Document ID: EPA-HQ-OPP-2004-0162-0054
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-11T04:00Z

Appendix B

Data Supporting Guideline Requirements for the Reregistration of
Napropamide

GUIDE TO APPENDIX B

Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the chemical case covered
by this RED.  It contains generic data requirements that apply 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 (Columns 1, 2 & 3).  The data requirements are listed
in the order of New Guideline Number and appear in 40 CFR § 158.  The
reference numbers accompanying each test refer to the test protocols set
in the Pesticide Assessment Guidance, which are available from the
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161-0002, (703) 487-4650.

Use Pattern (Column 4).  This column indicates the use patterns for
which the data requirement apply.  The following letter designations are
used for the given use patterns.

Terrestrial Food

Terrestrial Feed

Terrestrial Nonfood

Aquatic Nonfood

Aquatic Nonfood Outdoor

Aquatic Nonfood Industrial

Aquatic Nonfood Residential

Greenhouse Food

Greenhouse Nonfood

Forestry

Residential 

Indoor Food

Indoor Nonfood

Indoor Medical

Indoor Residential

Bibiographical Citation (Column 5). If the Agency has acceptable data in
its files, this column lists the identification number of each study. 
Normally, this is the Master Record Identification (MRID) Number, but
may be a “GS” number if no MRID number has been assigned.  Refer to
the Bibliography (Appendix D) for a complete citation of the study.



New Guideline Number	

Old Guideline Number	

Requirement	

Use Pattern	

Bibliographical Citation(s)

PRODUCT USE CHEMISTRY

830.1550	

61-1	

Product Identity and Composition	

All	44409301, 46459101, 46699301, 41222501, 41222502, 43160601

830.1600	

61-2A	

Starting Materials and Manufacturing	

All	

44409301, 46459101, 46699301, 41222501, 42013001 

830.1620	

61-2B	

Description of Production Process	

All	

44409301, 46459101, 46699301, 40491301, 41222501, 42013001

830.1670

Discussion of Formation of Impurities	

All	

44409301, 46459101, 46699301, 40924701, 41222502, 43160601, 43160602

830.1700	

62-1	

Preliminary Analysis (Technical)	

All	

44409302, 46459101, 46699301, 41222502

830.1750	

62-2	

Certified Limits	

All	

44409301, 46459101, 46699301

830.1800	

62-3	

Analytical Method	

All	

44409302, 46459101, 41222502, 42013002, 42275201, 42679201, 43160601

830-6302	

63-2	

Color	

All	

41610201, 41222503

830.6303	

63-3	

Physical State	

All	

41610201, 41222503

830.6304	

63-4	

Odor	

All	

41610201, 41222503

830.6313	

63-13	

Stability to Normal and Elevated Temperature, Metals and Metal Ions
(stability)	

All	

41222503

830.6317	63-17	Storage Stability	All	41222503, 42013003, 4207801

830.6320	63-20	Corrosion Characteristics	All	41222503, 42013003

830.7000	

63-12	

pH	

All	

41610201, 41222503

830.7050	

None	

UV/Visible Absorption	

All	

46459102

830.7200	

63-5	

Melting Point	

All	

41610201, 41222503

830.7300	

63-7	

Density	

All	

41610201, 41222503

830.7550	

63-11	

Octanol/Water Partition Coeffient	

All	

41610201, 41222503

830.7840 / 830.7860	

63-8	

Solubility	

All	

41610201, 41222503

830.7950	

63-9	

Vapor Pressure	

All	

41610201, 41222503

ECOLOGICAL EFFECTS

850.2100	

71-1A	

Avian Acute Oral Toxicity Test 	

A,B,C,I,K	

79548,79555

850.2200	

71-2A	

Avian Acute Dietary Toxicity Test	

A,B,C,I,K	

41610203

850.2300	

71-4A	

Avian Reproduction Test, Bobwhite Quail	

A,B,K	

42081301

850.2300	

71-4B	

Avian Reproduction, Mallard Duck	

A,B,C,K	

42027701

850.1075	

72-1A	

Fish Acute Toxicity Test, Freshwater	

A,B,C,K	

41610204, 46459109

850.1010	

72-2	

Invertebrate Toxicity	

A,B,C,I,K	

88064, 57805, 41610205

None	

72-3A	

Estuarine/Marine Fish Acute Toxicity Test	

A,B,C,K	

41610206

850.1025	

72-3B	

Estuarine/Marine Mollusk	

A,B,C,K	

41667101

850.1035	

72-3C	

Estuarine/Marine Mysid (Shrimp)	

