High Production Volume (HPV) Challenge Program

Test Plan & Robust Summary

For PBTC Sodium Salt CAS# 40372 - 66 - 5

Prepared by Nalco Company 1601 W Diehl Rd Naperville, IL 60563

Date October 12 , 2009Page 2 of 26

HPV Challenge Program 10/12/2009 Page 2 of 26 TABLE OF CONTENTS 1 INTRODUCTION ................................ ................................ ................................ .. 3 2 GENERAL INFORMATION ................................ ................................ .................. 4 2.1 Quant it y ................................ ................................ ................................ .......... 4 2.2 Use Pattern & Sources of Exposure ................................ ................................ . 4 3 TEST PLAN ................................ ................................ ................................ ........... 5 4 ROBUST SUMMARY ................................ ................................ ........................... 6 4.1 PHYSICAL/CHEMICAL ELEMENTS ................................ ........................... 6 4.1.1 Mel

ti ng Point ................................ ................................ ............................... 6 4.1.2 Vapor Pressure ................................ ................................ ............................ 6 4.1.3 Partition Coefficient ................................ ................................ .................... 7 4.1.4 Water Solubilit y ................................ ................................ .......................... 7 4.2 ENVIRONMENTAL FATE AND P ATHWAY ELEMENTS ......................... 7 4.2.1 Photodegradation ................................ ................................ ......................... 7 4.2.2 Stabilit y in Water ................................ ................................ ......................... 9 4.2.3 Transport Between Environmental Depart me nt s (Fugacit y) ......................... 9 4.2.4 Biodegradation ................................ ................................ .......................... 10 4.3 ECOTOXICITY ELEMENTS ................................ ................................ ....... 13 4.3.1 Acute Toxicit y t o Fish ................................ ................................ ............... 13 4.3.2 Toxicit y t o Aquatic Organisms (e.g. Algae) ................................ ............... 15 4.3.3 Acute and/or Chronic Toxicit y to Aquatic Invertebrates (e.g. daphnia) ...... 17 4.3.4 Sediment Phase Toxicit y ................................ ................................ ........... 19 4.4 HEALTH ELEMENTS ................................ ................................ ................. 20 4.4.1 Acute Toxicit y ................................ ................................ ........................... 20 4.4.2 Genet ic Toxicit y in vivo (Chromosomal Aberrat io ns) ................................ 23 4.4.3 Genet ic Toxicit y in vit ro (Gene Mutations) ................................ ................ 23 4.4.4 Repeated Dose Toxicit y ................................ ................................ ............. 24 4.4.5 Toxicit y t o Reproduction ................................ ................................ ........... 25 4.4.6 Developmental Toxicit y/ Teratogenici ty ................................ .................... 25Page 3 of 26

HPV Challenge Program 10/12/2009 Page 3 of 26 1 INTRODUCTION Under the EPA High Production Volume (HPV) Challenge Program , Nalco agreed to develop Test Plans and R ob ust S ummaries for all toxicit y d ata rel ated to Nalco sponsored chemica ls. Within this HPV submissio n is included the test plan and robust st udy summaries for the Nalco - sponsored chemical: 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5. (PBTC mo nosodium salt) All available chemical and toxici ty data fo r PBTC , mo nosodi um sal t w ere evaluated and rated against the OECD Screening Informat io n Data Sets (SIDS) data endpoints and the guidance put forth by the EPA under the High Production Volume Challenge Program . Included in the EPA guidelines for HPV submissio ns are guidance documents in relat io n to Chemical Categorical approaches 1 and the use of Structure Activit y Relat io nships (SAR) 2
. Based on the Chemical Categories guidance 1 , we have concluded that the use of data associ ated with th e acid form of this compound, 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , CAS# 37971 - 36 - 1, and the tetrasodium salt, 1,2,4 - Butanetricarboxylic ac id, 2 - phosphono - , tetrasodi

um sal t, CAS # 66669 - 53 - 2, is relevant in fulfilling the SIDS endpo int s fo r this compound. Therefore, the data for th e OECD SIDS submissio n fo r PBTC, acid, CAS# 37971 - 36 - 1 was used as read across . 3 T he individual studies are inc luded in the r obust summary. Use of specific Structure Activit y Relat io nships has been internationally agreed to by the OECD member countries and the EPA. In order to fulfill the physicochemical properties fo r PBTC, m

onosodi um sal t, the accepted EPISUIT E 4.0 models were utilized. These include: mel

ti ng po int , boiling po int , vapor pressure, MPBPVP; partition coefficient, KOWWIN; w ater sol

ubilit y, WSKOW; p hotodegradation, AOPWIN; and for f ugaci ty .Page 4 of 26

HPV Challenge Program 10/12/2009 Page 4 of 26 2 GENERAL INFORMATION PBTC, Mo nosodium Salt PBTC, Acid PBTC, Tetrasodium salt CAS # 40372 - 66 - 5 37971 - 36 - 1 66669 - 53 - 2 CAS Name 1,2,4 - Butanetricarboxylic

acid, 2 - phosphono - , sodium sal t 1,2,4 - Butanetricarboxylic acid, 2 - phosphono 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , tetrasodi um sal t Synomyms 2 - phosp hono - 1,2,4 -

butanetricarboxylic acid, sodi um sal t 2 - phosphono - 1,2,4 -

butanetricarboxylic acid 2 - phosphono - 1,2,4 - butanetricarboxylic acid, tetrasodi um sal t Structural Formula H O
P O H

O O

O O O H
O H O

N a H O
P O H

O H O

O O O H
O H O O
P O

O O

O O O H
O O

N a N a N a

N a Molecular Weight 292.11 270.13 361.08 Molecular Formula C 7 H 10 O 9 P.Na C 7 H 11 O 9 P C 7 H 11 O 9 P.Na 4 SMILES OC(=O)CCC(C(=O)O)(P(=O)

