STUDY REPORT

Study Title

Assessment of Chemical Sensitization Potential Using In Vitro Methods

Report Title

Assessment of Chemical Sensitization Potential of Selected Isothiazolinone Compounds Using In Vitro Methods

Study Number NIEHSO 20180515

Report Number NIEHSO 20180515-1

Testing Facility Burleson Research Technologies, Inc. (BRT) 120 First Flight Lane Morrisville, NC 27560

03 December 2019

BURLESON RESEARCH TECHNOLOGIES, INC.

NIEHSO 20180515-1 Page 1 of 75 In Vitro Assessment of Chemical Sensitization Potential Study No. NIEHSO 20180515 of Selected Isothiazolinone Compounds Report No. NIEHSO 20180515-1

STUDY IDENTIFICATION STUDY TITLE Assessment of Chemical Sensitization Potential Using In Vitro Methods STUDY NUMBER NIEHSO 20180515

Assessment of Chemical Sensitization Potential of Selected REPORT TITLE Isothiazolinone Compounds Using In Vitro Methods

REPORT NUMBER NIEHSO 20180515-1

SPONSOR National Toxicology Program (NTP) Immunotoxicology Testing Systems Toxicology Group Toxicology Branch 530 Davis Drive Durham, NC 27713

STUDY MONITOR Dori. R. Germolec, Ph.D. (NTP)

TESTING FACILITY Burleson Research Technologies, Inc. (BRT) 120 First Flight Lane

Morrisville, NC 27560 Phone: 919-719-2500 Fax: 919-719-2505

STUDY DIRECTOR Travis V. Gulledge, Ph.D. (BRT)

PRINCIPAL Victor J. Johnson, Ph.D. (BRT) INVESTIGATOR FOR NTP IMMUNOTOXICOLOGY CONTRACT

BURLESON RESEARCH TECHNOLOGIES, INC.

NIEHSO 20180515-1 Page 2 in Vitro Assessment of Chemical Sensitization Potential Study No. NIEHSO 20180515 of Selected Isothiazolinone Compounds Report No. NIEHSO 20180515-1

COMPLIANCE STATEMENT

Although this study was perfonned as indicated in the study protocol and applicable BRT standard operating procedures (SOPs), it was investigational in nature and is not expected to conform to good laboratory practice (GLP) standards.

Travis V. Gulledge, PhD Date Study Director Burleson Research Technologies, Inc. 120 First Flight Lane Morrisville, NC 27560 USA

BURLESON RESEARCH TECHNOLOGIES, INC.

N1EHSO 20180515-1 Page 3 In Vitro Assessment of Chemical Sensitization Potential Study No. NJEHSO 20180515 of Selected Isothiazolinone Compounds Report No. N1EHSO 20180515-1

APPROVAL Study Director Approval

Travis V. Gulledge, PhD Date Study Director Burleson Research Technologies, Inc.

Vic r J. Johnson, P Date Principa . tor for TP [mmunotoxicology Burleson Research Technologies, Inc.

BRT Management Approval

~ . Florence G. rtesoo,PhD Date Executive V President (Management) Burleson Research Technologies, Inc.

Report Review:

Gary R. Burleson, Phi') - Date Deputy Principal Investigator Burleson Research Technologies, Inc.

BURLESON RESEARCH TECHNOlOGIES, INC.

NIEHSO 20180515-1 Page 4 In Vitro Assessment of Chemical Sensitization Potential Study No. NIEHSO 20180515 of Selected Tsothiazolinone Compounds Report No. NIEHSO 20180515-1

QUALITY ASSURANCE STATEMENT STUDY NUMBER NlEHSO 20180515 STUDY TITLE Assessment of Chemical Sensitization Potential Using In Vitro Methods REPORT NUMBER NIEHSO 20180515-1 REPORT TITLE Assessment of Chemical Sensitization Potential of Selected Isothiazolinone Compounds Using In Vitro Methods SPONSOR National Toxicology Program Immunotoxicology Testing Program Systems Toxicology Group Toxicology Branch 530 Davis Drive, Morrisville, NC 27560 TESTING FACILITY Burleson Research Technologies, Inc. 120 First Flight Lane Morrisville, NC 27560 STUDY DIRECTOR Travis V. Gulledg:e PhD Date of Date Report Sent to Study Phase Insnected Inspection DirectorlManagement Protocol 26 Jun 18 26Jun 18

Amendment 1 22 Oct 19 22 Oct 19 Draft Report and Raw Data (IT Chemicals) 01 Nov 19 0lNovl9 Final Report (IT Chemicals) 03 Dec 19 03 Dec 19

The final report and data record audit were performed by the BRT Quality Assurance Unit. To the best of my knowledge, this final report accurately describes the