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Naohiro Nishiyama - One of the best experts on this subject based on the ideXlab platform.
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The Short Time Exposure (STE) test for predicting Eye Irritation potential: intra-laboratory reproducibility and correspondence to globally harmonized system (GHS) and EU Eye Irritation classification for 109 chemicals.
Toxicology in Vitro, 2011Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Kazuhiko Hayashi, Naohiro NishiyamaAbstract:Abstract Short Time Exposure (STE) test is an easy in vitro Eye Irritation test that assesses cytotoxicity in SIRC cells (rabbit corneal cell line) following a 5 min dose treatment. To assess intra-laboratory reproducibility, medium control, three vehicles (saline, saline containing 5% (w/w) dimethyl sulfoxide, and mineral oil) and three standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) were evaluated. Assessments were repeated 30 times for vehicles and 18 times for standard chemicals; resulting in almost the same cell viability and a low coefficient of variation value. In addition, the STE Eye Irritation rankings of three standard chemicals, as calculated on the cell viabilities in 5% and 0.05% solutions were in agreement in all tests. Based on these results, high intra-laboratory reproducibility was confirmed. In addition, the Irritation category (irritant and non-irritant) was evaluated for 109 chemicals with STE test, globally harmonized system (GHS) classification, and European Union (EU) classification. The results of the evaluation found the STE classification to have an accuracy with GHS classification of 87% and with EU classification of 83%, which confirmed the excellent correspondence. The correspondence of STE rankings (1, 2, and 3) based on the prediction model by STE test with the Eye Irritation rankings by GHS (non-irritant, categories 2 and 1) and EU (non-irritant, R36, and R41) was 76% and 71%, respectively. Based on the above results, STE test was considered to be a promising alternative method for assessing Eye Irritation that has high intra-laboratory reproducibility as well as an excellent predictability of Eye Irritation.
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and Ocular Toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration t...
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and ocular toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration tested, exhibiting high between-laboratory reproducibility. The correspondence rates for predicting Eye Irritation potential of undiluted raw materials and a diluted solution (10%) were over 85% at each laboratory for the 5% and 0.05% test concentrations in the STE. Lastly, the correspondence rate for the rank classification by the STE test prediction model at each laboratory was over 72%, and the correspondence rate became almost 90% when acids, amines, and alcohols were excluded from the analysis. From the above data, excellent transferability, high between-laboratory reproducibility, and high predictive capacity of the STE test were observed in the interlaboratory study by 2 laboratories.
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Development of the short time exposure (STE) test: An in vitro Eye Irritation test using SIRC cells
Toxicology in Vitro, 2007Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Hiroyuki Suzuki, Hiroshi Honda, Naohiro NishiyamaAbstract:Abstract Using SIRC (rabbit corneal cell line) cells, we developed an alternative Eye Irritation test: the short time exposure (STE) test. This STE test is a cytotoxicity test using physiological saline or mineral oil as the test solvent. Evaluation exposure time is short (5 min), which is similar to actual exposure situations, and uses the cell viability (CV) at a constant concentration as the endpoint for Irritation potential. First, in order to confirm the usefulness of this STE test in assessing Eye Irritation potential of chemicals, 51 raw materials were tested and the correlation between CV in the STE test and the Eye Irritation score in the Draize test was examined. For the undiluted raw materials tested in the Draize test, the 5% test concentration in the STE test gave Irritation classes that correlated well with the Irritation classes from the Draize test (accuracy: 89.6%). For those materials tested as a 10% solution in the Draize test, STE Irritation classes with 0.05% test concentration corresponded well with the Draize Irritation classes (accuracy: 80.0%). Next, using the cell viabilities at these two concentrations, the STE prediction model (PM) was developed. A score of 1 or 2 was given for the results from each tested concentration in the STE test and Draize test. The scores from each test were then summed to yield a 3-level (Rank 1: minimally irritant, Rank 2: moderate irritant, Rank 3: severe irritant) Eye Irritation potential classification. Rank classification in the STE test showed a good correlation mostly to that in the Draize test (Irritation class correspondence rate: 70.2%, but after exclusion of data of alcoholic materials, the rate was 91.7%). In most cytotoxicity test, the cytotoxicity of acids and amines is generally underestimated due the use of medium as the solvent. This is the result of the buffering capacity of the media. On the other hand, the STE test could predict the Eye Irritation potential by evaluating the chemical with a 5% test concentration. Eleven water insoluble materials such as toluene, octanol, and hexanol could be evaluated by using mineral oil as test solvent in the STE test. The STE test demonstrated itself to be simple, promising, have great potential, be of value, and to be an easily standardized alternative Eye Irritation test.
