[Assessment of the suitability of selected non-measuring models for dermal exposure estimation for the purposes of assessing compliance of working conditions with restrictions 71 and 76 in Annex XVII of the REACH regulation]. / Ocena przydatnosci wybranych modeli bezpomiarowych do szacowania narazenia dermalnego dla potrzeb oceny zgodnosci warunków pracy z ograniczeniami 71 i 76 zalacznika XVII do rozporzadzenia REACH.

BACKGROUND: Occupational exposure to chemicals occurs mainly through inhalation and the skin. The inhalation exposure assessment is regulated by law, while in Poland the method of conducting measurements for dermal exposure has not been indicated in the law. However, due to the restrictions 71 and 76 from Annex XVII of REACH for 1-methyl-2-pyrrolidone (NMP) and N,N-dimethylformamide (DMF), exposure assessment by the dermal route is necessary. These restrictions require to ensure that exposure of workers is below the derived no-effect levels (DNELs) for dermal exposure. The aim of the work was assessment of suitability of selected non-measurement forecasting models for the estimation of dermal occupational exposure to chemicals for the purposes of assessing compliance of working conditions with the restrictions 71 and 76 of the REACH regulation. MATERIAL AND METHODS: Three tools estimating dermal exposure, recommended by European Chemical Agency (ECHA), were selected: ECETOC TRA, RISKOFDERM and IH SkinPerm, which were used to estimate 2 exemplary workplaces. RESULTS: Results of the estimations of dermal exposure showed that non-measuring models are useful for fulfilling the obligations under restrictions 71 and 76 of Annex XVII of REACH. The type of exposure scenario and amount of data available for the workplace are crucial for the selection of the model. The ECETOC TRA was considered the best model for this type of analysis, whose main advantages are direct comparison of the output data in mg/kg/day with the DNEL value and use of standardized descriptors system. CONCLUSIONS: Exposure modeling is a good and cheap way to determine the dermal exposure magnitude at workplaces, also to comply with the requirements of restrictions 71 and 76 of Annex XVII of REACH. The application of modeling in the case of occupational exposure by the dermal route is one of the solutions when it is necessary to comply with the DNEL for dermal exposure. Med Pr Work Health Saf. 2023;74(6):487-500.

[Butane-2-one oxime as a potential carcinogen for humans - evidence and effects on businesses resulting from reclassification]. / Oksym butan-2-onu jako potencjalny czynnik rakotwórczy dla ludzi ­ dowody i skutki dla przedsiebiorstw wynikajace ze zmiany klasyfikacji.

Evidence of a change in the carcinogenicity category of butan-2-one oxime (MEKO) and the results of this change for manufacturing and using companies was presented and assessed. The online databases of scientific journals were reviewed, taking into account the reports on the harmonization of MEKO classification and labeling at EU level available on the ECHA website. Commission Regulation (EU) 2020/1182 introduced harmonized classification and labeling of MEKO for carcinogenicity to category 1B. The induction of tumors, the nature and importance of tumors for humans, and the sensitivity of the 2 species tested, both sexes - all of these factors support the classification of MEKO into the carcinogenicity category 1B. On the other hand, MEKO is negative in genotoxicity studies, including in mammalian cells and in vivo in animals. This is the argument that the classification of MEKO as carcinogen category 2 remains appropriate. The change in the MEKO carcinogenicity category results in legal consequences for companies, such as compliance with the conditions of REACH restriction, which includes restrictions on placing MEKO on the market for sale to the general public, keeping a register of works that require contact with MEKO or its mixtures containing MEKO in a concentration ≥0.1%. According to the opinion of MEKO suppliers, there is currently no practical MEKO substitute that has been so well researched, despite attempts to find it in recent years. The risk of additional liver cancer in the case of 40-year occupational exposure to MEKO is 4:100 000 at a concentration of approx. 0.7 mg/m3, and it is an acceptable risk in accordance with the arrangements adopted in Poland. Compliance with the permissible concentrations of MEKO in the air of the working environment at this level should protect employees against the carcinogenic effect of MEKO. Med Pr. 2022;73(6):457-70.

