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.

1. Company Name and Address4. EPA ProductRegistration

United States Environmental Protection 

Agency Washington, D.C. 20460

DATA CALL-IN RESPONSE

3. Date and Type of DCI 

PRODUCT SPECI01-Sep-2011ID # PDCI-04430

2. Case # and Name

0161 DodineChemical # and Name 044303

Dodecylguanidine hydrochloride

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."

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 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 SPEC01-Sep-2011

PDCI-04430

2. Case # and Name

0161 Dodine

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

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Progress

Reports

1 2 3

Product Chemistry Data Requirements (Antimicrobial)

830.1550 Product Identity and composition (56) V, DD, X EP; MP; TGAI 830.1600 Description of materials used to produce the product (24) V, DD, X EP; MP; TGAI 830.1620 Description of production process (1) V, DD, X TGAI 830.1650 Description of formulation process (2) V, DD, X EP; MP 830.1670 Discussion of formation of impurities (9) V, DD, X EP; MP; TGAI 830.1700 Preliminary analysis (4 ,22 ,23) V, DD, X TGAI 830.1750 Certified limits (21) V, DD, X EP; MP; TGAI 830.1800 Enforcement analytical method (49) V, DD, X EP; MP; TGAI 830.6302 Color (50) V, DD, X EP; MP; TGAI 830.6303 Physical state (20) V, DD, X EP; MP; TGAI 830.6304 Odor (14) V, DD, X 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 SPEC01-Sep-2011

PDCI-04430

2. Case # and Name

0161 Dodine

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.6313 Stability to normal and elevated temperatures, (7 ,25 ,26) V, DD, X TGAI 

metals, and metal ions

830.6314 Oxidizing or reducing action (15) V, DD, X EP; MP 830.6315 Flammability (10) V, DD, X EP; MP 830.6316 Explodability (8) V, DD, X EP; MP 830.6317 Storage stability (60) V, DD, X EP; MP 830.6319 Miscibility (13) V, DD, X EP; MP 830.6320 Corrosion characteristics (57) V, DD, X EP; MP 830.6321 Dielectric breakdown voltage (3) V, DD, X EP; MP 830.7000 pH (18 ,19) V, DD, X EP; MP; TGAI 

830.7050 UV/Visible absorption V, DD, X PAI; TGAI 

830.7100 Viscosity (29) V, DD, X EP; MP 830.7200 Melting point/melting range (11 ,12) V, DD, X 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 SPEC01-Sep-2011

PDCI-04430

2. Case # and Name

0161 Dodine

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

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L

Progress

Reports

1 2 3

830.7220 Boiling point/boiling range (32 ,33) V, DD, X TGAI 830.7300 Density/relative density (51 ,52) V, DD, X EP; MP; TGAI 830.7370 Dissociation constants in water (5 ,6) V, DD, X PAI; TGAI 830.7550 Partition coefficient (n-octanol/water), shake flask (17) V, DD, X PAI; TGAI 

method

830.7560 Partition coefficient (n-octanol/water), generator (55 ,59) V, DD, X TGAI or PAI 

column method

830.7570 Partition coefficient (n-octanol/water), estimation by (16) V, DD, X PAI; TGAI 

liquid chromatography

830.7840 Water solubility: Column elution method, shake flask (31 ,58) V, DD, X PAI; TGAI 

method

830.7860 Water solubility, generator column method (30) V, DD, X PAI; TGAI 830.7950 Vapor pressure (27 ,28) V, DD, X PAI; TGAI 

Toxicology Data Requirements (Antimicrobial)

870.1100

Acute Oral Toxicity (34 ,35 ,53) V, DD, X EP; MP; TGAI 

(36 ,37 ,38,54)

870.1200

Acute dermal toxicity V, DD, X 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 SPEC01-Sep-2011

PDCI-04430

2. Case # and Name

0161 Dodine

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

(39 ,40 ,41,42)

870.1300

Acute inhalation toxicity V, DD, X EP; MP; TGAI 

(43 ,44 ,45,46)

870.2500

Acute dermal irritation V, DD, X EP; MP; TGAI 

870.2600 Skin sensitization (47 ,48) V, DD, X EP; MP; TGAI 

870.2400

Acute eye irritation V, DD, X EP; MP; TGAI 

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

Date
Case # and Name: 0161 Dodine

DCI Number: PDCI-044303-30192

Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI = Technical Grade Active In

Use Categories Key:

V - X - DD - 

Medical premises and equipmen

Materials preservativesAquatic areas

1 Data must be provided in accordance with 40 CFR Part 158.330.2 Data must be provided in accordance with 40 CFR Part 158.335.3 Required if the end-use product is a liquid and is to be used around electrical equipment.4 Data must be provided in accordance with 40 CFR Part 158.345.5 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).

