The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS)

In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g. colorants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers summited to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition.

Toimintamalli asuinkiinteistö öljyvahingon hoitamiseksi

Pienkiinteistöjen öljyvahingot ovat viime vuosina lisääntyneet. Tämän työn tarkoituksena on luoda öljyvahingon torjuntaan ja jälkihoitoon osallistuvalle urakoitsijalle toimintamalli asuinkiinteistön öljyvahingon hoitamiseksi. Mallin halutaan erityisesti kuvaavan öljyvahingon hoitoon osallistuvien viranomaisten ja muiden tahojen vastuita ja velvollisuuksia. Työn tavoitteena on myös tunnistaa pienkiinteistöissä tapahtuvat öljyvahinkotyypit sekä niille altistavat riskitekijät. Öljyn päästäminen ympäristöön sekä öljyn käsittely ja varastointi niin, että siitä aiheutuu öljyvahingon vaara, kielletään laissa. Vahinkojen torjumiseksi on annettu määräyksiä muun muassa öljylämmityslaitteistojen turvallisuutta koskien. Asuinkiinteistöjen öljyvahingot liittyvät yleensä öljysäiliön täyttötilanteisiin. Vahinkojen syynä on usein säiliön ja sen varusteiden puutteellisuus tai huono kunto. Asuinrakennusten lämmitykseen käytetään kevyttä polttoöljyä. Maahan joutuessaan polttoöljy imeytyy sora- ja hiekkamaahan nopeasti, jolloin vaarana on öljyn kulkeutuminen pohjaveteen ja vesistöihin. Asuinkiinteistön öljyvahingossa öljyä joutuu usein myös rakenteisiin. Öljyvahingosta tulee ilmoittaa aina hätäkeskukseen. Vastuu öljyvahinkojen torjunnasta kuuluu alueelliselle pelastustoimelle. Torjuntatoimiin osallistuu usein myös urakoitsija. Jos vahinkokohdetta ei torjuntatoimin saada kunnostettua, alueellinen ympäristökeskus voi määrätä puhdistamisesta vastuussa olevan selvittämään pilaantuneen alueen laajuuden ja puhdistamistarpeen sekä toteuttamaan mahdollisen kunnostuksen. Pilaantuneen maaperän kunnostus voidaan toteuttaa massan vaihtona tai paikan päällä maata kaivamatta. Likaantuneiden rakenteiden saneerausta tarvitaan sisäilman hajuhaittojen poistamiseksi. Öljyvahingon kustannukset voivat nousta hyvinkin suuriksi. Ensisijainen vastuu niistä kuuluu vahingonaiheuttajalle.

Design and physicochemical stability studies of paediatric oral formulations of sildenafil

Personalized medicine is a challenging research area in paediatric treatments. Elaborating new paediatric formulations when no commercial forms are available is a common practice in pharmacy laboratories; among these, oral liquid formulations are the most common. But due to the lack of specialized equipment, frequently studies to assure the efficiency and safety of the final medicine cannot be carried out. Thus the purpose of this work was the development, characterization and stability evaluation of two oral formulations of sildenafil for the treatment of neonatal persistent pulmonary hypertension. After the establishment of a standard operating procedure (SOP) and elaboration, the physicochemical stability parameters appearance, pH, particle size, rheological behaviour and drug content of formulations were evaluated at three different temperatures for 90 days. Equally, prediction of long term stability, as well as, microbiological stability was performed. Formulations resulted in a suspension and a solution slightly coloured exhibiting fruity odour. Formulation I (suspension) exhibited the best physicochemical properties including Newtonian behaviour and uniformity of API content above 90% to assure an exact dosification process.

