Draft Guidance on Developing Robust Summaries
(October 22, 1999)
The guidance in the following tables are presented exactly as they appear
in the official OECD document entitled "Guidance for Developing Robust
Summaries for SIDS Dossiers" (Document number ENV/JM/EXCH(99)13, dated
10/8/99). EPA provides the following narrative as an introduction to the
OECD tables.
Definition/Background
The purpose of the U.S. HPV Chemical Challenge Program is to make hazard
data (either existing or newly acquired information) available to the
public for all U.S. 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 reports (especially old reports that may date to
the 1960s or earlier). Instead, electronic summaries of full study reports
will be prepared that contain the appropriate technical information for
that particular endpoint.
The purpose of this document is to present guidance on what technical
information, on an endpoint-by-endpoint basis, is necessary to adequately
describe an experiment or study. The term "robust summary" is used to
describe this technical content. Robust study summaries are intended to
provide sufficient 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 summary 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
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 pointEnvironmental Fate and Pathways Elements
2) Boiling point
3) Vapor pressure
4) Partition coefficient
5) Water solubility
6) PhotodegradationEcotoxicity Elements
7) Stability in water
8) Transport between Environmental Compartments (Fugacity)
9) Biodegradation
10) Acute toxicity to fishHealth Elements
11) Toxicity to aquatic plants
12) Acute toxicity to aquatic invertebrates
13) Acute toxicityNo templates are currently available for non-SIDS endpoints. Information on these is nevertheless encouraged to be included where available and relevant to the assessment.
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
Explanation of the Templates
Each template identifies the information items that should be included in a robust study summary 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 vocabulary 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" allows the input of optional information.
Often, the "Remarks" section can be used as a means to further explain the contents of a particular section, much as is done in the "Discussion" portion 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 substance
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 reported. 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 reliability 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 noted if given, together with any comments by the person preparing the robust study summary.
Data Quality
This section can be used to denote the adequacy of data, at the discretion of the person preparing the robust study summary
References
This free text field allows the person preparing the robust study summary to provide the full citation for the critical study on which the robust study summary is based.
Other
This section includes a data field for revisions, a number useful for sorting, and a free text field for general remarks.
1) MELTING POINT
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) GLP (Y/N) Year (study performed) 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 (yes-temperature °C/ no /ambiguous) Sublimation (yes/no/ambiguous) 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 submitter DATA QUALITY Reliabilities (Klimisch Code, if used, possibly a flag for key study) Remarks field for Data Reliability key 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.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method (include calculated as one of the possible methods) GLP (Y/N) Year (study performed) Remarks field for Test Conditions (Detail and discuss any signification protocol deviations.) RESULTS Boiling point value in °C (include >300°C as acceptable answer) Pressure 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 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) Remarks field for General Remarks (Use for any comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method (include calculated as one of the possible methods) GLP (Y/N) Year (study performed) Remarks field for Test Conditions (Detail and discuss any significant protocol deviations.) RESULTS Vapor Pressure value (include < 1 x 10-5 Pa as an acceptable answer) Temperature °C 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 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) Remarks field for General Remarks (Use for any comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks). METHOD Method (include calculated as one of the possible methods) GLP (Y/N) Year (study performed) Remarks field for Test Conditions (Detail and discuss any signification protocol deviations.) RESULTS Log Pow Temperature °C 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.) CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method (include calculated as one of the possible methods) GLP (Y/N) Year (study performed) Remarks field for Test Conditions (Detail and discuss any signification protocol deviations.) RESULTS 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 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 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) Remarks field for General Remarks (Use for any comments necessary for clarification.) |
6) PHOTODEGRADATION
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) Year (study performed) Light Source Light Spectrum (nm) Relative Intensity based on Intensity of Sunlight 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) RESULTS Concentration of Substance Temperature °C Direct photolysis - Half-life t ½ (preferred)Indirect photolysis - Sensitizer (type) Breakdown products (yes/no) If yes describe breakdown products and 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 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) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
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) Year (study performed) 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)RESULTS 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) Breakdown products (yes/no) If yes describe breakdown products and 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 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Test (test type) Method (Y/N) Year (study performed) Remarks field for Test Conditions. Detail the model used (title, version and date) and the input parameters (chemical-specific, environmental conditions) as necessary. RESULTS Media Estimated Distribution and Media Concentration (levels II/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 coefficientCONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
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) Test Type (test type/aerobic/anaerobic) GLP (Y/N) Year (study performed) Contact time (units) Innoculum 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 sludge - Concentration of test chemical, vehicle used, pre-acclimation conditionsRESULTS 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. 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 standard deviation, kinetics, time required for 10% degradation and total degradation at the end of the test.) CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
