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, 2009
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TABLE OF CONTENTS

1 INTRODUCTION .................................................................................................. 3

2 GENERAL INFORMATION.................................................................................. 4

2.1 Quantity .......................................................................................................... 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 Melting Point............................................................................................... 6

4.1.2 Vapor Pressure ............................................................................................ 6

4.1.3 Partition Coefficient .................................................................................... 7

4.1.4 Water Solubility .......................................................................................... 7

4.2 ENVIRONMENTAL FATE AND PATHWAY ELEMENTS ......................... 7

4.2.1 Photodegradation......................................................................................... 7

4.2.2 Stability in Water......................................................................................... 9

4.2.3 Transport Between Environmental Departments (Fugacity) ......................... 9

4.2.4 Biodegradation .......................................................................................... 10

4.3 ECOTOXICITY ELEMENTS....................................................................... 13

4.3.1 Acute Toxicity to Fish ............................................................................... 13

4.3.2 Toxicity to Aquatic Organisms (e.g. Algae)............................................... 15

4.3.3 Acute and/or Chronic Toxicity to Aquatic Invertebrates (e.g. daphnia) ...... 17

4.3.4 Sediment Phase Toxicity ........................................................................... 19

4.4 HEALTH ELEMENTS ................................................................................. 20

4.4.1 Acute Toxicity........................................................................................... 20

4.4.2 Genetic Toxicity in vivo (Chromosomal Aberrations)................................ 23

4.4.3 Genetic Toxicity in vitro (Gene Mutations)................................................ 23

4.4.4 Repeated Dose Toxicity............................................................................. 24

4.4.5 Toxicity to Reproduction........................................................................... 25

4.4.6 Developmental Toxicity/ Teratogenicity.................................................... 25
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1 INTRODUCTION

Under the EPA High Production Volume (HPV) Challenge Program, Nalco agreed to 

develop Test Plans and Robust Summaries for all toxicity data related to Nalco sponsored 

chemicals. Within this HPV submission is included the test plan and robust study 

summaries for the Nalco-sponsored chemical:

1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, CAS# 40372-66-5. (PBTC 

monosodium salt)

All available chemical and toxicity data for PBTC, monosodium salt were evaluated and 

rated against the OECD Screening Information 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 submissions are guidance documents in relation 

to Chemical Categorical approaches1and the use of Structure Activity Relationships 

(SAR)2. 

Based on the Chemical Categories guidance1, we have concluded that the use of data 

associated with the acid form of this compound, 1,2,4-Butanetricarboxylic acid, 2-

phosphono-, CAS# 37971-36-1, and the tetrasodium salt, 1,2,4-Butanetricarboxylic acid, 

2-phosphono-, tetrasodium salt, CAS # 66669-53-2, is relevant in fulfilling the SIDS 

endpoints for this compound. Therefore, the data for the OECD SIDS submission for 

PBTC, acid, CAS# 37971-36-1 was used as read across.

3

The individual studies are

included in the robust summary. 

Use of specific Structure Activity Relationships has been internationally agreed to by the 

OECD member countries and the EPA. In order to fulfill the physicochemical properties 

for PBTC, monosodium salt, the accepted EPISUITE 4.0 models were utilized. These 

include: melting point, boiling point, vapor pressure, MPBPVP; partition coefficient, 

KOWWIN; water solubility, WSKOW; photodegradation, AOPWIN; and for fugacity.
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2 GENERAL INFORMATION

PBTC, Monosodium 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 

salt

1,2,4-Butanetricarboxylic 

acid, 2-phosphono1,2,4-Butanetricarboxylic acid, 2-phosphono-, 

tetrasodium salt

Synomyms 2-phosphono-1,2,4-

butanetricarboxylic acid, 

sodium salt

2-phosphono-1,2,4-

butanetricarboxylic acid

2-phosphono-1,2,4-

butanetricarboxylic acid, 

tetrasodium salt

Structural 

Formula

HO

P

OH

O

O

O

O

OH

OH

O

Na

HO

P

OH

OH

O

O

O

OH

OH

O

O

P

O

O

O

O

O

OH

O

O

Na

Na

Na

Na

Molecular 

Weight

292.11 270.13 361.08

Molecular 

Formula

C7H10O9P.Na C7H11O9P C7H11O9P.Na4

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 Quantity

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, monosodium salt is manufactured as a component of liquid formulations, which

are used as scale inhibitors in industrial cooling towers across multiple industry sectors. 