A,B,C,K 	

41610207

850.1300	

72-4A	

Daphnid Chronic Toxicity Test (early life stage in fish)	

A,B,C,K	

46478704

850.1350	

72-4B	

Aquatic Invertebrate Life-Cycle	

A,B,C,K	

46478704

850.1500	

72-5	

Fish Life Cycle Study	

A,B,C,K	

46459109

850.3020	141-1	Honey Bee Acute Contact

850.3030	141-2	Honey Bee Residue on Foliage

850.4225	

123-1A	

Seedling Emergence	

A,B,C,K	

41610209, 42656202

850.4250	

123-1B	

Vegetative Vigor, Tier 2	

A,B,C,K	

41610209

850.4400	

123-2A	

Aquatic Plant Toxicity Test	

A,B,C,K	

41610210, 46459111, 46459112, 46459113, 4645914

TOXICOLOGY

870.1100	

81-1	

Acute Oral Toxicity-Rat	

A,B,C,I,K	

40362902

870.1200	

81-2	

Acute Dermal Toxicity-Rabbit	

A,B,C,I,K	

40362902

870.1300	

81-3	

Acute Inhalation Toxicity-Rat	

A,B,C,I,K	

42231501

870.2400	

81-4	

Primary Eye Irritation - Rabbit	

A,B,C,I,K	

40362902

870.2500	

81-5	

Primary Skin Irritation	

A,B,C,I,K	

40362902

870.2600	

81-6	

Dermal Sensitization	

A,B,C,I,K	

40362903

870.3100	

82-1A	

Subchronic Oral Toxicity Test (90-day Feeding, Rodent)	

A,B,C,I,K	

00113809, 113810

870.3200	

82-2	

21-Day Dermal-Rabbit/Rat	

A,B,C,I,K	

42006701

870.3700	

83-3A	

Developmental Toxicity-Rat	

A,B,C,I,K	

128104,42006703

870.3700	

83-3B	

Prenatal Developmental Toxicity (Teratogenicity), Rabbit	

A,B,C,I,K	

42006704

870.3800	

83-4	

2-Generation Reproduction-Rat	

A,B,C,I,K	

92125069

870.4100	

83-1B	

Chronic Feeding Study (Non-Rodent)	

A,B,C,I,K	

41156602

870.4200	

83-2B	

Carcinogenicity (Mouse)	

A,B,C,I,K	

42189101

870.4300	

83-5	

Chronic/Carcinogen	

A,B,C,I,K	

42189102,43068801

870.5100	

84-2	

Bacterial (Escherichia Coll Wp2 and Wp2 urvA) Reverse Gene Mutation
Assay Test	

A,B,C,I,K	

00025880

870.5300	

84-2	

Detection of Gene Mutations in Somatic Cells in Culture (In Vitro),
Mammalian	

A,B,C,I,K	

00147490, 00162137,41582201

870.5395	

84-2	

In Vitro Mammalian Cytogenetics Tests (Erythrocyte Micronucleus Assay)	

A,B,C,I,K	

0014789, 00162136

870.5550	

84-2	

Unscheduled DNA Synthesis in Mammalian Cells in Culture	

A,B,C,I,K	

41610208

870.7485	

85-1	

Metabolism and Phrmacokinetics	

A,B,C,I,K	

42758901, 42758902, 42758903

870.7600	

85-2	

Dermal Penetration	

A,B,C,I,K	

40838601

ENVIRONMENTAL FATE

835.2120	

161-1	

Hydrolysis	

A,B,C,I,K	

41863201

835.2240	

161-2	

Photodegradation in Water	

A,B,C	

41575301, 43175301

835.2410	

161-3	

Photodegradation in Soil	

A,B,C	

41863202

835.4100	

162-1	

Aerobic Soil Metabolism	

A,B,C,I,K	

41105901, 41901801

835.4200	

162-2	

Anaerobic Aquatic Metabolism	

A,B	

00163271, 92125017

835.4400	

162-3	

Anaerobic Aquatic Metabolism Study	

A,B	

42699701

835.1230	

163-1	

Leaching-Adsorption/Desorption	

A,B,C,I,K	

41575302 , 43514401

835.6100	

164-1	

Terrestrial Field Dissipation Study	

A,B,C,K	

43742401, 43742402, 42707201

860.1950	

165-4	

Accumulation in Fish	

A,B,C,K	

39774, 92125019

RESIDUE CHEMISTRY

860.1200	

171-3	

Directions for Use	

A,B,C,I,K	

New Data Requirement (Confirmatory)

