## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required



## PRODUCT

CHEMISTRY

Product Identity,

Composition, and Analysis

830.1550 Product Identity and

Composition 1 1 1 1 1 1 1 7

830.1600 Description of Materials Used to

Produce the Product 1 1 1 1 1 1 6

830.1620 Description of Production

Process 1 1 1 1 1 1 6

830.1650 Description of Formulation

Process 1 1 1 1 1 1 6

830.1670 Description of Formation of

Impurities 1 1 1 1 1 5

830.1700 Preliminary Analysis 1 1 1 1 1 1 1 7

830.1750 Certified Limits 1 1 1 1 1 1 1 1 1 9

830.1800 Enforcemtent Analytical Method 1 1 1 3

830.1900 Submittal of Samples 0

Physical and Chemical

Properties

830.6302 Color 1 1 1 1 1 1 1 1 1 1 10

830.6303 Physical State 1 1 1 1 1 1 1 1 1 1 10

830.6304 Odor 1 1 1 1 1 1 1 1 1 1 10

830.7200 Melting Point/Melting Range 1 1 1 1 1 5

830.7220 Boiling Point/Boiling Range 1 1 1 1 4

830.7300 Density/Relative Density/Bulk

Density 1 1 1 1 1 1 1 1 1 1 10

830.7840

830.7860 Water Solubility 1 1 1 1 1 1 6

830.7950 Vapor Pressure 1 1 1 1 1 1 6

830.7370 Dissociation Constants in Water 1 1 1 3

830.7550

830.7560

830.7570 Partition Coefficient (n

octanol/water) 1 1

830.7000 pH 1 1 1 1 1 1 1 1 1 9

830.6313 Stability 1 1 1 1 1 1 1 7

830.6314 Oxidation/Reduction: Chemical

Incompatibility 1 1 1 1 1 1 6

830.6315 Flammability 1 1 1 1 1 1 1 7

830.6316 Explodability 1 1 1 1 1 5

830.6317 Storage Stability 1 1 1 1 1 1 6

830.7100 Viscosity 1 1 1 1 4

830.6319 Miscibility 1 1

830.6320 Corrosion Characteristics 1 1 1 1 1 1 6

830.6321 Dielectric Breakdown Voltage 1 1

830.7050 UV/visible light absorption

-- new requirement 1 1

## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required

830.7520 Particle Size, Fiber Length, and

Diameter Distribution 0



## TOXICOLOGY

Acute Testing

870.1100 Acute oral toxicity

- rat 1 1 1 1 1 1 1 1 1 9

870.1200 Acute dermal toxici ty 1 1 1 1 1 1 1 7

870.1300 Acute inhalation toxicity

- rat 1 1 1 1 1 5

870.2400 Primary eye irritation

- rabbit 1 1 1 1 1 1 6

870.2500 Primary dermal irritation 1 1 1 1 1 1 1 1 8

870.2600 Dermal sensitization 1 1 1 1 1 1 1 1 8

870.6200 Acute neurotoxicity

- rat 1 1

Subchronic Testing

870.3100 90

- Day oral toxicity

- rodent 1 1 1 1 1 1 1 1 8

870.3150 90

- Day oral toxicity

- nonrodent 1 1 1 3

870.3250 21/28

- Day dermal toxicity 1 1

870.2500 90

- Day dermal toxicity 1 1 1 3

870.3465 90

- Day inhalation

- toxicity

- rat 1 1 1 3

870.6200 90

- Day neurotoxicity

- rat 1 1

Chron ic Testing

870.4100 Chronic toxicity

- rodent 1 1 1 3

870.4100 Chronic toxicity

- non

- rodent 1 1 2

870.4200 Carcinogenicity

- rat preferred 1 1

870.4200 Carcinogenicty

- mous e

preferred 1 1

Developmental Toxicity and

Reproduction

870.3700 Prenatal developmental toxicity

- rat preferred 1 1 1 1 1 1 1 1 1 9

870.3700 Prenatal developmental toxicity

- rabbit preferred 1 1 1 3

870.3800 Reproduction and fertility

effects 1 1 2

870.6300 Developmental neurotoxicity 0

Subdivision F,

App. 9 Mutagenicity

870.5100 Bacterial reverse mutation

assay 1 1 1 1 1 1 1 1 1 9

870.5300

870.5375 In vitro mammalian gene

mutation 1 1 1 1 1 1 1 7

870.5380

870.5385

870.5395 In vivo cytogenetics

(mutagenicity) 1 1 1 1 1 1 1 7

Special Testing

870.7485 Metabolism and

pharmaco kinetics 1 1 2

870.7200 Companion animal safety 0

870.7600 Dermal penetration 0

870.6500 Scheduled controlled operant 0

## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required

behavior

870.6850 Peripheral nerve function 0

870.6855 Neurophysiology: sensory

evoked potentials 0

870.7800 Immunotoxicity 0



## APPLICATOR

EXPOSURE

875.1100 Dermal outdoor exposure 0

875. 1200 Dermal indoor exposure 0

875.1300 Inhalation outdoor exposure 0

875.1400 Inhalation indoor exposure 0

875.1500 Biological monitoring 0

875.1600 Data reporting and calculations 0

875.1700 Product use information 0



## POST

APPLICATION

875.2200 Soil residue dissipation 0

875.2300 Indoor surface residue

dissipation 0

875.2400 Dermal exposure 0

875.2500 Inhalation exposure 0

875.2600 Biological monitoring 0

875.2700 Product use information 0

875.2800 Description o f human activity 0

875.2900 Data reporting and calculations 0

875.3000 Non

- dietary ingestion exposure 0



## NONTARGET

ORGANISM

Avian Testing

850.2100 Avian acute oral toxicity 1 1 1 1 1 5

850.2200 Avian dietary toxicity 2 2 2 6

850.2300 Avian reproduction 0

Aquatic Organisms Testing

850.1010 Acute freshwater inver tebrates 1 1 1 1 1 5

