[Plasticizers Used in Polyvinyl Chloride Toys (2019-2020)].

We determined the fifteen types of plasticizers, including four kinds of phthalic acid esters (PAEs) used in 220 polyvinyl chloride (PVC) toys on Japanese market from 2019 to 2020. Three kinds of previously undetected types of PAEs were also detected, but not identified in this study. Di (2-ethylhexyl) terephthalate (DEHTP) was the highest detection rate in 209 soft PVC toys out of 220 toys, with 71.2% for designated toys and 88.9% for not-designated toys, respectively, showing a gradual increase from the previous reports in 2009 and 2014. On the other hand, the usages of o-acetyl tributyl citrate and adipic acid esters decreased, but the six types of PAEs prohibited to use for the designated toys in Japan were not detected in them, the usage of diisobutyl phthalate were increased. In contrast, four types of PAEs were detected in not-designated toys. Among them, the detection ratio of di (2-ethyhexyl) phthalate decreased to about 1/10. The content levels of plasticizers in per each sample were continued to keep low level from the report five years ago. These results showed that the main plasticizer used in PVC toys is DEHTP, and that the usage of other plasticizers was decreased.

Effects of Parental Involvement on Glycemic Control in Adolescents With Type 1 Diabetes Mellitus: A Scoping Review.

Type 1 diabetes mellitus (T1DM) is typically diagnosed in pediatric patients. Transitioning from supported management in childhood to self-management in adolescence is an important step. Parental psychosocial influence is a possible factor in adolescents' disease control. This review summarized the effects of parental involvement on glycemic control in adolescents with T1DM by focusing on hemoglobin A1c (HgbAIc). A scoping review per the Guidance for Systematic Scoping Reviews was conducted with the following inclusion criteria: (a) studies in English, (b) focused on adolescents with T1DM, (c) outcomes included HgbAIc, and (d) focused on parental influence of children with T1DM. Of 476 articles, 14 were included. The study outcomes were classified based on direct or indirect influence. "Parental support for adherence" and "parental conflict" significantly affected HgbAIc control. This study provides current evidence on parental influence on glycemic control in adolescents.

[Validation Study on Migration Test for Plastic Food Utensils, Containers, and Packaging].

Migration test of food utensils, containers, and packaging is an important test method for confirming the safety and their compliance to the standards. However, there is little report on inter-laboratory study which was performed to evaluate the entire migration test, including migration operations and quantification. An interlaboratory study was performed participating 22 laboratories using 8 types of model synthetic resin samples containing 10 substances with a wide range of Log Pow values to evaluate the accuracy of the entire migration test. As a result, most of HorRat (r) values met the target criteria (0.3

[Inter-laboratory Study on the Modified Method Assessment for the Determining Methanol Content in Kitchen Detergents].

We modified a method for determining methanol content in detergents used in kitchens. Furthermore, an inter-laboratory study was conducted in 10 laboratories to validate the modified method. In this study, two concentrations of samples were blindly coded. Each laboratory determined the methanol content in each sample according to a protocol. The determined values were statistically analyzed according to an international harmonized guideline. HorRat values were calculated based on the reproducibility relative standard deviation (RSDR) which was estimated from the interlaboratory study, and predicted RSDR calculated from the Horwitz/Thompson equation. The HorRat values of the two samples were 0.8 and 1.8, meeting the performance criteria of less than 2 set by the Codex Alimentarius for analytical method approval. These results confirm that this modified analytical method shows good performance as an analytical method for determining methanol content in kitchen detergents.

Impact of informal care with multiple medical devices on caregiver burden: A cross-sectional national survey in Japan.

