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National Toxicology Program. NTP Technical Report on the Toxicity Studies of Trans-resveratrol (CASRN 501-36-0) Administered by Gavage for Two Weeks or Three Months to F344/NTac Rats, Wistar Han [Crl:WI(Han)] Rats, and B6C3F1/N Mice: Toxicity Report 102 [Internet]. Research Triangle Park (NC): National Toxicology Program; 2021 Dec.
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NTP Technical Report on the Toxicity Studies of Trans-resveratrol (CASRN 501-36-0) Administered by Gavage for Two Weeks or Three Months to F344/NTac Rats, Wistar Han [Crl:WI(Han)] Rats, and B6C3F1/N Mice: Toxicity Report 102 [Internet].
Show detailsC.1. Methods
Rodents used in the National Toxicology Program are produced in optimally clean facilities to eliminate potential pathogens that might affect study results. The Sentinel Animal Program is part of the periodic monitoring of animal health that occurs during the toxicological evaluation of test compounds. Under this program, the disease state of the rodents is monitored via sera or feces from extra (sentinel) or dosed animals in the study rooms. The sentinel animals and the study animals are subject to identical environmental conditions. Furthermore, the sentinel animals are from the same production source and weanling groups as the animals used for the studies of test compounds.
In these toxicity studies, blood samples were collected from each sentinel animal, allowed to clot and the serum was separated. All samples were processed appropriately with serology testing performed by BioReliance Corp., Rockville, MD for the 2-week studies and IDEXX BioResearch (formerly Rodent Animal Diagnostic Laboratory (RADIL), University of Missouri), Columbia, MO, for the 3-month studies, for determination of the presence of pathogens. Evaluation for endo- and ectoparasites was performed in-house by the testing laboratory.
The laboratory methods and agents for which testing was performed are tabulated below; the times at which samples were collected during the studies are also listed (Table C-1, Table C-2).
Table C-1Methods and Results for Sentinel Animal Testing in Male and Female Rats
| Collection Time Points | Two-week Study (F344/NTac Rats) | Three-month Study (Wistar Han Rats) | ||
|---|---|---|---|---|
| End of Quarantine | Quarantinea | 4 Weeksb | End of Study | |
| Number Examined (Males/Females) | 5/5 | 0/10 | 0/10 | 5/5 |
| Method/Test | ||||
| Enzyme-linked Immunosorbent Assay (ELISA) | ||||
| Pneumonia virus of mice (PVM) | – | NT | NT | NT |
| Rat coronavirus/sialodacryoadenitis virus (RCV/SDA) | – | NT | NT | NT |
| Sendai | – | NT | NT | NT |
| Multiplex Fluorescent Immunoassay (MFI) | ||||
| Kilham rat virus (KRV) | NT | – | – | – |
| Mycoplasma pulmonis | NT | – | – | – |
| Parvo NS-1 | NT | – | – | – |
| Pneumonia virus of mice (PVM) | NT | – | – | – |
| Rat coronavirus/sialodacryoadenitis virus (RCV/SDA) | NT | – | – | – |
| Rat minute virus (RMV) | NT | – | – | – |
| Rat parvo virus (RPV) | NT | – | – | – |
| Rat theilovirus (RTV) | NT | – | NT | – |
| Sendai | NT | – | – | – |
| Theiler’s murine encephalomyelitis virus (TMEV) | NT | – | – | – |
| Toolan’s H-1 | NT | – | – | – |
| Immunofluorescence Assay (IFA) | ||||
| Parvovirus | – | NT | NT | NT |
– = negative; + = positive; NT = not tested.
- a
Age-matched nonpregnant females.
- b
Time-mated females that did not have a litter; 3.5 weeks after arrival.
Table C-2Methods and Results for Sentinel Animal Testing in Male and Female B6C3F1/N Mice
| Collection Time Points | Two-week Study | Three-month Study | |
|---|---|---|---|
| Quarantine | 1 Month | End of Study | |
| Number Examined (Males/Females) | 5/5 | 5/5 | 5/5 |
| Method/Test | |||
| Enzyme-linked Immunosorbent Assay (ELISA) | |||
| Ectromelia virus | – | NT | NT |
| Epizootic diarrhea of infant mice (EDIM) | – | NT | NT |
| Lymphocytic choriomeningitis virus (LCMV) | – | NT | NT |
| Mouse adenovirus (MAd-1) | – | NT | NT |
| Mouse hepatitis virus (MHV) | – | NT | NT |
| Mouse parvovirus (MPV) | – | NT | NT |
| Mouse minute virus (MMV) | – | NT | NT |
| Pneumonia virus of mice (PVM) | – | NT | NT |
| Reovirus type 3 (Reo-3) | – | NT | NT |
| Sendai | – | NT | NT |
| Theiler’s encephalomyelitis virus (TMEV GD VII) | – | NT | NT |
| Multiplex Fluorescent Immunoassay (MFI) | |||
| Ectromelia virus | NT | – | – |
| Epizootic diarrhea of infant mice (EDIM) | NT | – | – |
| Lymphocytic choriomeningitis virus | NT | – | – |
| Mycoplasma pulmonis | NT | – | – |
| Mouse hepatitis virus (MHV) | NT | – | – |
| Mouse norovirus (MNV) | NT | – | – |
| Parvo NS-1 | NT | – | – |
| Mouse parvovirus (MPV) | NT | – | – |
| Minute virus of mice (MVM) | NT | – | – |
| Pneumonia virus of mice (PVM) | NT | – | – |
| Reovirus (REO3) | NT | – | – |
| Sendai | NT | – | – |
| Theiler’s murine encephalomyelitis virus (TMEV) GDVII | NT | – | – |
– = negative; + = positive; NT = not tested.
C.2. Results
F344/NTac Rats: All test results were negative.
Wistar Han Rats: All test results were negative.
B6C3F1/N Mice: All test results were negative.
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