, 

conventional whitefly compounds such as organophosphates, carbamates, pyrethroids, pymetrozine and 

IGR ́s (Rauch & Nauen, 2003). The resistance pattern of the T. vaporariorum strains is not known in detail, 

but UH-06 and GrKS-05 were obtained from places with difficulties to control these pests. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Table 1. Whitefly strains tested. 

Strain Origin Date Host plant Biotype

Bemisia tabaci

CRE04-01 Crete 2004 Tomato Q 

BR-JM03 Brazil 2003 Tomato B 

ISR-02 Israel 2002 Roses B 

MEX03-02 Mexico 2003 Tomato B 

ESP-00 Spain 2000 Pepper Q 

SUD-S Sudan 1994 Cotton - 

Trialeurodes vaporariorum

UH-06 Germany 2006 Vegetables - 

GrKS-05 Greece 2005 Vegetables - 

HS-Ref Germany 1996 Ornamentals - 

Bioassays useful to monitor resistance

Leaf-dip bioassay aphids: A leaf-dip bioassay procedure was designed to test all compounds under the 

same conditions in 6-well tissue culture plates. The wells of the tissue culture plates were filled with 2 ml 

Agar (1% (w/v)). Several plates were usually prepared and stored at 4°C until used. Plates were equilibrated 

to room temperature and leaf discs (Ø 30 mm) were cut out of the first and second fully expanded true 

leaves from three-week old plants, for example Brassica olearacea for M. persicae or G. hirsutum for A. 

gossypii. The leaf discs were then dipped into serial aqueous dilutions of active ingredient in 0.02 % (w/v) 

Triton X-100, and after drying the leaf discs were transferred to 6-well plates. In order to assess baseline 

susceptibility using strains NS (M. persicae) and AGS (A. gossypii), respectively, spirotetramat was tested at 

least twice with up to six replicates per concentration. Ten 3-4d old nymphs from synchronized populations 

were confined to each well. Diagnostic concentrations for each insecticide, i.e. rounded LC50,95,99-values, 

were calculated from log-dose probit-mortality regressions using Polo PC (LeOra Software, California) after 

72h. Field strains collected can be tested at diagnostic concentrations, i.e. a single plate consists of six 

replicates of one insecticide concentration. Aphids unable to move and showing strong symptoms of 

poisoning were scored as dead. The methodology has been published including results in more detail by 

Nauen and Elbert (2003). However, no serious case of field resistance in any aphid species has yet been 

detected with spirotetramat. 

Leaf-dip bioassay whiteflies: In leaf dip bioassays, cotton leaf discs (30 mm in diameter) were dipped for 5 

sec in aqueous solutions of insecticides containing 0.2 g litre-1 Triton X-100 as a non-ionic wetting agent 

(Elbert & Nauen, 1996). Air-dried leaf discs were then placed with their adaxial surface downwards onto a 

bed of agar (14 g litre-1) in a small Petri dish (40mm in diameter). Adult whiteflies were collected from rearing 

cages by means of a vacuum-pump powered aspirator and after brief CO2 anesthesia, 20 adults were placed 

onto the leaf-discs. Afterwards each Petri dish was sealed with a ventilated lid and stored upside down. 

Whiteflies were scored for mortality after 72 h. 

Egg/larval-dip bioassay whiteflies: Due to the fact that spirotetramat is particularly effective against 

juvenile stages all tests were done using whitefly nymphs. One leaf of cotton plants with two true leaves was 

removed and the remaining one was cut to a size of c. 12-15 cm2. These plants were infested with adult

whiteflies (c. 300 per leaf) for 8h. Afterwards, the whiteflies were removed and the infested leaves were 

dipped in serial dilutions of insecticide for 5 s. Each set of plants was dipped at appropriate time intervals 

after infestation to cover the correct developmental stages in the bioassays, i.e. eggs or 2nd/3rd instar 

nymphs. Percentage mortality was scored on representative leaf areas after the last larval instar has been 

reached (after 14-17 d at 25°C, 65% RH and 16h:8h (L:D), starting from the egg stage). A typical experiment 

with spirotetramat against 2nd instar nymphs (both species) was assessed for efficacy 8-10d after treatment. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Calculations 

LC50- and LC95,99-values and their 95% confidential intervals were calculated from probit regressions using 

the computer program POLO-PC (LeOra Software, Berkeley, USA) or GrapPad Prism v4.0 (GraphPad 

Software, San Diego, USA). 

Results 

Baseline susceptibility and cross-resistance studies. 

Aphids

Spirotetramat (BYI 8330) showed excellent efficacy against all strains of aphids tested in a leaf-dip bioassay 

(Table 2). 

Table 2. Log-dose probit-mortality baseline data of spirotetramat for some strains of M. persicae and 

A. gossypii. Leaf-dip bioassay, 3rd instar nymphs, 3d. 

Species Strain LC50, ppm LC95, ppm LC99, ppm 

M. persicae NS 0.69 5.5 17.7 

JR 0.59 4.1 12.3 

F04-01 0.27 1.8 5.3 

A. gossypii HS 3.5 21 58 

Strain JR is known to be resistant against organophosphates, carbamates and pyrethroids due to esterase 

E4 over-expression and MACE (modified acetylcholinesterase), respectively. However, strain JR originally 

derived from tobacco plants represents a typical R3 strain of M. persicae (Nauen & Elbert, 2003). Strain F04-

01 is a field strain collected in France and shows a similar resistance pattern as JR. Spirotetramat showed 

excellent efficacy against both strains, which can be considered as representatives of the most resistant 

strains of M. persicae currently known. There is a max. 3-fold (natural) variation in response to spirotetramat 

between the three different M. persicae strains tested (Table 2), and never been exposed to spirotetramat 

under field conditions. The insecticide susceptible reference strain HS of A. gossypii was about 3-4 times 

less susceptible than M. persicae NS. P. humuli obtained from German hop (Hallertau) turned out to be as 

susceptible as M. persicae, so field samples of both species can be checked using the same diagnostic 

dose. 

For future resistance monitoring purposes it is suggested to use a diagnostic dose of spirotetramat of 10 and 

30 ppm in a leaf-dip bioassay for nymphs of M. persicae (P. humuli) and A. gossypii, respectively. 

Whiteflies

Bemisia tabaci 

All strains of B. tabaci tested responded quite susceptible to spirotetramat with a maximum variation of 3.8-

fold between strains, irrespective which biotype is considered (Table 3). 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Table 3. Log-dose probit-mortality baseline data of spirotetramat on some strains of B. tabaci. Leafdip bioassay, 2nd instar nymphs, 10d. 