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Development of the short time exposure (STE) test: An in vitro Eye Irritation test using SIRC cells
Toxicology in Vitro, 2007Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Hiroyuki Suzuki, Hiroshi Honda, Naohiro NishiyamaAbstract:Abstract Using SIRC (rabbit corneal cell line) cells, we developed an alternative Eye Irritation test: the short time exposure (STE) test. This STE test is a cytotoxicity test using physiological saline or mineral oil as the test solvent. Evaluation exposure time is short (5 min), which is similar to actual exposure situations, and uses the cell viability (CV) at a constant concentration as the endpoint for Irritation potential. First, in order to confirm the usefulness of this STE test in assessing Eye Irritation potential of chemicals, 51 raw materials were tested and the correlation between CV in the STE test and the Eye Irritation score in the Draize test was examined. For the undiluted raw materials tested in the Draize test, the 5% test concentration in the STE test gave Irritation classes that correlated well with the Irritation classes from the Draize test (accuracy: 89.6%). For those materials tested as a 10% solution in the Draize test, STE Irritation classes with 0.05% test concentration corresponded well with the Draize Irritation classes (accuracy: 80.0%). Next, using the cell viabilities at these two concentrations, the STE prediction model (PM) was developed. A score of 1 or 2 was given for the results from each tested concentration in the STE test and Draize test. The scores from each test were then summed to yield a 3-level (Rank 1: minimally irritant, Rank 2: moderate irritant, Rank 3: severe irritant) Eye Irritation potential classification. Rank classification in the STE test showed a good correlation mostly to that in the Draize test (Irritation class correspondence rate: 70.2%, but after exclusion of data of alcoholic materials, the rate was 91.7%). In most cytotoxicity test, the cytotoxicity of acids and amines is generally underestimated due the use of medium as the solvent. This is the result of the buffering capacity of the media. On the other hand, the STE test could predict the Eye Irritation potential by evaluating the chemical with a 5% test concentration. Eleven water insoluble materials such as toluene, octanol, and hexanol could be evaluated by using mineral oil as test solvent in the STE test. The STE test demonstrated itself to be simple, promising, have great potential, be of value, and to be an easily standardized alternative Eye Irritation test.
Hitoshi Sakaguchi - One of the best experts on this subject based on the ideXlab platform.
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Predictive performance of the Short Time Exposure test for identifying Eye Irritation potential of chemical mixtures.
Toxicology in Vitro, 2015Co-Authors: Kazutoshi Saito, Masaaki Miyazawa, Yuko Nukada, Kyo Ei, Hitoshi SakaguchiAbstract:Abstract The Short Time Exposure (STE) test is an in vitro Eye Irritation test based on the cytotoxicity in SIRC cells (rabbit corneal cell line) following a 5 min treatment of chemicals. This study evaluated the predictive performance of the STE test to identify the globally harmonized system (GHS) Not Classified category and other irritant categories (i.e., GHS Category 1 or 2) when used to test 40 chemical mixtures that included irritants. The STE test correctly identified 30 tested mixtures classified as GHS irritant categories and 5 out of 10 tested mixtures classified as GHS Not Classified. The sensitivity, specificity, positive predictivity, negative predictivity, and overall accuracy of the STE test were 100% (30/30), 50% (5/10), 86% (25/30), 100% (5/5), and 88% (35/40), respectively. These predictive performances were comparative to or greater than those in other in vitro Eye Irritation tests that have been accepted as test guideline by the Organisation for Economic Co-operation and Development. This suggests that the STE test has sufficient predictivity for identifying the Eye Irritation potential of chemical mixtures. Since no false negatives in this study were found, this indicates that the STE test is applicable as a part of the bottom-up approach.
