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K L Hintze - One of the best experts on this subject based on the ideXlab platform.
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a comparison of low volume Draize and in vitro eye irritation Test data iii surfactant based formulations
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The third phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 25 representative surfactant-based personal-care formulations. In general, these formulations were minimally to moderately irritating. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.87; LVET-MAS values were typically about 30% lower then corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of 95% confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Twenty in vitro endpoints were shown to have the greaTest agreement with the LVET (these endpoints included those with low discordance rates relative to the Draize Test) and were therefore selected for regression modelling. Although prediction interval widths tended to be narrower when predicting LVET-MAS compared with predicting MAS, the confidence with which the selected in vitro endpoints predicted both LVET-MAS and MAS for surfactant-based formulations was greaTest when values were close to the lower or upper limits of the observed irritation range (i.e. 95% prediction interval widths were most narrow in these areas). Overall precision of LVET-MAS prediction for surfactant-based formulations was similar to that previously reported for hydroalcoholic formulations and considerably better than was reported for oil/water emulsions.
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a comparison of low volume Draize and in vitro eye irritation Test data ii oil water emulsions
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The second phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro eye irritation Test protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 18 representative oil/water based personal-care formulations. In general, these formulations were minimally to mildly irritating; only three were classified as moderate eye irritants. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.85; LVET-MAS values were typically about half the corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and each in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower 95% prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Sixteen endpoints were shown to have the greaTest agreement with the LVET (all but two were selected for modelling when compared with the Draize procedure). While the lower maximum average scores values (compared with the Draize Test) in the LVET led to lower variability in LVET-MAS compared to MAS, the upper and lower bounds on predicted LVET-MAS values conditional on observed in vitro scores were still wide. Because there was overlap in the range of scores determined by the prediction bounds for many formulations, each of the selected endpoints was frequently unable to distinguish between Test formulations in terms of statistically different predicted LVET-MAS values. In summary, none of the in vitro endpoints evaluated were able to reliably predict values of LVET-MAS among the set of oil/water emulsions considered here.
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the cfta evaluation of alternatives program an evaluation of in vitro alternatives to the Draize primary eye irritation Test phase iii surfactant based formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, D.m. Bagley, Phillip L. Casterton, R A Lordo, K L Hintze, M Chudkowski, R D Curren, J L Demetrulias, I C Dipasquale, L K EarlAbstract:Abstract The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation Test and comparable data from a selection of promising in vitro eye irritation Tests. In Phase III, data from the Draize Test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modelling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0–45), where variability in MAS was smallest. Thus, the confidence with which the MAS of surfactant-based formulations is predicted is greaTest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize Test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro Test results if the purpose is to predict in vivo response using in vitro data.
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Comparison of low-volume, Draize and in vitro eye irritation Test data. I. Hydroalcoholic formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, R A Lordo, J L Demetrulias, P.i. Feder, K L HintzeAbstract:Abstract The first phase in a series of investigations of the relationship between low-volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from 25 in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro assay data generated previously as part of the Cosmetic, Toiletry and Fragrance Association (CTFA) Evaluation of Alternatives Program. LVET data were generated de novo using the same 10 representative hydroalcoholic personal-care formulations. The linear correlation between maximum average score (MAS) as determined by the Draize Test and the LVET (LVET-MAS) was 0.93. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. As in the CTFA program, regression modelling is the primary means of enabling such a comparison. The objective is to predict LVET-MAS for a given Test material (and to place upper and lower prediction interval bounds in the range in which the LVET-MAS is anticipated to fall with high probability) conditional on observing an in vitro assay score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Four assays [EYTEX™ MPA (membrane partition assay), HET-CAM (hen's egg Test-chorioallantoic membrane HET-CAM) I, neutral red release and HET-CAM II] were shown to have the greaTest agreement with the LVET. These assays were also among those with low discordance rates relative to the Draize Test. Prediction of LVET-MAS values from experimentally determined in vitro scores was more accurate for hydroalcoholic formulations with lower rather than higher irritancy potential.
