The Experts below are selected from a list of 186 Experts worldwide ranked by ideXlab platform
Helena Kandarova - One of the best experts on this subject based on the ideXlab platform.
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con4ei development of Testing strategies for hazard identification and labelling for serious eye damage and eye irritation of Chemicals
Toxicology in Vitro, 2017Co-Authors: Els Adriaens, Helena Kandarova, Robert Guest, Sandra Verstraelen, Nathalie Alepee, A Drzewiecka, K Gruszka, Jamin A Willoughby, A R Van RompayAbstract:Abstract Assessment of acute eye irritation potential is part of the international regulatory requirements for safety Testing of Chemicals. In the last decades, many efforts have been made in the search for alternative methods to replace the regulatory in vivo Draize rabbit eye test (OECD TG 405). Success in terms of complete replacement of the regulatory in vivo Draize rabbit eye test has not yet been achieved. The main objective of the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation Testing strategy) project was to develop tiered Testing strategies for serious eye damage and eye irritation assessment that can lead to complete replacement of OECD TG 405. A set of 80 reference Chemicals ( e . g . balanced by important driver of classification and physical state), was tested with seven test methods. Based on the results of this project, three different strategies were suggested. We have provided a standalone (EpiOcular ET-50), a two-tiered and three-tiered strategy, that can be used to distinguish between Cat 1 and Cat 2 Chemicals and Chemicals that do not require classification (No Cat). The two-tiered and three-tiered strategies use an RhCE test method (EpiOcular EIT or SkinEthic™ EIT) at the bottom (identification No Cat) in combination with the BCOP LLBO (two-tiered strategy) or BCOP OP-KIT and SMI (three-tiered strategy) at the top (identification Cat 1). For our proposed strategies, 71.1% - 82.9% Cat 1, 64.2% - 68.5% Cat 2 and ≥ 80% No Cat Chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach.
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con4ei consortium for in vitro eye irritation Testing strategy epiocular time to toxicity epiocular et 50 protocols for hazard identification and labelling of eye irritating Chemicals
Toxicology in Vitro, 2017Co-Authors: Helena Kandarova, Robert Guest, Els Adriaens, Sandra Verstraelen, Nathalie Alepee, A Drzewiecka, K Gruszka, Jamin A Willoughby, Silvia Letasiova, A R Van RompayAbstract:Abstract Assessment of acute eye irritation potential is part of the international regulatory requirements for Testing of Chemicals. The objective of the CON4EI (CONsortium for in vitro Eye Irritation Testing strategy) project was to develop tiered Testing strategies for eye irritation assessment for all drivers of classification. A set of 80 reference Chemicals (38 liquids and 42 solids) was tested with eight different alternative methods. Here, the results obtained with reconstructed human cornea-like epithelium (RhCE) EpiOcular™ in the EpiOcular time-to-toxicity Tests (Neat and Dilution ET-50 protocols) are presented. The primary aim of this study was to evaluate whether test methods can discriminate Chemicals not requiring classification for serious eye damage/eye irritancy (No Category) from Chemicals requiring classification and labelling for Category 1 and Category 2. In addition, the predictive capacity in terms of in vivo drivers of classification was investigated. The Chemicals were tested in two independent runs by MatTek In Vitro Life Science Laboratories. Results of this study demonstrate very high specificity of both test protocols. With the existing prediction models described in the SOPs, the specificity of the Neat and Dilution method was 87% and 100%, respectively. The Dilution method was able to correctly predicting 66% of GHS Cat 2 Chemicals, however, prediction of GHS Cat 1 Chemicals was only 47%–55% using the current protocols. In order to achieve optimal prediction for all three classes, a Testing strategy was developed which combines the most predictive time-points of both protocols and for tests liquids and solids separately. Using this new Testing strategy, the sensitivity for predicting GHS Cat 1 and GHS Cat 2 Chemicals was 73% and 64%, respectively and the very high specificity of 97% was maintained. None of the Cat 1 Chemicals was underpredicted as GHS No Category. Further combination of the EpiOcular time-to-toxicity protocols with other validated in vitro systems evaluated in this project, should enable significant reduction and even possible replacement of the animal tests for the final assessment of the irritation potential in all of the GHS classes.
