Api tr 408 1995 (american petroleum institute)

A P I T R r ä 95 11' ~ O732290 0555063 T American Petroleum Institute Health and Environmental Sciences Department Tert-Amyl Methyl Ether (TAME)Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-through Conditions `,,-`-`,,`,,`,`,,` - TSCA Guideline 5797.1400 FEBRUARY 1995 TOXICOLOGY REPORT NUMBER 408 CAIS ABSTRACT NO 42-1 521 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*408 95 = 2 0555064 730 W `,,-`-`,,`,,`,`,,` - One of the most significant long-term trends affecting the future vitality of the petroleum industry is the public’s concerns about the environment Recognizingthis 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 communicating them to the public The foundation of STEP is the API EnvironmentalMission and Guiding Environmental Principles API ENVIRONMENTAL MISSION AND GUIDING ENVIRONMENTALPRINCIPLES 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 efficiently meeting 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: 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 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 To counsel customers, transporters and others in the safe use, transportation and disposal of our raw materials, products and waste materials To economically develop and produce natural resourcesand to conserve those 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 To commit to reduce overall emission and waste generation To work with others to resolve problems created by handling and disposal of hazardous substances from our operations To participate with government and others in creating responsible laws, regulationsand standards to safeguard the communiỵy, workplace and environment To 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 2 0555065 677 D A P I TRa408 75 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, MANUFACTURERS, 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 CONSTRUED AS GRANTING ANY RIGHT, BY IMPLICATION OR OTHERWISE, FOR THE MANUFACTURE, SALE, OR USE OF ANY METHOD, APPARATUS, OR PRODUCT COVERED BY LEITERS PATENT NEI'EER SHOULDANYTHING CONTAINED IN THE PUBLICATION BE CONSTRUED AS INSURING ANYONE AGAINST LIABILìïY FOR I"GEMENT OF LEïTERS PATENT Copyright 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 TR*40ô 95 m 0732290 0555066 503 H ACKNOWLEDGMENTS - THE FOLLOWING PEOPLE ARE RECOGNIZED FOR THEIR CONTRIBUTIONS OF TIME AND EXPERTISE DURING THIS STUDY AND IN THE PREPARATION OF THIS REPORT: Richard Rhoden, Ph.D., Health and Environmental Sciences Department CTS WORKGROUP `,,-`-`,,`,,`,`,,` - Russell D White, Ph.D., C h u i m n , Chevron Research & Technology, Inc Rudolph J Breglia, Ph.D., BP America, Inc Charles R Clark, Ph.D., Unocal Wayne Daughtrey, Ph.D., Exxon Biomedical Sciences, Inc David Duncan, Texaco, Inc Francis J Koschier, 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 Study Title: Tert-Amyl Methyl Ether (TAME) - Acute Toxicity to Rainbow Trout (oneat>imcliur~&) Under Flow-Through Conditions Testing Facility: Springborn Laboratories, Inc SLI Study Number: 12827.0692.6104.108 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 InsDection/Review Type of InsDection 8/28/92 Protocol Evaluation 8/28/92 Draft Report Audit 5/5/93 Draft Report Audit 4/29/94 5/5/93 4/27-28/94 Date of Report to Manaqement 10/15/94 Revised Final Draft Report Acceptance 10/15/94 12/20/94 Final Report 12/20/94 Date Quality Assurance Coordinator *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 `,,-`-`,,`,,`,`,,` - 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 - A P I TRU40B 75 ~ 2 0 5 386 W Page of 72 `,,-`-`,,`,,`,`,,` - - TEM-AMYL METHYL ETHER (TAME) ACUTE TOXICTTY TO RAINBOW TROUT (O~CO~I~C mykiss) ~ U S UNDER FLOWTHROUGH CONDITIONS TSCA GUIDEUNE 797.1 400 Submitted to: American Petroleum Institute 1220 L Street, Northwest Washington, D.C 20005 SU Report # 93-3-4682 Study # 12827.0692.61 04.1 08 Study Director: Mark W Machado Springborn Laboratories, Inc Environmental Sciences Division 790 Main Street Wareham, Massachusetts 02571-1 075 19 December 1994 FINAL REPORT Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Not for Resale ~ ~~ API TR*408 95 2 0 5 212 Page of 72 Report No 93-3-4682 