S D Gettings - One of the best experts on this subject based on the ideXlab platform.
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a comparison of low volume Draize and in vitro eye irritation Test data iii surfactant based formulations
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The third phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 25 representative surfactant-based personal-care formulations. In general, these formulations were minimally to moderately irritating. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.87; LVET-MAS values were typically about 30% lower then corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of 95% confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Twenty in vitro endpoints were shown to have the greaTest agreement with the LVET (these endpoints included those with low discordance rates relative to the Draize Test) and were therefore selected for regression modelling. Although prediction interval widths tended to be narrower when predicting LVET-MAS compared with predicting MAS, the confidence with which the selected in vitro endpoints predicted both LVET-MAS and MAS for surfactant-based formulations was greaTest when values were close to the lower or upper limits of the observed irritation range (i.e. 95% prediction interval widths were most narrow in these areas). Overall precision of LVET-MAS prediction for surfactant-based formulations was similar to that previously reported for hydroalcoholic formulations and considerably better than was reported for oil/water emulsions.
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a comparison of low volume Draize and in vitro eye irritation Test data ii oil water emulsions
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The second phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro eye irritation Test protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 18 representative oil/water based personal-care formulations. In general, these formulations were minimally to mildly irritating; only three were classified as moderate eye irritants. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.85; LVET-MAS values were typically about half the corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and each in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower 95% prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Sixteen endpoints were shown to have the greaTest agreement with the LVET (all but two were selected for modelling when compared with the Draize procedure). While the lower maximum average scores values (compared with the Draize Test) in the LVET led to lower variability in LVET-MAS compared to MAS, the upper and lower bounds on predicted LVET-MAS values conditional on observed in vitro scores were still wide. Because there was overlap in the range of scores determined by the prediction bounds for many formulations, each of the selected endpoints was frequently unable to distinguish between Test formulations in terms of statistically different predicted LVET-MAS values. In summary, none of the in vitro endpoints evaluated were able to reliably predict values of LVET-MAS among the set of oil/water emulsions considered here.
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the cfta evaluation of alternatives program an evaluation of in vitro alternatives to the Draize primary eye irritation Test phase iii surfactant based formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, D.m. Bagley, Phillip L. Casterton, R A Lordo, K L Hintze, M Chudkowski, R D Curren, J L Demetrulias, I C Dipasquale, L K EarlAbstract:Abstract The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation Test and comparable data from a selection of promising in vitro eye irritation Tests. In Phase III, data from the Draize Test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modelling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0–45), where variability in MAS was smallest. Thus, the confidence with which the MAS of surfactant-based formulations is predicted is greaTest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize Test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro Test results if the purpose is to predict in vivo response using in vitro data.
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Comparison of low-volume, Draize and in vitro eye irritation Test data. I. Hydroalcoholic formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, R A Lordo, J L Demetrulias, P.i. Feder, K L HintzeAbstract:Abstract The first phase in a series of investigations of the relationship between low-volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from 25 in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro assay data generated previously as part of the Cosmetic, Toiletry and Fragrance Association (CTFA) Evaluation of Alternatives Program. LVET data were generated de novo using the same 10 representative hydroalcoholic personal-care formulations. The linear correlation between maximum average score (MAS) as determined by the Draize Test and the LVET (LVET-MAS) was 0.93. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. As in the CTFA program, regression modelling is the primary means of enabling such a comparison. The objective is to predict LVET-MAS for a given Test material (and to place upper and lower prediction interval bounds in the range in which the LVET-MAS is anticipated to fall with high probability) conditional on observing an in vitro assay score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Four assays [EYTEX™ MPA (membrane partition assay), HET-CAM (hen's egg Test-chorioallantoic membrane HET-CAM) I, neutral red release and HET-CAM II] were shown to have the greaTest agreement with the LVET. These assays were also among those with low discordance rates relative to the Draize Test. Prediction of LVET-MAS values from experimentally determined in vitro scores was more accurate for hydroalcoholic formulations with lower rather than higher irritancy potential.
R A Lordo - One of the best experts on this subject based on the ideXlab platform.
