Api tr 407 1995 (american petroleum institute)

American Petroleum Institute Health and Environmental Sciences Department Tert-Amyl Methyl Ether (TAME)Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) under Static Renewal Conditions TSCA Guideline 5797.1930 TOXICOLOGY REPORT NUMBER 407 CAIS ABSTRACT NO 42-1 520 Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale `,,-`-`,,`,,`,`,,` - FEBRUARY 1995 ~~ A P I TR*407 ~ 95 W 2 0 5 733 W 41 E n v r r o n w l Partmbrp One of the most significant long-term trends affecting the future vitality of the petroleum industry is the public’s concerns about the environment Recognizing this trend, API member companies have developed a positive, forward-looking strategy called STEP: Strategies for Today’s Environmental Partnership.This program aims to address public concerns by improving our industry’s environmental, health and safety performance; documenting performance improvements; and communicatingthem to the public The foundation of STEP is the API EnvironmentalMission and Guiding Environmental Principles API ENVIRONMENTAL MISSION AND GUIDING ENVIRONMENTAL PRINCIPLES The members of the American Petroleum Institute are dedicated to continuous efforts to improve the compatibility of our operations with the environment while economically developing energy resources and supplying high quality products and services to consumers The members recognize the importance of efficientlymeeting society’s needs and our responsibility to work with the public, the government, and others to develop and to use natural resources in an environmentally sound manner while protecting the health and safety of our employees and the public To meet these responsibilities, API members pledge to manage our businesses according to these principles: o To recognize and to respond to community concerns about our raw materials, products and operations + To operate our plants and facilities, and to handle our raw materials and products in a manner that protects the environment, and the safety and health of our employees and the public To make safety, health and environmental considerations a priority in our planning, and our development of new products and processes o To advise promptly, appropriate officials, employees, customers and the public of information on significant industry-related safety, health and environmental hazards, and to recommend protective measures U* To counsel customers, transporters and others in the safe use, transportation and disposal of our raw materials, products and waste materials To economicallydevelop and produce natural resourcesand to conservethose resources by using energy efficiently To extend knowledge by conducting or supporting research on the safety, health and environmental effects of our raw materials, products, processes and waste materials Q To commit to reduce overall emission and waste generation o To work with others to resolve problems created by handling and disposal of hazardous substances from our operations o To participate with government and others in creating responsible laws, regulations and standards to safeguard the community, workplace and environment lo promote these principles and practices by sharing experiences and offering assistance to others who produce, handle, use, transport or dispose of similar raw materials, petroleumproducts and wastes `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 m 0732290 0554984 ï T m FOREWORD API PUBLICATIONS NECESSARILY ADDRESS PROBLEMS OF A GENERAL NATURE WITH RESPECT TO PARTICULAR CIRCUMSTANCES, LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS SHOULD BE REVIEWED API IS NOT UNDERTAKING TO MEET THE DUTIES OF EMPLOYERS, MANUFACTLTRERS, OR SUPPLIERS TO WARN AND PROPERLY TRAiN AND EQUIP THEIR EMPLOYEES, AND OTHERS EXPOSED, CONCERNING HEALTH AND SAFETY RISKS AND PRECAUTIONS, NOR UNDERTAKING THEIR OBLIGATIONS UNDER LOCAL, STATE, OR FEDERAL LAWS `,,-`-`,,`,,`,`,,` - NOTHING CONTAINED IN ANY API PUBLICATION IS TO BE CONSTRiJED AS GRANTING ANY RIGHT, BY IMPLICATION OR OTHERWISE, FOR THE MANUFACTURE, SALE, OR USE OF ANY METHOD, APPARATUS, OR PRODUCT COVERED BY LETTERS PATENT NEITHER SHOULD A N Y T " G CONTAINED IN THE PUBLICATION BE CONSTRUED AS INSURING ANYONE AGAINST LIABLI'TY FOR INFRINGEMENT OF LETTERS PATENT Copyright O 1995 American Petroleum Institute Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale `,,-`-`,,`,,`,`,,` - A P I TRUY07 75 0732270 0554785 706 ACKNOWLEDGMENTS - THE FOLLOWING PEOPLE ARE RECOGNIZED FOR THEIR CONTRIBUTIONS OF TJME AND EXPERTISE DURING THIS STUDY AND IN THE PREPARATION OF THIS REPORT Richard Rhoden, Ph.D., Health and Environmental Sciences Department -FO ERS EFFECTS WORKGROUP Russell D White,Ph.D., Chainnun, Chevron Research & Technology, Inc Rudolph J Breglia, Ph.D., BP America, Inc Charles R Clark, Ph.D., Unocal Wayne Daughaey, Ph.D., Exxon Biomedical Sciences, Inc David Duncan, Texaco, Inc Francis J Koscher, Ph.D., ARCO Charles A Lapin, Ph.D., ARCO David C Logan, M.D., Mobil Corporation John H Mitchell, M.D., Amoco Corporation Susan A Rodney, Ph.D., Texaco, Inc Ceinwen A Schreiner, Ph.D., Stonybrook Laboratories David R Steup, Ph.D., Shell Oil Company Michael S Wells, Ph.D., Amoco Corporation Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale American Petroleum Institute Health and Environmental Sciences Department QUALITY ASSURANCE/GLP COMPLIANCE STATEMENT Tert-Amyl Methyl Ether (TAME) - Acute Toxicity to the Mysid Shrimp(M&sis6&)Under Static Renewal Conditions Teating Facility: Springborn Laboratories, Inc SLI Study Number: 12827.0394.6110.510 Study T i t l e : This study was reviewed by API Quality Assurance personnel under the direction of API Management on the dates indicated below for compliance with EPA (TSCA) Good Laboratory Practice (GLP) regulations These studies were conducted in accordance with EPA GLP regulations, with the exceptions* listed below, as well as those listed on the Springborn GLP Compliance Statement Copies of reports by API Quality Assurance personnel are available upon written request to the Director of the Health and Environmental Sciences Department of the American Petroleum Institute or his designee Date(s) of Inspection/Review Type of Inspection 8/28/92 Protocol Evaluation 8/28/92 Second Protocol Review 4/25/94 4/25/94 Date of Report to Manaaement 4/27-28/94 In-Life Inspection 5/2/94 and Data Audit 6/13/94 Draft Report Audit 6/14/94 10/15/94 Revised Final Draft 10/15/94 Report Review 12/21/94 Final Report Review 12/30/94 `,,-`-`,,`,,`,`,,` - -ec>dí/p Christine Seksmith Quality Assurance Coordinator 12/21/94 Amended Final Report Review and Acceptance 12 /30/94 Jd&&$& Date *Test article characterization, other than that received by the manufacturer (98.8% pure TAME) was not performed, storage stability for this test article is not known, and the method of fabrication is maintained with the test article supplier Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 m 0732290 0554987 589 Springborn Laboratories, Inc Environmental Sciences Diviaion 790 Main Street Wareham, Massachusetts02571-1075 (506) 295-2550 Telex 4436041 Facsimile (508) 295-8107 AMENDMENT TO THE STUDY FINAL REPORT Final Report Title: Tert-Amyl Methyl Ether (TAME) - Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Static Renewal Conditions Amendment No SU Study No 12827.O3!%.6110.51O SU Report No 94-5-5269 Study Sponsor: American Petroleum Institute Study Director: Mark W Machado Amendment Date: 29 December 1994 Final Report Modifications and / or Additions: Page 8: The date of Protocol Amendment #1 was changed to the corrected date of the amendment Page 40-41 : The corrected version of Protocol Amendment #1 was included on these pages Approval Signatures: t 2/99 ?!/Y Date Study Director d ? C qLi Date `,,-`-`,,`,,`,`,,` - Patricia D Royal Manager, Regulatory Affairs and Quality Assurance Unit @Springborn umaam Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 I0 2 0 5 8 415 I Page of 73 - TEM-AMYL METHYL ETHER (TAME) ACUTE TOXICITY TO MYSID SHRIMP (Mysldopsls brhia) UNDER STATIC RENEWAL CONDITIONS TSCA Guideline 797.1 930 Submitted to: American Petroleum Institute 1220 L Street, Northwest Washington, D.C 20005 `,,-`-`,,`,,`,`,,` - S U Report #94-5-5269 SU Study #12827.0394.6110.51 O Study Director: Mark W Machado Springborn Laboratories, Inc Environmental Sciences Division 790 Main Street Wareham, Massachusetts 02571-1075 29 December 1994 AMENDED FINAL REPOFIT Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 2 0 5 9 351 Page of 73 Report No 94-5-5269 GOOD LABORATORY PRACTICE COMPUANCE STATEMENT `,,-`-`,,`,,`,`,,` - - The data and report presented for Tert-Amyl Methyl Ether (TAME) Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Static