A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.

This study assesses whether currently available acute oral toxicity (AOT) in silico models, provided by the widely employed Leadscope software, are fit-for-purpose for categorization and labelling of chemicals. As part of this study, a large data set of proprietary and marketed compounds from multiple companies (pharmaceutical, plant protection products, and other chemical industries) was assembled to assess the models' performance. The absolute percentage of correct or more conservative predictions, based on a comparison of experimental and predicted GHS categories, was approximately 95%, after excluding a small percentage of inconclusive (indeterminate or out of domain) predictions. Since the frequency distribution across the experimental categories is skewed towards low toxicity chemicals, a balanced assessment was also performed. Across all compounds which could be assigned to a well-defined experimental category, the average percentage of correct or more conservative predictions was around 80%. These results indicate the potential for reliable and broad application of these models across different industrial sectors. This manuscript describes the evaluation of these models, highlights the importance of an expert review, and provides guidance on the use of AOT models to fulfill testing requirements, GHS classification/labelling, and transportation needs.

Evaluating the Impact of the Healthy Beverage Executive Order for City Agencies in Boston, Massachusetts, 2011-2013.

INTRODUCTION: Intake of sugar-sweetened beverages (SSBs) is associated with negative health effects. Access to healthy beverages may be promoted by policies such as the Healthy Beverage Executive Order (HBEO) established by former Boston mayor Thomas M. Menino, which directed city departments to eliminate the sale of SSBs on city property. Implementation consisted of "traffic-light signage" and educational materials at point of purchase. This study evaluates the impact of the HBEO on changes in beverage availability. METHODS: Researchers collected data on price, brand, and size of beverages for sale in spring 2011 (899 beverage slots) and for sale in spring 2013, two years after HBEO implementation (836 beverage slots) at access points (n = 31) at city agency locations in Boston. Nutrient data, including calories and sugar content, from manufacturer websites were used to determine HBEO beverage traffic-light classification category. We used paired t tests to examine change in average calories and sugar content of beverages and the proportion of beverages by traffic-light classification at access points before and after HBEO implementation. RESULTS: Average beverage sugar grams and calories at access points decreased (sugar, -13.1 g; calories, -48.6 kcal; p<.001) following the implementation of the HBEO. The average proportion of high-sugar ("red") beverages available per access point declined (-27.8%, p<.001). Beverage prices did not change over time. City agencies were significantly more likely to sell only low-sugar beverages after the HBEO was implemented (OR = 4.88; 95% CI, 1.49-16.0). DISCUSSION: Policies such as the HBEO can promote community-wide changes that make healthier beverage options more accessible on city-owned properties.

Efeito alelopático e análise dos rótulos de garrafadas comercializadas no Mercado Municipal de Montes Claros – MG / Allelopathic effect and analysis of bottle labels commercialized in the municipal market of Montes Claros – MG

RESUMO O presente estudo teve como objetivo analisar o efeito alelopático e o rótulo dos produtos vegetais contidos nas garrafadas comercializadas no mercado municipal de Montes Claros - MG. Adquiriram-se oito garrafadas que foram utilizadas para tratar, cada uma, 20 sementes de alface (Lactuca sativa L.) dispostas em placas de Petri sobre papel saturado com 4mL do conteúdo de cada garrafada em 04 concentrações: 12,5; 25; 50; e 75%. O controle positivo foi realizado com solução de sulfato de zinco a 1%, além dos controles: água mineral, água da torneira, e água destilada. As placas de Petri foram lacradas com filme plástico, cobertas com saco plástico e incubadas em escuro por sete dias à temperatura média de 27,2°C e na umidade média de 54%. Após 7 dias, mediu-se o comprimento da radícula e do hipocótilo (mm) de cada uma das plântulas e quantificou-se o número de sementes que germinaram. Os dados foram submetidos à análise de variância pelo software Sisvar, sendo os resultados comparados pelo Teste Scott-Knott ao nível nominal de 5%. Os resultados do teste de germinação indicaram que houve efeito significativo das garrafadas sobre a germinação das sementes de Lactuca sativa L., onde o percentual de germinação das sementes foi inversamente proporcional ao aumento da concentração das garrafadas. Portanto, observou-se que as garrafadas apresentaram potencial alelopático ao inibirem a germinação das sementes de alface.