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The Short Time Exposure (STE) test for predicting Eye Irritation potential: intra-laboratory reproducibility and correspondence to globally harmonized system (GHS) and EU Eye Irritation classification for 109 chemicals.
Toxicology in Vitro, 2011Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Kazuhiko Hayashi, Naohiro NishiyamaAbstract:Abstract Short Time Exposure (STE) test is an easy in vitro Eye Irritation test that assesses cytotoxicity in SIRC cells (rabbit corneal cell line) following a 5 min dose treatment. To assess intra-laboratory reproducibility, medium control, three vehicles (saline, saline containing 5% (w/w) dimethyl sulfoxide, and mineral oil) and three standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) were evaluated. Assessments were repeated 30 times for vehicles and 18 times for standard chemicals; resulting in almost the same cell viability and a low coefficient of variation value. In addition, the STE Eye Irritation rankings of three standard chemicals, as calculated on the cell viabilities in 5% and 0.05% solutions were in agreement in all tests. Based on these results, high intra-laboratory reproducibility was confirmed. In addition, the Irritation category (irritant and non-irritant) was evaluated for 109 chemicals with STE test, globally harmonized system (GHS) classification, and European Union (EU) classification. The results of the evaluation found the STE classification to have an accuracy with GHS classification of 87% and with EU classification of 83%, which confirmed the excellent correspondence. The correspondence of STE rankings (1, 2, and 3) based on the prediction model by STE test with the Eye Irritation rankings by GHS (non-irritant, categories 2 and 1) and EU (non-irritant, R36, and R41) was 76% and 71%, respectively. Based on the above results, STE test was considered to be a promising alternative method for assessing Eye Irritation that has high intra-laboratory reproducibility as well as an excellent predictability of Eye Irritation.
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and Ocular Toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration t...
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and ocular toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration tested, exhibiting high between-laboratory reproducibility. The correspondence rates for predicting Eye Irritation potential of undiluted raw materials and a diluted solution (10%) were over 85% at each laboratory for the 5% and 0.05% test concentrations in the STE. Lastly, the correspondence rate for the rank classification by the STE test prediction model at each laboratory was over 72%, and the correspondence rate became almost 90% when acids, amines, and alcohols were excluded from the analysis. From the above data, excellent transferability, high between-laboratory reproducibility, and high predictive capacity of the STE test were observed in the interlaboratory study by 2 laboratories.
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Development of the short time exposure (STE) test: An in vitro Eye Irritation test using SIRC cells
Toxicology in Vitro, 2007Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Hiroyuki Suzuki, Hiroshi Honda, Naohiro NishiyamaAbstract:Abstract Using SIRC (rabbit corneal cell line) cells, we developed an alternative Eye Irritation test: the short time exposure (STE) test. This STE test is a cytotoxicity test using physiological saline or mineral oil as the test solvent. Evaluation exposure time is short (5 min), which is similar to actual exposure situations, and uses the cell viability (CV) at a constant concentration as the endpoint for Irritation potential. First, in order to confirm the usefulness of this STE test in assessing Eye Irritation potential of chemicals, 51 raw materials were tested and the correlation between CV in the STE test and the Eye Irritation score in the Draize test was examined. For the undiluted raw materials tested in the Draize test, the 5% test concentration in the STE test gave Irritation classes that correlated well with the Irritation classes from the Draize test (accuracy: 89.6%). For those materials tested as a 10% solution in the Draize test, STE Irritation classes with 0.05% test concentration corresponded well with the Draize Irritation classes (accuracy: 80.0%). Next, using the cell viabilities at these two concentrations, the STE prediction model (PM) was developed. A score of 1 or 2 was given for the results from each tested concentration in the STE test and Draize test. The scores from each test were then summed to yield a 3-level (Rank 1: minimally irritant, Rank 2: moderate irritant, Rank 3: severe irritant) Eye Irritation potential classification. Rank classification in the STE test showed a good correlation mostly to that in the Draize test (Irritation class correspondence rate: 70.2%, but after exclusion of data of alcoholic materials, the rate was 91.7%). In most cytotoxicity test, the cytotoxicity of acids and amines is generally underestimated due the use of medium as the solvent. This is the result of the buffering capacity of the media. On the other hand, the STE test could predict the Eye Irritation potential by evaluating the chemical with a 5% test concentration. Eleven water insoluble materials such as toluene, octanol, and hexanol could be evaluated by using mineral oil as test solvent in the STE test. The STE test demonstrated itself to be simple, promising, have great potential, be of value, and to be an easily standardized alternative Eye Irritation test.