[Health hazards resulting from occupational exposure to enfluran - overview of tests and analysis of admissible concentration values]. / Zagrozenia zdrowotne wynikajace z narazenia zawodowego na enfluran ­ przeglad badan i próba analizy wartosci dopuszczalnych stezen.

The aim of this work is to analyze the health hazards of enflurane exposure and to analyze the occupational exposure limits (OEL). The method of obtaining evidence based on a review of online databases of scientific journals was used. Enflurane is an inhalation anesthetic. Malignant hyperthermia, seizures, arrhythmias, respiratory depression and hypotension have been observed in patients. Occupational exposure to enflurane may occur in healthcare professionals. The target organ for enflurane is the central nervous system with a critical consequence of deterioration in psychomotor performance. In studies on volunteers recruited from the medical staff of operating rooms exposed to enflurane, a significant deterioration in the results of the Simple Reaction Time Test was shown. World experts' groups assume that the LOAEC (lowest observed adverse effect concentration) value for the deterioration of psychomotor test results is 5-10% of the MAC value (minimal anesthetic concentration), i.e., 6342-12 684 mg/m3. Assessment of the nephrotoxic potential of enflurane has shown that it is unlikely to occur because biotransformation of enflurane in humans results in a low peak serum fluoride concentration of 15 µmol/l. Early reports about liver damage in patients were not be supported. Occupational exposure epidemiological studies have raised concerns about the effects of anesthetic gas mixtures on the abortion rate or on fetal development and birth defects in children, but none of these studies specifically determined the type and concentration of anesthetic gases used. The carcinogenicity and mutagenicity studies were negative. Occupational exposure to enflurane is not monitored in Poland, as no standard value has been established for it in the air of the working environment. It is necessary to quickly introduce this anesthetic along with the applicable limit value to the OEL list. Med Pr. 2022;73(1):51-69.

The overview of current evidence on the reproductive toxicity of dibutyl phthalate.

Over the past years, many legitimate concerns have been raised about the effects of dibutyl phthalate (DBP) as an endocrine disruptor, especially on reproduction. The aim of this publication is to critically review the literature related to the developmental and reproductive toxicity of DBP in animals. Several electronic databases were systematically searched until 2019. Studies were qualified for the review if they: linked exposure to DPB with reproduction, were published in English after 1990, and were conducted on animals. In the studies of the testicular effects of DBP on experimental animals, the most common effects of exposure included reduced fertility, atrophic changes in male gonads, degenerative changes in the epididymis, as well as a reduction in sperm count and motility, cryptorchidism, hypospadias, poor sperm quality and other genital defects (decreased testicular weight, delayed spermatogenesis, Leydig cell aggregation, impaired Sertoli cell maturation, and significant inhibitions of testicular enzymes). The embryotoxic effects of DBP on laboratory animals included mainly an increase in fetal resorption and a decrease in live births. The teratogenic effects of DBP also manifest as skeletal malformations in fetuses, malformations of male gonads and other genital effects. On the basis of the literature data, it is clearly demonstrated that DBP shows anti-androgenic effects; however, there are also reports confirming its weak estrogenic effect. Additionally, lower doses cause more adverse effects than the highest dose, which is an important fact because of the widespread environmental exposure to DBP. The studies clearly confirm that DBP is an endocrine disruptor. Int J Occup Med Environ Health. 2021;34(1):15-37.

Occupational risk resulting from exposure to mineral wool when installing insulation in buildings.