Strain LC50, ppm FL 95% RR 

SUD-S 0.26 0.11 – 0.59 

CRE04-01 1.0 0.72 – 1.4 3.8 

BR-JM03 0.64 0.30 – 1.4 2.5 

ISR-02 0.72 0.25 – 2.0 2.8 

MEX03-02 0.49 0.38 – 0.63 1.9 

ESP-00 0.74 0.15 – 3.5 2.8 

Composite 

LC50, ppm 0.78 0.47 – 1.3

LC95, ppm 12 5.9 – 15

LC99, ppm 36 15 – 170

Abbreviations: FL = Fiducial Limits, RR = Resistance Ratio, Composite = all data combined 

The highest concentration applied against nymphs was 200ppm and provides a 100% efficacy against all 

strains tested. A mean LC99-value of 36ppm was obtained and derived from all results combined (composite, 

Table 3). Therefore future monitoring activities for spirotetramat susceptibility in field populations will be 

carried out using two concentrations, i.e. 10ppm and 40ppm representing the approx. LC95 and LC99, 

respectively.

Apart from spirotetramat also other insecticides belonging to different mode of action classes were tested 

against some strains in order to check for possible, metabolically or target-site driven cross-resistance. 

Especially the Q-type strains (ESP-00 and CRE04-01) and the B-type 

strain ISR-02 were highly resistant to neonicotinoid insecticides and other insecticides when compared to 

SUD-S (Tables 4-7). No cross-resistance between spirotetramat and any other insecticide was observed in 

the experiments conducted. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Table 4. Cross resistance pattern of B. tabaci strain SUD-S. Leaf-dip bioassay using either 2nd instar 

nymphs (*) or adults as described under materials and methods. 

Table 5. Cross resistance pattern of B. tabaci strain ESP-00. Leaf-dip bioassay using either 2nd instar 

nymphs (*) or adults as described under materials and methods. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Table 6. Cross resistance pattern of B. tabaci strain CRE04-01. Leaf-dip bioassay using either 2nd

instar nymphs (*) or adults as described under materials and methods. 

Table 7. Cross resistance pattern of B. tabaci strain ISR-02. Leaf-dip bioassay using either 2nd instar 

nymphs (*) or adults as described under materials and methods. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Trialeurodes vaporariorum 

In addition to B. tabaci, three strains of the greenhouse whitefly were tested for their susceptibility against 

spirotetramat. Second instar nymphs of T. vaporariorum were in general somewhat less susceptible to 

spirotetramat when compared to B. tabaci nymphs. However, variation in LC50-values between strains was 

also 3-fold, and similar diagnostic doses will be used. 

Table 8. Log-dose probit-mortality baseline data of spirotetramat on some strains of T. vaporariorum. 

Leaf-dip bioassay, 2nd instar nymphs, 10d. 

Strain LC50, ppm FL 95% 

UH-06 2.49 1.63 – 3.80 

GrKS-05 1.76 1.40 – 2.20 

HS-Ref 5.44 2.27 – 11.9 

Abbreviations: FL = Fiducial Limits 

RESISTANCE MANAGEMENT RECOMMENDATIONS 

Monitoring for resistance will be carried out routinely (wherever possible even annually) with important pests 

such as some aphid species and whiteflies and results will be published regularly. According to EU directive 

91/414/EEC national authorities have to consider resistance risk associated with the introduction of plant 

protection products as part of the authorization process (Heimbach et al., 2000). Guidelines for proper 

resistance risk evaluation have recently been approved by the European and Mediterranean Plant Protection 

Organization (EPPO) and are taken into account during the registration procedure (OEPP/EPPO, 1999; 

McNamara and Smith, 2000). The directives presented hereafter include a number of options. If possible, the 

first one should be used. So long-term a.i. rotation is considered better than short-term rotation; being better 

than a mixture; and the last one better than a spraying sequence with only one active ingredient. 

Control practices for the mentioned pests differ considerably between countries, crops, varieties and climatic 

conditions. Therefore a general strategy has to cover a wide range of flexibility. Its concrete implementation 

and adaptation to local conditions has therefore to be achieved by regional specialists. 

Spirotetramat is a tetramic acid derivative with a similar mode of action as spirodiclofen and spiromesifen, 

and therefore a member of IRAC Group 23 within the IRAC Mode of Action Classification scheme (www.iraconline.org). In order to prevent possible resistance development against spirotetramat the following points 

should be considered as a preliminary guidance until further recommendations will be published: 

• Long-term rotation act best against rapid selection of resistant populations. This means, that a 

change of active ingredient should take place when the next generation of the pest has to be treated 

to prevent a selection with the other chemical group within the same generation of the pest. 

• Use effective doses of the individual components when applying tank mixtures and the full 

recommended rate of in co-formulations. 

• Control should not be carried out with products of just one chemical class. 

• The use of non-specific products helps to prevent the development of resistance. 

• All possible cultivation techniques should be used alongside physical and biological pest control 

methods. 

• Crop protection products should be used in such a way as to reduce the risk to beneficial organisms. 

• Preparations should be used at the recommended doses and spray intervals. 

• Ensure that uniform spray coverage is achieved. 

• If signs of diminished efficacy become evident, do not carry out a follow-up treatment with an active

ingredient of the same chemical class. 

• Monitor the situation wherever possible so as to detect the first signs of resistance. 
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Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.2 Data on application relevant to the plant protection product (Annex IIIA 3) 

B.3.2.1 Field of use (Annex IIIA 3.1) 

Spirotetramat is an insecticide in agriculture for foliar application. 

