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 SPEC09-Jul-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

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T

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Progress

Reports

1 2 3

Product Chemistry Data Requirements (Antimicrobial)

830.1550 Product Identity and composition (1) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1600 Description of materials used to produce the product V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1620 Description of production process V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1650 Description of formulation process V, R, U, CC, Y, T, X, Z, EP; MP 

L

N

830.1670 Discussion of formation of impurities V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1700 Preliminary analysis (2 ,3) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1750 Certified limits (4) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.1800 Enforcement analytical method (5) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

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 SPEC09-Jul-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

O

T

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Progress

Reports

1 2 3

830.6302 Color (6) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6303 Physical state (7) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6304 Odor (8) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6313 Stability to normal and elevated temperatures, (9) EP; MP; TGAI 

metals, and metal ions

V, R, U, CC, Y, T, X, Z,L

N

830.6314 Oxidizing or reducing action V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6315 Flammability V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6316 Explodability V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6317 Storage stability (10) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6319 Miscibility V, R, U, CC, Y, T, X, Z, EP; MP 

L

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 SPEC09-Jul-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.6320 Corrosion characteristics (11) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.6321 Dielectric breakdown voltage V, R, U, CC, Y, T, X, Z, EP 

L

N

830.7000 pH (12) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.7050 UV/Visible absorption (13) V, R, U, CC, Y, T, X, Z, MP; TGAI 

L

N

830.7100 Viscosity V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.7200 Melting point/melting range (14) V, R, U, CC, Y, T, X, Z, MP; TGAI 

L

N

830.7220 Boiling point/boiling range (15) V, R, U, CC, Y, T, X, Z, MP; TGAI 

L

N

830.7300 Density/relative density (16) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

830.7370 Dissociation constants in water (17) V, R, U, CC, Y, T, X, Z, MP; PAI; TGAI 

L

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 SPEC09-Jul-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

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 (18) MP; PAI; TGAI 

method

V, R, U, CC, Y, T, X, Z,L

N

830.7560 Partition coefficient (n-octanol/water), generator (19) MP; PAI; TGAI 

column method

V, R, U, CC, Y, T, X, Z,L

N

830.7570 Partition coefficient (n-octanol/water), estimation by (20) MP; PAI; TGAI 

liquid chromatography

V, R, U, CC, Y, T, X, Z,L

N

830.7840 Water solubility: Column elution method, shake flask (21) MP; PAI; TGAI 

method

V, R, U, CC, Y, T, X, Z,L

N

830.7860 Water solubility, generator column method (22) V, R, U, CC, Y, T, X, Z, MP; PAI; TGAI 

L

N

830.7950 Vapor pressure (23) V, R, U, CC, Y, T, X, Z, MP; PAI; TGAI 

L

N

Toxicology Data Requirements (Antimicrobial)

870.1100 Acute Oral Toxicity V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

870.1200 Acute dermal toxicity (24) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

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 SPEC09-Jul-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

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, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

870.2500 Acute dermal irritation (26) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

870.2600 Skin sensitization (27) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

N

870.2400 Acute eye irritation (25) V, R, U, CC, Y, T, X, Z, EP; MP; TGAI 

L

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: 3122 Poly(hexamethylenebiguanide

DCI Number: PDCI-111801-30511

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 AManufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; EP = End Use 

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - X - 

Residential and public access pr

Medical premises and equipmenMaterials preservatives

Y - Z - CC - 

Industrial processes and water s

Industrial processes and water sSwimming pools

1 The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This informa

determine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analytical data, the make and modeinstrument operating conditions under which the data were generated.

2 The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This informa

determine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analytical data, the make and modeinstrument operating conditions under which the data were generated.

3 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Required for EP if produced by unregistered source of active ingredient or produced by an integrated system.

4 The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This informa

determine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analytical data, the make and modeinstrument operating conditions under which the data were generated.

5 The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This informa

determine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analytical data, the make and modeinstrument operating conditions under which the data were generated.

6 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).May be waived, if conditions in PR notice 92-5 apply.

7 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the cative ingredient is either an acid, base or ionic form, 

the concentration of the active infredient in these products must be expressed in acid equivalent or active equivalent).
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: 3122 Poly(hexamethylenebiguanide

DCI Number: PDCI-111801-30511

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 AManufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; EP = End Use 

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - X - 

Residential and public access pr

Medical premises and equipmenMaterials preservatives

Y - Z - CC - 

Industrial processes and water s

Industrial processes and water sSwimming pools

8 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).May be waived, if conditions in PR notice 92-5 apply.

9 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).

10 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 subm

3 months following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In existing study or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideltemperatures may be conducted and, if found acceptable, may be used to replace the one-year study. Details of the test requirements are attached to thGUIDANCE: Combined Accelerated Storage Stability and Corrosion Characteristics Study.

11 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 subm

3 months following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In existing study or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideltemperatures may be conducted and, if found acceptable, may be used to replace the one-year study. Details of the test requirements are attached to thGUIDANCE: Combined Accelerated Storage Stability and Corrosion Characteristics Study.

12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).

13 Data may be waived if the MP is formulated.14 If the TGAI cannot be isolatged, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Data are waived if the MP is formulated.
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: 3122 Poly(hexamethylenebiguanide

DCI Number: PDCI-111801-30511

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 A

Manufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; EP = End Use 

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - X - 

Residential and public access pr

Medical premises and equipmenMaterials preservatives

Y - Z - CC - 

Industrial processes and water s

Industrial processes and water sSwimming pools

15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Data are waived if the MP is formulated.

16 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic ofrm, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).True density or specific density is required for all test substances. Data on bu k density is required for MPs that are solid at room temperature.

17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Data may be waived if the MP is formulated.

18 Data may be waived if the MP is formulated.19 Data may be waived if the MP is formulated.20 Data may be waived if the MP is formulated.21 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingrdient in these products must be expressed in acid equivalent or active equivalent).Data may be waived if the MP is formulated.

22 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Data may be waived if the MP is formulated.
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: 3122 Poly(hexamethylenebiguanide

DCI Number: PDCI-111801-30511

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 AManufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; EP = End Use 

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - X - 

Residential and public access pr

Medical premises and equipmenMaterials preservatives

Y - Z - CC - 

Industrial processes and water s

Industrial processes and water sSwimming pools

23 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, 

the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).Data may be waived if the MP is formulated.

24 Not required if test material is corrosive to skin or has pH < 2 or > 11.5; such product will be classified as Toxicity Category I on the basis of potential der25 Not required if test material is corrosive to skin or has pH < 2 or > 11.5; such product will be classified as Toxicity Category I on the basis of potential der26 Not required if test material is corrosive to skin or has pH < 2 or > 11.5; such product will be classified as Toxicity Category I on the basis of potential der27 Not required if test material is corrosive to skin or has pH < 2 or > 11.5; such product will be classified as Toxicity Category I on the basis of potential der