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-2015ID # PDCI-04390

2. Case # and Name

2315 GlutaraldehydeChemical # and Name 043901

Glutaraldehyde

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.

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-2015

PDCI-04390

2. Case # and Name

2315 Glutaraldehyde

EPA Reg. No.

7. Test Substance

6. Use Pattern

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Progress

Reports

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Product Chemistry Data Requirements (Antimicrobial)

830.1550 Product Identity and composition (1) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.1600 Description of materials used to produce the product (2) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.1620 Description of production process (3) N V, R, U, Y, T, X, Z EP; TGAI 830.1650 Description of formulation process (4) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.1670 Discussion of formation of impurities (5) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.1700 Preliminary analysis (6 ,7) N V, R, U, Y, T, X, Z EP; MP; TGAI 

830.1750 Certified limits N V, R, U, Y, T, X, Z EP; MP; TGAI 830.1800 Enforcement analytical method N V, R, U, Y, T, X, Z EP; MP; TGAI 

830.6302 Color (8 ,9) N V, R, U, Y, T, X, Z MP; TGAI 830.6303 Physical state (10 ,11) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.6304 Odor (12 ,13) N V, R, U, Y, T, X, Z 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-2015

PDCI-04390

2. Case # and Name

2315 Glutaraldehyde

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

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Progress

Reports

1 2 3

830.6313 Stability to normal and elevated temperatures, (14 ,15) TGAI 

metals, and metal ions

N V, R, U, Y, T, X, Z

830.6314 Oxidizing or reducing action (16 ,17) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.6315 Flammability (18 ,19) N V, R, U, Y, T, X, Z EP; MP 830.6316 Explodability (20 ,21) N V, R, U, Y, T, X, Z EP; MP 

(22 ,23 ,24,25)

830.6317 Storage stability N V, R, U, Y, T, X, Z EP; MP 830.6319 Miscibility (26 ,27) N V, R, U, Y, T, X, Z EP; MP 

(28 ,29 ,30,31)

830.6320 Corrosion characteristics N V, R, U, Y, T, X, Z EP; MP 830.6321 Dielectric breakdown voltage (32 ,33 ,34) N V, R, U, Y, T, X, Z EP 830.7000 pH (35 ,36 ,37) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.7050 UV/Visible absorption (38 ,39) N V, R, U, Y, T, X, Z TGAI 830.7100 Viscosity (40 ,41) N V, R, U, Y, T, X, Z EP; MP 830.7200 Melting point/melting range (42 ,43) N V, R, U, Y, T, X, Z 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-2015

PDCI-04390

2. Case # and Name

2315 Glutaraldehyde

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

830.7220 Boiling point/boiling range (44 ,45) N V, R, U, Y, T, X, Z TGAI 830.7300 Density/relative density (46 ,47 ,48) N V, R, U, Y, T, X, Z EP; MP; TGAI 830.7370 Dissociation constants in water (49 ,50) N V, R, U, Y, T, X, Z TGAI 830.7550 Partition coefficient (n-octanol/water), shake flask (51 ,52) TGAI 

method

N V, R, U, Y, T, X, Z

830.7560 Partition coefficient (n-octanol/water), generator (53 ,54) TGAI 

column method

N V, R, U, Y, T, X, Z

830.7570 Partition coefficient (n-octanol/water), estimation by (55 ,56) TGAI 

liquid chromatography

N V, R, U, Y, T, X, Z

830.7840 Water solubility: Column elution method, shake flask (57 ,58) TGAI 

method

N V, R, U, Y, T, X, Z

830.7860 Water solubility, generator column method (59 ,60) N V, R, U, Y, T, X, Z TGAI 830.7950 Vapor pressure (61 ,62) N V, R, U, Y, T, X, Z TGAI 

Toxicology Data Requirements (Antimicrobial)

870.1100 Acute Oral Toxicity N V, R, U, Y, T, X, Z 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-2015

PDCI-04390

2. Case # and Name

2315 Glutaraldehyde

EPA Reg. No.

