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1.
J Toxicol Environ Health A ; 87(19): 773-791, 2024 Oct.
Article in English | MEDLINE | ID: mdl-38959023

ABSTRACT

The application of biosolids, manure, and slurry onto agricultural soils and the growing use of treated wastewater in agriculture result in the introduction of human and veterinary pharmaceuticals to the environment. Once in the soil environment, pharmaceuticals may be taken up by crops, resulting in consequent human exposure to pharmaceutical residues. The potential side effects of pharmaceuticals administered in human medicine are widely documented; however, far less is known regarding the risks that arise from incidental dietary exposure. The aim of this study was to evaluate human exposure to pharmaceutical residues in crops and assess the associated risk to health for a range of pharmaceuticals frequently detected in soils. Estimated concentrations of carbamazepine, oxytetracycline, sulfamethoxazole, trimethoprim, and tetracycline in soil were used in conjunction with plant uptake and crop consumption data to estimate daily exposures to each compound. Exposure concentrations were compared to Acceptable Daily Intakes (ADIs) to determine the level of risk. Generally, exposure concentrations were lower than ADIs. The exceptions were carbamazepine, and trimethoprim and sulfamethoxazole under conservative, worst-case scenarios, where a potential risk to human health was predicted. Future research therefore needs to prioritize investigation into the health effects following exposure to these compounds from consumption of contaminated crops.


Subject(s)
Crops, Agricultural , Soil Pollutants , Humans , Crops, Agricultural/chemistry , Soil Pollutants/analysis , Risk Assessment , Drug Residues/analysis , Dietary Exposure , Pharmaceutical Preparations/analysis
2.
PeerJ ; 12: e17463, 2024.
Article in English | MEDLINE | ID: mdl-38827315

ABSTRACT

Background: The use of antimicrobials to treat food animals may result in antimicrobial residues in foodstuffs of animal origin. The European Medicines Association (EMA) and World Health Organization (WHO) define safe antimicrobial concentrations in food based on acceptable daily intakes (ADIs). It is unknown if ADI doses of antimicrobials in food could influence the antimicrobial susceptibility of human-associated bacteria. Objectives: This aim of this study was to evaluate if the consumption of ADI doses of erythromycin could select for erythromycin resistance in a Galleria mellonella model of Streptococcus pneumoniae infection. Methods: A chronic model of S. pneumoniae infection in G. mellonella larvae was used for the experiment. Inoculation of larvae with S. pneumoniae was followed by injections of erythromycin ADI doses (0.0875 and 0.012 µg/ml according to EMA and WHO, respectively). Isolation of S. pneumoniae colonies was then performed on selective agar plates. Minimum inhibitory concentrations (MICs) of resistant colonies were measured, and whole genome sequencing (WGS) was performed followed by variant calling to determine the genetic modifications. Results: Exposure to single doses of both EMA and WHO ADI doses of erythromycin resulted in the emergence of erythromycin resistance in S. pneumoniae. Emergent resistance to erythromycin was associated with a mutation in rplA, which codes for the L1 ribosomal protein and has been linked to macrolide resistance in previous studies. Conclusion: In our in vivo model, even single doses of erythromycin that are classified as acceptable by the WHO and EMA induced significant increases in erythromycin MICs in S. pneumoniae. These results suggest the need to include the induction of antimicrobial resistance (AMR) as a significant criterion for determining ADIs.


Subject(s)
Anti-Bacterial Agents , Drug Resistance, Bacterial , Erythromycin , Larva , Microbial Sensitivity Tests , Moths , Streptococcus pneumoniae , Erythromycin/pharmacology , Animals , Streptococcus pneumoniae/drug effects , Streptococcus pneumoniae/genetics , Anti-Bacterial Agents/pharmacology , Moths/microbiology , Moths/drug effects , Drug Resistance, Bacterial/genetics , Drug Resistance, Bacterial/drug effects , Larva/microbiology , Larva/drug effects , Pneumococcal Infections/drug therapy , Pneumococcal Infections/microbiology , Disease Models, Animal , Humans
3.
Regul Toxicol Pharmacol ; 150: 105642, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38735521

