p . 1 EPA/OPPTlHigh Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht

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# Progra m Recent Additions i Contact Us I Print Version Search : EPA ligme > Prevention . Pesticides & Toxic Substances > Pollution Pr evention & Toxics > NiC h Production Volume (HPVI Challe nge Program y Draft Guidance on Developing Robust Summarie s 

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# Draft Guidance on Developing Robust 

# ; ~", ,'" .' Summarie s Chemicals HPV Challenge 

### (October 22, 1999) Program RODUST Summaries, Tes t Plans & The guidance in the following tables are presented exactly as they appear in th e Comments official OECD document entitled "Guidance for Developing Robust Summa ri es for o Children's SIDS Dossiers" ( Document number ENVIJM/EXCH(99)13, dated 10/8/99) . EPA Chemical Eval . • . Provides the following narrative as an introduction to the OECD tables . Persistent, DefinitionlBackground
. oaccumulativ e Bi, and Toxic (PBT) The purpose of the U .S . HPV Chemical Challenge Program is to make hazard data Chemicals Rules ( either existing or newly acquired information) available to the public for all U .S . Related Websites high production volume chemicals . Most HPV Challenge sponsors will have at least some existing data in the form of full study repo rts for some or all of the endpoints in the Screening Information Data Set (SIDS) . Sponsors need to determine whether available information already adequately describes a given endpoint . EPA guidance for determining data adequacy has already been provided . Once one or more studies have been identified as adequate, then they need to be made public in the Challenge Program . From a practical standpoint, it is not reasonable to a ttempt to create an electronic version of full study repo rts (especially old repo rts that may date to the 1960s or earlier) . Instead, electronic summaries of full study repo rts will be prepared that contain the appropriate technical information for that pa rt icular endpoint . The purpose of this document is to present guidance on what technica l information, on an endpoint-by-endpoint basis, is necessa ry to adequately describe an experiment or study . The term "robust summa ry " is used to describe this technical content . Robust study summaries are intended to provide su ffi cient information to allow a technically qualified person to make an independent assessment of a given study report without having to go back to the full study repo rt , and to also allow evaluation of the proposed test plan
. A robust study summa ry therefore reflects the objectives, methods, results, and conclusions of the full study repo rt , which can either be an experiment or in some cases an estimation or prediction method . Which Studies Require Robust Summaries ? A complete robust study summa ry should be prepared for at least one key or critical study for each SIDS endpoint that has been considered adequate according to EPA guidance . Robust summaries may also be prepared for other adequate studies that are considered suppo rt ive of the key study . When you don't have an adequate study, but some information is available, it is suggested that robust summaries be prepared for each study . In addition, a single "best" study would contain a weight-of-the-evidence analysis in its remarks section ( see below) which refers to, and ties together, the other studies . Origin of the Guidanc e

1 of 31 8/23/2004 12 :53 PMp . 2 EPAlOPPTlHigh Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epagov/chemrtk/robsumgd .ht The templates for robust study summaries presented in the following pages wer e based on : (1) current guidance in the Organization of Economic Cooperation and Development (OECD) SIDS Manual ; (2) work carried out by the US EPA in the context of the US HPV Challenge Program ; (3) work carried out by the Chemical Manufacturers Association (CMA) and the Business and Industry Association Council (BIAC) relating to both the U .S . Challenge Program and the OECD SIDS program ; and (4) work relating to the International Uniform Chemical Information Database (IUCLID) carried out by the European Commission . The draft guidance contained in this document is currently being considered by an international group of scientists associated with the OECD for its usefulness in the OECD SIDS program . Therefore, while there might be some changes made over the next few months, the EPA believes it is useful to place these templates on our website as guidance for early submitters and those who have been following the discussion of this issue over the past year . EPA intends to combine this document with the data adequacy document because the guidance presented herein simply captures the information gleaned during the data adequacy determination
. Robust Study Summary Template s A series of templates for the different SIDS endpoints have been developed . They have been structured to allow for computerised data entry by describing the items in each robust study summary as "data fields" with allowance for free text . The proposed robust study summary templates have seven sections on : Test Substance, Methods, Results, Conclusion, Data Quality, References, and Other . In the following pages, templates for the listed SIDS endpoints are provided : Physical/Chemical Elements 1) Melting point 2) Boiling poin t 3) Vapor pressur e 4) Partition coefficient 5) Water solubilit y Environmental Fate and Pathways Elements 6) Photodegradatio n 7) Stability in wate r 8) Transport between Environmental Compartments (Fugacity) 9) Biodegradatio n Ecotoxicity Element

s 10) Acute toxicity to fis h 11) Toxicity to aquatic plant s 12) Acute toxicity to aquatic invertebrates Health Element s 13) Acute toxicity 14) Genetic toxicity in vivo(chromosomal aberrations) 15) Genetic toxicity in vitro (gene mutations ) 16) Repeat dose toxicity 17) Reproductive Toxicity 18) Developmental Toxicity/Teratogenicity No templates are currently available for non-SIDS endpoints . Information on these is nevertheless encouraged to be included where available and relevant to the assessment . Explanation of the Template s
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Each template identifies the information items that should be included in a robus t study summa ry for that SIDS endpoint . As many items of information as possible should be provided since robust study summaries concern the key study(s) on which the assessment of each SIDS endpoint is based . It is generally expected that the most adequate, reliable, and relevant study for each SIDS endpoint will be clearly identified and repo rted to the fullest level of the template . In cases where the study is considered inadequate, this should be clearly marked together with the reasons . Each template is composed of seven sections, each section each of which has two different ty pes of fields : controlled vocabula ry and free text . The controlled vocabula ry fields are identified in the templates by individual bullets, which are required to be filled out, while the free text field under each section entitled

