Validation study on the Ocular Irritection assay for eye irritation testing.

Both a prospective and a retrospective validation study were undertaken to assess the suitability of the Ocular Irritection assay to discriminate ocular hazards as defined by the OECD and UN Globally Harmonized System (UN GHS) for classification. The primary focus of the study was to evaluate the usefulness of the Ocular Irritection assay to reliably discriminate chemicals not requiring classification (UN GHS non-classified), from classified chemicals (UN GHS Categories 1 and 2). Furthermore a post-hoc evaluation was carried out to evaluate the usefulness of the assay to discriminate chemicals inducing serious eye damage (UN GHS Category 1) from other classes. The prospective validation study was conducted between 2009 and 2012 following internationally agreed principles. A set of 56 coded test chemicals for which quality and/or peer-reviewed in vivo data were available were used to obtain prospective data on the assay's reliability (reproducibility within and between laboratories) and relevance (predictive capacity). The assay showed good within-laboratory variability, transferability including to a naïve laboratory, and between-laboratory concordance of classifications (82% for the discrimination of non-classified from classified chemicals, and 83% for the discrimination of Category 1 from other classes). The obtained prospective data were then combined with existing data on the Ocular Irritection collected from various sources, totaling 88 chemicals with parallel in vivo and in vitro data to obtain a comprehensive assessment of the test method performances. The enlarged dataset comprised 43 non-classified, 25 Category 2 and 20 Category 1 chemicals according to the UN GHS classification. When used for the identification of UN GHS non-classified versus classified materials (based on the existing cut-off of 12.5) the Ocular Irritection assay showed an overall a sensitivity of 93% and a specificity of 58%. An evaluation on possible reasons for misclassification identified some organic functional groups (acrylate, carboxamide and cycloalkene) to correlate with the observed mispredictions. If these functional groups were excluded from the Ocular Irritection applicability domain, the obtained dataset (n=79 chemicals distributed as 41 UN GHS Classified and 38 Non-Classified chemicals) had an overall sensitivity of 98%, and specificity of 63%, which is in line with currently adopted test methods. When used for the identification of UN GHS Category 1 versus other categories (based on the existing cut-off of 30.0) the Ocular Irritection assay showed an overall specificity of 81% and a sensitivity of 50% which is again in line with currently adopted test methods. The Ocular Irritection assay appeared therefore as a useful test method to predict chemicals not requiring classification for eye hazards according to the UN GHS classification system. Furthermore the method was found suitable to identify serious/irreversible eye damage (UN GHS Category 1). The detailed documentation and results of the study have been submitted to an internationally recognized validation centre for peer-review.

Which dimensions of food-related lifestyle are likely to be associated with obesity in Italy?

OBJECTIVE: To compare obese v. non-obese consumers in terms of their general food-related lifestyles and to explore possible food-related factors affecting obesity in Italy. DESIGN: The data were collected using a self-completion questionnaire. Data included sociodemographic information, measures of the Food-Related Lifestyle scale (FRL) and self-reported weight and height. A logistic regression model was fitted for the sample with obesity as the dependent variable and sociodemographic characteristics and FRL dimensions as the independent variables. SETTING: The survey was carried out in Italy between October and November 2010. SUBJECTS: One thousand respondents were recruited with equal quotas for men v. women. The sample was representative of the Italian population in term of age groups and geographic areas. The participants were over 18 years of age and were solely or jointly responsible for the family's food shopping. RESULTS: Our analyses revealed that sociodemographic, economic and cultural variables affect the increasing rate of obesity in Italy. Obese respondents appeared to find more enjoyment from shopping and interest in cooking compared with non-obese ones. Moreover, they were more likely to find self-fulfilment in foods. However, obese respondents appeared to be less interested in the nutritional content of foods, suggesting their weak involvement in nutritional aspects when they eat. In fact, the obese respondents gave preference to snacks over meals. CONCLUSIONS: The outcome of the study would suggest that in targeted interventions for public health purposes in order to address obesity, attention should be placed on the role that food plays in obese consumers' lives.

A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches.

In spite of over 20 years of effort, no single in vitro assay has been developed and validated as a full regulatory replacement for the Draize Eye Irritation test. However, companies have been using in vitro methods to screen new formulations and in some cases as their primary assessment of eye irritation potential for many years. The present report shows the outcome of an Expert Meeting convened by the European Centre for the Validation of Alternative Methods in February 2005 to identify test strategies for eye irritation. In this workshop test developers/users were requested to nominate methods to be considered as a basis for the identification of such testing strategies. Assays were evaluated and categorized based on their proposed applicability domains (e.g., categories of irritation severity, modes of action, chemical class, physicochemical compatibility). The analyses were based on the data developed from current practice and published studies, the ability to predict depth of injury (within the applicable range of severity), modes of action that could be addressed and compatibility with different physiochemical forms. The difficulty in predicting the middle category of irritancy (e.g. R36, GHS Categories 2A and 2B) was recognized. The testing scheme proposes using a Bottom-Up (begin with using test methods that can accurately identify non-irritants) or Top-Down (begin with using test methods that can accurately identify severe irritants) progression of in vitro tests (based on expected irritancy). Irrespective of the starting point, the approach would identify non-irritants and severe irritants, leaving all others to the (mild/moderate) irritant GHS 2/R36 categories.

Willingness to use functional breads. Applying the Health Belief Model across four European countries.

The present study focused on the role of the Health Belief Model (HBM) in predicting willingness to use functional breads, across four European countries: UK (N=552), Italy (N=504), Germany (N=525) and Finland (N=513). The behavioural evaluation components of the HBM (the perceived benefits and barriers conceptualized respectively as perceived healthiness and pleasantness) and the health motivation component were good predictors of willingness to use functional breads whereas threat perception components (perceived susceptibility and perceived anticipated severity) failed as predictors. This result was common in all four countries and across products. The role of 'cue to action' was marginal. On the whole the HBM fit was similar across the countries and products in terms of significant predictors (the perceived benefits, barriers and health motivation) with the exception of self-efficacy which was significant only in Finland. Young consumers seemed more interested in the functional bread with a health claim promoting health rather than in reducing risk of disease, whereas the opposite was true for older people. However, functional staple foods, such as bread in this European study, are still perceived as common foods rather than as a means of avoiding diseases. Consumers seek these foods for their healthiness (the perceived benefits) as they expect them to be healthier than regular foods and for the pleasantness (the perceived barriers) as they do not expect any change in the sensory characteristics due to the addition of the functional ingredients. The importance of health motivation in willingness to use products with health claims implies that there is an opening for developing better models for explaining health-promoting food choices that take into account both food and health-related factors without making a reference to disease-related outcome.

Food Choice Questionnaire (FCQ) revisited. Suggestions for the development of an enhanced general food motivation model.

Recognising the need for a more statistically robust instrument to investigate general food selection determinants, the research validates and confirms Food Choice Questionnaire (FCQ's) factorial design, develops ad hoc a more robust FCQ version and tests its ability to discriminate between consumer segments in terms of the importance they assign to the FCQ motivational factors. The original FCQ appears to represent a comprehensive and reliable research instrument. However, the empirical data do not support the robustness of its 9-factorial design. On the other hand, segmentation results at the subpopulation level based on the enhanced FCQ version bring about an optimistic message for the FCQ's ability to predict food selection behaviour. The paper concludes that some of the basic components of the original FCQ can be used as a basis for a new general food motivation typology. The development of such a new instrument, with fewer, of higher abstraction FCQ-based dimensions and fewer items per dimension, is a right step forward; yet such a step should be theory-driven, while a rigorous statistical testing across and within population would be necessary.