Appendix B. Table of Generic Data Requirements and Studies Used to Make the 

Reregistration Decision for Pyrethrins (PC 069001)

GUIDE TO APPENDIX B

Appendix B contains a listing of data requirements which support the 

reregistration for active ingredients within the pyrethrins case covered by this RED. It 

contains generic data requirements that apply pyrethrins in all products, including data 

requirements for which a “typical formulation” is the test substance.

The data table is organized in the following formats:

1. Data requirement (Column 1). The data requirements are listed in the order in 

which they appear in 40 CFR 158. The reference numbers accompanying each 

test refer to the test protocols set in the Pesticide Assessment Guidance, which is 

available from the National Technical Information Service, 5285 Port Royal 

Road, Springfield, VA 22161. (703) 487-4650.

2. Use Pattern (Column 2). This column indicates the use patterns for which the 

data requirements apply. The following letter designations are used for the given 

use patterns.

A. Terrestrial food

B. Terrestrial feed

C. Terrestrial non-food

D. Aquatic food

E. Aquatic non-food outdoor

F. Aquatic non-food industrial

G. Aquatic non-food residential

H. Greenhouse food

I. Greenhouse non-food

J. Forestry

K. Residential

L. Indoor food

M. Indoor non-food

N. Indoor medical

O. Indoor residential

3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this 

column lists the identifying number of each study. This normally is the Master Record 

Identification (MRID) number, but may be a “GS” number is no MRID number has been 

assigned. Refer to the Bibliography appendix for a complete citation of the study.
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

PRODUCT CHEMISTRY

(unknown) 61-2

Description of Beginning Materials 

and Manufacturing Process All 43495201

(unknown) 61-3 

Discussion of Formation of 

Impurities All 43495201

830.1550 61-1 Product Identity and Composition All 40836301, 41311201, 

41474601, 43495201

830.1600 61-2A Description of materials used to 

produce the product All

45923201, 41311201, 

00161540, 41474601, 

41474601, 

00156652, 41365501, 

44325201

830.1620 61-2B Description of production process Al

44245101, 45923201, 

00161540, 41311201, 

41474601, 41193901, 

00156652, 41365501, 

44325201

830.1670 61-2B Formation of Impurities All

40836301, 41311201, 

41474601, 45923201, 

41193901, 41365501, 

44325201

830.1700 62-1 Preliminary Analysis All

41311201, 00165269, 

41193901, 41365501, 

44325201,40836302

830.1750 62-2 Certification of Limits All 40836302, 41311201, 

41474601, 40836302

830.1800 62-3 Analytical Method All

40836301, 45923201, 

41311202, 41474601,, 

41193901, 41365501, 

40836302

830.6302 63-2 Color All

40836303, 45625306, 

41311203, 41474601, 

41474601, 41193901, 

41365501

830.6303 63-3 Physical State All

40836303, 40836303

45625306, 41311203, 

41474601, 41193901, 

45923201, 41365501 

830.6304 63-4 Odor All

40836303, 41311203, 

41474601, 41474601, 

45625306, 41193901, 

41474601, 41365501

830.6313 63-13

Stability to normal and elevated 

temperatures, metals, and metal 

ions

All

40836303, 42103901, 

41311203 , 41193901, 

41365501

830.7000 63-12 pH All 45625306, 41474601, 

41474601, 45625306

830.7050 None UV/Visible Absorption All DATA GAP

830.7220 63-6 Boiling Point/boiling range All 40836303, 41311203, 
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

