The U.S. Environmental Protection Agency assigns toxicity
categories based on a substance's potency (ability to cause harm
at low doses) by various routes of exposure (e.g., oral, inhalation, dermal). Precautionary
labels are required to bear a Signal Word ("Danger" and/or "Poison"; "Warning";
or "Caution") corresponding to one of four categories of toxicity. Additionally,
the statement, "Keep out of reach of children" is required on the label. The Signal
Word must appear with sufficient prominence relative to other front panel text and
graphic material to assure that it will not be overlooked under customary conditions
of purchase and use.
Table 1 - Toxicity Categories
Study
Category I
Category II
Category III
Category IV
Acute Oral
Up to and including 50 mg/kg
> 50 thru 500 mg/kg
> 500 thru 5000 mg/kg
> 5000 mg/kg
Acute Dermal
Up to and including 200 mg/kg
> 200 thru 2000 mg/kg
> 2000 thru 5000 mg/kg
> 5000 mg/kg
Acute Inhalation1
Up to and including 0.05 mg/liter
> 0.05 thru 0.5 mg/liter
> 0.5 thru 2 mg/liter
> 2 mg/liter
Primary
Eye Irritation
Corrosive (irreversible destruction of ocular tissue) or corneal involvement
or irritation persisting for more than 21 days
Corneal involvement or other eye irritation clearing in
8-21 days
Corneal involvement or other eye irritation clearing in
7 days or less
Minimal effects clearing in less than 24 hours
Primary
Skin Irritation
Corrosive (tissue destruction into the dermis and/or scarring)
Severe irritation at 72 hours (severe erythema or edema)
Moderate irritation at 72 hours (moderate erythema)
Mild or slight irritation at 72 hours (no irritation or
slight erythema)
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