To Be Filled in by the National Agency of Environmental Protection

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To Be Filled in by the National Agency of Environmental Protection

Danger category Group Date of approval

To be filled in by the National Agency of Environmental Protection.

APPLICATION to the National Agency of Environmental Protection Miljøstyrelsen

Strandgade 29, DK-1401 Copenhagen K, Denmark

for approval of a biocidal product

in pursuance of Statutory Order from the Ministry of the Environment on Chemical Pesticides.

APPLICATION CONCERNING THE FORMULATED PRODUCT

A 1 1.1. Name of the applicant (company), address, Contact-person and e- mail address. telephone number and SE no. 1.2. Name/style and address of the manufacturer

1.3 Name of the product (trade name) and code

Registration No...... (Further copies of the application can be ordered from 2 oc. page No. Reference No...... 19 the National Agency of Environmental Protection) For office use only 3 Doc. Page No

A 2 INFORMATION ABOUT THE PRODUCT 2.1. Type of biocidal For instance insecticide, herbicide etc. product (Use ISO classification)

2.2 Mode of function If possible, indicate mode of function, for instance systemic, contact or stomach poison etc.

2.3 Active ingredients State the declaration name or chemical name of (Type and each of the active ingredients and the percentage by percentage) weight, and, for liquid products, g/l.

2.4 Auxiliary matters State type, chemical name and percentage of each of the solvents, dispersing agents, emulsifiers, and others contained in the product in accordance with IUPAC or CA, and CAS number.

2.5 Physical state of the State whether the product is a liquid, wettable product powder, dust, fumigation powder, impregnated article (type), aerosol etc. 4 oc. page No. A 3 APPLICATION OF THE PRODUCT

3.1 Application field State types of plant diseases, pest etc. to be controlled by the pesticide in accordance with the enclosed or contemplated directions for use, in which crop or on which material, etc. it shall be used, and whether the product shall be used in agriculture, horticulture, fruit growing etc., in closed rooms (greenhouses, stables, poultry houses, food factories, storage rooms, kitchens, living quarters) etc.

3.2 Dosing and For each field of application, state the application rate recommended dosing for instance by kg of active ingredients/hectare, or g of active ingredient/unit, and the application rate to be recommended in the directions for use etc. The rate shall be indicated as the percentage of the product in the ready-for-use solution, and in quantity of liquid/hectare.

3.3 Application Recommended application method, frequency, time. For sprays, indicate spray pressure. If additives are recommended, state type and quantities. 5 oc. page No. 3.4 Miscibility State the miscibility or immiscibility of the product with other pesticides/other substances. State if it is recommended to apply the product together with other pesticides.

3.5 Efficacy Wood preservatives: State the results of tests made under standard conditions. The tests shall relate to the intended application of the product, and the wood to which it is applied. Test method Species of Dose limit fungus or insects

Other products:

Tests in laboratory, climatic chamber and greenhouse. State results of tests made under standard conditions and with different doses, and under conditions relevant to the practical application of the product.

Field tests. State results of tests made under 6 oc. page No. climatic, agricultural and other conditions comparable to the conditions under which the product is to be used in Denmark in accordance with the directions for use.

Unwanted effects (or side effects). Phytotoxicity. State relevant tests of impact on cultivated plants and later crops.

Nuisances, and effects on materials, furniture, domestic animals and pet animals, and indoor plants etc.

A 4 PACKAGING

4.1 Proposal for label- ling and directions for use

4.2 Packaging State weight (or for liquids, volume) of the size of package in which the product is to be marketed; 7 oc. page No. and, for each size, the type of package, for instance 1 kg in cans with screw plug, and 50 kg in iron drums. Please note that the product must be sold only in the package size and type notified to the National Agency of Environmental Protection and for which the label is approved.

A 5 TOXICOLOGICAL DATA The tests shall in principle be carried out in accordance with OECD Guidelines. If this is not the case, state other methods used.

5.1 Acute oral toxicity LD50, mg/kg animal species

Effects observed, including damage to organs.

Were the results achieved by testing or calculation? (Calculation, if any, shall be stated).

Were the animals fasting Yes No

5.2 Acute dermal LD50, mg/kg animal species toxicity

Effects observed, including damage to organs

5.3 Acute toxicity by concentra- duration of tests LC animal inhalation tion (mg/l) (hours) 50 species 8 oc. page No. actual

nominal

Effects observed, including damage to organs

5.4 Skin irritation State value of primary irritation index.

5.5 Irritation of eyes State value of primary irritation index.

5.6 Other toxicological data concerning the product which may be known to the ap- plicant 5.7 Toxicological data concerning non- active ingredients which may be known to the applicant

A 6 ECOTOXICOLOGICAL STUDIES 6.1 Does the product Yes No contain substances dangerous to bees? 6.2 Other ecotoxicological effects 6.3 Ecotoxicological effects of non-active ingredients which may be known to the applicant

A 7 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PRODUCT 7.1 Free acidity or State pH 9 oc. page No. alkalinity

7.2 Density (for liquids)

7.3 Particle size (for powder and dust)

7.4 Suspension or emulsification properties

7.5 Storage stability, including sensitivity to cold

7.6 Corrosive properties

7.7 Vapour pressure

7.8 Flash point

7.9 Properties during heating and fire

7.10 Relevant supplementary information

A 8 SUPPLEMENTARY INFORMATION TO BE USED FOR CLASSIFICATION AND LABELLING 8.1 Inflammability In accordance with the definitions given in classification Statutory Order from the Ministry of the Environment on Classification, Packaging and 10 oc. page No. Labelling etc.

8.2 Classification during transport

A 9 Destruction method Chemical or other method to destroy the product and its packaging

A 10 Method of analysis Methods to determine the active ingredients of the product, qualitatively and quantitatively.

A 11 INFORMATION FOR THE LABOUR INSPECTION SERVICE 11.1 Protective Protective equipment proposed during handling of equipment the concentrated product and during application of the product as such or diluted.

11.2 Measures to be taken during fire, with proposals for suitable fire extinguishers 11 oc. page No.

Date Signature

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