TABLE LEGEND

See Sample LSE Table (page C-5)

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Route of exposure. One of the first considerations when reviewing the toxicity of a substance using these tables and figures should be the relevant and appropriate route of exposure. Typically, when sufficient data exist, three LSE tables and two LSE figures are presented in the document. The three LSE tables present data on the three principal routes of exposure (i.e., inhalation, oral, and dermal). LSE figures are limited to the inhalation and oral routes. Not all substances will have data on each route of exposure and will not, therefore, have all five of the tables and figures. Profiles with more than one chemical may have more LSE tables and figures.

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Exposure period. Three exposure periods—acute (<15 days), intermediate (15–364 days), and chronic (≥365 days)—are presented within each relevant route of exposure. In this example, two oral studies of chronic-duration exposure are reported. For quick reference to health effects occurring from a known length of exposure, locate the applicable exposure period within the LSE table and figure.

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Figure key. Each key number in the LSE table links study information to one or more data points using the same key number in the corresponding LSE figure. In this example, the study represented by key number 51 identified NOAELs and less serious LOAELs (also see the three “51R” data points in sample LSE Figure 2-X).

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Species (strain) No./group. The test species (and strain), whether animal or human, are identified in this column. The column also contains information on the number of subjects and sex per group. Chapter 1, Relevance to Public Health, covers the relevance of animal data to human toxicity and Section 3.1, Toxicokinetics, contains any available information on comparative toxicokinetics. Although NOAELs and LOAELs are species specific, the levels are extrapolated to equivalent human doses to derive an MRL.

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Exposure parameters/doses. The duration of the study and exposure regimens are provided in these columns. This permits comparison of NOAELs and LOAELs from different studies. In this case (key number 51), rats were orally exposed to “Chemical X” via feed for 2 years. For a more complete review of the dosing regimen, refer to the appropriate sections of the text or the original reference paper (i.e., Aida et al. 1992).

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Parameters monitored. This column lists the parameters used to assess health effects. Parameters monitored could include serum (blood) chemistry (BC), behavioral (BH), biochemical changes (BI), body weight (BW), clinical signs (CS), developmental toxicity (DX), enzyme activity (EA), food intake (FI), fetal toxicity (FX), gross necropsy (GN), hematology (HE), histopathology (HP), lethality (LE), maternal toxicity (MX), organ function (OF), ophthalmology (OP), organ weight (OW), teratogenicity (TG), urinalysis (UR), and water intake (WI).

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Endpoint. This column lists the endpoint examined. The major categories of health endpoints included in LSE tables and figures are death, body weight, respiratory, cardiovascular, gastrointestinal, hematological, musculoskeletal, hepatic, renal, dermal, ocular, endocrine, immunological, neurological, reproductive, developmental, other noncancer, and cancer. “Other noncancer” refers to any effect (e.g., alterations in blood glucose levels) not covered in these systems. In the example of key number 51, three endpoints (body weight, hematological, and hepatic) were investigated.

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NOAEL. A NOAEL is the highest exposure level at which no adverse effects were seen in the organ system studied. The body weight effect reported in key number 51 is a NOAEL at 25.5 mg/kg/day. NOAELs are not reported for cancer and death; with the exception of these two endpoints, this field is left blank if no NOAEL was identified in the study.

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LOAEL. A LOAEL is the lowest dose used in the study that caused an adverse health effect. LOAELs have been classified into “Less Serious” and “Serious” effects. These distinctions help readers identify the levels of exposure at which adverse health effects first appear and the gradation of effects with increasing dose. A brief description of the specific endpoint used to quantify the adverse effect accompanies the LOAEL. Key number 51 reports a less serious LOAEL of 6.1 mg/kg/day for the hepatic system, which was used to derive a chronic exposure, oral MRL of 0.008 mg/kg/day (see footnote “c”). MRLs are not derived from serious LOAELs. A cancer effect level (CEL) is the lowest exposure level associated with the onset of carcinogenesis in experimental or epidemiologic studies. CELs are always considered serious effects. The LSE tables and figures do not contain NOAELs for cancer, but the text may report doses not causing measurable cancer increases. If no LOAEL/CEL values were identified in the study, this field is left blank.

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Reference. The complete reference citation is provided in Chapter 8 of the profile.

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Footnotes. Explanations of abbreviations or reference notes for data in the LSE tables are found in the footnotes. For example, footnote “c” indicates that the LOAEL of 6.1 mg/kg/day in key number 51 was used to derive an oral MRL of 0.008 mg/kg/day.

FIGURE LEGEND

See Sample LSE Figure (page C-6)

LSE figures graphically illustrate the data presented in the corresponding LSE tables. Figures help the reader quickly compare health effects according to exposure concentrations for particular exposure periods.

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Exposure period. The same exposure periods appear as in the LSE table. In this example, health effects observed within the chronic exposure period are illustrated.

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Endpoint. These are the categories of health effects for which reliable quantitative data exist. The same health effect endpoints appear in the LSE table.

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Levels of exposure. Concentrations or doses for each health effect in the LSE tables are graphically displayed in the LSE figures. Exposure concentration or dose is measured on the log scale “y” axis. Inhalation exposure is reported in mg/m³ or ppm and oral exposure is reported in mg/kg/day.

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LOAEL. In this example, the half-shaded circle that is designated 51R identifies a LOAEL critical endpoint in the rat upon which a chronic oral exposure MRL is based. The key number 51 corresponds to the entry in the LSE table. The dashed descending arrow indicates the extrapolation from the exposure level of 6.1 mg/kg/day (see entry 51 in the sample LSE table) to the MRL of 0.008 mg/kg/day (see footnote “c” in the sample LSE table).

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CEL. Key number 59R is one of studies for which CELs were derived. The diamond symbol refers to a CEL for the test species (rat). The number 59 corresponds to the entry in the LSE table.

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Key to LSE figure. The key provides the abbreviations and symbols used in the figure.