ABSTRACT

Isoeugenol is one of several phenylpropenoid compounds that is used as a fragrance, food flavoring agent and in aquaculture as a fish anesthetic. Carcinogenicity testing in rats and mice by NTP resulted in clear evidence of carcinogenicity (hepatic adenomas/carcinomas) in male mice only. A nongenotoxic threshold mode of action (MOA) is postulated for isoeugenol and is discussed considering the IPCS MOA and Human Relevance Framework. The weight of evidence indicates that isoeugenol is not genotoxic and that the carcinogenic outcome in male mice relates directly to the metabolism of individual compounds. Benchmark Dose (BMD) modeling was conducted to determine a Point of Departure (POD) and potential threshold of carcinogenicity. The results of the BMD evaluation for isoeugenol resulted in an estimated POD for carcinogenicity in the male mouse of 8 mg/kg with a lower limit of 4 mg/kg, representing a POD for the determination of an acceptable daily intake. With application of uncertainty factors, an ADI of 40 µg/kg is calculated. This daily dose in humans would be protective of human health, including carcinogenicity. A corresponding maximum residual level (MRL) of 3200 µg/kg fish is also estimated based on this POD that considers the threshold MOA.


Subject(s)
Carcinogenicity Tests , Dose-Response Relationship, Drug , Eugenol , Animals , Eugenol/analogs & derivatives , Eugenol/toxicity , Male , Humans , Mice , Rats , Carcinogens/toxicity , Risk Assessment , Female , Flavoring Agents/toxicity
4.
Food Chem Toxicol ; 189: 114715, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38729342

ABSTRACT

As a commonly used food preservative, glycerol monocaprylate (GMC) has limited information and lacked a comprehensive risk assessment. In this study, we conducted in vitro genotoxicity tests, a 90-day subchronic toxicity study, and dietary exposure assessment in China. Rats (n = 10/sex/group) were orally administered GMC at doses of 1.02, 2.04, and 4.08 g/kg BW/day along with a water and corn oil for 90 days, including satellite groups (n = 5/sex/group) in the control groups and 4.08 g/kg BW dose group for observation after 90 days. Body weight, food consumption, hematology, serum biochemistry, urinalysis, endocrine hormone level and other metrics were examined. GMC did not exhibit genotoxicity based on the genotoxicity tests results, and an acceptable daily intake (ADI) of 40.8 mg/kg BW/day was established based on the 90-day subchronic toxicity study. Estimated daily intake of GMC for general population and consumer population in China were 0.99 mg/kg BW/day and 3.19 mg/kg BW/day respectively, which were significantly lower than the ADI. Our findings suggest that GMC does not pose a known health risk to Chinese consumers at the current usage level.


Subject(s)
Glycerol , Rats, Sprague-Dawley , Animals , Male , Glycerol/toxicity , Female , Rats , Toxicity Tests, Subchronic , Mutagenicity Tests , Food Preservatives/toxicity , Dietary Exposure , Body Weight/drug effects , China
5.
Drug Dev Ind Pharm ; : 1-9, 2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38459761

ABSTRACT

OBJECTIVES: This study aimed to determine the incidence, types and predictors of Potentially Harmful Excipients (PHE) exposure among hospitalized neonates. METHODS: A prospective observational study was conducted from March to April 2022 in neonatal wards at a state hospital in Malaysia. The PHEs of interest were aspartame, benzalkonium chloride, benzyl alcohol, benzoic acid or benzoates, ethanol, parabens, polysorbate 80, propylene glycol, saccharin sodium, sorbitol and sulfites. Product information leaflets (PILs) and summaries of product characteristics (SPCs) were referred to obtain information on active pharmaceutical ingredient, strength, trade name as well as type and amount of the excipients. RESULTS: A total of 108 neonates were recruited and 97.2% of them were exposed to at least one PHE. Parabens (47.2%) and sulfites (27.5%) were the two most commonly administered PHEs. Benzyl alcohol is contraindicated in neonates but was administered to 8% of neonates in this study. The median daily dose of ethanol (24.11 mg/kg/day, IQR 19.73, 28.49) exceeded the acceptable daily intake (ADI) by four times. However, the dose was not available for all PHEs as this information is not always available in the PIL or SPC. Administration of cardiovascular drugs was associated with a higher risk of exposure to any PHE (OR 6.38, CI 2.75, 14.79, p-value < 0.001). CONCLUSION: The exposure of PHE among neonates in this study is high with certain PHEs exceeding the ADI. It highlights the need for certain strategies to be implemented to reduce such exposure in neonates.