Family caregivers provide long-term, home-based, informal medical care to patients with special healthcare needs. We examined whether informal care involving medical device use is associated with caregiver burden, considering potential risk variables as moderators. Data were collected from March to May 2019 through a Japanese public visiting care system. This system is offered to patients with severe chronic or intractable disease or impairment. After contacting government-certified offices that provide visiting care systems, the offices that agreed to participate invited dyads of patients and caregivers to complete our questionnaire. To focus on new parameters other than the caregiver factor that had been clarified previously, we aimed to analyse the data from patient-caregiver dyads. Using a questionnaire-based cross-sectional design, we asked participants about caregiver and patient characteristics, care types, and caregiver burden using the Zarit Caregiver Burden Interview. Logistic regression analyses were conducted to test the association between caregiver burden and informal medical care. Data from 371 complete patient-caregiver dyads were analysed; 49.3% showed high caregiver burden, and 40.4% were administering at least one informal medical care procedure. Univariate analyses indicated a relationship between high caregiver burden among caregivers who slept less, provided care for longer periods daily, performed medical care procedures and cohabited with patients. Importantly, logistic regression analyses indicated a significant relationship between high caregiver burden and care involving multiple medical procedures (i.e. 4-6 procedures with medical devices; adjusted odds ratio (AOR) = 2.03, 95% confidence intervals (95% CI) = [1.01, 4.09]). In propensity-matched participants (n = 314), results continued to show that multiple medical care procedures were significantly related to high caregiver burden (AOR = 2.19, 95% CI [1.14-4.22]). The effects of non-medical informal care on caregiver burden were moderate. This result suggests that more intensive interventions are required for patients with multiple medical care needs to reduce caregiver burden.

Determination of formaldehyde and acetaldehyde levels in poly(ethylene terephthalate) (PET) bottled mineral water using a simple and rapid analytical method.

A simple and rapid analytical method was developed for the determination of formaldehyde (FA) and acetaldehyde (AA) contents in water. FA and AA were derivatized by 2,4-dinitrophenylhydrazine in an LC vial for 20 min at room temperature, about 25 °C, and analyzed using LC-MS/MS. The calibration curve exhibited excellent linearity for FA and AA concentrations of 2-150 ng/mL. Recovery tests using ultra-pure water and commercially available PET-bottled mineral water samples showed good trueness and precision. We determined the FA and AA contents in 105 PET-bottled mineral water samples on the Japanese market using this method. FA was detected in 61% of the samples at levels from 2.6 to 31.4 ng/mL, while AA was detected in 68% at levels from 5.3 to 143.5 ng/mL. These results demonstrate that the concentrations of FA and AA in PET-bottled mineral water on the Japanese market have not changed significantly over the last decade.

[Consideration of the Evaporation Residue Test for Plastics Intended to Contact with Oils and Fatty Foods].

The Japanese Food Sanitation Act designates the evaporation residue test as a specification for plastics that intended to contact with foods. The test conditions and migration limits for oils and fatty foods were considered on the basis of the results obtained from the evaporation residue test according to the Japanese Act and the overall migration test into olive oil according to EN1186-2. The evaporation residue test was conducted using heptane at 25℃ for 1 hour. The results of most samples were under 30 µg/mL although those of high impact polystyrene,polymethylpentene and polyvinyl chloride were found to be over 30 µg/mL. However, these results were within the acceptable range of the relaxed limits (240, 120, 150 µg/mL). Regarding the overall migration into olive oil, most plastics were under the determination limit at 60℃ for 30 min. But the results for polyethylene, polypropylene and polyvinyl chloride were over 30 µg/mL at 95 and 121℃, which were higher than their evaporation residues. In other words, the existing test conditions and limits of the evaporation residue test could be used for testing plastics that come into contact with oils and fatty foods at lower temperatures. However, they are not adequate for evaluating some plastics that come into contact with oils and fatty foods at higher temperatures.

[Changes in Status of Plasticizers Used in Polyvinyl Chloride Toys].

Analytical survey of plasticizers used in about 500 polyvinyl chloride (PVC) toys in Japanese market was performed in 2014. The results obtained were compared with those obtained in 2009. Fifteen types of plasticizers including di (2-ethylhexyl) terephthalate (DEHTP) were detected. These plasticizers were also detected in the products in 2009, suggesting that the types of plasticizers used in PVC toys have not been changed. Among these detected plasticizers, the detection ratios of DEHTP were 60.3 and 73.7% in both designated and not-designated toys, respectively, both of which are the highest. These ratios are over 20-points higher than those in 2009. The six types of phthalic acid esters (PAEs) prohibited to use for the designated toys in Japan were not detected in designated toys used in this study. However, four types of PAEs, including three types of prohibited PAEs, were detected in not-designated toys with the detection ratios from 2.8 to 15.5%. These ratios are lower than those in 2009. The content levels of plasticizers used in the toys are lower than those in 2009. These results show that the main plasticizer used in PVC toys is DEHTP, and that the usage levels of plasticizers have been decreased.