B.3.2.2 Effects on harmful organisms (Annex IIIA 3.2) 

Spirotetramat is very effective against aphids, scales, mealy bugs, psyllids, white flies and selected thrips .It 

has a slow initial but an excellent residual activity and acts mainly against larvae. It requires oral ingestion. It 

outperforms most of the currently used products and is an important tool in resistance management, as it 

has a new mode of action. 
– 14 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.2.3 Details of representative uses (Annex IIIA 3.3) B.3.2.3.1 Summary of representative uses evaluated (Spirotetramat) (Annex IIA 3.3.1) 

Crop and/ 

or situation

(a) 

Membe

r 

State or

Countr

y 

Product 

name 

F 

G 

or 

I 

(b) 

Pests or 

Group of 

pests 

controlled 

(c) 

Formulation Application Application rate per treatment 

PHI 

(days)

(l) 

Remarks: 

(m) 

 Type 

(d-f) 

Conc. 

of as 

(i) 

method

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min max 

(k) 

interval 

between 

application

s (min) 

kg as/hL 

min max

water L/ha 

min max 

kg as/ha 

min max

Citrus 

all types 

EU-S Spirotetramat F scales, 

aphids, 

mealy bugs, 

mites 

OD 150 

spray 

BBCH 78 at 

last 

application; 

First 

application not 

earlier than 

mid of May 

2 21 0.0096 1000 L/ha 

and m CH*, max 3000 L/ha 

0.096 kg 

as./ha and 

m CH*, 

max 

0.288 kg 

as./ha 

(3 metres) 

14 representative use 

for the EUevaluation 

Lettuce 

head and 

leafy 

EU-N 

EU-S 

Spirotetramat F aphids OD 150 spray BBCH 48 at last application max. 2 14 0.0072 - 0.0144 500-1000 0.072 7 representative use for the EUevaluation

Lettuce, 

head and 

leafy 

EU-N 

EU-S 

Spirotetramat G aphids OD 150 spray BBCH 48 at last application max. 2 14 0.0072 - 0.0144 500-1000 0.072 7 representative use for the EUevaluation

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the 

use situation should be described (eg. fumigation of a structure) 

(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds (d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants - 

type of equipment used must be indicated 

 (i) g/kg or g/l 

(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, 

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application 

(k) The minimum and maximum number of application possible under practical conditions 

of use must be provided 

(l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions 
– 15 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Details of existing and intended uses 

Crops Crop Code 

citrus ssp.: 

oranges 

mandarins 

lemons 

limes 

Pummelo 

Clementine 

CIDSS 

CIDSI 

CIDRE 

CIDLI 

CIDAF 

CIDGR 

CIDCL 

lettuce LACSP

B.3.2.3.2 Harmful organisms against which protection is afforded (Annex IIIA 3.3.2) 

Crops Crop Code Pest Pest Code 

citrus ssp.: 

oranges 

mandarins 

lemons 

limes 

CIDSS 

CIDSI 

CIDRE 

CIDLI 

CIDAF 

Aonidiella aurantii 

Parlatoria pergandei 

Aleurothrixus floccosus 

Pseudococcus citri 

Aspidiotus nerii 

AONDAU 

PARLPE 

ALTHFL 

PSECCI 

ASPDNE 

lettuce LACSP Nasonovia ribis-nigri 

(Myzus persicae 

 (Hyperomyzus 

lactucae 

(Pemphigus bursarius 

NASORN 

MYZUPE) 

HYLEPA) 

PEMPBU) 

B.3.2.3.3 Effects achieved (Annex IIIA 3.3.3) 

After having ingested spirotetramat, juvenile stages of insects such as aphids, whiteflies cannot moult 

properly and die within 2 to 5 days. The speed of lethal effect is variable, depending on the life stages or on 

external parameters. Spirotetramat can also drastically reduce the number of viable larvae deposited by 

adults aphids. 

B.3.2.4 Application rate (Annex IIIA 3.4) 

Rate of application per unit treated: 

Crop L product/ha kg as /ha 

citrus ssp: 

oranges, mandarins, lemons, 

limes 

0.64 per m CH* 

max.:1.92 

0.096 per m CH* 

max.: 0.288 

lettuce, field 0.48 0.072 

lettuce, glasshouse 0.48 0.072 

*: CH: Canopy Height 

B.3.2.5 Concentration of active substance in material used (Annex IIIA 3.5) 

Spirotetramat OD 150 contains 150 g active substance/L finished product. 
– 16 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

The concentration of active substance in the spray solution applied is as follows: 

Citrus: 0.0096% 

Lettuce: 0.0072% - 0.0144% 

B.3.2.6 Method of application (Annex IIIA 3.6) 

Lettuce, field: Overall spray application with standard tractor mounted field sprayers or Knappsacksprayers 

with spray volume of 500-1000 L/ha 

Lettuce, greenhouse: Overall spray application with Knappsacksprayers with spray volume of 500-1000 

l/ha 

Citrus: Overall spray application with standard tractor mounted field sprayers or Knappsacksprayers with 

spray volume of 1000-5000 L/ha 

B.3.2.7 Number and timing of application, timing, growth stages (of crop and harmful 

organism) and duration of protection (Annex IIIA 3.7) 

Crop number of 

applications 

timing of applications duration of protection

citrus ssp: 

oranges, mandarins, 

clementines, lemons, limes 

1-2 at movement of crawlers 

(scales, mealybugs); at 

beginning of infestation 

(whiteflies) 

min. 21 days 

lettuce, field 1-2 at beginning of infestation min. 14 days 

lettuce, glasshouse 1-2 at beginning of infestation min. 14 days 

B.3.2.7.1 Maximum number of applications and their timings (Annex IIIA 3.7.1) 

Crop maximum number of 

applications 

timing of applications 

citrus ssp: 

oranges, mandarins, clementines, lemons, 

limes 

2 

lettuce, field 2 

lettuce, glasshouse 2 

The spray is performed only when 

the relevant pest is present and 

when the Economic Threshold 

Level (ETL) is reached. 

B.3.2.7.2 Growth stages of crops or plants to be protected (Annex IIIA 3.7.2) 

Crop timing of applications 

citrus ssp: 

oranges, mandarins, clementines, 

lemons, limes 

BBCH 71-78 

lettuce, field BBCH 42-43 

lettuce, glasshouse BBCH 42-43 
– 17 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.2.7.3 Development stages of the harmful organism concerned (Annex IIIA 3.7.3) 

Spirotetramat is mostly active against juvenile stages. For scales control such as for A. aurantii the product 

should be targed at crawlers movement (which corresponds to the first larval which is a mobile one. For 

aphids , where populations are frequently composed of mixed development stages, Spirotetramat should be 

applied at beginning of infestations, when populations start to develop. For whiteflies, beginning of infestation 

is also the optimal timing as the product is mainly active against larvae and nymphs. 

B.3.2.7.4 Duration of protection afforded by each application (Annex IIIA 3.7.4) 

Duration of the protection of at least 7 days up to 28 days is afforded. 

B.3.2.7.5 Duration of protection afforded by the maximum number of applications 

(Annex IIIA 3.7.5) 

Duration of the protection of at least 7 days up to 28 days is afforded. 