6.
Toxicol Res ; 40(1): 23-30, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38223671

ABSTRACT

As veterinary drugs available for fish is very restricted, there is growing trials for repurposing livestock drugs as aquatic animal drugs. Tylosin is one of the most effective antibiotics to treat bacterial infections approved for livestock, and would be used in fish. Hence, we investigated the toxicological and microbiological aspects of tylosin to establish health-based guidance value (HBGV) and maximum residue limit (MRL) in fishes, and reevaluated the microbiological acceptable daily intake (mADI) based on updated relevant data and international guildeline. Lastly, exposure assessment was performed to confirm the appropriateness of MRL. By investigating available microbiologcial studies on tylosin, the microbiological point of departure was determined as 0.308 µg/mL, which was mean 50% minimum inhibitory concentration (MIC50), obtained from the Food Safety Committee of Japan (FSCJ) evaluation report. Furthermore, as a factor for the derivation of mADI, the volume of colon content was recently changed to 500 mL in compliance with the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines. This was previously defined as the mass of colon content (220 g). We applied correction factor 0.224 to the mean MIC50 for tylosin in the equation of mADI, since the drug is transformed to metabolites with reduced activity prior to entering the colon and bound to fecal materials within the colon of human. The mADI was evaluated as 0.01 mg/kg bw/day. Finally, the hazard index, calculated by dividing the estimated chronic dietary exposure by mADI, did not exceed 100%, suggesting that chronic dietary exposure to tylosin residues from veterinary use was unlikely to be a public health concern. Overall, this study contributes significantly in updating HBGV by application of the concept of mADI for the first time in Korea based on the revised microbiological risk assessment guidelines and in providing scientific rationale for the risk management of veterinary drug residues in food. Supplementary Information: The online version contains supplementary material available at 10.1007/s43188-023-00179-z.

7.
Toxics ; 11(12)2023 Dec 05.
Article in English | MEDLINE | ID: mdl-38133392

ABSTRACT

Isoeugenol has recently been evaluated as possibly carcinogenic (Group 2B) by the WHO International Agency for Research on Cancer (IARC). In light of this evaluation, an updated risk assessment of this common food constituent was conducted using the benchmark dose (BMD) approach as recommended by the European Food Safety Authority (EFSA) for point of departure (POD) determination, as an alternative to the no observed adverse effect level (NOAEL). This approach was specifically chosen, as for the relevant neoplastic endpoints only lowest observed adverse effect level (LOAEL) values are available. The toxicological endpoint from the animal studies with the most conservative BMD lower confidence limit (BMDL) value was identified. Using the obtained BMDL value of 8 mg/kg body weight/day as POD, an acceptable daily intake (ADI) of 16 µg/kg body weight/day was obtained, which-despite being more conservative than previous approaches-is still clearly above the estimated daily exposure level to isoeugenol in the USA and in Europe. These results confirm a low risk of the estimated daily exposure levels of isoeugenol.

8.
Eur J Pediatr ; 182(12): 5701-5705, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37776354

ABSTRACT

The 2017 European Food Safety Authority (EFSA) recommendation of an acceptable daily intake (ADI) of 30 mg glutamic acid/kg bw/day did not take into consideration the primary energy sources during infancy, including infant formulas. In the present study, we determined total daily intakes of glutamic acid in a contemporary cohort of healthy infants who were fed either cow milk formula (CMF) or extensive protein hydrolysate formula (EHF); the formulas differed substantially in glutamic acid content. The infants (n = 141) were randomized to be fed either CMF or EHF. Dietary intakes were determined from weighed bottle methods and/or prospective diet records, and body weights were measured on 14 occasions from 0.5 to 12.5 months. Secondary data analysis determined the glutamic acid content of the diet over time. The trial was registered at  http://www. CLINICALTRIALS: gov/ as NCT01700205, 3 October 2012. Glutamic acid intake from formula and other foods was significantly higher in infants fed EHF when compared to CMF. As glutamic acid intake from formula decreased, intake from other nutritional sources steadily increased from 5.5 months. Regardless of formula type, every infant exceeded the ADI of 30 mg/kg bw/day from 0.5 to 12.5 months.   Conclusion: Given that the ADI recommendation was not based on actual intake data of primary energy sources during infancy, the present findings on the growing child's ingestion of glutamic acid from infant formula and the complementary diet may be of interest when developing future guidelines and communications to parents, clinical care providers, and policy makers. WHAT IS KNOWN: • The 2017 re-evaluation of the safety of glutamic acid-glutamates and the recommended acceptable daily intake (ADI) of 30 mg/kg bw/d by the European Food Safety Authority (EFSA) did not include actual intake data of the primary energy sources during infancy. WHAT IS NEW: • During the first year, glutamic acid intake from infant formula and other food sources exceeded the ADI of 30 mg/kg bw/day.