" Remarks" Oiffl> allows the input of optional information . Often, the "Remarks" section can be used as a means to fu rt her explain the contents of a pa rt icular section, much as is done in the "Discussion" po rt ion of a publication in academic journals . For example, under the "Results" section, unexpected results could be fu rt her explained in the "Remarks" field (i .e ., results seen were due to the complex nature of the test substance, deviations in protocol, etc .) . Test substanc e This refers to the identi ty of the HPV chemical . If the chemical used in the specific test was different from the specific HPV chemical in identity (purity, additives, different solvent carrier, etc), then those differences need to be noted in the Test Substance Remarks field together with the chemical name, CAS number, purity of the materials, additives, and chemical structure as appropriate . If the chemical(s) is listed in the IUCLID system, it would also be useful to have an IUCLID identification number . Methods This section refers to the methodologies used to conduct the study . If the study was done according to OECD Test Guidelines, or other widely recognized guidelines, then it does not need to be fully described . For example, only the name of the guideline ( e .g ., OECD 421) needs to be repo rt ed . If there have been deviations from the Test Guideline, then those deviations that will significantly impact either the study reliabili ty or the interpretation of the data need to be individually listed . On the other hand, if a study is based on a guideline that is not widely recognized, more items under the "Remarks" field may need to be included to justify use of the guideline . There may also be situations in which a single study addresses several endpoints, such as with a study that follows the OECD combined repeat dose/reproduction/developmental Test Guideline 421 . In this example, if this single study was to be the key one for each of these endpoints, then three separate robust study summaries would be prepared for each endpoint - all pointing to the same study . Results This section has standard items to fill in under discrete bullets, and also a "Remarks" field with additional items that may be needed to adequately assess data for reliabili ty and use . At a minimum, qualitative descriptions of elements where dose-related observations were seen should be described . Conclusion s This section has a "Remarks" field only, so that the conclusions of the study can b e
3 of 31 8/23/2004 12 :53 PMp . 4 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg :l/14/http ://www .epagov/chemrtk/robsumgd .ht noted if given, together with any comments by the person preparing the robus t study summa ry . Data Quality This section can be used to denote the adequacy of data, at the discretion of the person preparing the robust study summa ry References This free text field allows the person preparing the robust study summa ry to provide the full citation for the critical study on which the robust study summa ry is based . Other This section includes a data field for revisions, a number useful for sorting, and a free text field for general remarks . PHYSICAUCHEMICAL ELEMENTS 1) MELTING POIN T TEST SUBSTANCE • Identity Remarks field for Test Substance (Use for any pertinent, test

~ substance-specific remarks . ) METHOD 1 I r Method/guideline followed ( include calculated as one of the possible

~ methods ) ; +t GLP (Y/N ) * Year (study performed ) 491> Remarks field for Test Conditions (Detail and discuss any significant protocol deviations . ) RESULTS

* Melting point value in °C (include <0°C as an acceptable answer) * Decomposition °C/ no /ambiguous )

(yes-temperature * Sublimation (yes/no/ambiguous ) ~I 40> Remarks field for Results (Describe additional information that may be needed to confirm data reliability and relevance) CONCLUSION S

~ Remarks fi eld with the ability to identify source of comment, i .e . ; author and/or submi tte r iDATA QUALITY
Ef Reliabilities (Klimisch Code, if used, possibly a flag for key study )

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sE Remarks field for Data Reliabili ty key REFERENCES (Free Text ) 1 ; OTHER ~, * Last changed (administrative field for updating) • Order number for so rt ing (administrative field ) 4~1> Remarks field for General Remarks ( Use for any other comments necessary for clarification .) 2) BOILING POINT

_ J EST SUBSTANC E Identity Remarks field for Test Substance (Use for any pe rt inent, test substance-specific remarks . ) 1 METHOD

* Method ( include calculated as one of the possible methods) * GLP (Y/N )

~ * Year ( study performed ) 149> Remarks field for Test Conditions (Detail and discuss any (signification protocol deviations . ) RESULTS '+r Boiling point value in °C (include >300°C as acceptable answer) Pressure s Pressure uni t 

### Decomposition (yes/no/ambiguous ) ® Remarks field for Results ( Describe additional information that may be needed to adequately assess data for reliability and use .) !CONCLUSION S Remarks field with the ability to identify source of comment, i .e . ~ author and/or submi tte r 1DATA QUALIT Y Reliabilities (Klimisch Code, if used, possibly a flag if'key study') 1!4ffl> Remarks field for Data Reliabili ty €?RFFFRFIU( FC [Fru o Tov4 1
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. ._~ . . . . . . .~ ., ~ . . ., . . . . . . ., ~ OTHER a Last changed (administrative field for updating) # Order number for sorting ( administrative field) ~l Remarks field for General Remarks (Use for any comments (necessary for clarification . ) 3) VAPOUR PRESSURE x':TEST SUBSTANC E +r Identity 49~ Remarks field for Test Substance ( Use for any pe rt inent, test substance-specific remarks . ) METHOD

* Method ( include calculated as one of the possible methods) # GLP (Y/N ) # Year (study performed) k E

~ 491~ Remarks field for Test Conditions (Detail and discuss any

, signi fi cant protocol deviations . ) I RESULTS !• Vapor Pressure value ( include < I x 10-5 Pa as an acceptable ~ answer) * Temperature ° C 

### + Decomposition (yes/no/ambiguous ) !g Remarks field for Results (Describe additional information that 1 (may be needed to adequately assess data for reliability and use .) ,1 CONCLUSION S 49> Remarks field with the abili ty to identify source of comment, i .e . author and/or submi tt

e r i DATA QUALIT Y

* Reliabilities (Klimisch Code, if used, possibly a flag if 'key study')

~ 49> Remarks field for Data Reliabilit y ;REFERENCES (Free Text) OTHE R
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. )

