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 

GENERIC03-Mar-2008ID # GDCI-09890

2. Case # and Name

3026 Benzisothiazolin-3-oneChemical # and Name 098901

1,2-Benzisothiazolin-3-one

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. 

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__________________________________
1,2-Benzisothiazolin-3-one

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 #GENERIC03-Mar-2008

GDCI-09890

2. Case # and Name

3026 Benzisothiazolin-3-one

Chemical # and Name 098901

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 (9 ,10 ,15) EE, K, M, Q, X TGAI 875.1400 Inhalation exposure--indoor (1 ,2 ,3 ,16) EE, K, M, Q, X EP 875.1600 Application exposure monitoring data reporting (8 ,13 ,17) EE, K, M, Q, X 

Postapplication Exposure Data Requirements (Antimicrobial)

875.2800 Description of human activity (11 ,14 ,18) EE, K, M, Q, X 

Toxicology Data Requirements (Antimicrobial)

(4 ,5 ,6 ,7,12)

870.1300 Acute inhalation toxicity EE, K, M, Q, X TGAI 

870.4200 Carcinogenicity EE, K, M, Q, 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: 3026 Benzisothiazolin-3-one

DCI Number: GDCI-098901-27548

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 = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

K - M - Q - 

ResidentialIndoor nonfood useResidential outdoor use

X - EE - 

Materials preservativesIndoor use

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

2 Protocols must be submitted to the Agency for approval before initiating a study.3 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.4 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

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

6 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 

7 Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g. gas, volatile substances, or aerosol particulate8 Data reporting and calculations are required when exposure data are submitted.9 Protocols must be submitted to the Agency for approval before initiating a study.10 Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.11 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.

12 The requirement for an acute inhalation toxicity study was waived at the time of registration (1973) for the technical grade powder form of the active ingre

2% of the test material with aerodynamic diameter of < 15 microns). Since that time, waiver criteria have been updated based on advances in inhalation a registrant requesting a waiver on the basis of particle size must demonstrate that their product contains large, non-inhalable particles which are resistaessentially non-inhalable if > 99% of the particles by mass are >100 um in diameter. The Agency's information indicates a large proportion of the particlediameters less than 100 microns.

13 If the exposure monitoring data reporting is not submitted in conjunction with the indoor dermal and inhalation applicator exposure studies, the Agency m

the fullest extent to conduct its human health exposure and risk assessments. The lack of such data could cause the Agency to use inadequate surrogalevel risk assessment and a potential overestimation of exposures.
Case # and Name: 3026 Benzisothiazolin-3-one

DCI Number: GDCI-098901-27548

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 = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]

Use Categories Key:

K - M - Q - 

ResidentialIndoor nonfood useResidential outdoor use

X - EE - 

Materials preservativesIndoor use

14 If review and evaluation of the descriptions of human activity data indicate that only closed-systems are used for mixing/loading and applying metal work

carcinogenicity study is negated. Therefore, submission of acceptable human activity data demonstrating the metal working fluid scenario for BIT is an esignificant cost and burden for the registrant (specifically, the costs associated with generating the carcinogenicity data).For the other use scenarios, desthe Agency to refine its risk assessment and make decisions using fewer assumptions and more reliable data.

15 The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these dat

involve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for review and approval. The scheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved for use, the Agency understhis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not praspecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protoprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.

16 The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these dat

involve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for review and approval. The scheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved for use, the Agency understhis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not praspecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protoprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.

17 The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these dat

involve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for review and approval. The scheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved for use, the Agency understhis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not praspecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protoprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.

18 The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these dat

involve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for review and approval. The scheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved for use, the Agency understhis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not praspecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protoprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.