Subject(s)
Glutamic Acid , Infant Formula , Infant , Female , Animals , Cattle , Child , Humans , Prospective Studies , No-Observed-Adverse-Effect Level , Milk , Protein Hydrolysates , Infant Nutritional Physiological Phenomena
9.
Environ Geochem Health ; 45(12): 9559-9582, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37776469

ABSTRACT

Brazil, a global frontrunner in pesticide consumption and sales, particularly glyphosate, appears to be at odds with other countries that increasingly ban these products in their territories. This study gathers the values of Acceptable Daily Intake and Maximum Residue Limits (MRL) in the European Union for dozens of substances and subsequently contrasts them with the corresponding benchmarks upheld in Brazil concerning its predominant crops. Furthermore, this study delves into the toxicity levels and the potential health ramifications of glyphosate on humans through the ingestion of food containing its residues. The findings from this research underscore a notable surge in glyphosate and pesticide sales and usage within Brazil over the past decade. In stark contrast to its European counterparts, Brazil not only sanctioned the sale and application of 474 new pesticides in 2019, but extended the authorization for glyphosate sales while downgrading its toxicity classification. Finally, this review not only uncovers disparities among research outcomes but also addresses the complexities of replacing glyphosate and introduces environmentally friendlier alternatives that have been subject to evaluation in the existing literature.


Subject(s)
Pesticide Residues , Pesticides , Humans , Pesticide Residues/analysis , Brazil , Risk Assessment , Glyphosate
10.
Food Addit Contam Part B Surveill ; 16(4): 321-331, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37581338

ABSTRACT

Upward trend in the use of food supplements urged the assessment of their safety. Eighty-eight liquid herbal supplements collected in Novi Sad (Serbia) in 2018 (36 samples) and 2021 (52 samples) were analysed for the presence of benzoates and sorbates (HPLC-UV) and benzene (HS-GC/MS). Benzoic acid varied from 599 to 9253 mg/kg and sorbic acid between 185 and 1658 mg/kg. The acceptable daily intake of sorbic acid was not reached, but in case of benzoic acid, it was exceeded by 5.3% of the samples. The presence of benzene was confirmed in 41.2% of benzoate preserved supplements (0.9-51.7 µg/kg). Benzene exposure revealed no health concern: maximum hazard quotients ranged from 0.39% (toddlers) to 0.84% (adolescents); minimum margins of exposure were between 35,680 (adolescents) and 77,419 (toddlers); estimates of lifetime cancer risk did not reach one extra cancer case per 100 000 persons. However, measures to mitigate benzene presence in food should be considered.


Subject(s)
Benzoates , Neoplasms , Adolescent , Humans , Benzoates/analysis , Benzene/analysis , Food Contamination/analysis , Sorbic Acid , Benzoic Acid/analysis , Dietary Supplements/analysis , Risk Assessment
11.
Foods ; 12(11)2023 May 26.
Article in English | MEDLINE | ID: mdl-37297397

ABSTRACT

This study aimed to determine chemical composition and assess exposure in flavored milk among Chinese residents, based on risk assessment methodologies of acceptable daily intake (ADI) and toxicological concern threshold (TTC). Esters (32.17%), alcohols (11.19%), olefins (9.09%), aldehydes (8.39%), and ketones (7.34%) comprised the majority of the flavoring samples. Methyl palmitate (90.91%), ethyl butyrate (81.82%), and dipentene (81.82%) had the highest detection rates in flavor samples. This study screened fifteen flavor components of concern and discovered that 2,3,5-trimethylpyrazine, furfural, benzaldehyde, and benzenemethanol were detected in 100% of flavored milk samples. Benzenemethanol was found in the highest concentration (14,995.44 µg kg-1). The risk assessment results revealed that there was no risk for Chinese residents in consuming flavored milk, and the maximum per capita daily consumption of 2,3,5-trimethylpyrazine, furfural, and benzenemethanol were 226.208 g, 140.610 g, and 120.036 g, respectively. This study could provide guidelines for amounts of flavor additive ingredients in milk.

