Determination and risk assessment of phthalates in face masks. An Italian study.

Serious human health concerns have been recently raised from daily use of face masks, due to the possible presence of hazardous compounds as the phthalic acid esters (PAEs). In this study, the content of 11 PAEs in 35 commercial masks was assessed by applying a specific and accurate method, using Gas Chromatography/Mass Spectrometry. Surgical, FFP2 and non-surgical models, for both adults and children were collected from the Italian market. Analyses showed that four of the target analytes were detected in all tested samples with median total concentrations ranging between 23.6 mg/kg and 54.3 mg/kg. Results obtained from the experimental analysis were used in the risk assessment studies carried out for both carcinogenic and non-carcinogenic effects. Doses of exposure (Dexp) of PAEs ranged from 6.43 × 10-5 mg/kg bw/day to 1.43 × 10-2 mg/kg bw/day. Cumulative risk assessment was performed for non-carcinogenic and carcinogenic effects. No potential risk was found for non-carcinogenic effects, yet the 20% of the mask samples showed potential carcinogenic effects for humans. A refined exposure assessment was performed showing no risk for carcinogenic effects. This paper presents a risk assessment approach for the identification of potential risks associated to the use of face masks.

Cancer incidence in Priolo, Sicily: a spatial approach for estimation of industrial air pollution impact.

The territory around the industrial Sicilian area of Priolo, Italy, has been defined as a contaminated site (CS) of national priority for remediation because of diffuse environmental contamination caused by large industrial settlements. The present study investigates the spatial distribution of cancer into the CS territory (period 1999-2006). Different geographical methods used for the evaluation of the impact of industrial air pollutants were adopted. Using the database of Syracuse Province Cancer Registry, gender-specific standardised incidence ratios were calculated for 35 tumour sites for the CS overall and for each municipality included in the CS. A cluster analysis for 17 selected neoplasms was performed at micro-geographical level. The identification of the priority index contaminants (PICs) present in environmental matrices and a review of their carcinogenicity have been performed and applied in the interpretation of the findings. The area has a higher cancer incidence with respect to the provincial population, in particular excess is registered among both genders of lung, bladder and breast cancers as well as skin melanoma and pleural mesothelioma and there is an a priori evidence of association with the exposure to PICs. The study highlights the need to provide different approaches in CSs where several exposure pathways might be relevant for the population. The presence of potential sources of asbestos exposure deserves specific concern.

[Index contaminants and target organs]. / Inquinanti indice e organi bersaglio.

SENTIERI Project evaluates the health impact of environmental exposures on residential population of National Priority Contaminated Sites (NPCSs). It takes into account a priori etiological hypotheses, based on the epidemiological evidence of an association between those exposures and selected diseases or causes of death. Building on the previous chapter, this one acts as a blueprint for future causal inferences based on scientific evidence relating to the health effects of exposure to specific pollutants present in the sites. In order to select the relevant pollutants, we make use of data concerning soil, aquifers, the food chain and the atmosphere. For each pollutant, we indicate cancer site and target organs, for non-neoplastic diseases, based on scientific assessment by international Agencies. We have chosen to focus on two sites: Brescia-Caffaro and Priolo. This method may conceivably be used by SENTIERI in the future to carry out more specific studies and provides the basis for a systematic analysis of contaminated sites.

Information gathering for CLP classification.

Regulation 1272/2008 includes provisions for two types of classification: harmonised classification and self-classification. The harmonised classification of substances is decided at Community level and a list of harmonised classifications is included in the Annex VI of the classification, labelling and packaging Regulation (CLP). If a chemical substance is not included in the harmonised classification list it must be self-classified, based on available information, according to the requirements of Annex I of the CLP Regulation. CLP appoints that the harmonised classification will be performed for carcinogenic, mutagenic or toxic to reproduction substances (CMR substances) and for respiratory sensitisers category 1 and for other hazard classes on a case-by-case basis. The first step of classification is the gathering of available and relevant information. This paper presents the procedure for gathering information and to obtain data. The data quality is also discussed.

Prevention, ethics and science: lessons from Lorenzo Tomatis.

This paper is dedicated to Lorenzo Tomatis, former director of the International Agency for Research on Cancer (IARC), promoter of prevention principles with a precautionary approach, supported by an important scientific foundation. He has recommended an appropriate consideration of both "false negatives" and "false positives" errors in the evaluation of epidemiological and experimental data on toxicological and carcinogenic risk. The current rules for IARC Monographs preparation include both a full transparency of the data used and of the possible conflicts of interest of the experts involved. Tomatis has also underlined that "Dismissing animal carcinogenicity findings would lead to human cases as the only means of demonstrating carcinogenicity of environmental agents. This is an unacceptable public health policy". The main role of experimental studies is presently included in both the new preamble of IARC Monographs and the method adopted for the World Health Organization Air Quality Guidelines for low-dose carcinogenic risk assessment.

The ISS Carcinogens Data Bank (BDC).

The Data Bank on Carcinogens (Banca Dati Cancerogeni, BDC) is a factual data bank, available on the Istituto Superiore di Sanità website, aimed at supporting the risk management decision making of central and local administrators. It can also represent a valuable tool for industry. The available information on carcinogenicity evaluations/classifications produced by European Union and by other institutions (IARC, USEPA, NTP, CCTN) is presented in a concise form accompanied by bibliographic references enabling the users to consult the original sources and, in some cases, to be directly connected to the relevant website. The classifications carried out by each organization in accordance with its own criteria assign the examined agents to specific qualitative categories and do not include quantitative assessment. BDC intends to provide an easy tool for experts, researchers and risk managers dealing with carcinogenic agents.