B.3.2.8 Necessary waiting periods or other precautions to avoid phytotoxic effects on 

succeeding crops (Annex IIIA 3.8) 

B.3.2.8.1 Minimum waiting periods or other precautions between last application and sowing or 

planting succeeding crops (Annex IIIA 3.8.1) 

Must be clarified. 

B.3.2.9 Limitations on choice of succeeding crops (Annex IIIA 3.8.2) 

There is no such limitation. 

B.3.2.9.1 Description of damage to rotational crops (Annex IIIA 3.8.3) 

Rotational crops sown at the appropriate time will not be damaged. 

B.3.2.10 Proposed instructions for use (Annex IIIA 3.9) 

Please refer to attached label proposal. 

B.3.2.11 Other/Special Studies (Annex IIIA 3.10) 

No other special study was carried out. 
– 18 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.3 Summary of data on application 

Spirotetramat (BYI 08330) is intended to be used as an insecticide in agriculture on a range of crops such as 

citrus, pome and stone fruits; grape; strawberries, fruiting and leafy vegetables (indoor and outdoor); 

brassica and bulb vegetables, hops but also on tubers and tropical fruits such as pineapple, mangoes, 

bananas, tree nuts and cotton. In the EU the representative uses for Annex-1-inclusion consist of lettuce as a 

low crop and citrus as a high crop. 

Spirotetramat is very effective against aphids, scales, mealy bugs, psyllids, white flies and selected thrips. It 

has a slow initial but an excellent residual activity and acts mainly against immature stages and requires oral 

ingestion. In many cases it outperforms most of the currently used products, as for example control of the 

Californian red scale (Aonidiella aurantii) on citrus, or control of the sweet potato whitefly (Bemisia tabaci) on 

vegetables. It is an important tool in resistance management, as it has a new mode of action. 

Spirotetramat is highly systemic and possesses not only xylem-, but also phloem-mobility. Once taken up by 

the plant, the active substance moves acropetal in the xylem and acropetal and basipetal in the phloem. 

After treatment, even the new shoots or the roots are protected from sap-sucking pests due to this specific 

biological property. 
– 19 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.4 Further information on the active substance (Annex IIA 3.7 - 3.9) 

B.3.4.1 Recommended methods and precautions concerning handling, storage, transport or 

fire (Annex IIA 3.7) 

A Safety Data Sheet for the technical material is provided. 

Reference: Safety Data Sheet 

Author(s), year: Bayer CropScience Safety Data Sheet for Spirotetramat TC, Version 1, EU 

Document No. 102000009024 

Guideline(s): not relevant 

GLP: not relevant 

B.3.4.1.1 Handling and storage: 

Handling: 

Advice on safe handling

Use only in area provided with appropriate exhaust ventilation. 

Advice on protection against fire and explosion

Dust may form explosive mixtures with air. 

Take measures to prevent the build up of electrostatic charge. 

Keep away from heat and sources of ignition. 

Storage: 

Requirements for storage areas and containers

Store in original container. 

Keep container tightly closed. 

Store in a place accessible by authorized persons only. 

Advice on common storage

Keep away from food, drink and animal feedingstuffs. 

Suitable materials

Only use containers that are approved specifically for the product 

B.3.4.1.2 Transport information: 

Land transport - ADR/ RID/ ADNR:

UN-No: 3077 

Labels: 9 

Packaging group III 

Hazard no 90 

Description of the goods: UN 3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. 

(SPIROTETRAMAT) 

Sea transport - IMDG:

UN-No: 3077 

Class: 9 

Packaging group: III 

EMS: F-A, S-F 

Marine pollutant: Marine pollutant 

Description of the goods: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. 

(SPIROTETRAMAT) 
– 20 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Air transport - IATA:

UN-No: 3077 

Class: 9 

Packaging group: III 

Description of the goods: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. 

(SPIROTETRAMAT) 

B.3.4.1.3 Fire fighting measures: 

Suitable extinguishing media

water spray 

foam 

carbon dioxide (C02) 

sand 

Specific hazards during fire fighting

In the event of fire the following can be released:

hydrogen cyanide (hydrocyanic acid) 

carbon monoxide (CO) 

nitrogen oxides (NOx) 

Special protective equipment for fire-fighters

In the event of fire and/or explosion do not breathe fumes. 

Use breathing apparatus. 

Further information 

Collect contaminated fire extinguishing water separately. This must not be discharged into drains. 

B.3.4.2 Procedures for destruction or decontamination (Annex IIA 3.8) 

B.3.4.2.1 Pyrolytic behaviour (Annex IIA 3.8.1) 

Not applicable as the product contains no chlorine. 

B.3.4.2.2 Detailed instructions for safe disposal (Annex IIA 3.8.2) 

Product:

Do not dispose of waste into the sewerage system. Dispose of by incineration in an authorized special waste 

incineration plant. Comply with local legislation. 

For larger quantities, contact manufacturer. 

Contaminated packaging:

Packaging that cannot be cleaned should be disposed of as product waste. 

It must be incinerated in an authorized special waste incineration plant. Comply with local legislation. 

B.3.4.2.3 Methods other than controlled incineration for disposal of the a.s., contaminated 

packaging and contaminated materials (Annex IIA 3.8.3) 

No methods, other than controlled incineration are recommended for disposal. 
– 21 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.4.3 Emergency measures in case of accident (Annex IIA 3.9) 

B.3.4.3.1 First aid measures: 

General advice

Move out of dangerous area. Place and transport victim in stable position (lying sideways). 

Remove contaminated clothing immediately and dispose of safely. 

Inhalation

Keep patient warm and at rest. Move to fresh air. Call a physician or poison control center 

immediately. 

Skin contact

Wash off thoroughly with plenty of water and soap, if available with polyethyleneglycol 400, 

subsequently rinse with water. 

Eye contact

Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. 

Ingestion

Do NOT induce vomiting. Call a physician or poison control center immediately. Rinse mouth. 

Notes to Physician

Treatment 

Elementary aid, decontamination and symptomatic treatment. 

B.3.4.3.2 Procedures for the decontamination of water in case of an accident: 

In case of contamination of water with Spirotetramat accidental spillage, always try to isolate and protect the 

contaminated area. Water should be used as sparingly as possible to clean up the area. Where feasible, the 

contaminated water should be pumped out and isolated for further appropriate treatment. The collected 

contaminated water must be burnt in a commercial incinerator. If incineration facilities are inadequate, obtain 

advice from the manufacturer on other decontamination methods. In any case, the contaminated water must 

not come in contact with surface water. If accidentally contaminated water is used to produce drinking water, 

ensure with the competent authorities that the level of contamination does not reach the parametric value for 

drinking water. 