4) PARTITION COEFFICIENT TEST SUBSTANC E • Identity 4fl> Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks)
. ,!,METHOD • Method (include calculated as one of the possible methods) 1! ~ GLP (Y/N ) r Year (study performed ) Remarks field for Test Conditions (Detail and discuss any signification protocol deviations
. )

' ` RESULTS

. ;~ Log Pow Temperature ° C IfO> Remarks field for Results (Describe additional information that may be needed to adequately assess data for reliability and use . In particular note if compound is surface active, dissociative, insoluble in water, etc . ) 

### 1 : CONCLUSIONS Remarks field with the ability to identify source of comment, i .e . ~!author and/or submitte r 1 DATA QUALIT Y rF * Reliabilities (Klimisch Code, if used, possibly a flag if'key study') 40> Remarks field for Data Reliabilit y ,,REFERENCES (Free Text) 1 i OTHER

* Last changed (administrative field for updating) * Order number for sorting (administrative field )
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1 I 491> Remarks field for General Remarks ( Use for any comments l (necessa ry for clarification . ) 5) WATER SOLUBILITY TEST SUBSTANC E +r Identity 49> Remarks field for Test Substance (Use for any pe rt inent, test -substance-specific remarks . ) METHOD • Method ( include calculated as one of the possible methods) • GLP (Y/N )

~ * Year (study pe rformed ) -4~1> Remarks field for Test Conditions ( Detail and discuss any signification protocol deviations . ) 

### RESULTS +e Value (mg/L) at temperature ° C
* Description of solubili ty ( e .g ., miscible to soluble to not soluble) (see Note 6 below ) * pH value and concentration at temperature °C * pKa value at 25 ° C 49~ Remarks field for Results ( Describe additional information that may be needed to adequately assess data for reliabili ty and use .) ~[CONCLUSION S Affl> Remarks field with the ability to identify source of comment, i .e . l author and/or submi tt e r IDATA QUALIT Y E• Reliabilities (Klimisch Code, if used, possibly a flag if 'key study') 14ffP Remarks field for Data Reliabilit y

~ I REFERENCES ( Free Text) OTHE R

* Last changed (administrative field for updating) ; Order number for so rt ing (administrative field )

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### ~ i necessa ry for clarification
. ) 

### ENVIRONMENTAL FATE AND PATHWAY ELEMENTS

6) PHOTODEGRADATIO N TEST SUBSTANCE a~ Identit y 491> Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) 

### METHOD w Method/guideline followed (include calculated as one of the possible methods ) * Type (test type) • GLP (Y/N ) * Year (study performed) * Light Sourc e • Light Spectrum (nm ) • Relative Intensity based on Intensity of Sunligh t * Spectrum of substance (max lambda, max epsilon and epsilon 295) Remarks field for Test Conditions . Detail and discuss any significant protocol deviations . Detail differences from the guideline followed including the following as appropriate : - Test medium (air, water, soil, other - specify) - Duratio n - Positive Controls - Negative Controls RESULTS ( ; • Concentration of Substance Temperature ° C ( : # Direct photolysis

z E ;j - Half-life t'/Z (preferred) s : - Degradation % afte r - Quantum yield Indirect photolysi s - Sensitizer (type ) - Concentration of sensitizer - Rate Constan t - Degradation % afte r

9 of 31 8/23/2004 12 :53 PMp .10 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .h t i• Breakdown products (yes/no) If yes describe breakdown products and whether they were transient or stable in the Remarks field for ~Results
. i'~ Remarks field for Results (Describe additional information that may be needed to adequately assess data for reliability and use .) i ! CONCLUSION S !4=~ P' Remarks field with the ability to identify source of comment, i .e . !author and/or submitte r DATA QUALIT Y Reliabilities (Klimisch Code, if used, possibly a flag if 'key study') Remarks field for Data Reliability REFERENCES (Free Text ) # Last changes (administrative field for updating) +► Order number for sorting (administrative field ) j ;lllg~ Remarks field for General Remarks (Use for any other comments necessa ry for clarification
. )



### 7) STABILITY IN WATER TEST SUBSTANC E Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) METHOD

~ Method/guideline followed (include calculated as one of the possible ;methods) Type (test type ) GLP (Y/N ) i ~ Year (study performed ) 49~ Remarks field for Test Conditions . Detail and discuss any significant protocol deviations . Detail differences from the guideline followed including the following as appropriate : - Duration (days) - Positive Controls - Negative Control s - Analytical procedure s

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!RESULT S ~E # Nomina l Measured value (the value with units preferably as mg/L ) • Degradation % at a specified pH and temperature °C % after a

~ specified time o r

~ * Half-life (t(1/2) in days or hours at a specific pH (pH 4, 7, 9, and € other) and temperature ) i +e Breakdown products (yes/no) If yes describe breakdown products land whether they were transient or stable in the Remarks field for Results
. ~ Remarks field for Results ( Describe additional information that may be needed to adequately assess data for reliability and use .) CONCLUSION S fO> Remarks field with the ability to identify source of comment, i .e . author and/or submi tte r ~E ~i DATA QUALIT Y +r Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study') E4 Remarks field for Data Reliabili ty !REFERENCES (Free Text ) OTHER Last changed (administrative field for updating) • Order number for sorting ( administrative field ) Remarks field for General Remarks (Use for any other comments Inecessa ry for clarification . )



### 8) TRANSPORT BETWEEN ENVIRONMENTAL COMPARTMENTS(FUGACITY)

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~ITEST SUBSTANC E Identi ty Remarks field for Test Substance (Use for any pe rt inent, test fsubstance-specific remarks . ) METHOD • Test (test type) • Method (Y/N ) °' • Year ( study performed ) lffl> Remarks field for Test Conditions . Detail the model used (title, version and date) and the input parameters (chemical-specific, ~environmental conditions) as necessa ry . f RESULTS Media Estimated Distribution and Media Concentration ( levels If/III ) Remarks field for Results . Describe additional information that may be needed to adequately assess data for reliability and use

~ !including the following if available :

Absorption coefficient - Desorptio n ~` - Volatility 

### CONCLUSIONS

{ VD, Remarks field with the ability to identify source of comment, i .e . author and/or submi tte r ~'DATA QUALIT Y

* Reliabilities (Klimisch Code, if used, possibly a flag if 'key study') " llffl> Remarks field for Data Reliability REFERENCES ( Free Text)

` OTHE R # Last changed ( administrative field for updating) Order number for sorting ( administrative field ) Remarks field for General Remarks ( Use for any other comments necessa ry for clarification .) 

