Poly(oxy-1,2-ethanediyl(dimethylimino)-1,2-ethanediyl(d

dichloride)

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 #GENERIC29-Sep-2011

GDCI-06918

2. Case # and Name

3034 Busan 77 (*)

Chemical # and Name 069183

7. Test 

Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

Applicator Exposure Data Requirements (Antimicrobial)

(6 ,7 ,8 ,28,35)

875.1100 Dermal exposure--outdoor N V, Y, T, X, O, L, S 

(9 ,10 ,11 ,29,36)

875.1200 Dermal exposure--Indoor N V, Y, T, X, O, L, S 

(12 ,13 ,14,30 ,37)

875.1300 Inhalation exposure--outdoor N V, Y, T, X, O, L, S 

(15 ,16 ,17,18 ,31 ,38)

875.1400 Inhalation exposure--indoor N V, Y, T, X, O, L, S 875.1600 Application exposure monitoring data reporting (19 ,32 ,34) N V, Y, T, X, O, L, S 

Postapplication Exposure Data Requirements (Antimicrobial)

875.2300 Indoor surface residue dissipation (3 ,4 ,5 ,20) N V, Y, T, X, O, L, S 

Terrestrial and Aquatic Nontarget Organisms DataRequirements (Antimicrobial)

850.1735 Whole sediment: acute freshwater invertebrates (1 ,2 ,21) N V, Y, T, X, O, L, S 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
Poly(oxy-1,2-ethanediyl(dimethylimino)-1,2-ethanediyl(d

dichloride)

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 #GENERIC29-Sep-2011

GDCI-06918

2. Case # and Name

3034 Busan 77 (*)

Chemical # and Name 069183

7. Test 

Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

850.1300 Daphnid chronic toxicity test (23) N V, Y, T, X, O, L, S 850.1400 Fish early-life stage toxicity test (24) N V, Y, T, X, O, L, S 850.4225 Seedling emergence, Tier II (25) N V, Y, T, X, O, L, S 850.4400 Aquatic plant toxicity test using Lemna spp. Tiers I (26) 

and II

N V, Y, T, X, O, L, S

850.5400 Algal toxicity, Tiers 1 and II (27) N V, Y, T, X, O, L, S SS-AFM-1 Aquatic Field Monitoring, Once-Through Cooling (33 ,39) 

Water Systems

N V, Y, T, X, O, L, S

850.1740 Whole sediment: acute marine invertebrates (22) N V, Y, T, X, O, L, S 

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

Date
Case # and Name: 3034 Busan 77 (*)

DCI Number: GDCI-069183-30193

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

TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

L - O - S - 

Indoor food useResidential Indoor useFood handling/storage establish

T - V - X - 

Commercial, institutional and ind

Medical premises and equipmenMaterials preservatives

Y - Industrial processes and water s

1 Data are required on a case-by-case basis depending on: (i) The results of lower-tier ecological effects studies in the active ingredient or end-use produ

organisms. (ii) Physicochemical properties indicate cumulative effects may occur (e.g., Kow is greater than or equal to 1,000). (iii) The active ingredient persistent in water (e.g., hydrolysis half-life in water is greater than 4 days). (iv) For wood preservative uses, these data are required if any of the conditiowood will be used in the aquatic environment (including estuarine/marine environments) or use of treated wood in aquatic environments is not prohibited 

2 Sediment toxicity testing is required if a pesticide meets any of the following conditions: (i) Solubility is less than or equal to 0.1 mg/L. (ii) Koc is greater th

equal to 4.0). (iii) Kd is greater than or equal to 50. (iv) The pesticide persists in sediments with a half-life greater than 10 days. (v) Concentration in the iconcentrations known to be toxic in the water column. (vi) For wood preservative uses, these data are required if any of the conditions in note (16)(i)-(iii) the aquatic environment (including estuarine/marine environments) or when use of treated wood in aquatic environments is not prohibited by product lab

3 The Agency will require postapplication exposure data beyond the required product use and human activity information by the appropriate route(s) of ex

exposure criteria and one of the following toxicity criteria are met by the TGAI or any of the pesticide's metabolites:(i) Exposure criteria. (A) Dermal expobystanders and residents, is likely to occur. (B) Inhalation exposure to workers upon reentry, or to bystanders and residents, is likely to occur. (C) The hpesticide use pattern (e.g. use in swimming pools and spas) can lead to potentially high exposures. (D) Surrogate exposure data that the Agency deemthe magnitude of exposure for a particular postapplication work activity, with an adequate degree of confidence, are unavailable.(ii) Toxicity criteria. (A) (Guideline 870.1200) is less than or equal to 2000 mg/kg (i.e., Toxicity Category I or II as per 40 CFR 156.10). (B) The acute inhalation LC50 of the TGAequal to 0.5 mg/liter (i.e., 4-hour exposure, Toxicity Category I or II) and the TGAI has a vapor pressure greater than 10-3 mm Hg at 25 degrees C if useregardless of the vapor pressure. (C) The acute oral LD50 of the TGAI (Guideline 870.1100) is less than 50 mg/kg (i.e., Toxicity Category I). (D) The pe(Guideline 870.6200). (E) The pesticide is found to be a developmental toxicant (Guidelines 870.3700 and 870.6300). (F) The pesticide is found to be a The pesticide shows potential adverse effects in subchronic studies such as the 90-day oral (Guideline 870.3100), 21-day repeated dose dermal toxicity toxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproduction a