(O)O)CC(=O)O[Na] OC(=O)CCC(C(=O)O)(P(= O)(O)O)CC(=O)O OC(=O)CCC(C(=O)O)(P(= O)(O)O)CC(=O)O[Na][Na] [Na][Na] 2.1 Q uantity PBTC monosodium salt is manufactured by Nalco on the order of 500,000 to >1,000,000 pounds annually. 2.2 Use Pattern & Sources of Exposure PBTC , m onosodi um sal t is manufactured as a component of liquid fo rm ulat io ns , which are used as scale inhibitor s i n industrial cooling towers acr oss mult iple industry sectors. Due to cooling tower processes typically exist ing as closed and cont inuous systems , human exposure consists of occasional controlled exposures such as during water sampling or maintenance of th e towers. Environmental exposure consists of waste water di scharges, which to a great extent are to surface water and not to waste water treatment facilit ies. A detailed evaluat io n on the human and environmental exposur e is included in th e OECD SIDS p ubl icat io n fo r PBTC acid . 3Page 5 of 26

HPV Challenge Program 10/12/2009 Page 5 of 26 3 TEST PLAN In reference to the OECD SIDS submissio n fo r PBTC acid as a source for read across data based on the EPA’s categorical approach, and the use of Structure Activit y Relationships, all SIDS endpo int s fo r the PBTC, monosodiu m salt are fulfilled. No addi tional toxici

ty data is proposed at this time. E Endpoint Data Available Other Source for Data Fulfillment SIDS Testing

Requi red Physical/ Chemical Elements Mel ti ng Point N M N Vapor Pressure N M N Parti tion Coefficient N M N Water Solubilit y N M N

Envi ronmental Fate and Pathway Elements Photodegradation N M N Stabilit y in Water N M N Fugacit y N M N Biodegradation Y M N Ecotoxicit y E lements Acute Toxicit y t o Fish Y R,M N Toxicit y t o Aquatic Organisms N R,M N Acute Toxici

ty to Aquat ic Invertebrates N R,M N Heal th Elements Acute Toxicit y N R N Genet ic Toxicit y in vivo N R N Genet ic Toxicit y in vitro N R N Repeated Dose Toxicit y N R N Toxicit y t o Reproduction N R (fro m r epeat dose toxici

ty and developmental toxici ty) 6 N Developmental Toxicit y/ Teratogenicit y N R N Y - Yes N - No M - Modeled R - Read AcrossPage 6 of 26

HPV Challenge Program 10/12/2009 Page 6 of 26 4 ROBUST SUMMARY Nalco provided three additional studies for a 50% solut io n of PBTC acid, which have been assigned a Klimisch rating of 1 or 2 , as a supplement to the exist ing SIDS data for PBTC, CAS#37971 - 36 - 1 3
. Summary o f t he data wit hin the SIDS document has also been provided for ease of reference, in addit io n to the robust summaries for the Nalco studies. Summary of Nalco Data Endpoint Result Rating Ac ute Toxici

ty to Fi sh ( Cyprinodon variegatus , Sheepshead minnow) LC50 for 96 hours = 550 mg/L. NOEC: 300 mg/L Klimisch 2 - reliable with restrict io ns Sediment Phase Toxicit y ( Corophium volutator

) 10 day LC 50 = 3715 mg/kg (95% C.I., 3020

– 4786) of dry we ight sediment. NOEC = 250 mg/kg of dry weight sediment. Klimisch 2 - reliable with restrict io ns Biodegradation The test substance was degraded by 30% after 28 days based on COD calculat io ns and measurements to account for O 2 co nsumption. Klimisch 1 - reli able with out restrict io ns

4.1 PHYSICAL/CHEMICAL ELEMENTS 4.1.1 Melting Point Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Method EPA’s MPBPVP modeling software. Results 90.27°C (estimated) Data Quality Use of MPBPVP fo r thi s chemical class is acceptable based on EPA

guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, MPBPVP tool , v1.43 Other Analyt ical test results are not available for this material under the

OECD 102 guidelines. It has been found acceptab le both for EPA HPV submissio ns and for OECD SIDS Endpoints to use Structure Act ivit y Relat io nships (SAR) in fulfillment of specific endpo int s. 4.1.2 Vapor Pressure Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Me thod EPA’s MPBPVP modeling software. Results 6.06 x 10 - 11 mm Hg @ 25°C (est imated) Data Quality Use of MPBPVP for this chemical class is acceptable based on EPAPage 7 of 26

HPV Challenge Program 10/12/2009 Page 7 of 26

guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, MPBPVP tool , v1.43 Other Analyt ical test results are not available for this material under the

OECD 104 guidelines. It has been found acceptable both for EPA HPV submissio ns and for OECD SIDS Endpoints to use Structure Act ivit y Relat io nships (SAR) in fulfillment of specific endpo int s. 4.1.3 Partition Coefficient Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Method EPA’s KOWWIN modeling software. Results - 5.17 (estimated) Data Quality Use of KOWWIN for this chemical class is acceptable based on EPA

guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, KOWWIN tool , v1.67 Other Analyt ical test results are not available for this material under the

OECD 10 7 guidelines. It has been found acceptable both for EPA HPV submissio ns and for OECD SIDS Endpoints to use Structure Act ivit y Relat io nships (SAR) in fulfillment of specific endpo int s. 4.1.4 Water Solubility Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Method EPA’s WSKOW modeling software. Results 1 x 10 6 mg/L @ 25°C (estimated), (Log Kow of - 5.17 was used.) Data Quality Use of WSKOW fo r thi s chemical class is acceptable based on EPA

guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, WSKOW tool , v1.41 Other Analyt ical test results are not available for this material under the