Reinhilde Weltens - One of the best experts on this subject based on the ideXlab platform.
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Successful prevalidation of the slug mucosal Irritation test to assess the Eye Irritation potency of chemicals.
Toxicology in Vitro, 2008Co-Authors: Els Adriaens, Bart De Wever, H Bytheway, D Eschrich, Philippe Vanparys, Greet Schoeters, N. Warren, Robert Guest, Erik Hansen, Reinhilde WeltensAbstract:Abstract A previous ‘in house’ validation study showed that the SMI assay can be used as an alternative to the in vivo Draize Eye Irritation test. The aim of this multi-centre study with four participating laboratories was to assess the transferability and inter-laboratory variability of the assay using 20 reference chemicals covering the whole irritancy range. The Eye Irritation potency of the chemicals was assessed by measuring the amount of mucus produced during a 60-min contact period with a 1% dilution, and a second 60-min treatment with a 3.5% dilution. After each contact period the protein release from the mucosal surface was measured. Linear discriminant equations were used to convert the results into the corresponding EU Eye Irritation categories (NI, R36 and R41). All the non-irritants were predicted correctly by the four laboratories resulting in a 100% specificity. For the R36 compounds a correct classification rate of 89% (VITO) and 100% (SPL, JNJ and UGent) was obtained. The R41 compounds were classified correctly in 78% of the cases for VITO, 89% for SPL and JNJ and 100% for UGent. We can conclude that the SMI assay is a relevant, easily transferable and reproducible alternative to predict the Eye Irritation potency of chemicals.
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Successful prevalidation of the slug mucosal Irritation test to assess the Eye Irritation potency of chemicals.
Toxicology in Vitro, 2008Co-Authors: Els Adriaens, H Bytheway, D Eschrich, Philippe Vanparys, Greet Schoeters, N. Warren, Robert Guest, Erik Hansen, B. De Wever, Reinhilde WeltensAbstract:Abstract A previous ‘in house’ validation study showed that the SMI assay can be used as an alternative to the in vivo Draize Eye Irritation test. The aim of this multi-centre study with four participating laboratories was to assess the transferability and inter-laboratory variability of the assay using 20 reference chemicals covering the whole irritancy range. The Eye Irritation potency of the chemicals was assessed by measuring the amount of mucus produced during a 60-min contact period with a 1% dilution, and a second 60-min treatment with a 3.5% dilution. After each contact period the protein release from the mucosal surface was measured. Linear discriminant equations were used to convert the results into the corresponding EU Eye Irritation categories (NI, R36 and R41). All the non-irritants were predicted correctly by the four laboratories resulting in a 100% specificity. For the R36 compounds a correct classification rate of 89% (VITO) and 100% (SPL, JNJ and UGent) was obtained. The R41 compounds were classified correctly in 78% of the cases for VITO, 89% for SPL and JNJ and 100% for UGent. We can conclude that the SMI assay is a relevant, easily transferable and reproducible alternative to predict the Eye Irritation potency of chemicals.
M K Prinsen - One of the best experts on this subject based on the ideXlab platform.
