| QUERY NAME: Mammalian Health Endpoints, TABLE NAME: V_MAMMALIAN_EZ |
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Animals at Final Sacrifice |
The number of animals examined at the final sacrifice. |
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Animals at Interim Sacrifice |
The number of animals examined at the interim sacrifice. |
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Body Fluids Sampled |
All bodily fluids monitored by the study. |
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Carcinogenic Effect |
An indicator of the carcinogenicity of the chemical tested. |
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CAS Number |
A standardized number assigned by the Chemical Abstracts Service (CAS) to identify a chemical (e.g., 10595-60-5). |
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Category Chemical |
The system generated ID for the category chemical for which the study is being performed. |
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Challenge Exposure Period |
Duration of the challenge portion of the test. |
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Challenge Exposure Period Units |
Time units represented by the exposure period value. |
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Challenge Frequency of Treatment |
Description of the administration of doses to the test animals during the challenge phase of the test (e.g., n doses per per week). |
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Chemical Category Name |
The name of the chemical category. |
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Clinical Observations |
Additional information that may be needed for an adequate assessment of data reliability. Provide, at a minimum, qualitative descriptions of observations indicating dose-related effects:
1. Body Weight
2. Food/Water Consumption
3. Identity, Severity, Time of Onset (e.g., date/time of day, days after exposure) and Duration of Clinical Signs
4. Clinical chemistry (e.g., hematology, urinalysis), if possible
5. Other examination, e.g., Enzyme Induction, Cell Proliferation, Reversibility of Effects |
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Concentration Percentage |
Percentage of test test subjects impacted by the observed concentration. |
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Concentration Result Type |
An indicator signifying whether the value reported is a lethal concentration of an effective concentration. |
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Concentration Units |
The unit of the concentration of the substance in water during the pH determination, preferably in mg/L. |
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Concentration Upper Value |
The upper concentration value. |
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Concentration Value |
Concentration that causes the indicated effect on the indicated percentage of the test subjects. |
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Concentration Value Description |
The mathematical symbol to describe the measured/estimated lethal concentration. |
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Conclusion |
Sponsor's characterization of whether the validity criteria of the test guidelines followed can be considered fulfilled for Genetic Toxicity in vitro. |
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Conclusion |
Sponsor's characterization of whether the validity criteria of the test guidelines followed can be considered fulfilled. |
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Conjunctivae (Chemosis) |
Irritation score. |
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Conjunctivae (Redness) |
Irritation score. |
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Consortium Name |
The names of the companies that belong to the consortium or partnership if applicable. |
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Control Group Type |
Describe the concurrent controls used in the study |
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Cornea Irritation |
Irritation score. |
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Details on Cytogenetic Assay |
Any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. |
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Dose Remarks |
Information about the Doses or Concentrations applied to the test subjects. |
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Edema |
Irritation score. |
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Endpoint Name |
The specific endpoint about which data is reported. |
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Erythema |
Irritation score. |
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Excretion Routes |
Excretion routes monitored by the study. |
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Exposure Period |
Duration of the test. |
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Exposure Period Units |
Time units represented by the exposure period value. |
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Exposure Period Upper Value |
Upper duration of the test. |
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Final Sacrifice Time |
The number of weeks following the initiation of the study when the final sacrifice occurred. |
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Frequency of Treatment |
Description of the administration of doses to the test animals (e.g., n doses per day, n days per week). |
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Gender |
Gender of the tested animals. |
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Genotoxic Effect |
Description of study results for each dose/concentration level. |
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Genotoxic Effect |
Description of study results for each dose/concentration level. |
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GLP |
Indicate if the study was conducted following Good Laboratory Practice standards. Enter Not Applicable for studies involving estimated values. |
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Grade |
Grade determined for the result. |
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Grading Scale |
Identify the scale/grading system used. |
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Interim Sacrifice Time |
The number of weeks following the initiation of the study when the interim sacrifice occurred. |
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Interpretation of Results |
Overall interpretation of or conclusions drawn from the test results. |
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Iris Irritation |
