[Methodical aspects of hygienic safety assessment of polymeric materials in contact with foodstuffs].

It was purposed new technique by capillary gas chromatography (GC) for the low level determination of monomer hexamethylenediamine (HMDA) in food simulants water from polymeric materials in contact with foodstuffs. Hexamethylenediamine, HN2-(CH2)6-NH2, is a monomer used in the manufacture of certain of polyamide plastic materials and articles intended to come into contact with foodstuffs. Compound exhibits all the chemical properties of aliphatic amines, is an irritant, causing dermatitis, can accumulate in the body, the degree of human exposure to HMDA assigned to the 2nd class of hazard - the substance is highly dangerous. There was studied two methodological approaches pre-derivatization of compound for GC determination. The first approach involves conversion of the free diamine using ethyl chloroformate as derivatizing agent followed by analysis of the resulting diurethan by gas chromatography using a flame ionization and mass selective detection (HMDA was quantitated by selective ion monitoring at m/z 102, the lower detection limit of 1 ng). According to second methodological approach the water samples were mixed with sodium chloride and extracted with toluene, then derivatized with trifluoroacetic anhydride (60 min, 55 degrees C) to diamide, 1 M potassium phosphate buffer (pH 7,0) was add to remove excess derivatizing agent, followed by analysis of resulting diamide by gas chromatography with electron capture detection (lower limit value 0,01 ng). Conformation of HMDA levels is carried out by combined gas chromatography/mass spectrometry (HMDA was quantitated by selective ion monitoring at m/z 126, the lower limit value of 0,1 ng). The optimal pre-derivatization of the second approach for the determination of low levels of HMDA in the water extracts. The range of measured concentrations of 0,005-0,5 mg/dm3, recovery 88-101%, the total error of measurement is 16%, the relative standard deviation is 1,85%. The method was tested in the study of aqueous extracts of the 10 random samples intended for food purchased in the consumer market. Shows the corresponding output level hexamethylenediamine requirements for products of this type.

An intranasal irritation assessment of antibacterial ointment alone or in combination with mupirocin versus Bactroban Nasal in rabbits.

The purpose of this study was to evaluate the potential irritating effects and the systemic exposure level of an antibacterial ointment containing REP8839 as a single agent or in combination with mupirocin versus Bactroban Nasal in rabbits. Additionally, the reversibility of REP8839 effects during a 14-day recovery period was assessed. Five treatment groups of six male and six female New Zealand White rabbits received dose levels of 1%, 2%, and 4% REP8839, 2% Bactroban Nasal, or 2% REP8839/2% mupirocin combination. One additional group of six animals/sex served as the control and received the vehicle, Petrolatum/Softisan 649. The test article or vehicle was administered to all groups via topical administration to the external nares, twice a day (approx. 8h intervals between the doses) for 21 consecutive days, at a dose volume of 100 microL per nare/dose for a total of 400 microL per day (200 microL per nare). Two animals/sex/group were maintained for a 14-day recovery period. The external nares were reflected back and the mucosal lining was evaluated and scored for erythema and edema within 30-60 min following the first dose each day. Blood samples were collected from all animals at designated time points on Day 21 of the study to assess systemic exposure levels. Cross-sectioning of the nasal tract was conducted in all the groups for microscopic evaluation. Mucosal scoring of the nares did not reveal any edema or erythema in any of the dose groups with the antibacterial alone, with the combination product, or with Bactroban Nasal. Mean body weights and food consumption were not adversely impacted by the test articles. Minimal plasma exposure was observed in the rabbits (<5 ng/mL). The REP8839 groups did appear to have dose-responsive exposure (from below the limit of quantitation to 5 ng/mL with 1%, 2%, and 4% REP8839, respectively). Microscopic changes on the nasal sectioning noted in these animals were infrequent and considered incidental findings unrelated to administration of the test articles. In conclusion doses of up to 4% of REP8839 ointment as a single agent or 2% in the combination product, as well as 2% Bactroban Nasal, were not found to induce mucosal irritation when applied topically to the external nares twice a day for 21 consecutive days. Additionally, no delayed effects were observed in the recovery animals.

A clinical assessment of a patch test kit marketed to U.K. hairdressers for detecting hair dye allergy.

BACKGROUND: In 2004 a U.K.-based company developed and marketed a patch test kit (Colourstart); Trichocare, Ridgmont, Beds, U.K.) for use by hairdressers. It is intended to assess whether clients have a 'problem with hair dye' and promotes itself as the 'only practical solution to sensitivity testing'. However, a patient presented with a hair dye reaction that had not been detected while using this patch test system. OBJECTIVES: To assess the Colourstart system in the next seven consecutive patients presenting with a history of adverse reactions to hair dyes. METHODS: The Colourstart system was tested in parallel with commercially available hair dye patch test reagents, where applicable. RESULTS: Only three of seven patients allergic to p-phenylenediamine were detected using this system and one patient allergic to toluene-2,5-diamine sulphate was not detected using this system. CONCLUSIONS: The results raise concerns about the sensitivity of this kit for consumer protection, but also wider questions about the regulation, use and interpretation of 'home diagnostic patch test kits' in general.

Assessment of renal toxicity by urinary enzymes in patients receiving chemotherapy with 8-methyl-8-acetylenic-putrescine.

Renal toxicity was assessed in 19 patients receiving methyl acetylenic putrescine (MAP), an irreversible inhibitor of ornithine decarboxylase. Patients received 250 mg t.d.s. for up to 13 weeks. This dose effectively inhibited the target enzyme, as shown by elevations in decarboxylated S-adenosyl methionine levels. No significant nephrotoxicity was observed in these patients as determined by plasma urea, creatinine and creatinine clearance measurements, although minor elevations of the urinary enzymes lactate dehydrogenase, N-acetyl-beta-glucosaminidase, alkaline phosphatase and alanine aminopeptidase were observed. As this could represent sub-clinical renal damage, caution should be exercised when using MAP in combination with other cytotoxic drugs.