### 9) BIODEGRADATIO N

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TEST SUBSTANC E ! +r Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) METHOD # Method/guideline followed (include calculated as one of the possible methods) * Test Type (test type/aerobic/anaerobic) * GLP (Y/N ) • Year (study performed) • Contact time (units ) +r Innoculu m 40> Remarks field for Test Conditions . Detail and discuss any significant protocol deviations, whether there was bacterial inhibition, and detail differences from the guideline followed including the following as appropriate : - Innoculum (concentration and source) Fresh activated sludg e Sludge from SCAS test (concentration and time of adaptation), o r Other - Concentration of test chemical, vehicle used, pre-acclimation condition s - Temperature of incubation °C - Dosing procedure 

### - Sampling frequency - Appropriate controls and blank system used ? - Analytical method used to measure biodegradation - Method of calculating measured concentrations (i .e ., arithmetic mean, geometric mean, etc
. ) (RESULTS € +~ Degradation % after time Results • Kinetic (for sample, positive and negative controls) - For each time period % Breakdown products (yes/no) If yes describe breakdown products (and whether they were transient or stable in the Remarks field for Results
. E fffl> Remarks field for Results (Describe additional information that may be needed to adequately assess data for reliability and use, e .g . lag (time, observed inhibition, excessive biodegradation, excessive standar d

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gt 4=~ Remarks field with the ability to identify source of comment, i .e . author and/or submitte r DATA QUALIT Y +r Reliabilities (Klimisch Code, if used, possibly a flag if 'key study') Remarks field for Data Reliabilit y REFERENCES (Free Text) OTHE R ~! ~ ► Last changed (administrative field for updating) Order number for sorting (administrative field) Yf CJ> Remarks field for General Remarks (Use for any other comments "necessary for clarification
. )



### ECOTOXICITY ELEMENTS 10) ACUTE TOXICITY TO FISH



## ---------- TEST SUBSTANC E + Identity fllffl> Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) ,(METHOD

* Method/guideline followed (experimental/calculated) +► Type (test type ) * GLP (Y/N )

- +r Year (study performed) * Species/Strain/Supplier * Analytical monitorin g • Exposure period (unit) * Statistical method s i 49> Remarks field for Test Conditions . Detail and discuss any significant protocol deviations, and detail differences from the guideline 11followed including the following as appropriate : ~` - Test fish (Age/length/weight, loading, pretreatment) - Tes t
[4 of 31 8/23/2004 1 7• sa nr Ap . 1 5 EPAlOPPT/High Production Volume (HPV) C
. . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht conditions, e .g . • Details of test (static, semi-static, flow-through ) Dilution water sourc e Dilution water chemistry (hardness, alkalinity, pH, TOC, TSS, salinity) Stock and test solution and how they are prepare d • Concentrations dosing rate, flow-through rate, in what mediu m Vehicle/solvent and concentrations Stability of the test chemical solutions Exposure vessel type (e .g ., size , headspace, sealed, aeration, lighting, # per treatment) Number of replicates, fish per replicate Water chemistry in test (D .O ., pH) in the control and one concentration where effects were observe d Test temperature range - Method of calculating mean measured concentrations (i .e . arithmetic mean, geometric mean, etc . ) RESULTS

* Nominal concentrations (as mg/L) ♦ Measured concentrations (as mg/L) * Unit (results expressed in what unit ) * Element value (e .g . LC50, LCo, LL50, or LLO at 48, 72 and 96 ;hours, etc ., based on measured or nominal concentrations ) ( + ► Statistical results, as appropriate Remarks field for Results . Discuss if element effect concentration 'is greater than materials solubility . Describe additional information that may be needed to adequately assess data for reliability and use, including the following, if available : ~± - Biological observation s

Table showing cumulative mortalit y - Lowest test substance concentration causing 100% mortality - Mortality of controls - Abnormal response s - Reference substances (if used) - result s - Any observations, such as precipitation that might cause a difference between measured and nominal values
. CONCLUSION S 4ffl ► Remarks field with the ability to identify source of comment, i .e . ~,author and/or submitte r !DATA QUALITY Reliabilities (Klimisch Code, if used, possibly a flag if 'key study' )

15 of 31 8/23/2004 12 :53 PMp .16 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtklrobsumgd .ht 49~ Remarks field for Data Reliability REFERENCES (Free Text ) OTHER +e Last changed (administrative field for updating) * Order number for sorting (administrative field ) Remarks field for General Remarks (Use for any other comments necessary for clarification
. ) 

### 11) TOXICITY TO AQUATIC PLANTS (E .G ., ALGAE) m . .~,_μ_... .~_ .. . .~ . . .. . . .~~ ..,,, . ._. .. .... . . . . .... . .~~. .~ . .. . ... ., ., . ._, . .~, _,_.. . . . .... ... . . .r,~ . ._~.. . .. . . TEST SUBSTANC E # Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) .,METHOD • Method/guideline followed (experimental/calculated) • Test type (static/other) • GLP (Y/N ) # Year (study performed ) # Species/strain # and source Element basis (i .e . number of cells/ml, area under the curve, growth irate, etc
. ) Exposure period, date of start and end of the test [Duration] • Analytical monitorin g ~ Statistical method s 49> Remarks field for Test Conditions . Detail and discuss any ~significant protocol deviations and detail differences from the guideline followed including the following as appropriate : Test organisms Laboratory culture iE Method of cultivation