Mineral wool is widely used for thermal and sound insulation. The subject of the study is to identify hazards for employees resulting from exposure to mineral wool, when it is used to insulate buildings, and to assess the risk arising from this exposure. When installing mineral wool insulation, respirable mineral fibers, dust, and volatile organic compounds may pose a hazard at workplaces. Based on the results of concentration measurements, it was assessed that the probability of adverse health effects related to the work of insulation installers, resulting from exposure to mineral wool fibers, is low, but for dust associated with exposure, an average health risk was estimated. An additional threat may be the sensitizing effect of substances used as binders and additives improving the utility properties of mineral wool, for example, phenol formaldehyde resins. The paper also contains some information on the labeling of mineral wool; this is very important because the label allows downstream users to recognize mineral wools, the composition and properties of which cause that they are not classified as carcinogens. Int J Occup Med Environ Health. 2020;33(6):757-69.

[Fluorouracil and doxorubicin - cardiotoxic cytostatics in the workplace]. / Fluorouracyl i doksorubicyna ­ kardiotoksyczne cytostatyki w miejscu pracy.

The aim of the study is to analyze the potential occupational hazards of fluorouracil (FU) and doxorubicin (DOX). The literature review was based on factual and bibliographic scientific databases of the available peer-reviewed journals and the so-called gray literature. In Poland, the process of determining the acceptable levels of occupational exposure for selected anticancer drugs has been underway since 2014, and the basis for determining the maximum allowable concentration values is usually the concentration equivalent to 0.1% of the lowest therapeutic dose found in the literature. In addition, uncertainty coefficients are used, which take into account the mechanism of action of the cytostatics, the dynamics of metabolism, the assessment of classification and labeling for carcinogenic, mutagenic, genotoxic, reproductive toxicity, organ toxicity, the ability to accumulate cytostatics, the assessment of cumulative effects with other cytostatics, the physicochemical form and data completeness. Where possible, the risk of additional cancer is estimated. Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (the carcinogens and mutagens directive ‒ CMD) is a key legal solution in the field of public health in the European Union, focused on the issue of occupational cancer. These cytostatics, FU and DOX, are genotoxic and are classified as hazardous. Life-threatening heart damage is a serious side effect of both FU and DOX. The analysis has shown that the inclusion of dangerous drugs in the list of substances subject to the requirements of the CMD is completely justified. The cytostatics classification and labeling procedure should be harmonized throughout the European Union, which will ensure a reliable and credible risk management in this area. Med Pr. 2020;71(3):363-73.

[Ten years of the application of REACH and CLP - assessing the knowledge and implementation of these regulations by Polish users of chemicals]. / Dziesiec lat obowiazywania REACH i CLP ­ ocena znajomosci i wdrazania przepisów przez polskich uzytkowników chemikaliów.

BACKGROUND: The aim of this work was to assess the awareness among both downstream users and distributors of chemicals in Poland, as regards legal regulations applicable to chemicals (i.e., the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals - REACH, and the Registration on classification, labelling and packaging - CLP), and to identify on this basis the needs for training and information campaigns addressed to these professional groups, by means of a questionnaire survey. MATERIAL AND METHODS: The SurveyMonkey Internet survey software was selected for this purpose. Two groups of respondents were surveyed - downstream users (DU) and distributors (D) of chemicals, and consumers. RESULTS: Responses were obtained from 65 downstream users and distributors of chemicals, and from 98 consumers. As many as 23% of the respondents did not know the obligations imposed on their company by REACH and CLP. Over 59% of the DU/D respondents did not have the opportunity to participate in chemical safety management (CSM) training in the last 5 years. Eighty percent of the respondents were interested in participating in free courses that would enable them to broaden their knowledge of the classification, labeling and marketing of chemicals. CONCLUSIONS: Despite the 10 years of the application of REACH and CLP, many people working for chemical enterprises still do not know their company's obligations set out in these regulations. The percentage of people positively assessing their competences increases with the size of the enterprise. The results of the survey indicate the need to organize continuous training for people using chemicals in their professional activity and for distributors. It is very important to ensure training at the basic level of chemical distributors. Such training should provide them with elementary knowledge on the hazards posed by chemicals, which could then be passed to consumers in an understandable manner. Med Pr. 2019;70(4):435-44.