GOOD LABORATORY PRACTICES COMPLIANCE STATEMENT - The data and report presented for Tertdmyl Methyl Ether FAME) Acute Toxicity to Rainbow Trout (Oncorbyncbus mykiss) Under Flow-Through Conditions" were produced and compiled in accordance with all pertinent EPA Good Laboratory Practice Regulations (40 CFR, Part 792) with the following exceptions: routine water and food contaminant screening analyses PCBs and metals are conducted using standard U.S EPA procedures by Lancaster Laboratories, Lancaster, PA These data were not collected in accordance with Good Laboratory Practice procedures (¡.e., 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 At the termination of the testing program, all remaining test material will be sent to the Study Sponsor Archival of a sample of the test material is the responsibility of the Study Sponsor SPRINGBORN LABORATORIES, INC Mark W Machado Study Director Date ~~ 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 ~ `,,-`-`,,`,,`,`,,` - for pesticides, A P I TR*408 95 0732290 0555070 T34 `,,-`-`,,`,,`,`,,` - Report No 93-3-4682 Page of 72 TABLE OF CONTENTS Page GOOD LABORATORY PRACTICES COMPUANCE STATEMENT USTOFTABLES USTOFFIGURES 2.0 MATERIALS AND METHODS 2.1 Protocol 2.2 Test Material 2.3 Test Organisms 2.4 Test Dilution Water 2.5 Test Conditions 2.6 Test Concentrations 2.7 Test Solution Preparation and Delivery 9 10 11 12 12 12 3.0 TESTPROCEDURES 3.1 Test Initiation 3.2 Test Monitoring 3.3 Water Quality Measurements 3.4 Analytical Measurements 13 13 13 14 14 SUMMARY 1.0 INTRODUCTION 4.0 STATISTICS 5.0 RESULTS 5.1 Preliminary Testing 5.2 DefinitiveTest 16 16 17 19 20 21 30 31 PROTOCOL DEVIATION QUALITY ASSURANCE UNIT STATEMENT REFERENCES 15 SIGNATURES AND APPROVAL - 6.0 APPENDIX I STUDY PROTOCOL 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*408 95 ~ ~~~ ~~ ~ 2 O555073 970 ReDort NO 93-3-4682 Paae of 72 ~ ~~ CERTIFICATE OF ANALYSIS 44 8.0 APPENDIX 111 CULTURE FOOD ANALYSIS 47 DILUTION WATER ANALYSIS 50 7.0 APPENDIX II 9.0 APPENDIX N 10.0 APPENDIX V ANALYTICAL METHODOLOGY 53 67 `,,-`-`,,`,,`,`,,` - 11.0APPENDIXW-RAWDATA 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 API TR*YOB 95 = 2 O555072 Report No 93-3-4682 Page of 72 LIST OF TABLES Page Table Table The water quality parameters measured during the 96-hour flow-through toxicity test exposing rainbow trout (Oncorbynchus mykiss) to TAME 23 Concentrations of TAME measured in replicate (A,B) test solutions during the 96-hour flow-through exposure of rainbow trout (Oncorhynchus mykiss) 24 `,,-`-`,,`,,`,`,,` - Table Mean measured concentrations tested, corresponding mortalities and observations made during the 96-hour flow-through exposure of rainbow trout (Oncorhynchus mykiss) to TAME 25 Table The LC50 values (95% confidence interval) and No-ObservedEffect Concentration for rainbow trout (Oncorhynchus mykiss) exposed to TAME under flow-through conditions 26 Table 1A Analytical results for the recovery of TAME from AAP media Table 2A 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 0.026mg/L 63 Table 3A Table 4A 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 , 60 A P I T R * 95 = 0732290 0555127 744 Page 60 of 72 Report No 93-3-4682 Table 1A Analytical results for the recovery of TAME from AAP media Concentration Recovered (m9U Percent Recovered (mg/L) Volume Purged (mL) 10.4 5.o0 8.92 85.8 10.4 5.00 9.17 88.1 10.4 5.00 9.39 90.3 4.16 5.00 3.79 91.1 4.16 5.00 3.88 93.2 4.16 5.00 3.84 92.3 0.052 5.00 0.W62 88.9 O.052 5.00 0.0462 88.9 0.052 5.00 0.0462 88.9 Control 5.00 < 0.026 NA Control 5.00 < 0.026 NA Control 5.00 < 0.026 NA Nominal Concentration `,,-`-`,,`,,`,`,,` - Mean Recovery: 89.7 (%I * 23% The minimum detectable concentrationwas 0.026mg/L for a 5.00 mL sample which is the lowest standard used in the poiynomiaifit 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 API TR*K408 95 2 0 5 b8O Page 61 of 72 Report No 93-3-4682 Table 2A Analytical resuits for the recovery of TAME from filtered seawater Nomlnai Concentration (mg/L) Volume Purged (mL) Concentration Recovered (msW Percent Recovered (96) 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 5.00 3.79 91.1 4.16 5.00 3.78 90.9 4.16 5.00 3.79 91.2 0.026 5.00 0.027 