850.1025

850.1035

850.1045

850.1055

850.1075 Acute toxicity estuarine and

marine organisms 1 2 3 1 7

850.1075 Fish acute freshwater 1 2 2 2 1 1 1 10

850.1400 Fish early

- life stage 1 1 2

850.1300

850.1350 Aqatic invertebrate life cycle 1 1 1 3

850.1500 Fish life cycle 1 1

## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required

850.1710

850.1730

850.1850 Aquatic organism

bioavailability/

biomagnification/toxicity tests 1 1 2

850.1710 Aquatic

bioavailability/biomagnification:

Oyster BCF 0

850.1730 Aquatic

bioavailability/biomagnification:

Fish BCF

850.1850 Aquatic food chain transfer

- bioavailability 0

850.1950 Simulated or actual field testing

for aquatic organisms 0

see Notes Acute pore water invertebrates 1 1

Sediment Testing

850.1735 Whole sediment, acute

freshwater invertebrat es 1 1 1 3

850.1740 Whole sediment, acute marine

invertebrates 1 1

None Whole sediment, chronic

freshwater and marine 0

Insect Pollinator Testing

850.3020 Honey bee acu te contact

850.3030 Toxicity of residues to

honeybees 1 1 2



## NONTARGET

PLANT

PROTECTION

850.4225 Seedling emergence, Tier II

- dose response 1 1 2

850.4250 Vegetative vigor, Tier II

- dose

response 1 1 2

850.4400 Aquatic plant growth (Lemma

gibba) Tier II

- dose response 1 1 1 3

850.5400 Aquatic plant growth (algal)

Tier II

- dose response 1 1 2

850.4300 Terrestria l field

850.4450 Aquatic field



## ENVIRONMENTAL

FATE

Degradation Studies

-- Laboratory

835.2120 Hydrolysis 1 1 1 3

835.2240 Photodegradati on in water 1 1 2

835.2410 Photodegradation in soil

Biodegradation Studies

-- Laboratory

835.1110 Activated Sludge Sorption

Isotherm

## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required

835.3110 Ready Biodegradab ility

850.6800 Modified Activated Sludgge,

Respiration Inhibition Test

Mobility Studies

835.1230 Adsorption/desorption 1 1 2

835.1240 Soil column leaching 1 1 2

Metabolism Studies

-- Laboratory

835.4100 Aerobic soil metabolism 1 1 2

835.4200 Anaerobic soil metabolism 1 1 2

835.4300 Aerobic aquatic metabolism 1 1 1 3

835.4400 Anaerobic aquatic metabolism 1 1 1 3

Dissipation Studies

835.6200 Aquatic (sediment) 0

Ground and Surface Water

Monitoring

None Monitoring of represen tative

U.S. waters 0

Special Studies

None Special leaching 1 1 2



## RESIDUE

CHEMISTRY

Supporting Information

860.1100 Chemical Identity 0

860.1200 Directions for Use 0

860.1550 Proposed Tolerance 0

860.1560 Reasonable Grounds In Support

of Petition 0

860.1650 Submittal of Analytical

Reference Standa rds 0

Nature of the Residue

860.1300 Nature of the Residue in Plants 0

860.1300 Nature of the Residue in

Livestock 0

860.1850 Confined Rotational Crops 0

Analytical Methods

860.1340 Residue Analytical Method 0

861.1340 Residue Analytical Method

- plants

860.1340 Residue Analytical Method

-

livestock 0

860.1360 Multiresidue Method 0

Magnitude of the Residue

860.1380 Storage Stability 0

860.1500 Crop Field Trials 0

860.1520 Processed Food or Feed 0

860.1480 Meat/Milk/Poultry/Eggs 0

860.1400 Potable Water 0

## Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration #8622-588622-596836-23674412-11258-124916930-5224-3271654-273696-275661-111631-2Total Tests2000-2005



### Use Site Group* I I W A L L L L L L L



## Guideline Data Requirement 1 = Test was required; blank = no test was required

860.1400 Fish 0

860.1400 Irrigated Crops 0

860.1460 Food Handling 0

860.1540 Anticipated Residues 0

none Migration Studies 0



## EFFICACY No efficacy tests were required for new active ingredients during 2000

-

2005.



### Total Cost for this

Registration Action$2,532,692$6,999,552$4,627,839$20,613$763,920$56,761$675,496$1,880,394$369,247$319,317$417,177



### Data in this Table. This table indicates whether a test was required for new active ingredients only. “1” means

the test was required; “2” means the test was r equired twice, etc. Blank means no test was required. These

requirements are indicated by:

Registration Number

. (Column Headings) The registration number assigned to the registration action.

Data Requirement. (Row Headings) Data requirements are lis ted by their guideline number and name

of the test.

Use Site Group ing

. The use site group ing that applies to the registration action is indicated as follows: (See

Table 5

- 1 for descriptions.)

I = Indirect Food Use

W = Wood Preservative

A = Antifoulant

L = Low Exposur e Use