Cytostatics as hazardous chemicals in healthcare workers' environment.

Cytostatics not only induce significant side-effects in patients treated oncologically but also pose a threat to the health of occupationally exposed healthcare workers: pharmacists, physicians, nurses and other personnel. Since the 1970s numerous reports from various countries have documented the contamination of working areas with cytostatics and the presence of drugs/metabolites in the urine or blood of healthcare employees, which directly indicates the occurrence of occupational exposure to these drugs. In Poland the significant scale of occupational exposure to cytostatics is also confirmed by the data collected in the central register of occupational carcinogens/mutagens kept by the Nofer Institute of Occupational Medicine. The assessment of occupational exposure to cytostatics and health risks constitutes employers' obligation. Unfortunately, the assessment of occupational risk resulting from exposure to cytostatics raises a number of concerns. Provisions governing the problem of workers' health protection are not unequivocal because they derive from a variety of law areas, especially in a matter of hazard classification and safety data sheets for cytostatics. Moreover, no legally binding occupational exposure limits have been set for cytostatics or their active compounds, and analytical methods for these substances airborne and biological concentrations are lacking. Consequently, the correct assessment of occupational exposure to cytostatics, the evaluation of health hazards and the development of the proper preventive strategy appear difficult. The authors of this article described and discussed the amendments to the European provisions concerning chemicals in the light of employers' obligations in the field of employees' heath protection against the consequences of exposure to cytostatics. Some modifications aimed at a more effective health protection of workers occupationally exposed to cytostatics were also proposed. Int J Occup Med Environ Health. 2019;32(2):141-59.

[Hygiene and legal aspects of occupational exposure assessment to cytostatics]. / Aspekty higieniczne i prawne oceny narazenia zawodowego na cytostatyki.

The employers responsibilities for the assessment of occupational exposure to cytostatics in the workplace were analyzed in the light of existing legal regulations. Cytostatics may pose a threat to health and life of workers taking care of patients treated oncologically, i.e., pharmacists, physicians, nurses and other personnel. The significant scale of occupational exposure to cytostatics in Poland is confirmed by the data collected in the Central Register of Data on Exposure to Carcinogenic or Mutagenic Substances, Mixtures, Agents or Technological Processes, maintained by the Nofer Institute of Occupational Medicine, Lódz, Poland. The issue of occupational risk assessment of exposure to cytostatics gives raise to numerous concerns. Polish regulations concerning health protection of employees occupationally exposed to cytostatics are not unequivocal, as they are derived from different areas of the law, especially those applying to hazard classification, labeling and preparation of safety data sheets for cytostatics. There are neither binding occupational exposure limits legally set for active compounds of antineoplastic drugs nor methods for monitoring of these substances concentrations in a worker's breathing zone and biological material. This prevents the employer to carry out the correct assessment of occupational exposure, the results of which are the basis for preparing the proper preventive strategy. In this article the consequences of amendments to the European chemical legislation for employers responsible for adequate protection of health and life of employees exposed to cytostatics, were discussed, as well as some legal changes aimed at a better health and life protection of workers exposed to cytostatics in a workplace were proposed. Med Pr 2018;69(1):77-92.

[Assessment of predictive dermal exposure to chemicals in the work environment]. / Bezpomiarowa ocena narazenia na dzialanie substancji chemicznych przez kontakt ze skóra w srodowisku pracy.

