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. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 1 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC15-Sep-2014PDCI-111801-350372. Case # and Name3122 Poly(hexamethylenebiguanideEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321Product Chemistry Data Requirements (Antimicrobial)(2)830.15508EP; MP; TGAIProduct Identity and compositionV, R, U, CC, Y, T, Z, LN830.16008EP; MP; TGAIDescription of materials used to produce the productV, R, U, CC, Y, T, Z, LN830.16208EP; MP; TGAIDescription of production processV, R, U, CC, Y, T, Z, LN830.16508EP; MP; TGAIDescription of formulation processV, R, U, CC, Y, T, Z, LN830.16708EP; MP; TGAIDiscussion of formation of impuritiesV, R, U, CC, Y, T, Z, LN(3 ,4)830.17008EP; MP; TGAIPreliminary analysisV, R, U, CC, Y, T, Z, LN(5)830.17508EP; MP; TGAICertified limitsV, R, U, CC, Y, T, Z, LN(6)830.18008EP; MP; TGAIEnforcement analytical methodV, R, U, CC, Y, T, Z, LN(7)830.63028EP; MP; TGAIColorV, R, U, CC, Y, T, Z, LN(8)830.63038EP; MP; TGAIPhysical stateV, R, U, CC, Y, T, Z, LN(9)830.63048EP; MP; TGAIOdorV, R, U, CC, Y, T, Z, LN12. Name of Company13. Phone NumberSignature and Title of Company'sAuthorized Representative__________________________________10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. Iacknowledge that anyknowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law11. DateINSTRUCTIONS: 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. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 2 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC15-Sep-2014PDCI-111801-350372. Case # and Name3122 Poly(hexamethylenebiguanideEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(10)830.63138EP; MP; TGAIStability to normal and elevated temperatures,metals, and metal ionsV, R, U, CC, Y, T, Z, LN830.63148EP; MP; TGAIOxidizing or reducing actionV, R, U, CC, Y, T, Z, LN830.63158EP; MP; TGAIFlammabilityV, R, U, CC, Y, T, Z, LN830.63168EP; MP; TGAIExplodabilityV, R, U, CC, Y, T, Z, LN(11)830.631716EP; MP; TGAIStorage stabilityV, R, U, CC, Y, T, Z, LN830.63198EP; MP; TGAIMiscibilityV, R, U, CC, Y, T, Z, LN(12)830.632016EP; MP; TGAICorrosion characteristicsV, R, U, CC, Y, T, Z, LN830.63218EP; MPDielectric breakdown voltageV, R, U, CC, Y, T, Z, LN(13)830.70008EP; MP; TGAIpHV, R, U, CC, Y, T, Z, LN(14)830.70508MP; PAI; TGAIUV/Visible absorptionV, R, U, CC, Y, T, Z, LN830.71008EP; MP; TGAIViscosityV, R, U, CC, Y, T, Z, LN(15)830.72008MP; TGAIMelting point/melting rangeV, R, U, CC, Y, T, Z, LNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateINSTRUCTIONS: 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. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 3 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC15-Sep-2014PDCI-111801-350372. Case # and Name3122 Poly(hexamethylenebiguanideEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(16)830.72208MP; TGAIBoiling point/boiling rangeV, R, U, CC, Y, T, Z, LN(17)830.73008EP; MP; TGAIDensity/relative densityV, R, U, CC, Y, T, Z, LN(18)830.73708MP; TGAIDissociation constants in waterV, R, U, CC, Y, T, Z, LN(19)830.75508MP; TGAIPartition coefficient (n-octanol/water), shake flaskmethodV, R, U, CC, Y, T, Z, LN(20)830.75608MP; TGAIPartition coefficient (n-octanol/water), generatorcolumn methodV, R, U, CC, Y, T, Z, LN(21)830.75708MP; TGAIPartition coefficient (n-octanol/water), estimation byliquid chromatographyV, R, U, CC, Y, T, Z, LN(22)830.78408MP; TGAIWater solubility: Column elution method, shake flaskmethodV, R, U, CC, Y, T, Z, LN(23)830.78608MP; TGAIWater solubility, generator column methodV, R, U, CC, Y, T, Z, LN(24)830.79508MP; TGAIVapor pressureV, R, U, CC, Y, T, Z, LNToxicology Data Requirements (Antimicrobial)870.11008EP; MP; TGAIAcute Oral ToxicityV, R, U, CC, Y, T, Z, LNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateINSTRUCTIONS: 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. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 4 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC15-Sep-2014PDCI-111801-350372. Case # and Name3122 Poly(hexamethylenebiguanideEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(25)870.12008EP; MP; TGAIAcute dermal toxicityV, R, U, CC, Y, T, Z, LN870.13008EP; MP; TGAIAcute inhalation toxicityV, R, U, CC, Y, T, Z, LN(26)870.25008EP; MP; TGAIAcute dermal irritationV, R, U, CC, Y, T, Z, LN(27)870.26008EP; MP; TGAISkin sensitizationV, R, U, CC, Y, T, Z, LN(28)870.24008EP; MP; TGAIAcute eye irritationV, R, U, CC, Y, T, Z, LN(29)810.21008SterilantsV, R, U, CC, Y, T, Z, LN(30)810.22008Disinfectants for Use on Hard SurfacesV, R, U, CC, Y, T, Z, LN(31)810.23008Sanitizers for Use on Hard SurfacesV, R, U, CC, Y, T, Z, LN(32)810.24008Disinfectants and Sanitizers for Use on Fabrics andTextilesV, R, U, CC, Y, T, Z, LN(1)810.25008Air SanitizersV, R, U, CC, Y, T, Z, LN(33)810.26008Disinfectants for Use in WaterV, R, U, CC, Y, T, Z, LNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateThe 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 anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:3122 Poly(hexamethylenebiguanideDCI Number:PDCI-111801-35037Page 1 of 4Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; MP; PAI; TGAI =Manufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient;EP; MP = End Use Product, Manufacturing Use ProductUse Categories Key:L -R -T -Indoor food useAgricultural premises and equipmCommercial, institutional and indU -V -Y -Residential and public access prMedical premises and equipmenIndustrial processes and watersZ -CC -Industrial processes and watersSwimming pools1Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.2The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This information will enable the registrant to alsodetermine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analyticaldata, the make and model of the instrument used, and theinstrument operating conditions under which the data were generated.3The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This information will enable the registrant to alsodetermine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analyticaldata, the make and model of the instrument used, and theinstrument operating conditions under which the data were generated.4If 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, and it is formulated into salts or esters,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.5The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This information will enable the registrant