105 0.026 5.00 O 027 105 0.026 5.00 0.028 1o9 Control 5.00 < 0.026 NA Control 5.00 0.026 NA Control 5.00 0.026 NA Mean Recovery: 1O4 11% minimum detectable concentration was 0.026 mg/L for a 5.00 mL sample which is the lowest calibration standard used in the polynomial fit The 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*408 Reoort '75 W 0732290 0555129 527 W No 93-3-4682 Table 3A Nominal Concentration (m9M Paoe 62 of 72 Anaiytlcal results for the recovery of TAME from freshwater (reconstituted to increase hardness) Dllution Factor ~~ Volume Purged (mu Concentration Recovered (m9/L) Percent Recovered (%I ~~ `,,-`-`,,`,,`,`,,` - 695 200 5.00 694 99.8 695 200 5.00 693 99.6 695 200 5.00 705 1o1 248 1O0 5.00 268 1O8 248 100 5.00 258 104 248 1O0 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.o0 5.00 c 0.248 NA Control 1.o0 5.00 < 0.248 NA Control 1.o0 5.00 e 0.248 NA Mean Recovery: 102 i 5% (10%)' The minimum detectable concentration was 0.248 mg/Lfor a 5.00 mL sample which is the lowest standard used in the linear regression analysis ' The anaiyte purging efficiency from a hard reconstitutedwater matrix presents a greater degree of instrumental variability Therefore the standard deviation acceptance criteria has been increased to 10% to more accurately represent the recovery data Springborn Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS Laboratories, Not for Resale Inc A P I T R * : 95 0732290 0555330 239 Page 63 of 72 Report No 93-3-4682 Table 4A Repeatability of TAME analysis from ASTM Type II water at 0.026 mg/L Replicate Height Area ~ 4751O 5725 54711 6099 46909 5631 36628 5646 36305 5699 55640 6292 54256 6365 Mean: 47423 5922 Std Dev.: 8243 320 % RSD: 17.4 5.4 `,,-`-`,,`,,`,`,,` - 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 Report No 93-3-4682 Figure 1A Page 64 of 72 A representative chromatogram of TAME purge and trap GC/FID analysis a IF I ' I `,,-`-`,,`,,`,`,,` - C I L " 'I .*** *&*E **o IR Y.59 .**e e** o** 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 1SlC Page 65 of 72 Report No 93-3-4682 Figure 2A A representative linear regression analysisfrom standard TAME analysis GC w i t h Flame Ionization Detection Correlation Coefficient 0.900966 300 240 180 120 60 0.0 I l I l l 1.1 2.2 3.3 I 4.4 Nominal Concentration (mg/L) Springborn Laboratories, inc Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS t Not for Resale 5.5 `,,-`-`,,`,,`,`,,` - I O ~ A P I TR*408 95 O732290 0555333 T Report No 93-3-4682 Figure 3A Page 66 of 72 A representative polynomial regression analysis from standard TAME analysis /' 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 w 95 2 0555334 Report No 93-3-4682 Page 67 of 72 - 11.O 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 TRa408 = 0732290 0555335 830 W Report No 93-34682 Page 68 of 72 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*4ûâ 95 H 2 0 5 3 7 Report No 93-3-4662 `,,-`-`,,`,,`,`,,` - Page 69 of 72 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 TRx408 95 0732290 0555337 693 Report No 93-3-4682 Page 70 of 72 l ìb I l I I I I I i I i 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 T R 8 95 0732290 0555138 52T Report No 93-3-4682 Page 71 of 72 `,,-`-`,,`,,`,`,,` - u u 2-95-11V3on O 5.2799 2-95-1191 5-95-115 3-95-116 O O O 5.2799 5.2074 5.2074 2-95-11v1 2.V3-11Pz J-95-11? 343-118 120 120 120 120 n.2 C 16.7 210 110 6.n y1s 2â.6 51.3 87.0 2-95-11m 2-9s-llW 3-IR-11V 3-95-120 210 210 210 2-QJ- 1187 no 2-95-11&¶ 3-95-121 yo 3-95-122 yo 2-95-trair 2-QJ-llU 34-121 3-V3-124 570 570 570 yo rn S O 950 -0 950 2-vs-llas 2-9S-lla4 s-9s-lzs 3-95-126 2-9s-1195 J-vs-luI L 7mm 2.MlE.Ol 7- 9.GS.Ol WZSR 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 u Report No 93-34682 Page 72 of 72 `,,-`-`,,`,,`,`,,` - ILlw I LIP.DEV 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 110 IS `,,-`-`,,`,,`,`,,` - 76PP Copyright American Petroleum Institute Provided by IHS under license with API No reproduction or networking permitted without license from IHS 0295.5C1P Not for Resale ~~ 75 0732270 5 OLY `,,-`-`,,`,,`,`,,` - A P I TR*408 ~ 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, Notthwest Washington, D.C.20005 Order No 848-00408 Not for Resale