Document ID: EPA-HQ-OPP-2005-0128-0294
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-02-15T05:00Z

SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision for Dazomet (PC
035602)

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the dazomet case covered by
this RED.  It contains generic data requirements that apply to dazomet
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

X .   Materials preservatives

Y.    Industrial processes and    water systems-once through

Z.    Industrial processes and water  systems-not once through

BB. Wood preservatives

FF.  High Exposure Antimicrobial

GG. Low Exposure Antimicrobial



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

830.7050	None	UV/Visible Absorption	ALL	DATA GAP

830.7550	63-11	Partition coefficient, shake flask method	ALL	43540903

ECOLOGICAL EFFECTS

850.1010	72-2   	Acute Toxicity to Freshwater Invertebrates	ALL
41819302

850.1025	72-3B	Estuarine/Marine Toxicity – Mollusk	ALL	DATA GAP

850.1035	72-3C	Estuarine/Marine Toxicity – Shrimp	ALL	DATA GAP

850.1075	72-1A	Fish Acute Toxicity Bluegill	ALL	DATA GAP

850.1075	72-1B	Fish Acute Toxicity – Rainbow Trout	ALL	45919420

850.1075	72-3A	Estuarine/Marine Toxicity – Fish	ALL	DATA GAP

850.1300	72-4(b)	Aquatic Invertebrate Lifecycle (Freshwater)	ALL
45634001

850.2100	71-1A	Avian Acute Oral Toxicity – Bobwhite quail	ALL	42365101

850.2200	71-2a,b	Avian Dietary	ALL	42365102

850.2300

Avian Reproduction	ALL	DATA GAP

850.3020	141-1

	Honey bee acute contact LD50	ALL	DATA GAP

850.4225	122-1(a)	Seedling Emergence, Tier II	ALL	DATA GAP

850.4250	122-1(b)	Vegetative Vigor, Tier II	ALL	DATA GAP

850.5400	122-2B	Aquatic Plant Growth, Tier II	ALL	45919422, 44588903,
45919421, DATA GAP 

Special Study	NA	Avian Acute Inhalation	C	DATA GAP

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity - Rat	ALL	00132468, 00162331

870.1200	81-2	Acute Dermal Toxicity – Rat	ALL	00162330

42443501, 42328802

870.1300	81-3	Acute Inhalation Toxicity – Rat 	ALL	45919410, 41563003

870.2400	81-4	Primary Eye Irritation  - Rabbit	ALL	44400401, 00162328,
41563002

870.2500	81-5	Primary Skin Irritation – Rabbit 	ALL	00162329, 42328801

870.2600	81-6	Dermal Sensitization	ALL	43514802, 47014505,

44031801

870.3100

Subchronic Feeding – Rat/Mouse 	ALL	41865502

870.3465	82-5	90- Day Inhalation Toxicity – Rat/Mouse	ALL	45314802,
00162041

870.3700	83-3A	Developmental Toxicity – Rat	ALL	41577101, 42170101,
DATA GAP

870.3800	83-4	Reproduction and Developmental Effects	ALL	DATA GAP

870.4100	83-1B	Chronic Feeding Toxicity Study - Dog	ALL	43275801

870.4200	83-2	Carcinogenicity – Mouse/Rat	ALL	DATA GAP

870.5100	84-2	Bacterial Reverse Mutation Test (Ames Assay)	ALL	00131910,
41482301,

41497903

870.5375	84-2	Chromosomal Aberration in Chinese Hamster Ovary	ALL
41497901

870.5395	84-2	Unscheduled DNA Synthesis – Rat 	ALL	41482303, DATA GAP

870.5700	84-2	In vitro mammalian gene mutation test	ALL	41497902,
41482302

870.6200a	81-8   	Acute neurotoxicity screen study in rats,
Inhalation Acute Neurotoxicity	ALL	43465302

870.7800	85-7	Immunotoxicity	ALL	DATA GAP

ENVIRONMENTAL FATE

835.8100	163-3	Field Volatility	ALL	46340401, DATA GAP

835.2120	161-1	Hydrolysis	ALL	45908301,

41479003,

42111401, 00158162

835.2240	161-2	Photodegradation - Water	ALL	41479901,

42111402

835.2410	161-3	Photodegradation - Soil	ALL	42569201

835.4100	162-1	Aerobic Soil Metabolism	ALL	40211901, 

42111403

835.4400	162-3	Anaerobic Aquatic Metabolism	ALL	43596501, 43908426

835.6100	164-1	Terrestrial Field Dissipation	ALL	41874801,

41874802

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

875.1200	233	Dermal Exposure – Indoor	F, X, Y, Z, BB, FF, GG	DATA GAP

875.1400	234	Inhalation Exposure – Indoor	F, X, Y, Z, BB, FF, GG	DATA
GAP

875.1600	235	Application exposure monitoring data reporting	F, X, Y, Z,
BB, FF, GG	DATA GAP

875.1700	236	Product Use Information	F, X, Y, Z, BB, FF, GG	DATA GAP

875.2500	133-4	Inhalation Exposure – Outdoor (Post-Application)	F, X,
Y, Z, BB, FF, GG	DATA GAP

875.2700	235	Product Use Information	F, X, Y, Z, BB, FF, GG	DATA GAP

875.2800	133-1	Description of Human Activity	F, X, Y, Z, BB, FF, GG	DATA
GAP

875.2900	134	Data Reporting and Calculations	F, X, Y, Z, BB, FF, GG	DATA
GAP

Special 	NA	Fumigant Buffer Zone Posting Signs	C, I	DATA GAP

Special 	NA	Training for Applicators Supervising Fumigations	C, I	DATA
GAP

Special	NA	Training Material for Handlers	C, I	DATA GAP