Food Safety Testing: Rapid Molecular Methods for Chemical and Biological Hazards

The central goal of food safety policy in the European Union (EU) is to protect consumer health by guaranteeing a high level of food safety throughout the food chain. This goal can in part be achieved by testing foodstuffs for the presence of various chemical and biological hazards. The aim of this study was to facilitate food safety testing by providing rapid and user-friendly methods for the detection of particular food-related hazards. Heterogeneous competitive time-resolved fluoroimmunoassays were developed for the detection of selected veterinary residues, that is coccidiostat residues, in eggs and chicken liver. After a simplified sample preparation procedure, the immunoassays were performed either in manual format with dissociation-enhanced measurement or in automated format with pre-dried assay reagents and surface measurement. Although the assays were primarily designed for screening purposes providing only qualitative results, they could also be used in a quantitative mode. All the developed assays had good performance characteristics enabling reliable screening of samples at concentration levels required by the authorities. A novel polymerase chain reaction (PCR)-based assay system was developed for the detection of Salmonella spp. in food. The sample preparation included a short non-selective pre-enrichment step, after which the target cells were collected with immunomagnetic beads and applied to PCR reaction vessels containing all the reagents required for the assay in dry form. The homogeneous PCR assay was performed with a novel instrument platform, GenomEra^™, and the qualitative assay results were automatically interpreted based on end-point time-resolved fluorescence measurements and cut-off values. The assay was validated using various food matrices spiked with sub-lethally injured Salmonella cells at levels of 1-10 colony forming units (CFU)/25 g of food. The main advantage of the system was the exceptionally short time to result; the entire process starting from the pre-enrichment and ending with the PCR result could be completed in eight hours. In conclusion, molecular methods using state-of-the-art assay techniques were developed for food safety testing. The combination of time-resolved fluorescence detection and ready-to-use reagents enabled sensitive assays easily amenable to automation. Consequently, together with the simplified sample preparation, these methods could prove to be applicable in routine testing.

Motorways, tolls and road safety. Evidence from European Panel Data

The use of tolls is being widespread around the world. Its ability to fund infrastructure projects and to solve budget constraints have been the main rationale behind its renewed interest. However, less attention has been payed to the safety effects derived from this policy in a moment of increasing concern on road fatalities. Pricing best infrastructures shifts some drivers onto worse alternative roads usually not prepared to receive high traffic in comparable safety standards. In this paper we provide evidence of the existence of this perverse consequence by using an international European panel in a two way fixed effects estimation.

Protection of the high-voltage equipment with reduced insulation strength

Power transformer is the most expensive equipment on a substation. It is always necessary to get needed benefit with the lowest expenses. Producing of power transformers with reduced insulation strength is one of the possible ways to reduce expenses. Exploitation of such transformers was begun in the end of 70-th in the last century. Protection from overvoltages was done with valve-type magnetic combined surge arresters with increased blanking voltage during switching overvoltages. Nowadays there is the necessity of replacement of those devices. That’s why modernized nonlinear surge arrester was invented. This master’s thesis is focused on the use research of that modernized device in comparison with usual nonlinear surge arresters. The goal is to show the lightning overvoltages level using different types of nonlinear surge arresters and then calculations of the lightning protection reliability.

Thermal-Hydraulic Studies on the Safety Of VVER-440 Type Nuclear Power Plants

This thesis includes several thermal hydraulic analyses related to the Loviisa WER 440 nuclear power plant units. The work consists of experimental studies, analysis of the experiments, analysis of some plant transits and development of a calculational model for calculation of boric acid concentrations in the reactor. In the first part of the thesis, in the case of won of boric acid solution behaviour during long term cooling period of LOCAs, experiments were performed in scaled down test facilities. The experimental data together with the results of RELAPS/MOD3 simulations were used to develop a model for calculations of boric acid concentrations in the reactor during LOCAs. The results of calculations showed that margins to critical concentrations that would lead to boric acid crystallization were large, both in the reactor core and in the lower plenum. This was mainly caused by the fact that water in the primary cooling circuit includes borax (Na)BsO,.IOHZO), which enters the reactor when ECC water is taken from the sump and greatly increases boric acid solubility in water. In the second part, in the case of simulation of horizontal steam generators, experiments were performed with PACTEL integral test loop to simulate loss of feedwater transients. The PACTEL experiments, as well as earlier REWET III natural circulation tests, were analyzed with RELAPS/MOD3 Version Sm5 code. The analysis showed that the code was capable of simulating the main events during the experiments. However, in the case of loss of secondary side feedwater the code was not completely capable to simulate steam superheating in the secondary side of the steam generators. The third part of the work consists of simulations of Loviisa VVER reactor pump trip transients with RELAPSlMODI Eur, RELAPS/MOD3 and CATHARE codes. All three codes were capable to simulate the two selected pump trip transients and no significant differences were found between the results of different codes. Comparison of the calculated results with the data measured in the Loviisa plant also showed good agreement.