Due to cooling tower processes typically existing as closed and continuous systems, 

human exposure consists of occasional controlled exposures such as during water 

sampling or maintenance of the towers. Environmental exposure consists of waste water 

discharges, which to a great extent are to surface water and not to waste water treatment 

facilities. A detailed evaluation on the human and environmental exposure is included in 

the OECD SIDS publication for PBTC acid.

3
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3 TEST PLAN

In reference to the OECD SIDS submission for PBTC acid as a source for read across 

data based on the EPA’s categorical approach, and the use of Structure Activity 

Relationships, all SIDS endpoints for the PBTC, monosodium salt are fulfilled. No 

additional toxicity data is proposed at this time.

EEndpoint Data Available Other Source for 

Data Fulfillment

SIDS Testing 

Required

Physical/ Chemical Elements

Melting Point N M N

Vapor Pressure N M N

Partition Coefficient N M N

Water Solubility N M N

Environmental Fate and Pathway Elements

Photodegradation N M N

Stability in Water N M N

Fugacity N M N

Biodegradation Y M N

Ecotoxicity Elements

Acute Toxicity to Fish Y R,M N

Toxicity to Aquatic 

Organisms N R,M N

Acute Toxicity to 

Aquatic Invertebrates N R,M N

Health Elements

Acute Toxicity N R N

Genetic Toxicity in 

vivo N R N

Genetic Toxicity in 

vitro N R N

Repeated Dose 

Toxicity

N R N

Toxicity to 

Reproduction N

R (from repeat 

dose toxicity and 

developmental 

toxicity)

6

N

Developmental 

Toxicity/

Teratogenicity

N R N

Y- Yes

N- No

M- Modeled

R- Read Across 
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4 ROBUST SUMMARY

Nalco provided three additional studies for a 50% solution of PBTC acid, which have 

been assigned a Klimisch rating of 1 or 2, as a supplement to the existing SIDS data for 

PBTC, CAS#37971-36-1

3

. Summary of the data within the SIDS document has also been 

provided for ease of reference, in addition to the robust summaries for the Nalco studies. 

Summary of Nalco Data

Endpoint Result Rating

Acute Toxicity to Fish 

(Cyprinodon variegatus, 

Sheepshead minnow)

LC50 for 96 hours = 550 mg/L. 

NOEC: 300 mg/L 

Klimisch 2- reliable 

with restrictions

Sediment Phase Toxicity 

(Corophium volutator)

10 day LC50 = 3715 mg/kg (95% C.I., 

3020 – 4786) of dry weight sediment. 

NOEC = 250 mg/kg of dry weight 

sediment.

Klimisch 2- reliable 

with restrictions

Biodegradation The test substance was degraded by 

30% after 28 days based on COD 

calculations and measurements to 

account for O2 consumption.

Klimisch 1- reliable 

without restrictions

4.1 PHYSICAL/CHEMICAL ELEMENTS

4.1.1 Melting Point

Test Substance 1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, CAS# 

40372-66-5

Method EPA’s MPBPVP modeling software. 

Results 90.27°C (estimated)

Data Quality Use of MPBPVP for this chemical class is acceptable based on EPA 

guidelines for HPV Chemicals.

References EPA’s EPIWEB 4.0, MPBPVP tool, v1.43

Other Analytical test results are not available for this material under the 

OECD 102 guidelines. It has been found acceptable both for EPA 

HPV submissions and for OECD SIDS Endpoints to use Structure 

Activity Relationships (SAR) in fulfillment of specific endpoints. 

4.1.2 Vapor Pressure

Test Substance 1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, CAS# 

40372-66-5

Method EPA’s MPBPVP modeling software. 

Results 6.06 x 10-11 mm Hg @ 25°C (estimated)

Data Quality Use of MPBPVP for this chemical class is acceptable based on EPA 
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guidelines for HPV Chemicals.

References EPA’s EPIWEB 4.0, MPBPVP tool, v1.43

Other Analytical test results are not available for this material under the 

OECD 104 guidelines. It has been found acceptable both for EPA 

HPV submissions and for OECD SIDS Endpoints to use Structure 

Activity Relationships (SAR) in fulfillment of specific endpoints. 