Assessment of dermal exposure to chemicals in the work environment is problematic, mainly as a result of the lack of measurement data on occupational exposure to chemicals. Due to common prevalence of occupational skin exposure and its health consequences it is necessary to look for efficient solutions allowing for reliable exposure assessment. The aim of the study is to present predictive models used to assess non-measured dermal exposure, as well as to acquaint Polish users with the principles of the selected model functioning. This paper presents examples of models to assist the employer in the the assessment of occupational exposure associated with the skin contact with chemicals, developed in European Union (EU) countries, as well as in countries outside the EU. Based on the literature data dermal exposure models EASE (Estimation and Assessment of Substance Exposure), COSHH Essentials (Control of Substances Hazardous to Health Regulations), DREAM (Dermal Exposure Assessment Method), Stoffenmanager , ECETOC TRA (European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment), MEASE (Metal's EASE), PHED (Pesticide Handlers Exposure Database), DERM (Dermal Exposure Ranking Method) and RISKOFDERM (Risk Assessment of Occupational Dermal Exposure to Chemicals) were briefly described. Moreover the characteristics of RISKOFDERM, guidelines for its use, information on input and output data were further detailed. Problem of full work shift dermal exposure assessment is described. An example of exposure assessment using RISKOFDERM and effectiveness evaluation to date were also presented. When no measurements are available, RISKOFDERM allows dermal exposure assessment and thus can improve the risk assessment quality and effectiveness of dermal risk management. Med Pr 2017;68(4):557-569.

Application of predictive models for estimation of health care workers exposure to sevoflurane.

OBJECTIVES: The aim of this study was to assess the potential use of predictive models to estimate professional exposure to chemicals in the workplace, such as the operating room, by simultaneous determination of the levels of exposure using a model and measurements. METHODS: Measurements included determinations of sevoflurane (SEV) in the workplace air of 117 operating rooms of 31 hospitals in one Polish region. Measurements were carried out at the time of various surgical procedures during administration of anaesthetics by endotracheal intubation. The measurement results were compared with the values estimated using two models: ECETOC TRA and Stoffenmanager. RESULTS: In one case the ECETOC TRA estimated the exposure concentration almost equal to the measured concentration but, because of the need to maintain a margin of safety in case of modelling, it can be concluded that the model underestimated the concentration. The Stoffenmanager model provided accurate exposure estimates in the examined case, and it can be used as a screening tool for the assessment of occupational inhalation exposure of medical personnel to anaesthetics. CONCLUSIONS: The results are of particular importance to the circumstances in Eastern Europe, where the levels of anaesthetics often exceed the relevant occupational exposure limits.

OELs derivation in Poland and in the former Eastern Bloc with reference to approaches and practices applied in the EU.

Based on the literature, current legislation and the European Union (EU) directives, the rules to protect the health of workers in Poland and the countries of the former Eastern Bloc were analyzed. Since 2002, the activities in the field of hygiene standards in the countries of the former Eastern Bloc have been correlated with the EU policy. The functioning of the system of maximum admissible concentrations (MAC) having been implemented in Poland for many years before the accession to the EU, has provided for a relatively quick adjustment of Polish regulations on chemicals to the relevant European law. The Polish list includes 543 substances. In the former Eastern Bloc countries, intensification of work after joining the EU has caused the lists in those countries to contain from 285 substances in Slovakia to 780 in Lithuania. Currently, all substances included in the EU lists (up to and including the 3rd list of occupational exposure limit values of the Directive 2009/161/EC) have been governed by the Polish, Lithuanian, Czech, Latvian and Hungarian law. In Estonia and Slovakia the provisions of the Directive 2006/15/EC establishing the second list of occupational exposure limits have been implemented. Individual national lists contain much more chemicals than the EU list containing currently 122 substances. The legislative process in the EU is slow, and that is why the national law is important and necessary due to the local needs in selected areas. It is necessary to correlate the activities in the field of determining regional occupational exposure limit (OEL) values in the countries of the Eastern Bloc and the EU.

[METHOTREXATE - GENOTOXIC AND TERATOGENIC FOR MEDICAL STAFF OF ONCOLOGY WARDS?]. / METOTREKSAT - GENOTOKSYCZNY I TERATOGENNY DLA PERSONELU MEDYCZNEGO ONKOLOGICZNYCH ODDZILÓW SZPITALNYCH?

