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~- i

_._... ...... ..,........,.

~.~~z' ~~. U.S. Environmental

Q ` High Production Volume P

, ' • ' Program

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Production Volume (HPVI Challe nge Program y Draft Guidance on Developing Robust Summarie s

•• Participate Draft Guidance on Developing Robust

; ~", ,'" .' Summaries

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 Summaries 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 Bi, oaccumulativ . e

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 reports 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 attempt to create an electronic version of full study repo rts

(especially old reports 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 rticular 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 fficient

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

report, and to also allow evaluation of the proposed test plan. A robust study

summary therefore reflects the objectives, methods, results, and conclusions of the

full study report, 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 supportive 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 Guidance

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The templates for robust study summaries presented in the following pages were

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 Templates

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 point

3) Vapor pressure

4) Partition coefficient

5) Water solubility

Environmental Fate and Pathways Elements

6) Photodegradation

7) Stability in water

8) Transport between Environmental Compartments (Fugacity)

9) Biodegradatio n

Ecotoxicity Elements

10) Acute toxicity to fish

11) Toxicity to aquatic plants

12) Acute toxicity to aquatic invertebrates

Health Elements

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 Templates

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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 reported 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 types of fields : controlled vocabula ry and free text. The controlled

vocabulary 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 rther explain the

contents of a particular section, much as is done in the "Discussion" po rtion of a

publication in academic journals. For example, under the "Results" section,

unexpected results could be further 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 identity 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 rted. If there have been

deviations from the Test Guideline, then those deviations that will significantly

impact either the study reliability 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 .

Conclusions

This section has a "Remarks" field only, so that the conclusions of the study can be

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noted if given, together with any comments by the person preparing the robust

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-temperatur )

Sublimation (yes/no/ambiguous e * )

~I 40> Remarks field for Results (Describe additional information that

may be needed to confirm data reliability and relevance)

CONCLUSIONS

~

Remarks field with the ability to identify source of comment, i .e .

; author and/or submi tter

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 sorting (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 rtinent, 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 unit

Decomposition (yes/no/ambiguous)

® Remarks field for Results (Describe additional information that

may be needed to adequately assess data for reliability and use.)

!CONCLUSIONS

Remarks field with the ability to identify source of comment, i .e.

~ author and/or submitter

1DATA QUALITY

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

1!4ffl> Remarks field for Data Reliability

€?RFFFRFIU( FC [Fru o Tov41

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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 SUBSTANCE

+r Identity

49~ Remarks field for Test Substance (Use for any pe rtinent, 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

, significant 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 submitter

i

DATA QUALIT Y

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

~ 49> Remarks field for Data Reliability

;REFERENCES (Free Text)

OTHER

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+r Last changed (administrative field for updating)

* Order number for sorting (administrative field )

4E1> Remarks field for General Remarks (Use for any comments

necessary for clarification. )

4) PARTITION COEFFICIENT

TEST SUBSTANCE

• 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

1 water, etc .)

:

CONCLUSIONS

Remarks field with the ability to identify source of comment, i .e.

~!author and/or submitter

1 DATA QUALITY

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

40> Remarks field for Data Reliability

,,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 SUBSTANCE

+r Identity

49> Remarks field for Test Substance (Use for any pe rtinent, 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 solubility (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 reliability and use.)

~[CONCLUSIONS

Affl> Remarks field with the ability to identify source of comment, i.e.

l author and/or submitter

IDATA QUALIT Y

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

14ffP Remarks field for Data Reliability

~ I REFERENCES (Free Text)

OTHER

* Last changed (administrative field for updating)

; Order number for sorting (administrative field )

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1 E 4-mP Remarks field for General Remarks (Use for any comments

~ inecessary for clarification .)

ENVIRONMENTAL FATE AND PATHWAY ELEMENTS

6) PHOTODEGRADATION

TEST SUBSTANCE

a~ Identity

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 Source

• 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)

- Duration

- Positive Controls

- Negative Controls

RESULTS

( ; • Concentration of Substance

Temperature °C

( : # Direct photolysis

z E

;j - Half-life t'/Z (preferred)

s : - Degradation % after

- Quantum yield

Indirect photolysis

- Sensitizer (type)

- Concentration of sensitizer

- Rate Constant

- Degradation % afte r

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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 ! CONCLUSIONS

!4=~ P' Remarks field with the ability to identify source of comment, i .e.

!author and/or submitter

DATA QUALITY

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

necessary for clarification.)