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The isolated chicken Eye test as a suitable in vitro method for determining the Eye Irritation potential of household cleaning products.
Regulatory Toxicology and Pharmacology, 2009Co-Authors: Katrin Schutte, M K Prinsen, Pauline Mcnamee, R RoggebandAbstract:Eye Irritation is an important endpoint in the safety evaluation of consumer products and their ingredients. Several in vitro methods have been developed and are used by different industry sectors to assess Eye Irritation. One such in vitro method in use for some time already is the isolated chicken Eye test (ICE). This investigation focuses on assessing the ICE as a method to determine the Eye Irritation potential of household cleaning products, both for product safety assurance prior to marketing and for classification and labeling decisions. The ICE involves a single application of test substances onto the cornea of isolated chicken Eyes. Endpoints are corneal swelling, corneal opacity and fluorescein retention. The ICE results were compared to historic LVET data in this study due to availability of such in vivo data and the ability to correlate LVET to human experience data on the outcome of accidental exposures to household cleaning products in general. The results of this study indicate that the ICE test is a useful in vitro method for evaluating the Eye Irritation/corrosion potential and establishing classification and labeling for household cleaning products. For new product formulations, it is best used as part of a weight-of-evidence approach and benchmarked against data from comparable formulations with known Eye Irritation/corrosion profiles and market experience. © 2009 Elsevier Inc. All rights reserved.
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Human volunteer study with PGME: Eye Irritation during vapour exposure.
Toxicology letters, 2003Co-Authors: H H Emmen, Hans Muijser, J H E Arts, M K PrinsenAbstract:The objective of this study was to establish the possible occurrence of Eye Irritation and subjective symptoms in human volunteers exposed to propylene glycol monomethyl ether (PGME) vapour at concentrations of 0, 100 and 150 ppm. Testing was conducted in 12 healthy male volunteers using a repeated measures design. Each subject was exposed for 2.5 h to each of the three exposure conditions that were spaced 7 days apart. The exposure sequences were counterbalanced and the exposure to the test substance and the effect measurements were conducted in a double-blind fashion. During all exposure sessions, 20 ppm diethyl ether was used as a 'masking agent' for vapour exposure. Measurements of pre- and post exposure Eye redness, corneal thickness, tear film break-up time, conjunctival epithelial damage, blinking frequency, and subjective ratings on discomfort were used to evaluate the possible irritating effects of PGME. The results indicated no significant treatment effects for any of the objective parameters. Results of the subjective ratings indicated very slight effects on the Eyes in the 150 ppm PGME condition only. No significant effects of treatment were found for the remaining questions concerning the perceived intensity of the smell in the room, the (un)pleasantness of the smell, the perceived effects on the skin, effects on the throat, shivering, muscle aching, and intestinal cramps. In conclusion, the results of the present study indicated minimal subjective Eye effects at 150 ppm only, and no impact on the objective measures of Eye Irritation at either of the two exposure levels. It was concluded that the no adverse effect concentration for Eye Irritation due to PGME vapour was at least 150 ppm.
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Human volunteer study with PGME: Eye Irritation during vapour exposure
Toxicology Letters, 2003Co-Authors: H H Emmen, Hans Muijser, J H E Arts, M K PrinsenAbstract:The objective of this study was to establish the possible occurrence of Eye Irritation and subjective symptoms in human volunteers exposed to propylene glycol monomethyl ether (PGME) vapour at concentrations of 0, 100 and 150 ppm. Testing was conducted in 12 healthy male volunteers using a repeated measures design. Each subject was exposed for 2.5 h to each of the three exposure conditions that were spaced 7 days apart. The exposure sequences were counterbalanced and the exposure to the test substance and the effect measurements were conducted in a double-blind fashion. During all exposure sessions, 20 ppm diethyl ether was used as a 'masking agent' for vapour exposure. Measurements of pre- and post exposure Eye redness, corneal thickness, tear film break-up time, conjunctival epithelial damage, blinking frequency, and subjective ratings on discomfort were used to evaluate the possible irritating effects of PGME. The results indicated no significant treatment effects for any of the objective parameters. Results of the subjective ratings indicated very slight effects on the Eyes in the 150 ppm PGME condition only. No significant effects of treatment were found for the remaining questions concerning the perceived intensity of the smell in the room, the (un)pleasantness of the smell, the perceived effects on the skin, effects on the throat, shivering, muscle aching, and intestinal cramps. In conclusion, the results of the present study indicated minimal subjective Eye effects at 150 ppm only, and no impact on the objective measures of Eye Irritation at either of the two exposure levels. It was concluded that the no adverse effect concentration for Eye Irritation due to PGME vapour was at least 150 ppm. © 2003 Elsevier Science Ireland Ltd. All rights reserved.
