Page 1 of 1INSTRUCTIONS: 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.1. Company Name and Address4. EPA ProductRegistrationOMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460DATA CALL-IN RESPONSE3. Date and Type of DCI and NumberPRODUCT SPECIFIC01-Sep-2011ID # PDCI-044303-301922. Case # and Name0161 DodineChemical # and Name044303Dodecylguanidine hydrochloride5. I wish tocancel thisproduct registration voluntarily6. Generic Data7. Product Specific Data7a. My product is an MUP andI agree to satisfy the MUPrequirements on the attachedform entitled "RequirementsStatus and Registrant'sResponse."7b. My product is an EUP andI agree to satisfy the EUPrequirements on the attachedform entitled "RequirementsStatus and Registrant'sResponse."6a. I am claiming a GenericData Exemption because Iobtain the active ingredientfrom the source EPA registration number listed below.6b. I agree to satisfy GenericData requirements as indicatedon the attached form entitled"Requirements Status andRegistrant's Response."N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.10. Name of Company11. Phone Number9. Date8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that anyknowingly 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. 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 SPECIFIC01-Sep-2011PDCI-044303-301922. Case # and Name0161 Dodine8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321Product Chemistry Data Requirements (Antimicrobial)(56)830.15508EP; MP; TGAIV, DD, XProduct Identity and composition(24)830.16008EP; MP; TGAIV, DD, XDescription of materials used to produce the product(1)830.16208TGAIV, DD, XDescription of production process(2)830.16508EP; MPV, DD, XDescription of formulation process(9)830.16708EP; MP; TGAIV, DD, XDiscussion of formation of impurities(4 ,22 ,23)830.17008TGAIV, DD, XPreliminary analysis(21)830.17508EP; MP; TGAIV, DD, XCertified limits(49)830.18008EP; MP; TGAIV, DD, XEnforcement analytical method(50)830.63028EP; MP; TGAIV, DD, XColor(20)830.63038EP; MP; TGAIV, DD, XPhysical state(14)830.63048EP; MP; TGAIV, DD, XOdor12. Name of Company13. Phone NumberSignature 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. 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 SPECIFIC01-Sep-2011PDCI-044303-301922. Case # and Name0161 Dodine8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(7 ,25 ,26)830.63138TGAIV, DD, XStability to normal and elevated temperatures,metals, and metal ions(15)830.63148EP; MPV, DD, XOxidizing or reducing action(10)830.63158EP; MPV, DD, XFlammability(8)830.63168EP; MPV, DD, XExplodability(60)830.631716EP; MPV, DD, XStorage stability(13)830.63198EP; MPV, DD, XMiscibility(57)830.632016EP; MPV, DD, XCorrosion characteristics(3)830.63218EP; MPV, DD, XDielectric breakdown voltage(18 ,19)830.70008EP; MP; TGAIV, DD, XpH830.70508PAI; TGAIV, DD, XUV/Visible absorption(29)830.71008EP; MPV, DD, XViscosity(11 ,12)830.72008TGAIV, DD, XMelting point/melting rangeInitial to indicate certification as 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 SPECIFIC01-Sep-2011PDCI-044303-301922. Case # and Name0161 Dodine8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(32 ,33)830.72208TGAIV, DD, XBoiling point/boiling range(51 ,52)830.73008EP; MP; TGAIV, DD, XDensity/relative density(5 ,6)830.73708PAI; TGAIV, DD, XDissociation constants in water(17)830.75508PAI; TGAIV, DD, XPartition coefficient (n-octanol/water), shake flaskmethod(55 ,59)830.75608TGAI or PAIV, DD, XPartition coefficient (n-octanol/water), generatorcolumn method(16)830.75708PAI; TGAIV, DD, XPartition coefficient (n-octanol/water), estimation byliquid chromatography(31 ,58)830.78408PAI; TGAIV, DD, XWater solubility: Column elution method, shake flaskmethod(30)830.78608PAI; TGAIV, DD, XWater solubility, generator column method(27 ,28)830.79508PAI; TGAIV, DD, XVapor pressureToxicology Data Requirements (Antimicrobial)(34 ,35 ,53)870.11008EP; MP; TGAIV, DD, XAcute Oral Toxicity(36 ,37 ,38,54)870.12008EP; MP; TGAIV, DD, XAcute dermal toxicityInitial to indicate certification as 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 SPECIFIC01-Sep-2011PDCI-044303-301922. Case # and Name0161 Dodine8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(39 ,40 ,41,42)870.13008EP; MP; TGAIV, DD, XAcute inhalation toxicity(43 ,44 ,45,46)870.25008EP; MP; TGAIV, DD, XAcute dermal irritation(47 ,48)870.26008EP; MP; TGAIV, DD, XSkin sensitization870.24008EP; MP; TGAIV, DD, XAcute eye irritationInitial to indicate certification as to information on this page (fulltext of certification is on page one).DateCase # and Name:0161 DodineDCI Number:PDCI-044303-30192Page 1 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes: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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Active Ingredient; TGAI or PAI =Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI =Technical Grade Active Ingredient [TGAI]Use Categories Key:V -X -DD -Medical premises and equipmenMaterials preservativesAquatic areas1Data must be provided in accordance with 40 CFR Part 158.330.2Data must be provided in accordance with 40 CFR Part 158.335.3Required if the end-use product is a liquid and is to be used around electrical equipment.4Data must be provided in accordance with 40 CFR Part 158.345.5If 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).6Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).7Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to hightemperatures are required if the TGAI is expected to be subjectedto temperatures >50 degrees Celsius (122 degrees Fahrenheit) during production or storage.8Required when the product is potentially explosive.9Data must be provided in accordance with 40 CFR Part 158.340.10Required when the product contains combustible liquids.11If 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).12Required when the TGAI is solid at room temperature.13Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.14If 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).15Required if the product contains an oxidizing or reducing agentCase # and Name:0161 DodineDCI Number:PDCI-044303-30192Page 2 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes: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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Active Ingredient; TGAI or PAI =Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI =Technical Grade Active Ingredient [TGAI]Use Categories Key:V -X -DD -Medical premises and equipmenMaterials preservativesAquatic areas16Required if the TGAI or PAI is organic and non-polar.17Required if the TGAI or PAI is organic and non-polar.