7) STABILITY IN WATER

TEST SUBSTANCE

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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!RESULTS

~E # Nominal

Measured value (the value with units preferably as mg/L)

• Degradation % at a specified pH and temperature °C % after a

~ specified time or

~ * 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 .)

CONCLUSIONS

fO> Remarks field with the ability to identify source of comment, i .e.

author and/or submitter ~E

~iDATA QUALITY

+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

Inecessary for clarification.)

8) TRANSPORT BETWEEN ENVIRONMENTAL

COMPARTMENTS(FUGACITY)

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~ITEST SUBSTANCE

Identi ty

Remarks field for Test Substance (Use for any pe rtinent, 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 necessary.

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 submitter

~'DATA QUALIT Y

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

" llffl> Remarks field for Data Reliability

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

necessary for clarification.)

9) BIODEGRADATION

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TEST SUBSTANCE

! +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 Innoculum

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), or

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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fldeviation, kinetics, time required for 10% degradation and total

degradation at the end of the test .)

CONCLUSIONS

gt

4=~ Remarks field with the ability to identify source of comment, i .e.

author and/or submitter

DATA QUALITY

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

Remarks field for Data Reliability

REFERENCES (Free Text)

OTHER

~! ~ ► 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 SUBSTANCE

+ 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 methods

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

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conditions, e.g.

• Details of test (static, semi-static,

flow-through )

Dilution water source

Dilution water chemistry (hardness,

alkalinity, pH, TOC, TSS, salinity)

Stock and test solution and how they are

prepared

• 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 observed

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 observations

Table showing cumulative mortalit y

- Lowest test substance concentration causing 100%

mortality

- Mortality of controls

- Abnormal response s

- Reference substances (if used) - results

- 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')

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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 SUBSTANCE

# 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 monitoring

~ Statistical methods

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 Conditions

Test temperature rang e

Growth/test medium chemistry (hardness,

alkalinity, pH, TOC, TSS, dissolved oxygen,

salinity, EDTA)

Dilution water source

Exposure vessel type (e.g ., size,

headspace, sealed, aeration, # per

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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 exposure

- 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, LOEL

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 solubility. Describe additional information that

may be needed to adequately assess data for reliability and use

including the following:

- Biological obse rvations

Cell density at each flask at each measuring point

Growth curves

Percent biomass/growth rate inhibition per

concentration Observations

CONCLUSIONS

j4fft~ Remarks field with the ability to identify source of comment, i .e.

author and/or submitter

DATA QUALITY

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

# 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

;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 rtinent, test

substance-specific remarks.

METHOD

* Method/guideline followed (experimental/calculated)

* Test type

• GLP (Y/N)

{ * Year (study performed)

* Analytical procedures

+► Species/Strain

• Test details (static, semi-static, dosing rate, flow-through rate, etc .)

* Statistical methods

(~► 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

source, supplier, any pretreatment, breeding method

Age at study initiation

Control group

.

Test conditions

• Stock solutions preparation ( vehicle,

solvent, concentrations) and stability

Test temperature range

Exposure vessel type (e.g., size,

£j headspace, sealed, aeration, # per

treatment)

Dilution water source

Dilution water chemistry (hardness,

alkalinity, pH, TOC, TSS, salinity, Ca/Mg

ratio, Na/K ratio)

Lighting (quality, intensity and periodicity)

Water chemistry in test (D.O., pH) in the

control and at least one concentration where

effects were observed

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

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- Analytical monitoring

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 appropriate

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 rvations

Number immobilized as compared to the

number exposed

• Concentration response with 95%

confidence limits

Cumulative immobilization

Was control response satisfacto ry

(yes/no/unknown )

;CONCLUSIONS

€

~!'HD► Remarks field with the ability to identify source of comment, i .e.

author and/or submi tter

DATA QUALITY

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

~► Remarks field for Data Reliability

~~REFERENCES (Free Text)

OTHER

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

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, • 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

* Sex

* No. of animals per sex per dose

• Vehicle

• 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 :

- Age

- 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 level

- Necropsy findings, included doses affected, severity and

number of animals affected

- Potential target organs (if identified in the report)

- If both sexes tested, results should be compared

I CONCLUSIONS

4E> Remarks field with the ability to identify source of comment, i .e.

author and/or submitte r

!DATA QUALITY

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• Reliabilities ( Klimisch Code, if used, possibly a flag if study' Y 9 i )

Remarks field for Data Reliability Y 40>

11 REFERENCES (Free Text)

OTHER

* Last changed (administrative field for updating)

* Order number for so rting (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 SUBSTANCE

+► Identity

Affl> Remarks field for Test Substance (Use for any pertinent, test

fsubstance-specific remarks.)