Intravitreal docosahexaenoic acid in a rabbit model: preclinical safety assessment

Purpose The purpose of the present study was to evaluate the retinal toxicity of a single dose of intravitreal docosahexaenoic acid (DHA) in rabbit eyes over a short-term period. Methods Sixteen New Zealand albino rabbits were selected for this pre-clinical study. Six concentrations of DHA (Brudy Laboratories, Barcelona, Spain) were prepared: 10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µl, 50 µg/50 µl, 25 µg/50 µl, and 5 µg/50 µl. Each concentration was injected intravitreally in the right eye of two rabbits. As a control, the vehicle solution was injected in one eye of four animals. Retinal safety was studied by slit-lamp examination, and electroretinography. All the rabbits were euthanized one week after the intravitreal injection of DHA and the eyeballs were processed to morphologic and morphometric histological examination by light microscopy. At the same time aqueous and vitreous humor samples were taken to quantify the concentration of omega-3 acids by gas chromatography. Statistical analysis was performed by SPSS 21.0. Results Slit-lamp examination revealed an important inflammatory reaction on the anterior chamber of the rabbits injected with the higher concentrations of DHA (10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µ) Lower concentrations showed no inflammation. Electroretinography and histological studies showed no significant difference between control and DHA-injected groups except for the group injected with 50 µg/50 µl. Conclusions Our results indicate that administration of intravitreal DHA is safe in the albino rabbit model up to the maximum tolerated dose of 25 µg/50 µl. Further studies should be performed in order to evaluate the effect of intravitreal injection of DHA as a treatment, alone or in combination, of different retinal diseases.

Piensarjatuotannon hitsauksen robotisointi

Diplomityön tarkoituksena on selvittää hitsauksen robotisointimahdollisuudet vakiintuneelle piensarjatuotteelle. Tarkastelun kohteeksi valittiin maanpäällisen porausyksikön runkopari, joka rakentuu ylä- ja alarungosta. Hitsaus on nykytilanteessa käsinhitsausta ja tuotetta tehdään noin 300 kpl / vuosi. Hitsauksen robotisoinnilla halutaan aikaansaada kustannussäästöä hitsauksen osalta ja tuotantokapasiteetin nousua. Työn teoriaosa voidaan jakaa neljään osaan: hitsaustekniikka, robottihitsattava tuote, robotisoituhitsaus ja investointilaskelmat. Hitsaustekniikassa lähdetään liikkeelle hitsauksen kannalta oleellisimmista perusasioista, jolloin lukijalle syntyy laajempi kokonaiskuva asiasta. Hitsauksen robotisointia suunniteltaessa korostuu tuotteen hitsattavuus. Hyvin suunniteltu tuote mahdollistaa robotisoidun hitsauksen ja luo edellytykset laadukkaalle, taloudelliselle ja tuottavalle hitsaukselle. Robotisoidun hitsauksen osassa rakennetaan kokonaisuus, jolloin lopputuloksena on tehokas robottijärjestelmä. Samalla käsitellään sekä varsinaista hitsausteknistä toteutusta että robottijärjestelmän komponentteja. Investointilaskelmien avulla varmistetaan robottijärjestelmän ja koko tuotantoketjun kannattavuus. Käytännön osuudessa selvitetään robotisoidun hitsauksen mahdollisuudet valitulle tuotteelle ja robotisoinnin aikaansaamat kustannussäästöt. Tuotteen ylärungosta valitaan etuosa tarkempaa CASE tyylistä tarkastelua varten. CASE:ssa käydään läpi etuosan valmistettavuus ja selvitetään robotisoinnista aikaansaamat säästöt. Investointilaskelmien avulla selvitetään käytännön osuudessa robotisoidun hitsauksen kannattavuus tietyille robottijärjestelmille.

Multichannel distribution strategy for electrical equipment marketing

The thesis examines System Integration and original equipment manufacturer (OEM) channel in the St. Petersburg drives market. The aim of the study was to increase understanding the relationship between OEM and SI and producers, problems and ongoing trends. The collected data was analyzed in order to find out which features of a power electronic drive product exercise a significant influence for the Russian companies decision. An essential part of this study was interviews as primary information sources, organized with SI and OEM companies which represented the basic SPb industry segments. The wholesalers and end users are left out from the analysis. The collected data was analyzed in order to find out which features of a power electronic drive product exercise a significant influence for the Russian companies decision.