Irritation score. |
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Key Study Sponsor Indicator |
An indicator entered by the sponsor specifying whether or not the Robust Summary's test results for this endpoint are summarized from a "key" or "critical" study. |
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Lesions |
Description of lesions, if seen. |
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Limit Test |
An indicator that the experiment was a limit test. |
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Mammalian Strain |
Strain of mammal tested. |
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Measurement Period |
Measurement time applicable to the test result value. |
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Measurement Period Units |
Time units represented by the measurement period value. |
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Metabolic Activation |
Indicate whether metabolic activation was applied or not. Select "not applicable" for mammalian cell lines when no exogenous metabolic system is required for Genetic Toxicity in vitro. |
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Metabolic Activation |
Identify use of mammalian metabolism in non-mammalian (in vitro) experiments. |
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Metabolites Excreted |
List all the excreted metabolites. |
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Metabolites in Body Fluids |
List all the metabolites found in sampled body fluids. |
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Metabolites in Tissues |
List all the metabolites found in sampled tissues. |
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Method/Guideline Followed |
The name of the Method or Guideline followed in performing the study. |
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MTD Indicator |
Was Maximum Tolerated Dose (MTD) reached or exceeded? |
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Negative Control Substance |
Identify the negative control used in the test. |
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Neoplastic Effect |
Describe the benign or malignant neoplasm. |
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Ninth Collective Chemical Index Name |
A standardized chemical name taken from the Ninth Collective Index for the CAS Number. |
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Number of Animals per Sex and Dose Group |
Textual description of the number of animals dosed per sex and dose group |
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Number of Deaths Females |
Number of female animals that died per dose/concentration. |
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Number of Deaths Males |
Number of male animals that died per dose/concentration. |
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Number of Deaths Total |
Number of animals that died per dose/concentration. The sum of male and female deaths if reported by gender, otherwise the total number of non-gender specific deaths. |
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Number of Organisms per Dose/Concentration |
The number of organisms dosed at each dose level of the study. |
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Other Endpoint Description |
Any additional pertinent information about a non-standard Endpoint. |
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Other Endpoint Name |
The name assigned by the submitter to the Endpoint when it is not one of the existing system defined Endpoint Names. |
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Other Route of Administration |
How the chemical was administered to the test animals for non-standard methods. |
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Other Species |
Identify the species tested for Genetic Toxicity in vitro. |
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Other Species |
Identify the species tested when not available from the list of standard species. |
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Other Strain |
The mammalian strain tested, when not available from the list of standard strains. |
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Other Strain |
The mammalian strain tested, when not available from the list of standard strains for Genetic Toxicity in vitro. |
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Other Vehicle Name |
Chemical identity of a non-standard vehicle. |
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Overall Irritation Score |
Total of the individual irritation measures. |
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Percent Sensitized -- Negative Control |
Percentage of the test subjects sensitized by exposure to this dosage of the negative control substance. |
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Percent Sensitized -- Positive Control |
Percentage of the test subjects sensitized by exposure to this dosage of the positive control substance. |
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Percent Sensitized -- Test Substance |
Percentage of the test subjects sensitized by exposure to this dosage. |
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Population |
The population of test subjects in whom the referenced effect was observed. |
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Positive Control Substance |
Identify the positive control used in the test. |
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Positive, Negative and Solvent Control Substance(s) |
Indicate whether a positive, negative and solvent control substance was used in this study. If yes, please indicate the postive, negative and solvent control substance. Also describe the validity of the positive, negative and solvent control substance tests. |
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Post-Exposure Period Value Description |
The mathematical symbol to describe the measured/estimated value. |
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Post-Exposure/Depuration Period |
Observation period after last exposure to the test chemical. |
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Post-Exposure/Depuration Period Units |
Time units represented by the post-exposure period value. |
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Pre-Mating Exposure Period for Females |
Number of days females dosed prior to mating. |
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Pre-Mating Exposure Period for Males |
Number of days males dosed prior to mating. |
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Preparation of Test Site |
Indicator whether test site was shaved or abraded. |