OECD 1 05 guidelines. It has been found acceptable both for EPA HPV submissio ns and for OECD SIDS Endpoints to use Structure Act ivit y Relat io nships (SAR) in fulfillment of specific endpo int s. 4.2 ENVIRONMENTAL FA TE AND PATHWAY ELEMENTS 4.2.1 Photodegradation Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Method EPA’s AOPWIN mo deling so ft ware.Page 8 of 26

HPV Challenge Program 10/12/2009 Page 8 of 26 Results Half

- life = 2.707 days, 32.488 hours (estimated), Overall OH rate constant = 3.9508 x 10 - 12 cm 3 /m ol ecule - sec. Fractio n sorbed to ai rb orne particulates (phi): 1 (Junge - Pankow, Mackay avg), 1 (Koa method). The sorbed fract io n ma y be resistant to atmospheric oxidat io n. Data Quality Use of Fugacit y mo del fo r thi s chemical class is acceptable based on

EPA guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, AOPWIN tool , v1.92 Other Analyt ical test results are not available fo r thi s materi al under the

OECD guidelines. It has been found acceptable both for EPA HPV submissio ns and for OECD SIDS Endpoints to use Structure Activit y Relationships (SAR) in fulfillment of specific endpoints. Test Substance PBTC acid, CAS# 37971 - 36 - 1 Method Field Study Results Half

- life of 4.3 - 6.4 h with 5 and 50 mg/L NO 3 . In the presence o f photochemically induced sensit iz ers. Half - life of 7 days in a field test with the PBTC/Fe - com plex at a water depth of 40 cm. Conclusions “T he mo st relevant degradation process in the hydrosphere is

photooxidat ive transformat io n.” Data Quality N/A Refer ences OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) Test Substance PBTC/Fe complex Method Field Test, in aqueous medium at a dose concentration of 0.01

mo l/m 3 , Achlachtensee Lake (Berlin, Germany), Light source: sunlight; method: measured; (1988) direct photolysis, global int ensity : 1893 mW/cm2 , over 7 day s; absorption spectrum; 254 450 nm. “The apparit io n o f H 3 PO 4 was determined.” Results Half

- life of approximately 7 days in the depth of 40 cm. 6 5% degradation after 7day s in water depth of 0cm. 45% degradation in water depth of 50 cm. 0% degradation in water depth of 250 cm. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) Test Substance PBTC in buffered so lut io n Method Lab stu dy in aqueous medium wit h a concentration of 100 mg/L.

Exposure of samples in natural sunlight (measured) (1990) Results 77.2% phot odegradation at daylight after 50 days at pH of 5. 12%Page 9 of 26

HPV Challenge Program 10/12/2009 Page 9 of 26

photodegradation at daylight after 50 days at pH of 7. 100% photodegradation at daylight after 50 days at pH 9. Conclusions Not provided on SIDS document Data Quality Not run under GLP References O ECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Held, S. Zum Text ilveredlung, 24(11), 394 - 398, (1989) 4.2.2 Stability in Water Test Substance PBTC/Fe complex Method Lab stud y in aqueous medium wit h a concentration of 0.05 mol/m3
.

Light source: Hg - la mp; light spectrum: 254 nm; quantum yield: 0.27. Method: determinat io n of quantum yield with monochromat ic light at 254 nm (measured) (1988); intensit y: 15 W Results 1% degradation with 0.1 mo l/ m 3

– OH and 0.1 mo l/m 3 PBTC/Fe Conclusions “T he influence o f OH - radicals on the degradation was determined

and found to be negligible. (To prove the direct photolysis).” Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OEC D High

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ume Chemicals Programme (1994) taken fro m UBA. Abschlussbericht des UBA - FE - Vorhabens Wasser Phosphorverbindungen, 102 06 322, 32 - 57, (1988) Test Substance PBTC - di ssodi um sal t Method Method : Suntest measured (1990) C oncentration of 10 mg/L; Light

source: Xenon lamp; Intensit y o f lig ht source: 11.2 - 13.7 mW/cm 2 ; light spectrum: 290 - 1220 nm. Indirect photolysis; sensit izer; NO 3 (concentration 5 and 50 mg/L).. Temperature = 25°C Results Measured half - life o f 4.3 - 6.4 hours Conclusions “ No hydrolysis at ambient temperatures” Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Untersuchungen zum Photobbau von Bayhibit . Bericht Nr. anc47 (Invest igat io ns on Photodegradation of Bayhibit. Report No. anc47), anc47, (1990) 4.2.3 Transport Between Environmental Departments (Fugacity) Test Substance 1,2,4 - Butanetricarboxylic acid, 2 - phosphono - , sodi um sal t, CAS# 40372 - 66 - 5 Method EPA’s Fug aci ty mo deling so ft ware, EPIWEB 4.0Page 10 of 26

HPV Challenge Program 10/12/2009 Page 10 of 26 Results Level III Fugacit y Mo del Mass Amount (%) Half

- life (hours) Emissio ns

(kg/hr) Air 1.25 x 10 - 15 65 1000 Water 24.4 208 1000 Soil 75.5 416 1000 Sediment 0.0649 1.87 x 10 3 0 Persi stence time: 432 hours D ata Quality Use of Fugacit y mo del fo r thi s chemical class is acceptable based on

EPA guidelines for HPV Chemicals. References EPA’s EPIWEB 4.0, Fugacit y t ool Other It has been found acceptable both for EPA HPV submissio ns and for

OECD SIDS Endpoints to u se Structure Activit y R el at io nships (SAR) in fulfillment of specific endpo int s. 4.2.4 Biodegradation Test Substance PBTC acid, CAS# 37971 - 36 - 1, 50% solut io n in water Method Guideline OECD 306 “Biodegradabilit y in Seawater - Closed Bottle Test”