Controls Test Condition s Test temperature rang e Growth/test medium chemistry (hardness, alkalinity, pH, TOC, TSS, dissolved oxygen, salinity, EDTA) Dilution water sourc e Exposure vessel type (e .g ., size, headspace, sealed, aeration, # pe r
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treatment ) 

### Water chemistry in test ( pH) in at least one replicate of each concentration (at sta rt and end of the test ) Stock solutions preparation (vehicle, solvent, concentrations ) Light levels and quality during exposur e - Test design ( number of replicates, concentrations ) - Method of calculating mean measured concentrations (i .e . arithmetic mean, geometric mean, etc . ) RESULTS it * Nominal concentrations in mg/L # Measured concentrations in mg/L * Unit [results expressed in what unit ] # Element value (e .g . ErC50, ErL50, EbC50, EbL50, EC1 0-CD , It EL10-CD, EC50-CD, EL50-CD, EL90-CD, EC90-CD, ECo, or ELo at 24, 48, 72 or 96 hours) Note whether cells removed prior to measurement. ~ NOEC, LOEC, or NOEL, LOE L Was control response satisfacto ry (yes/no/unknown) Statistical results, as appropriat e ~i~ Remarks field for Results . Discuss if element effect concentration !is not less than materials solubili ty . Describe additional information that may be needed to adequately assess data for reliability and use including the following : - Biological obse rvation s Cell density at each flask at each measuring point Growth curve s Percent biomass/growth rate inhibition per concentration Observations CONCLUSION S j4fft~ Remarks fi eld with the ability to identify source of comment, i .e . author and/or submi tte r DATA QUALIT Y

• Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study') # Remarks field for Data Reliabili ty REFERENCES (Free Text) OTHE R • Last changed (administrative field for updating) Order number for so rt ing (administrative field ) Remarks field for General Remarks (Use for any other comments ;necessa ry for clarification . )
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### 12) ACUTE TOXICITY TO AQUATIC INVERTEBRATES (E .G ., DAPHNIA)

._ _ TEST SUBSTANCE Identity 491> Remarks field for Test Substance (Use for any pe rt inent, test substance-specific remarks . METHOD

* Method/guideline followed (experimental/calculated) * Test typ e • GLP (Y/N ) { * Year (study performed) * Analytical procedures +► Species/Strai n • Test details ( static, semi-static, dosing rate, flow-through rate, etc .) * Statistical method s (~► Remarks field for Test Conditions . Detail and discuss any ~significant protocol deviations and detail differences from the guideline !followed including the following as appropriate : 

### Test organism s source, supplier, any pretreatment, breeding method Age at study initiatio n 

### Control group

. Test condition s

• Stock solutions preparation ( vehicle, solvent, concentrations) and stability Test temperature rang e Exposure vessel ty pe (e .g ., size, £j headspace, sealed, aeration, # per

treatment ) Dilution water sourc e Dilution water chemistry ( hardness, alkalinity, pH, TOC, TSS, salinity, Ca/Mg ratio, Na/K ratio ) Lighting (quality, intensi ty and periodici ty ) Water chemistry in test (D .O ., pH) in the control and at least one concentration where effects were observe d Element (unit) basis ( i .e . immobilization ) - Test design ( number of replicates, individuals per replicate, concentrations ) - Method of calculating mean measured concentrations (i .e . arithmetic mean, geometric mean, etc . ) Exposure perio d
18 of 31 8/23/2004 12 :53 PMP
. 1 9 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht - Analytical monitorin g RESULTS

* Nominal concentrations in mg/L +► Measured concentrations in mg/L ; Unit [results expressed in what unit ] • EC50, EL50, LCO, LLO, at 24, 48 hours * Statistical results, as appropriat e Remarks field for Results . Discuss if element effect concentration is not less than materials solubili ty . Describe additional information that may be needed to adequately assess data for reliability and use including the following as appropriate : - Biological obse rv ation s Number immobilized as compared to the number exposed • Concentration response with 95% confidence limits Cumulative immobilizatio n Was control response satisfacto ry ( yes/no/unknown ) ;CONCLUSIONS € ~!'H D ► Remarks field with the abili ty to identify source of comment, i .e . author and/or submi tte r DATA QUALITY "• Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study')

~ ► Remarks field for Data Reliability ~~REFERENCES ( Free Text) OTHE R Last changed (administrative field for updating) • Order number for sorting (administrative field ) ff> Remarks field for General Remarks (Use for any other comments Enecessa ry for clarification .)
HEALTH ELEMENTS 13) ACUTE TOXICITY iTEST SUBSTANCE

19 of 31 8/23/2004 12 :53 PMp . 2 0 EPA/OPPT/High Production Volume (HPV) C
. . .Guidance on Developing Robust Summaries wysiwyg :/l14/http ://www .epa .gov/chemrtk/robsumgd .ht
, • Identity 10> Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks
. ) METHOD ; Method/guideline followed (experimental/calculated) +r Type (test type) * GLP (Y/N ) * Year (study performed) * Species/Strai n * Se x * No . of animals per sex per dose • Vehicl e • Route of administration (if inhalation - aerosol, vapor, gas, particulate ) Remarks field for Test Conditions . Detail and discuss any isignificant protocol deviations and detail differences from the guideline followed including the following as appropriate : 