10) ACUTE TOXICITY TO FISH
TEST SUBSTANCE Identity 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) Year (study performed) Species/Strain/Supplier Analytical monitoring Exposure period (unit) 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 fish (Age/length/weight, loading, pretreatment) - Test conditions, e.g. · Details of test (static, semi-static, flow-through) - 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 LL0 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 CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
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 rate, etc.) Exposure period, date of start and end of the test [Duration] Analytical monitoring 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 RESULTS Nominal concentrations in mg/L Measured concentrations in mg/L Unit [results expressed in what unit] Element value (e.g. ErC50, ErL50, EbC50, EbL50, EC10-CD, EL10-CD, EC50-CD, EL50-CD, EL90-CD, EC90-CD, EC0, or EL0 at 24, 48, 72 or 96 hours) Note whether cells removed prior to measurement. NOEC, LOEC, or NOEL, LOEL Was control response satisfactory (yes/no/unknown) Statistical results, as appropriate 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 observationsCONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, 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 RESULTS Nominal concentrations in mg/L Measured concentrations in mg/L Unit [results expressed in what unit] EC50, EL50, LC0, LL0, at 24, 48 hours Statistical results, as appropriate 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 as appropriate: - Biological observationsCONCLUSIONS· Number immobilized as compared to the number exposed 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
13) ACUTE TOXICITY
TEST SUBSTANCE Identity 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) Year (study performed) Species/Strain 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 significant protocol deviations and detail differences from the guideline followed including the following as appropriate: - Age RESULTS Value [LD50 or LC50] with confidence limits if calculated Number of deaths at each dose level Remarks field for Results. Describe additional information that may be needed to adequately assess data for reliability and use, including the following, if available: - Time of death (provide individual animal time if less than 24 hours after dosing)CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
14) GENETIC TOXICITY IN VIVO (CHROMOSOMAL ABERRATIONS)
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method/guideline followed Type (test type) GLP (Y/N) Year (study performed) Species Strain Sex Route of administration (if inhalation - aerosol, vapor, gas, particulate) Doses/concentration levels Exposure 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: - Age at study initiation RESULTS Effect on mitotic index or PCE/NCE ratio by dose level by sex Genotoxic effects (positive, negative, unconfirmed, dose-response, equivocal) NOAEL(NOEL) (C)/LOAEL(LOEL) (C) Statistical results, as appropriate Remarks field for Results Describe additional information that may be needed to adequately assess data for reliability and use, including the following, if available: - Mortality at each dose level by sex CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method/guideline followed 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 (Y/N) Year (study performed) Species/Strain or cell type and or cell line, bacterial or non-bacterial Metabolic activation - Species and cell typeConcentrations tested Statistical Methods Remarks field for Test Conditions. Detail and discuss any significant protocol deviations. Detail differences from the guideline followed including the following as appropriate: - Test DesignRESULTS Result Cytotoxic concentration - With metabolic activation Genotoxic effects (e.g. positive, negative, unconfirmed, dose-response, equivocal) - With metabolic activationStatistical results, as appropriate 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 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 CONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method/guideline followed Test type GLP (Y/N) Year (study performed) Species Strain Route of administration, oral (gavage, drinking water, feed), dermal, inhalation (aerosol, vapor, gas, particulate), other Duration of test Doses/concentration levels Sex Exposure period Frequency of treatment Control group and treatment 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 SubjectsRESULTS NOAEL (NOEL) LOAEL (LOEL) Actual dose received by dose level by sex, if known, Toxic response/effects by dose level Statistical results, as appropriate Remarks field for Results. Describe additional information that 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 observations were seen. - Body weightCONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks [Note - Use for any other comments necessary for clarification.] |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method/guideline followed Type (one generation, two generation, etc.) GLP (Y/N) Year (study performed) Species Strain Route of administration - oral (gavage, drinking water, feed), dermal, inhalation (aerosol, vapor, gas, particulate), other Doses/concentration levels 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 F1) as appropriate 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 animalsRESULTS· Number, age, sex per dose for P, F1 and F2, if appropriate- Test design· Vehicle- Mating procedures (M/F ratios per cage, length of cohabitation, proof of pregnancy) NOAEL (NOEL) and LOAEL (LOEL) for P, F1 and F2, as appropriate Actual dose received by dose level by sex if known 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 seen Offspring toxicity F1 and F2, as appropriate (toxic response/effects with NOAEL value). Provide at a minimum qualitative descriptions of elements where dose related observations were seen. Statistical results, as appropriate Remarks field 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: - Parental data and F1 as appropriate, provide at a minimum qualitative descriptions of elements were dose related observations were seenCONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |
TEST SUBSTANCE Identity Remarks field for Test Substance (Use for any pertinent, test substance-specific remarks.) METHOD Method/guideline followed GLP (Y/N) 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 period Frequency of treatment 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 RESULTS NOAEL (NOEL) and LOAEL (LOEL) maternal toxicity NOAEL (NOEL) and LOAEL (LOEL) developmental toxicity Actual dose received by dose level by sex if available Maternal data with dose level (with NOAEL value). Provide at a minimum qualitative descriptions of responses where dose related effects were seen. 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 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 related effects were seen. - Mortality and day of deathCONCLUSIONS 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) Order number for sorting (administrative field) Remarks field for General Remarks (Use for any other comments necessary for clarification.) |