Inoculum N/A - Natural seawater microorganisms found in seawater sample Te st Method 2 - 10 mg of a predetermined amount of test material was disso lved

in t est m edium. Bottles were filled and closed and kept for 28 days in t he dark at a temperature range of 20.0°C ± 1.4 °C. The degradation was measured by oxygen analysis. Oxygen Measurements A WT W 320 oxygenmeter was used to measure disso lved oxygen

concentrations ( with corrections for salinit y, tem perature, and pressure ) on days 0, 7, 14, 21, and 28. Chemical Oxygen Dema nd 4.24 x 10 5 mg O 2 /kg Concentration of test

substance 4.76 m

g/L Salinity of decanted and aged seawater Day 0, 34.8 o/ oo Te st Validity The test in considered valid in relat io n to the required parameters

being met according to OECD 306: Inoculum con trol reached the level of 50% degradation within 7 days (69% , sodium benzoate ), not including lag phase; the blank respiration did not exceed 30% of th e oxygen in the test bottle (7 day s – 0.0 m g O 2 /L, 14 days 0.1, 21 day s - 0.4, 28 days 0.3); the temperatu re variation was wit hin acceptable range (20.0 ± 1.4°C); the BOD of the mixture of test andPage 11 of 26

HPV Challenge Program 10/12/2009 Page 11 of 26

reference substance was nearly equal to the sum of the BOD of the separate solution of th e two substances; the microbial count was within the acceptable range of 10 2

– 10 4 cfu/mL (9.5 x 10 2 cfu/mL) Results The test substance was degraded by 30% after 28 days based on

COD calculations and measurements to account for O 2 con sumption. The results for the test substance, inoculum control, and control of inhibitory act io n are summarized in the fo llo wing table: % Biodegradation Test Substance Day 0 Day 7 Day 14 Day 21 Day 28 Control of Inhibitory Action 0 >100 >100 >100 95 Inoculum 0 69 79 75 76 50% neutralized PBTC 0 <0 <0 0 30 Conclusions The test substance can no t be characterized as “readily

biodegradable” in the marine environment Data Quality Run according to OECD Principles of Good Laboratory Practice

(1997). Klimisch rating of 1 - reliable wi thout restrictions. References Nalco Ltd. Report for neutralized s ol ution of 50% PBTC acid. AnalyCen Ecotox AS. Report # R 325 - 04. (2004) Test Substance PBTC acid, CAS# 37971 - 36 - 1 Method OECD Guideline 301E “Ready Biodegradabilit y: Modified OECD

Screening Test” (1988), aerobic. 10 mg/L effluent fro m waste water treat me nt plant. Results 0% degradation was observed after a period of 28 days Conclusions Substance is not “readily biodegradable” Data Quality N/A References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (19 94) taken fro m UBA. Abschlussbericht des UBA - FE - Vorhabens Wasser Phosphorverbindungen, 102 06 322, 32 - 57, (1988) Test Substance PBTC acid, CAS# 37971 - 36 - 1, activated sludge, domestic (adapted),

aerobic Method Di

rect ive 84/449/EEC, C.6 “Biotic Degradat ion – Closed Bottle Test” (1976) Results 0% degradation observed after 30 days. Conclusions Substance is not “readily biodegradable” Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD HighPage 12 of 26

HPV Challenge Program 10/12/2009 Page 12 of 26

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ume Chem icals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report (1976) Test Substance PBTC tetrasodi um sal t Method EPA - met hod Guideline 796.3140 - End point: development of CH 4

and CO 2 . 20 mg/L concentration, activated sludge, anaerobic Results 0% degradation observed after 56 days Conclusions Substance is not “anaerobically degradable” Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report Test Substance PBTC tetrasodi um sal t Method DIN 38412 Teil 25; OECD 302B “Biodegradat io n: Zahn - Wellens

Test”. 408 mg/L concentration, activated sludge, industrial, aerobic Results 17% degradation observed after 28 days Conclusions Substance is not “inherently biodegradable” Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1989) Test Substance PBTC acid, CAS# 37971 - 36 - 1 Method Determinat io n of the biodegradabilit y o f anio nic synt het ic surface

active agents . OECD, Paris (1971); (1973). A ctivated sludge, aerobic . Results 0% degradation observed Conclusions Substance is not “readily biodegradable” Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1973) Test Substance PBTC acid, CAS# 37971 - 36 - 1 Method OECD G uideline 302A “Inherent Biodegradabilit y: Modified SCAS

Test” (1988). 20 mg/L concentration, activated sludge, aerobic (Daily addition of waste water from a treatment plant influent with 20 mg/L DOC of test substance during 126 days) Results 0% biodegradation observed. Related to DOC; 60% maximum

eliminat io n in t he fir st day which was probably due to adsorp tion on sl udge. Al so bacteri al inhibit io n was observed. Conclusions Substance is not “inherently biodegradable”Page 13 of 26

HPV Challenge Program 10/12/2009 Page 13 of 26 Data Quality N/A References OECD/S IDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m UBA. Abschlussbericht des UBA - FE - Vorhabens Wasser Phosphorverbindungen, 102 06 322, 32 - 57, (1988) Test Substance PBTC acid, CAS# 37971 - 36 - 1 Method N/A Results “T he only possible contribut io n of PBTC to the eutrophicat io n of

surface water would be through its degradation to ortho - phosphate. The biodegradat io n t est s have shown that significant biodegradation in surface waters is to be expected. The only identified way o f o rtho phosphate formation is through photooxidative degradation of certain PBTC - met al com

plexes. As thi s process is relevant only near the surface of water bodies, the overall contribut io n of PBTC to the eutrophicat io n of surface w aters is probably low.” Conclusions N/A Data Quality N/A References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) 4.3 ECOTOXICITY ELEMENTS 4.3.1 Acute Toxicity to Fish Test Substance 50% PBTC acid in water Method Test guideline PARCOM 1995 Part B Protocol for Fish Acute Toxicit y T est

