Incorporating lines of evidence from New Approach Methodologies (NAMs) to reduce uncertainties in a category based read-across: A case study for repeated dose toxicity.

A group of triazole compounds was selected to investigate the confidence that may be associated with read-across of a complex data gap: repeated dose toxicity. The read-across was evaluated using Assessment Elements (AEs) from the European Chemicals Agency's (ECHA's) Read-Across Assessment Framework (RAAF), alongside appraisal of associated uncertainties. Following an initial read-across based on chemical structure and properties, uncertainties were reduced by the integration of data streams such as those from New Approach Methodologies (NAM) and other existing data. In addition, addressing the findings of the ECHA RAAF framework, complemented with specific questions concerning uncertainties, increased the confidence that can be placed in read-across. Although a data rich group of compounds with a strong mechanistic basis was analysed, it was clearly demonstrated that NAM data available from publicly available resources could be applied to support read-across. It is acknowledged that most read-across studies will not be so data rich or mechanistically robust, therefore some targeted experimentation may be required to fill the data gaps. In this sense, NAMs should constitute new experimental tests performed with the specific goal of reducing the uncertainties and demonstrating the read-across hypothesis.

Perspectives on trace chemical safety and chemophobia: risk communication and risk management.

Safety issues regarding consumer products contaminated with trace amounts of chemicals are of great concern to consumers, with the degree of concern occasionally escalating to the psychological syndrome, chemophobia (i.e., the fear of chemicals). Hazardous substances frequently implicated in safety concerns include heavy metals (arsenic, mercury, cadmium, and lead), volatile organic compounds (VOC) such as benzene and o-toluidine, pesticides, carcinogens, radioactive substances, and endocrine disrupting chemicals (EDC) such as bisphenol A and phthalates. To improve communication of risk to society, members of academia, government, consumer organizations, and industry participated in this workshop to discuss and exchange perspectives on trace chemical safety. From the perspective of academia, integrated risk assessments need to be implemented to encompass various exposure sources and routes. The identification and investigation of new exposure-related biomarkers are also recommended to verify direct causal relationships between specific chemical exposure and effects on human health. As for regulation, governments need to establish and maintain acceptable limits for trace chemicals in products. In addition, harmonized efforts need to be undertaken among government agencies to share regulatory limits and effectively control trace chemicals in consumer products. Manufacturers need to faithfully abide by Good Manufacturing Practice (GMP) guidelines, monitor sources of contamination, and minimize these for consumer safety. To effectively resolve safety issues arising from trace chemicals exposure, collaborative efforts are needed involving academia, government, consumer organizations, and industry. Further, scientific evidence-based risk assessment is a critical approach to effectively manage trace chemical safety issues.

Perspectives on trace chemical safety and chemophobia: risk communication and risk management.

Safety issues regarding consumer products contaminated with trace amounts of chemicals are of great concern to consumers, with the degree of concern occasionally escalating to the psychological syndrome, chemophobia, i.e., the fear of chemicals. Hazardous substances frequently implicated in safety concerns include heavy metals (arsenic, mercury, cadmium, and lead), volatile organic compounds (VOC) such as benzene and o-toluidine, pesticides, carcinogens, radioactive substances, and endocrine disrupting chemicals (EDC) such as bisphenol A and phthalates. To improve communication of risk to society, members of academia, government, consumer organizations, and industry participated in this workshop to discuss and exchange perspectives on trace chemical safety. From the perspective of academia, integrated risk assessments need to be implemented to encompass various exposure sources and routes. The identification and investigation of new exposure-related biomarkers are also recommended to verify direct causal relationships between specific chemical exposure and effects on human health. As for regulation, governments need to establish and maintain acceptable limits for trace chemicals in products. In addition, harmonized efforts need to be undertaken among government agencies to share regulatory limits and effectively control trace chemicals in consumer products. Manufacturers need to faithfully abide by Good Manufacturing Practice (GMP) guidelines, monitor sources of contamination, and minimize these for consumer safety. To effectively resolve safety issues arising from trace chemicals exposure, collaborative efforts are needed involving academia, government, consumer organizations, and industry. Further, scientific evidence-based risk assessment is a critical approach to effectively manage trace chemical safety issues.