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a comparison of low volume Draize and in vitro eye irritation Test data iii surfactant based formulations
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The third phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 25 representative surfactant-based personal-care formulations. In general, these formulations were minimally to moderately irritating. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.87; LVET-MAS values were typically about 30% lower then corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of 95% confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Twenty in vitro endpoints were shown to have the greaTest agreement with the LVET (these endpoints included those with low discordance rates relative to the Draize Test) and were therefore selected for regression modelling. Although prediction interval widths tended to be narrower when predicting LVET-MAS compared with predicting MAS, the confidence with which the selected in vitro endpoints predicted both LVET-MAS and MAS for surfactant-based formulations was greaTest when values were close to the lower or upper limits of the observed irritation range (i.e. 95% prediction interval widths were most narrow in these areas). Overall precision of LVET-MAS prediction for surfactant-based formulations was similar to that previously reported for hydroalcoholic formulations and considerably better than was reported for oil/water emulsions.
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a comparison of low volume Draize and in vitro eye irritation Test data ii oil water emulsions
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The second phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro eye irritation Test protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 18 representative oil/water based personal-care formulations. In general, these formulations were minimally to mildly irritating; only three were classified as moderate eye irritants. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.85; LVET-MAS values were typically about half the corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and each in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower 95% prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Sixteen endpoints were shown to have the greaTest agreement with the LVET (all but two were selected for modelling when compared with the Draize procedure). While the lower maximum average scores values (compared with the Draize Test) in the LVET led to lower variability in LVET-MAS compared to MAS, the upper and lower bounds on predicted LVET-MAS values conditional on observed in vitro scores were still wide. Because there was overlap in the range of scores determined by the prediction bounds for many formulations, each of the selected endpoints was frequently unable to distinguish between Test formulations in terms of statistically different predicted LVET-MAS values. In summary, none of the in vitro endpoints evaluated were able to reliably predict values of LVET-MAS among the set of oil/water emulsions considered here.
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the cfta evaluation of alternatives program an evaluation of in vitro alternatives to the Draize primary eye irritation Test phase iii surfactant based formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, D.m. Bagley, Phillip L. Casterton, R A Lordo, K L Hintze, M Chudkowski, R D Curren, J L Demetrulias, I C Dipasquale, L K EarlAbstract:Abstract The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation Test and comparable data from a selection of promising in vitro eye irritation Tests. In Phase III, data from the Draize Test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modelling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0–45), where variability in MAS was smallest. Thus, the confidence with which the MAS of surfactant-based formulations is predicted is greaTest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize Test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro Test results if the purpose is to predict in vivo response using in vitro data.
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Comparison of low-volume, Draize and in vitro eye irritation Test data. I. Hydroalcoholic formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, R A Lordo, J L Demetrulias, P.i. Feder, K L HintzeAbstract:Abstract The first phase in a series of investigations of the relationship between low-volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from 25 in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro assay data generated previously as part of the Cosmetic, Toiletry and Fragrance Association (CTFA) Evaluation of Alternatives Program. LVET data were generated de novo using the same 10 representative hydroalcoholic personal-care formulations. The linear correlation between maximum average score (MAS) as determined by the Draize Test and the LVET (LVET-MAS) was 0.93. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. As in the CTFA program, regression modelling is the primary means of enabling such a comparison. The objective is to predict LVET-MAS for a given Test material (and to place upper and lower prediction interval bounds in the range in which the LVET-MAS is anticipated to fall with high probability) conditional on observing an in vitro assay score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Four assays [EYTEX™ MPA (membrane partition assay), HET-CAM (hen's egg Test-chorioallantoic membrane HET-CAM) I, neutral red release and HET-CAM II] were shown to have the greaTest agreement with the LVET. These assays were also among those with low discordance rates relative to the Draize Test. Prediction of LVET-MAS values from experimentally determined in vitro scores was more accurate for hydroalcoholic formulations with lower rather than higher irritancy potential.
Hajime Kojima - One of the best experts on this subject based on the ideXlab platform.
