Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations

Registration # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 (noctanol/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 # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 toxicity 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

Chronic 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 - mouse 

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 

pharmacokinetics 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 # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 of 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 invertebrates 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 # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 invertebrates 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 acute 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 Terrestrial field

850.4450 Aquatic field

ENVIRONMENTAL 

FATE

Degradation Studies --

Laboratory

835.2120 Hydrolysis 1 1 1 3

835.2240 Photodegradation 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 # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 Biodegradability

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 representative 

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 Standards 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 # 

8622-588622-59

6836-236

74412-1

1258-1249

16930-5

224-32

71654-273696-275661-111631-2

Total Tests

2000-2005

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 required 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 listed by their guideline number and name 

of the test.

Use Site Grouping. The use site grouping 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 Exposure Use