Renewal Conditions' were produced and compiled in accordance with all pertinent EPA Good Laboratory Practice Regulations (40 CFR, Part 792) with the following exception: routine water and food contaminant screening analyses for pesticides, PCBs and toxic metals These analyses were conducted using standard US EPA procedures by Lancaster Laboratories, Lancaster, Pennsylvania These data were not collected in accordance with Good Laboratory Practice procedures (Le., no distinct protocol, Study Director, etc.) Storage stability, characterization and verification of the test substance identity and maintenance of these records on the test substance are the responsibility of the Study Sponsor Total organic carbon analyses for filtered seawater conducted by Galbraith Laboratories, Knoxville, Tennessee, utilized standard U.S EPA procedures, but were not conducted in accordance with Good Laboratory Practice procedures At the termination of the testing program, all remaining test substance will be sent to the Study Sponsor Archival of a sample of the test substance is the responsibility of the Study Sponsor SPRINGBORN LABORATORIES, INC Maik W Machado Study Director Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale daté ' A P I TR*407 95 = 0732290 5 9 073 Report No 94-55269 = Page of 73 TABLE OF CONTENTS Page USTOFFIGURES SUMMARY USTOFTABLES MATERIALS AND METHODS 2.1 Protocol 1.0IMRODUCTION 3.0 TEST PROCEDURES 3.1 Stability and Aqueous Solubility Trials 3.2 Test Initiation 2.2 2.3 2.4 2.5 2.6 27 Test Substance Test Organisms Test Dilution Water Test Conditions Test Concentrations Exposure Solution Preparation B 3.3 Test Monitorin 3.4 Water Quality easurements 3.5 Analytical Measurements 8 8 10 11 11 11 12 12 13 13 13 13 14 5.0RESULTS 15 5.1 Prelimjna Test 15 5.2 DefinitNeyest 16 5.2.1 Evaluation of Test Conditions 16 5.2.2 Analytical Results 17 5.2.3 Biological Results 17 PROTOCOL DEVIATIONS 19 QUAUTY ASSURANCE UNIT STATEMENT 20 REFERENCES 21 SIGNATORES AND APPROVAL 30 6.0 APPENDIX I - STUDY PROTOCOL 31 7.0 APPENDIX II - CERTIFICATE OF ANALYSIS 42 8.0 APPENDIX 111 - CULTURE FOOD ANALYSIS 45 9.0 APPENDIX IV - DILUTION WATER ANALYSIS 48 10.0 APPENDIX V - ANALYnCAL METHODOLOGY 53 11.0 APPENDIX VI - RAW DATA 67 4.0STATISTICS Springborn Laboratories Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale `,,-`-`,,`,,`,`,,` - GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT Page of73 Report No 94-5-5269 UST OF TABLES Page Table nie water quality parameters measured during the 96-hour static renewal exposure of mysid shrimp (Mysidopsis bahia) t o TAME Table Concentrations of TAME measured in the replicate (A,B) test solutions during the 96-hour static renewal exposure of mysid shrimp (Mysldopsis bahia) 24 Mean measured concentrations tested, corresponding cumulative percent mortality and observations made during the 96-hour static acute exposure of mysid shrimp (AßysMopsis bahia) to TAME 25 The LC50 values, corresponding 95% confidence intervals and the No-ûbserved-Eff ect Concentration (NOEC) for the 96-hour static renewal toxicity test exposing mysid shrimp (Mysidopsis bahla) to TAME 26 Table Table Table iA Table 2A Table 3A Table 4A Analytical results for the recovery of TAME from AAP media 60 Analytical results for the recovery of TAME from filtered seawater 61 Analytical results for the recovery of TAME from freshwater (reconstituted to increase hardness) 62 Repeatability of TAME analysis from ASTM Type II water at 0.026mgA 63 `,,-`-`,,`,,`,`,,` - Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS 23 Not for Resale A P I TR*407 95 I0 2 0 5 I Page 61 of 73 Report No 94-5-5269 Analytical results for the recovery of TAME from filtered seawater Nominal Concentration - Consentratlon Recovered Percent Recovered (ma) Volume Purged (mL) (mgn) (W 10.4 5.00 10.0 96.3 10.4 5.00 121 116 10.4 5.00 121 117 10.4 5.00 11.9 114 4.16 5.Do 3.79 91.1 4.16 5.00 3.78 90.9 4.16 5.00 3.79 91.2 0.026 5.00 O.027 105 0.026 5.00 0.027 105 0.026 5.00 0.028 1o9 Control 5.00 c 0.026 NA Control 5.00 < 0.026 NA Control 5.00 < 0.026 NA Mean Recovery: 104 * 11% The minimum detectable concentration was 0.026 mg/L for a 5.00 mL sample which is the lowest calibration standard used in the polynomial fn ~ Springborn Laboratories, inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale ~~ `,,-`-`,,`,,`,`,,` - Table 