The experience of parents of adult sons with Duchenne muscular dystrophy regarding their prolonged roles as primary caregivers: a serial qualitative study.

PURPOSE: Mechanical ventilation has allowed a greater number of patients with Duchenne muscular dystrophy (DMD) to transition into adulthood. However, the role of a child's parent as a caregiver lasts throughout the child's lifetime. We explored parents' experiences of prolonged caregiving using serial interviews, analyzed using constructivist grounded theory. MATERIALS AND METHODS: Fourteen parents (average age 53.9 years) with sons with DMD (average age 23.2 years) were interviewed two to four times, over a 3-year period. Data were analyzed using a grounded theory approach. RESULTS: Two categories of responses were defined as strengths, and four as weaknesses. The strengths were related to family member support and confidence in parenting ability. The weaknesses were related to the anticipation of aging with the ongoing burden of caring for adult sons, regrets, sharing of responsibility versus having a fixed role as the primary caregiver, and economic burden. The weaknesses became more pronounced as the duration of caregiving increased. Parents' acceptance of and immobilization in their role of primary caregiver led to prolonged derivative dependency. CONCLUSION: Practical support for parental caregivers, who experience a marked increase in the duration of their caregiving role while facing their own aging-related challenges, are required. Implications for Rehabilitation Children with DMD are living longer and are transitioning into adulthood; a successful transition involves becoming as independent as possible and maintaining a positive sense of personal identity. Despite entering adulthood, the parental caregiver's caregiving role continues. Rehabilitation professionals, who are able to provide long-term, continued support from childhood into adulthood, should be aware that parental caregivers' weakness are exacerbated as the duration of caregiving increases. Families affected by DMD require multifaceted support that should include support for the parental caregiver.

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 1)].

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using three food-simulating solvents (water, 4% acetic acid and 20% ethanol), based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. For evaporation, a water bath was used in the official method, and a hot plate in the modified method. In most laboratories, the test solutions were heated until just prior to evaporation to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods, regardless of the heating equipment used. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method.

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 2)].

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using heptane as a food-simulating solvent for oily or fatty foods, based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. In the official method, heating for evaporation was done with a water bath. In the modified method, a hot plate was used for evaporation, and/or a vacuum concentration procedure was skipped. In most laboratories, the test solutions were heated until just prior to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method. Furthermore, an interlaboratory study was performed to evaluate and compare two leaching solutions (95% ethanol and isooctane) used as food-simulating solvents for oily or fatty foods in the EU. The results demonstrated that there was no significant difference between heptane and these two leaching solutions.

Interlaboratory Study on Caprolactam Test for Food-Contact Nylon Products.

The Japanese Food Sanitation Law sets a limit on the migration level of caprolactam for food-contacting nylon products. Here, we carried out an interlaboratory study in twenty laboratories to evaluate the performance of the official GC-FID test method and a GC-MS method as an alternative test method to the official method. Each laboratory quantified caprolactam in three test solutions in 20% ethanol as blind duplicates using GC-FID or GC-MS. The official method (GC-FID with absolute calibration) gave trueness, repeatability (RSDr) and reproducibility (RSDr) values of 96-97%, 3.3-5.4% and 4.0-6.7%, respectively. These values met the target criteria (trueness: 80-110%, RSDr: 10%, RSDr: 25%). The performance of the method was further improved by the introduction of heptalactam as an internal standard. As for GC-MS method, some values of the RSDr exceeded 10% when absolute calibration was used. However, when an internal standard was introduced, the trueness, RSDr and RSDr of GC-MS method were all acceptable at 94-96%, 2.0-4.4% and 7.0-9.4%, respectively. Therefore, GC-MS with an internal standard is available as an alternative test method to the official method.

Interlaboratory Study on Volatiles Test for Food-Contacting Polystyrene Products.

