Pet collars containing tetrachlorvinphos (TCVP): evaluation of the results of torsion and on-animal release studies and implications for post-application consumer exposure and risk analysis.

Tetrachlorvinphos (TCVP) is the pesticidal active ingredient found in some flea and tick collars for dogs and cats. Recent studies sponsored by The Hartz Mountain Corporation, confirm the safety of TCVP as an active ingredient in pet collars. Based upon data from these new studies and results previously relied upon by the U.S. Environmental Protection Agency, the following conclusions have been made: Torsion study data clearly indicate that approximately 93% of released formulation from TCVP containing pet collars is in a liquid phase immediately following activation.Further, even more relevant to human health risk analysis associated with post-application exposures, in vivo data from dogs wearing TCVP pet collars definitively document that TCVP dust released from the collar is rapidly absorbed into the sebum. The maximum ratio of dust to liquid was 0.023% dust to 99.977% liquid.In vivo fur data provide scientific evidence confirming that the mechanism of dissemination of TCVP from pet collars is as a liquid suspended or dissolved in the animal's sebum, even though it may be released from the collar as a solid. Thus, potential post-application exposure to TCVP, including immediately following collar placement, is almost entirely to a liquid phase.Based upon EPA's refined and conservative "untrimmed" collar risk assessment, post-application incidental oral hand-to-mouth activity by children aged 1 to <2 years of age results in margins of exposure significantly greater than the level of concern of 1000, and therefore do not present unreasonable health risk.

Contact sensitizers in commercial hair dye products in the Indian market: A consumer exposure study.

BACKGROUND: Hair dye is a concoction of various ingredients that can result in allergic contact dermatitis (ACD) which is a common problem encountered by dermatologists. OBJECTIVES: To find out the presence of potent contact sensitizers in commercially available hair dyes in Puducherry, a union territory in South India, and to compare the findings with similar studies conducted in different countries. METHODS: Ingredients labels of 159 hair dye products from 30 brands that were manufactured and marketed in India screened for the presence of contact sensitizers. RESULTS: A total of 25 potent contact sensitizers were found in 159 hair dye products. p-Phenylenediamine and resorcinol were the most frequent contact sensitizer found in the study. The mean contact sensitizer concentration in a single hair dye product is 3.72 ± 1.81. The number of potent contact sensitizers in individual hair dye products ranged from 1 to 10. CONCLUSION: We observed that most of the consumer-available hair dyes contain multiple contact sensitizers. Also, an inadequacy in mentioning the p-Phenylenediamine content, and appropriate warning contents regarding hair dye use were not mentioned in the cartons.

Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk.

Our aim is to develop and apply next generation approaches to skin allergy risk assessment that do not require new animal test data and better quantify uncertainties. Quantitative risk assessment for skin sensitisation uses safety assessment factors to extrapolate from the point of departure to an acceptable human exposure level. It is currently unclear whether these safety assessment factors are appropriate when using non-animal test data to derive a point-of departure. Our skin allergy risk assessment model Defined Approach uses Bayesian statistics to infer a human-relevant metric of sensitiser potency with explicit quantification of uncertainty, using any combination of human repeat insult patch test, local lymph node assay, direct peptide reactivity assay, KeratinoSens™, h-CLAT or U-SENS™ data. Here we describe the incorporation of benchmark exposures pertaining to use of consumer products with clinical data supporting a high/low risk categorisation for skin sensitisation. Margins-of-exposure (potency estimate to consumer exposure level ratio) are regressed against the benchmark risk classifications, enabling derivation of a risk metric defined as the probability that an exposure is low risk. This approach circumvents the use of safety assessment factors and provides a simple and transparent mechanism whereby clinical experience can directly feed-back into risk assessment decisions.

Chemical Characterization of Recycled Consumer Products Using Suspect Screening Analysis.

Recycled materials are found in many consumer products as part of a circular economy; however, the chemical content of recycled products is generally uncharacterized. A suspect screening analysis using two-dimensional gas chromatography time-of-flight mass spectrometry (GC × GC-TOFMS) was applied to 210 products (154 recycled, 56 virgin) across seven categories. Chemicals in products were tentatively identified using a standard spectral library or confirmed using chemical standards. A total of 918 probable chemical structures identified (112 of which were confirmed) in recycled materials versus 587 (110 confirmed) in virgin materials. Identified chemicals were characterized in terms of their functional use and structural class. Recycled paper products and construction materials contained greater numbers of chemicals than virgin products; 733 identified chemicals had greater occurrence in recycled compared to virgin materials. Products made from recycled materials contained greater numbers of fragrances, flame retardants, solvents, biocides, and dyes. The results were clustered to identify groups of chemicals potentially associated with unique chemical sources, and identified chemicals were prioritized for further study using high-throughput hazard and exposure information. While occurrence is not necessarily indicative of risk, these results can be used to inform the expansion of existing models or identify exposure pathways currently neglected in exposure assessments.