860.1300	

171-4A	

Nature of Residue - Plants	

A,B,K	

00049481, 00113800, 00132824, 42349801, 42349802, 42393901, 42845901

860.1300	

171-4B	

Nature of Residue - Animals	

A,B	

42775801, 42775802

860.1340	

171-4C	

Residue Analytical Method - Plants	

A,B,K	

32356,49482, 49483, 94087, 126316, 132824, 43345102, 43345105, 43345106,
43345108

860.1340	

171-4D	

Residue Analytical Method - Animal	

A,B	

00132824

860.1380	

171-4E	

Storage Stability Data	

A,B,K	

00049489, 00094488, 41575306, 41575307, 44020101, 44020102

Root and Tuber Vegetable Group

860.1500	

171-4K	

Crop Field Trials (Sweet Potato)	

A,B,K	

42256501

Leafy Vegetables Group

860.1500	

171-4K	

Crop Field Trials (Rhubarb)	

A,B,K	

00126316

Brassica (Cole) Leafy Vegetables Group

860.1500	

171-4K	

Crop Field Trials (Broccoli, Brussels sprouts, Cabbage, Cauliflower,
Asparagus)	

A,B,K	

00025888

Fruiting Vegetables Group

860.1500	

171-4K	

Crop Field Trials (Eggplant, Pepper, Tomato)	

A,B,K	

00023230, 00027319, 00027320, 00027321, 00028796, 00033961, 00035669,
00049483, 00049484, 00067872, 00067873, 00070786, 00070814, 00113800

Tree Nuts Group

860.1500	

171-4K	

Crop Field Trials (Almond, Pecan, Filbert)	

A,B,K	

00023883, 00032358, 00035666, 00049488, 00070780, 00113800,  00113821,
00115128, 00118001

Berries  Group

860.1500	

171-4K	

Crop Field Trials (Blackberry, Blueberry, Boysenberry, Loganberry,
Raspberry, Strawberry, Cranberry)	

A,B,K	

113821, 118001, 120304

Herb and Spice Group

860.1500	

171-4K	

Crop Field Trials (Basil)	

A,B,K	

00094087, 41575308

860.1500	

171-4K	

Crop Field Trials (Marjoram)	

A,B,K	

115110, 41575310, 46459103

860.1500	

171-4K	

Crop Field Trials (Rosemary)	

A,B,K	

00115110, 41575309, 46459103

860.1500	

171-4K	

Crop Field Trials (Savory)	

A,B,K	

00115110, 41575310

Additional Crops

860.1500	

171-4K	

Crop Field Trials (Asparagus)	

A,B,K	

00025884

860.1500	

171-4K	

Crop Field Trials (Coffee Beans)	

A,B,K	

00113814

860.1500	

171-4K	

Cranberry	

A,B,K	

00065363, 00113821, 00118001

860.1500	

171-4K	

Grape	

A,B,K	

23883, 35667, 49486, 113800, 113821, 115128

860.1500	

171-4K	

Kiwifruit	

A,B,K	

25887

860.1500	

171-4K	

Mint	

A,B,K	

00025889

860.1500	

171-4K	

Persimmon	

A,B,K	

00025890

860.1500	

171-4K	

Strawberry	

A,B,K	

00027322, 00118001

860.1500	

171-4K	

Tobacco	

A,B,K	

00120304

Processed Food/Feed

860.1520	

171-4L	

Processed Food (Coffee Bean)	

A,B	

New Data Requirement (Confirmatory)

860.1520	

171-4L	

Processed Food (Grape)	

A,B	

43249402

860.1520	

171-4L	

Processed Food (Mint)	

A,B	

New Data Requirement (Confirmatory)

860.1520	

171-4L	

Processed Food (Tomato)	

A,B	

43249405

860.1850	

165-1	

Confined Accumulation in Rotational Crops	

A,B,C	

42794501

860.1900	

165-2	

Field Accumulation in Rotational Crops	

A,B,C	

43419901