Bulletin of National Institute of Health Sciences最新文献

Chemicals in household products have been paid much attention as main cause of health damage on consumers, such as allergic contact dermatitis. Preventive measures against health damage due to chemicals in fabric, plastic and rubber products for household uses, are reviewed, focusing on (1) regulation and voluntary control by manufacturers, (2) incidence of health damage from household products, (3) causative product-chemical investigation, (4) case studies on skin damage and respiratory tract damage.

Phenylbenzoimidazol sulfonic acid (PBS) is a kind of sunscreens in cosmetics and is nominated as the restricted ingredients in cosmetics in Japanese Pharmaceutical Affairs Act. So the analytical method for PBS was investigated by HPLC. 1.0 g of the lotions with 1.0% PBS was exactly weighed, put into a 50-mL volumetric flask. Water was added to make exactly 50 mL and this mixture was used as the sample solution. On the other hand, 1.0 g of the creams with 1.0% PBS was exactly weighed, put into a beaker. After adding 1 mL of tetrahydrofuran and dissolving the cream, that mixture was transferred to a 50-mL volumetric flask. And then the beaker was rinsed with 1 mL of tetrahydrofuran and the rinsed solution was put together into the volumetric flask. After adding water to the volumetric flask to make exactly 50 mL, this mixture was used as the sample solution. If necessary, the mixture was filtrated with a membrane filter (0.45 microm). 5.0 mL of the sample solution was pipetted and put into a 200-mL volumetric flask. After adding water to make exactly 200 mL, 20 microL of this solution was analyzed by HPLC using the ODS column (CAPCELL PAK C18 column, 4.6 mm i.d. x 250 mm), the mixture of 40 mmol/L acetic buffer (pH 3.4) and acetonitrile (3:1) with 0.8 mmol/L dodecyltrimethyl ammonium bromide and the detection wavelength of 305 nm. The working curve from 0.5 to 20.0 microg/mL showed a linear line between the concentrations of PBS and the peak areas. There was no interference of peak of PBS from the lotion and cream.

Databases for ADI (Acceptable Daily Intake) and relevant information on food additives, pesticides and veterinary drugs were developed. The databases we developed are easily accessible on the web, and contain ADIs, latest evaluation year, classification and use, as well as synonym and CAS registry number. The databases are designed to be easily updated by researchers as ADI and relevant information are updated or added without delay. The database for food additives has already provided from the homepage of NIHS, and the access log of the web site was 1325/month in December 2005 and 2179/month in March 2006.

Environmental risk assessment of human pharmaceuticals is needed to protect aquatic life from the toxic exposure because unaltered drugs and/or the metabolites are released to environment after human use. Application for new drugs shall be accompanied by an evaluation report of environmental risk assessment on basis of predicted use volume, already in US and near future in EU. In Japan, the specialists are reviewing methodology of environmental risk assessment of drugs now. To provide the basic information, we investigated excretion forms of drugs after human use for two groups of Japanese drugs; high sale products top 20 in the 2004 fiscal year and new molecular entities approved in 2004 and 2005. The assessment targets are materials produced for direct use in US, but those are active substances or active metabolites, excluding orphan drugs, vitamins, amino acids, peptides and proteins, in EU. According to EU condition, almost two thirds of 20 high sale products and one third of recently approved new molecular entities were identified to be the targets for environmental risk assessment.

Disodium monofluorophosphate is one kind of the prohibited ingredients in cosmetics due to the Japanese Pharmaceutical Affairs Act. We established the analytical method for disodium monofluorophosphate in cosmetics by capillary electrophoresis (CE). The tooth paste of 1 g was put into a 50-ml plastic tube. After adding 7.0 mg of disodium monofluorophosphate and 50 ml of milliQ water into the plastic tube, the mixture was ultrasonicated for 10 min. After centrifuging, the supernatant was filtrated through a milli-pore membrane (0.45 microm). After filtration, the solutionwas put into a 100-ml volumetric flask, made up to 100 ml with milliQ water and used as the test solution. The mouthwash of 1 ml and 7.0 mg of disodium monofluorophosphate were put into a 100-ml volumetric flask, made up to 100 ml with milliQ water and used as the test solution. The testing solution was analyzed by CE. The working curve from 10 to 100 microg/ml showed a linear line between the concentrations of disodium monofluorophosphate and monofluorophosphate peak areas. Detection limit of disodium monofluorophosphate is 0.3 microg/ml. There was no interference of peak of monofluorophosphate with the ingredients in the tooth paste and mouthwash.

