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  • 1. Beronius, Anna
    et al.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Hanberg, Annika
    Håkansson, Helen
    Health risk assessment procedures for endocrine disrupting compounds within different regulatory frameworks in the European Union2009In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, no 2, p. 111-122Article in journal (Refereed)
    Abstract [en]

    In this study we have investigated how different regulatory frameworks in Europe cope with identification and risk assessment of endocrine disrupting compounds (EDCs). Four regulatory groups were selected for the investigation: existing industrial chemicals, environmental pollutants in food, pharmaceuticals and plant protection products. The legislation and guidelines for each of these groups were scrutinized and compared in detail. In addition, one recent European risk assessment document each for three identified EDCs, i.e. bisphenol A, dioxins and vinclozolin, were reviewed and compared. We found that the requirements for toxicity testing and availability and scope of risk assessment guidelines varied between the four regulatory frameworks. Also, the general principles regarding the human relevance of the mode of action identified in animal tests differed in the different risk assessments. In conclusion, there is little conformity in the risk assessment processes between these groups of chemicals. Because of the complicated nature of endocrine disruption, test methods, principles and criteria for data interpretation traditionally used might not be directly applicable to EDCs and further development of a transparent and reliable risk assessment process for this type of substances is needed.

  • 2.
    Ding, Qian
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Schenk, Linda
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Malkiewicz, Katarzyna
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Occupational exposure limits in Europe and Asia – Continued divergence or global harmonization?2011In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 61, no 3, p. 296-309Article in journal (Refereed)
    Abstract [en]

    Occupational exposure limits (OELs) are used as a risk management tool aiming at protecting against negative health effects of occupational exposure to harmful substances. The systems of OEL development have not been standardized and divergent outcomes have been reported. However some harmonization processes have been initiated, primarily in Europe. This study investigates the state of harmonization in a global context. The OEL systems of eight Asian and seventeen European organizations are analyzed with respect to similarities and differences in: (1) the system for determining OELs, (2) the selection of substances, and (3) the levels of the OELs. The majority of the investigated organizations declare themselves to have been influenced by the American Conference of Governmental Industrial Hygienists (ACGIH), and in many cases this can be empirically confirmed. The EU harmonization process is reflected in trends towards convergence within the EU. However, comparisons of Asian and European organizations provide no obvious evidence that OELs are becoming globally harmonized.

  • 3.
    Hansson, Sven Ove
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Molander, Linda
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    The substitution principle2011In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 59, no 3, p. 454-460Article in journal (Refereed)
    Abstract [en]

    According to the substitution principle, hazardous chemicals should be replaced by less hazardous alternatives. In this paper, the major issues concerning the more precise definition of the principle are analyzed, and a general purpose definition is proposed. It is claimed that the priority between reducing hazard, functionality and economical considerations in the application of the substitution principle is a matter for adjustment in each particular case that cannot be settled beforehand. None of these objectives can have absolute priority over the others, but the substitution principle is aimed at increasing the priority given to the reduction of hazards to human health and the environment. Major methods to promote and implement the principle are summarized, current legislative approaches are discussed, and proposals for efficient implementation are made. It is emphasized that the primary responsibility for avoiding hazardous substances and processes rests with industry.

  • 4.
    Hansson, Sven Ove
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Towards, a theory of tiered testing2007In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 48, no 1, p. 35-44Article in journal (Refereed)
    Abstract [en]

    Tiered testing is an essential part of any resource-efficient strategy for the toxicity testing of a large number of chemicals, which is required for instance in the risk management of general (industrial) chemicals, In spite of this, no general theory seems to be available for the combination of single tests into efficient tiered testing systems. A first outline of such a theory is developed. It is argued that chemical, toxicological, and decision-theoretical knowledge should be combined in the construction of such a theory. A decision-theoretical approach for the optimization of test systems is introduced. It is based on expected utility maximization with simplified assumptions covering factual and value-related information that is usually missing in the development of test systems.