A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products.

Next generation Risk Assessment (NGRA) is an exposure-led, hypothesis-driven approach which integrates new approach methodologies (NAMs) to assure safety without generating animal data. This hypothetical skin allergy risk assessment of two consumer products - face cream containing 0.1% coumarin and deodorant containing 1% coumarin - demonstrates the application of our skin allergy NGRA framework which incorporates our Skin Allergy Risk Assessment (SARA) Model. SARA uses Bayesian statistics to provide a human relevant point of departure and risk metric for a given chemical exposure based upon input data that can include both NAMs and historical in vivo studies. Regardless of whether NAM or in vivo inputs were used, the model predicted that the face cream and deodorant exposures were low and high risk respectively. Using only NAM data resulted in a minor underestimation of risk relative to in vivo. Coumarin is a predicted pro-hapten and consequently, when applying this mechanistic understanding to the selection of NAMs the discordance in relative risk could be minimized. This case study demonstrates how integrating a computational model and generating bespoke NAM data in a weight of evidence framework can build confidence in safety decision making.

Influence of Bacillus subtilis and Trichoderma harzianum on Penthiopyrad Degradation under Laboratory and Field Studies.

In plant protection, biological preparations are used alternately with chemical pesticides. The applied microorganism can influence the concentration of chemical substances. Laboratory and field studies were conducted to assess the influence of Bacillus subtilis and Trichoderma harzianum on the penthiopyrad concentration. In laboratory studies, the effectiveness of penthiopyrad degradation by B. subtilis was approximately 5% during 14 days of the experiment. For penthiopyrad treated with T. harzianum strains, the degradation effectiveness ranged from 34.2% on Day 3 to 56.9% on Day 14. In experiments testing the effects of mixed culture of microorganisms, the effectiveness of penthiopyrad degradation ranged from 23.7% on Day 3 to 29.1% on Day 14. After treatment of apple trees of Gala and Golden Delicious varieties with a biological preparation, a maximum degradation of penthiopyrad of 20% was found in both varieties. Samples of apples were prepared by the quick, easy, cheap, effective, rugged and safe (QuEChERS) method, and penthiopyrad was analyzed by gas chromatography with a mass detector. A determined value of the chronic exposure to penthiopirad was 1.02% of the acceptable daily intake, both for children and for adults. The acute exposure amounted to 7.2% and 1.9% of the acute reference dose for children and adults, respectively. These values were considered to be acceptable and not threatening to health.

Essential and xenobiotic elements in cottage cheese from the Slovak market with a consumer risk assessment.

The examination of various elements in the milk products is very important in the food sector in respect of food quality and safety. The aim of this study was to determine the concentrations of calcium (Ca), cobalt (Co), cadmium (Cd), copper (Cu), chromium (Cr), iron (Fe), mercury (Hg), potassium (K), magnesium (Mg), sodium (Na), nickel (Ni), phosphorus (P), lead (Pb) and zinc (Zn) in white cottage cheese or cottage cheese supplemented with various additives (white, lacto-free, chive, tzatziki, mustard + onion, chili, active protein) available on the market of Slovakia. All essential elements were within the reference range. Cottage cheese enriched with tzatziki showed higher amount of Cu, Fe, K, and Zn. Mustard + onion cheese contained high values of Ca, Co, Mg, and Ni. In white cottage cheese high amount of Cr, Mn, and P was measured. The content of xenobiotic metals was below permitted limit. The contribution to PTWI (Provisional tolerable weekly intake) suggested very low dietary exposure to heavy metals as Cd, Hg, and Pb as well as other metals (Cu, Ni, and Zn) in cottage cheese. Numerous correlations between concentrations were observed. MOE (Margin of Exposure) evaluation denoted that average consumption of cottage cheese does not pose any high cardiovascular and nephrotoxicity threat.

A quantitative structure-property relationship (QSPR) for estimating solid material-air partition coefficients of organic compounds.