The ISS Reclamation Data Bank.

Since the issue of the first regulations concerning the remediation of contaminated sites, the Istituto Superiore di Sanità, on the basis of specific requests, has drawn up various technical opinions regarding the proposed reference values (quality standards) for soils and underground waters, to be achieved when remediating contaminated sites, for substances for which no standard limit values did not exist at that time. These reference values, widely used throughout the country and accepted and adopted as "remediation aim" values by various territorial bodies responsible for the approval and monitoring of remediation projects, have been collected in a specific reclamation oriented data bank known as the "Banca Dati Bonifiche (BDB)" (Reclamation Data Bank). The BDB contains the related standardized "rationale" for each reference value, in order to serve as a useful reference for the national bodies concerned with the remediation of contaminated sites.

Low-dose risk, hormesis, analogical and logical thinking.

The hormesis theory proposes the low-dose beneficial and high-dose detrimental pattern, existing for specific conditions, as a "general default assumption" for toxicology and carcinogenicity. Crump and Kitchin and Drane underline that in a post hoc retrospective scientific literature searching for hormetic dose-response patterns, the consideration of the whole available relevant studies is necessary and, for statistical testing purposes, for instance at a 0.05 standard level, a P value obtained from 1 - (1 - P)(n) = 0.05 (i.e., P = 0.0005 for 100 examined cases) should be used (otherwise, by definition, 5 "positive" results are expected by chance over 100 cases). The hypothesis, based on some experimental data on rodents, by Calabrese and Baldwin, of an hormetic effect of 2,3,7,8-TCDD at the 1-10 ng/kgbw/day dose, of Na-saccharine in the < or = 1% of diet exposure range, of Cadmium Chloride in the 0-5 micromol/kg dose range, single injection, and of neutrons in the 0- to 2-rad dose range, are not confirmed, and, rather, are contradicted, when the whole relevant data presented by international and national agencies are considered. As far as the radiation risk is in particular concerned, a recently published epidemiological study on more than 400,000 nuclear plant workers, co-ordinated by the IARC has indicated a small, but significant risk, at the current exposure limits, and possibly below them. Therefore, the hormesis theory-based criticism of current radiation protection criteria, assumed to be excessively conservative, is not justified. Also not justified is the assumption that "by dismissing hormesis, regulatory agencies such as U.S. EPA deny the public the opportunity for optimal health and avoidance of diseases;" rather, the contrary is here considered true. Analogical considerations are not necessarily logical ones and the single result should be considered in its whole context.

Development of carcinogenicity classifications and evaluations: the case of formaldehyde.

In this paper carcinogenicity classification and evaluations case of formaldehyde made by national and international agencies and organizations (such as European Union, International Agency for Research on Cancer, World Health Organization) both in occupational (such as American Conference of Government Industrial Hygienists, National Institute of Occupational Safety and Health and Occupational Health and Safety Administration) and non occupational environment (such as United States Environmental Protection Agency) are proposed. The differences in the database and consequently in the conclusion are described in a short historical review since formaldehyde was considered for the first time as regard as health effects.

Some non neoplastic effects of ELF magnetic fields in experimental animals.

This study has been addressed to the non neoplastic effects observed in experimental animals exposed to the ELF magnetic fields exposure, giving particular attention to the large and comprehensive data of the two-year NTP (National Toxicology Program) studies. The statistical analysis of non neoplastic incidences, whenever not presented by the study authors, has been carried out in the present study. Only the effects coherently emerging for both the animal genders have been considered; gender specific effects have obviously been separately analysed. The trend analysis has been carried out over the 4 exposure levels (0, 2, 200 microT, and 1000 microT -microTesla) and on the first 3 ones. For 28 dose-response relationships, non neoplastic effects significantly emerged (6 for hyperplasia, 4 for cyst, 4 for inflammation, 3 for focus, 3 for atrophy, 2 for cellular infiltration, and 1 for each of other 6 effects). This number is much higher than the one of neoplastic effects indicated by the NTP as significant. For many of these dose-response relationships, the trend was significant only over the first 3 treatment levels (excluding the highest one, 1000 microT/1 mT), in agreement with the results of some other studies indicating a response reduction, or even a possible anticarcinogenic effects, at considerably high exposures (mT range). The obtained results suggest a complex effect modulation pattern.

Information resources in toxicology--Italy.

The purpose of the present paper is to provide an overview of current resources in the field of toxicology in Italy. The discussion will begin with a brief history of toxicology in this country, which includes the study of the toxicity of plants and other natural substances, and the birth of industrial and forensic toxicology. We will also provide information on research, education, and hazard control in the field of toxicology. Within this context we will examine the public bodies responsible for surveillance and regulatory activities, state-owned and private structures involved in toxicological research, and the educational programs and research activities of universities. Particular emphasis will be placed on the activities of the National Health Service, which plays an important role in areas such as clinical toxicology, food safety, and animal health, as well as those of national and regional agencies dedicated to the protection of the environment. The presentation will be organized as follows: (1) A Brief History of Toxicology in Italy; (2) Professional Societies; (3) National Health Service; (4) National Bodies; (5) Resources for the Environment; (6) Biomedical Websites; (7) Recent Publications; (8) Research Structures; (9) Graduate and Postgraduate Programs; (10) Legislation.