Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. 

Use additional sheet(s) if necessary.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

6b. I agree to satisfy Generic Data

Requirements as indicated on the 

attached form entitled 

"Requirements Status and 

Registrant's Response."

7a. My product is an MUP and I 

agree to satisfy the MUP 

requirement on the attached form

entitled "Requirements Status and

Registrant's Response."

7b. My product is an EUP and I 

agree to satisfy the EUP 

requirement on the attached form 

entitled "Requirements Status and 

Registrant's Response."

OMB Approval 2070-0174

1. Company Name and Address

 

N/A - Denatonium saccharide

Chemical # and Name: 129045

Benzenemethanaminium, N-(2-((2,6-dimethylphenyl)amino)-2-

oxoethyl)-N,N-diethyl-, saccharide

29-Jan-2010

GENERIC

ID # GDCI-129045-904

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page of 1 1

8. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

12. Name of Company

11. Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

 

Environmental Fate Data Requirements (Conventional 

Chemical)

Product Chemistry Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

835.1230

835.2120

835.4100

830.7050

850.1010

850.1075

Sediment and soil absorption/desorption for parent 

and degradates

Hydrolysis of parent and degradates as a function of 

pH at 25 C

Aerobic soil metabolism

UV/Visible absorption

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Fish acute toxicity test, freshwater and marine

N/A - Denatonium saccharide

Chemical # and Name: 129045

Benzenemethanaminium, N-(2-((2,6-dimethylphenyl)amino)-2-oxoethyl)-N,Ndiethyl-, saccharide

29-Jan-2010

GENERIC

ID # GDCI-129045-904

C

C

C

C

C

C

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI/PAI

TGAI, TEP

TGAI, TEP

12

12

24

8

12

12

Page 1 of 

(15)

(2)

(3)

(1, 4, 6, 7, 

12)

(1, 5, 8, 13, 

14)

N

N

N

N

N

N

2
Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.2100

850.2200

Avian acute oral toxicity test

Avian dietary toxicity test

N/A - Denatonium saccharide

Chemical # and Name: 129045

Benzenemethanaminium, N-(2-((2,6-dimethylphenyl)amino)-2-oxoethyl)-N,Ndiethyl-, saccharide

29-Jan-2010

GENERIC

ID # GDCI-129045-904

C

C

TGAI, TEP

TGAI

12

24

Page 2 of 

(4, 9, 11)

(7, 10)

N

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Denatonium saccharide

GDCI-129045-904

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be 

tested with the EP or TEP using the same species tested with the TGAI.

Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, 

barnyards, and beehives.

Required for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.

For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support enduse products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if 

there is no potential for environmental exposure.

EP or TEP testing is required for any product which meets any of the following conditions: 

i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed. 

ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is?one-half the LC50or EC50of the TGAI when the 

EP is used as directed.

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.

EP or TEP testing is required for any product which meets any of the following conditions:

i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.

ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is?one-half the LC50or EC50of the TGAI when the 

EP is used as directed.

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.

Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a 

highly volatile liquid, a highly reactive solid, or a highly corrosive material.

Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a

highly volatile liquid, a highly reactive solid, or a highly corrosive material.

Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile 

liquid, a highly reactive solid, or a highly corrosive material. 

Data are required on waterfowl and upland game bird.

Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred

on waterfowl or upland game bird species for indoor and greenhouse uses.

Data are required on one freshwater aquatic invertebrate species.

Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species.

Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

Case # and Name:

DCI Number:

Page: 1 of

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. 

These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement.

Use Categories Key:

C - Terrestrial nonfood crop

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Denatonium saccharide

GDCI-129045-904

15

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

Adsorption and desorption using a batch equilibrium method is preferred. However in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged 

columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.

Case # and Name:

DCI Number:

Page: 2 of 2
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Denatonium saccharide

Page: 1 of 1

81117 MCB L.L.C.

Co. Nr. Company Name Agent For Company

2901 CLINT MOORE RD #129

Address City ZIP

BOCA RATON 33496 

OMB Approval 2070-0174

State

FL

 DCI Number: GDCI-129045-904
LINKS TO FORMS:

The pesticide registration forms that are listed below can be found at:

http://www.epa.gov/opprd001/forms/

Link to Confidential Statement of Formula and Instructions (Form # 8570-4)

http://www.epa.gov/opprd001/forms/8570-4.pdf

Certification of Attempt to Enter Into an Agreement With Registrants for 

Development of Data (Form # 8570-32)

http://www.epa.gov/opprd001/forms/8570-32.pdf

Certification With Respect to Citation of Data (Form # 8570-34)

http://www.epa.gov/opprd001/forms/8570-34.pdf