to alsodetermine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analyticaldata, the make and model of the instrument used, and theinstrument operating conditions under which the data were generated.6The registrants is required to use Gel Permeation Chromatography (GPC) to characterize various mers (polymeric units) of PHMB products. This information will enable the registrant to alsodetermine the size and size distributions of the PHMB polymeric units. The registrant must submit to the Agency the analyticaldata, the make and model of the instrument used, and theinstrument operating conditions under which the data were generated.7If 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, and it is formulated into salts or esters,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 footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:3122 Poly(hexamethylenebiguanideDCI Number:PDCI-111801-35037Page 2 of 4Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; MP; PAI; TGAI =Manufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient;EP; MP = End Use Product, Manufacturing Use ProductUse Categories Key:L -R -T -Indoor food useAgricultural premises and equipmCommercial, institutional and indU -V -Y -Residential and public access prMedical premises and equipmenIndustrial processes and watersZ -CC -Industrial processes and watersSwimming pools8If 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, and it is formulated into salts or esters,the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).9If 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, and it is formulated into salts or esters,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.10If 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, and it is formulated into salts or esters,the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).11The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. Youare then required to submit a progress report to the Agency within3 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 Notice. If you intend to submit anexisting study or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined,abbreviated, non-guideline, 14-day study at elevatedtemperatures may be conducted and, if found acceptable, may be used to replace the one-year study. Details of the test requirements are attached to this PDCI in a 2-page document entitledGUIDANCE: Combined Accelerated Storage Stability and Corrosion Characteristics Study.12The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. Youare then required to submit a progress report to the Agency within3 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 Notice. If you intend to submit anexisting study or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined,abbreviated, non-guideline, 14-day study at elevatedtemperatures may be conducted and, if found acceptable, may be used to replace the one-year study. Details of the test requirements are attached to this PDCI in a 2-page document entitledGUIDANCE: Combined Accelerated Storage Stability and Corrosion Characteristics Study.13If 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, and it is formulated into salts or esters,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 footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:3122 Poly(hexamethylenebiguanideDCI Number:PDCI-111801-35037Page 3 of 4Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; MP; PAI; TGAI =Manufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient;EP; MP = End Use Product, Manufacturing Use ProductUse Categories Key:L -R -T -Indoor food useAgricultural premises and equipmCommercial, institutional and indU -V -Y -Residential and public access prMedical premises and equipmenIndustrial processes and watersZ -CC -Industrial processes and watersSwimming pools14Data may be waived if MP is formulated15If 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, and it is formulated into salts or esters,the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).16If 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, and it is formulated into salts or esters,the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).17If 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, and it is formulated into salts or esters,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 solidat room temperature.18If 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, and it is formulated into salts or esters,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.19May be waived if the MUP is formulated20Data may be waived if the MP is formulated21Data may be waived if the MP is formulated22If 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, and it is formulated into salts or esters,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 footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:3122 Poly(hexamethylenebiguanideDCI Number:PDCI-111801-35037Page 4 of 4Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; MP; PAI; TGAI =Manufacturing Use Product, Pure Active Ingredient, Technical Grade Active Ingredient;EP; MP = End Use Product, Manufacturing Use ProductUse Categories Key:L -R -T -Indoor food useAgricultural premises and equipmCommercial, institutional and indU -V -Y -Residential and public access prMedical premises and equipmenIndustrial processes and watersZ -CC -Industrial processes and watersSwimming pools23If 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, and it is formulated into salts or esters,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.24If 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, and it is formulated into salts or esters,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.25Not required if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity CategoryI on the basis of potential dermal toxicity.26Not required if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity CategoryI on the basis of potential dermal toxicity.27Not required if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity CategoryI on the basis of potential dermal toxicity.28Not required if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity CategoryI on the basis of potential dermal toxicity.29Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.30Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.31Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.32Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.33Refer to the Product Performance Test Guideline 810.2000 on general considerations for testing antimicrobial products.