ABSTRACT This study aimed to analyze the allelopathic effect and label of plant products put in bottles commercialized in the municipal market of Montes Claros - MG. Eight bottles were employed to treat, each one, 20 lettuce seeds (Lactuca sativa L.) placed at Petri plaques over saturated paper with 4mL of the content of each bottle in 04 concentrations of 12.5; 25; 50; 75% for each bottle, 1% of zinc sulfate solution (positive control) and 3 negative control groups (containing mineral water, tap water and distilled water). The Petri plaques were sealed with plastic film, covered with plastic bag and incubated in the dark for seven days at an average temperature of 27.2°C and average humidity of 54%. After 7 days, it was measured the length of the radicle and the hypocotyl (mm) of each one of the seedlings and the number of seeds that germinated was quantified. The data were submitted to analysis of variance by Sisvar software and the results were compared by Scot-Knott Test at a nominal level of 5%. The results of the germination test indicated that there was a significant impact of the bottles in the germination of the lactuca sativa L. seeds, where the percentage of seeds germination was inversely proportional to the concentration increase in the analyzed bottles. Therefore, it has been observed that the bottles presented allelopathic potential when they inhibited the germination of lettuce seeds.

GlassAllergy: a Google Glass-based solution to empower patients with skin allergies.

A variety of substances contained in cosmetic products can lead to allergic reactions for certain individuals. The names of such substances are predominantly printed onto a product in small-sized expert language. For this reason, consumers often have difficulties to assess whether some of the ingredients might be harmful for them. Consequently, patients are exposed to a risk of buying a cosmetic product that might cause a minor to severe allergic reaction. A Google Glass-based software solution for consumers suffering from skin allergies is presented. It enables users to check cosmetic products in a mobile context and empowers patients to make informed buying decisions. In particular, the solution could help to avoid or reduce the risk for allergic reactions.

Intranasal substituted cathinone "bath salts" psychosis potentially exacerbated by diphenhydramine.

In this report, we describe a case of intranasal "bath salts"-associated psychosis. Symptoms developed during a 3-week binge and were potentially exacerbated by oral diphenhydramine taken for insomnia. The clinical case conference includes expert discussion from 3 disciplines: emergency medicine toxicology, behavioral pharmacology, and addiction medicine. It is hoped that the discussion will provide insight into the clinical aspects and challenges of addressing acute substituted cathinone toxicity, including acute psychosis, a major adverse effect of bath salts consumption.

Substituted cathinone products: a new trend in "bath salts" and other designer stimulant drug use.

There is a growing concern about the availability of a new generation of "designer drug" stimulants that are marketed as "bath salts" and other household products. The products are not true bath salts and contain substituted cathinone stimulant substances, such as methylenedioxypyrovalerone (MDPV) and mephedrone. Calls to the American Association of Poison Control Centers regarding "bath salts" consumption began in 2010 and have continued since that time. Few reports of systematic epidemiologic surveillance or definitive clinical effects of toxicity specifically associated with "bath salts" consumption have been reported in the medical literature. The current narrative review describes the growing trend of designer substituted cathinone use, pharmacology, clinical effects, and recent regulatory changes. It is hoped that a greater understanding of the clinical effects and use patterns will help inform policy and practice.

The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations.

INTRODUCTION: The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. HAZARD CLASSIFICATION: The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). PRODUCT NOTIFICATION PROCEDURES: At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. CONCLUSION: Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.

Guidance for the classification of carcinogens under the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).

The United Nations Conference on Environment and Development (UNCED) has developed criteria for a globally harmonised system of classification and labelling of chemicals (GHS). With regard to carcinogenicity, GHS distinguishes between Category 1 ('known or presumed human carcinogens') and Category 2 ('suspected human carcinogens'). Category 1 carcinogens are divided into Category 1A ('known to have carcinogenic potential for humans'), based largely on human evidence, and 1B ('presumed to have carcinogenic potential for humans'), based largely on experimental animal data. Concerns have been raised that the criteria for applying these carcinogenicity classifications are not sufficiently well defined and potentially allow different conclusions to be drawn. The current document describes an attempt to reduce the potential for diverse conclusions resulting from the GHS classification system through the application of a series of questions during the evaluation of data from experiments with rodents; epidemiological data, which could lead to Category 1A, have not been considered. Answers to each question can lead either to a classification decision or to the next question, but this process should only be implemented in an environment of informed scientific opinion. The scheme is illustrated with five case studies. These questions are: (1) Has a relevant form of the substance been tested? (2) Is the study design relevant to human exposure? (3) Is there a substance-related response? (4) Is the target tissue exposure relevant to humans? (5) Can a mode of action be established? (6) Is the mode of action relevant to humans? (7) What is the potency?