The material-air partition coefficient (Kma ) is a key parameter to estimate the release of chemicals incorporated in solid materials and resulting human exposures. Existing correlations to estimate Kma are applicable for a limited number of chemical-material combinations without considering the effect of temperature. The present study develops a quantitative structure-property relationship (QSPR) to predict Kma for a large number of chemical-material combinations. We compiled a dataset of 991 measured Kma for 179 chemicals in 22 consolidated material types. A multiple linear regression model predicts Kma as a function of chemical's Koa , enthalpy of vaporization (∆Hv ), temperature, and material type. The model shows good fitting of the experimental dataset with adjusted R2 of 0.93 and has been verified by internal and external validations to be robust, stable and has good predicting ability ( Rext2  > 0.78). A generic QSPR is also developed to predict Kma from chemical properties and temperature only (adjusted R2  = 0.84), without the need to assign a specific material type. These QSPRs provide correlation methods to estimate Kma for a wide range of organic chemicals and materials, which will facilitate high-throughput estimates of human exposures for chemicals in solid materials, particularly building materials and furniture.

Assessment of Human Exposure to ENMs.

Human exposure assessment of engineered nanomaterials (ENMs) is hampered, among other factors, by the difficulty to differentiate ENM from other nanomaterials (incidental to processes or naturally occurring) and the lack of a single metric that can be used for health risk assessment. It is important that the exposure assessment is carried out throughout the entire life-cycle as releases can occur at the different stages of the product life-cycle, from the synthesis, manufacture of the nano-enable product (occupational exposure) to the professional and consumer use of nano-enabled product (consumer exposure) and at the end of life.Occupational exposure surveys should follow a tiered approach, increasing in complexity in terms of instruments used and sampling strategy applied with higher tiers in order tailor the exposure assessment to the specific materials used and workplace exposure scenarios and to reduce uncertainty in assessment of exposure. Assessment of consumer exposure and of releases from end-of-life processes currently relies on release testing of nano-enabled products in laboratory settings.

Human health risk evaluation of selected VOC, SVOC and particulate emissions from scented candles.

Airborne compounds in the indoor environment arise from a wide variety of sources such as environmental tobacco smoke, heating and cooking, construction materials as well as outdoor sources. To understand the contribution of scented candles to the indoor load of airborne substances and particulate matter, candle emission testing was undertaken in environmentally controlled small and large emission chambers. Candle emission rates, calculated on the basis of measured chamber concentrations of volatile and semi-volatile organic compounds (VOC, SVOC) and particulate matter (PM), were used to predict their respective indoor air concentrations in a standard EU-based dwelling using 2 models: the widely accepted ConsExpo 1-box inhalation model and the recently developed RIFM 2-box indoor air dispersion model. The output from both models has been used to estimate more realistic consumer exposure concentrations of specific chemicals and PM in candle emissions. Potential consumer health risks associated with the candle emissions were characterized by comparing the exposure concentrations with existing indoor or ambient air quality guidelines or, where not existent, to established toxicity thresholds. On the basis of this investigation it was concluded that under normal conditions of use scented candles do not pose known health risks to the consumer.

Risk Assessment of residual monomer migrating from acrylic polymers and causing Allergic Contact Dermatitis during normal handling and use.

Acrylic, Poly Methyl Methacrylate (PMMA) based polymers are found in many industrial, professional and consumer products and are of low toxicity, but do contain very low levels of residual monomers and process chemicals that can leach out during handling and use. Methyl Methacrylate, the principle monomer is of low toxicity, but is a recognized weak skin sensitizer. The risk of induction of contact allergy in consumers was determined using a method based upon the Exposure-based Quantitative Risk Assessment approach developed for fragrance ingredients. The No Expected Sensitization Induction Level (NESIL) was based on the threshold to induction of sensitization (EC3) in the Local Lymph Node Assay (LLNA) since no Human Repeat Insult Patch Test (HRIPT) data were available. Categorical estimation of Consumer Exposure Level was substituted with a worst case assumption based upon the quantitative determination of MMA monomer migration into simulants. Application of default and Chemical-Specific Adjustment Factors results in a Risk Characterization Ratio (RCR) of 10,000 and a high Margin of Safety for induction of Allergic Contact Dermatitis (ACD) in consumers handling polymers under conservative exposure conditions. Although there are no data available to derive a RCR for elicitation of ACD it is likely to be lower than that for induction.

Levels of Essential and Trace Elements in Mozzarella Available on the Slovak Market with the Estimation of Consumer Exposure.

The aim of this study was to determinate the content of some elements in a specific dairy product, mozzarella, in a particular area of western Slovakia and to evaluate the estimation of the risk to the consumers based on the contribution to the provisional tolerable weekly intake. The consumption of mozzarella can contribute to the intake of important elements in the diet, such as calcium and magnesium, along with others. The contents of some toxic and trace elements were low and have not exceeded the permitted limit. In addition, the contribution to PTWI was found to be very low, which means that the consumption of mozzarella possesses no risk to humans. It is concluded that the data obtained in this study can help as a valuable addition to methodological and scientific material in the field of food safety of dairy products and their positive impact on human health.