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Interlaboratory Validation of the in vitro Eye Irritation Tests for Cosmetic Ingredients. (4) Haemoglobin Denaturation Test.
Toxicology in Vitro, 1999Co-Authors: Masato Hatao, Kazutami Sakamoto, Chiho Matsushige, Hideshi Kakishima, K. Matsukawa, Hajime Kojima, N. Murakami, Masaaki Ohnuma, T Ogawa, K. MasudaAbstract:Abstract Interlaboratory validation of the haemoglobin denaturation (HD) Test on 38 cosmetic ingredients was conducted by five to eight participating laboratories. The HD Test was evaluated as an alternative method to the Draize eye irritation Test (Draize Test) based on three indices of protein denaturation: the Test substance concentration that induces 50% HD of the positive control (RDC50), a relative HD rate at 1% of the Test substance (1%RDR) and a relative change in maximum absorption wavelength (1% λmax). The coefficients of variation associated with a positive HD Test among the participating laboratories were within an acceptable range for practical application. The in vitro Test results were in relatively good agreement with the Draize Test. The correlation coefficient (r) between the in vivo maximal average Draize total score (MAS) and log (RDC50), 1%RDR and 1% λmax were −0.91, 0.67 and 0.79, respectively. The results revealed several limitations associated with the HD Test: (1) the HD Test cannot be applied to coloured Test substances with a strong absorption, around 418 nm; (2) water-insoluble Test substances cannot be evaluated by RDC50 or 1%RDR; (3) the HD Test cannot be applied to strong acids that exceed the buffering capacity of a phosphate buffer solution; (4) the HD Test cannot be used to determine the potential for eye irritation caused by factors other than protein denaturation, for example, polyoxyethylene octylphenylether (10 E.O.). Thus, the HD Test alone is not appropriate for predicting eye irritation potential. Nevertheless, the good agreement between the HD Test results and in vivo irritation scores as well as the ease of application suggest that this Test may play an important role in a Test system to determine eye irritation potential.
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interlaboratory validation of the in vitro eye irritation Tests for cosmetic ingredients 8 evaluation of cytotoxicity Tests on sirc cells
Toxicology in Vitro, 1999Co-Authors: N Tani, N. Murakami, Y Okamoto, S Kinoshita, M Kotani, Hiroshi Itagaki, S Sugiura, M Usami, K Kato, Hajime KojimaAbstract:Abstract Two common assays, the neutral red uptake assay (SIRC–NRU) and the crystal violet staining assay (SIRC–CVS), were evaluated as alternatives to the Draize eye irritation Test (Draize Test).The cytotoxicity of thirty-eight cosmetic ingredients as well as a physiological saline solution was determined on SIRC cells at five to seven laboratories. SIRC–NRU and SIRC–CVS were performed according to the common standard operating procedure (SOP). The 50% effective concentration (EC 50 ) was determined for each ingredient. The EC 50 of SIRC–CVS was similar to that of SIRC–NRU, showing a strong correlation (r=0.995). The coefficient of variation (CV) of EC 50 which represents the interlaboratory reproducibility of SIRC–NRU was 32.1%, whereas that of SIRC–CVS was 32.8%. The logarithmically transformed EC 50 values showed a strong correlation with the maximal average Draize total score (MAS) (SIRC–NRU: r=−0.816 (n=30), SIRC–CVS: r=−0.805 (n=29)). Both methods could be applied to water-insoluble substances and dyes. However, strong acids, alkanolamines and alcohols had a tendency to deviate from the linear regression lines which were obtained from the in vivo and in vitro data for both methods in the present study. These results suggest that cytotoxicological Testing on SIRC cells may provide an alternative method to the Draize Test for cosmetic ingredients.
P.i. Feder - One of the best experts on this subject based on the ideXlab platform.