Targeted vs. standard treatment against Helicobacter pylori: safety assessment clinical trial

Helicobacter pylori (H. pylori) is a gram negative bacteria that represents a considerable global burden in the world and is related to many gastrointestinal diseases (peptic ulcer, gastric MALT lymphoma or gastric cancer). Currently the triple standard therapy is less used as there is an increase of the clarithromycin resistance. Therefore patients have to receive several lines of treatment with the consequence of adverse events and the possibility to interrupt the treatment. This is why the main objective is to determine if making a culture and antibiogram to do a targeted treatment cause less adverse events with the same eradication than making an empirical treatment to eradicate H. pylori. The secondary objective is to determine the prevalence of resistance to clarithromycin in the province of GironaThis is a multicentre clinical trial without blinding; patients are selected by non-probabilistic sampling, with a total sample of 868 patients randomized in two equal groups of 434 patients in each group. The study will last 2 years. The endpoints will be to evaluate the adverse events and eradication of each group of patients. Also it will be evaluated the resistance to clarithromycin

Safety Culture and Maritime Personnel’s Safety Attitudes: Interview Report

”METKU –projektissa” (Merenkulun turvallisuuskulttuurin kehittäminen) tutkitaan kansainvälisen turvallisuusjohtamiskoodin (ISM-koodin) vaikutuksia merenkulun turvallisuuteen ja etsitään kehittämiskohteita merenkulun turvallisuusjohtamisen parantamiseksi. Tämä haastatteluraportti on laadittu METKU –projektin yhteistyössä työpakettien 1 ja 2 kesken. Tähän raporttiin haastateltiin yhteensä 94 merenkulun ammattilaista. Suurimman osan haastateltavista muodostivat aktiiviset merenkulkijat: miehistön jäsenet, päällystö ja alusten päälliköt. Haastattelukohteena oli seitsemän suomalaista varustamoa. Haastatteluissa kerättiin merenkulkijoiden kokemuksia ja mielipiteitä ISM-koodin vaikutuksesta heidän käytännön työhönsä. Suomalaiset merenkulkijat uskovat, että tänä päivänä varustamoiden johtajat ovat hyvin sitoutuneita turvallisuuteen. Myös miehistön asenteet turvallisuuteen ovat ISM-koodin käytön myötä parantuneet. Haasteltavien yhteinen huoli kohdistui jatkuvan parantamisen toimivuuteen. Kaikki haastatellut ryhmät olivat samaa mieltä siitä, että poikkeamien raportointi ei ISMkoodin vaatimuksesta huolimatta toimi kunnolla. ISM-koodin käyttöön otosta on ollut merenkululle selkeää hyötyä. Haastateltavat esittivät hyötyinä parantuneen yhteistyön ja tiedonkulun alusten ja varustamon välillä sekä sen, että merenkulun toiminnan laatu on parantunut. Monet haastateltavat korostivat, että ISM-koodin selkeät turvallisuusvastuut yhtiölle on ollut merkittävä hyöty. Itse ISM-koodiin merenkulkijoilla ei ollut juurikaan huomauttamista. Sen sijaan turvallisuusjohtamisen käytännön toteutuksessa nähtiin parantamisen varaa. ISMkoodin aiheuttamina ongelmina mainittiin mm. lisääntynyt byrokratia ja liian monimutkaiset ja yksityiskohtaiset turvallisuuskäsikirjat. Monet haastateltavat toivovat, että ISM-koodin käytännön soveltamiseen laadittaisiin ohjeita.

Processamento de cartuchos de impressoras de jato de tinta: um exemplo de gestão de produto pós-consumo

This work presents a route for processing spent ink-jet cartridges in an experimental course. The disassembly of the cartridges requires several steps and the recognition of their different components is essential to define the best final destination (recycling, co-processing). The plastic strips were chemically processed so as to recover gold and copper. The students recognized the difficulty of processing multicomponent wastes and the importance of the chemical work under the best safety conditions; they also experienced many laboratory techniques and recognized the value of the selective collection and the reverse logistics to reach a viable commercial scale recycling.

Compliance of crane electrics with electrical safety standards and codes

Master’s thesis focuses on the questions of crane electrics compliance with electrical safety standards. Overview and short comparison of the world’s effective standards in the field is made in order to understand their demands. Basic concepts of a proper electrical circuit design are presented. Characteristics, construction and operation principles of overcurrent protective devices are studied in details. Electrics of the basic crane is designed according to the assumed customer’s demands, compliance with the requirements of the standards is checked. Solutions to achieve better compliance in some issues are proposed. Accent is made on the National Electrical Code (NEC) and standards by Underwriters Laboratories (UL) latests demands. Requirements of the International Electrotechnical Commission (IEC) are also taken into account.