  • 5.
    Hedberg, Yolanda
    et al.
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science. Karolinska Institutet, Sweden.
    Herting, Gunilla
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Latvala, S.
    Elihn, K.
    Karlsson, H. L.
    Odnevall Wallinder, Inger
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Surface passivity largely governs the bioaccessibility of nickel-based powder particles at human exposure conditions2016In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 81, p. 162-170Article in journal (Refereed)
    Abstract [en]

    The European chemical framework REACH requires that hazards and risks posed by chemicals, including alloys and metals, are identified and proven safe for humans and the environment. Therefore, differences in bioaccessibility in terms of released metals in synthetic biological fluids (different pH (1.5–7.4) and composition) that are relevant for different human exposure routes (inhalation, ingestion, and dermal contact) have been assessed for powder particles of an alloy containing high levels of nickel (Inconel 718, 57 wt% nickel). This powder is compared with the bioaccessibility of two nickel-containing stainless steel powders (AISI 316L, 10–12% nickel) and with powders representing their main pure alloy constituents: two nickel metal powders (100% nickel), two iron metal powders and two chromium metal powders. X-ray photoelectron spectroscopy, microscopy, light scattering, and nitrogen absorption were employed for the particle and surface oxide characterization. Atomic absorption spectroscopy was used to quantify released amounts of metals in solution. Cytotoxicity (Alamar blue assay) and DNA damage (comet assay) of the Inconel powder were assessed following exposure of the human lung cell line A549, as well as its ability to generate reactive oxygen species (DCFH-DA assay). Despite its high nickel content, the Inconel alloy powder did not release any significant amounts of metals and did not induce any toxic response. It is concluded, that this is related to the high surface passivity of the Inconel powder governed by its chromium-rich surface oxide. Read-across from the pure metal constituents is hence not recommended either for this or any other passive alloy.

  • 6. Henderson, Rayetta G.
    et al.
    Verougstraete, Violaine
    Anderson, Kim
    Arbildua, Jose J.
    Brock, Thomas O.
    Brouwers, Tony
    Cappellini, Danielle
    Delbeke, Katrien
    Herting, Gunilla
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Hixon, Greg
    Wallinder, Inger Odnevall
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Rodriguez, Patricio H.
    Van Assche, Frank
    Wilrich, Peter
    Oller, Adriana R.
    Inter-laboratory validation of bioaccessibility testing for metals2014In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 70, no 1, p. 170-181Article in journal (Refereed)
    Abstract [en]

    Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (S-r) and reproducibility (S-R) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the s(R):s(r) ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of s(r) showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed.

  • 7.
    Levin, Rikard
    et al.
    KTH, Superseded Departments, History of Science and Technology.
    Hansson, Sven Ove
    KTH, Superseded Departments, History of Science and Technology.
    Rudén, Christina
    KTH, Superseded Departments, History of Science and Technology.
    Indicators of uncertainty in chemical risk assessments2004In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 39, no 1, p. 33-43Article in journal (Refereed)
    Abstract [en]

    For most of the chemical substances that are subject to regulatory and industrial decision making, important toxicological data are missing. The available dataset is often difficult to interpret, and the differences between alternative, scientifically reasonable interpretations may have major impact on decision making. Since such uncertainties are an important factor in decision making it is essential that they be reported in a transparent and understandable way. In order to clarify how toxicologists report uncertainties, 30 risk assessments for one and the same substance (trichloroethylene) from the years 1973-2001 were searched for phrases indicating uncertainty. These phrases can be divided between four categories: contentual, epistemic, conditionalising, and inferential uncertainty indicators. A typology of uncertainty indicators, based on these categories, is proposed. It is concluded that the use of uncertainty indicators in these texts is not transparent and that the development of standardised uncertainty indicators should significantly improve communications both within the scientific community and between scientists and policymakers.

  • 8.
    Mazinanian, Neda
    et al.
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Hedberg, Yolanda
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Odnevall Wallinder, Inger
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Nickel release and surface characteristics of fine powders of nickel metal and nickel oxide in media of relevance for inhalation and dermal contact2013In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 65, no 1, p. 135-146Article in journal (Refereed)
    Abstract [en]

