# Annex B



# Spirotetramat

B.1 Identity

Reviewed by:

PMRA, Canada

Peer-reviewed by:

US EPA, USA

AGES, Austria- 2 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### Table of contents

B.1 Identity 3

B.1.1 Identity of the active substance (IIA 1) 3

B.1.2 Identity of the plant protection product (IIIA 1) 7

B.1.3 References relied on 9- 3 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### B.1 Identity

B.1.1 Identity of the active substance (IIA 1)

B.1.1.1 Applicant (name, address, contact, phone and fax nu mbers) (IIA 1.1)
Bayer CropScience AG Development Global Regulatory Affairs
Alfred-Nobel-Str. 50
D-40789 Monheim am Rhein Germany

Person to contact: Dr. H.-W. Rauen Telephone No.: +49 2173 / 38 4333
Telefax No.: +49 2173 / 38 3580
Email: hans-werner.rauen@bayercropscience.com

US applicant

Bayer CropScience
P.O. Box 12014
2 T.W. Alexander Drive Research Triangle Park, NC 27709

Clive A. Halder, Ph. D 919-549-2824 Clive.halder@bayercropscience.com

Alternate Contact: Larry Hodges 919-549-2870 Larry.hodges@bayercropscience.com

Canada applicant

Bayer CropScience Inc. 3131 114 th Ave. S.E., Suite 100 Calgary, Alberta T2Z 3X2

Person to contact Roy Lidstone Tel. 613-722-8111 Fax. 613-722-1470 Email. roy.lidstone@bayercropscience.com- 4 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008


### B.1.2.1 Manufacturer(s) (name, address, contact, phone and fax numbers) (IIA 1.2)
Bayer CropScience AG Industrial Operations
Alfred-Nobel-Str. 50
D-40789 Monheim am Rhein Germany

Person to contact: as applicant

Location of plant(s)

D-41538 Dormagen Germany



### B.1.1.3 ISO common name proposed or accepted, and s ynonyms (IIA 1.3)
Spirotetramat (ISO), no synonyms



### B.1.1.4 Chemical name(s) (IIA 1.4)

IUPAC: cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-x ylyl)-1-azaspiro[4.5]dec-3-en-2-

one

CAS: cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-a zaspiro[4.5]dec-3-en-4-yl

ethyl carbonate



### B.1.1.5 Manufacturer's codes, names and patent stat us (IIA 1.5)

B.1.1.5.1 Manufacturer's code number(s), incl. coun tries and periods where used (IIA

1.5.1)
BYI 08330 (applicant's code number)



### B.1.1.5.2 Trade name(s) (IIA 1.5.2)
EU: Not a EU requirement
USA: Movento Canada: Spirotetramat technical



### B.1.1.5.3 Patent status (IIA 1.5.3)
EU: Not a EU requirement

USA: Expiry: 2017 (LeA 31920 (WO 98/05638): BYI 8 330) Expiry: 2023 (LeA 36137 (WO 04/007448): cis BYI 8330)

Canada: Expiry: 2023 (LeA 36137 (WO 04/007448): ci s BYI 8330)- 5 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### B.1.1.6 Existing CAS, CIPAC, EINECS and ELINCS numb ers (IIA 1.6)

CAS number: 203313-25-1
EU index number: not allocated
EINECS number: not allocated
CIPAC number: 795



### B.1.1.7 Molecular formula, molecular mass and struc tural formula (IIA 1.7)

Molecular formula: C 21 H 27 NO 5

Structural formula:

N H O

O O

O CH 3

C H 3 C H 3

O C H 3

Molecular mass: 373.45 g/mol- 6 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### B.1.1.8 Method of manufacture (IIA 1.8)

B.1.1.8.1 Method of manufacture (pathways, by-produ cts and impurities) for each

plant, whether or not relevant to a pilot plant (II A 1.8.1)
Please refer to Volume 4, confidential part.



