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 SPEC15-Sep-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

7. Test Substance

6. Use Pattern

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Reports

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Product Chemistry Data Requirements (Antimicrobial)

830.1550 Product Identity and composition (2) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.1600 Description of materials used to produce the product N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.1620 Description of production process N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.1650 Description of formulation process N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.1670 Discussion of formation of impurities N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.1700 Preliminary analysis (3 ,4) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.1750 Certified limits (5) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.1800 Enforcement analytical method (6) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.6302 Color (7) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.6303 Physical state (8) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.6304 Odor (9) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

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 SPEC15-Sep-2014

PDCI-111801

2. Case # and Name

3122 Poly(hexamethylenebiguanide

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

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

metals, and metal ions

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

830.6314 Oxidizing or reducing action N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.6315 Flammability N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.6316 Explodability N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.6317 Storage stability (11) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.6319 Miscibility N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.6320 Corrosion characteristics (12) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

830.6321 Dielectric breakdown voltage N V, R, U, CC, Y, T, Z, L EP; MP 

830.7000 pH (13) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.7050 UV/Visible absorption (14) N V, R, U, CC, Y, T, Z, L MP; PAI; TGAI 

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

830.7200 Melting point/melting range (15) N V, R, U, CC, Y, T, Z, L MP; TGAI 

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 SPEC15-Sep-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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Reports

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830.7220 Boiling point/boiling range (16) N V, R, U, CC, Y, T, Z, L MP; TGAI 830.7300 Density/relative density (17) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 830.7370 Dissociation constants in water (18) N V, R, U, CC, Y, T, Z, L MP; TGAI 830.7550 Partition coefficient (n-octanol/water), shake flask (19) MP; TGAI 

method

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

830.7560 Partition coefficient (n-octanol/water), generator (20) MP; TGAI 

column method

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

830.7570 Partition coefficient (n-octanol/water), estimation by (21) MP; TGAI 

liquid chromatography

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

830.7840 Water solubility: Column elution method, shake flask (22) MP; TGAI 

method

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

830.7860 Water solubility, generator column method (23) N V, R, U, CC, Y, T, Z, L MP; TGAI 830.7950 Vapor pressure (24) N V, R, U, CC, Y, T, Z, L MP; TGAI 

Toxicology Data Requirements (Antimicrobial)

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

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 SPEC15-Sep-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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Progress

Reports

1 2 3

870.1200 Acute dermal toxicity (25) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

870.1300 Acute inhalation toxicity N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 

870.2500 Acute dermal irritation (26) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 870.2600 Skin sensitization (27) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 870.2400 Acute eye irritation (28) N V, R, U, CC, Y, T, Z, L EP; MP; TGAI 810.2100 Sterilants (29) N V, R, U, CC, Y, T, Z, L 810.2200 Disinfectants for Use on Hard Surfaces (30) N V, R, U, CC, Y, T, Z, L 810.2300 Sanitizers for Use on Hard Surfaces (31) N V, R, U, CC, Y, T, Z, L 810.2400 Disinfectants and Sanitizers for Use on Fabrics and (32) 

Textiles

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

810.2500 Air Sanitizers (1) N V, R, U, CC, Y, T, Z, L 810.2600 Disinfectants for Use in Water (33) N V, R, U, CC, Y, T, Z, L 

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-111801-35037

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

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - CC - 

Industrial processes and water s

Swimming pools

1 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.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 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.

4 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.

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 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.

7 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.
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-111801-35037

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

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - CC - 

Industrial processes and water s

Swimming 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).

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).May be waived, if conditions in PR notice 92-5 apply.

10 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).

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 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.

13 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).
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-111801-35037

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

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - CC - 

Industrial processes and water s

Swimming pools

14 Data may be waived if MP is formulated15 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).

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 form, 

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

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).True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.

18 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.

19 May be waived if the MUP is formulated20 Data may be waived if the MP is formulated21 Data may be waived if the MP is formulated22 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.
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-111801-35037

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

Use Categories Key:

L - R - T - 

Indoor food use

Agricultural premises and equip

m

Commercial, institutional and ind

U - V - Y - 

Residential and public access pr

Medical premises and equipmenIndustrial processes and water s

Z - CC - 

Industrial processes and water s

Swimming 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 are waived if the MP is formulated.

24 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.

25 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 derm

26 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 derm

27 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 derm

28 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 derm

29 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.30 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.31 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.32 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.33 Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.