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1. Company Name and Address4. EPA Product

Registration

United States Environmental Protection 

Agency Washington, D.C. 20460

DATA CALL-IN RESPONSE

3. Date and Type of DCI 

PRODUCT SPECI11-May-2015ID # PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarieChemical # and Name 069166

1-Octanaminium, N,N-dimethyl-N-octyl-, chloride

5. I wish to cancel this product registration voluntarily

6. Generic Data 7. Product Specific Data

7a. My product is an MUP andI agree to satisfy the MUP requirements on the attached form entitled "Requirements Status and Registrant's Response."

6a. I am claiming a GenericData 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."

10. Name of Company 11. Phone Numb

9. Date 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__________________________________
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

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

Product Chemistry Data Requirements (Antimicrobial)

830.1550 Product Identity and composition (1) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1600 Description of materials used to produce the product (2) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1620 Description of production process (3) V, AA, R, U, BB, CC, Y, EP; TGAI 

T, Z, S

N

830.1650 Description of formulation process (4) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1670 Discussion of formation of impurities (5) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1700 Preliminary analysis (6) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1750 Certified limits V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.1800 Enforcement analytical method V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

12. Name of Company 13. Phone NumbSignature and Title of Company's Authorized Representative__________________________________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

11. 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.

4. Guideline Requirement Number

5. Study Title

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.6302 Color (7) V, AA, R, U, BB, CC, Y, MP; TGAI 

T, Z, S

N

830.6303 Physical state (8) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.6304 Odor (9) V, AA, R, U, BB, CC, Y, MP; TGAI 

T, Z, S

N

830.6313 Stability to normal and elevated temperatures, (10) TGAI 

metals, and metal ions

V, AA, R, U, BB, CC, Y,T, Z, S

N

830.6314 Oxidizing or reducing action (11) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.6315 Flammability (12) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

830.6316 Explodability (13) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

830.6317 Storage stability (14) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

830.6319 Miscibility (15) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

Initial to indicate certification as to information on this page (fulltext 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.

4. Guideline Requirement Number

5. Study Title

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.6320 Corrosion characteristics (16) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

830.6321 Dielectric breakdown voltage (17) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

830.7000 pH (18) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.7050 UV/Visible absorption (19) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

830.7100 Viscosity (20) V, AA, R, U, BB, CC, Y, EP; MP 

T, Z, S

N

830.7200 Melting point/melting range (21) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

830.7220 Boiling point/boiling range (22) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

830.7300 Density/relative density (23) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

830.7370 Dissociation constants in water (24) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

Initial to indicate certification as to information on this page (fulltext 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.

4. Guideline Requirement Number

5. Study Title

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.7550 Partition coefficient (n-octanol/water), shake flask (25) TGAI 

method

V, AA, R, U, BB, CC, Y,T, Z, S

N

830.7560 Partition coefficient (n-octanol/water), generator (34) TGAI 

column method

V, AA, R, U, BB, CC, Y,T, Z, S

N

830.7570 Partition coefficient (n-octanol/water), estimation by (26) TGAI 

liquid chromatography

V, AA, R, U, BB, CC, Y,T, Z, S

N

830.7840 Water solubility: Column elution method, shake flask (27) TGAI 

method

V, AA, R, U, BB, CC, Y,T, Z, S

N

830.7860 Water solubility, generator column method (28) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

830.7950 Vapor pressure (29) V, AA, R, U, BB, CC, Y, TGAI 

T, Z, S

N

Toxicology Data Requirements (Antimicrobial)

870.1100 Acute Oral Toxicity V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

870.1200 Acute dermal toxicity (30) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

Initial to indicate certification as to information on this page (fulltext 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.

4. Guideline Requirement Number

5. Study Title

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

870.1300 Acute inhalation toxicity V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

870.2500 Acute dermal irritation (32) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

870.2600 Skin sensitization (33) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

870.2400 Acute eye irritation (31) V, AA, R, U, BB, CC, Y, EP; MP; TGAI 

T, Z, S

N

810.2100 Sterilants (40) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

810.2200 Disinfectants for Use on Hard Surfaces (35) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

810.2300 Sanitizers for Use on Hard Surfaces (38) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

810.2400 Disinfectants and Sanitizers for Use on Fabrics and (37) EP 

Textiles

V, AA, R, U, BB, CC, Y,T, Z, S

N

Initial to indicate certification as to information on this page (fulltext 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.

