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 

GENERIC11-Aug-2008ID # GDCI-10700

2. Case # and Name

3023 AzadioxabicyclooctaneChemical # and Name 107002

5-Hydroxymethyl-1-aza-3,7-dioxabicyclo(3.3.0)octane

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__________________________________
5-Hydroxymethyl-1-aza-3,7-dioxabicyclo(3.3.0)octane

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 #GENERIC11-Aug-2008

GDCI-10700

2. Case # and Name

3023 Azadioxabicyclooctane

Chemical # and Name 107002

7. Test Substance

6. Use Pattern

P

R

O

T

O

C

O

L

Progress

Reports

1 2 3

Applicator Exposure Data Requirements (Antimicrobial)

875.1200 Dermal exposure--Indoor (13 ,14 ,15) K, X 

(9 ,10 ,11,12)

875.1400 Inhalation exposure--indoor K, X 875.1600 Application exposure monitoring data reporting (8) K, X 

Postapplication Exposure Data Requirements (Antimicrobial)

875.2800 Description of human activity (7) K, X 

Toxicology Data Requirements (Antimicrobial)

870.2600 Skin sensitization (1 ,2) K, X MP; TGAI 870.4200 Carcinogenicity (3 ,4 ,5 ,6) K, X 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
Case # and Name: 3023 Azadioxabicyclooctane

DCI Number: GDCI-107002-27890

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

MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

K - X - 

ResidentialMaterials preservatives

1 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

2 Required if repeated dermal exposure is likely to occur under conditions of use.3 If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same specie

Guideline 870.3100, may be required to evaluate potential to produce preneoplastic lesions.

4 For low exposure antimicrobials, a carcinogenicity study in two species is required if any of the following criteria are met: (i) The weight of evidence indi

ingredient or any of its metabolites, transformation products or impurities based upon consideration of whether the substance: (A) Is structurally related mutagenic effects as demonstrated by in vitro or in vivo testing. (C) Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchrchange. (ii) Use of the pesticide product is likely to result inhuman exposure over a substantial portion of the human life span which is significant in terms of the frequency, magnitude, or duration of exposure.

5 If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same specie

Guideline 870.3100, may be required to evaluate potential to produce preneoplastic lesions.

6 For low exposure antimicrobials, a carcinogenicity study in two species is required if any of the following criteria are met: (i) The weight of evidence indi

ingredient or any of its metabolites, transformation products or impurities based upon consideration of whether the substance: (A) Is structurally related mutagenic effects as demonstrated by in vitro or in vivo testing. (C) Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchrchange. (ii) Use of the pesticide product is likely to result inhuman exposure over a substantial portion of the human life span which is significant in terms of the frequency, magnitude, or duration of exposure.

7 The required description of human activity data include data such as frequency and duration of exposure to evaluate the potential differences in exposur

and children), and to determine how specific postapplication activity patterns affect exposure levels.

8 Data reporting and calculations are required when exposure data are submitted.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.
Case # and Name: 3023 Azadioxabicyclooctane

DCI Number: GDCI-107002-27890

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

MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]

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

11 Protocols must be submitted to the Agency for approval before initiating a study.12 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.13 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.

14 Protocols must be submitted to the Agency for approval before initiating a study.15 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.
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: 3023,Azadioxabicyclooctane

INTERNATIONAL SPECIALTYPRODUCTS

1529 1361 ALPS RD. WAYNE