4.1.3 Partition Coefficient

Test Substance 1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, 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 Analytical test results are not available for this material under the 

OECD 107 guidelines. It has been found acceptable both for EPA 

HPV submissions and for OECD SIDS Endpoints to use Structure 

Activity Relationships (SAR) in fulfillment of specific endpoints. 

4.1.4 Water Solubility

Test Substance 1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, CAS# 

40372-66-5

Method EPA’s WSKOW modeling software. 

Results 1 x 106 mg/L @ 25°C (estimated), (Log Kow of -5.17 was used.)

Data Quality Use of WSKOW for this chemical class is acceptable based on EPA 

guidelines for HPV Chemicals.

References EPA’s EPIWEB 4.0, WSKOW tool, v1.41

Other Analytical test results are not available for this material under the 

OECD 105 guidelines. It has been found acceptable both for EPA 

HPV submissions and for OECD SIDS Endpoints to use Structure 

Activity Relationships (SAR) in fulfillment of specific endpoints. 

4.2 ENVIRONMENTAL FATE AND PATHWAY ELEMENTS

4.2.1 Photodegradation

Test Substance 1,2,4-Butanetricarboxylic acid, 2-phosphono-, sodium salt, CAS# 

40372-66-5

Method EPA’s AOPWIN modeling software. 
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Results Half-life = 2.707 days, 32.488 hours (estimated), Overall OH rate 

constant = 3.9508 x 10-12 cm3/molecule-sec. Fraction sorbed to 

airborne particulates (phi): 1 (Junge-Pankow, Mackay avg), 1 (Koa 

method). The sorbed fraction may be resistant to atmospheric 

oxidation.

Data Quality Use of Fugacity model for this chemical class is acceptable based on 

EPA guidelines for HPV Chemicals.

References EPA’s EPIWEB 4.0, AOPWIN tool, v1.92

Other Analytical test results are not available for this material under the 

OECD guidelines. It has been found acceptable both for EPA HPV 

submissions and for OECD SIDS Endpoints to use Structure Activity 

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 NO3. In the presence of 

photochemically induced sensitizers. Half-life of 7 days in a field 

test with the PBTC/Fe-complex at a water depth of 40 cm.

Conclusions “The most relevant degradation process in the hydrosphere is 

photooxidative transformation.”

Data Quality N/A

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994)

Test Substance PBTC/Fe complex

Method Field Test, in aqueous medium at a dose concentration of 0.01 

mol/m3, Achlachtensee Lake (Berlin, Germany), Light source: 

sunlight; method: measured; (1988) direct photolysis, global 

intensity: 1893 mW/cm2, over 7 days; absorption spectrum; 254 450 

nm. “The apparition of H3PO4 was determined.” 

Results Half-life of approximately 7 days in the depth of 40 cm. 65% 

degradation after 7days 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994)

Test Substance PBTC in buffered solution

Method Lab study in aqueous medium with a concentration of 100 mg/L. 

Exposure of samples in natural sunlight (measured) (1990)

Results 77.2% photodegradation at daylight after 50 days at pH of 5. 12% 
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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 OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Held, 

S. Zum Textilveredlung, 24(11), 394-398, (1989)

4.2.2 Stability in Water

Test Substance PBTC/Fe complex

Method Lab study in aqueous medium with a concentration of 0.05 mol/m3

. 

Light source: Hg-lamp; light spectrum: 254 nm; quantum yield: 0.27. 

Method: determination of quantum yield with monochromatic light at 

254 nm (measured) (1988); intensity: 15 W

Results 1% degradation with 0.1 mol/m

3

–OH and 0.1 mol/m3PBTC/Fe

Conclusions “The influence of 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from UBA. 

Abschlussbericht des UBA-FE-Vorhabens Wasser 

Phosphorverbindungen, 102 06 322, 32-57, (1988)

Test Substance PBTC-dissodium salt

Method Method: Suntest measured (1990) Concentration of 10 mg/L; Light 

source: Xenon lamp; Intensity of light source: 11.2-13.7 mW/cm2; 

light spectrum: 290-1220 nm. Indirect photolysis; sensitizer; NO3

(concentration 5 and 50 mg/L).. Temperature = 25°C

Results Measured half-life of 4.3-6.4 hours

Conclusions “No hydrolysis at ambient temperatures”

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Untersuchungen zum Photobbau von Bayhibit. Bericht Nr. 

anc47 (Investigations 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-, sodium salt, CAS# 

40372-66-5

Method EPA’s Fugacity modeling software, EPIWEB 4.0 
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Results

Level III Fugacity Model

Mass 

Amount (%)

Half-life 

(hours)

Emissions 

(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 1030

Persistence time: 432 hours

Data Quality Use of Fugacity model for this chemical class is acceptable based on 

EPA guidelines for HPV Chemicals.