(m odified OECD 203). 96 hour LC 50 to the j uvenile sheepshead minnow, Cyprinodon variegatus ; semi - static Refer ence Seawater Purchased and stored for no longer than 4 weeks at 18

– 22°C. Te st Method The test substance was ho mo genized before use. Concentrations of

test solut io n were added to test vessels at 0, 100, 300, and 1000 mg/L (no minal concentrations). The fish were inspected daily wit h rem oval of dead fish if applicab le. Measurements of all test vessels , including controls , w ere perform ed daily fo r pH, disso lved oxygen, salinit y, and temperature. Refer ence Substance 2.3 mg/L 3,5 - dichlorophenol from 06/07/04

– 10/07/04. Mortalit y

was 40% after 96 hours. pH pH had be en monitored during testing and found to be between 3.7 and 8.2. Te st Validity All measured parameters were within the reco mmended ranges:

Salinit y 3.0

– 3.6% (3.3%); Temperature 20±2.4°C (19.6 - 20.3°C); Di ssolved Oxygen •60% Saturation (•94% Saturatio n); % Mortalit yPage 14 of 26

HPV Challenge Program 10/12/2009 Page 14 of 26

in controls •10% (0%); % Mortalit y in reference 20 - 80% (40%); Results LC50 for 96 hours = 550 mg/L , NOEC: 300 mg/L

Analyt ical mo nit oring: no. Conclusions This substance is of low acute toxicit y t o thi s marine fish species. Data Quality Cond ucted in co mp liance with OECD (1997) : Principles of Good

Laboratory Practice. Klimisch rating of 2 - reliable with restrictions. References Nalco Ltd. Report for 50% PBTC acid in water. AnalyCen Ecotox

AS. Report # R 289 - 04. (2004) Test Substance Other test substance: neutralized 50% solut io n of PBTC Method 48 hour exposure to Onchorhynchus mykiss (Rainbow Trout) to a

concentration of 3440 mg/L. “Static; Best immung der akuten Wirkung von Stoffen auf Fishe. Arbeitskreis ‘Fischtest’ im Hauptausschuss ‘Det ergentien’ (15.10.73); (1975)” Results LC50 for 48 hours = 3440 mg/L. Analyt ical mo nit oring: no. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1975). Test Substance Other test substance: active substance PBTC Method 48 hour exposure to Leuciscus idus (Golden orfe). “Static;

Best immung der Wirkung von Wasserinhalt stoffen auf Fishe. DIN 38412 Teil 15” Results LC0 for 48 hours = 500 mg/L. LC50 for 48 hours > 500 mg/L.

LC100 for 48 hours > 500 mg/L. Analyt ical mo nit oring: no. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD /SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Kaestner, W. and Gode, P. Zeitschrift fuer Wasser und Abwasser Forschung, 16(2), 39 - 47, (1983) Test Substance Other test substance: 39.66% PBTC Method 14 day exposure to Brachydanio rerio (Zebrafish). “Semi - static;

UBA Verfarhrensvorschlag ‘Verlaengerter Toxizit aetstest beim Zebrabaerbling Brachydanio rerio ’ (Schwellenkonzentration der letalen und anderer Wirkungen; NOEC; mindestens 14 Tage) (1 - 2 - 1984); (1994)” Results NOEC for 14 days >= 1042 mg/L. Analyt ical mo nit oring: no.Page 15 of 26

HPV Challenge Program 10/12/2009 Page 15 of 26 Conclusions PBTCs effect i ve concentration had effect on mortalit y, length, and

weight Data Quality Not specified References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report (1994). Test Substance Other test substance: neutralized 50% solut io n of PBTC Method 72 hour exposure to Leuciscus idus (Golden orfe) at a co ncentration

of • 2000 mg/L. “Static; Best immung der akuten Wirkung von Stoffen auf Fishe. Arbeitskreis ‘Fischtest’ im Hauptausschuss ‘Detergent ie n’ (15.10.73)” Results LC0 for 72 hours • 2000 mg/L. Analyt ical mo nit oring: no. Conclusions Not provided on SIDS document D ata Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1973). 4.3.2 Toxicity to Aquatic Organisms (e.g. Algae) Test Subs tance Non - com plexed PBTC Method Green algae ( Scenedusmus quadricauda ) and microalgae (Nostoc

muscorum ). Freshwater. 10 day and 15 day exposure period. “Growth of algae on synthet ic nutrient solut io n with non - complexed PBTC as sole P - source; photometric de terminat io n of growth at 436 nm; control with K

2 PO 4 as P - so urce. Concentrations: 6.9 mg/L & 0.34 mg/L as related to P - results: 6.11.94” Results “T he test species could not use the phosphonate as P - source.” Conclusions “T he test with two algae species h as shown that PBTC cannot be

used as a P - source by algae. Bio lo gical processes in waste water treatm ent pl ants are n ot affected by PBTC.” Data Quality Not specified References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Che micals Programme (1994) taken fro m UBA. Abschlussbericht des UBA - FE - Vorhabens Wasser Phosphorverbindungen, 102 06 322, 32 - 57, 1988 Test Substance Other test substance: active substance PBTC Method Freshwater algae - Chlorella , Kessieri . 14 day exposure period, 500 -

> 500 mg/L. No analyt ical mo nit oring. “Test auf algizide Wirkung. Interne Testvorschrift der Hankel KgaA” Results Mortalit y at > 500 mg/L. No visible effect at 500 mg/LPage 16 of 26

HPV Challenge Program 10/12/2009 Page 16 of 26 Conclusions Not provided on SIDS document Data Quality Not specified References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Kaestner, W. and Gode, P. Zeitschrift fuer Wasser und Abwasser Forschung, 16(2), 39 - 47, 1983 Test Substance Other test substance: 39.66% PBTC Method Freshwater Green algae - Scenedesmus subspicatus . 72 hour exposure

with concentrations of 8

– 140 mg/L. Test Guideline “Algal Inhibit io n Test” (C.3); Direct ive 67/548/EEC (Draft 1992); (1994) end po int : bio mass Results Biomass: EC10 fo 72 hours = 8 mg/L; Bio ma ss EC50 for 72 hours =

