28-July-2015
English
28-July-2015
English
28-July-2015
English
28-July-2015
English
28-July-2015
English
This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application. This Test Guideline recommends sequential testing strategies, which include the performance of validated and accepted in vitro or ex vivo tests for corrosion/irritation.
The albino rabbit is the preferable laboratory animal. The substance to be tested is applied in a single dose to a small area of skin (approximately 6cm²) of an experimental animal; untreated skin areas of the test animal serve as the control. The exposure period is 4 hours. Residual test substance should then be removed. The dose is 0.5ml (liquid) or 0.5g (solid) applied to the test site. The method consists of two tests: the initial test and the confirmatory test (used only if a corrosive effect is not observed in the initial test). All animals should be examined for signs of erythema and oedema during 14 days. The dermal irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. When responses persist to the end of the 14-day observation period, the test substance should be considered an irritant.
28-July-2015
English
28-July-2015
English
28-July-2015
English
28-July-2015
English
The test described in this Test Guideline allows the identification of corrosive chemical substances and mixtures and it enables the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information. The test protocol may also provide an indication of the distinction between severe and less severe skin corrosives. This Test Guideline does not require the use of live animals or animal tissue for the assessment of skin corrosivity.
The test material (solid or liquid) is applied uniformly and topically to a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum. Two tissue replicates are used for each treatment (exposure time), and for controls. Corrosive materials are identified by their ability to produce a decrease in cell viability below defined threshold levels at specified exposure periods. Coloured chemicals can also be tested by used of an HPLC procedure. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers.
28-July-2015
English