References EPA’s EPIWEB 4.0, Fugacity tool

Other It has been found acceptable both for EPA HPV submissions and for 

OECD SIDS Endpoints to use Structure Activity Relationships 

(SAR) in fulfillment of specific endpoints. 

4.2.4 Biodegradation

Test Substance PBTC acid, CAS# 37971-36-1, 50% solution in water

Method

Guideline OECD 306 “Biodegradability in Seawater- Closed Bottle Test”

Inoculum N/A- Natural seawater microorganisms found in seawater sample

Test Method 2-10 mg of a predetermined amount of test material was dissolved 

in test medium. Bottles were filled and closed and kept for 28 days 

in the dark at a temperature range of 20.0°C ± 1.4°C. The 

degradation was measured by oxygen analysis.

Oxygen 

Measurements

A WTW 320 oxygenmeter was used to measure dissolved oxygen 

concentrations (with corrections for salinity, temperature, and 

pressure) on days 0, 7, 14, 21, and 28. 

Chemical Oxygen

Demand

4.24 x 105 mg O2/kg

Concentration of test 

substance

4.76 mg/L

Salinity of decanted 

and aged seawater

Day 0, 34.8o/oo

Test Validity The test in considered valid in relation to the required parameters 

being met according to OECD 306: Inoculum control reached the 

level of 50% degradation within 7 days (69%, sodium benzoate), 

not including lag phase; the blank respiration did not exceed 30% 

of the oxygen in the test bottle (7 days – 0.0 mg O2/L, 14 days 0.1, 

21 days- 0.4, 28 days 0.3); the temperature variation was within 

acceptable range (20.0 ± 1.4°C); the BOD of the mixture of test and 
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reference substance was nearly equal to the sum of the BOD of the 

separate solution of the two substances; the microbial count was 

within the acceptable range of 102– 104cfu/mL (9.5 x 102cfu/mL)

Results The test substance was degraded by 30% after 28 days based on 

COD calculations and measurements to account for O2

consumption. The results for the test substance, inoculum control, 

and control of inhibitory action are summarized in the following 

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 not 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 without restrictions.

References Nalco Ltd. Report for neutralized solution 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 Biodegradability: Modified OECD 

Screening Test” (1988), aerobic. 10 mg/L effluent from waste water 

treatment 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 Directive 84/449/EEC, C.6 “Biotic Degradation – 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 Information Data Set of OECD High 
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Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report (1976)

Test Substance PBTC tetrasodium salt 

Method EPA-method Guideline 796.3140- End point: development of CH4

and CO2. 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report 

Test Substance PBTC tetrasodium salt 

Method DIN 38412 Teil 25; OECD 302B “Biodegradation: 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1989)

Test Substance PBTC acid, CAS# 37971-36-1 

Method Determination of the biodegradability of anionic synthetic surface 

active agents. OECD, Paris (1971); (1973). Activated sludge, 

aerobic.

Results 0% degradation observed

Conclusions Substance is not “readily biodegradable”

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1973)

Test Substance PBTC acid, CAS# 37971-36-1

Method OECD Guideline 302A “Inherent Biodegradability: 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 

elimination in the first day which was probably due to adsorption on 

sludge. Also bacterial inhibition was observed.

Conclusions Substance is not “inherently biodegradable”
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Data Quality N/A

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 “The only possible contribution of PBTC to the eutrophication of 

surface water would be through its degradation to ortho- phosphate. 

The biodegradation tests have shown that significant biodegradation 

in surface waters is to be expected. The only identified way of orthophosphate formation is through photooxidative degradation of certain 

PBTC-metal complexes. As this process is relevant only near the 

surface of water bodies, the overall contribution of PBTC to the 

eutrophication of surface waters is probably low.”