METHOD

# Method/guideline followed

s Type (test type)

+► GLP (Y/N)

~ * Year (study performed)

Species

* Strain

• Sex

; # Route of administration (if inhalation - aerosol, vapor, gas,

particulate)

~ 9 Doses/concentration levels

• Exposure period

Statistical methods

` 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

Vehicle

Duration of test

- Frequency of treatmen t

- Sampling times and number of sample s

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Ff - Control groups and treatment

- Clinical observations performed (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:

- Mortality at each dose level by sex

- Mutant/aberration/mPCE/polyploidy frequency, as

appropriate

- Description, severity , 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

!CONCLUSIONS

AD> Remarks field with the abili ty to identify source of comment, i .e.

author and/or submitter

DATA QUALITY

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

149> Remarks field for Data Reliabili ty

iREFERENCES (Free Text)

I OTHER

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.)

15) GENETIC TOXICITY IN VITRO (GENE MUTATIONS )

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TEST SUBSTANCE

~ Identity

C~ Remarks field for Test Substance (Use for any pertinent, 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 tested

• Statistical Methods

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 Design

Number of replicates

Frequency of Dosing

Positive and negative control groups and

treatment

Number of metaphases analyzed

- Solvent

- Description of follow up repeat stud y

- Criteria for evaluating results (e .g. cell

~ evaluated per dose group )

s E

;RESULTS

Result

Cytotoxic concentratio n

- With metabolic activation

- Without metabolic activation

[

• Genotoxic effects (e .g. positive, negative, unconfirmed,

I dose-response, equivocal)

~! -With metabolic activatio n

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- Without metabolic activation

Statistical results, as appropriat e

Remarks field for Results . Note test-specific confounding factors

such as pH, osmolarity, whether substance is volatile, water soluble,

precipitated, etc ., particularly 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

„ ; observations were seen .

- Frequency of reversions/mutations/aberrations, polyploidy

as appropriate

- Precipitation concentration if applicable

- Mitotic index

iiCONCLUSIONS

~ Remarks field with the abili ty to identify source of comment, i .e.

author and/or submitter

HDATA QUALITY

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

114ffl ► Remarks field for Data Reliabili ty

REFERENCES (Free Text)

I OTHER

~ Last changed (administrative field for updating)

Order number for so rting (administrative field )

4ff)> Remarks field for General Remarks (Use for any other comments

necessary for clarification .)

16) REPEATED DOSE TOXICITY

jTEST SUBSTANCE

r Identity

Remarks field for Test Substance (Use for any pe rtinent, test

I substance-specific remarks .)

!METHOD

• Method/guideline followed

1 • Test type

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~ GLP (Y/N)

~ Year (study performed)

~ Species

• Strain

# Route of administration, oral (gavage, drinking water, feed), dermal,

inhalation (aerosol, vapor, gas, pa rticulate), othe r

* Duration of tes t

* Doses/concentration levels

* Sex

~I * Exposure period

* Frequency of treatmen t

• Control group and treatmen t

* Post exposure observation period

* Statistical methods

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 Subjects

Age at study initiation

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

observations, 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 appropriate

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 rvations were seen .

- Body weight

- Food/water consumption

- Description, severity, time of onset and duration of clinical

signs

- Ophthalmologic findings incidence and severi ty

- Hematological findings incidence and severity

- Clinical biochemistry findings incidence and severi ty

- Mortality and time to death

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- 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 submitt er

°`DATA QUALITY

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

Remarks field for Data Reliability

REFERENCES (Free Text)

OTHER

g5y E

xt

+ ► Last changed (administrative field for updating )

+r Order number for sorting (administrative field)

Remarks field for General Remarks [Note - Use for any other

icomments necessa ry for clarification. ]

17) TOXICITY TO REPRODUCTION

,TEST SUBSTANCE

~i

• Identity

€ 1119> Remarks field for Test Substance (Use for any pertinent, test

!substance-specific remarks .)

METHOD

~4 ~ ► Method/guideline followed

• Type (one generation, two generation, etc .)