Comunicação de riscos relacionada a agrotóxicos no Pólo floricultor de Nova Friburgo, RJ / Risk communication related to pesticides in the Hub florist Nova Friburgo, RJ

O uso intensivo de agrotóxicos nas lavouras desacompanhado de políticas normativas e de controle resulta numa série de impactos sobre a saúde humana e sobre o meio ambiente. As intoxicações sofridas pelos trabalhadores rurais podem estar atreladas a vários fatores como, por exemplo, a dificuldade de compreensão das informações sobre os agrotóxicos. Uma solução seria uma assistência técnica mais eficaz e dissociada das casas comerciais, fato cada vez mais presente, acarretando o aumento no consumo desses produtos. Em alguns casos, o acesso às informações fica restrito somente à leitura de bulas e rótulos dos produtos utilizados, sendo a única fonte de comunicação de riscos existente. É um dado preocupante, já que é reconhecido o baixo nível de escolaridade dos agricultores. O presente estudo tem como objetivo analisar o processo de comunicação de riscos relacionado aos agrotóxicos no trabalho rural do Pólo Floricultor de Nova Friburgo/RJ, através de um estudo de recepção de informações, por parte de agricultores, referente aos rótulos e bulas dos principais agrotóxicos utilizados por eles durante o seu processo de trabalho. Através de uma abordagem qualitativa, foram aplicados questionários semi-estruturados a 29 dos 30 produtores de flores locais, avaliando o seu processo de trabalho, seus anseios e o conhecimento acerca das questões que envolvem o uso dos agrotóxicos. A análise dos dados identificou uma série de situações relacionadas com o nível de informações e a sua interpretação pelos trabalhadores; o manejo indevido atribuído ao desconhecimento dos reais riscos que estão expostos é uma delas...

The intensive use of pesticides for crop protection results in impacts on human and environmental health status, particularly when this use is not associated with normative policies and control actions. Major rural workers poisonings can be straight associatedto a number of factors, including difficulties to comprehend the available information. One of many solutions should be a more effective and independent technical assistance,dissociated with commercial interests – a serious situation usually more seen and that can be pointed as one of the main determinants of pesticides use increase in the last few years. In some cases, information access is restricted to labels reading, constituting the only information resource available for a large group of rural workers. This situation is even more serious considering these professionals’ low formal-educational background. The present study aims to analyze pesticides risk communication process in a rural,flower-producer community of Nova Friburgo municipality, Rio de Janeiro State – Brazil, through an information-reception study focusing labels reading. Through a qualitative health research approach, semi-structured questionnaires were applied to 29of the 30 local flower producers aiming to characterize local work processes, workers beliefs and perceptions, as well as to identify their ability to correctly understand pesticides labels information (visual and written). Results showed that this information is not correctly understood by workers, leading to some unsafe work practices such asinappropriate pesticides formulation and use and several exposures situations, as well as the non-adoption of protective gear. These data point the need of a more effective risk communication policy, particularly involving the community...

[International Chemical Safety Cards: information source on hazards caused by chemical substances]. / Miedzynarodowe Karty Bezpieczenstwa chemicznego--zródlo informacji o zagrozeniach stwarzanych przez substancje chemiczne.

International Chemical Safety Cards (ICSC) are produced by the International Programme on Chemical Safety (IPCS) in collaboration with the European Commission and various IPCS-participating institutions in different countries. ICSCs disseminate essential information on chemicals to promote their safe production, transport and use. Application of standard terminology along with relevant criteria facilitates the comparison of risk related to different chemicals, which makes the cards a successful hazard-communication tool. Translation of the cards into various languages all over the world reflects the range of their growing use. A multi-stage compilation of information contained in ICSCs, based on the most up-to-date world literature and professional databases, assures its reliability. Their concise form makes them easy in everyday use as a source of information on chemical safety. The range of information contained in ICSCs corresponds to that provided by Material Safety Data Sheets (MSDS), however, the former are more concise and simpler. Although ICSCs have no legal status they may complement a 16-point MSDSs and help in the implementation of labeling and classification of chemicals according to the Globally Harmonized System.

Dental devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule.

The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.