Conclusions N/A

Data Quality N/A

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume 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 Toxicity Test 

(modified OECD 203). 96 hour LC50 to the juvenile sheepshead 

minnow, Cyprinodon variegatus; semi-static

Reference 

Seawater

Purchased and stored for no longer than 4 weeks at 18 – 22°C.

Test Method The test substance was homogenized before use. Concentrations of 

test solution were added to test vessels at 0, 100, 300, and 1000 mg/L

(nominal concentrations). The fish were inspected daily with 

removal of dead fish if applicable. Measurements of all test vessels,

including controls, were performed daily for pH, dissolved oxygen, 

salinity, and temperature.

Reference 

Substance

2.3 mg/L 3,5-dichlorophenol from 06/07/04 – 10/07/04. Mortality 

was 40% after 96 hours.

pH pH had been monitored during testing and found to be between 3.7 

and 8.2.

Test Validity All measured parameters were within the recommended ranges: 

Salinity 3.0–3.6% (3.3%); Temperature 20±2.4°C (19.6-20.3°C); 

Dissolved Oxygen •60% Saturation (•94% Saturation); % Mortality 
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in controls •10% (0%); % Mortality in reference 20-80% (40%); 

Results LC50 for 96 hours = 550 mg/L, NOEC: 300 mg/L 

Analytical monitoring: no.

Conclusions This substance is of low acute toxicity to this marine fish species.

Data Quality Conducted in compliance 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% solution of PBTC

Method 48 hour exposure to Onchorhynchus mykiss (Rainbow Trout) to a 

concentration of 3440 mg/L. “Static; Bestimmung der akuten 

Wirkung von Stoffen auf Fishe. Arbeitskreis ‘Fischtest’ im 

Hauptausschuss ‘Detergentien’ (15.10.73); (1975)”

Results LC50 for 48 hours = 3440 mg/L. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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; 

Bestimmung der Wirkung von Wasserinhaltstoffen 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. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 

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 Toxizitaetstest 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. Analytical monitoring: no.
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Conclusions PBTCs effective concentration had effect on mortality, length, and 

weight

Data Quality Not specified

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report (1994).

Test Substance Other test substance: neutralized 50% solution of PBTC

Method 72 hour exposure to Leuciscus idus (Golden orfe) at a concentration

of • 2000 mg/L. “Static; Bestimmung der akuten Wirkung von 

Stoffen auf Fishe. Arbeitskreis ‘Fischtest’ im Hauptausschuss 

‘Detergentien’ (15.10.73)”

Results LC0 for 72 hours • 2000 mg/L. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1973).

4.3.2 Toxicity to Aquatic Organisms (e.g. Algae)

Test Substance Non-complexed PBTC

Method Green algae (Scenedusmus quadricauda) and microalgae (Nostoc 

muscorum). Freshwater. 10 day and 15 day exposure period. “Growth 

of algae on synthetic nutrient solution with non-complexed PBTC as 

sole P-source; photometric determination of growth at 436 nm; 

control with K2PO4 as P-source. Concentrations: 6.9 mg/L & 0.34 

mg/L as related to P-results: 6.11.94”

Results “The test species could not use the phosphonate as P-source.” 

Conclusions “The test with two algae species has shown that PBTC cannot be 

used as a P-source by algae. Biological processes in waste water 

treatment plants are not affected by PBTC.”

Data Quality Not specified

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 analytical monitoring. “Test auf algizide Wirkung. 

Interne Testvorschrift der Hankel KgaA”

Results Mortality at > 500 mg/L. No visible effect at 500 mg/L 
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Conclusions Not provided on SIDS document

Data Quality Not specified

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 

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 

Inhibition Test” (C.3); Directive 67/548/EEC (Draft 1992); (1994) 

end point: biomass

Results Biomass: EC10 fo 72 hours = 8 mg/L; Biomass EC50 for 72 hours = 

140 mg/L. Analytical monitoring: yes.

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 Inhibition Test” 

(C.3); Directive 67/548/EEC (Draft 1992); (1994) end point: growth 

rate

Results Biomass: EC10 fo 72 hours >33.3 - <65.5 mg/L; Biomass EC50 for 

72 hours = > 1081 mg/L. Analytical monitoring: yes.