Using polystyrene, acrylonitrile-styrene resin and acrylonitrile-butadiene-styrene resin pellets as samples, an interlaboratory study was performed to evaluate the volatiles test method, based on the specifications described in the Japanese Food Sanitation Law for food-contacting polystyrene products. The study was conducted with the participation of twenty-one laboratories. Each laboratory quantified the contents of styrene, toluene, ethylbenzene, isopropylbenzene and propylbenzene in three test pellets using GC-FID, GC-MS or headspace-GC-FID. Statistical analysis revealed that the repeatability (RSDr) and reproducibility (RSDr) were 1.0-2.6 and 2.5-5.5% for the GC-FID method. The values of the performance parameters fulfilled the requirements (RSDr: 10%, RSDr: 25%), and the performance is sufficient for specifications testing. The RSDr and RSDr of results obtained using the GC-MS and HS-GC methods were 1.4-7.8 and 4.9-13%(GC-MS), and 2.0-2.6 and 3.3-6.9%(HS-GC-FID), respectively. The quantified levels were similar to those obtained with GC-FID. The study suggests that the GC-MS and HS-GC methods can be employed as alternative methods to the GC-FID method.

Survey of Primary Aromatic Amines and Colorants in Polyurethane, Nylon and Textile Toys.

The residual and migration levels of 28 primary aromatic amines (PAAs) in polyurethane and nylon toys were determined using LC-MS/MS, and the migration and residual amounts of PAAs and 15 colorants in textile toys were determined using LC-MS/MS and LC-TOF-MS according to the European Standard EN71. Among 34 polyurethane toy samples, 2,6-diaminotoluene and 2,4-diaminotoluene were detected in the same 12 samples at residual levels ranging from 2.1 to 19.7 and from 7.6 to 39.6 µg/g, respectively. Furthermore, 4,4'-diaminodiphenylmethane (4,4'-MDA) and aniline were detected in 9 samples (from 0.2 to 8.7 µg/g), and one sample (0.4 µg/g), respectively. PAAs were not detected in the 8 samples of nylon toys. As for the migration test into water, only 4,4'-MDA migrated from 3 polyurethane toys at levels ranging from 0.4 to 2.5 µg/g. PAAs did not migrate from the 43 textile toys, but colorants such as Solvent Yellow 1 and Basic Red 9 were detected at the residual level of 0.02 µg/g. The residual levels of PAAs and colorants detected in this study were significantly lower than the limit values established by the European Union regulation.

[Interlaboratory Study on Zinc Test for Food-Contact Rubber Products].

Using six kinds of zinc solution in water and 4% acetic acid as samples, an interlaboratory study was performed to evaluate a zinc (Zn) test method for food-contact rubber products, based on the Japanese Food Sanitation Law. Eighteen laboratories participated, and quantified Zn in six test solutions as blind duplicates using flame atomic absorption spectrometry, induced coupled plasma-optical emission spectrometry or induced coupled plasma-mass spectrometry. Statistical analysis revealed that the trueness, repeatability (RSDr) and reproducibility (RSDr) were 97-103%, 0.7-4.9% and 1.7-8.9% by all measuring methods. The values of the performance parameter fulfilled the target value (trueness: 80-110%, RSDr: 10%, RSDr: 25%). The performance of these methods is sufficient for testing the adherence of samples to the specifications.

Becoming a back-up carer: parenting sons with Duchenne muscular dystrophy transitioning into adulthood.

The population of adults with Duchenne muscular dystrophy is increasing rapidly. However, information for individuals with DMD and their parents about the transition to adulthood is lacking; young adult sons and their parents may struggle to maintain smooth family functioning and well-being during this period. This study examined the process of change in parental behaviors during their son's transition. The participants were 18 parents with sons aged 15-30 years. Data were obtained from semi-structured interviews and analyzed using a grounded theory approach. Eleven categories of behaviors were identified across three domains: emotional, physical, and determination. The changes made by parents were directed toward becoming a back-up carer: letting go of some control but still being active participants in their sons' lives. We identified several issues important for well-being in the transition period: psychological support, the aging of the parents (the primary caregivers) and the concomitant emergency and specialized care needs, and parents' intervention in the self-determination of adult sons with DMD. The findings of this study may provide a rationale to advocate for policies to improve support for parents of sons with DMD transitioning to adulthood and provide information to help parents in their role as primary care providers.

[Interlaboratory study on migration test of cadmium and lead for food contact articles].