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an in vitro skin irritation test sit using the epiderm reconstructed human epidermal rhe model
Journal of Visualized Experiments, 2009Co-Authors: Helena Kandarova, Patrick Hayden, Mitchell Klausner, Joseph Kubilus, John SheasgreenAbstract:The EpiDerm Skin Irritation test (EpiDerm SIT) was developed (1,2,3) and validated (4,5) for in vitro skin irritation Testing of Chemicals, including cosmetic and pharmaceutical ingredients. The EpiDerm SIT utilizes the 3D in vitro reconstructed human epidermal (RHE) model EpiDerm. The procedure described in this protocol allows for discrimination between irritants of GHS category 2 and non-irritants (6). The test is performed over the course of a 4 day time period, consisting of pre-incubation, 60 minute exposure, 42 hour post-incubation and MTT viability assay. After tissue receipt and overnight pre-incubation (Day 0), tissues are topically exposed to the test Chemicals (Day 1), which can be liquid, semi-solids, solid or wax. Three tissues are used for each test chemical, as well as for the positive control (5% aq. SDS solution), and a negative control (DPBS). Chemical exposure lasts for 60 minutes, 35 min of which the tissues are kept in an incubator at 37°C. The test substances are then removed from the tissue surface by an extensive washing procedure. The tissue inserts are blotted and transferred to fresh medium. After a 24 hr incubation period (Day 2), the medium is exchanged. The medium can be saved for further analysis of cytokines or other endpoints of interest. After the medium exchange, tissues are incubated for an additional 18 hours. At the end of the entire 42h post-incubation (day 3), the tissues are transferred into yellow MTT solution and incubated for 3 hours. The resultant purple-blue formazan salt, formed mainly by mitochondrial metabolism, is extracted for 2 hours using isopropanol. The optical density of the extracted formazan is determined using a spectrophotometer. A chemical is classified as an irritant if the tissue viability relative to the negative control treated tissues is reduced below 50%. This procedure can be used as full replacement of the in vivo rabbit skin irritation test for hazard identification and labeling of Chemicals in line with EU regulations (7).
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assessment of the human epidermis model skinethic rhe for in vitro skin corrosion Testing of Chemicals according to new oecd tg 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN and EpiDerm. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories -- ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%
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Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion Testing of Chemicals according to new OECD TG 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic™ reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm™ skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN™ and EpiDerm™. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories-ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic™ epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic™ model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%. © 2005 Elsevier Ltd. All rights reserved.
Armin O. Gamer - One of the best experts on this subject based on the ideXlab platform.
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assessment of the human epidermis model skinethic rhe for in vitro skin corrosion Testing of Chemicals according to new oecd tg 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN and EpiDerm. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories -- ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%
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Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion Testing of Chemicals according to new OECD TG 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic™ reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm™ skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN™ and EpiDerm™. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories-ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic™ epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic™ model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%. © 2005 Elsevier Ltd. All rights reserved.
Robert Guest - One of the best experts on this subject based on the ideXlab platform.
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con4ei development of Testing strategies for hazard identification and labelling for serious eye damage and eye irritation of Chemicals
Toxicology in Vitro, 2017Co-Authors: Els Adriaens, Helena Kandarova, Robert Guest, Sandra Verstraelen, Nathalie Alepee, A Drzewiecka, K Gruszka, Jamin A Willoughby, A R Van RompayAbstract:Abstract Assessment of acute eye irritation potential is part of the international regulatory requirements for safety Testing of Chemicals. In the last decades, many efforts have been made in the search for alternative methods to replace the regulatory in vivo Draize rabbit eye test (OECD TG 405). Success in terms of complete replacement of the regulatory in vivo Draize rabbit eye test has not yet been achieved. The main objective of the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation Testing strategy) project was to develop tiered Testing strategies for serious eye damage and eye irritation assessment that can lead to complete replacement of OECD TG 405. A set of 80 reference Chemicals ( e . g . balanced by important driver of classification and physical state), was tested with seven test methods. Based on the results of this project, three different strategies were suggested. We have provided a standalone (EpiOcular ET-50), a two-tiered and three-tiered strategy, that can be used to distinguish between Cat 1 and Cat 2 Chemicals and Chemicals that do not require classification (No Cat). The two-tiered and three-tiered strategies use an RhCE test method (EpiOcular EIT or SkinEthic™ EIT) at the bottom (identification No Cat) in combination with the BCOP LLBO (two-tiered strategy) or BCOP OP-KIT and SMI (three-tiered strategy) at the top (identification Cat 1). For our proposed strategies, 71.1% - 82.9% Cat 1, 64.2% - 68.5% Cat 2 and ≥ 80% No Cat Chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach.
