Skin irritation scoring systems

The following scoring system for irritation or sensitization reactions is included as an example of a scoring system that can be used for these studies. Other validated scoring systems can be used in quantifying skin reactions. The inclusion of this system should not be interpreted as an endorsement of the system by the agency. It is provided as an example only. 

7 = strong reaction spreading beyond test site 

A = slight glazed appearance B = marked glazing C = glazing with peeling and cracking D = glazing with fissures 

E = film of dried serous exudate covering all or part of the patch site F = small petechial erosions or scabs 

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

Skin and Eye Irritation The solvent should not be a skin or eye irritant. A product is considered to be a skin irritant if it has a mean score of 2 or more for either erythema and eschar formation or edema formation, based on the OECD dermal scoring system (OECD, TG 404). A product is classified as an eye irritant if it causes significant ocular lesions, in any type of ocular tissue (i.e., cornea, iris, or conjuncti-vae) within 72 hours after exposure and which persist for at least 24 hours. 

Any panellist that develops a positive reaction (defined by an in-house scoring system) to any material, is not retreated with that material at the following exposure(s). All other materials are tested for up to 4 h. If the number of skin reactions to the test material is similar or greater than the control material, then this would indicate that the material should be classified as R38-Irritant. 

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). 

Skin reactions by using a similar scoring system as described for dermal irritation are measured 24, 48 and 72 hours after administration of the drug (FDA 2003). 

In order to estimate the toxicity of the compound one must have data obtained at several dose levels and must see that there is a dose-related response. Further, there must be sufficient animals at each dose level so that the idiosyncracies of a few individual animals will not confuse the results. Excluded from this section are the consideration of eye and skin irritation tests, which have their own specialized scoring system previously 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... 

Toxicology Can cause mild eye Irritation, moderate skin Irritation may cause nausea, vomiting Ing. can cause chemical pneumonia, central nervous system depression repeated or prolonged Inh. may Irritate respiratory tract LD50 (oral, rat) 40 g/kg, (skin, rabbit) 2-4 g/kg skin Irritation Dralze score 5.2/8.0 OEL ACGIH/TLV TWA 5 mg/m OSHA/PEL TWA 5 mg/m ... 

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). 

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