For this application no new studies have been submitted. The studies in the reference list refer to the studies that have been used for the first product renewal application based on the old end points for Mammalian Toxicology. For data protection see the reference list in Part A of the re-authorization of Pokon Onkruid Weg ! d.d. 2 February 2018.
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 35 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex
point
Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant) – 14 days accelerated pack compatibility and storage stability study for the product stored in LDPE sacks, Scotts report C03FSP002,
De Smet, B. 2011 JUSTIFICATION FOR THE REQUEST TO WAIVE TESTS ON (1) EXPLOSIVE PROPERTIES AND (2) OXIDIZING PROPERTIES OF THE GRANULAR (GR)
FORMULATION ‘UKS 118’
CONTAINING THE ACTIVE SUBSTANCES
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 36 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex
point
Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant) 2,4-D + 2,4-Dicamba determination of physic-chemical harzardious Dicamba – 24 months ambient pack compatibility and storage stability study in LDPE sacks, Scotts report C05TSP007,
Harding, L 2013 Accelerated and long term stability study on UKS118A a granular Weed and feed Product
Harding, L 2013 Active ingredient of UKS118A, a granular Weed and feed Product by analytical method CEMAS SOP CEM-3563 CEMS-6050
GLP
Unpublished
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 37 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex
point
Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Scotts 2013 Explanation regarding the 2-year stability study
Harding, L 2011 Validation of the method for the analysis of 2,4-D and Dicamba in UKS 118A formulation.
CEM Analytical Services Limited (CEMAS), UK
Scotts Benelux bvba, Belgium No. CEMS-4990
GLP, Unpublished
N Y SCOTTS
IIIA 5.2.2/02
Apps, G. 2013 Validation of an analytical method for the determination of 2,4-D and Dicamba in UKS 118A formulation.
CEM Analytical Services Limited (CEMAS), UK
Scotts Benelux bvba, Belgium No. CEMS-5872
GLP, Unpublished
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 38 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 + Dicamba: Acute oral toxicity (limit test) in the rat; + Dicamba: Acute dermal toxicity (limit test) in the rat;
Report n°092/117;
GLP
Not published
Y SCOTTS Y
IIIA 7.1.4/01 1998 Greenmaster Fine Turf Extra: Acute dermal irritation in the rabbit;
Report n°092/138 GLP
Not published
Y SCOTTS Y
IIIA 7.1.5/01 2012 UKSFRAM2255-01
Assessment of acute eye irritation.
Report No: IO-OCDE-PH-12/0229-R1
GLP, not published
Y SCOTTS Y
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 39 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019
Local Lymph Node Assay in the mouse. Report n°2076/016
GLP
Not published
Y SCOTTS Y
*Data protected was already granted during previous evaluation and authorisation of this product.
Fate and behaviour
2012 Interception of UKS 151A (Evergreen Complete 4 in 1) particles by lawn turf.
The Scotts Company R & D, Marysville, Ohio, US, 31.08.2012 Non GLP, not published
N SCO Y Neustadt, Germany, Report No.
N COMPO
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 40 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 OECD Data
Point
Author Year Title Owner
Testing organisation Report №
GLP or GEP Status Published or not
Vertebr ate Study Y/N
Owner Study used Y/N
AS232, 2012-07-26 GLP, not published IIIA
9.6.1/01
Cuvelier, N. 2016 Copies of the Input Data and Results of Models FOCUS PELMO 5.5.3 and FOCUS PEARL 4.4.4 Used for the
Determination of the Predicted Environmental Concentrations in Groundwater (PECGW) for 2,4-D and its Metabolites (2,4-2,4-DCP and 2,4-DCA), and Dicamba and its Metabolite (DCSA), Following the Use of UKS118A
Redebel s.a., No. SCO-201602-01
Non GLP, Unpublished
N SCO Y
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 41 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019
GLP or GEP status (where relevant)
2006 Acute Toxicity Testing of UKS118A in Common Carp (Cyprinus Carpio) (rainbow trout) acute toxicity test (limit test)
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 42 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
2015 Final Report - Landscaper Pro Weed Control + Fertilizer a.s.
2,4-D and dicamba. Response to Ctgb’s evaluation regarding the bird and mammal risk
assessment for the non-professional use.
RIFCON GmbH Goldbeckstraße 13, 69493 Hirschberg,
GERMANY, Study No. R152063 Not GLP
2015 Additional Report - Landscaper Pro Weed Control + Fertilizer a.s.
2,4-D and dicamba. Response to Ctgb’s evaluation regarding the bird and mammal risk
assessment for the non-professional use.
RIFCON GmbH Goldbeckstraße 13, 69493 Hirschberg,
GERMANY, Study No. R152063 Not GLP
Not published
N Y SCOTTS
IIIA 10.1.8/01 Sterner, W., Korn, W.D.,
1988 Annahmeversuch an Wachteln mit “Nr. AP-ZA 20122-00-00”
nach BBA-Richtlinien 25-1., NATEC, Report No. 1-9-344-88.