Historically, outbreaks associated with Salmonella-contaminated milk products were recognized as early as the 1950's in the United Kingdom and Bulgaria. In the 1960's and 1970's there were also a number of outbreaks related to Salmonella in various powdered milk products. As a result, Salmonella criterion was included in the Codex Code of hygienic practice for foods for infants and children. Between 1985 and 2005 at least 6 outbreaks of salmonellosis, involving as many as 250 infants, have been associated with powdered infant formula (PIF). In 2005, in France, an outbreak affecting more than 100 infants was associated with PIF contaminated with Salmonella Agona. These reported outbreaks indicated that problems persisted. Experts from two FAO/WHO Expert Consultations, held in 2004 and 2006, concluded that intrinsic contamination of PIF with Enterobacter sakazakii and Salmonella has been a cause of infection and illness in infants, including severe disease which can lead to serious developmental sequelae and death. Most of the Salmonella outbreaks associated with PIF involved unusual Salmonella serotypes, which likely aided in the recognition of these outbreaks. In many regions of the world where Salmonella serotyping is not routinely performed, identification of geographically or temporarily diffused outbreaks could be difficult. It is therefore important to use the appropriate methodology to detect unusual strains of Salmonella that cause illnesses in infants, such as the lactose-positive strain, and to perform serotyping and/or pulsed-field gel electrophoresis (PFGE) genotyping for rapid identification of Salmonella outbreaks and to establish linkages between the illness and implicated food.

The number of new molecular entities (NMEs) approved in 2005 was 17 in Japan, 20 in US and 18 in EU, respectively. Among 53 NMEs approved in Japan and at least one other region during 2002 to 2005, 53 NMEs had been approved in US and 25 in EU by 2005, but there were no common approvals only between Japan and EU. On the other hand, 26 NMEs were solely approved in US and EU during this period. Among 79 NMEs approved in either two or three regions, the number of preceding NMEs was 3 in Japan, 62 in U.S. and 14 in EU.

Analytical methods for red tar colors, Helindone Pink CN (R226) and Permaton Red (R228), in cheek rouge were developed. R226 and R228 were extracted from cheek rouge with chloroform by ultrasonication. After centrifugation, the supernatant was collected for the determination of R226 and R228. Methanol was then added to the residue for the extraction of Pigment Red 57-1 (R201) and Pigment Red 57 (R202). Each R226 and R228 was separately detected by the silica-gel thin-layer chromatography using the mixture of hexane and chloroform (2:1) or (3:1), or hexane and tetrahydrofuran (THF) (2:1) as a developing solvent. For the determination of R226 and R228, the extract in chloroform was injected into the HPLC equipped with Amide colomn and UV-VIS detector (detection wavelength 535 nm and 487 nm) using the mixture of hexane and THF as mobile phase. The linearity was obtained between the peak areas and the concentrations of R226 and R228 in the range of 0.625-10 microg/ml. R201 and R202 were determined using ODS column and the mixture of acetonitrile and phosphate buffer as mobile phase. Seven cheek rouge samples were analyzed. The red tar colors listed in each cheek rouge were contained in the range of 247 to 6574 microg/g.

The 19th Screening Information Data Set (SIDS) Initial Assessment Meeting (SIAM 19) was held in Berlin, Germany, hosted by the Germen Federal Agency for the Environment. The initial assessment documents of four substances (CAS numbers: 92-70-6, 126-33-0,131-17-9, 7580-85-0) and one category (High Molecular Weight Phthalate Esters) at SIAM 19 were submitted by the Japanese Government with or without the International Council of Chemical Associations (ICCA) and all of them were agreed at the meeting. In this report, the documents of these substances are introduced.

Selenium disulfide is one kind of prohibited ingredients in cosmetics by the Japanese Pharmaceutical Affairs Act. We established the analytical method for selenium disulfide in cosmetics by ICP-MS. Selenium disulfide of 20 mg was put into a teflon vessel. After adding 5 ml of concentrated nitric acid and 2 ml of the shampoo into the teflon vessel, the mixture was digested with microwave-oven. After digesting, the mixture was made up to 25 ml with milliQ water and then it was filtrated through a milli-pore membrane (0.45 micro). After filtration, the solution was diluted with 7% of nitric acid and used as the test solution. The test solution of 100 microl was analyzed by ICP-MS (HP-4500, monitoring mass 82). The working curve from 10 to 1000 microg/l showed a linear line between the concentrations of selenium and the peak areas. Detection limit of selenium disulfide is 22 microg/l. There was no effect of the ingredients in the shampoo on selenium disulfide determination.