' +s GLP (Y/N)

Year (study performed)

Species

~E s Strain

Route of administration - oral (gavage, drinking water, feed),

!dermal, inhalation (aerosol, vapor, gas, particulate), other

~ Doses/concentration levels

~! a Sex

• Control group and treatment

Frequency of treatment

Duration of test

~ ► Premating exposure period for males (P and F1) as appropriate

~• Premating exposure period for females (P and Fl) as appropriate

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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 animals

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

appropriate

- Mating procedures (M/F ratios per cage, length of

cohabitation, proof of pregnancy )

- Standardization of litters (yes/no and if yes, how and

when )

- Parameters assessed during study P and F1 as

appropriate

Clinical observations performed and

frequency (clinical pathology, functional

observations, 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

appropriate

Clinical observations pe rformed and

frequency (weight gain, growth rate, etc .)

Others, for example anogenital distance, if

performed

• Organs examined at necropsy

(macroscopic and microscopic)

RESULTS

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:

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~€ - Parental data and F1 as appropriate, provide at a

minimum qualitative descriptions of elements were dose

related obse rvations were seen

- Body weight

- Food/water consumptio n

- Description, severity, time of onset and duration of clinical

signs

- Fertility 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 litters/pregnancies)

- Changes in lactatio n

- Changes in estrus cycles

- Effects on sperm

- Hematological findings incidence and severity

- Clinical biochemistry findings incidence and severity

- Mortality

- Gross pathology incidence and severity

- Number of implantations

- Number of corpora lutea (recommended)

- Ovarian primordial follicle counts

- 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 rvations were seen

- Litter size and weights

- Sex and sex ratios

- Viability index (pups surviving 4 days/total births)

- post natal su rvival until weaning

- Effects on offspring (grossly visible abnormalities)

- Postnatal growth, growth rate

- Vaginal opening (F) or preputial separation (M )

- Other observations, for instance anogenital distance, if

measured

Organ weight s

Gross pathology

'CONCLUSION S

40> Remarks field with the ability to identify source of comment, i .e. author and/or submitter

DATA QUALITY

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

Remarks field for Data Reliability

;REFERENCES (Free Text)

OTHER

Last changed (administrative field for updating)

1 E~ Order number for so rting (administrative field )

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1C]> Remarks field for General Remarks (Use for any other comments

1,necessary for clarification .)

18) DEVELOPMENTAL TOXICITY/TERATOGENICITY

____.._______..... .... .. .... .._._ .~.. . .. ..._ .._ ._.. . . . ._.. .. ._ _. . . . . . ...~. . . ._. .. .. .__. ._... . ..._. .. _ .. ... . . .. ._ . .. . . . . ._ . .. ._~ ...... . TEST SUBSTANCE

~ ► Identity

~ 49> Remarks field for Test Substance (Use for any pe rtinent, test

substance-specific remarks . )

!METHOD

Method/guideline followed

GLP (Y/N)

1 ~ Year (study performed)

Species

~ ► Strain

Route of administration - oral (gavage, drinking water, feed),

dermal, inhalation (aerosol, vapor, gas, particulate), other

( * Doses/concentration levels

# Sex

* Exposure perio d

* Frequency of treatmen t

; # Control group and treatment

# Duration of test

Statistical methods

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 initiation

- Number of animals per dose per sex

- Vehicl e

- Clinical obse rvations performed and frequency

- 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 toxicity

* 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.

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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 appropriate

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 aborting

- 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 weight

- Food/water consumptio n

- Description, severity, time of onset and duration of clinical

signs

- 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

weight

~ - Histopathology incidence and severity

- Fetal data, provide at a minimum qualitative descriptions

of responses where dose related effects were see n

Litter size and weights

Number viable (number alive and number

dead)

Sex ratio

Postnatal growth (depending on protocol)

Postnatal survival (depending on protocol)

Grossly visible abnormalities, external, soft

tissue and skeletal abnormalities

CONCLUSIONS

illffl> Remarks field with the ability to identify source of comment, i .e.

author and/or submitter

,IDATA QUALITY

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

49V Remarks field for Data Reliability

~ REFERENCES (Free Text)

~OTHER

# Last changed (administrative field for updating)

• Order number for sorting (administrative field )

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Remarks field for General Remarks (Use for any other comments

necessary for clarification .)

HPV Challenge Program I VCCEP I PBT

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Last updated on F riday, April 23rd, 2004

URL : http:/Mrww .epa .gov/chemrtk/robsumgd.htm

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