Yutaka Takahashi - One of the best experts on this subject based on the ideXlab platform.
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The Short Time Exposure (STE) test for predicting Eye Irritation potential: intra-laboratory reproducibility and correspondence to globally harmonized system (GHS) and EU Eye Irritation classification for 109 chemicals.
Toxicology in Vitro, 2011Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Kazuhiko Hayashi, Naohiro NishiyamaAbstract:Abstract Short Time Exposure (STE) test is an easy in vitro Eye Irritation test that assesses cytotoxicity in SIRC cells (rabbit corneal cell line) following a 5 min dose treatment. To assess intra-laboratory reproducibility, medium control, three vehicles (saline, saline containing 5% (w/w) dimethyl sulfoxide, and mineral oil) and three standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) were evaluated. Assessments were repeated 30 times for vehicles and 18 times for standard chemicals; resulting in almost the same cell viability and a low coefficient of variation value. In addition, the STE Eye Irritation rankings of three standard chemicals, as calculated on the cell viabilities in 5% and 0.05% solutions were in agreement in all tests. Based on these results, high intra-laboratory reproducibility was confirmed. In addition, the Irritation category (irritant and non-irritant) was evaluated for 109 chemicals with STE test, globally harmonized system (GHS) classification, and European Union (EU) classification. The results of the evaluation found the STE classification to have an accuracy with GHS classification of 87% and with EU classification of 83%, which confirmed the excellent correspondence. The correspondence of STE rankings (1, 2, and 3) based on the prediction model by STE test with the Eye Irritation rankings by GHS (non-irritant, categories 2 and 1) and EU (non-irritant, R36, and R41) was 76% and 71%, respectively. Based on the above results, STE test was considered to be a promising alternative method for assessing Eye Irritation that has high intra-laboratory reproducibility as well as an excellent predictability of Eye Irritation.
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and Ocular Toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration t...
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An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting Eye Irritation potential
Cutaneous and ocular toxicology, 2010Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Takumi Hayashi, Hirofumi Kuwahara, Naohiro NishiyamaAbstract:We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative Eye Irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative Eye Irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the Eye Irritation categories (irritants and nonirritants) were over 97% for each concentration tested, exhibiting high between-laboratory reproducibility. The correspondence rates for predicting Eye Irritation potential of undiluted raw materials and a diluted solution (10%) were over 85% at each laboratory for the 5% and 0.05% test concentrations in the STE. Lastly, the correspondence rate for the rank classification by the STE test prediction model at each laboratory was over 72%, and the correspondence rate became almost 90% when acids, amines, and alcohols were excluded from the analysis. From the above data, excellent transferability, high between-laboratory reproducibility, and high predictive capacity of the STE test were observed in the interlaboratory study by 2 laboratories.