Probabilistic Risk Characterization of Heavy Metals in Peruvian Coffee: Implications of Variety, Region and Processing.

Heavy metals are chemical contaminants, toxic, potentially carcinogenic and/or mutagenic, stable, persistent and are of concern in the food chain. The risk to the consumer of the presence of inorganic arsenic (iAs), cadmium (Cd), chromium (Cr), mercury (Hg) and lead (Pb) in five varieties (Bourbon, Típica, Catimor, Caturra and Pache) of parchment coffee from five regions (Amazonas, Cajamarca, Cusco, Huánuco and San Martín) was investigated in this study. A predictive model of the stages of coffee bean hulling, roasting and infusion was built to simulate the process. The results by region showed significant differences in which San Martín had the highest iAs, Cr and Pb values. The variety was only significant for Cr, of which Pache presented the highest concentration. The Cd and Hg values were below the detection limits. The hazard index (HI) was less than 1 for iAs, Cd, Cr and Hg and the combination of margin of exposure and the probability of exceedance (MOE-POE) for Pb indicated that an adverse health effect was not likely. The cancer risk (CR) for iAs and Pb in the 95th percentile was considered as both high and acceptable, respectively.

Improved Food-Processing Techniques to Reduce Isoflavones in Soy-Based Foodstuffs.

Soy is a growing protein source; however, the isoflavones it contains are of concern, as they exhibit estrogenic activities whose toxicological limits might be exceeded. Reducing their concentrations to safe levels while preserving nutritional quality in soy foodstuffs is therefore a matter of public health. The main objective of this paper is to develop at pilot scale a process for isoflavones' extraction from soybeans, and to show its feasibility and efficiency. The study was conducted by first optimizing the previously obtained laboratory treatment key factors. These data were then transposed to the pilot level. Finally, the process was adjusted to technical constraints which appeared at pilot scale: the mandatory use of drenching and the exploration of granulometry analysis. The involved steps were validated by monitoring the genistein and daidzein content variations through statistical analysis of the data of an ELISA and a Folin-Ciocalteu assay. Additionally, isoflavones' recovery from treatment waters for their valorisation and the water cleaning by means of filtration, centrifugation and resin adsorption were carried out. The results showed that the most successful pilot treatment developed involved soybean dehulling, drenching, washing and drying and almost halved isoflavones while preserving the main nutritional characteristics. A combination of techniques led to almost complete recovery of isoflavones from process waters.

Simplified Unified BARGE Method to Assess Migration of Phthalate Esters in Ingested PVC Consumer Products.

The unified bioaccessibility research group of Europe (BARGE) method (UBM) suggests using in vitro experimental conditions for simulating the release of chemicals from confined matrices, such as soils and sediments, in the human gastrointestinal tract. It contains comprehensive steps that simulate human digestion pathways and has good potential for application in the leaching of plastic additives from accidentally ingested plastic particles. However, its complexity could be a challenge for routine screening assessments of the migration of chemicals from consumer plastic products. In this study, the UBM was modified to assess the migration of plastic additives from consumer products with five model phthalate esters (i.e., dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), bis(2-ethylhexyl) phthalate (DEHP), and di-n-octyl phthalate (DNOP)) from polyvinyl chloride (PVC). The migration of phthalate esters was observed in four digestive phases (saliva, gastric, duodenal, and bile). Three separate experiments were conducted with the addition of (1) inorganic constituents only, (2) inorganic and organic constituents, and (3) inorganic and organic constituents in combination with digestive enzymes. While using enzymes with the UBM solution, the migrated mass for leached compounds was comparatively low (0.226 ± 0.04 µg) in most digestion phases, likely due to a self-generated coating of enzymes on the plastic materials. However, higher mass migration (0.301 ± 0.05) was observed when phthalate esters were analyzed in the UBM solution, excluding the enzymes. A ring test among six independent laboratories confirmed the robustness of the modified method. Therefore, we propose a simplified version of the original UBM designed mainly for the migration of inorganic elements using only the inorganic and organic components of the solution throughout all phases of digestion.

An assessment of the ECETOC TRA Consumer tool performance as a screening level tool.