Methotrexate (MTX) is one of the most widely used cytostatic drugs belonging to the folic acid antagonists. It is a substance non-classified as a carcinogen in the European Union and by the International Agency for Research on Cancer (IARC) as there is no evidence of its carcinogenicity to humans and animals. Nevertheless, MTX has been placed on the list of dangerous drugs used in chemotherapy, mainly due to geniotoxic and teratogenic effects, causing developmental toxicity and reproductive toxicity. Methotrexate was determined in the hospital ward air during the preparation of a medicament at a level of 0.3 mg/m3, as well as on protective gloves and preparatory room surfaces. In most research projects MTX was identified in the urine of health care workers, pharmacists and nursing staff. The highest cumulative concentration of MTX in 112 urine samples was 1416 mg in workers preparing infusions for patients. Studies carried out in pharmacies revealed the presence of MTX in 60% of tests, and the maximum concentration of 15 ng/cm2 surface of the tray to count tablets. Legal exposure limit values for MTX in the work environment have not yet been established. Occupational exposure limits have been established by some manufacturers at the level of 0.0003-0.0025 mg/m3. There is an urgent need to establish normative values. It should also be emphasized that MTX is absorbed through the skin, which may significantly-increase the exposure and measuring its concentration in the work environment may not be sufficient to estimate the actual exposure.

Assessment of Potential Health Hazards During Emission of Hydrogen Sulphide from the Mine Exploiting Copper Ore Deposit - Case Study.

AIM: The aim of this study was to determine hydrogen sulphide concentration emitted from the mine extracting copper ore, to evaluate potential adverse health effects to the population living in four selected villages surrounding the exhaust shaft. MATERIALS: Maximum measured concentration of hydrogen sulphide in the emitter is 286 µg/m³. Maximum emission calculated from the results of determinations of concentrations in the emitter is 0.44 kg/h. RESULTS: In selected villages hydrogen sulphide at concentrations exceeding 4 µg/m³ was not detected in any of the 5-hour air samples. In all locations, the estimated maximum 1-hour concentrations of hydrogen sulphide were below 1 µg/m³, and the estimated mean annual concentrations were below 0.53 µg/m³. CONCLUSION: Any risk to the health of people in the selected area is not expected. As indicated by the available data on the threshold odour, the estimated concentrations of hydrogen sulphide may be sensed by humans.

[Predictive models for the assessment of occupational exposure to chemicals: a new challenge for employers]. / Bezpomiarowa ocena narazenia zawodowego na substancje chemiczne--nowe wyzwanie dla pracodawców.

Employers are obliged to carry out and document the risk associated with the use of chemical substances. The best but the most expensive method is to measure workplace concentrations of chemicals. At present no "measureless" method for risk assessment is available in Poland, but predictive models for such assessments have been developed in some countries. The purpose of this work is to review and evaluate the applicability of selected predictive methods for assessing occupational inhalation exposure and related risk to check the compliance with Occupational Exposure Limits (OELs), as well as the compliance with REACH obligations. Based on the literature data HSE COSHH Essentials, EASE, ECETOC TRA, Stoffenmanager, and EMKG-Expo-Tool were evaluated. The data on validation of predictive models were also examined. It seems that predictive models may be used as a useful method for Tier 1 assessment of occupational exposure by inhalation. Since the levels of exposure are frequently overestimated, they should be considered as "rational worst cases" for selection of proper control measures. Bearing in mind that the number of available exposure scenarios and PROC categories is limited, further validation by field surveys is highly recommended. Predictive models may serve as a good tool for preliminary risk assessment and selection of the most appropriate risk control measures in Polish small and medium size enterprises (SMEs) providing that they are available in the Polish language. This also requires an extensive training of their future users.

Assessment of exposure to TDI and MDI during polyurethane foam production in Poland using integrated theoretical and experimental data.