### - Ag e - Doses (OECD guidelines 401 and 425 do not provide dose levels, so these must be described in detail ) 

### - Doses per time perio d - Volume administered or concentration - Post dose observation period - Exposure duration (for inhalation studies)
. RESULTS

* Value [LD50 or LC50] with confidence limits if calculated • Number of deaths at each dose leve l Remarks field for Results . Describe additional information that ,may be needed to adequately assess data for reliability and use, lincluding the following, if available : - Time of death (provide individual animal time if less than 24 hours after dosing ) - Description, severity, time of onset and duration of clinical signs at each dose leve l - Necropsy findings, included doses affected, severity and number of animals affecte d - Potential target organs (if identified in the report) - If both sexes tested, results should be compared I CONCLUSION S 4E> Remarks field with the ability to identify source of comment, i .e . author and/or submitte r !DATA QUALITY

20 of 31 8/23/2004 12 :53 PMp . 2 1 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht
• Reliabilities ( Klimisch Code, if used, possibly a flag if study' ) Y 9 i Y 40> Remarks field for Data Reliabili ty 11 REFERENCES (Free Text) OTHE R

* Last changed ( administrative field for updating) * Order number for so rt ing (administrative field ) Remarks field for General Remarks ( Use for any other comments I Enecessa ry for clarification . )



### GENETIC TOXICITY ELEMENTS 14) GENETIC TOXICITY IN VIVO (CHROMOSOMAL

ABERRATIONS) iTEST SUBSTANC E +► Identi ty Affl> Remarks field for Test Substance ( Use for any pe rt inent, test fsubstance-specific remarks . ) METHOD # Method/guideline followed s Type (test type ) +► GLP (Y/N )

~ * Year (study performed) Species * Strain • Se x ; # Route of administration (if inhalation - aerosol, vapor, gas, p a rt iculate )

~ 9 Doses/concentration levels • Exposure perio d Statistical method s

` 491 ► Remarks field for Test Conditions . Detail and discuss any 1 £significant protocol deviations and detail differences from the guideline i followed including the following as appropriate : Age at study initiation No . of animals per dose Vehicl e Duration of tes t - Frequency of treatmen t - Sampling times and number of sample s

21 of 31 8/23/2004 12 :53 PMp . 2 2 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht Ff - Control groups and treatmen t - Clinical observations pe rformed (clinical pathology, functional observations, etc. ) - Organs examined at necropsy ( macroscopic and microscopic) - Criteria for evaluating results (for example, cell types examined, number of cells counted in a mouse micronucleus test ) : - Criteria for selection of M .T .D
.

5$$E RESULTS fr~ * Effect on mitotic index or PCE/NCE ratio by dose level by se x • Genotoxic effects (positive, negative, unconfirmed, dose-response, equivocal ) +r NOAEL(NOEL) (C)/LOAEL(LOEL) (C) ' +► Statistical results, as appropriat e Remarks field for Results Describe additional information that may be needed to adequately assess data for reliabili ty and use, including the following, if available : - Mortali ty at each dose level by se x

- Mutant/aberration/mPCE/polyploidy frequency, as appropriat e - Description, severi ty , time of onset and duration of clinical signs at each dose level and se x - Body weight changes by dose and se x ; - Food/water consumption changes by dose and sex !CONCLUSION S AD> Remarks field with the abili ty to identify source of comment, i .e . author and/or submitte r DATA QUALITY !• Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study') 149> Remarks field for Data Reliabili ty iREFERENCES (Free Text) I OTHE R Last changed ( administrative field for updating) • Order number for so rt ing ( administrative fi eld ) Remarks field for General Remarks ( Use for any other comments ;necessa ry for clarification . ) 

### 15) GENETIC TOXICITY IN VITRO (GENE MUTATIONS )
22 of 31 8/23/2004 12 :53 PMp . 2 3 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht

TEST SUBSTANC E ~ Identi ty C~ Remarks field for Test Substance ( Use for any pe rt inent, test substance-specific remarks . ) METHOD

* Method/guideline followe d * Type ( e .g . reverse mutation assay, gene mutation study, cytogenetic assay, mammalian cell gene mutation assay, cytogenetic assay, etc . ) • System of testing [ bacterial, non bacterial] # GLP (YIN ) • Year (study pe rformed ) * Species/Strain or cell type and or cell line, bacterial or non-bacterial # Metabolic activatio n 

### - Species and cell type - Quantity - Induced or not induced

* Concentrations teste d • Statistical Method s 491> Remarks field for Test Conditions
. Detail and discuss any significant protocol deviations . Detail differences from the guideline followed including the following as appropriate : - Test Desig n Number of replicates Frequency of Dosin g 

### Positive and negative control groups and treatmen t Number of metaphases analyzed - Solven t - Description of follow up repeat stud y - Crite ri a for evaluating results (e .g . cell ~ evaluated per dose group )
s E ;RESULTS Result Cytotoxic concentratio n - With metabolic activatio n

- Without metabolic activation [ • Genotoxic effects (e .g . positive, negative, unconfirmed, I dose-response, equivocal ) ~! - With metabolic activatio n

23 of 31 8/23/2004 12 :53 PMp . 2 4 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtklrobsumgd .ht
- Without metabolic activation 

### Statistical results, as appropriat e Remarks field for Results . Note test-specific confounding factors such as pH, osmolari ty , whether substance is volatile, water soluble, precipitated, etc ., pa rt icularly if they effect the selection of test concentrations or interpretation of the results . Describe additional information that may be needed to adequately assess data for reliability l and use include the following if available . Provide at a minimum qualitative descriptions of elements where dose effect related
„ ; obse rv ations were seen . - Frequency of reversions/mutations/aberrations, polyploidy as appropriat e - Precipitation concentration if applicable - Mitotic index i iCONCLUSIONS ~ Remarks field with the abili ty to identify source of comment, i .e . author and/or submi tte r HDATA QUALIT Y • Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study') 114ffl ► Remarks field for Data Reliabili ty REFERENCES ( Free Text) I OTHE R ~ Last changed (administrative field for updating) Order number for so rt ing (administrative field ) 4ff)> Remarks field for General Remarks ( Use for any other comments necessa ry for clarification . )