B.3.4.3.3 Other/Special Studies 

No other or further special studies have been conducted nor have they been considered necessary or 

triggered. 
– 22 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.5 Further information on the plant protection product Movento 150 OD Insecticide 

(Annex IIIA 4) 

B.3.5.1 Packaging (type, materials, size, etc.), compatibility of the preparation with packaging 

materials (Annex IIIA 4.1) 

B.3.5.1.1 Specification of the packaging (Annex IIIA 4.1.1) 

Specific Requirement Examples 

Material Bottle / Canister: HDPE 

 PA / adhesive / HDPE 

 EVOH / adhesive / HDPE, 

Capacity: Bottle / canister up to 10 liter, which may or may not be packed in an 

outer corrugated fibreboard case such as: 

• 20 x 0.250 liter • 20 x 0.500 liter 

• 12 x 1 liter • 4 x 3 liter 

• 4 x 5 liter • 2 x 10 liter 

Canister / IBC over 10 liter such as: 

• 20 liter • 25 liter 

• 50 liter • 200 liter 

• 640 liter • 1000 liter 

Type of closure and size of 

opening 

Screw cap 36-50-63 mm (with HF seal or internal wad) - to fit container 

neck as defined in ECPA One Trip Container Guidelines. 

Tri – Sure, S 56 x 4 mm, guarantees closure. 

Screw cap DN 50 guarantees closure and DN 150 guarantees closure. 

Application devices None 

B.3.5.1.2 Suitability of the packaging and closure (strength, leak proof and resistance to 

transport and handling) (Annex IIIA 4.1.2) 

Statement of compliance:

The packaging complies with ADR regulations and it has been tested using the ADR test methods 

appropriate to the pack type and material and classification of the contents. Appropriate UN certificates are 

issued. 

B.3.5.1.3 Resistance of the packaging material to its content (Annex IIIA 4.1.3) 

The resistance of the packaging material is addressed by the shelf-life study data submitted under Annex III 

(2.7.3) and has been found to be acceptable. 

The resistance of packaging material to its contents has been tested in accordance with GIFAP Technical 

Monograph No 17 (May 1993); M-266311-01-1; M-266300-01-1 and M-266306-01-1. 
– 23 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Issuer: Christian Jürgensen 

Date: 2006-Sep.-15 

Job Title: Laboratory Manager 

Company Name: Bayer CropScience AG 

Address: BCS-IOP-TISS 

Packaging Technology 

Building 6820 

40789 Monheim 

Telephone: +49 2173 / 38 - 4679 

Fax: +49 2133 / 38 - 4761 

e-mail address: christian.juergensen@bayercropscience.com 

B.3.5.2 Procedures for cleaning equipment (Annex IIIA 4.2) 

All application equipment and contaminated protective clothing should be washed/cleaned with water or a 

dilute detergent solution and thoroughly rinsed. Care should be taken not to spill the contaminated washings 

from application equipment into waste water channels. Contaminated cleaning liquids should be disposed

safely according to local regulations. 

B.3.5.2.1 Procedures for cleaning application equipment and protective clothing (Annex IIIA 

4.2.1) 

Application equipment 

Field spraying equipment should be sufficiently cleaned in order to avoid product left over. Cleaning of field 

spaying equipment is in general an essential part of the recommendations for use of plant protection 

products. 

Empty the contents of the spraying equipment completely onto the field just sprayed. Remove all filters and 

nozzles, scrub clean and rinse them with clean water. Put 10 % clean water into the tank to cover the 

agitator and add about 0.5% liquid detergent. Operate a tank flushing system if fitted. Circulate water through 

the pump and controls for at least one minute. Drain sprayer, collect washings. Repeat procedure once 

more. Pump last washing water out through boom feed hoses and pipes. Collect washings. Clean off the 

outside of the sprayer using minimum water volumes. Collect washings. Replace cleaned nozzles and filters. 

Collect and put all washings back into the tank and spray out onto the field headland, or otherwise safely 

dispose of them. Ensure the sprayer systems are completely drained before storage. Plant protection 

equipment should always be stored in a properly designated storage facility. 

Protective clothing 

All contaminated clothing should be washed / cleaned with a dilute detergent solution and thoroughly rinsed 

with clean water. 

Impermeable overalls, boots and face shields should be washed clean and dried. 

Permeable overalls should be laundered after use. 

Disposable overalls and gloves should be washed and disposed of as contaminated waste. 

Gloves and boots should be washed clean, if necessary on the insides as well. 

B.3.5.2.2 Effectiveness of cleaning procedures (Annex IIIA 4.2.2) 

The product is dispersible in water. Therefore it can be removed from surfaces with water. Adding a dilute 

detergent solution will enhance the effectiveness of the cleaning process. 

The OD-formulation contains considerable amounts of natural oil, due to which the formulation may adhere 

to the wall of the container. Consequently, the rinsed residue of the OD-formulation will be somewhat higher 
– 24 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

than for the standard SC-formulations. Therefore, in case that material has dried on surfaces, the use of 

heated water (25 °C) will improve the cleaning effectiveness also. 

Nevertheless, under practical conditions of use in the EU and given that the rinsing water is not colder than 

7 °C the rinsed residues will be negligible. 

The general procedure for cleaning field sprayers is described below. For spray equipment the 

manufacturer’s manual must describe how to clean and/or flush the pumps and pipes and control gauges 

whilst spray mixture is still present in the tank or the sprayer have to be cleaned for the next crop completely. 

The basic technical steps have to be defined for every sprayer type separately by the manufacturer: 

General requirements: 

• The cleaning procedure has to be done immediately after spraying the product. 

• Empty the sprayer down to the technical leftover 

• The technical rest liquid have to be diluted with clear water (in minimum 10% of the total tank 

capacity) and have to be sprayed out - ensure that the inside walls of sprayer will be cleaned 

thoroughly – best option to use a rotating cleaning nozzle. 

• This step have to be repeated in case of products will be sensitive regarding crop safety or residues

in succeeded treated crops 

• Filters have to be removed and cleaned separately.

• The cleaning procedure has to be done in an untreated part of the field. 

• Personal protective clothing is required for the cleaning procedure. 