6 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).

7 Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required 

to temperatures >50 degrees Celsius (122 degrees Fahrenheit) during production or storage.

8 Required when the product is potentially explosive.9 Data must be provided in accordance with 40 CFR Part 158.340.10 Required when the product contains combustible liquids.11 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).

12 Required when the TGAI is solid at room temperature.13 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.14 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).

15 Required if the product contains an oxidizing or reducing agent
Case # and Name: 0161 Dodine

DCI Number: PDCI-044303-30192

Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI = Technical Grade Active In

Use Categories Key:

V - X - DD - 

Medical premises and equipmen

Materials preservativesAquatic areas

16 Required if the TGAI or PAI is organic and non-polar.17 Required if the TGAI or PAI is organic and non-polar.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).

19 Required if the product is dispersible with water.20 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).

21 Data must be provided in accordance with 40 CFR Part 158.350.22 Required for TGAIs and products produced by an integrated system.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).

24 Data must be provided in accordance with 40 CFR Part 158.325.25 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).

26 Data 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.

27 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).

28 Not required for salts.29 Required if the product is a liquid.30 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).
Case # and Name: 0161 Dodine

DCI Number: PDCI-044303-30192

Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI = Technical Grade Active In

31 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).

32 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).

33 Required if the TGAI is liquid at room temperature.34 Not required if test material is a gas or highly volatile.35 For 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 

diluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the la

36 Not required if test material is a gas or highly volatile.37 For 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 

diluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the la

38 Not 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 de

39 For 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 

diluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the la

40 Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas, vapor, aerosol or particulates).

41 The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be 

demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach 

42 Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g. gas, volatile substances, or aerosol particulate43 Not required if test material is a gas or highly volatile.44 For 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 

diluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the la

45 Not 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 e
Case # and Name: 0161 Dodine

DCI Number: PDCI-044303-30192

Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI = Technical Grade Active In

46 Required if intended use of the antimicrobial pesticide product will involve purposeful application on human skin or will result in comparable exposure to 

water), 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 routeis 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 

47 For 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 

diluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the la

48 Required if repeated dermal exposure is likely to occur under conditions of use.49 Data must be provided in accordance with 40 CFR Part 158.355.50 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).

51 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).

52 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.

53 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under 40 CF

consideration under 40 CFR Part 154.7(a)(1).

54 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under 40 CF

consideration under 40 CFR Part 154.7(a)(1).

55 Required if the TGAI or PAI is organic and non-polar.56 Data may be waived if the MP is formulated.57 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.

58 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).

59 Data may be waived if MP is formulated.
Case # and Name: 0161 Dodine

DCI Number: PDCI-044303-30192

Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]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; PAI; TGAI = Pure Active ingredient, Technical Grade of the Technical Grade of the Active Ingredient or Pure Active Ingredient; EP; MP = End Use Product, Manufacturing Use Product; TGAI = Technical Grade Active In

60 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.
United States Environmental Protection

Agency Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Co. Nr. Company Name Agent For Address City & S

Case # and Name: 0161,Dodine

55260 AGRIPHAR S.A. CERES INTERNATIONAL LLC 1087 HEARTSEASE DRIVE WEST C68387 CYTEC INDUSTRIES INC FIVE GARRET MOUNTAIN PLAZA WOODL74655 HERCULES INCORPORATED HERCULES INCORPORATED 7910 BAYMEADOWS WAY JACKSO67869 VERICHEM, INC. 3499 GRAND AVENUE PITTSB3876 GE BETZ, INC. 4636 SOMERTON ROAD TREVOS