(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/or
3.
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.