4 Required if the use pattern and formulation types involve significant potential exposure to humans by evaporation of residues from surfaces or contact w

5 Protocols must be submitted to the Agency for approval before initiating a study.6 The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at least one of the following expo

following toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermal exposure is likely to occur durto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity Category I (Guideline 870.1200) as per 40 LC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI has a vapor pressure greater thoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesttoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalatand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to (Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.
Case # and Name: 3034 Busan 77 (*)

DCI Number: GDCI-069183-30193

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

TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

L - O - S - 

Indoor food useResidential Indoor useFood handling/storage establish

T - V - X - 

Commercial, institutional and ind

Medical premises and equipmenMaterials preservatives

Y - Industrial processes and water s

7 Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.8 Protocols must be submitted to the Agency for approval before initiating a study.9 The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at least one of the following expo

following toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermal exposure is likely to occur durto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity Category I (Guideline 870.1200) as per 40 LC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI has a vapor pressure greater thoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesttoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalatand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to (Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.

10 Protocols must be submitted to the Agency for approval before initiating a study.11 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.

12 The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at least one of the following expo

following toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermal exposure is likely to occur durto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity Category I (Guideline 870.1200) as per 40 LC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI has a vapor pressure greater thoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesttoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalatand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to (Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.

13 Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.

14 Protocols must be submitted to the Agency for approval before initiating a study.
Case # and Name: 3034 Busan 77 (*)

DCI Number: GDCI-069183-30193

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

TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

L - O - S - 

Indoor food useResidential Indoor useFood handling/storage establish

T - V - X - 

Commercial, institutional and ind

Medical premises and equipmenMaterials preservatives

Y - Industrial processes and water s

15 The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at least one of the following expo

following toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermal exposure is likely to occur durto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity Category I (Guideline 870.1200) as per 40 LC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI has a vapor pressure greater thoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesttoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalatand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to (Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.

16 Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.

17 Protocols must be submitted to the Agency for approval before initiating a study.18 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.19 Data reporting and calculations are required when exposure data are submitted.20 Please see 40 CFR Sections 158 and/or 161 for additional information.21 Please see 40 CFR Sections 158 and/or 161 for additional information.22 Please see 40 CFR Sections 158 and/or 161 for additional information.23 Please see 40 CFR Sections 158 and/or 161 for additional information.24 Please see 40 CFR Sections 158 and/or 161 for additional information.25 Please see 40 CFR Sections 158 and/or 161 for additional information.26 Please see 40 CFR Sections 158 and/or 161 for additional information.
Case # and Name: 3034 Busan 77 (*)

DCI Number: GDCI-069183-30193

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

TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

L - O - S - 

Indoor food useResidential Indoor useFood handling/storage establish

T - V - X - 

Commercial, institutional and ind

Medical premises and equipmenMaterials preservatives

Y - Industrial processes and water s

27 Please see 40 CFR Sections 158 and/or 161 for additional information.28 Please see 40 CFR Sections 158 and/or 161 for additional information.29 Please see 40 CFR Sections 158 and/or 161 for additional information.30 Please see 40 CFR Sections 158 and/or 161 for additional information.31 Please see 40 CFR Sections 158 and/or 161 for additional information.32 Please see 40 CFR Sections 158 and/or 161 for additional information.33 A protocol must be submitted for review and approval by the Agency prior to initiating this study. The draft protocol must be submitted to the Agency wit

34 In accordance with 40 CFR 158.1020, OPPTS Guideline 875.1600 is required to accompany OPPTS Guidelines 875.1100 (Dermal Outdoor Exposure), 

875.1300 (Inhalation Outdoor Exposure), and 875.1400 (Inhalation Indoor Exposure). When all four GLNs are listed, the registrant is only required to peexposure and one inhalation exposure.

35 Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subj

EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in vStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DC

36 Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subj

EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in vStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DC

37 Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subj

EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in vStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DC

38 Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subj

EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in vStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DC
Case # and Name: 3034 Busan 77 (*)

DCI Number: GDCI-069183-30193

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

TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

L - O - S - 

Indoor food useResidential Indoor useFood handling/storage establish

T - V - X - 

Commercial, institutional and ind

Medical premises and equipmenMaterials preservatives

Y - Industrial processes and water s

39 Please see 40 CFR Sections 158 and/or 161 for additional information.