12.
Nutrients ; 15(11)2023 May 24.
Article in English | MEDLINE | ID: mdl-37299405

ABSTRACT

The sixth Total Diet Study (TDS) of China included a countrywide study to assess the health effects of MSG (monosodium glutamate). MSG detection, consumption analysis, and risk assessment were conducted on 168 samples from seven food categories of the most typical Chinese daily diet. The highest value of MSG in the daily diet of the Chinese population was 8.63 g/kg. An MSG intake of 17.63 mg/kg bw/d for the general population of China was obtained from content measurements combined with food consumption, while the data from the apparent consumption survey alone gave 40.20 mg/kg bw/d. The apparent consumption did not consider the loss of MSG during food cooking, resulting in an overestimate. To offer a global perspective, MSG content, food category contributions, and ingestion levels across nations were summarized and thoroughly investigated. A realistic, logical, and precise risk assessment protocol for MSG daily intake was developed in this article.


Subject(s)
Diet , Sodium Glutamate , Humans , Sodium Glutamate/adverse effects , Food , Risk Assessment , China/epidemiology
13.
Toxics ; 11(4)2023 Mar 30.
Article in English | MEDLINE | ID: mdl-37112553

ABSTRACT

As two commonly used fungicides, carbendazim and tebuconazole are widely found in the environment and in foods. Studies have reported that these fungicides can induce hepatic oxidative stress and other health risks. Nevertheless, the influences of exposure to carbendazim and tebuconazole at their acceptable daily intake (ADI) doses on hepatic oxidative stress, and the residual distributions in mice remain unclear. To fill these gaps, ICR (CD-1) mice were exposed to carbendazim and tebuconazole at their ADI doses by oral administration for 4 weeks in this study. The results showed that tebuconazole accumulated primarily in the epididymal fat of mice (16.84 µg/kg), whereas no significant residues of carbendazim in the tissues were observed. In addition, exposure to ADI doses of tebuconazole significantly reduced liver coefficients and induced hepatic oxidative stress in mice, including elevating the levels of glutathione and malonaldehyde. However, no significant impacts were observed on the hepatic redox homeostasis in mice after exposure to carbendazim at its ADI dose. The results could be helpful for understanding the exposure risks of carbendazim and tebuconazole in terms of low doses and long term.

14.
J Hazard Mater ; 453: 131372, 2023 07 05.
Article in English | MEDLINE | ID: mdl-37060753

ABSTRACT

Most PAHs produced by human activities can be absorbed and accumulated by edible organisms and pose a potential hazard to human health. However, the source apportionment and human health risk of PAHs accumulated in edible organisms remains largely unknown. Therefore, we conducted source analysis and health risk assessment based on the PAH concentrations in ten marine fish from coastal areas of Guangdong, China. Results showed that the pollution of PAHs in fish organisms was at "Minimally polluted" level, and that all marine fish had the ability to accumulate PAHs. Risk assessment indicated Carcinogenic risk of PAHs in four populations was at a "Cautionary risk" level, with urban children suffered the highest risk. Petroleum pollution, Coal and biomass combustion, and Marine transport emissions were identified as the main anthropogenic sources for PAHs in organisms, and Marine transport emissions accounted for the highest Carcinogenic risk. The Acceptable daily intake for all populations were far below their actual daily intake without causing "Cautionary risk". Our findings provide new insights into the source apportionment and health risk of PAHs from a "source-organism-human" perspective, and suggested that joint management of three anthropogenic sources would be an effective way to prevent the health risks of PAHs.


