In vitro test for dermal corrosive properties
First Claim
1. A method for determining the degree of corrosive toxicity of a test substance to human skin or membrane which method comprises:
- (a) providing a biobarrier having a first face and a second face, which biobarrier mimics human skin or membrane, the test substance being applied to said first face, andwhich biobarrier is in contact at its second face with a detection system for said substance, wherein contact of said test substance with said detection system produces a detectable signal;
orwhich biobarrier comprises at least one component which is broken down by a skin or membrane corrosive substance to form a breakdown product, said biobarrier being in contact at its second face with a breakdown product detection system wherein contact of said breakdown product with said detection system produces a detectable signal;
(b) applying the test substance at a time T1 to said first face;
(c) allowing the test substance to transit the biobarrier to the second face to contact the detection system and to produce said detectable signal;
orallowing the test substance to react in transit with the biobarrier component to produce said breakdown product and allowing the breakdown product to transit to the second face of the biobarrier and to contact the breakdown product detection system and to produce a detectable signal;
(d) detecting said signal at a subsequent time T2, said time T2 being that time at which said signal is first detectable at a predetermined level;
(e) obtaining the time difference between said times T1 and T2; and
(f) correlating said time difference with corrosive toxicity by comparing said time difference with time differences obtained using substances of known toxicity.
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Abstract
Methods and a device for determining the corrosivity of a substance to human skin or membrane are disclosed. In one approach, corrosivity is evaluated by measuring the time required for the test substance to transit a biobarrier that mimics human skin or membranes or the time required to cause a component of such biobarrier to break down and transit the membrane. The invention also envisions alternative approaches which involve series of layers of dyes and corrosive-resistant materials coated onto microspheres or test strips. Use of these methods provides a rapid determination of the corrosivity of test materials.
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Citations
33 Claims
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1. A method for determining the degree of corrosive toxicity of a test substance to human skin or membrane which method comprises:
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(a) providing a biobarrier having a first face and a second face, which biobarrier mimics human skin or membrane, the test substance being applied to said first face, and which biobarrier is in contact at its second face with a detection system for said substance, wherein contact of said test substance with said detection system produces a detectable signal;
orwhich biobarrier comprises at least one component which is broken down by a skin or membrane corrosive substance to form a breakdown product, said biobarrier being in contact at its second face with a breakdown product detection system wherein contact of said breakdown product with said detection system produces a detectable signal; (b) applying the test substance at a time T1 to said first face; (c) allowing the test substance to transit the biobarrier to the second face to contact the detection system and to produce said detectable signal;
orallowing the test substance to react in transit with the biobarrier component to produce said breakdown product and allowing the breakdown product to transit to the second face of the biobarrier and to contact the breakdown product detection system and to produce a detectable signal; (d) detecting said signal at a subsequent time T2, said time T2 being that time at which said signal is first detectable at a predetermined level; (e) obtaining the time difference between said times T1 and T2; and (f) correlating said time difference with corrosive toxicity by comparing said time difference with time differences obtained using substances of known toxicity. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A device for performing an in vitro test to determine the corrosiveness of a test substance to human skin or membrane, comprising
(a) a biobarrier having a first face and a second face, the biobarrier mimicking human skin or membrane, (b) a detection system which generates a detectable signal in the presence of said test substance contacting the second face of the biobarrier; - or
which biobarrier comprises at least one component which is broken down by a skin corrosive substance to form a breakdown product, said biobarrier being in contact at its second face with a breakdown product detection system wherein contact of said breakdown product with said detection system produces a detectable signal; and (c) a means for recording a time T1 when the test substance is applied to the first face of the biobarrier and for recording a subsequent time T2 when said signal is detected at a predetermined level by the detection system; and (d) a means for reporting the difference between the first and the second times. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method to determine the effect of a test substance on the corrosive toxicity of a known corrosive material which method comprises:
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(a) combining the test substance with the corrosive material to obtain a mixture; (b) providing a biobarrier having a first face and a second face, which biobarrier mimics human skin or membrane, and which biobarrier is in contact at its second face with a detection system wherein the contact of the corrosive material with said detection system produces a detectable signal;
orwhich biobarrier comprises at least one component which is broken down by a skin or membrane corrosive material to form a breakdown product, said biobarrier being in contact at its second face with a breakdown product detection system wherein contact of said breakdown product with said detection system produces a detectable signal; (c) applying said mixture at a time T1 to said first face; (d) allowing the mixture to transit the biobarrier to the second face to contact the detection system and to produce said detectable signal;
orallowing the test substance to react in transit with the biobarrier component to produce said breakdown product and allowing the breakdown product to transit to the second face of the biobarrier and to contact the breakdown product detection system and to produce a detectable signal; (e) detecting said signal at a subsequent time T2, said time T2 being that time at which said signal is first detectable at a predetermined level; (f) obtaining the time difference between said times T1 and T2; and (g) comparing said time difference obtained for the mixture with a similarly determined time difference obtained for the known corrosive material, wherein a larger time difference for the mixture indicates that the test substance has an anti-corrosive effect.
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30. A method for determining the degree of corrosive toxicity of a test substance to human skin or membrane, which method comprises:
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(a) applying the test substance to test microspheres, the microspheres having been prepared by applying a layer of corrosion-resistant material of one color to an underlying particle of a second color, such that if the microspheres are exposed to a sufficiently corrosive substance, the second color is exposed; (b) leaving the test substance in contact with the microspheres for a time greater than 1 second; and (c) observing the color of the contacted microspheres; whereby the test substance is determined to be corrosive if it exposes the second color. - View Dependent Claims (31, 32, 33)
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Specification