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a comparison of low volume Draize and in vitro eye irritation Test data iii surfactant based formulations
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The third phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 25 representative surfactant-based personal-care formulations. In general, these formulations were minimally to moderately irritating. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.87; LVET-MAS values were typically about 30% lower then corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of 95% confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Twenty in vitro endpoints were shown to have the greaTest agreement with the LVET (these endpoints included those with low discordance rates relative to the Draize Test) and were therefore selected for regression modelling. Although prediction interval widths tended to be narrower when predicting LVET-MAS compared with predicting MAS, the confidence with which the selected in vitro endpoints predicted both LVET-MAS and MAS for surfactant-based formulations was greaTest when values were close to the lower or upper limits of the observed irritation range (i.e. 95% prediction interval widths were most narrow in these areas). Overall precision of LVET-MAS prediction for surfactant-based formulations was similar to that previously reported for hydroalcoholic formulations and considerably better than was reported for oil/water emulsions.
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a comparison of low volume Draize and in vitro eye irritation Test data ii oil water emulsions
Food and Chemical Toxicology, 1998Co-Authors: S D Gettings, R A Lordo, P.i. Feder, K L HintzeAbstract:The second phase in a series of investigations of the relationship between low volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from in vitro eye irritation Test protocols is presented. These investigations utilize Draize eye Test and in vitro endpoint data generated previously as part of the CTFA Evaluation of Alternatives Program. LVET data were generated de novo using the same 18 representative oil/water based personal-care formulations. In general, these formulations were minimally to mildly irritating; only three were classified as moderate eye irritants. The linear correlation between maximum average score as determined by the Draize Test (MAS) and the LVET (LVET-MAS) was 0.85; LVET-MAS values were typically about half the corresponding MAS values. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and each in vitro endpoint. Regression modelling was the primary means of enabling such a comparison, the objective being to predict LVET-MAS for a given Test material (and to place upper and lower 95% prediction bounds on the range in which the LVET-MAS is anticipated to fall with high probability) based on observation of an in vitro score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Sixteen endpoints were shown to have the greaTest agreement with the LVET (all but two were selected for modelling when compared with the Draize procedure). While the lower maximum average scores values (compared with the Draize Test) in the LVET led to lower variability in LVET-MAS compared to MAS, the upper and lower bounds on predicted LVET-MAS values conditional on observed in vitro scores were still wide. Because there was overlap in the range of scores determined by the prediction bounds for many formulations, each of the selected endpoints was frequently unable to distinguish between Test formulations in terms of statistically different predicted LVET-MAS values. In summary, none of the in vitro endpoints evaluated were able to reliably predict values of LVET-MAS among the set of oil/water emulsions considered here.
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Comparison of low-volume, Draize and in vitro eye irritation Test data. I. Hydroalcoholic formulations
Food and Chemical Toxicology, 1996Co-Authors: S D Gettings, R A Lordo, J L Demetrulias, P.i. Feder, K L HintzeAbstract:Abstract The first phase in a series of investigations of the relationship between low-volume eye Test (LVET) data, Draize eye irritation Test data, and comparable data from 25 in vitro assay protocols is presented. These investigations utilize Draize eye Test and in vitro assay data generated previously as part of the Cosmetic, Toiletry and Fragrance Association (CTFA) Evaluation of Alternatives Program. LVET data were generated de novo using the same 10 representative hydroalcoholic personal-care formulations. The linear correlation between maximum average score (MAS) as determined by the Draize Test and the LVET (LVET-MAS) was 0.93. Comparison of in vitro assay performance with that of the LVET was determined by statistical analysis of the relationship between LVET-MAS and in vitro endpoint. As in the CTFA program, regression modelling is the primary means of enabling such a comparison. The objective is to predict LVET-MAS for a given Test material (and to place upper and lower prediction interval bounds in the range in which the LVET-MAS is anticipated to fall with high probability) conditional on observing an in vitro assay score for that material. The degree of confidence in prediction is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curves. Four assays [EYTEX™ MPA (membrane partition assay), HET-CAM (hen's egg Test-chorioallantoic membrane HET-CAM) I, neutral red release and HET-CAM II] were shown to have the greaTest agreement with the LVET. These assays were also among those with low discordance rates relative to the Draize Test. Prediction of LVET-MAS values from experimentally determined in vitro scores was more accurate for hydroalcoholic formulations with lower rather than higher irritancy potential.
