Section 650.005 - Supplemental Definitions(1)Toxic. To give specificity to the definition of "toxic" in 105 CMR 650.004(28), the following supplements that definition:(a)Acute Toxicity. Toxic means any substance that produces death within 14 days in half or more than half of a group of:1. White rats (each weighing between 200 and 300 grams) when a single dose of from 50 milligrams to five grams per kilogram of body weight is administered orally.2. White rats (each weighing between 200 to 300 grams) when an atmospheric concentration of more than 200 parts per million but not more than 20,000 parts per million by volume of gas or vapor, or more than two but not more than 200 milligrams per liter by volume of mist or dust is inhaled continuously for one hour or less, if such concentration is likely to be encountered by humans when the substance is used in any reasonably foreseeable manner; and/or3. Rabbits (each weighing between 2.3 and 3.0 kilograms) when a dosage of more than 200 milligrams but not more than two grams per kilogram of body weight is administered by continuous contact with the bare skin for 24 hours by the method described in 16 CFR § 1500.40 which is incorporated herein by reference. The number of animals tested shall be sufficient to give a statistically significant result and shall be in conformity with good pharmacological practices.
(b)Chronic Toxicity. Toxic also means any substance that presents a chronic hazard if it falls into one of the following categories. 1.For Carcinogens. A substance is toxic if it is or contains a known or probable human carcinogen.2.For Neurotoxicological Toxicants. substance is toxic if it is or contains a known or probable human neurotoxin.3.For Developmental or Reproductive Toxicants. A substance is toxic if it is or contains a known or probable human developmental or reproductive toxicant.(c)Toxic also applies to any substance that is TOXIC (but not HIGHLY TOXIC) on the basis of human experience.(2)Irritant. The definition of "irritant" in 105 CMR 650.004(17) is supplemented by the following: "Irritant" includes "primary irritant to the skin" as well as substances irritant to the eye or to mucous membranes. "Primary irritant" means a substance that is not corrosive and that human experience data indicate is a primary irritant and/or means a substance that results in an empirical score of five or more when tested by the method described in 16 CFR § 1500.41 which is incorporated herein by reference. "Eye irritant" means a substance that human experience data indicates is an irritant to the eye and/or means a substance for which a positive test is obtained when tested by the method described in 16 CFR § 1500.42 which is incorporated herein by reference.