According to Efficacy Guideline 302, proposed by PSD and published in December 2001 by the European 

and Mediterranean Plant Protection Organization as document 02/9740, specific studies to prove the 

cleaning efficacy of application equipment is not required, if the product is not expected to cause plant 

damage at recommended use rates. This holds true for almost all insecticides and fungicides and specifically 

for the Spirotetramat OD 150. 

Therefore, further studies are not considered to be necessary. 

B.3.5.3 Re-entry periods, necessary waiting periods or other precautions to protect man, 

livestock and the environment(Annex IIIA 4.3) 

B.3.5.3.1 Pre-harvest interval (in days) for each relevant crop(Annex IIIA 4.3.1) 

Crop Pre-harvest Interval (PHI) 

citrus ssp: 

oranges, mandarins, clementines, 

lemons, limes

14 

lettuce, field 7 

lettuce, glasshouse 7 

B.3.5.3.2 Re-entry period (in days) for livestock, to areas to be grazed(Annex IIIA 4.3.2) 

Re-entry period needs not to be established as the representative crops are not grazed. 
– 25 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.5.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces 

treated(Annex IIIA 4.3.3) 

A safe re-entry or handling of treated crops is possible when spray deposit has dried. For detailed calculation 

see Annex III, Section 3, point 7. 

B.3.5.3.4 Withholding period (in days) for animal feeding stuffs(Annex IIIA 4.3.4) 

Since a residue in feed items and the uptake of these residues by animals is negligible, no residues in animal 

matrices will occur if spirotetramat is use as recommend. Therefore, no withholding is deemed necessary. 

B.3.5.3.5 Waiting period (in days) between application and handling of treated products (Annex 

IIIA 4.3.5) 

Given the toxicological profile of the product and the residue levels at harvest in treated agricultural 

commodities, there is no need to define a waiting period between application and handling treated products. 

B.3.5.3.6 Waiting period for sowing or planting succeeding crops (Annex IIIA 4.3.6) 

As reported in point KIIA, section 4, point 6.6.3.2 “Magnitude of the residue in field rotational crops”, neither 

Spirotetramat (BYI 08330) nor its metabolites appear in concentrations above the LOQ in all rotational crop 

matrices (report no. RAFNY019). Therefore, no waiting period for sowing or planting succeeding crops is 

required. 

B.3.5.3.7 Conditions under which the preparation may or may not be used(Annex IIIA 4.3.6) 

Product should not be used in windy conditions in order to avoid drift into water bodies. 

B.3.5.4 Risks from recommended methods, precautions & procedures to minimize 

Annex IIIA 4.4) 

Reference: Bayer CropScience Safety Data Sheet for Spirotetramat OD 150 (06424376) 

Author(s), year: Anonymous, 2006 

Report/Doc. number: M-276466-01-1 

Guideline(s): EC Directive 2001/58/EC 

GLP: No 

B.3.5.4.1 Warehouse storage (Annex IIIA 4.4.1) 

Keep out of the reach of children. 

Keep away from food, drink and animal feeding stuffs. 

When using, do not eat, drink or smoke. 

Keep away from source of ignition. 

Store in the original container under usual warehouse conditions! Keep containers tightly closed in a cool, 

well-ventilated place. 

Store in a place accessible by authorized persons only! Keep away from direct sunlight and protect again 

frost. 

For more information see: 

Guidelines for the safe handling of pesticides during their formulation, packing, storage and transport 

(GCPF). 

Guidelines for the safe warehousing of crop protection products (GCPF). 

B.3.5.4.2 User level storage (Annex IIIA 4.4.2) 

Keep out of the reach of children. 
– 26 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Keep away from food, drink and animal feeding stuffs. 

When using, do not eat, drink or smoke. 

Keep away from source of ignition. 

B.3.5.4.3 Transport (Annex IIIA 4.4.3) 

Risks during transport of product are minimal. Follow the general rules and good practice for transport and 

the Dangerous Goods regulations. Do not stow the product together with food, feed and consumable items. 

Transport classification of the product in Europe is: 

Road and rail (ADR and RID): UN3082 (environmentally hazardous substance), Hazard No. 90. 

B.3.5.4.4 Fire (Annex IIIA 4.4.4) 

Extinguish fires with foam or carbon dioxide (CO2), sand or water spray. Do not allow run-off from fire 

fighting to enter drains or water courses, e.g. by bundling the area with sand or earth. 

Wear a self-contained breathing apparatus. Remove product from areas of fire or otherwise cool containers 

with water in order to avoid pressure being built up due to heat. 

Water should be used as sparingly as possible and if contaminated it must not come in contact with surface 

water. It must be collected and burned in a commercial incinerator. If burning facilities are inadequate, obtain 

the manufacturer's advice on decontamination methods. 

B.3.5.4.5 Nature of protective clothing proposed (Annex IIIA 4.4.5) 

If product is handled such that there is a risk: 

Respiratory protection: If product is handled while not enclosed, and if skin contact may occur: 

Full mask 

Multi-range filter ABEK/P2 

Hand protection: PVC or other plastic material gloves 

Eye protection: Safety glasses with side-shields 

Hygiene measures: Avoid contact with skin, eyes and clothing. 

Keep working clothes separately. 

Wash hands before breaks and at the end of workday.

Wash hands immediately after work, if necessary take a shower. 

Remove soiled or soaked clothing immediately and clean thoroughly before using 

again. 

Garments that cannot be cleaned must be destroyed (burnt). 

B.3.5.4.6 Characteristics of protective clothing proposed (Annex IIIA 4.4.6) 

Respiratory protection If product is handled while not enclosed, and if skin contact may occur: 

Full mask 

Multi-range filter ABEK/P2 

Hand protection PVC or other plastic material gloves 

Eye protection Safety glasses with side-shields 

B.3.5.4.7 Suitability and effectiveness of protective clothing and equipment (Annex IIIA 4.4.7) 

Safety glasses with side-shields are recommended to protect eyes from contact with the product. 
– 27 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Protective clothing is recommended as routine hygienic measure. Chemical resistant gloves are well known 

to sufficiently protect hands from contact with the product handled. 

B.3.5.4.8 Procedures to minimise the generation of waste (Annex IIIA 4.4.8) 

Product

To minimise product waste, users are required not to prepare more than they will use for the treatment. 

Package

To minimise package waste, empty and rinsed containers should be delivered to a local container collection 

programme, where available. Otherwise, they should be rendered unusable, e.g. by puncturing, and 

disposed in accordance with local regulations. 