41193901, 41365501

830.7300 63-7 Density All

40836303, 42103901, 

45625306, 41474601, 

41474601, 45625306, 

41365501

830.7370 63-10 Dissociation Constants in Water All 41311203, 41193901

830.7550 63-11 Partition coefficient, shake flask 

method All 40836303, 41311203, 41193901, 41365501

830.7840 63-8 Solubility All 40836303, 41311203, 

41193901, 41365501

830.7860 63-8

Water solubility, generator column 

method All 40836303, 41311203, 41193901, 41365501

830.7950 63-9 Vapor Pressure All

40836303, 

41311203, 41193901, 

41365501

ECOLOGICAL EFFECTS

850.1010 72-2 

Acute Toxicity to Freshwater 

Invertebrates A, B, C, K 43082305, 43082306

850.1025 72-3B Estuarine/Marine Toxicity –

Mollusk A, B, C, K 43082309, 43082310

850.1035 72-3C Estuarine/Marine Toxicity –

Shrimp A, B, C, K 43082311, 43082312

850.1045 72-3 Panaeid Acute Toxicity Test A, B, C, K 43082307, 43082308, 

43082311, 43082312

850.1075 72-1A Fish Toxicity Bluegill A, B, C, K 43082301, 43082302, 

43082303, 43082304

850.1075 72-3A Estuarine/Marine Toxicity – Fish A, B, C, K 43082307

43082308

850.1300 72-4A Daphnid Chronic Toxicity Test A, B, C, K 43252701

850.1350 72-4B Estuarine/Marine Invertebrate Life 

Cycle A, B, C, K 43252702, DATA GAP

850.1400 72-4C Early-life Stage Freshwater Fish A, B, C, K 43252701, DATA GAP

850.2100 71-1A Avian Acute Oral Toxicity A, B, C, K 42010901

850.2200 71-2A Avian Dietary Toxicity – Quail A, B, C, K 41968801, 41968802

850.3020 141-1Honey bee acute contact LD50 A, B, C, K

41968803

Atkins et al., 1967

Stevenson, 1968

Stevenson, 1978

850.4100 122-1 Seedling Emergence, Tier 1 A, B, C, K DATA GAP

850.4150 122-1 Vegetative Vigor, Tier 1 A, B, C, K DATA GAP

850.4400 123-2 Aquatic Plant Toxicity A, B, C, K DATA GAP

850.5400 122-2B Aquatic Plant Growth, Tier 2 A, B, C, K DATA GAP

NonGuideline 

Study

NonGuideline 

Study

Chronic Freshwater Sediment 

Testing A, B, C, K DATA GAP

NonGuideline 

Study

NonGuideline 

Study

Chronic Estuarine/Marine 

Sediment Testing A, B, C, K DATA GAP

TOXICOLOGY

870.1100 81-1 Acute Oral Toxicity - Rat A, B, C,H, I, 

K, L, M, O

42008101, 42599501, 

263780
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

870.1200 81-2

Acute Dermal Toxicity –

Rabbit/Rat

A, B, C,H, I, 

K, L, M, O 41964801

870.1300 81-3 Acute Inhalation Toxicity – Rat A, B, C,H, I, 

K, L, M, O 42008001, 

870.2400 81-4 Primary Eye Irritation - Rabbit A, B, C,H, I, 

K, L, M, O 41964802

870.2500 81-5 Primary Skin Irritation A, B, C,H, I, 

K, L, M, O 41964803

870.2600 81-6 Dermal Sensitization A, B, C,H, I, 

K, L, M, O 41964804

870.3200 82-2 21-Day Dermal – Rabbit/Rat A, B, C,H, I, 

K, L, M, O 42212601

870.3465 82-5 90- Day Inhalation Toxicity A, B, C,H, I, 

K, L, M, O 42478201

870.3700A 83-3A Developmental Toxicity – Rat A, B, C,H, I, 

K, L, M, O 40288202

870.3700B 83-3B Developmental Toxicity – Rabbit A, B, C,H, I, 

K, L, M, O 40288203

870.3800 83-4 2-Generation Reproduction – Rat A, B, C,H, I, 

K, L, M, O 41327501

870.4100A 83-1 Chronic Toxicity Rodents A, B, C,H, I, 

K, L, M, O 41559501

870.4100B 83-1B Chronic Feeding Toxicity Study -

Non-rodent

A, B, C,H, I, 

K, L, M, O 41496501

870.4200 83-2 Carcinogenicity - Rat A, B, C,H, I, 

K, L, M, O 41559501

870.4300 83-5

Combined Chronic 

Toxicity/Carcinogenicity: Rats

A, B, C,H, I, 

K, L, M, O 41559401

870.5265 84-2 Gene Mutation Ames Assay A, B, C,H, I, 

K, L, M, O 41344701

870.5375 84-2

Cytogenetis – CHO Chromosomal 

Aberrations

A, B, C,H, I, 

K, L, M, O 41344601, 43987001

870.5550 84-2

Unscheduled DNA Synthesis in 

Mammalian Cells in Culture

A, B, C,H, I, 

K, L, M, O

41344501

870.6200a 81-8 

Acute neurotoxicity screen study in 

rats

A, B, C,H, I, 

K, L, M, O 42925801

870.6300 83-6

Developmental Neurotoxicity 

Study

A, B, C,H, I, 

K, L, M, O DATA GAP

870.7485 85-1 General Metabolism A, B, C,H, I, 

K, L, M, O 43554304, 43884101

Non-guideline 

Study

Nonguideline 

Study

Definitive Mechanistic Toxicity 

Study in Rats

A, B, C,H, I, 

K, L, M, O 45889802, 45889803

Non-guideline 

Study

Nonguideline 

Study

Toxicology: Cellular Changes in 

Larynx 

A, B, C,H, I, 

K, L, M, O 46605701

Nonguideline 

Study

Nonguideline 

Study

Developmental Thyroid Assay A, B, C,H, I, 

K, L, M, O DATA GAP

ENVIRONMENTAL FATE

835.1240 163-1 Leaching/Adsorption/Desorption A, B, C, K 43096603
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