An interlaboratory study was performed to evaluate a migration test method of cadmium (Cd) and lead (Pb), based on the Japanese Food Sanitation Law for glassware, ceramicware, enamelware and metal cans. Seventeen laboratories participated, and quantified Cd and Pb in eight test solutions as blind duplicates using flame atomic absorption spectrometry (AAS), graphite furnace atomic absorption spectrometry (GF-AAS), inductively coupled plasma-optical emission spectrometry (ICP-OES) or induced coupled plasma-mass spectrometry (ICP-MS). Statistical analysis revealed that the trueness, repeatability (RSDr) and reproducibility (RSDr) were 93-105%, 0.7-8.4% and 2.6-19.3% by using AAS, ICP-OES and ICP-MS (internal standard method). The performance of these methods is sufficient for testing specifications. However, some of the RSDr values exceeded 10% in GF-AAS, and careful control of accuracy is required.

Survey of volatile substances in kitchen utensils made from acrylonitrile-butadiene-styrene and acrylonitrile-styrene resin in Japan.

Residual levels of 14 volatile substances, including 1,3-butadiene, acrylonitrile, benzene, ethylbenzene, and styrene, in 30 kitchen utensils made from acrylonitrile-butadiene-styrene resin (ABS) and acrylonitrile-styrene resin (AS) such as slicers, picks, cups, and lunch boxes in Japan were simultaneously determined using headspace gas chromatography/mass spectroscopy (HS-GC/MS). The maximum residual levels in the ABS and AS samples were found to be 2000 and 2800 µg/g of styrene, respectively. The residual levels of 1,3-butadiene ranged from 0.06 to 1.7 µg/g in ABS, and three of 15 ABS samples exceeded the regulatory limit for this compound as established by the European Union (EU). The residual levels of acrylonitrile ranged from 0.15 to 20 µg/g in ABS and from 19 to 180 µg/g in AS. The levels of this substance in seven ABS and six AS samples exceeded the limit set by the U.S. Food and Drug Administration (FDA). Furthermore, the levels of acrylonitrile in three AS samples exceeded the voluntary standard established by Japanese industries. These results clearly indicate that the residual levels of some volatile compounds are still high in ABS and AS kitchen utensils and further observations are needed.

Quantification of isocyanates and amines in polyurethane foams and coated products by liquid chromatography-tandem mass spectrometry.

An analytical method for the identification and quantification of 10 different isocyanates and 11 different amines in polyurethane (PUR) foam and PUR-coated products was developed and optimized. Isocyanates were extracted and derivatized with di-n-butylamine, while amines were extracted with methanol. Quantification was subsequently performed by liquid chromatography-tandem mass spectrometry. Using this methodology, residual levels of isocyanates and amines in commercial PUR products were quantified. Although the recoveries of certain isocyanates and amines were low, the main compounds used as monomers in the production of PUR products, and their decomposition species, were clearly identified at quantifiable levels. 2,4-and 2,6-toluenediisocyanate were detected in most PUR foam samples and a pastry bag in the range of 0.02-0.92 mg/kg, with their decomposition compounds, 2,4-and 2,6-toluenediamine, detected in all PUR foam samples in the range of 9.5-59 mg/kg. PUR-coated gloves are manufactured using 4,4'-methylenebisphenyl diisocyanate as the main raw material, and a large amount of this compound, in addition to 4,4'-methylenedianiline and dicyclohexylmethane-4,4'-diamine were found in these samples.

[Performance comparison of material tests for cadmium and lead in food contact plastics].

Based on the Japanese Food Sanitation Law, the performances of official and alternative material test methods for cadmium (Cd) and lead (Pb) in food contact plastics were compared. Nineteen laboratories participated to an interlaboratory study, and quantified Cd and Pb in three PVC pellets. in the official method, a sample is digested with H2SO4, taken up in HCl, and evaporated to dryness on a water bath, then measured by atomic absorption spectrometry (AAS) or inductively coupled plasma-optical emission spectrometry (ICP-OES). Statistical treatment revealed that the trueness, repeatability (RSDr) and reproducibility (RSDr) were 86-95%, 3.1-9.4% and 8.6-22.1%, respectively. The values of the performance parameters fulfilled the requirements , and the performances met the test specifications. The combination of evaporation to dryness on a hot plate and measurement by AAS or ICP-OES is applicable as an alternative method. However, the trueness and RSDr were inferior to those of the official method. The performance parameters obtained by using the microwave digestion method (MW method) to prepare test solution were better than those of the official method. Thus, the MW method is available as an alternative method. Induced coupled plasma-mass spectrometry (ICP-MS) is also available as an alternative method. However, it is necessary to ensure complete digestion of the sample.