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con4ei consortium for in vitro eye irritation Testing strategy epiocular time to toxicity epiocular et 50 protocols for hazard identification and labelling of eye irritating Chemicals
Toxicology in Vitro, 2017Co-Authors: Helena Kandarova, Robert Guest, Els Adriaens, Sandra Verstraelen, Nathalie Alepee, A Drzewiecka, K Gruszka, Jamin A Willoughby, Silvia Letasiova, A R Van RompayAbstract:Abstract Assessment of acute eye irritation potential is part of the international regulatory requirements for Testing of Chemicals. The objective of the CON4EI (CONsortium for in vitro Eye Irritation Testing strategy) project was to develop tiered Testing strategies for eye irritation assessment for all drivers of classification. A set of 80 reference Chemicals (38 liquids and 42 solids) was tested with eight different alternative methods. Here, the results obtained with reconstructed human cornea-like epithelium (RhCE) EpiOcular™ in the EpiOcular time-to-toxicity Tests (Neat and Dilution ET-50 protocols) are presented. The primary aim of this study was to evaluate whether test methods can discriminate Chemicals not requiring classification for serious eye damage/eye irritancy (No Category) from Chemicals requiring classification and labelling for Category 1 and Category 2. In addition, the predictive capacity in terms of in vivo drivers of classification was investigated. The Chemicals were tested in two independent runs by MatTek In Vitro Life Science Laboratories. Results of this study demonstrate very high specificity of both test protocols. With the existing prediction models described in the SOPs, the specificity of the Neat and Dilution method was 87% and 100%, respectively. The Dilution method was able to correctly predicting 66% of GHS Cat 2 Chemicals, however, prediction of GHS Cat 1 Chemicals was only 47%–55% using the current protocols. In order to achieve optimal prediction for all three classes, a Testing strategy was developed which combines the most predictive time-points of both protocols and for tests liquids and solids separately. Using this new Testing strategy, the sensitivity for predicting GHS Cat 1 and GHS Cat 2 Chemicals was 73% and 64%, respectively and the very high specificity of 97% was maintained. None of the Cat 1 Chemicals was underpredicted as GHS No Category. Further combination of the EpiOcular time-to-toxicity protocols with other validated in vitro systems evaluated in this project, should enable significant reduction and even possible replacement of the animal tests for the final assessment of the irritation potential in all of the GHS classes.
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assessment of the human epidermis model skinethic rhe for in vitro skin corrosion Testing of Chemicals according to new oecd tg 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN and EpiDerm. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories -- ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%
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Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion Testing of Chemicals according to new OECD TG 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic™ reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm™ skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN™ and EpiDerm™. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories-ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic™ epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic™ model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%. © 2005 Elsevier Ltd. All rights reserved.
Horst Spielmann - One of the best experts on this subject based on the ideXlab platform.
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assessment of the human epidermis model skinethic rhe for in vitro skin corrosion Testing of Chemicals according to new oecd tg 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN and EpiDerm. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories -- ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%
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Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion Testing of Chemicals according to new OECD TG 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic™ reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm™ skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN™ and EpiDerm™. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories-ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic™ epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic™ model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%. © 2005 Elsevier Ltd. All rights reserved.
Neil Warren - One of the best experts on this subject based on the ideXlab platform.
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assessment of the human epidermis model skinethic rhe for in vitro skin corrosion Testing of Chemicals according to new oecd tg 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN and EpiDerm. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories -- ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%
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Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion Testing of Chemicals according to new OECD TG 431
Toxicology in Vitro, 2006Co-Authors: Helena Kandarova, Elisabeth Schmidt, Elke Genschow, Dieter Traue, Andrew Whittingham, Neil Warren, Robert Guest, Horst Spielmann, Manfred Liebsch, Armin O. GamerAbstract:Based on two successfully completed ECVAM validation studies for in vitro skin corrosion Testing of Chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion Testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion Testing. In addition, the guideline requires correct prediction of 12 reference Chemicals and assessment of intra- and inter-laboratory variability. To show that the OECD TG 431 concept works, in 2003 ZEBET tested several Chemicals from the ECVAM validation trials on the SkinEthic™ reconstituted human epidermal (RHE) model. Based on knowledge that reconstructed human skin models perform similarly in toxicological studies, it was decided to adopt the validated EpiDerm™ skin corrosion test protocol and prediction model to the SkinEthic model. After minor technical changes, classifications were obtained in concordance with those reported for the validated human skin models EPISKIN™ and EpiDerm™. To allow adequate determination of inter-laboratory reproducibility, a blind trial was conducted in three laboratories-ZEBET (D), Safepharm (UK) and BASF (D), in which the 12 endorsed reference Chemicals were tested. Results obtained with the SkinEthic™ epidermal model were reproducible, both within and between laboratories, and over time. Concordance between the in vitro predictions of skin corrosivity potential obtained with the SkinEthic™ model and the predictions obtained with the accepted tests of OECD TG 430 and TG 431 was very good. The new test was able to distinguish between corrosive and non-corrosive reference Chemicals with an accuracy of 93%. © 2005 Elsevier Ltd. All rights reserved.