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 Inhibition 

Test” (C.3); Directive 67/548/EEC (Draft 1992); (1994) 

Results Biomass: NOEC for 72 hours 17.8 mg/L; Biomass: LOEC for 72 

hours = 33.3 mg/L. Analytical monitoring: yes.

Conclusions Not provided on SIDS document

Data Quality GLP
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References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, 1994

Other “The statistically derived NOEC is higher in this case than the EC10-

value”

Test Substance Other test substance: neutralized 50% solution of PBTC

Method Freshwater Green algae- Scenedesmus quadricauda. 96 hour 

exposure with a concentration of 860 mg/L. “Bestimmung der 

biologischen Schadwirkung toxischer Abwasser gegen Algen. DEV, 

L 9 (1968); (1975); endpoint: cell count”

Results Biomass: EC10 for 96 hours = 860 mg/L. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, 1975

4.3.3 Acute and/or Chronic Toxicity to Aquatic Invertebrates (e.g. daphnia)

Test Substance Other test substance: 39.66% PBTC

Method 21 day exposure to Daphnia magna at concentrations > 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: immobilization;”

Results EC 50 for 21 days > 1071 mg/L. Analytical monitoring: yes.

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report

Test Substance Other test substance: 39.66% PBTC

Method 21 day exposure to Daphnia magna at concentrations 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. Analytical monitoring: 

yes.

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 
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Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report

Test Substance Other test substance: active substance PBTC

Method 24 hour exposure to Daphnia magna at concentrations of 180-350 

mg/L “Daphnien-Kurzzeittest, DIN 38412 Teil 11, Bestimmung der 

Wirkung von Wasserinhaltsstoffen auf Kleinkrebse;”

Results EC0 for 24 hours = 180 mg/L. EC 50 for 24 hours = 265 mg/L 

EC100 for 24 hours = 350 mg/L. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 

Kaestner, W. and Gode, P. Zeitschrift fuer Wasser und Abwasser 

Forschung, 16(2), 39-47, (1983)

Test Substance PBTC acid: “The test solution was not neutralized (pH 4.8 – 5.4)”

Method 24 hour exposure of Daphnia magna to concentrations 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 

for 24 hours = 1250 mg/L. EC 50 in second test at pH 5.0 – 5.5 = 

1113 mg/L. Analytical monitoring: no. “The above results are 

nominal concentrations”

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from UBA. 

Abschlussbericht des UBA-FE-Vorhabens Wasser 

Phosphorverbindungen, 102 06 322, 32-57, (1988)

Test Substance Other test substance: neutralized 50% solution of PBTC

Method 24 hour exposure of daphnia magna to doses of > 500 mg/L 

“Bestimmung der biologischen Schawdwirkung toxischer Abwasser 

gegen niedere Metazoen. DEV, L 11 (1986); (1979)”

Results EC0 for 24 hours > 500 mg/L. Analytical monitoring: no.

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report (1979)
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4.3.4 Sediment Phase Toxicity

Test Substance 50% PBTC acid in water

Method

Guideline

LC50 Corophium volutator sediment reworker test. Based on draft 

1994 of Paris Commission Guideline: “MAFF/EWRT Harmonised 

Protocol. A Sediment Bioassay using an amphipod Corophium sp.”

Test Animals Animals were collected from Bergen, Norway. They were sieved 

from the sediment and acclimatised for 5-12 days in an aquarium 

under test conditions. Mortality 8 days prior to testing was 3%, 

which is within the acceptable range.

Reference 

Sediment

Sediment was collected from an inter-tidal area free of contamination 

and transported in polyethylene bags to the lab. It was sieved at the 

lab at 500 μm in a closed system using natural seawater and stored 

sealed in polyethylene bags in a dark room at 4oC until use.

Method Adult animals were exposed to sediment spiked with 50% PBTC acid 

for a period of 10 days. Five test concentrations were used with 3 

parallels for each concentration and 5 controls. The animals used 

were 5mm or greater in length. Water quality was monitored 

throughout the test. The test samples were aerated and a constant 

water level of (900ml) was maintained in the test vessels by topping 

off with distilled water.