4. Guideline Requirement Number

5. Study Title

1. Company Name and Address

United States Environmental Protection 

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3. Date and Type of DC

ID #PRODUCT SPEC11-May-2015

PDCI-06916

2. Case # and Name

3003 Aliphatic alkyl quaternarie

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

810.2500 Air Sanitizers (39) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

810.2600 Disinfectants for Use in Water (36) V, AA, R, U, BB, CC, Y, EP 

T, Z, S

N

Initial to indicate certification as to information on this page (fulltext of certification is on page one).

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

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

1 The Confidential Statement of Formula (CSF) form may be referenced.2 In addition to guideline information, providing the MSDS for each component in formulation is recommended.3 Waiver may be requested if the product is a non-integrated system.4 Providing a flow chart for the formulation process is recommended.5 Waiver may be requested if the product is a non-integrated system.6 Waiver may be requested if the product is a non-integrated system.

For an integrated system, a five batch analysis is preferred. The analysis must be based on the product to assay the active ingredient (AI). If the product analysis (COA) may be used in place of the five batch analysis. A COA for each supplier must be provided.

7 The method that was used must be provided.

Provide the temperature when the study was conducted.

8 The method that was used must be provided.

Provide the temperature when the study was conducted.
The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These fo

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

9 The method that was used must be provided.

Provide the temperature when the study was conducted.

10 The method that was used must be provided.

Provide the temperature when the study was conducted.

11 The method that was used must be provided.

Provide the temperature when the study was conducted.

12 The method that was used must be provided.

Provide the temperature when the study was conducted.

13 The method that was used must be provided.

Provide the temperature when the study was conducted.

14 The method that was used must be provided.

Provide the temperature when the study was conducted.

Accelerated (temperature between 40 to 55 oC) storage stability can be reported to be equivalent to this guideline as long as: the AI meets the EPA Stan

reported at the initial, in between, and at the end of the study for 14 or 30 days. If the study does not pass, then the applicant must conduct the one-year The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. You are then required to submimonths following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In Nstudy or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-dbe conducted and, if found acceptable, may be used to replace the one-year study.

15 The method that was used must be provided.

Provide the temperature when the study was conducted.
The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These fo

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

16 The method that was used must be provided.

Provide the temperature when the study was conducted.

An accelerated equivalent study may be conducted in conjunction with 830.6317.

The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. You are then required to submimonths following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In Nstudy or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-dbe conducted and, if found acceptable, may be used to replace the one-year study.

17 The method that was used must be provided.

Provide the temperature when the study was conducted.Waiver may be requested if the product is not intended to be use near electric outlet.

18 The method that was used must be provided.

Provide the temperature when the study was conducted.The value must be reflected on the CSF form.

19 The method that was used must be provided.

Provide the temperature when the study was conducted.

20 The method that was used must be provided.

Provide the temperature when the study was conducted.
The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These fo

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

21 The method that was used must be provided.

Provide the temperature when the study was conducted.

22 The method that was used must be provided.

Provide the temperature when the study was conducted.

23 The method that was used must be provided.

Provide the temperature when the study was conducted.The value must be reflected on the CSF form.

24 The method that was used must be provided.

Provide the temperature when the study was conducted.

25 The method that was used must be provided.

Provide the temperature when the study was conducted.
The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These fo

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

26 The method that was used must be provided.

Provide the temperature when the study was conducted.

27 The method that was used must be provided.

Provide the temperature when the study was conducted.

28 The method that was used must be provided.

Provide the temperature when the study was conducted.

29 The method that was used must be provided.

Provide the temperature when the study was conducted.

30 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 31 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 32 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 
The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These fo

test notes included in 40 CFR Part 158 with respect to the particular data requirement

Case # and Name: 3003 Aliphatic alkyl quaternarie

DCI Number: PDCI-069166-30858

Footnotes:Key:

United States Environmental Protection

Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - S - T - 

Agricultural premises and equip

m

Food handling/storage establishCommercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - AA - 

BB - 

Industrial processes and water s

Antifouling coatings

Wood preservatives

CC - Swimming pools

33 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as a dermal sensitizer.34 The method that was used must be provided.

Provide the temperature when the study was conducted.

35 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.36 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.37 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.38 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.39 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.40 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.