Document ID: EPA-HQ-OPP-2005-0043-0116
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-08-17T04:00Z

SEQ CHAPTER \h \r 1 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:

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.

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.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

Indoor non-food

Indoor medical

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, 
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	141-1

	Honey 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

Non-Guideline Study	Non-Guideline Study	Chronic Freshwater Sediment
Testing	A, B, C, K	DATA GAP

Non-Guideline Study	Non-Guideline 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

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	Non-guideline Study	Definitive Mechanistic Toxicity
Study in Rats	A, B, C,H, I,  K, L, M, O	45889802, 45889803

Non-guideline Study	Non-guideline Study	Toxicology:  Cellular Changes in
Larynx 	A, B, C,H, I,  K, L, M, O	46605701

Non- guideline Study	Non- guideline 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

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, non-oily 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, 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	A, B, H	DATA GAPS

107652, 43232801, 43248701, 43292701, 43298901, 43370801, 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	SDTF

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

875.1300	232	Inhalation Exposure	L, M, O	ORETF

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	Non-guideline Study	Incident Analysis	All	46694701, 
46694801, 46757301

Non-guideline Study	Non-guideline Study	Pyrethrins Stewardship Program
All	DATA GAP

 Data owned by the Spray Drift Task Force.

 Data owned by the Outdoor Residential Exposure Task Force.