Quality of Chemical Safety Information in Printing Industry.

OBJECTIVES: Employees in printing industries can be exposed to multiple solvents in their work environment. The objectives of this study were to investigate the critical components of chemical solvents by analyzing the components of the solvents and collecting the Safety data sheets (SDSs), and to evaluate the hazard communication implementation status in printing industries. METHOD: About 152 printing-related industries were recruited by area-stratified random sampling and included 23 plate-making, 102 printing and 27 printing-assistance companies in Taiwan. We analyzed company questionnaires (n = 152), SDSs (n = 180), and solvents (n = 20) collected from this sample of printing-related companies. RESULTS: Analytical results indicated that benzene and ethylbenzene, which were carcinogen and possibly carcinogen, were detectable in the cleaning solvents, and the detection rate were 54.5% (concentrations: <0.011-0.035 wt%) and 63.6% (concentrations: <0.011-6.22 wt%), respectively; however, neither compound was disclosed in the SDS for the solvents. Several other undisclosed components, including methanol, isopropanol and n-butanol, were also identified in the printing inks, fountain solutions and dilution solvents. We noted that, of the companies we surveyed, only 57.2% had a hazard communication program, 61.8% had SDSs on file and 59.9% provided employee safety and health training. We note that hazard communication programs were missing or ineffective in almost half of the 152 printing industries surveyed. CONCLUSIONS: Current safety information of solvents components in printing industries was inadequate, and many hazardous compounds were undisclosed in the SDSs of the solvents or the labels of the containers. The implementation of hazard communications in printing industries was still not enough for protecting the employees' safety and health.

Allergic contact dermatitis from acrylic nails in a flamenco guitarist.

Acrylates are molecules that are well known for their strong sensitizing properties. Historically, many beauticians and individuals using store-bought artificial nail products have developed allergic contact dermatitis from acrylates. More recently, the use of acrylic nails among flamenco guitarists to strengthen their nails has become very popular. A 40-year-old non-atopic male patient working as a flamenco guitarist developed dystrophy, onycholysis and paronychia involving the first four nails of his right hand. The lesions were confined to the fingers where acrylic materials were used in order to strengthen his nails to play the guitar. He noticed improvement whenever he stopped using these materials and intense itching and worsening when he began reusing them. Patch tests were performed and positive results obtained with 2-hydroxyethyl methacrylate (2-HEMA), 2-hydroxyethyl acrylate (2-HEA), ethyleneglycol-dimethacrylate (EGDMA) and 2-hydroxypropyl methacrylate (2-HPMA). The patient was diagnosed with occupational allergic contact dermatitis likely caused by acrylic nails. Artificial nails can contain many kinds of acrylic monomers but most cases of contact dermatitis are induced by 2-HEMA, 2-HPMA and EGDMA. This is the first reported case of occupational allergic contact dermatitis from acrylates in artificial nails in a professional flamenco guitar player. Since the practice of self-applying acrylic nail products is becoming very popular within flamenco musicians, we believe that dermatology and occupational medicine specialists should be made aware of the potentially increasing risk of sensitization from acrylates in this setting.

Evaluating a county-based healthy nail salon recognition program.

OBJECTIVES: The City of San Francisco, California established a recognition program for nail salons that use safer nail products and receive worker safety training. This pilot study examined whether participating salons had reduced levels of toluene, methyl methacrylate (MMA), and total volatile organic compounds (TVOC), and improved knowledge and behavior compared to control salons. METHODS: We conducted personal air monitoring and administered surveys assessing knowledge and behaviors of two workers from each of six intervention salons and five control salons. We conducted assessments before and after the worker training. RESULTS: Although non-significant, there was a reduction in toluene (-46% vs. 0%) and TVOC (-19% vs. +47%), but an increase in MMA (+113% and +72%) among intervention salons compared to control salons. Awareness of dibutyl phthalates in nail products increased (+55%) among intervention salons between surveys. CONCLUSIONS: A government-administered nail salon recognition program may reduce chemical exposures and increase work-related knowledge.