Subject(s)
Environmental Monitoring , Polycyclic Aromatic Hydrocarbons , Animals , Child , Humans , Environmental Monitoring/methods , Aquatic Organisms , Environmental Pollution , China , Coal/analysis , Risk Assessment/methods , Carcinogens/analysis , Polycyclic Aromatic Hydrocarbons/toxicity , Polycyclic Aromatic Hydrocarbons/analysis
15.
Article in English | MEDLINE | ID: mdl-36669121

ABSTRACT

To estimate the daily intake of food additives by young children aged 1-6 years in Japan, an intake survey was conducted in 2018 using the market basket method for food additives, including twelve types of colourants, three kinds of preservatives, three kinds of sweeteners and two kinds of food manufacturing agents. A list of the daily consumption of processed foods was prepared based on a special survey (MHLW 2011) and used for the estimation. The results of the survey showed that the food additives with the highest daily intake were phosphorus compounds (phosphoric acid and its salts; 11.2 mg/kg bw/day, expressed as phosphorus), followed by propylene glycol (0.80 mg/kg bw/day). The daily intake of other food additives ranged from 0 to 0.20 mg/kg bw/day. The estimated daily intake of each food additives by young children was compared with the acceptable daily intake (ADI) or maximum tolerable daily intake (MTDI). The highest ratio of the estimated daily intake to ADI was 3.2% for propylene glycol, whereas the ratios of the estimated daily intake to ADI for colourants, preservatives and sweeteners ranged from 0 to 1.1% (benzoic acid). The ratio of the estimated daily intake to MTDI for phosphorus compounds was 16%.


Subject(s)
Diet , East Asian People , Food Additives , Child , Child, Preschool , Humans , Propylene Glycol , Sweetening Agents , Infant , Phosphorus Compounds
16.
J Expo Sci Environ Epidemiol ; 33(5): 787-793, 2023 09.
Article in English | MEDLINE | ID: mdl-35233072

ABSTRACT

BACKGROUND: Food and Drug Administration (FDA) Food Drug and Cosmetic (FD&C) synthetic color additives (SCAs) have been associated with attentional and behavioral problems in children. Efforts to quantify exposure have focused on foods, while the contribution of medications and supplements remains unknown. OBJECTIVE: To estimate exposures to SCAs in children (2-16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins. METHODS: We estimated single-day exposure (mg/kg/day) to FD&C SCAs based on measurements of 25 different products and recommended dosages on product labels. Exposures were compared to SCA exposure estimates from food we previously developed and acceptable daily intakes (ADIs) established by FDA and the World Health Organization. RESULTS: The highest exposure was found for FD&C Red No. 40 in a children's cold/cough/allergy syrup. A child aged 12-16 years consuming the maximum daily dosage would have an exposure of 0.221 mg/kg/day, which is twice this age group's typical exposure to this additive from food. No estimated exposures exceeded the ADIs. SIGNIFICANCE: Some children's OTC medications and vitamins may cause daily SCA exposures comparable to those from foods. OTC medications and vitamins should be considered in efforts to quantify population exposure to FD&C SCAs. IMPACT: Exposure to synthetic color additives (SCAs) from foods has been associated with behavioral problems in children. Exposures from over-the-counter (OTC) medications and vitamins remain unquantified despite widespread use. We estimated exposures in children and pregnant women for 25 different OTC medication and vitamin products sold in the United States. While exposures were below acceptable daily intakes (ADIs) established by the US Food and Drug Administration and the World Health Organization, some were comparable to typical daily exposures from foods. This work critically informs future SCA exposure assessments and provides valuable information for parents concerned about the health effects of SCAs.


Subject(s)
Pregnant Women , Vitamins , Child , Humans , Female , Pregnancy , United States , Vitamins/analysis , Pharmaceutical Preparations , Food Additives , Dietary Supplements/adverse effects , Vitamin A , Vitamin K
17.
Regul Toxicol Pharmacol ; 137: 105284, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36402242