2A Page 62 of 73 Report No 94-5-5269 Table 3A Analytical results for the recovery of TAME from freshwater (reconstituted to increase hardness) Nominal Concentratlon Dlluìlon (mgR) Factor 695 Volume Purged `,,-`-`,,`,,`,`,,` - (mu Concentratlon Recovered (mgB) Percent Recovered 200 5.00 694 99.8 695 200 5.00 693 99.6 695 200 5.00 705 1o1 248 100 5.00 268 1O8 248 100 5.00 258 104 248 100 5.00 265 107 49.7 20.0 5.00 50.9 102 49.7 20.0 5.00 44.9 90.3 49.7 20.0 5.00 51.7 104 Control 1.00 5.00 c 0.248 NA Control 1.o0 5.00 < 0.248 NA Control 1.00 5.00 e 0.248 NA (%I Mean Recovery: 102 5% (10)' The minimum detectable concentrationwas 0.248 m g nfor a 5.00 mLsample which is the lowest standard used in the linear regression analysis ' The anatyte purging efficiency from a hard reconstitutedwater matrix presents a greater degree of instrumental variabiïi Therefore the standard deviation acceptance criteria has been increasedto 10%to more accuratety represent the recovery data Springbom Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TRm407 95 = 0732290 5 5 LYb = Report No 94-5-5269 Table 4A Repeatability of 0.026 mg/L Page 63 of73 TAME analysis from ASTM Type II water at Replicate Area Height 4751O 5725 5471 6099 46909 5631 36628 5646 WO5 5699 55640 6292 54256 6365 Mean: 47423 5922 Std Dev.: 8243 320 % RSD: 17.4 5.4 ~- Springbom Laboratories, Inc `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale ~~~ A P I T R w 95 2 0555053 Report No 94-5-5269 A representative chromatogram of TAME purge and trap GC/F1D analysis `,,-`-`,,`,,`,`,,` - Figure 1A Page 64 of 73 Springborn Laboratories, inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale ~ A P I TR*407 95 I0 2 0 5 5 T ï I Page 65 of 73 Report No 94-5-3269 Figure 2A A representative linear regression analysis from standard TAME analysis GC with Flame Ionization Detection Correiation Coefficient 0.990968 300 240 180 123 `,,-`-`,,`,,`,`,,` - 6û II'/ /* I 0 0.0 l I l I I I I 1.1 2.2 * 3.3 4.4 Nominal Ccncentrction (mg/t) Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale 5.5 ~ ~~ ~ A P I TR*407 95 0732290 0555053 955 = Report No 94-5-5269 Figure 3A Page 66 of 73 A representative polynomial regression analysis from standard TAME analysis -I- / c R t S c a aC i / Springborn Laboratories, Inc `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 2 0 5 5 891 Report No 94-5-5269 Page 67 of 73 - 11.0 APPENDIX VI RAW DATA ~ ~~ ~~ Springborn Laboratories, Inc `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 95 2 0555055 728 Report No 94-5-5269 Page 68 of 73 Springborn Laboratories, Inc `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I T R 95 2 0555056 6 Report No 94-5-5269 Springbom Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale `,,-`-`,,`,,`,`,,` - Page 69 of 73 2 0555057 T O Paqe 70 of 73 Reoort No 94-5-3269 NONE - Gbsekcn was made anc: nothing t u t of me ordinary w z s ocseme CS - C N B C N C M UN - UNCISSCLVZ3 CXEMICAL ?M - A ñ Ï i C U U E MA== Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale `,,-`-`,,`,,`,`,,` - A P I TR*407 95 A P I TR*:407 95 = 0732290 5 5 437 Page 71 of 73 Report No 94-5-5269 a U O O O UA U U U U L u U U & 1.A /I/ /// s //I s I b 1.b 111 /I/ s /// 1.5 1A & & 97.2 124 lu 131 4 7.3 IS1 7.3 7.3 141 124.9 6-99 o.sa4 L 16.: iSU 9.51 1.27 L 13.: I27 19.3 2.R i 1L.S 116 34.7 *.JI & 18.2 tw 6S.2 lC4 1rS 15 1.UU-al 1:o 1s ?Aos41 114 S 1.W24l 2.2sE-U 130 1s U) SO li*.2 2.PJISEJI 963 so 3.3sp-01 1s1 SO b.alE-01 116 Lo 1s PI.) 1oó W 117 60 Lo Springborn Laboratories, Inc `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS U Not for Resale ~ 95 0732290 0555059 373 Page 72 of 73 Report No 94-5-5269 Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS = Not for Resale `,,-`-`,,`,,`,`,,` - A P I TR*407 A P I TR*407 95 2 O555060 O95 Pace 73 of 73 `,,-`-`,,`,,`,`,,` - ReDort NO 94-5-5269 1.214E-X = E I -roo M.9 31.1 92.6 '05 95.3 98.2 IIWI I SfD.D.oCY C.V 9a.L 10.0 10.13 Springborn Laboratories, Inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale : 1 ~ ~ ~~~ ~ A P I TRx407 75 0732270 0555063 T2L 80PP 0295.561P `,,-`-`,,`,,`,`,,` - Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale A P I TR*407 I0 2 O555062 `,,-`-`,,`,,`,`,,` - P American Petroleum Institute Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS 1220 L Street, Northwest Washington, D.C 20005 Order No 848-00407 Not for Resale