[PRIORITY TECHNOLOGIES OF THE MEDICAL WASTE DISPOSAL SYSTEM].

The annual production of waste in health care institutions (HCI) tends to increase because of the growth of health care provision for population. Among the many criteria for selecting the optimal treatment technologies HCI is important to provide epidemiological and chemical safety of the final products. Environmentally friendly method of thermal disinfection of medical waste may be sterilizators of medical wastes intended for hospitals, medical centers, laboratories and other health care facilities that have small and medium volume of processing of all types of waste Class B and C. The most optimal method of centralized disposal of medical waste is a thermal processing method of the collected material.

[The safety data sheets of the paint and coatings sector: analysis of the items of most interest to health and safety in the workplace]. / Le schede di dati di sicurezza del comparto vernici e rivestimenti: analisi degli elementi di maggior interesse per la salute e sicurezza nei luoghi di lavoro.

INTRODUCTION: The interlinked REACH-CLP regulations promote the sharing of knowledge regarding the risks and hazards of chemicals throughout the supply chain. The safety data sheet (SDS) is the main instrument to achieve this goal. OBJECTIVE: to study 100 SDS of paints and coatings sector in order to highlight major criticisms related to health and safety of workers. MATERIALS AND METHODS: Using the criteria prescribed by Regulation 453/2010/EC and preparing a suitable check list, some items of the sections 1 "Identification of the substance/mixture and of the company", 2 "Hazards identification", 3 "Composition/information on ingredients", the first part of section 7 "Precautions for safe handling", sections 8 "Exposure controls/personal protection" and 16 "Other information", were therefore evaluated for their appropriateness. RESULTS: Seven SDS were written in a foreign language and were excluded from further analysis. Of the remaining 93 SDS, only 23% had a proportion of adequate items greater than 80%, 49 % had adequate items between 60 and 80%, and 28% had less than 60% adequate items. The most critical sections were those relating to workers' safe handling and exposure controls and protection. CONCLUSION: In conclusion, from the analysis of SDS we found high percentages of inadequacy, especially in sections 7 and 8, the most relevant for the protection of the health and safety of workers.

Workshop: use of "read-across" for chemical safety assessment under REACH.

Read-across has generated much attention, since it may be used as an alternative approach for addressing the information requirements under REACH. Experience in the application of "read-across" has undoubtedly been gained within the context of the 2010 registrations (>1000 tonnes/annum). Industry, European Chemicals Agency (ECHA) and EU Member States all conceptually accept read-across approaches but difficulties still remain in applying them consistently in practice. A workshop on the 'Use of Read-Across for Chemical Safety Assessment under REACH', organised by ECHA with the active support of Cefic LRI was held on the 3rd October 2012 to gain insight on how ECHA evaluates read-across justifications, to share Industry experiences with read-across approaches and to discuss practical strategies to help develop scientifically valid read-across for future submissions.

[Anniversary of the medical department of the Federal Office for Safe Storage and Destruction of Chemical Weapons].

The article is devoted to the process of formation and development of CW destruction management system and medical support of professional activities of personnel. Founders of Medical department of the Federal Directorate for Safe Storage and Destruction of Chemical Weapons are presented. Main principles and ways of working of medical department in specific conditions are covered.

[The urgency of the application of the medical sanitary passport in the system for chemical safety in the areas of location of high-risk chemical facilities in the Russian Federation].

The main provisions concerning the need for a creation of medical and sanitary passport for territories in the protective measures zones (PMZ) of storage facilities and facilities for the destruction of chemical weapons (FDCW) are presented in the article. The assessment of results of certification of the territory of PMZ and FDCW in "Maradykovsky" in the Kirov region has been done.