835.1410 163-2 Laboratory Volatilization (from 

Soil) Study A, B, C, K 43096604

850.1730 165-4 Accumulation in Fish A, B, C, K 43302301, 43884102

835.2120 161-1 Hydrolysis A, B, C, K 43188201, 43567502, 

835.2240 161-2 Photodegradation - Water A, B, C, K 43096601, 43567601 

835.2410 161-3 Photodegradation - Soil A, B, C, K 43096602

835.4100 162-1 Aerobic Soil Metabolism A, B, C, K 43499803

835.4200 162-2 Anaerobic Soil Metabolism A, B, C, K 43499802

835.4300 162-4 Aerobic Aquatic Metabolism A, B, C, K 43499801, 43499802

835.4400 162-3 Anaerobic Aquatic Metabolism A, B, C, K 43499801

835.6100 164-1 Terrestrial Field Dissipation A, B, C, K 42745501

835.6200 164-2 Aquatic Field Dissipation A, B, C, K 43818501, 43195201

RESIDUE CHEMISTRY

860.1300 171-4A2 Nature of the Residue in Plants A, B, H

43554301, 43554302, 

43554303, 43628402, 

43668001, 45900802, 

43628401, 

860.1300 171-4A3 Nature of the Residue in Livestock A, B, H

43628301, 43628302, 

43833403, 43837601, 

45900802 43837602, 

860.1340 171-4C Residue Analytical Method –

Plants A, B, H

PAM Volume II, 

43910601

860.1360 171-4m Multiresidue Method A, B, H PAM Volume I

860.1380 171-4E Plant commodities: (oilseeds, nonoily grains, and root crops) A, B, H

DATA GAPS

43232801, 43248701,

43292701, 43440001,

43470801, 43470802,

43470806, 44126901,

45037101, 45037102,

45037103, 45037104,

45048001, 45256501,

45398401, 45900801 

43440002, 43470801,

43470805, 44140401, 

44140402, 43195201

860.1400 171-4f Magnitude of the Residue - Water,

Fish, and Irrigated Crops A, B, H 43195201

860.1460 171-4i Mag. of res. food handling A, B, H

42009801, 42009802, 

42009803, 42009804, 

42009805

860.1480 171-4j Magnitude of the Residue - Meat, 

Milk, Poultry, Eggs A, B, H 43833401, 43833402

860.1500 171-4K

Crop field trials: Crop Groups 1, 2, 

3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 

15, 16, 17, 18, 19, and the 

following miscellaneous 

commodities: asparagus, atemoya, 

A, B, H

DATA GAPS

107652, 43232801, 

43248701, 43292701, 

43298901, 43370801, 
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

avocado, banana, cacao bean, carob 

bean, cherimoya, coconut, coffee 

(green bean), cotton (seed and gin 

byproduct), cranberry, date, durian, 

fig, flax, grape, guava, jojoba, 

kiwifruit, lychee, mango, 

mushroom, okra, papaya, peanut, 

persimmon, pomegranate, 

pineapple, safflower, strawberry, 

sugarcane, sunflower, tea, and 

tobacco

43440002, 43470805, 

43470805, 43470806, 

44249301, 45398401, 

45900801

860.1520 171-4L

Magnitude of Residue in Processed 

Food/Feed: apple, barley, cacao 

bean, coconut, coffee, corn (field), 

cotton, fig, flax, oat, peanut, 

pineapple, plum, rice, rye, 

safflower, sorghum, soybean, 

sugarcane, sunflower, tea, and 

wheat

A, B, H

DATA GAPS

43470803, 45900801

43440001, 45900801

43470802, 45900801 

43470804, 45900801, 

43470801, 45900801 

860.1850 165-1

Confined Accumulation in 

Rotational Crops A, B, H DATA GAP

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

840.1100 201-1 Spray Droplet Size Spectrum A, B, C, K SDTF1

840.1200 202-1 Spray Drift Field Deposition A, B, C, K SDTF

875.1300 232 Inhalation Exposure L, M, O ORETF2

875.1400 234 Inhalation Indoor Exposure –

Metered Release Device L, M, O DATA GAP

875.1400 234 Inhalation Indoor Exposure – Ultra 

Low Volume Cold Fogger L, M, O DATA GAP

875.1700 none

Product Use Information – Metered 

Release Device L, M, O DATA GAP

875.2300 None Indoor Surface Residue 

Dissipation, Post application L, M, O

46188602, 46188613, 

46188618, 46188623, 

46188629

875.2400 133-3

Dermal Exposure – Loading and 

application of dust A, B, C, K 44459801

875.2500 133-4

Inhalation Exposure – Outdoor 

Residential Misting System C, K 47062801

875.2500 133-4

Inhalation Exposure – Fogging 

Data L, M, O 45869301

875.2500 133-4

Inhalation Exposure – Trigger 

Pump Spray L, M, O 41054701

875.2500 133-4

Inhalation Exposure – Loading and 

Application of Dust A, B, C, K 44459801

OTHER

Non-guideline 

Study

Nonguideline 

Study

Incident Analysis All 46694701, 46694801, 

46757301

 

1 Data owned by the Spray Drift Task Force.

2 Data owned by the Outdoor Residential Exposure Task Force. 
Data Requirement

Use Patterns Citations New 

Guideline 

Number

Old 

Guideline 

Number

Description

Non-guideline 

Study

Nonguideline 

Study

Pyrethrins Stewardship Program All DATA GAP