Duration 10 days

Concentrations 0, 52, 250, 876, 3003, and 10001 mg/kg (dry weight)

End point lethality

Validity This test is considered valid with exception for pH. Range of 

required parameters (actual values): Salinity 3.3±0.4% (3.3 – 3.5%); 

Temperature 15±2.4oC, max 17.4oC (15±2.4oC); Dissolved Oxygen 

>85% Saturation (>94% saturation); pH 7.5 – 8.5 (4.3 – 8.1); % 

lethality in controls •10% (0%). pH was outside the test range, 

which is thought to be due to the test substance. According to the 

protocol the pH should not be readjusted as this may be a source of 

toxicity.

Deviations Twelve animals were found in control number 3- this is not thought 

to have any consequences for the test.

Results 10 day LC50 = 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 fully compliant with OECD (1997): OECD Principles 

of Good Laboratory Practice. Klimisch rating of 2- reliable with 

restrictions.

References Nalco Ltd. “Sediment Phase Toxicity Test Results with Corophium 

volutator for the Test Substance R-2244” AnalyCen Ecotox As. 

Report No. R 376-04. 2004.
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4.4 HEALTH ELEMENTS

4.4.1 Acute Toxicity

Test Substance Tetrasodium salt, commercial product

Method Dermal LD50 in rats, single dermal application, post-exposure period 

of 19 days.

Results LD50 of > 4000 mg/kg-bw

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1990)

Other Report no. 19382

Test Substance Tetrasodium salt, 41.4% solution in water

Method Inhalation LD50 in rats, aerosol, dynamic inhalation

Results LD50 >1979 mg/m3

/4h

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1976)

Test Substance Tetrasodium salt, commercial product

Method Oral LD50 in rats, single oral application, post-exposure period of 14 

days.

Results LD50 of > 4000 mg/kg-bw

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1990)

Other Report no. 19383

Test Substance Tetrasodium salt, 41.8% solution in water

Method Oral LD50 in male rats, single oral application, post-exposure period 

of 14 days.

Results LD50 of 20.1 mL/kg

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 
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AG. Bayer AG Data Short Report, (1971)

Test Substance Tetrasodium salt, 41.8% solution in water

Method Oral LD50 in male mice, single oral application, post-exposure 

period of 14 days.

Results LD50 of 16.2 mg/kg

Conclusions Not provided on SIDS document

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1971)

Test Substance PBTC acid, 50% aqueous solution

Method Oral LD50 in rats, single oral application, 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 Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1979)

Test Substance Tetrasodium salt, 32.6%

Method Maximization test in DHPW guinea pigs, according to M. Kligman

Results Not sensitizing

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1990)

Other Report no. 19052A

Test Substance Tetrasodium salt, 41.8% solution in water

Method Primary skin irritation in rabbits; Application to the ear, postexposure observation of 7 days.

Results Not irritating

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1976)

Test Substance PBTC acid

Method Primary skin irritation in rabbits; Application on back skin, patch 
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test, intact or abraded skin. No data on application period, postexposure observation period 72 hours. Acute dosing of 0.5 mL

Results Not irritating

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1971)

Test Substance Tetrasodium salt, 41.4% solution in water

Method Primary skin irritation in rabbits; The test substance was applied to 

the ear, application period of 24 hours, post-exposure observation of 

7 days.

Results Not irritating

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1976)

Test Substance PBTC acid, 50% solution in water

Method Primary skin irritation in New Zealand rabbits; The test substance 

was applied to the ear, application period of 24 hours, post-exposure 

observation of 7 days.

Results Not irritating

Data Quality Not specified

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1977)

Test Substance PBTC acid, 50% solution in water

Method Primary eye irritation in rabbits; post-exposure observation of 7 days.

Results Weak irritant

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1977)

Test Substance Tetrasodium salt, 41.8% solution in water

Method Primary eye irritation in rabbits; post-exposure observation of 7 days.

Results Not irritating

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1976)
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Test Substance Tetrasodium salt, 41.8% solution in water

Method Primary eye irritation in rabbits; post-exposure observation of 72 

hours. Dose of 0.1 mL

Results Not irritating

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1971)

Test Substance Tetrasodium salt, 41.4% solution in water

Method Primary eye irritation in rabbits; post-exposure observation of 7 days. 

Dose of 0.1 mL

Results Weak irritant

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1976)

4.4.2 Genetic Toxicity in vivo (Chromosomal Aberrations)

Test Substance PBTC acid, 50% solution in water

Method Mouse Micronucleus Assay in male and female mice. OECD 

Guideline 474- Genetic Toxicology Micronucleus Test; Single oral 

application by gavage. Acute exposure with a dose of 2000 mg/kgbw.