BACKGROUND: The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) Consumer tool was developed to fill in a methodology gap for a high throughput, screening level tool to support industry compliance with the European Union's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. OBJECTIVE: To evaluate if the TRA Consumer tool has met its design of being a screening level tool (i.e., one which does not under-predict potential exposures). METHODS: The TRA Consumer tool algorithms and defaults were reviewed and performance benchmarked vs. other consumer models and/or empirical data. Findings from existing reviews of the TRA consumer tool were also considered and addressed. RESULTS: TRA predictions based on its default inputs exceeded measured exposures when available, typically by orders of magnitude, and were generally greater than or similar to those of other consumer exposure tools. For dermal exposure from articles, there was no evidence that a diffusivity approach would provide more appropriate exposure estimates than those of the TRA. When default values are refined using more specific data, the refined values must be considered holistically to reflect the situation being modeled as some parameters may be correlated. SIGNIFICANCE: This is the first evaluation of the ECETOC TRA consumer tool in its entirety, considering algorithms, input defaults, and associated predictions for consumer products and articles. The evaluation confirmed its design as a screening level tool. IMPACT STATEMENT: The ECETOC TRA Consumer tool has been widely applied to generate exposure estimates to support chemical registrations under the EU REACH regulation. This evaluation supports the appropriateness of the TRA as a screening level exposure assessment tool. It also warrants additional measurements of consumer exposure, especially for article use scenarios, to aid the development of consumer exposure tools and chemical risk assessment.

Development of an Assay for Soy Isoflavones in Women's Hair.

Soy isoflavones, at adequate dosages, have estrogenic and anti-thyroidal effects in animals and humans, which can either be beneficial or adverse, depending on the consumer's physiological status. Hence, this study presents an assay of soy isoflavones in hair, aiming to give new information about a person's exposure to isoflavones, when health issues related to estrogenic or thyroidal effects are observed. Aqueous or organic extraction procedures following acidic, basic, or enzymatic digestions were tested on 60 hair samples (from volunteers) from a hairdresser, and a clinical trial 2017T2-29. The acidic digestion method was the most efficient regarding isoflavones. A specific inquiry was developed to assess the dietary habits of French consumers based on the analysis of 12,707 food labels from France. It was used to check for the reliability of the new assay method. A score for the consumer exposures to isoflavones was built considering, among other parameters, soy-based diets and foodstuff containing soy as an ingredient, i.e., "hidden-soy". The correlation between this score and isoflavone measurements in hair reached 0.947; p < 0.001. Therefore, providing that relevant data are considered to assess isoflavone exposure, hair that smoothens daily isoflavone intake variations, is a relevant tissue to assess human isoflavone exposure for subsequent health analyses.

Endocrine disruptors on and in fruits and vegetables: Estimation of the potential exposure of the French population.

Fruits and vegetables are considered to be healthy compared to fats, carbohydrates, and meats. However, their production involves plant protection products (PPPs) or they can contain phytoestrogens which may exhibit endocrine effects. Thus, the exposure to the main PPPs and to phytoestrogens known as endocrine disruptors (EDs) is estimated. PPPs include fungicides, growth substances, herbicides, and insecticides authorised in France. ED-PPPs exposure is estimated from the maximum residue limits (MRLs) of 70 potential ED-PPPs used in France on 64 fruits and vegetables. The estimated exposure to potential ED-PPPs is 509 µg/d and involves agonist and antagonist substances in complex mixtures. Anti-androgens are preeminent, at 353 µg/d. Exposure to genistein and daidzein is calculated from 140 measurements in 9 categories of food-items containing soy. The global exposure to isoflavones in France is evaluated at 6700 µg/d. Phytoestrogen exposure is much higher than that of ED-PPPs. Their endocrine effects should be considered.

Modeling Primary Emissions of Chemicals from Liquid Products Applied on Indoor Surfaces.

Liquid products applied on material surfaces and human skin, including many household cleaning products and personal care products, can lead to intermittent emissions of chemicals and peak concentrations in indoor air. The existing case-based models do not allow inter-comparison of different use scenarios and emission mechanisms. In this context, the present work developed a mechanistic model based on mass transfer theories, which allowed emissions into the air from the liquid product to be characterized. It also allowed for diffusion into the applied surface during product use and re-emission from the applied surface after the depletion of the liquid product. The model was validated using literature data on chemical emissions following floor cleaning and personal care product use. A sensitivity analysis of the model was then conducted. The percentage of the chemical mass emitted from the liquid to the air varied from 45% (applied on porous material) to 99% (applied on human skin), and the rest was absorbed into the applied material/skin. The peak gas-phase concentration, the time to reach the peak concentration, and the percentage of the liquid-to-air emission depended significantly on the chemical's octanol/gas and material/gas partition coefficients and the diffusion coefficient of the chemical in the applied material/skin.