### 16) REPEATED DOSE TOXICITY jTEST SUBSTANC E r Identity Remarks field for Test Substance (Use for any pe rt inent, test I substance-specific remarks . ) !METHOD • Method/guideline followed 1 • Test typ e

24 of 31 8/23/2004 12 :53 PMp . 2 5 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht ~ GLP (Y/N ) ~ Year (study pe rformed) ~ Specie s 

### • Strai n # Route of administration, oral (gavage, drinking water, feed), dermal, inhalation (aerosol, vapor, gas, pa rt iculate), othe r * Duration of tes t * Doses/concentration levels * Sex ~I * Exposure perio d * Frequency of treatmen t • Control group and treatmen t * Post exposure obse rvation period * Statistical method s Remarks field for Test Conditions . Detail and discuss any significant protocol deviations and detail differences from the guideline followed including the following as appropriate : - Test Subject s Age at study initiatio n No . of animals per sex per dose - Study Desig n Vehicle Satellite groups and reasons they were added Clinical observations performed and frequency (clinical pathology, functional obse rv ations, etc . ) Organs examined at necropsy (macroscopic and microscopic) (RESULTS NOAEL (NOEL ) LOAEL (LOEL ) Actual dose received by dose level by sex, if known, Toxic response/effects by dose leve l 

### Statistical results, as appropriat e Remarks field for Results . Describe additional information that ti may be needed to adequately assess data for reliability and use include the following if available . Provide at a minimum qualitative descriptions of elements where dose effect related obse rv ations were seen . - Body weigh t - Food/water consumptio n - Description, severity, time of onset and duration of clinical sign s - Ophthalmologic findings incidence and severi ty - Hematological findings incidence and severit y - Clinical biochemist ry findings incidence and severi ty - Mo rtality and time to deat h

25 of 31 8/23/2004 12 :53 PMp . 2 6 EPAIOPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg :lll4/http ://www .epa .gov/chemrtk/robsumgd .ht - Gross pathology incidence and severity 

### Organ weight changes iE - Histopathology incidence and severity 11 CONCLUSION S y~f
ti $ ; Remarks field with the ability to identify source of comment, i .e . d author and/or submi tt er °`DATA QUALITY Reliabilities (Klimisch Code, if used, possibly a flag if'keY study') Remarks field for Data Reliabilit y REFERENCES (Free Text) OTHE R g 5y E xt 

### + ► Last changed (administrative field for updating ) +r Order number for so rt ing (administrative field ) Remarks field for General Remarks [Note - Use for any other icomments necessa ry for clarification . ]



### 17) TOXICITY TO REPRODUCTION ,TEST SUBSTANCE ~i • Identi ty € 1119> Remarks field for Test Substance ( Use for any pe rt inent, test !substance-specific remarks . ) METHOD ~4 ~ ► Method/guideline followe d • Type ( one generation, two generation, etc .) ' +s GLP (Y/N ) Year ( study performed) Species ~E s Strai n Route of administration - oral (gavage, drinking water, feed), !dermal, inhalation ( aerosol, vapor, gas, pa rt iculate), othe r ~ Doses/concentration levels ~! a Se x • Control group and treatment Frequency of treatment Duration of tes t

~ ► Premating exposure pe ri od for males ( P and F1) as appropriate ~• Premating exposure period for females ( P and Fl) as appropriat e

:6 of 31 8/23/2004 12 :53 PMp . 2 7 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht
Statistical methods ii 49 ' Remarks field for Test Conditions . Detail and discuss any significant protocol deviations and detail differences from the guideline

~ followed including the following as appropriate : - Test animal s Number, age, sex per dose for P, F1 and F2, if appropriat e - Test design Vehicle Dosing schedules and pre and post dosin g observations periods for P, F1 and F2, if appropriat e - Mating procedures ( M/F ratios per cage, length of cohabitation, proof of pregnancy ) - Standardization of li tters (yes/no and if yes, how and when ) - Parameters assessed during study P and F1 as appropriat e Clinical observations performed and frequency (clinical pathology, functional obse rvations, etc . ) • Estrous cycle length and pa ttern ( number of days spent in each phase ) Sperm examination (epididymal or vas sperm, concentration, motility, morphology) - Parameters assessed during study F1 and F2, as appropriat e Clinical obse rv ations pe rformed and frequency (weight gain, growth rate, etc .) Others, for example anogenital distance, if performe d • Organs examined at necropsy (macroscopic and microscopic) RESULT S NOAEL (NOEL) and LOAEL (LOEL) for P, F1 and F2, as iappropriat e

~ * Actual dose received by dose level by sex if known 9 Parental data and F1 as appropriate ( toxic response/effects with NOAEL value) . Provide at a minimum qualitative descriptions of 'elements were dose related observations were see n ~ Offspring toxici ty F1 and F2, as appropriate ( toxic response/effects !,elements NOAEL value) . Provide at a minimum qualitative descriptions of ~€elements where dose related obse rvations were seen . Statistical results, as appropriat e

' ffl> Remarks field for Results . Describe additional information that may be needed to adequately assess data for reliabili ty and use include the following when there are dose related effects if available :

27 of 31 8/23/2004 12 :53 PMp . 2 8 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht
~€ - Parental data and F1 as appropriate, provide at a minimum qualitative descriptions of elements were dose related obse rvations were see n - Body weigh t