Packaging that cannot be cleaned should be disposed of as product waste. It must be incinerated in an 

authorised special waste incineration plant. Comply with local legislation. 

To minimise generation of leftovers, users are recommended to store not more than will be consumed within 

the shelf life period of the product. 

B.3.5.4.9 Combustion products likely to be generated in the event of fire (Annex IIIA 4.4.9) 

The following can be released in case of fire: 

Carbon dioxide (CO2) 

Carbon monoxide (CO) 

Nitrous gases (NOx) 

Hydrogen cyanide (hydrocyanic acid) 

B.3.5.5 Emergency measures in case of an accident (Annex IIIA 4.5) 

B.3.5.5.1 Containment of spillages (Annex IIIA 4.5.1) 

Keep people and animals away. 

Do not discharge into drains / surface water / groundwater. Cover any spilled liquid with absorbent material 

such as sand, earth or a proprietary absorbent material. After the liquid has been absorbed, carefully sweep 

it up into a disposable container and tightly seal. Dispose by incineration in an authorised special waste 

incineration plant. Comply with local legislation. 

For larger quantities contact manufacturer. 

If spillage enters drains leading to sewage works, inform local company immediately. If spillage enters rivers 

or watercourses, inform the Environmental Agency. 

B.3.5.5.2 Decontamination of areas, vehicles and buildings (Annex IIIA 4.5.2) 

Take up with adsorbent material (e.g. sand, earth or a proprietary absorbent material). 

Transfer collected material to heavy duty plastic drums and keep safe for disposal. 

Clean contaminated floors and objects thoroughly, observing environmental regulations. 

B.3.5.5.3 Disposal of damaged packaging, adsorbents and other materials (Annex IIIA 4.5.3) 

After the liquid has been absorbed (sand, earth or proprietary absorbent material), carefully sweep it up into 

a disposable container and tightly seal. Damaged packaging and adsorbents should be collected into heavy 

duty plastic drums. 

Containers and drums can be taken to waste disposal site or incineration plant, after consultation with site 

operator and/or with the responsible authority. Dispose of by incineration in an authorised special waste 

incineration plant. Comply with local legislation. For larger quantities, contact manufacturer. 
– 28 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.5.5.4 Protection of emergency workers and bystanders (Annex IIIA 4.5.4) 

Keep people and animals away. Avoid contact with spilled product or contaminated surfaces and wear 

personal protective equipment (see B.3.5.4.6). 

In the event of fire and/or explosion, do not breathe fumes. Wear self contained breathing apparatus for fire 

fighting if necessary. Remove product from area of fire or otherwise cool containers with water in order to 

avoid pressure being built up due to heat. 

When dealing with a spillage, do not eat, drink or smoke. Remove soiled or soaked clothing immediately. 

Clean hands and face at work intervals and after work. 

B.3.5.5.5 First aid measures (Annex IIIA 4.5.5) 

General advice: Move out of dangerous area. If the patient is likely to become unconscious, place 

and transport in stable sideways position. Remove soiled or soaked clothing 

immediately. 

After inhalation: Move the patient to fresh air and keep at rest. Call a physician immediately. 

After eye contact: In the case of contact with eyes, rinse immediately with plenty of water. Call a 

physician immediately. 

After skin contact: After contact with skin, wash immediately with soap and plenty of water. Call a 

physician immediately. 

After ingestion: Do not induce vomiting. Wash out mouth with water. Call a physician immediately. 

B.3.5.6 Neutralisation procedures, pyrolytic behaviour and other methods (Annex IIIA 4.6) 

B.3.5.6.1 Details of proposed procedures for small quantities (Annex IIIA 4.6.1) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 

B.3.5.6.2 Evaluation of products of neutralization (small quantities) (Annex IIIA 4.6.2) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 

B.3.5.6.3 Procedures for disposal of small quantities of neutralized waste (Annex IIIA 4.6.3) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 

B.3.5.6.4 Details of proposed procedures for large quantities (Annex IIIA 4.6.4) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 

B.3.5.6.5 Evaluation of products of neutralization (large quantities) (Annex IIIA 4.6.5) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 

B.3.5.6.6 Procedures for disposal of large quantities of neutralized waste (Annex IIIA 4.6.6) 

No neutralization procedure (e.g. reaction with alkali to form less toxic compounds) is suitable for 

spirotetramat OD 150. 
– 29 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.6 Pyrolytic Behaviour of the Active Substance (Annex IIIA 4.7) 

Not applicable as the product spirotetramat OD 150 does not contain chlorine. 

B.3.7 Disposal Procedures for the Plant Protection Product (Annex IIIA 4.8) 

B.3.7.1 Detailed instructions for safe disposal of product and its packaging (Annex IIIA 4.8.1) 

Leftover quantities of the product have to be burned in an authorised special waste incineration plant. 

Comply with local legislation. 

As containers are combustible (HDPE): Burn these emptied containers in an authorised special waste 

incineration plant. Comply with local legislation. 

Otherwise, they should be rendered unusable after cleaning, e.g. by puncturing, and disposed of in 

accordance with local regulations. 

Note that empty containers can be land filled after cleaning, when in compliance with local regulations. 

B.3.7.2 Methods other than controlled incineration for disposal (Annex IIIA 4.8.2) 

No methods other than controlled incineration are recommended for disposal. 

B.3.7.3 Other/Special Studies (Annex IIIA 4.9) 

No other / special studies have been conducted. 
– 30 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

B.3.8 References relied on 

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

Annex II Data and Information

KIIA 3.6 /06 Anonymous 2002 Efficacy evaluation of plant protection 

products - Resistance risk analysis 

Publisher:European and Mediterranean 

Plant Protection Organization, 

Journal:Efficacy evaluation of plant 

protection products, 

Volume:1, 

Issue:PP1/213(2, 

Pages:76-93, 

Year:2004, 

Report No.: M-256143-01-1, 

Edition Number: M-256143-01-1 

Non GLP, published 

No 

KIIA 3.7 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.1 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.2 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.3 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 
– 31 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 3.6 /06 Anonymous 2002 Efficacy evaluation of plant protection 

products - Resistance risk analysis 

Publisher:European and Mediterranean 

Plant Protection Organization, 

Journal:Efficacy evaluation of plant 

protection products, 

Volume:1, 

Issue:PP1/213(2, 

Pages:76-93, 

Year:2004, 

Report No.: M-256143-01-1, 

Edition Number: M-256143-01-1 

Non GLP, published 

No 

KIIA 3.7 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.1 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.2 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.8.3 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 3.9 /01 Anonymous 2006 Spirotetramat TC 

Bayer CropScience AG, 

Report No.: M-276780-01-1, 

Edition Number: M-276780-01-1 

Date: 01.09.2006 

Non GLP, unpublished 

Yes BCS 
– 32 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 3.6 /01 Elbert, A.; 

Nauen, R. 

