This reporting checklist was developed to help researchers design, perform and report in vivo toxicity studies in a transparent way that fulfill the reliability criteria for regulatory risk assessment. Not all items apply to all studies.
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Item to be described |
Purpose and aim |
Purpose and/or aim. |
Endpoints |
Endpoints included in investigation. |
Test substance |
Name and/or CAS-number. |
Source, i.e. manufacturer and batch/lot number. |
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Purity, including information on contaminants, isomers, etc. |
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Other relevant information, e.g. radiolabelled. |
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Relevant and available information on toxicokinetics and toxicodynamics. |
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Stability and homogeneity of the preparation in the vehicle or carrier and in e.g. urine, blood and milk (as relevant) under the conditions of use and storage. |
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Vehicle |
Type/characteristics. |
Justification for choice of vehicle if other than water. |
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Ethical statement |
Ethical review permissions, licenses and national or institutional guidelines for animal care and use, as relevant. |
Animals |
Species. |
Strain, using complete genetic nomenclature. |
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Source. |
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Number. |
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Sex. |
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Age and life stage. |
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Body weight at the start of the study. |
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Time allowed for acclimatization to lab conditions. |
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Method for individual identification of animals. |
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Housing conditions |
Temperature (oC). |
Relative humidity. |
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Light-dark cycle, hours light vs. dark as well as if the light-dark cycle has been reversed. |
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Number of animals/sex/cage. Reported for F0, pregnant dams and litters as relevant. |
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Cage material. |
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Bedding material. NOTE: The level of phytoestrogens contained in the selected bedding material should be minimal. |
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Water bottle material. |
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Description of any cage enrichment, including materials. |
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Feed |
Type and source. |
Contaminant content, e.g. pesticide residues, persistent organic pollutants, heavy metals and mycotoxins. |
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Phytoestrogen content. |
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Frequency and method of feeding. |
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Drinking water |
Source. |
Contaminant content. |
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Administration of test substance |
Number of animals/sex/dose groups. |
Method for deciding on optimal group size, e.g. power calculations. |
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Dose levels and number of dose groups. |
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Rationale for selection of dose levels. |
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Enough information to calculate/convert to mg/kg body weight/day if doses are not stated in this format. |
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Method of assignment of animals to different dose groups, e.g. randomization, exclusion, inclusion, etc. |
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Information about controls, are they concurrent, historical, matched, etc. |
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Administration route. |
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Rationale for choice of administration route, e.g. most relevant to human exposure scenario. |
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Administration method, e.g. if oral: via feed, gavage, drink from pipette, etc.; if s.c: injection, pump, etc. |
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If administered in feed/water:
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Age and life stage of animals at start of administration. |
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Duration of administration, e.g. days, weeks or age when administration was ended. |
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Frequency of administration, e.g. single, repeated or continuous. |
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Methods |
Methods should be described in enough detail to allow replication either in the Methods section or in another publication to which a clear reference is made. |
Description of randomization procedures for assigning animals to different tests/analyses. NOTE: it should be clear if the same animals are subjected to several tests/measurements. |
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Number of animals/sex/dose subjected to test/tissue collection/analyses. |
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Age and life stage of animals at testing/analyses. |
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Description of method and how it is relevant to the endpoint being investigated. |
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Data supporting the reliability and sensitivity of the method, i.e. positive control or historical/previously published data or participation in inter-laboratory calibration programs. |
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Description of any apparatus used. |
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Description of parameters measured. |
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Method for termination of animals. |
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Age and life stage at termination of animals. |
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Statistics |
Details of statistical methods applied. |
Description that shows that the assumptions of the statistical methods used are fulfilled. |
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Observations |
Body weight data. |
Food and water consumption. |
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Time and cause of death for animals that died during the study. |
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Clinical observations. |
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Details of all adverse events in each experimental group. |
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Data |
Response data by sex and treatment group. |
All data relevant to the endpoints investigated, including statistically significant changes and the appropriate measures of precision/variance should be presented in a transparent manner for all treatment groups, including negative (and positive) controls. |
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Historical control data if available. |
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Number of animals/sex/dose included in each analysis in absolute numbers. |
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Discussion |
Description of the dose-response relationships for the measured parameters. |
Possible mechanism of action for the observed effects. |
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How do the results relate to other research within the relevant field, e.g. are the results supported by other research. |
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Relevance to humans. |
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Other |
List of study personnel, including professional training. |
Contact information for raw data access. |
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Disclosure of any financial conflicts of interest. |
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For reproductive and developmental toxicity studies the following additional information should be reported: |
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Vaginal smear data for parental females before treatment (if collected). |
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Designation of day of parturition, e.g. PND 0. |
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Description of randomization procedures to select pups for culling. |
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Day of culling. |
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Number of animals/sex/litter after culling. |
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Method for individual identification of offspring. |
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Litter of origin for all offspring. |
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For endpoints measured in offspring it should be clear if littermates are subjected to the same tests/analyses. |
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Statistical unit, i.e. if it is the litter or the individual pup. |
Contact: anna.beronius@ki.se
Download the reporting checklist for in vivo toxicity studies here (excel).