140 mg/L. Analyt ical mo nit oring: yes. Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1 994) taken fro m Bayer AG. Bayer AG Data Short Report, 1994 Test Substance Other test substance: 39.66% PBTC Method Freshwater Green algae - Scenedesmus subspicatus . 72 hour exposure

with dosages of > 1081 mg/L. Test Guideline “Algal Inhibit io n Test” (C. 3); Directive 67/548/EEC (Draft 1992); (1994) end po int : growth rate Results Biomass: EC10 fo 72 hours >33.3 - <65.5 mg/L; Bio mass EC50 for

72 hours = > 1081 mg/L. Analyt ical mo nit ori ng: yes. Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, 1994 Test Substance Other test substance: 39.66% PBTC Method Freshwater Green algae - Scenedesmus subspicatus . 72 hour exposure

with dosages of 17.8

– 33.3 mg/L. Test Guideline “Algal Inhibit io n Test” (C.3); Direct ive 67/548/EEC (Draft 1992); (1994) Results Biomass: NOEC for 72 hours 17.8 mg/L; Bio mass: LOEC for 72

hours = 33.3 mg/L. Analyt ic al mo nit oring: yes. Conclusions Not provided on SIDS document Data Quality GLPPage 17 of 26

HPV Challenge Program 10/12/2009 Page 17 of 26 References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, 1994 Other “ Th e stati st ically derived NOEC is higher in this case than the EC10 -

value” Test Substance Other test substance: neutralized 50% solut io n of PBTC Method Freshwater Green algae - Scenedesmus quadricauda . 96 hour

exposure with a concentration of 860 mg/L. “ Bestimmung der bio lo gischen Schadwirkung toxischer Abwasser gegen Algen. DEV, L 9 (1968); (1975); endpo int : cell count” Results Biomass: EC10 for 96 hours = 860 mg/L. Analyt ical mo nit ori ng: no. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, 1975 4.3.3 Acute and/or Chronic Toxicity to Aquatic Invertebrates (e.g. daphnia) Tes t Substance Other test substance: 39.66% PBTC Method 21 day exposure to D aphnia magna at co ncentrations > 1071 mg/L

“Semi - static; Prolonged Study with Daphnia magna: Effects on Reproduction (Proposal for an up date of OECD Guideline 202, Part II; Draft 6/ 5/1991); (1994). End point: immo bilizatio n;” Results EC 50 for 21 days > 1071 mg/L. Analyt ical mo nit oring: yes. Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

Production Vo lu me Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report Test Substance Other test substance: 39.66% PBTC Method 21 day exposure to D aphnia magna at co ncentrations 104 - <1071

mg/L “Semi - static; Prolonged Study with Daphnia magna: Effects on Reproduction (Proposal for an up date of OECD Guideline 202, Part II; Draft 6/5/1991); (1994). End point: reproduction rate;” Results NOEC for 21 days = 104 mg/L. LOEC for 21 days = 329 mg/L. EC

50 for 21 days > 329 mg/L and <1071 mg/L. Analyt ical monitoring: yes. Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD HighPage 18 of 26

HPV Challenge Program 10/12/2009 Page 18 of 26

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report Test Subst ance Other test substance: active substance PBTC Method 24 hour exposure to D aphnia magna at co ncentrations of 180 - 350

mg/L “Daphnien - Kurzzeittest, DIN 38412 Teil 11, Bestimmung der Wirkung von Wasserinhaltsstoffen auf Kleinkrebse;” Results EC0 for 24 ho urs = 180 mg/L. EC 50 for 24 hours = 265 mg/L

EC100 for 24 hours = 350 mg/L. Analyt ical mo nit oring: no. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Kaestner, W. and Gode, P. Zeitschrift fuer Wasser und Abwasser Forschung, 16(2), 39 - 47, (1983) Test Substance PBTC acid: “The test solut io n was not neutralized (pH 4.8

– 5.4)” Method 24 hour exposure of D aphnia magna to co ncentrations of 313

– 1250

m/L. DIN 38412 part 11 Results EC0 for 24 hours = 313 mg/L. EC50 for 24 hours 747 mg/L. EC100

fo r 24 hours = 1250 mg/L. EC 50 in second test at pH 5.0

– 5.5 = 1113 mg/L. Analyt ical monitoring: no. “The above r esul ts are no minal concentrations” Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m UBA. Abschlussbericht des UBA - FE - Vorhabens Wasser Phosphorverbindungen, 102 06 322, 32 - 57, (1988) Test Substance Other test substance: neutralized 50% solut io n of PBTC Method 24 hour exposure of daphnia magna to doses of > 500 mg/L

“Best immung der bio lo gischen Schawdwirkung toxischer Abw asser gegen niedere Metazoen. DEV, L 11 (1986); (1979)” Results EC0 for 24 hours > 500 mg/L. Analyt ical mo nit oring: no. Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of O ECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report (1979)Page 19 of 26

HPV Challenge Program 10/12/2009 Page 19 of 26 4.3.4 Sediment Phase Toxicity Test Substance 50% PBTC acid in water Method Guideline LC 50 Corophium volutator sediment reworker test. Based on draft

