Draize scoring system

Draize Scoring System for Evaluation of Skin Irritating and Corrosive Properties... 

Toxicology. The nitroparaffins have minimal effects by way of actual contact. There were neither systemic effects nor irritation in dermal studies in rabbits. Human exposure of a prolonged or often-repeated nature has led to low grade irritation attributable to removal of oil from the skin, an effect produced by most organic solvents. Eye irritation potential of all four nitroparaffins has been deterrnined in rabbits. Other than a transient slight redness and some lachrymation, no effects were noted. The average Draize score was 0.0. The acute oral toxicity, LD q, of all four nitroparaffins has been deterrnined in the rat (Table 8). 

The test guideline methods use the scoring system developed by Draize (1944), see Tables 4.8 and 4.9. The EU criteria for classification are based on the mean tissue scores obtained over the first 24—72h period after exposure and on the reversibUity or irreversibility of the effects observed. 

Comeal organ culture combined with objectively quantifiable assays for comeal epithelial barrier disruption reduces the high variability associated to the subjectively scored Draize Test. Although the surface biotinylation allows for an objective outcome measure, the scoring system is not yet quantitatively comparable for assessment of ocular irritancy to multiple test products. As it is utilized more extensively in varied laboratories with numerous test chemicals a standardized scoring system can be elicited similar to the familiar Draize Test. 

Draize also developed a scoring system which allows classifying the test material with regard to their irritation potential 24 and 72 hours after administration. See Table 3. 

The results are evaluated in comparison to controls with regard to induction of erythema and skin oedema. A similar scoring system is used as in the case of dermal irritation. The signs of local dermal inflammation determine the degree of the allergenic potential (Draize 1944 OECD 1981 Klecak 1983). 

Modified Draize et al. (1944) or a slit-lamp scoring system... 

More that 5300 test samples have been studied in the Skintex system, including petrochemicals, agrochemicals, household products, and cosmetics. The reproducibility with standard deviations of 5-8% is excellent. New protocols applicable to very low irritation test samples and alkaline products have increased the applicability of this method. Skintex validation studies resulting in an 80-90% correlation to the Draize scoring have been reported by S.C. Johnson Son and the Eood and Drug and Safety Center. 

Based on the fact that the lens is embryologically derived from the same ectodermal source as comeal and conjunctival epithelium, Sivak et al. (1992) used an automated scanning laser system to monitor spherical aberration and transmission of the lens in culture. They believed that this method of measuring lens damage compared favorably with standard Draize. scores. 

Animals will be examined for signs of erythema and edema and the responses scored at 24,48, and 72 h after the initial test article application according to the Draize reaction grading system previously presented in this Chapter. 

Opacity. Corneal opacity is the most heavily weighted of the components of the Draize eye score (80 out of 110 possible points) (Conquet et al., 1977). Thus, an in vitro system that provides an accurate measure of opacification should contribute substantially toward in vitro modeling of the classical Draize test. Two assays attempting to model this process are discussed. 

Toxicoiogy LD50 (orai, rat) > 5 g/kg primary skin irritation index 3.04 24 hrs., 0,88-1,5 4 hrs, Draize eye irritation score 54/110 336 hrs. eye, respiratory system irritant may cause skin irritation TSCA listed Precaution Fiamm. iiq. incompat. with carbon steel, strong oxidizers, reducers Hazardous Decomp. Prods. Under lean oxygen conditions ammonia, low m.w. hydrocarbons... 

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