- Food/water consumptio n - Description, severity, time of onset and duration of clinical sign s - Fe rt ility index ( pregnancies/matings )

- Precoital inte rval (w/number of days until mating and number of estrous periods until mating ) - Duration of gestation (calculated from day 0 of pregnancy)

- Gestation index (live li tters/pregnancies) - Changes in lactatio n - Changes in estrus cycles - Effects on sper m - Hematological findings incidence and severit y - Clinical biochemist ry findings incidence and severity - Mo rtali ty - Gross pathology incidence and severity - Number of implantation s - Number of corpora lutea (recommended) - Ovarian primordial follicle count s - Organ weight changes Histopathology incidence and severit y - Offspring toxicity F1 and F2, as appropriate, provide as a minimum qualitative descriptions of elements where dose related obse rv ations were see n - Litter size and weights - Sex and sex ratio s - Viability index (pups surviving 4 days/total bi rt hs) - post natal su rvival until weanin g - Effects on offspring (grossly visible abnormalities) - Postnatal growth, growth rat e - Vaginal opening (F) or preputial separation (M ) - Other obse rvations, for instance anogenital distance, if measured Organ weight s Gross pathology 'CONCLUSION S 40> Remarks field with the abili ty to identify source of comment, i .e . author and/or submi tte r DATA QUALITY Reliabilities ( Klimisch Code, if used, possibly a flag if 'key study') Remarks field for Data Reliabili ty ;REFERENCES ( Free Text) OTHE R Last changed (administrative field for updating) 1 E~ Order number for so rt ing ( administrative field )

28 of 31 8/23/2004 12 :53 PMp . 2 9 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chenutk/robsumgd .ht
1C]> Remarks field for General Remarks ( Use for any other comment s 

### 1,necessary for clarification . ) 18) DEVELOPMENTAL TOXICITY/TERATOGENICITY

____. ._______..... .... .. .... .._._ .~ .. . .. .. ._ .._ ._.. . . . ._.. .. ._ _. . . . . . .. .~ . . . ._. .. .. .__. ._... . .. ._. . . _ .. ... . . .. ._ . .. . . . . ._ . .. ._~ ... . .. . TEST SUBSTANC E

~ ► Identity

~ 49> Remarks field for Test Substance (Use for any pe rt inent, test substance-specific remarks . ) !METHOD Method/guideline followed GLP (Y/N ) 1 ~ Year (study performed) Species

~ ► Strai n Route of administration - oral (gavage, drinking water, feed), dermal, inhalation ( aerosol, vapor, gas, pa rt iculate), othe r ( * Doses/concentration levels # Sex * Exposure perio d * Frequency of treatmen t ; # Control group and treatment # Duration of tes t Statistical method s Remarks field for Test Conditions . Detail and discuss any significant protocol deviations and detail differences from the guideline followed including the following as appropriate : - Age at study initiatio n - Number of animals per dose per sex - Vehicl e - Clinical obse rvations performed and frequenc y

- Mating procedures ( M/F ratios per cage, length of cohabitation, proof of pregnancy ) - Parameters assessed during study ( maternal and fetal) - Organs examined at necropsy ( macroscopic and microscopic) [ (RESULTS +► NOAEL ( NOEL) and LOAEL ( LOEL) maternal toxicit y * NOAEL (NOEL) and LOAEL (LOEL) developmental toxicity 1 • Actual dose received by dose level by sex if availabl e # Maternal data with dose level (with NOAEL value) . Provide at a minimum qualitative descriptions of responses where dose related effects were seen .
29 of 31 8/23/2004 12 :53 PMp . 3 0 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht s Fetal data with dose level (with NOAEL value) . Provide at a minimum qualitative descriptions of responses where dose related effects were seen
. ~ Statistical results, as appropriat e 11491> Remarks for Results . Describe additional information that may be needed to adequately assess data for reliability and use include the -following when there are dose related effects if available : Maternal data, provide at a minimum qualitative descriptions of responses where dose 11related effects were seen
. - Mortality and day of death - Number pregnant per dose level - Number abortin g - Number of resorptions, early/late if available - Number of implantation s - Pre and post implantation loss, if available - Number of corpora lutea (recommended) - Duration of Pregnancy 

### - Body weigh t - Food/water consumptio n - Description, severity, time of onset and duration of clinical sign s - Hematological findings incidence and severit y - Clinical biochemistry findings incidence and severity - Gross pathology incidence and severit y 

### - Organ weight changes, particularly effects on total uterine weigh t ~ - Histopathology incidence and severit y - Fetal data, provide at a minimum qualitative descriptions of responses where dose related effects were see n Litter size and weight s Number viable (number alive and number dead ) 

### Sex rati o Postnatal growth (depending on protocol) Postnatal survival (depending on protocol) Grossly visible abnormalities, external, soft tissue and skeletal abnormalitie s CONCLUSIONS illffl> Remarks field with the ability to identify source of comment, i .e . author and/or submitte r ,I DATA QUALITY +r Reliabilities (Klimisch Code, if used, possibly a flag if 'key study') 49V Remarks field for Data Reliabilit y

~ REFERENCES (Free Text) ~OTHE R # Last changed (administrative field for updating) • Order number for sorting (administrative field )

30 of 31 8/23/2004 12 :53 PMp . 3 1 EPA/OPPT/High Production Volume (HPV) C . . .Guidance on Developing Robust Summaries wysiwyg ://14/http ://www .epa .gov/chemrtk/robsumgd .ht

Remarks field for General Remarks ( Use for any other comment s 

### necessary for clarification . )

HPV Challenge Program I VCCEP I PBT EPA Home I Privacy and Security Notice { Contact U Last updated on F ri day, April 23rd, 200 4 URL : http :/Mrww .epa .gov/chemrtk/robsumgd .ht m

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