1 994 of Paris Commissio n Guideline: “MAFF/EWRT Harmonised Protocol . A Sediment Bioassay using an amphipod Corophium sp. ” Te st Animals Animals were co llected fro m Bergen, Norway. They were sieved

fro m t he sediment and acclimat ised for 5 - 12 days in an aquar iu m under test condit io ns. Mortalit y 8 days prior to testing was 3%, which is within the acceptable range. Refer ence Sediment Sediment was collected fro m an int er - tidal area free of contaminat io n

and transported in polyethylene bags to the lab. It was s ieved at the lab at 500 μm in a closed system using natural seawater and stored sealed in po lyethylene bags in a dark room at 4oC unt il u se. Method Adult animals were exposed to sediment spiked with 50% PBTC acid fo r a period of 10 days. Five test co ncentration s were used with 3 parallels for each concentration and 5 controls. The animals used were 5mm or greater in length. Water qualit y was mo nit ored th roughout the test. The test samples were aerated and a constant water level of (900ml) was maintained in t he test vessels by topping off wit h distilled water. Duration 10 day s Concentration s 0, 52, 250, 876, 3003, and 10001 mg/kg (dry weight) End point lethalit y Validity This test is considered valid wit h exception for pH. Range of requi red param

et ers (actual values): Salinit y 3.3±0.4% (3.3

– 3.5%); Tem perature 15±2.4oC, max 17.4oC (15±2.4oC); Disso lved Oxygen >85% Saturation (>94% saturation); pH 7.5

– 8.5 ( 4.3

– 8.1 ); % lethalit y in contro ls •10% (0%). pH was outside the test range, which is thought to be due to the test substance. According to the protocol th e pH should not be readjusted as this may be a source of toxici ty . Deviations Twelve animals were found in control number 3 - this is not thought

to have any consequences for the test. Results 10 day LC 50 = 3715 mg/kg ( 95% C.I., 3020

– 4786) of dry weight

sediment. NOEC = 250 mg/kg of dry weight sediment. Data Quality The study was full y co mp liant wi th OECD (1997): OECD Principl es of Good Laboratory Practice. Klimis c h rating of 2 - reliable wi th restrictions. References Nalco Ltd. “Sediment Phase Toxicit y T est Results with Corophium

volutator fo r the Test Substance R - 2244” AnalyCen Ecotox As. Report No. R 376 - 04. 2004.Page 20 of 26

HPV Challenge Program 10/12/2009 Page 20 of 26 4.4 HEALT H ELEMENTS 4.4.1 Acute Toxicity Test Substance Tetrasodi um sal t, commercial product Method Dermal LD50 in rats, single dermal application, post - exposure period

of 19 day s. Results LD50 of > 4000 mg/kg - bw Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1990) Other Report no. 19382 Test Substance Tetrasodi um sal t, 41.4% sol

ution in wate r Method Inhalat io n LD50 in rats, aerosol, dynamic inhalat io n Results LD50 >1979 mg/m 3 /4h Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Che micals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1976) Test Substance Tetrasodi um sal t, commercial product Method Oral LD50 in rats, single oral applicat io n, post - exposure period of 14

days. Results LD50 of > 4000 mg/kg - bw Con clusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1990) Other Report no. 19383 Test Substance Tetrasodi um sal t, 41.8% sol

ution in water Method Oral LD50 in male rats, single oral applicat io n, post - exposure period

of 14 day s. Results LD50 of 20.1 mL/kg Conclusions Not provided on SIDS document Data Quality Not run under GLP Reference s OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m BayerPage 21 of 26

HPV Challenge Program 10/12/2009 Page 21 of 26

AG. Bayer AG Data Short Report, (1971) Test Substance Tetrasodi um sal t, 41.8% sol

ution in water Method Oral LD50 in male mice, single oral applicat io n, post - exposure

period of 14 day s. Results LD50 of 16.2 mg/kg Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

Production Vol

ume Chemicals Progr amme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1971) Test Substance PBTC acid, 50% aqueous solution Method Oral LD50 in rats, single oral applicat io n, post - exposure period of 14

days Results LD50 > 6500 mg/kg - bw Conclusions Not provided on SIDS document Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1979) Test Substance Tetrasodi um sal t, 32 .6% Method Maximization test in DHPW guinea pigs, according to M. Kligman Results Not sensit iz ing Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Baye r AG Data Short Report, (1990) Other Report no. 19052A Test Substance Tetrasodi um sal t, 41.8% sol

ution in water Method Primary skin irritation in rabbits; Applicat io n to th e ear, post exposure observat io n of 7 days. Results Not irritating Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1976) Test Substance PBTC acid Method Primary skin irritation in rabbi ts; Applicat io n on back skin, patchPage 22 of 26

HPV Challenge Program 10/12/2009 Page 22 of 26

test, intact or abraded skin. No data on applicat io n period, post exposure observat io n period 72 hours. Acute dosing of 0.5 mL Results Not irritating Data Quality Not run under GLP References OECD/SIDS . Screening Inf ormat io n Data Set of OECD High Production Vol

ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1971) Test Substance Tetrasodi um sal t, 41.4% sol

ution in water Method Primary skin irritation in rabbits; The test substance wa s applied to

th e ear, applicat io n period of 24 hours, post - exposure observat io n of 7 day s. Results Not irritating Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (19 94) taken fro m Bayer AG. Bayer AG Data Short Report, (1976) Test Substance PBTC acid, 50% solut io n in water Method Primary skin irritation in New Zealand rabbit s; The test substance

was applied to the ear, applicat io n period of 24 hours, post - exposure o bservat io n of 7 days. Results Not irritating Data Quality Not specified References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1977) Test Substa nce PBTC acid, 50% solut io n in water Method Primary eye irritation in rabbits; post - exposure observat io n of 7 days. Results Weak irritant Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1977) Test Substance Tetrasodi um sal t, 41.8% sol

ution in water Method Primary eye irritation in rabbits; post - exposure observat io n of 7 days. Results Not irritating Data Qu ality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1976)Page 23 of 26

HPV Challenge Program 10/12/2009 Page 23 of 26 Test Substance Tetrasodi um sal t, 41.8% sol

ution in water Met ho d Primary eye irritation in rabbits; post - exposure observat io n of 72

hours. Dose of 0.1 mL Results Not irritating Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme ( 1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1971) Test Substance Tetrasodi um sal t, 41.4% sol

ution in water Method Primary eye irritation in rabbits; post - exposure observat io n of 7 days.

