OAR 333-016-0025
Method of Testing Primary Irritant Substances

(1)

Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1“ X 1” two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semi-solids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values in the following evaluation of skin reactions:

(a)

Erythema and eschar formation:

(A)

No erythema — Value of 0;

(B)

Very slight erythema (barely perceptible) — Value of 1;

(C)

Well-defined erythema — Value of 2;

(D)

Moderate to severe erythema — Value of 3;

(E)

Severe erythema (beet redness) to slight eschar (injuries in depth) — Value of 4.

(b)

Edema formation:

(A)

No edema — Value of 0;

(B)

Very slight edema (barely perceptible) — Value of 1;

(C)

Slight edema (edges of area well defined by definite raising) — Value of 2;

(D)

Moderate edema (raised approximately 1 millimeter) — Value of 3;

(E)

Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) — Value of 4.
NOTE: The “value” recorded for each reading is the average value of the six or more animals subject to the test.

(2)

Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score. Exposure times and units:

(a)

Erythema and eschar formation:

(A)

Intact skin:
(i)
24 hours — Value of 2;
(ii)
72 hours — Value of 1.

(B)

Abraded skin:
(i)
24 hours — Value of 3;
(ii)
72 hours — Value of 2.

(C)

Subtotal of exposure unit values = 8.

(b)

Edema formation:

(A)

Intact skin:
(i)
24 hours — Value of 0;
(ii)
12 hours — Value of 1.

(B)

Abraded skin:
(i)
24 hours — Value of 1;
(ii)
72 hours — Value of 2.

(C)

Subtotal of exposure unit values = 8.

(c)

Total exposure unit values = 12.
NOTE: Primary irritation score is 12 divided by 4 = 3.

Source: Rule 333-016-0025 — Method of Testing Primary Irritant Substances, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-0025.

333‑016‑0005
Definitions 333‑016‑0010
Human Experience with Hazardous Substances 333‑016‑0015
Hazardous Mixtures 333‑016‑0020
Testing Procedures for Hazardous Substances 333‑016‑0025
Method of Testing Primary Irritant Substances 333‑016‑0030
Test for Eye Irritants 333‑016‑0035
Tentative Method of Test for Flashpoint of Volatile Flammable Materials by Tagliabue Open-Cup Apparatus 333‑016‑0040
Method for Determining Extremely Flammable and Flammable Solids 333‑016‑0045
Method for Determining Extremely Flammable and Flammable Contents of Self-Pressurized Containers 333‑016‑0050
Method for Determining Flashpoint of Extremely Flammable Contents of Self-Pressurized Containers 333‑016‑0055
Method for Determining the Sound Pressure Level Produced by Toy Caps 333‑016‑0056
Test Methods for Simulating Use and Abuse, Toys, Games, and Other Articles Intended for Use by Children 333‑016‑0057
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children 18 Months of Age or Less 333‑016‑0058
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 18 But not Over 36 Months of Age 333‑016‑0059
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 36 But Not Over 96 Months of Age 333‑016‑0060
Products Declared to be Hazardous Substances Under ORS 453.055(1) 333‑016‑0065
Products Requiring Special Labeling Under ORS 453.055(2) 333‑016‑0070
Labeling of Fire Extinguishers 333‑016‑0075
Banned Hazardous Substances 333‑016‑0077
Pointed Objects in Food Items of Particular Appeal to Children 333‑016‑0080
Toys and Other Articles Intended for Use by Children 333‑016‑0082
Repurchase of Banned Hazardous Substances 333‑016‑0085
Exemptions for Foods, Drugs, Cosmetics, and Fuels 333‑016‑0090
Exemption from Full Labeling and Other Requirements 333‑016‑0095
Exemptions for Small Packages, Minor Hazards, and Special Circumstances 333‑016‑0100
Exemption for Unlabeled Containers 333‑016‑0105
Exemptions from Classification as Banned Hazardous Substances 333‑016‑0110
Labeling of Toys, Including Games 333‑016‑0115
Labeling Requirements, Placement, Conspicuousness, Contrast 333‑016‑0120
Deceptive Use of Disclaimers 333‑016‑0125
Condensation of Label Information 333‑016‑0130
Labeling Requirements for Accompanying Literature 333‑016‑0135
Substances Determined to be “Special Hazards” (e.g., to children) 333‑016‑0140
Substances with Multiple Hazards or Other Special Hazards 333‑016‑0145
For the Following Substances and at the Following Concentrations, the Word “Poison” Is Necessary Instead of Any Signal Word 333‑016‑0150
Self-Pressurized Containers 333‑016‑0155
Methyl Alcohol-Base Radiator Antifreeze 333‑016‑0160
Ethylene Glycol-Base Radiator Antifreeze 333‑016‑0165
Extremely Flammable Contact Adhesives 333‑016‑0170
Procedural Rules 333‑016‑0175
Prohibited Acts and Penalties 333‑016‑0180
Guaranty 333‑016‑0185
Examinations and Investigations 333‑016‑0190
“Administrator” Intended to Include “State Public Health Officer” 333‑016‑2001
Toxic Free Kids Program 333‑016‑2010
Definitions 333‑016‑2020
Chemicals of High Concern to Children 333‑016‑2030
Modifications to the List of High Priority Chemicals of Concern for Children’s Health 333‑016‑2035
Manufacturer Disclosure of High Priority Chemicals of Concern for Children’s Health Used in Children’s Products: Practical Quantification Limits 333‑016‑2060
Notification Requirements 333‑016‑2065
Formal Communications Regarding Toxic Free Kids 333‑016‑2070
Exemptions from Notice Requirement 333‑016‑2080
Fees 333‑016‑3010
Removal or Substitution of High Priority Chemicals 333‑016‑3015
Exemptions from Removal or Substitution Requirements 333‑016‑3020
Requirements for Chemical Substitution 333‑016‑3030
Hazard Assessment for Substitute Chemicals 333‑016‑3040
Waiver from Removal or Substitution Requirement 333‑016‑3050
Quantitative Exposure Assessment 333‑016‑3060
Alternatives Assessment 333‑016‑3070
Trade Secrets 333‑016‑3080
Enforcement and Civil Penalties
Last Updated

Jun. 8, 2021

Rule 333-016-0025’s source at or​.us