Or. Admin. Code § 333-016-0020

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-016-0020 - Testing Procedures for Hazardous Substances

Method of testing toxic substances. The method of testing the toxic substances defined in OAR 333-016-0005(5)(c) and (6)(c) is as follows:

(1) Acute dermal toxicity (single exposure). In the acute exposures the agent is held in contact with the skin by means of a sleeve for periods varying up to 24 hours. The sleeve, made of rubber dam or other impervious material, is so constructed that the ends are reinforced with additional strips and should fit snugly around the trunk of the animal. The ends of the sleeve are tucked, permitting the central portion to "balloon" and furnish a reservoir for the dose. The reservoir must have sufficient capacity to contain the dose without pressure. In the following table are given the dimensions of sleeves and the approximate body surface exposed to the test substance. The sleeves may vary in size to accommodate smaller or larger subjects. In the testing of unctuous materials that adhere readily to the skin, mesh wire screen may be employed instead of the sleeve. The screen is padded and raised approximately two centimeters from the exposed skin. In the case of dry powder preparations, the skin and substance are moistened with physiological saline prior to exposure. The sleeve is then slipped over the gauze which holds the dose applied to the skin. In the case of finely divided powders, the measured dose is evenly distributed on cotton gauze, which is then secured to the area of exposure. (See Table 1.)

(2) Preparation of test animals. The animals are prepared by clipping the skin of the trunk free of hair. Approximately one-half of the animals are further prepared by making epidermal abrasions every 2 centimeters or 3 centimeters longitudinally over the area of exposure. The abrasions are sufficiently deep to penetrate the stratum corneum (horny layer of the epidermis), but not to disturb the derma -- That is, not to obtain bleeding.

(3) Procedures for testing. The sleeve is slipped onto the animal which is then placed in a comfortable but immobilized position in a multiple animal holder. Selected doses of liquids and solutions are introduced under the sleeve. If there is slight leakage from the sleeve which may occur during the first few hours of exposure, it is collected and reapplied. Dosage levels are adjusted in subsequent exposures (if necessary) to enable a calculation of a dose that would be fatal to 50 percent of the animals. This can be determined from mortality ratios obtained at various doses employed. At the end of 24 hours the sleeves or screens are removed, the volume of unabsorbed material, if any, is measured, and the skin reactions are noted. The subjects are cleaned by thorough wiping, observed for gross symptoms of poisoning, and then observed for two weeks.

Or. Admin. Code § 333-016-0020

HD 40, f. 8-2-73, ef. 8-15-73

Tables referenced are available from the agency.

Stat. Auth.: ORS 453.095

Stats. Implemented: ORS 453.005 & 453.055