The aim of this study was to develop an optimal strategy for the assessment of inhalation exposure to isocyanates such as TDI and MDI in the production of polyurethane foam by integration of theoretical and experimental data. ECETOC TRA and EASE predictive models were used to determine the estimated levels of exposure to isocyanates. The results of our study suggest that both applications EASE and ECETOC TRA can be used as a screening 1st Tier tool in this case study. PROC12 ECETOC TRA category can be linked to exposure on TDI during polyurethane foam manufacturing because it is working properly and exceeds 90th percentile measured concentration with factor 3 and the maximum measured value with factor 1, 5. The value estimated by using category PROC2 is underestimated so this category should not be linked to this scenario. At the same time, the applications of EASE overstate the expected concentrations although the scenario "Use in closed process" seems to underestimate the exposure at the "lower end". For MDI the both models estimate exposure in a conservative manner.

Evaluation of the TRA ECETOC model for inhalation workplace exposure to different organic solvents for selected process categories.

OBJECTIVE: The aim of this work is to describe the operation principle of the TRA ECETOC model developed using the descriptor system, and the utilization of that model for assessment of inhalation exposures to different organic solvents for selected process categories identifying a given application. METHOD: Measurement results were available for toluene, ethyl acetate and acetone in workplace atmosphere in Poland. The following process categories have been postulated: (1) Paints and lacquers factory: use in closed, continuous process with occasional controlled exposure; (2) Shoe factory: roller or brush application of glues; (3) Refinery: use in closed process, no likelihood of exposure. The next step was to calculate the workplace concentration at chosen process categories by applying the TRA ECETOC model. RESULTS: The selected categories do not precisely describe the studied applications. Very high concentration values of acetone were measured in the shoe factory, mean 443 ppm. The concentration obtained with the aid of the model is underestimated, ranging from 25.47 to 254.7 ppm, for the case with and without activation of the local exhaust ventilation (LEV), respectively. Estimated concentration at a level corresponding to that of the measured concentration would be possible if the process category involving spraying, e.g., PROC 7 was considered. For toluene and ethyl acetate, the measured concentrations are within the predicted ranges determined with the use of the model when we assume the concentration predicted with active ventilation for the beginning, and the concentration predicted with inactive ventilation for the end of the range. CONCLUSIONS: Model TRA ECETOC can be easily used to assess inhalation exposure at workplace. It has numerous advantages, its structure is clear, requires few data, is available free of charge. Selection of appropriate process categories related to the uses identified is guarantee of successful exposure assessment.

[Application of predictive model to estimate concentrations of chemical substances in the work environment]. / Zastosowanie modelu predykcyjnego do szacowania wielkosci stezen wybranych substancji chemicznych w powietrzu srodowiska pracy.

BACKGROUND: Based on the Estimation and Assessment of Substance Exposure (EASE) predictive model implemented into the European Union System for the Evaluation of Substances (EUSES 2.1.), the exposure to three chosen organic solvents: toluene, ethyl acetate and acetone was estimated and compared with the results of measurements in workplaces. MATERIAL AND METHODS: Prior to validation, the EASE model was pretested using three exposure scenarios. The scenarios differed in the decision tree of pattern of use. Five substances were chosen for the test: 1,4-dioxane tert-methyl-butyl ether, diethylamine, 1,1,1-trichloroethane and bisphenol A. After testing the EASE model, the next step was the validation by estimating the exposure level and comparing it with the results of measurements in the workplace. We used the results of measurements of toluene, ethyl acetate and acetone concentrations in the work environment of a paint and lacquer factory, a shoe factory and a refinery. Three types of exposure scenarios, adaptable to the description of working conditions were chosen to estimate inhalation exposure. RESULTS: Comparison of calculated exposure to toluene, ethyl acetate and acetone with measurements in workplaces showed that model predictions are comparable with the measurement results. Only for low concentration ranges, the measured concentrations were higher than those predicted. CONCLUSIONS: EASE is a clear, consistent system, which can be successfully used as an additional component of inhalation exposure estimation. If the measurement data are available, they should be preferred to values estimated from models. In addition to inhalation exposure estimation, the EASE model makes it possible not only to assess exposure-related risk but also to predict workers' dermal exposure.