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).19Required if the product is dispersible with water.20If 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).21Data must be provided in accordance with 40 CFR Part 158.350.22Required for TGAIs and products produced by an integrated system.23If 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).24Data must be provided in accordance with 40 CFR Part 158.325.25If 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).26Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.27If 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).28Not required for salts.29Required if the product is a liquid.30If 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).Case # and Name:0161 DodineDCI Number:PDCI-044303-30192Page 3 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes: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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Active Ingredient; TGAI or PAI =Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI =Technical Grade Active Ingredient [TGAI]31If 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).32If 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).33Required if the TGAI is liquid at room temperature.34Not required if test material is a gas or highly volatile.35For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.36Not required if test material is a gas or highly volatile.37For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.38Not required if test material is corrosive to skin or has pH < 2 or >11.5; such a product will be classified as Toxicity Category I on the basis of potential dermal toxicity.39For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.40Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas, vapor, aerosol or particulates).41The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any orall of these studies may be granted when the applicant candemonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.42Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g. gas, volatile substances, or aerosol particulate).43Not required if test material is a gas or highly volatile.44For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.45Not required if test material is corrosive to skin or has pH < 2 or > 11.5; such a product will be classified as Toxicity Category I on the basis of potential eye irritation effects.Case # and Name:0161 DodineDCI Number:PDCI-044303-30192Page 4 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes: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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Active Ingredient; TGAI or PAI =Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI =Technical Grade Active Ingredient [TGAI]46Required if intended use of the antimicrobial pesticide product will involve purposeful application on human skin or will result in comparable exposure to the product (e.g. uses in swimming poolwater), or if the active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredientis the toxic moiety. The EP shall also be tested if any component of the EP may increase dermal absorption of the active ingredient(s) or potentiate toxic or pharmacologic effects.47For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.48Required if repeated dermal exposure is likely to occur under conditions of use.49Data must be provided in accordance with 40 CFR Part 158.355.50If 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).51If 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).52True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solidat room temperature.53Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under 40 CFR Part 152.170(b) or special reviewconsideration under 40 CFR Part 154.7(a)(1).54Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under 40 CFR Part 152.170(b) or special reviewconsideration under 40 CFR Part 154.7(a)(1).55Required if the TGAI or PAI is organic and non-polar.56Data may be waived if the MP is formulated.57The 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.58If 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).59Data may be waived if MP is formulated.Case # and Name:0161 DodineDCI Number:PDCI-044303-30192Page 5 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes: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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Active Ingredient; TGAI or PAI =Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI =Technical Grade Active Ingredient [TGAI]60The 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.United States Environmental ProtectionAgency Washington, D.C. 20460LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICECo. Nr.Company NameAgent ForAddressCity & StateZipCase # and Name:0161,DodineAGRIPHAR S.A.CERES INTERNATIONAL LLC1087 HEARTSEASE DRIVEWEST CHESTERPA1938255260CYTEC INDUSTRIES INCFIVE GARRET MOUNTAIN PLAZAWOODLAND PARKNJ0742468387HERCULES INCORPORATEDHERCULES INCORPORATED7910 BAYMEADOWS WAYJACKSONVILLEFL3225674655VERICHEM, INC.3499 GRAND AVENUEPITTSBURGHPA1522567869GE BETZ, INC.4636 SOMERTON ROADTREVOSEPA1905367833876