90-Day Inhalation

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Extract nominal concentrations in ppm and mg/m3 (that are reported in the Applicant's summary and conclusion section as g/m3), and also extract analytical concentrations as another dose representation with unit 'ppm (analytical)'.

Create separate male and female groups. Use dummy variables for all endpoints (except mortality) and set LOAELs based on statistically significant change from control (or based author's determination of test substance-related effect when no statistical analysis was done for an endpoint, or based on author's conclusion when a non-significant change was considered adverse). Copy text describing the results for the specific endpoint you are extracting and paste it into results notes for each endpoint. If significance is stated, assume p-value of 0.05 (unless authors specifically report a different p-value). For any endpoints reported in methods but not specifically discussed in results or executive summary, assume no treatment-related effects observed. Extract findings at the end of the exposure period for the main group unless instructed to extract other timepoints. (In general, do not extract recovery timepoints unless it was the only timepoint with a significant change noted. Can add information about recovery of effects into results notes field.)

Extract all health endpoints that are reported in methods and/or results including:

Mortality - extract quantitatively as incidence 0 in all groups

Body weight, absolute (90d) and body weight change (0-90d)

Feed consumption

Ophthalmology, Unspecified

Hematology, Clinical chemistry, Urinalysis - extract each parameter listed in methods. Extract significant changes at end of exposure (week 13/14) only, unless an endpoint was only significant at an interim (5wk) or recovery (17wk) timepoint, in which case extract that timepoint. For endpoints not mentioned in results, assume no significant changes. Do not extract urine fluoride as that is more related to ADME.

Organ weights - absolute and relative weights for kidney and liver, absolute weights for all other organs that were listed in methods

Kidney, Hydronephrosis, Unilateral - indicate increase for high-concentration males; use general kidney histopathology endpoint for females and indicate no changes.

Histopathology of other organs listed in methods - create general histopathology endpoint (e.g., Heart Histopathology, Abnormal) for all organs listed in methods and indicate no treatment-related changes. (duodenum, jejunum, ileum can be grouped together as small intestine and cecum, colon, rectum can be grouped together as large intestine)

Male Wistar-Derived Rat