ABSTRACT

Mineral oils (food grade white oil or liquid paraffin) have historically been safely used in a number of sensitive end-uses, including pharmaceutical, cosmetic and food. Recent concern that certain mineral hydrocarbons (branched and cyclo-alkanes) may accumulate in human tissues has prevented European Food Safety Authority (EFSA) from deriving guidance values for food exposures. Analysis of human and animal tissue indicate that an unresolved cloud of mostly highly branched alkanes and alkylated cycloalkanes within the C20-C35 range is consistently present in all tissues. This critical review thoroughly assesses the retention of "mineral oil saturated hydrocarbons" (MOSH) in human and animal tissues and evaluates if the presence of MOSH is considered adverse and appropriate to use for risk assessment, generation of guidance values for food exposure and/or generation of derivation of health-based guidance values. An adversity framework was utilized to perform an in-depth weight of the evidence analysis, and it was concluded that mere presence of MOSH does not translate to hazard identification, and is not considered adverse. In light of this conclusion, it would not be appropriate to utilize this endpoint as the point of departure to calculate a health guidance value.


Subject(s)
Cosmetics , Mineral Oil , Animals , Humans , Hydrocarbons , Food Safety , Alkanes , Food Contamination/analysis
18.
Medicina (B Aires) ; 82(6): 881-890, 2022.
Article in Spanish | MEDLINE | ID: mdl-36571527

ABSTRACT

INTRODUCTION: Non-caloric sweeteners (NCS) are used to replace added sugars in foods and beverages. For this replacement to be a health benefit, the intake of each NCS should not exceed its Acceptable Daily Intake (ADI). The main objective of this study is to determine the consumption of aspartame, acesulfame-K, sucralose, and saccharin in the argentine population aged 15 to 65 years and to evaluate this consumption in relation to the ADI. Other objectives are to stratify the consumption based on different sociodemographic variables and to determine the main sources of NCS consumed by the argentine population. METHODS: The sample consisted of 1266 individuals (urban population aged 15-65), stratified by region, age, sex, and socioeconomic level. Intake data was collected with two 24-hour recalls. RESULTS: In Argentina, the average consumption of saccharin, aspartame, acesulfame-K and sucralose is well below their respective ADI: 8.4%, 3.2%, 2% and 0.3% of the ADI, respectively. The maximum reported consumptions do not exceed the ADI either. There is a higher proportion of women who consume NCS. The proportion of NCS consumers increases with age. The Northeast and South regions have the lowest percentage of NCS consumers. Beverages constitute the main source of NCS, followed by tabletop sweeteners. The contribution of food to NCS consumption is negligible. DISCUSSION: In Argentina there is a good safety margin for the reformulation of sugary products aimed at reducing the excess calories and added sugars consumed by the population.


Introducción: Los edulcorantes no calóricos (ENC) se utilizan para sustituir azúcares en alimentos y bebidas. Para que este reemplazo sea beneficioso para la salud, la ingesta de cada ENC no debería superar su ingesta diaria admisible (IDA). El objetivo principal de este estudio es determinar el consumo de aspartamo, acesulfame-K, sucralosa y sacarina en la población argentina de 15 a 65 años y evaluar este consumo en relación con la IDA. Otros objetivos son estratificar el consumo en función de distintas variables sociodemográficas y determinar las principales fuentes de ENC consumidas por la población argentina. Métodos: La muestra fue de 1266 individuos (población urbana 15-65 años), estratificada por región, edad, sexo y nivel socioeconómico. Los datos de ingesta fueron recolectados con dos recordatorios de 24 horas. Resultados: En Argentina, el consumo promedio de sacarina, aspartamo, acesulfame-K y sucralosa está muy por debajo de su respectiva IDA: 8.4%, 3.2%, 2% y 0.3% de la IDA respectivamente. Los consumos máximos reportados tampoco superan la IDA. Hay una mayor proporción de mujeres consumidoras de ENC. La proporción de consumidores de ENC aumenta con la edad. Las regiones noreste y sur presentan el menor porcentaje de consumidores de ENC. Las bebidas constituyen la principal fuente de ENC, seguidas por los edulcorantes de mesa. La contribución de los alimentos al consumo de ENC es despreciable. Discusión: En Argentina existe un buen margen de seguridad para la reformulación de productos azucarados tendiente a disminuir el exceso de calorías y el consumo de azúcares añadidos.