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Development of the short time exposure (STE) test: An in vitro Eye Irritation test using SIRC cells
Toxicology in Vitro, 2007Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Hiroyuki Suzuki, Hiroshi Honda, Naohiro NishiyamaAbstract:Abstract Using SIRC (rabbit corneal cell line) cells, we developed an alternative Eye Irritation test: the short time exposure (STE) test. This STE test is a cytotoxicity test using physiological saline or mineral oil as the test solvent. Evaluation exposure time is short (5 min), which is similar to actual exposure situations, and uses the cell viability (CV) at a constant concentration as the endpoint for Irritation potential. First, in order to confirm the usefulness of this STE test in assessing Eye Irritation potential of chemicals, 51 raw materials were tested and the correlation between CV in the STE test and the Eye Irritation score in the Draize test was examined. For the undiluted raw materials tested in the Draize test, the 5% test concentration in the STE test gave Irritation classes that correlated well with the Irritation classes from the Draize test (accuracy: 89.6%). For those materials tested as a 10% solution in the Draize test, STE Irritation classes with 0.05% test concentration corresponded well with the Draize Irritation classes (accuracy: 80.0%). Next, using the cell viabilities at these two concentrations, the STE prediction model (PM) was developed. A score of 1 or 2 was given for the results from each tested concentration in the STE test and Draize test. The scores from each test were then summed to yield a 3-level (Rank 1: minimally irritant, Rank 2: moderate irritant, Rank 3: severe irritant) Eye Irritation potential classification. Rank classification in the STE test showed a good correlation mostly to that in the Draize test (Irritation class correspondence rate: 70.2%, but after exclusion of data of alcoholic materials, the rate was 91.7%). In most cytotoxicity test, the cytotoxicity of acids and amines is generally underestimated due the use of medium as the solvent. This is the result of the buffering capacity of the media. On the other hand, the STE test could predict the Eye Irritation potential by evaluating the chemical with a 5% test concentration. Eleven water insoluble materials such as toluene, octanol, and hexanol could be evaluated by using mineral oil as test solvent in the STE test. The STE test demonstrated itself to be simple, promising, have great potential, be of value, and to be an easily standardized alternative Eye Irritation test.
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Development of the short time exposure (STE) test: An in vitro Eye Irritation test using SIRC cells
Toxicology in Vitro, 2007Co-Authors: Yutaka Takahashi, Mirei Koike, Hitoshi Sakaguchi, Hiroyuki Suzuki, Hiroshi Honda, Naohiro NishiyamaAbstract:Abstract Using SIRC (rabbit corneal cell line) cells, we developed an alternative Eye Irritation test: the short time exposure (STE) test. This STE test is a cytotoxicity test using physiological saline or mineral oil as the test solvent. Evaluation exposure time is short (5 min), which is similar to actual exposure situations, and uses the cell viability (CV) at a constant concentration as the endpoint for Irritation potential. First, in order to confirm the usefulness of this STE test in assessing Eye Irritation potential of chemicals, 51 raw materials were tested and the correlation between CV in the STE test and the Eye Irritation score in the Draize test was examined. For the undiluted raw materials tested in the Draize test, the 5% test concentration in the STE test gave Irritation classes that correlated well with the Irritation classes from the Draize test (accuracy: 89.6%). For those materials tested as a 10% solution in the Draize test, STE Irritation classes with 0.05% test concentration corresponded well with the Draize Irritation classes (accuracy: 80.0%). Next, using the cell viabilities at these two concentrations, the STE prediction model (PM) was developed. A score of 1 or 2 was given for the results from each tested concentration in the STE test and Draize test. The scores from each test were then summed to yield a 3-level (Rank 1: minimally irritant, Rank 2: moderate irritant, Rank 3: severe irritant) Eye Irritation potential classification. Rank classification in the STE test showed a good correlation mostly to that in the Draize test (Irritation class correspondence rate: 70.2%, but after exclusion of data of alcoholic materials, the rate was 91.7%). In most cytotoxicity test, the cytotoxicity of acids and amines is generally underestimated due the use of medium as the solvent. This is the result of the buffering capacity of the media. On the other hand, the STE test could predict the Eye Irritation potential by evaluating the chemical with a 5% test concentration. Eleven water insoluble materials such as toluene, octanol, and hexanol could be evaluated by using mineral oil as test solvent in the STE test. The STE test demonstrated itself to be simple, promising, have great potential, be of value, and to be an easily standardized alternative Eye Irritation test.