Calculating the dermal flux of chemicals with OELs based on their molecular structure: An attempt to assign the skin notation.

Our objectives included calculating the permeability coefficient and dermal penetration rates (flux value) for 112 chemicals with occupational exposure limits (OELs) according to the LFER (linear free-energy relationship) model developed using published methods. We also attempted to assign skin notations based on each chemical's molecular structure. There are many studies available where formulae for coefficients of permeability from saturated aqueous solutions (K(p)) have been related to physicochemical characteristics of chemicals. The LFER model is based on the solvation equation, which contains five main descriptors predicted from chemical structure: solute excess molar refractivity, dipolarity/polarisability, summation hydrogen bond acidity and basicity, and the McGowan characteristic volume. Descriptor values, available for about 5000 compounds in the Pharma Algorithms Database were used to calculate permeability coefficients. Dermal penetration rate was estimated as a ratio of permeability coefficient and concentration of chemical in saturated aqueous solution. Finally, estimated dermal penetration rates were used to assign the skin notation to chemicals. Defined critical fluxes defined from the literature were recommended as reference values for skin notation. The application of Abraham descriptors predicted from chemical structure and LFER analysis in calculation of permeability coefficients and flux values for chemicals with OELs was successful. Comparison of calculated K(p) values with data obtained earlier from other models showed that LFER predictions were comparable to those obtained by some previously published models, but the differences were much more significant for others. It seems reasonable to conclude that skin should not be characterised as a simple lipophilic barrier alone. Both lipophilic and polar pathways of permeation exist across the stratum corneum. It is feasible to predict skin notation on the basis of the LFER and other published models; from among 112 chemicals 94 (84%) should have the skin notation in the OEL list based on the LFER calculations. The skin notation had been estimated by other published models for almost 94% of the chemicals. Twenty-nine (25.8%) chemicals were identified to have significant absorption and 65 (58%) the potential for dermal toxicity. We found major differences between alternative published analytical models and their ability to determine whether particular chemicals were potentially dermotoxic.

[Setting limit values for chemical substances in the workplace: DNEL(INH) setting according to REACH principles following the example of 2-butyne-1,4-diol]. / Wyznaczenie bezpiecznych wartosci substancji chemicznych obecnych na stanowiskach pracy-- wyznaczenie wartosci DNEL(INH) zgodnie z zalozeniami REACH na przykladzie but-2-yno-1,4-diolu.

BACKGROUND: Derived No Effect Level (DNEL(inh)) has been set for occupational exposure to but-2-yno-1,4-diol according to REACH principles. Maximum allowable concentration (MAC) and DNEL(inh) have been compared. MATERIAL AND METHODS: Experimental data from two inhalation studies on rats and three oral studies have been used to calculate DNEL. RESULTS: Estimated DNEL(inh) values show significant differences and fall within the range of 0.33-0.02 mg/m3, depending on the chosen experiment and critical effect. It seems that a 30-day inhalation study best reflects the penetration of xenobiotic to the human organism. This experiment has been used to set MAC value of but-2-yno-1,4-diol of 0,25 mg/m3 and it is close to local DNEL(inh)--0.10 mg/m3. Both values have been estimated on the same starting point NOAEC(loc)--0.5 mg/m3, but different assessment factors have been applied. CONCLUSIONS: A general feeling is that because of the differences in methodologies for calculating DNELs versus those used for calculating health-based OELs, the DNEL will tend to be lower than any corresponding health-based OEL for that chemical. This indicates that the OEL does not provide the appropriate level of protection required by REACH. The calculation leads to a new value (DNEL) that requires different risk management measures and operational conditions.