Results Negative 

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 

Henkell KgaA, (1993)

Other Report no. 9300322

4.4.3 Genetic Toxicity in vitro (Gene Mutations)

Test Substance PBTC acid, commercial product, 49% solution in water

Method AMES test- Directive 84/449/EEC, B. 14 “Other effectsMutagenicity (Salmonella typhimurium –Reverse Mutation Assay)” 

Concentration of 16-1000 μg/plate. Test performed with and without 

metabolic activation. Strains: TA98, TA100, TA1535, TA 1537

Results Negative results for mutagenicity, with and without metabolic 

activation
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Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1992)

Other Report no. 21134

Test Substance PBTC acid, commercial product, 45-50% solution in water

Method AMES test. Concentration of 20-12500 μg/plate. Test performed 

with and without metabolic activation. Strains: TA98, TA100, 

TA1535, TA 1537

Results Negative results for mutagenicity, with and without metabolic 

activation

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1979)

Other Report no. 6821

Test Substance PBTC acid

Method Cytogenetic Assay. OECD Guideline 473 “Genetic Toxicology: In 

vitro Mammalian Cytogenetic Test”; Chinese hamster lung cells, 

V79. Concentrations of 125, 250 and 500 μg/mL without S9-mix and 

625, 1250 or 2500 μg/mL with S9-mix were used.

Results Negative results with and without metabolic activation

Conclusions Not provided on SIDS document

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from May, 

Ch. Forschungsbericht – Bundesanstalt fuer Arbeitsschutz und 

Unfallforschung, (1993)

4.4.4 Repeated Dose Toxicity

Test Substance Tetrasodium salt

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, biochemical, pathological, or histopathological 

parameters were unaffected.”

Conclusions “A 90-day test (rats feeding study with the tetrasodium salt, up to 

5000 mg/kg diet for 12 weeks) showed no substance related effects. 
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NOAEL of 375 mg/kg body weight (5000 mg/kg/diet) was derived. 

OECD/SIDS conclusion: ‘Low toxicity, no damage in oral doses up 

to 375 mg/kg/body weight.’”

Data Quality Not run under GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from 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 fulfills this category.5

4.4.6 Developmental Toxicity/ Teratogenicity

Test Substance PBTC acid, commercial product, 49% solution in water

Method OECD Guideline 414 “Teratogenicity”

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 embyrotoxocity or teratogenicity was recorded up to the highest 

administered dose of 1000 mg/kg body weight. No maternal toxicity.

Parenteral NOEL: 1000 mg/kg-bw/day. NOEL for offspring: 1000 

mg/kg-bw/day.

Data Quality GLP

References OECD/SIDS . Screening Information Data Set of OECD High 

Production Volume Chemicals Programme (1994) taken from Bayer 

AG. Bayer AG Data Short Report, (1984)
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References

1) EPA High Production Volume (HPV) Challenge. “Development of Chemical 

Categories in the HPV Challenge Program.” 

http://www.epa.gov/HPV/pubs/general/categuid.htm

2) EPA High Production Volume (HPV) Challenge. “The Use of Structure-Activity 

Relationships (SAR) in the High Production Volume Chemicals Challenge 

Program.” http://www.epa.gov/chemtrk/pubs/general/sarfin11.htm

3) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production 

Volume Chemicals Programme for PBTC, CAS# 37971-36-1

4) EPA High Production Volume (HPV) Challenge. “Determining the Adequacy of 

Existing Data.” http://www.epa.gov/chemrtk/pubs/general/datadfin.htm

5) EPA. “Guidance for Meeting the SIDS Requirements: Chemical Right-to-Know 

Initiative.” http://www.epa.gov/opptintr/chemrtk/sidsappb.htm

6) Klimisch HJ, Andreae M, and Tillman U; “A Systematic Approach for Evaluating 

the Quality of Experimental Toxicological and Ecotoxicological Data.” 

Regulatory Toxicology and Pharmacology 25, 1-5 (1997).

7) EPA High Production Volume (HPV) Challenge. “Draft Guidance on Developing 

Robust Summaries.” http://www.epa.gov/chemrtk/pubs/general/robsumgd/htm