### B.1.1.8.2 Description of starting materials (IIA 1. 8.2)
Please refer to Volume 4, confidential part.



### B.1.1.9 Specification of purity of the active subst ance (IIA 1.9)

B.1.1.10 Minimum and/or nominal content (g/kg) of p ure active substance (excluding

inactive isomers), whether or not relevant to a pil ot plant (IIA 1.9.1)

B.1.1.10.1 Minimum content (g/kg) of pure active su bstance (excluding inactive

isomers), whether or not relevant to a pilot plant (IIA 1.9.1.1)
960 g/kg No information concerning the status of production (pilot or large scale) is given by the

notifier.



### B.1.1.10.2 Nominal content (g/kg) of pure active su bstance (excluding inactive isomers),

whether or not relevant to a pilot plant (IIA 1.9.1 .2)
Please refer to Volume 4, confidential part.



### B.1.1.10.3 Control product specification form or co nfidential statement of formula (IIA

1.9.3)

Please refer to Volume 4, confidential part.



### B.1.1.11 Identity of inactive isomers, impurities a nd additives (IIA 1.10)

Please refer to Volume 4, confidential part.



### B.1.1.12 Analytical profile of batches (IIA 1.11)

Please refer to Volume 4, confidential part.



### B.1.1.12.1 Results of analyses of batches prodused in laboratory or pilot scale

production systems and used in toxicological testin g (IIA 1.11.1)
Please refer to Volume 4, confidential part.- 7 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008 

### B.1.1.13 Other/special studies (IIA 1.12)

B.1.2 Identity of the plant protection product (IIIA 1)

Please refer to Volume 4, confidential part.



### B.1.2.1 Manufacturer or manufacturers of the plant protection product (AIII 1.2)

Bayer CropScience AG D-41538 Dormagen Germany

And

Bayer CropScience P.O. Box 12014, 2 T.W. Alexander Drive Research Triangle Park
NC 27709

B.1.2.2 Current, former and proposed trade names a nd development code numbers (IIIA

1.3)

Movento® 150 OD Insecticide 

### Movento® 240 SC Insecticide

B.1.2.3 Composition of the preparation (IIIA 1.4)

Please refer to Volume 4, confidential part.



### B.1.2.3.1 Contents of technical active substance (I IIA 1.4.1.a)

Movento® 150 OD Insecticide
Technical active substance: 15.7%



### Movento® 240 SC Insecticide
Technical active substance: 23.0%



### B.1.2.3.2 Contents of pure active substance (IIIA 1 .4.1.b)

Movento® 150 OD Insecticide Active substance: Nominal 152 g/L Minimum 144 g/L Maximum 160 g/L- 8 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### Movento® 240 SC Insecticide Active substance: Nominal 240 g/L Minimum 233 g/L Maximum 248 g/L



### B.1.2.3.3 Formulants (IIIA 1.4.1.c)

Please refer to Volume 4, confidential part.



### B.1.2.3.4 Certified limits of each component (IIIA 1.4.2)

Please refer to Volume 4, confidential part.



### B.1.2.3.5 Names and codes identifying the active su bstance (IIIA 1.4.3)

Please refer to Volume 4, confidential part.



### B.1.2.3.6 Co-formulant details: identity, structure , trade name and specification (IIIA

1.4.4)

Please refer to Volume 4, confidential part.



### B.1.2.4 Formulation process (IIIA 1.4.5)

B.1.2.4.1 Description of formulation process (IIIA 1.4.5.1)

Please refer to Volume 4, confidential part.



### B.1.2.4.2 Discussion of the formulation of impuriti es of toxicological concern (IIIA

1.4.5.2)

Please refer to Volume 4, confidential part.



### B.1.2.5 Type of Preparation and Code (IIIA 1.5)

Movento® 150 OD Insecticide, suspension SU (PMRA), Oil dispersion (EU) Movento® 240 SC Insecticide, suspension SU (PMRA) , Suspension concentrate (EU)



### B.1.2.6 Function (IIIA 1.6)

Both formulations are insecticides.

B.1.2.7 Other/Special Studies (IIIA 1.7)

Not required by Directive 91/414/EEC- 9 -

Spirotetramat – Volume 3, Annex B.1, Identity April 2008



### B.1.3 References relied on

Please refer to Volume 4, confidential part.