Subject(s)
Aspartame , Sweetening Agents , Adult , Female , Humans , Argentina/epidemiology , Saccharin , Male , Adolescent , Young Adult , Middle Aged , Aged
19.
Medicina (B.Aires) ; 82(6): 881-890, dic. 2022. graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1422083

ABSTRACT

Resumen Introducción: Los edulcorantes no calóricos (ENC) se utilizan para sustituir azúcares en alimentos y bebidas. Para que este reemplazo sea beneficioso para la salud, la ingesta de cada ENC no de bería superar su ingesta diaria admisible (IDA). El objetivo principal de este estudio es determinar el consumo de aspartamo, acesulfame-K, sucralosa y sacarina en la población argentina de 15 a 65 años y evaluar este consumo en relación con la IDA. Otros objetivos son estratificar el consumo en función de distintas variables sociodemográficas y determinar las principales fuentes de ENC consumidas por la población argentina. Métodos: La muestra fue de 1266 individuos (población urbana 15-65 años), estratificada por región, edad, sexo y nivel socioeconómico. Los datos de ingesta fueron recolectados con dos recordatorios de 24 horas. Resultados: En Argentina, el consumo promedio de sacarina, aspartamo, acesulfame-K y sucralosa está muy por debajo de su respectiva IDA: 8.4%, 3.2%, 2% y 0.3% de la IDA respectivamente. Los consumos máximos reportados tampoco superan la IDA. Hay una mayor proporción de mujeres consumidoras de ENC. La proporción de consumidores de ENC aumenta con la edad. Las regiones noreste y sur presentan el menor porcentaje de consumidores de ENC. Las bebidas constituyen la principal fuente de ENC, seguidas por los edulcorantes de mesa. La contri bución de los alimentos al consumo de ENC es despreciable. Discusión: En Argentina existe un buen margen de seguridad para la reformulación de productos azucarados tendiente a disminuir el exceso de calorías y el consumo de azúcares añadidos.


Abstract Introduction: Non-caloric sweeteners (NCS) are used to replace added sugars in foods and bev erages. For this replacement to be a health benefit, the intake of each NCS should not exceed its Acceptable Daily Intake (ADI). The main objective of this study is to determine the consumption of aspartame, acesulfame-K, sucralose, and saccharin in the argentine population aged 15 to 65 years and to evaluate this consumption in relation to the ADI. Other objectives are to stratify the consumption based on different sociodemographic vari ables and to determine the main sources of NCS consumed by the argentine population. Methods: The sample consisted of 1266 individuals (urban population aged 15-65), stratified by region, age, sex, and socioeconomic level. Intake data was collected with two 24-hour recalls. Results: In Argentina, the average consumption of saccharin, aspartame, acesulfame-K and sucralose is well below their respective ADI: 8.4%, 3.2%, 2% and 0.3% of the ADI, respectively. The maximum reported consumptions do not exceed the ADI either. There is a higher proportion of women who consume NCS. The proportion of NCS consumers increases with age. The Northeast and South regions have the lowest percentage of NCS consumers. Beverages constitute the main source of NCS, followed by tabletop sweeteners. The contribution of food to NCS consumption is negligible. Discussion: In Argentina there is a good safety margin for the reformulation of sugary products aimed at reduc ing the excess calories and added sugars consumed by the population.

20.
Toxics ; 10(11)2022 Nov 06.
Article in English | MEDLINE | ID: mdl-36355961

ABSTRACT

Toxicological investigations of pesticides largely focus on the declared active ingredient, which constitutes only between a few percent to around 50% of the total formulation. The complete formulations are unknown. For each declared active ingredient, there are dozens or hundreds of formulations. We demonstrate that petroleum has always been and is still always in pesticides. Gas chromatography and mass spectrometry (GC-MS) were applied for 24 pesticides. The measured compounds were the 16-priority polycyclic aromatic hydrocarbons (PAHs). The ratio of the PAHs to the threshold of toxicity was from 2.16 to 8288 times. The levels and distribution of PAHs per pesticide were different. Petroleum residues appear to be a waste product. The declared active component is taken alone for toxicity calculations, such as the acceptable daily intake (ADI). The PAHs with 2-3 cycles are more represented in pesticides than those with 4-6 cycles, which underlines that the petroleum residues appear to come mainly from crude unburned material. The ADI should be divided by 1000 if it is considered that petroleum residues amplify the toxicity by 1000. The admixture of PAHs in pesticides can be highly carcinogenic or toxic in the long term, even more than the declared active ingredient itself.

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