Quality Control: Personal Protective Equipment for Use When Handling Hazardous Drugs.

United States Pharmacopeia Chapter <800>, concerned with the handling of hazardous drugs in healthcare settings, requires that any entity handling such drugs maintain a hazardous drug list. While this list must include any drug found on the latest NIOSH List of Antineoplastic and Other Hazardous Drugs in Health Settings, entities are expected to include other drugs and substances of concern. The intent of this article is to provide concrete information concerning articles of personal protective equipment, as well as guidance as to where and how they should be donned, used, and removed. This information will cover every aspect of handling hazardous drugs from receipt to disposal, most certainly including both sterile and nonsterile compounding.

Safe Handling of Hazardous Drugs: ASCO Standards.

PURPOSE: To provide 2019 ASCO standards on the safe handling of hazardous drugs. METHODS: An Expert Panel was formed, and a systematic review of the literature on closed system transfer devices was performed to May 2017 using PubMed. The Cochrane Database of Systematic Reviews, PubMed, and Google Scholar were used to search for studies of medical surveillance and external ventilation/health effects of exposure to vapors to November 2017. Available standards were considered for endorsement. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The search for primary research found no studies that addressed health outcomes as they relate to the identified interventions of interest. The ASCO Expert Panel endorses the best practices for safe handling of hazardous drugs as issued by the Occupational Safety and Health Administration, US Pharmacopeia Chapter 800, and Oncology Nursing Society with clarifications in four key areas: medical surveillance, closed system transfer devices, external ventilation of containment secondary engineering controls or containment segregated compounding areas, and alternative duties. CONCLUSION: The ASCO standards address the need for clear standards concerning safe handling of hazardous oncology drugs. More research is needed in several key areas to quantify the level of risk associated with handling hazardous drugs in current workplace settings where the hierarchy of controls is consistently applied. Additional information is available at www.asco.org/safe-handling-standards .

The Need for, and the Role of the Toxicological Chemist in the Design of Safer Chemicals.

During the past several decades, there has been an ever increasing emphasis for designers of new commercial (nonpharmaceutical) chemicals to include considerations of the potential impacts a planned chemical may have on human health and the environment as part of the design of the chemical, and to design chemicals such that they possess the desired use efficacy while minimizing threats to human health and the environment. Achievement of this goal would be facilitated by the availability of individuals specifically and formally trained to design such chemicals. Medicinal chemists are specifically trained to design and develop safe and clinically efficacious pharmaceutical substances. No such formally trained science hybrid exists for the design of safer commercial (nonpharmaceutical) chemicals. This article describes the need for and role of the "toxicological chemist," an individual who is formally trained in synthetic organic chemistry, biochemistry, physiology, toxicology, environmental science, and in the relationships between structure and commercial use efficacy, structure and toxicity, structure and environmental fate and effects, and global hazard, and trained to integrate this knowledge to design safer commercially efficacious chemicals. Using examples, this article illustrates the role of the toxicological chemist in designing commercially efficacious, safer chemical candidates.

Green Toxicology-Know Early About and Avoid Toxic Product Liabilities.

Toxicology uniquely among the life sciences relies largely on methods which are more than 40-years old. Over the last 3 decades with more or less success some additions to and few replacements in this toolbox took place, mainly as alternatives to animal testing. The acceptance of such new approaches faces the needs of formal validation and the conservative attitude toward change in safety assessments. Only recently, there is growing awareness that the same alternative methods, especially in silico and in vitro tools can also much earlier and before validation inform decision-taking in the product life cycle. As similar thoughts developed in the context of Green Chemistry, the term of Green Toxicology was coined to describe this change in approach. Here, the current developments in the alternative field, especially computational and more organo-typic cell cultures are reviewed, as they lend themselves to front-loaded chemical safety assessments. The initiatives of the Center for Alternatives to Animal Testing Green Toxicology Collaboration are presented. They aim first of all for forming a community to promote this concept and then for a cultural change in companies with the necessary training of chemists, product stewards and later regulators.