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

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L

Progress

Reports

1 2 3

870.1200 Acute dermal toxicity (63) N V, R, U, Y, T, X, Z EP; MP; TGAI 

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

870.2500 Acute dermal irritation (65) N V, R, U, Y, T, X, Z EP; MP; TGAI 870.2600 Skin sensitization (66) N V, R, U, Y, T, X, Z EP; MP; TGAI 870.2400 Acute eye irritation (64) N V, R, U, Y, T, X, Z EP; MP; TGAI 810.2100 Sterilants (68) N V, R, U, Y, T, X, Z EP 810.2200 Disinfectants for Use on Hard Surfaces (69) N V, R, U, Y, T, X, Z EP 810.2300 Sanitizers for Use on Hard Surfaces (70) N V, R, U, Y, T, X, Z EP 810.2400 Disinfectants and Sanitizers for Use on Fabrics and (71) EP 

Textiles

N V, R, U, Y, T, X, Z

810.2500 Air Sanitizers (67) N V, R, U, Y, T, X, Z EP 810.2600 Disinfectants for Use in Water (72) N V, R, U, Y, T, X, Z EP 

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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - T - U - 

Agricultural premises and equip

m

Commercial, institutional and indResidential and public access pr

V - X - Y - 

Medical premises and equipmen

Materials preservativesIndustrial processes and water s

Z - Industrial processes and water s

1 The Confidential Statement of Formula (CSF) form may be referenced.2 In addition to guideline information, providing the MSDS for each component in formulation is recommended.3 Waiver may be requested if the product is a non-integrated system.4 Providing a flow chart for the formulation process is recommended.5 Waiver may be requested if the product is a non-integrated system.6 Waiver may be requested if the product is a non-integrated system.7 For an integrated system, a five batch analysis is preferred. The analysis must be based on the product to assay the active ingredient (AI). If the product 

analysis (COA) may be used in place of the five batch analysis. A COA for each supplier must be provided

8 The method that was used must be provided.9 Provide the temperature when the study was conducted.10 The method that was used must be provided.11 Provide the temperature when the study was conducted.12 The method that was used must be provided.
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - T - U - 

Agricultural premises and equip

m

Commercial, institutional and indResidential and public access pr

V - X - Y - 

Medical premises and equipmen

Materials preservativesIndustrial processes and water s

Z - Industrial processes and water s

13 Provide the temperature when the study was conducted.14 The method that was used must be provided.15 Provide the temperature when the study was conducted.16 The method that was used must be provided.17 Provide the temperature when the study was conducted.18 The method that was used must be provided.19 Provide the temperature when the study was conducted.20 The method that was used must be provided.21 Provide the temperature when the study was conducted.22 The method that was used must be provided.23

Accelerated (temperature between 40 to 55 oC) storage stability can be reported to be equivalent to this guideline as long as: the AI meets the EPA Stan

reported at the initial, in between, and at the end of the study for 14 or 30 days. If the study does not pass, then the applicant must conduct the one-year 
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

Use Categories Key:

R - T - U - 

Agricultural premises and equip

m

Commercial, institutional and indResidential and public access pr

V - X - Y - 

Medical premises and equipmen

Materials preservativesIndustrial processes and water s

Z - Industrial processes and water s

24 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 submi

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 N

study or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-dbe conducted and, if found acceptable, may be used to replace the one-year study.

25 Provide the temperature when the study was conducted.26 Provide the temperature when the study was conducted.27 The method that was used must be provided.28 The method that was used must be provided.29

An accelerated equivalent study may be conducted in conjunction with 830.6317.

30 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 submi

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 Nstudy or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-dbe conducted and, if found acceptable, may be used to replace the one-year study.

31 Provide the temperature when the study was conducted.32 The method that was used must be provided.33 Provide the temperature when the study was conducted.34 Waiver may be requested if the product is not intended to be use near electric outlet.
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

35 The method that was used must be provided.36 The value must be reflected on the CSF form.37 Provide the temperature when the study was conducted.38 The method that was used must be provided.39 Provide the temperature when the study was conducted.40 Provide the temperature when the study was conducted.41 The method that was used must be provided.42 The method that was used must be provided.43 Provide the temperature when the study was conducted.44 The method that was used must be provided.45 Provide the temperature when the study was conducted.46 The value must be reflected on the CSF form.47 Provide the temperature when the study was conducted.
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

48 The method that was used must be provided.49 The method that was used must be provided.50 Provide the temperature when the study was conducted.51 The method that was used must be provided.52 Provide the temperature when the study was conducted.53 The method that was used must be provided.54 Provide the temperature when the study was conducted.55 Provide the temperature when the study was conducted.56 The method that was used must be provided.57 The method that was used must be provided.58 56 Provide the temperature when the study was conducted.59 The method that was used must be provided.60 Provide the temperature when the study was conducted.
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

61 The method that was used must be provided.62 Provide the temperature when the study was conducted.63 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 64 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 65 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of 66 Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as a dermal sensitizer.67 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.

68 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.

69 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.

70 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.

71 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.
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: 2315 Glutaraldehyde

DCI Number: PDCI-043901-30503

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 AProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = End Use Product; Technical G

72 Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guid

http://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.