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.

Best practices for developmental toxicity assessment for classification and labeling.

Many chemicals are going through a hazard-based classification and labeling process in Europe. Because of the significant public health implications, the best science must be applied in assessing developmental toxicity data. The European Teratology Society and Health and Environmental Sciences Institute co-organized a workshop to consider best practices, including data quality and consistency, interpretation of developmental effects in the presence of maternal toxicity, human relevance of animal data, and limits of chemical classes. Recommendations included larger historical control databases, more pharmacokinetic studies in pregnant animals for dose setting and study interpretation, generation of mechanistic data to resolve questions about whether maternal toxicity is causative of developmental toxicity, and more rigorous specifications for what constitutes a chemical class. It is our hope that these recommendations will form the basis for subsequent consensus workshops and other scientific activities designed to improve the scientific robustness of data interpretation for classification and labeling.

The juvenile toxicity study as a tool for a science-based risk assessment in the children population group.

Children show unique features concerning chemical hazards and risks, due to different exposure scenarios, age-related metabolic capacity and biological susceptibility linked to post-natal development. Chemical Regulatory frameworks state the need of children risk characterization. Current testing guidelines covering post-natal development are not routinely required by regulatory applications other than pesticides and biocides. Juvenile toxicity studies are foreseen for paediatric drugs: the toxicological repeated-dose tests don't allow accurate evaluations of effects upon direct exposure of immature organism. The paper discusses a testing approach aimed to address regulatory requirements of chemical hazard identification/characterization in a children-specific perspective. Juvenile toxicity test could be performed primarily on chemicals that may have relevant modes of action and/or age-related toxicokinetic differences and/or lead to important children exposure. This could be pursued by updating existing guidelines/test protocols with triggers for endpoints relevant to juvenile toxicity.

Testosterone-induced micronuclei and increased nuclear division rate in L929 cell line expressing the androgen receptor.

Data on the possible genotoxic effects of testosterone are limited: in particular, the potential clastogenic and/or aneugenic effects have not yet been properly investigated. An in vitro micronucleus (MN) assay was performed on L929 cells exposed to testosterone at doses of 10, 15, 20, 30, and 40 µg/mL. Significantly increased MN frequencies were detected at doses of 20, 30, and 40 µg/mL after 24 h and 48 h of incubation. The nuclear division index was higher after 48 h than 24 h of incubation. A benchmark dose (BMD) calculation was used to estimate the 1% extra risk level for MN and increased tetranucleated cells. The calculated 1% extra risk level for MN at 24 h was 12.01 µg/mL, with a 95% lower confidence limit (BMDL) at 8.98 µg/mL; the corresponding BMD and BMDL at 48 h were 17.35 µg/mL and 10.69 µg/mL, respectively. The BMD for tetranucleated cells at 24 h was 14.86 µg/mL, with a BMDL of 7.75 µg/mL; the corresponding values at 48 h were 0.50 µg/mL for BMD and 0.87µg/mL for BMD. These findings suggest that the intensity of the mitogenic effect of testosterone increases upon prolonged exposure. The results of our study show that testosterone acts both as a mitogenic and genotoxic agent in L929 cells.

Artificial-turf playing fields: contents of metals, PAHs, PCBs, PCDDs and PCDFs, inhalation exposure to PAHs and related preliminary risk assessment.

The artificial-turf granulates made from recycled rubber waste are of health concern due the possible exposure of users to dangerous substances present in the rubber, and especially to PAHs. In this work, we determined the contents of PAHs, metals, non-dioxin-like PCBs (NDL-PCBs), PCDDs and PCDFs in granulates, and PAH concentrations in air during the use of the field. The purposes were to identify some potential chemical risks and to roughly assess the risk associated with inhalation exposure to PAHs. Rubber granulates were collected from 13 Italian fields and analysed for 25 metals and nine PAHs. One further granulate was analysed for NDL-PCBs, PCDDs, PCDFs and 13 PAHs. Air samples were collected on filter at two fields, using respectively a high volume static sampler close to the athletes and personal samplers worn by the athletes, and at background locations outside the fields. In the absence of specific quality standards, we evaluated the measured contents with respect to the Italian standards for soils to be reclaimed as green areas. Zn concentrations (1 to 19 g/kg) and BaP concentrations (0.02 to 11 mg/kg) in granulates largely exceeded the pertinent standards, up to two orders of magnitude. No association between the origin of the recycled rubber and the contents of PAHs and metals was observed. The sums of NDL-PCBs and WHO-TE PCDDs+PCDFs were, respectively, 0.18 and 0.67×10(-5) mg/kg. The increased BaP concentrations in air, due to the use of the field, varied approximately from <0.01 to 0.4 ng/m(3), the latter referring to worst-case conditions as to the release of particle-bound PAHs. Based on the 0.4 ng/m(3) concentration, an excess lifetime cancer risk of 1×10(-6) was calculated for an intense 30-year activity.