Not GLP Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 43 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant) 2,4-D + 2,4-Dicamba 2,4-Daphnia magna STRAUS, Acute Immobilisation Test, 48h,
Dr. U. Noack-Laboratorium, Project No. 950317LW. Study No. DAI46771 (SCUKS118A) : Inhibition of Growth to the Alga Selenastrum capricornutum,
Covance Laboratories Ltd.
Study No. 2076/009, Report No.
2076/009-D2149 GLP
Not published
N Y SCOTTS
IIIA10.2.2.4/01 Weber, K. 2011 UKS 118 A – Assessment of Toxic Effects on the Duckweed Lemna gibba in a Semi-Static Eurofins Agroscience Services, EcoChem GmbH,
Test. Study code/Report : S11-01875
GLP
Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 44 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Hooftman, R.N. 1995 Semi-static reproduction test with F-2453 TB + 2 and Daphnia magna,
TNO Institute of Environmental, Report No. TNO-MW R 94/328.
GLP (oryctolagus cuniculus) in an agrocoenosis, Folia
IIIA 10.5.1/01 Swales, S. 2003 A test for evaluating the chronic effects of plant protection products on the rove beetle, Aleochara bilineata Gyll.
(Coleoptera: Staphylinidae) under laboratory conditions, Covance Laboratories Ltd.
Project No. 2076/003-D2149, 26 November 2003
GLP
Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 45 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
IIIA 10.5.1/02 Swales, S. 2003 A test for evaluating effects of plant protection products on spiders of the genus, Pardosa (Araneae: Lycosidae) under laboratory conditions, Covance Laboratories Ltd.
Project No. 2076/004-D2149, 26 November 2003
GLP
Not published
N Y SCOTTS
IIIA 10.5.1/03 Mead-Briggs, M., Halsall, N.
1990 An evaluation of a granular lawn fertilizer/herbicide for side-effects to the carabid beetle, Nebria brevicollis,
Agrochemical Evaluation Unit, Project No. FIS-90-3, 21 December 1990 GLP
Not published
N Y SCOTTS
IIIA 10.5.1/04 Mead-Briggs, M., Halsall, N.
1991 An evaluation of a granular lawn fertilizer/herbicide for side-effects to lycosid spiders (Pardosa spp.), Agrochemical Evaluation Unit, Project No. FIS-90-4, 10 May 1991
GLP
Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 46 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
IIIA 10.5.1/05 Moll, M. 2005 Statement for non-target arthropod studies with 22-5-5 + 2,4-D, Dicamba, Statement
IIIA 10.6.2/01 Sewell I.G., Handley J.W.
1991 The acute toxicity of FHD 71281H to earthworms (Eisenia foetida).
Safepharm Laboratories Ltd.
Report No. 92/86, 7 January 1991
GLP
Not published
N Y SCOTTS
IIIA 10.6.3/01 Friedrich, S. 2007b Sublethal toxicity of UKS 118A to the earthworm Eisenia fetida in artificial soil with 5% peat, BioChem agrar,
IIIA 10.6.6/01 Lührs, U. 2005 Effects of 22-5-5+2,4-D+Dicamba on reproduction of the
Collembola Folsomia candida in artificial soil,
IBACON GmbH,
Report No. 24145016, 21 June 2005
GLP
Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 47 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
IIIA 10.7.1/01 Mallett, M.J. 2003 Fertiliser 22-5-5 with and without herbicide: Effects on soil
microbial respiration and nitrogen transformation according to OECD Guidelines 217 and 216.
CEM Analytical Services Limited (CEMAS), Report No. CEMR-2145, 12 December 2003 GLP
Not published
N Y SCOTTS
IIIA 10.10/02 Scheerbaum, D 1995 20-5-8 + 5% SRN (MSCU) + 2,4-D + 2,4-Dicamba, Alga Growth Inhibition Test,
Dr. U. Noack-Laboratorium, Project No. 950317LW. Study No. SSO46771
GLP
Not published
N Y SCOTTS
IIIA 10.10/03 Dommröse, A.M 1989 Untersuchung mit der
Prüfsubstanz “Rasendünger mit Unkrautvernichter” im
verlängerten Toxizitätstest (OECD Richtlinie No. 204) an Fischen (Regenbogenforelle), NATEC Institut NA 89 9656/2.3, Dezember 1989, report NA 89 9656/2.3.
Not GLP Not published
N Y SCOTTS
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 48 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019 Annex point Author Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
IIIA 10.10/04 Gossmann, A. 1996 Effects of Scotts Unkrautvernichter mit
Rasenduenger on reproduction and growth of earthworms Eisenia fetida (Savigny 1826) in artificial soil (combined range-finding and limit test), IBACON GmbH
Report No.1040022, 12 February 1996
GLP
Not published
N Y SCOTTS
IIIA 10.10/05 Friedrich, S. 2007a Sublethal toxicity of UKS 118A – Fertilizer Blank to the earthworm Eisenia fetida in artificial soil with 5% peat
assessment for earthworms from exposure to 22-5-5 + 2,4-D,
Part B – Section 9
National Addendum – The Netherlands
Pokon Onkruid Weg ! Registration Report – Central Zone Page 49 of 49
Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb
Date : April 2019