Document 43Vox48Z6oRq8BNpnKO8986p

William D. Broddle (conoco) To T. Grumbles Date 10/31/84 Attached Is a copy of the eye Irritancy assay mentioned In OSHA's Hazard Communication Regulation (CFR 16/ 1500.42). Page 580 describes a positive result and will require some interpretation of the test data. Am also sending a recent Conoco MSDS form. Good to hear from Bill lei Copy: Fife: X-F: YEV-l48985 s and should ,-*x of the niisve are tucked Portion to "balservoir for the have sufficient . dose without table are given s and the apexposed to the 38 may vary in aller or larger unctuous ma ty to the skin, employed inreen Is padded 2 centimeters the case of dry skin and subt Physiological The sleeve or the gauze that te skin. In the era, the meas>uted on cotecured to the percentage of >1 body surface 10.7 Is can be atios obloyed. At the 3 or screens unabsorbed ed, and the -Tie subjects wiping, ob>f poisoning, eks. hg primary he skin is ichnique on i of the alair. A min: in abraded ace under a deal gauze nd two sin(in the case the case of Chapter II--Consumer Product Safety Commission 1500.42 solids and semisolids) of the test sub stance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The aniwaia are immobilized with patches secured in place by ad hesive tape. The entire trunk of the ani mal Is then wrapped with an impervious material, such as rubberized cloth, for the 24-hour period of exposure. This ma terial aids In maintaining the test patches In position and retards the evap oration of volatile substances. After 24 hours of exposure, the patches are re moved and the resulting reactions are evaluated on the basis of the designated values In the following table: Skin reaction Valued Erythema and eschar formation: He erythema---------------------------- --____- 0 Very slight erythema (barely percep tible) ..... l Well-defined erythema______ ___ ...... 3 Moderate to severe erythema_______ -- 8 Seven erythema (beet redness) to slight eschar formations (Injuries In depth)______________-- 4 Edema formation: Ho edema....._______________________ 0 Very slight edema (barely percepti ble) _________________ ______________ 1 Slight edema (edges of area weU de fined by definite raising) .......... 3 Moderate edema (raised approximately 1 millimeter) ________ _______ ___ $ Severe edema (raised more than 1 mil limeter and extending beyond the area of exposure)_________ 4 `The "value" recorded tor each reading ts the average value of the six or mere sntmals subject to me teat. Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of ex posures are made on areas of skin that have been previously abraded. The abra sions 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 thin paragraph. Add the values for erythema and eschar forma tion at 24 hours and at 72 hours for in tact 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). Hie total of the eight values is divided by four to give the primary irritation score: for example: SHn reaction Exposure Evalua time tion value (hours) Erythema and eschar forma. tlonr Do........................................... Do....................................... Subtotal......................... Edense formation*. Intact skin........................... . Do...................................... Do....................................... Subtotal........................ 74 72 24 72 24 72 24 72 2 1 3 2 8 0 1 1 2 4 12 Thus, the primary irritation score is 12-t-4s>3. 1500.42 Teat for eye Irritants. (a) (I) Six albino rabbits are used for each test substance. Animal faculties for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous ma terials 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 de fects or Irritation shall be used. The anhwai is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance la dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining un treated, serves as a control. For testing liquids, 0.1 milliliter is used. For solids or pastes, 100 milligram* of the test sub stance is used, except that for substances in flake, granule, powder, or other par ticulate form the amount that has a volume of 0.1 milliliter (after compact ing 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. (2) The eyes are examined and the grade of ocular reaction is recorded at 24. 48, and 72 hours. Reading of reac tions is facilitated by use of a binocular 579 A / ft 1500.43 Title 16--Commercial Practice* loupe, hand slit-lamp, or other expert means. Alter the recording of observa tions at 24 hours, any or all eyes may be further examined after applying fluores cein. For this optional test, one drop of fluorescein sodium ophthalmic solution UJ9P. or equivalent is dropped directly cm the cornea. After flushing out the excess flouresceln with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized In a darkened room under ultraviolet illumination. Any or all eyes may be washed with sodium chloride so lution UJ9P. or equivalent after the 24hour reading. (b)(1) 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 stippling), 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 circumcomeal injection of the blood ves sels), or if such substance produces in the conjunctivae (excluding the cornea and iris) an obvious swelling with par tial eversion of the lids or a diffuse crimson-red with individual vessels not easily discernible. (2) The test shall be considered posi tive if four or more of the *im*ia in the tot group exhibit a positive reaction. If only one animal exhibits a positive re action, the test shall be regarded as negative, if two or three animals ex hibit a positive reaction, the test is re peated using a different group of six animals. The second test shall be con sidered 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. <c) 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 paragraph (a) of this sec tion, an "Illustrated Guide for Grading Eye Irritation by Hazardous Substances'* will be sold by the Superintendent of Documents, T7H. Government Printing Office, Washington, D.C. 20402. The guide will contain color plates depicting re sponses of varying intensity to specific test solutions. The grade of response and the substance used to produce the re sponse will be Indicated. {88 FR 27012, Sept. 27, 1978; 88 PR SOUR. NOV. 1, 1978] 1500.43 Method of test for flashpoint of volatile flammable materials by Tagtiobue open-cup apparatus. Scon 1. (a) This method deearlbea a test proceOure tor the determination at open-cup flashpoints of volatile flammable materials having flashpoints below 178* F. (b) This method, when applied to paints and resin volutions which tend to skin over or which are very viscous, gives lssa repro ducible results than when applied to solvents. Omars or lCrrsoo 2. The sample is placed In the cup of Tag Open Teeter, and heated at a alow but conatant rate. A email teat flame la passed at a uniform rate across the cup at specified intervals. The flashpoint Is taken aa the lowest temperature at which application of the test flame causes the vapor at the sur face of the liquid to flssh, that is. Ignite but not continue to burn. AfpaX&tus a. The Tag open-cup tester Is illustrated in Fig. 1. It oonslsts of the following parts, which must conform to the dimensions shown, and have the additional characteris tics aa noted; (a) Copper bath, preferably equipped with a conatant level overflow so placed as to maintain the bath liquid level ft Inch below the rim of the glass cup. (b) Thermometer holder. Support firmly with rlngstand and clamp. (s) Thermometer. For flashpoints above 40* F,, use the ASTM Tag doted Tester Thermometer, range of +20 to +230* F,, in 1* F. divisions, and conforming to thermom eter 9P. of ASTM Standard 8 1. For4la*hpolnta from 20* F. to 40* F,, use ASTM;Tkg Closed Tester, how Range, Thermometer 6TF. For flashpoints below 20* 7.. use ASTM Ther mometer S8F. The original Tag Open-Cup (Paper scale) Thermometer will be a permis sible alternate until January 1, 1962. It Is calibrated to --20* F. (d) Glass tert cup. Olaas test cup (Fig. 3), of molded clear glass, annealed, heat-re sistant, and free from surface defects. (e) Leveling device. Leveling device or guide, for proper adjustment of the liquid level In the cup (Fig. 8). This shall be made of No. 18-gage polished aluminum, with a projection for adjusting the liquid level when the sample is added to exactly ft-inch be low the level of the edge or rim of the cup. (f) "Micro,'* or small gas burner of suita ble dimensions for heating the bath. A screw damp may be used to help regulate the gas. A smau electric heater may be used. 680