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Primary Irritation Index |
Note the Irritation Index score. |
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Program Flag |
Program that the submission is associated with. |
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Reliability |
Indication of the adequacy of data at the discretion of the person preparing the Robust Summary. |
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Reliability Remarks |
Comments about how the reliability of data was determined and other related remarks. If a numeric or other coded system, such as Klimisch Codes are used to denote reliability, identify and/or define the coding system. |
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Remarks |
Comments, discussions, or other related EPA remarks. |
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Results Remarks |
Sponsor provided additional descriptive text about the results of the study. |
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Route of Administration |
How the chemical was administered to the test animal. |
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Route of Challenge Exposure |
Indicate the route of challenge exposure. |
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Route of Induction |
Indicate the route of induction exposure. |
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Sensitization Score |
Numeric characterization of the Sensitization properties of the test substance at this dosage, ranging from 0 (no Sensitization potential) to 4. |
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Species |
Organism/cell culture used in the experiment. |
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Species or in Vitro System |
Organism/cell culture used in the experiment. |
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Sponsor Name |
The name of the individual company or consortium (i.e., two or more companies) making a commitment in the HPV Challenge Program to provide data for a chemical or category of chemicals
(e.g., Eastman Chemical Company). |
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Sponsored Chemical Result Type |
Indicator showing whether the test result represents a measured or an estimated value for the sponsored chemical. |
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Statistical Results |
Note statistical results, with appropriate p value and 95% Confidence Limit. |
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Strain |
Strain of the tested species for Genetic Toxicity in vitro. |
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Study Reference |
Identify reference(s) used to compile the summary by entering: author(s), year, title, laboratory name, laboratory report number, report date (if published, list journal name, volume, pages). |
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Study Type |
Type of experiment performed. |
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Submission Name |
The sponsor provided name associated with the submission. |
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Submitter's Name |
The name of the individual company or consortium formally providing test plan related information. |
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Survival Rate Females |
Percentage of female animals that survived per dose/concentration. |
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Survival Rate Males |
Percentage of male animals that survived per dose/concentration. |
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Survival Rate Total |
Percentage of animals that survived per dose/concentration. |
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Systemic Toxicity |
The effect of a substance on body tissues after absortion into the bloodstream. |
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Test Conditions Remarks |
Additional comments describing the characteristics of the Test Conditions. |
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Test or Estimation Type |
Type of test or estimation performed. |
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Test Substance ID |
The system generatedl ID of the chemical substance actually used to perform the test (sponsored or supporting). |
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Test Substance Purity |
The purity of the chemical used in the study or estimation. Not applicable to mixtures. Note if not available. |
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Test Type |
Type of test performed. |
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Tissues Sampled |
All bodily tissue types monitored by the study. |
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Tool |
Tool used to asses the irritation scores. |
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Total Volume Applied |
The total volume of active/test substance applied/instilled. |
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Total Volume Applied Units |
The unit of measure applied to the total value of active/test substance. |
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Type of Coverage |
Indicator whether the test material was covered on the site applied to. |
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Type of Exposure |
Further definition of dose administration. |
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Type of Study |
Indicate the type of study regardless of whether it is already specified in the guideline, as this field can be used for query purposes. |
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Type of Test |
Names a specific genetic toxicity test type, which is a refinement of the genotoxicity study type. |
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Unable to Measure or Estimate Justification |
A short description of why neither a measured test result nor estimated value will be provided for this endpoint. |
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Vehicle Amount |
The amount of carrier/solvent used to deliver the test substance to the experimental system. |
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Vehicle Name |
Chemical identity of the vehicle |
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Vehicle Units |
Units of measure describing the Vehicle Amount. |
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Vehicle Used |
Indicator that a chemical was used to emulsify or mix the experimental chemical to enhance its solubility. |
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Year Study Performed |
If known, the sponsor provided year in which the test being described was conducted. |