OAR 333-016-0030
Test for Eye Irritants


(1)

Intentionally left blank —Ed.

(a)

Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous material that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defect or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control. For testing liquids, 0.1 milliliter is used. For solids or pastes, 100 milligrams of the test substance is used, except that for substances in flake, granule, powder, or other particulate form the amount that has a volume of 0.1 milliliter (after compacting as much as possible without crushing or altering the individual particles, such as by tapping the measuring container) shall be used whenever this volume weighs less than 100 milligrams. In such a case, the weight of the 0.1 milliliter test dose should be recorded. The eyes are not washed following instillation of test material except as noted below;

(b)

The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours. Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution, U.S.P., or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution, U.S.P., or equivalent, injured areas of the cornea appear yellow; this best visualized in a darkened room under ultraviolet illumination. Any or all eyes may be washed with sodium chloride solution, U.S.P., or equivalent after the 24-hour reading.

(2)

Intentionally left blank —Ed.

(a)

An animal shall be considered as exhibiting a positive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stipplin), or opacity of the cornea (other than a slight dulling of the normal luster), or inflammation of the iris (other than a slight deepening of the folds (or rugae) or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctive (excluding the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not easily discernible;

(b)

The test shall be considered positive if four or more of the animals in the test group exhibit a positive reaction. If only one animal exhibits a positive reaction, the test shall be regarded as negative. If two or three animals exhibit a positive reaction, the test is repeated using a different group of six animals. The second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test shall be repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits a positive response.

(3)

To assist testing laboratories and other interested persons in interpreting the results obtained when a substance is tested in accordance with the method described in section (1) of this rule, an “Illustrated Guide for Grading Eye Irritation by Hazardous Substances” will be sold by the Superintendent of Documents, Government Printing Office, Washington, D.C. The guide will contain color plates depicting responses of varying intensity to specific test solutions. The grade of response and the substance used to produce the response will be indicated.

Source: Rule 333-016-0030 — Test for Eye Irritants, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-0030.

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 333-016-0030’s source at or​.us