1996 Bioassays for Imidacloprid for resistance 

monitoring against the whitefly Bemisia 

Tabaci 

Publisher:Brighton Crop Protection 

Conference, 

Journal:Proceedings of the Brigthon Crop 

Protection Conference - Pests and 

Diseases, 

Issue:6D-8, 

Pages:731-738, 

Year:1996, 

Report No.: MO-01-021697, 

Edition Number: M-087913-01-1 

Non GLP, published 

No 

KIIA 3.6 /02 Heimbach, U.; 

Kral, G.; 

Niemann, P. 

2000 Implementation of resistance risk analysis 

of plant protection products in the German 

authorisation procedure 

Publisher:BCPC (British Crop Protection 

Council), 

Location:Farnham, Surrey, UK, 

Journal:The BCPC Conference - Pest & 

Diseases 2000 - Conference Proceedings,

Volume:2 (7B-2), 

Pages:771 - 776, 

Year:2000, 

Report No.: M-256236-01-1, 

Edition Number: M-256236-01-1 

Non GLP, published 

No 

KIIA 3.6 /03 McNamara, D. 

G.; Smith, I. M. 

2000 Development of an international standard 

on resistance risk analysis 

Publisher:BCPC (British Crop Protection 

Council), 

Location:Farnham, Surrey, UK, 

Journal:The BCPC Conference - Pest & 

Diseases 2000 - Conference Proceedings,

Volume:2 (7B-1), 

Pages:765 - 770, 

Year:2000, 

Report No.: M-256264-01-1, 

Edition Number: M-256264-01-1 

Non GLP, published 

No 
– 33 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 3.5.1 /01 Nauen, R. 2005 Spirodiclofen: Mode of action, resistance 

risk assessment in Tetranychid pest 

mites 

Publisher:Pesticide Science Society of 

Japan, 

Location:Anonymous, 

Journal:Journal of Pesticide Sciences, 

Volume:30, 

Issue:3, 

Pages:1-4, 

Year:2005, 

Report No.: M-277046-01-1, 

Edition Number: M-277046-01-1 

Non GLP, published 

No 

KIIA 3.6 /05 Nauen, R., 

Denholm, I. 

2005 Resistance of insect pests to 

neonicotinoid insecticides: current status 

and future prospects 

Publisher:Wiley InterScience, 

Location:Wiley-Liss, Inc., 

Journal:Archives of Insect Biochemistry 

and Physiology, 

Volume:58, 

Issue:2005, 

Pages:200-215, 

Year:2005, 

Report No.: MO-05-007838, 

Edition Number: M-250577-01-1 

Non GLP, published 

No 

KIIA 3.6 /07 Nauen, R.; 

Bretschneider, 

T.; Elbert, A.; 

Fischer, R.; 

Reckmann, U.; 

van 

Waetermeulen, 

X. 

2005 Biological and mechanistic considerations 

on the mode of action of Spirotetramat 

Publisher:Anonymous, 

Location:Anonymous, 

Journal:Journal of Pesticide Science, 

Volume:30, 

Issue:-, 

Pages:272, 

Year:2005, 

Report No.: M-277043-01-1, 

Edition Number: M-277043-01-1 

Non GLP, published 

No 
– 34 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 3.6 /04 Nauen, R.; 

Elbert, A. 

2003 European monitoring of resistance to 

selected insecticides in Myzus persicae 

and Ahis gossypii (Homoptera: Aphididae) 

with special reference to imidacloprid 

Publisher:Bulletin of Etmological 

Research, 

Volume:93, 

Pages:47-54, 

Year:2003, 

Report No.: MO-03-004948, 

Edition Number: M-089162-01-1 

Non GLP, published 

No 

KIIA 3.6 /08 Rauch, N.; 

Nauen, R. 

2003 Identification of biochemical markers 

linked to neonicotinoid cross resistance in 

Bemisia tabaci (Hemiptera: aleyrodidae) 

Publisher:Wiley-Liss, Inc., 

Journal:Archives of Insect Biochemistry 

and Physiology, 

Volume:54, 

Pages:165 - 176, 

Year:2003, 

Report No.: MO-05-009326, 

Edition Number: M-252537-01-1 

Non GLP, published 

No 
– 35 – 

Spirotetramat – Volume 3, Annex B.3, Data on application and further information April 2008

Annex point/ 

reference 

number 

Author(s) Year Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

Annex III Data and Information

KIIIA1 4.2.1 /01

KIIIA1 4.2.2 /01

KIIIA1 4.4.1 /01

KIIIA1 4.4.2 /01

KIIIA1 4.4.3 /01

KIIIA1 4.4.4 /01

KIIIA1 4.4.5 /01

KIIIA1 4.4.6 /01

KIIIA1 4.4.7 /01

KIIIA1 4.4.8 /01

KIIIA1 4.4.9 /01

KIIIA1 4.5.1 /01

KIIIA1 4.5.2 /01

KIIIA1 4.5.3 /01

KIIIA1 4.5.4 /01

KIIIA1 4.5.5 /01

KIIIA1 4.6.1 /01

KIIIA1 4.6.2 /01

KIIIA1 4.6.3 /01

KIIIA1 4.6.4 /01

KIIIA1 4.6.5 /01

KIIIA1 4.6.6 /01

KIIIA1 4.7 /01

KIIIA1 4.8.1 /01

KIIIA 4.8.2 /01

Anonymous. 2006 Spirotetramat OD 150 G 

Bayer CropScience AG, 

Report No.: M-276466-01-1, 

Edition Number: M-276466-01-1 

Date: 04.08.2006 

Non GLP, unpublished 

Yes BCS 

KIIIA1 4.2.2 /02 Anonymous 2001 Efficacy guideline 302, european and 

mediterranean plant protection 

organisation - Cleaning application 

equipment - Efficacy aspects 

Publisher:PSD, 

Location:Great Britain, 

Year:2001, 

Report No.: M-279919-01-1, 

Edition Number: M-279919-01-1 

Non GLP, published 

No