Dose of 0.1 mL Results Weak irritant Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1976) 4.4.2 Genetic Toxicity in vivo (Chromosomal Aberrations) Test Substance PBTC acid, 50% solut io n in water Method Mouse Micronucleus Assay in male and female mice. OECD

Guideline 474 - Genet ic Toxico lo gy Micronucleus Test; Single oral applicat io n by gavage. Acute exposure with a dose of 2000 mg/kg bw. Results Negative Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Henkell KgaA, (1993) Other Report no. 9300322 4.4.3 Genetic Toxicity in vitro (Gene M ut ations) Test Substance PBTC acid, commercial product, 49% solution in water Method AMES test - Direct ive 84/449/EEC, B. 14 “Other effects Mutagenicit y ( Salmo nella t yp himuri um – Reverse Mutation Assay)” C oncentration of 16 - 1000 μ g/pl ate. Test performed w it h and without metabo lic act ivat io n. Strains: TA98, TA100, TA1535, TA 1537 Results Negative results for mutagenicit y, with and wit hout metabolic

activat io nPage 24 of 26

HPV Challenge Program 10/12/2009 Page 24 of 26 Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Inf ormat io n Data Set of OECD High Production Vol

ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1992) Other Report no. 21134 Test Substance PBTC acid, commercial product, 45 - 50% solut io n in water Method AMES test. C oncentr at io n of 20 - 12500 μ g/plate. Test performed

with and with out m

etabo lic act ivat io n. Strains: TA98, TA100, TA1535, TA 1537 Results Negative results for mutagenicit y, with and wit hout metabolic

activat io n Conclusions Not provided on SIDS document Data Qual ity GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1979) Other Report no. 6821 Test Substance PBTC acid Method Cy

togenetic Assay. OE CD Gu ideline 473 “Genetic Toxico lo gy : In vit ro Mammalian Cytogenetic Test ” ; Chinese hamster lung cells, V79. Concentrations of 125, 250 and 500 μ g/mL without S9 - mix and 625, 1250 or 2500 μ g/mL wit h S9 - mix were used. Results Negative results wit h and witho ut metabo lic act ivation Conclusions Not provided on SIDS document Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m May, Ch. Forschungsbericht

– Bundesanstalt fuer Arbeitsschutz und Unfallforschung, (1993) 4.4.4 Repeated Dose Toxicity Test Substance Tetrasodi um sal t Method 90 day feeding study in male and female Wistar rats; 0, 50, 200,

1000, or 5000 mg/kg in diet Results NOAEL: 375 mg/kg - bw. “No symptoms of toxicity were observed.

Haematological, bio chemical, patho lo gical , or hi stopathological param eters were unaffected.” Conclusions “A 90 - day test (rats feeding study with th e tetrasodium salt, up to

5000 mg/kg diet for 12 weeks) showed no substance related effects.Page 25 of 26

HPV Challenge Program 10/12/2009 Page 25 of 26

NOAEL o f 375 mg/kg body weight (5000 mg/kg/diet) was derived. OECD/SIDS conclusion: ‘Low toxicit y, no damage in oral doses up to 375 mg/kg/body weight.’” Data Quality Not run under GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1976) Other Report no. 6176 4.4.5 Toxicity to Reproduction Use of the 90 - day feeding study with lack of systemic effects and the developmental study below sufficiently fu lfills this category. 5 4.4.6 Developmental Toxicity/ Teratogenicity Test Substance PBTC acid, commercial product, 49% solution in water Method OECD Guideline 414 “Teratogenicit y” Results Oral administration in female Wistar Rats; Doses of 0, 100, 300 or

1000 mg/kg bw administered from 6 to 15 days of gestation. Conclusions No embyrotoxocit y o r teratogenici ty was recorded up to the highest administered dose of 1000 mg/kg body weight. No maternal toxicit y. Parenteral NOEL: 1000 mg/kg - bw/day. NOEL for offs pring: 1000 mg/kg - bw/day . Data Quality GLP References OECD/SIDS . Screening Informat io n Data Set of OECD High

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ume Chemicals Programme (1994) taken fro m Bayer AG. Bayer AG Data Short Report, (1984)Page 26 of 26

HPV Challenge Program 10/12/2009 Page 26 of 26 References 1) EPA High Production Volume ( HPV) Challenge. “Development of Chemical Categories in the HPV Challenge Program.” ht tp://www.epa.gov/HPV/pubs/general/categuid.htm 2) EPA High Production Volume (HPV) Challenge. “The Use of St ructure - Activit y Relationships (SAR) in the High Production Volume Chemicals Challenge Program .” ht tp://www.epa.gov/chemtrk/pubs/general/sarfin11.ht m 3) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Vol ume Chemicals Programme for PBTC, CAS# 37971 - 36 - 1 4) EPA High Production Volume (HPV) Challenge. “Determining the Adequacy o f Exist ing Data.” http://www.epa.gov/chemrtk/pubs/general/datadfin.ht m 5) EPA. “Guidance for Meeting the SIDS Requirements: Chemical Right - to - Kno w Initi ative.” ht tp://www.epa.gov/opptintr/chemrtk/sidsappb.ht m 6) Klimisch HJ, Andreae M, and Tillman U; “A Systemat ic Approach for Evaluat ing th e Qualit y o f E xperimental Toxico lo gical and Ecotoxico lo gical Data.” Regulatory Toxico lo gy and Pharmaco lo gy 25, 1 - 5 (1997). 7) EPA High Production Volume (HPV) Challenge. “Draft Guid ance on Developing Robust Summaries.” ht tp://www.epa.gov/chemrtk/pubs/general/robsumgd/ht m