    Differences in surface oxide characteristics and extent of nickel release have been investigated in two thoroughly characterized micron-sized (mainly <4 mu m) nickel metal powders and a nickel oxide bulk powder when immersed in two different synthetic fluids, artificial sweat (ASW-pH 6.5) and artificial lysosomal fluid (ALF-pH 4.5) for time periods up to 24 h. The investigation shows significantly more nickel released from the nickel metal powders (<88%) compared to the NiO powder (<0.1%), attributed to differences in surface properties. Significantly more nickel was released from the nickel metal powder with a thin surface oxide predominantly composed of non-stoichiometric nickel oxide (probably Ni2O3), compared to the release from the nickel metal powder with a thicker surface oxide predominantly composed of NiO and to a lesser extent Ni2O3 (88% and 25% release after 24 h in ALF, respectively). Significantly lower amounts of nickel were released from the nickel metal powders in ASW (2.2% and <1%, respectively). The importance of particle and surface characteristics for any reliable risk assessment is discussed, and generated data compared with literature findings on bioaccessibility (released fraction) of nickel from powders of nickel metal and nickel oxide, and massive forms of nickel metal and nickel-containing alloys.

  • 9.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Narrow-and-sharp or broad-and-blunt - Regulations of hazardous chemicals in consumer products in the European Union2012In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 62, no 3, p. 523-531Article in journal (Refereed)
    Abstract [en]

    Chemicals are incorporated into a vast number of consumer products, and it has been recognized that considerable exposures of humans and the environment to chemicals are due to diffuse emissions from everyday products. Different approaches to the management of risks concerning chemicals in products are discussed on the international arena, but no general strategy has yet been adopted. The aim of this study is to investigate how health and environmental risks associated with chemicals in consumer products are currently managed in European Union legislations, mainly by the Toys Directive, the RoHS Directive, and REACH. Significant differences were found between the risk reduction strategies in these legislations, including substance prioritization, type of restrictions and requirements, and information dissemination to consumers. REACH regulates chemicals in products to a limited extent, and via quite complicated processes. Product-specific rules are therefore useful supplements to REACH for regulating chemicals in products. The combined effects of the RoHS and WEEE directives seem to be effective in promoting substitution of substances identified as problematic in electrical and electronic equipment, and it is recommended that the possibility to develop similar systems should be considered also for other product categories.

  • 10.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals2009In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, no 3, p. 367-371Article in journal (Refereed)
    Abstract [en]

    A significant number of Active Pharmaceutical Ingredients (APIs) have been identified in the environment and in surface waters. Data on the environmental hazards associated with these substances are emerging but are still scarce. We have compiled publicly available ecotoxicity data for APIs into a database called WikiPharma. The use of the database is free of charge. It can be accessed and updated continuously as a "wiki". The aim of WikiPharma is to provide an easily accessible, comprehensive and up-to-date overview of effects caused by pharmaceuticals on non-target organisms. The database currently contains basic information, i.e. substance name, ATC code(s) and pharmaceutical group(s), for 831 APIs representing 35 different drug classes. Effect data have been identified and included for 116 of these substances. These ecotoxicity test data have been extracted from 156 different sources. The development of a comprehensive database on ecological hazard of APIs can facilitate identification of data gaps and promote environmental risk assessment of these substances. The database is available at www.wikipharma.org.

  • 11.
    Mörsdorf, Alexander
    et al.
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Odnevall Wallinder, Inger
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Hedberg, Yolanda
    KTH, School of Chemical Science and Engineering (CHE), Chemistry, Surface and Corrosion Science.
    Bioaccessibility of micron-sized powder particles of molybdenum metal, iron metal, molybdenum oxides and ferromolybdenum - Importance of surface oxides2015In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 72, no 3, p. 447-457Article in journal (Refereed)
    Abstract [en]

    The European chemical framework REACH requires that hazards and risks posed by chemicals, including alloys and metals, that are manufactured, imported or used in different products (substances or articles) are identified and proven safe for humans and the environment. Metals and alloys need hence to be investigated on their extent of released metals (bioaccessibility) in biologically relevant environments. Read-across from available studies may be used for similar materials. This study investigates the release of molybdenum and iron from powder particles of molybdenum metal (Mo), a ferromolybdenum alloy (FeMo), an iron metal powder (Fe), MoO<inf>2</inf>, and MoO<inf>3</inf> in different synthetic body fluids of pH ranging from 1.5 to 7.4 and of different composition. Spectroscopic tools and cyclic voltammetry have been employed to characterize surface oxides, microscopy, light scattering and nitrogen absorption for particle characterization, and atomic absorption spectroscopy to quantify released amounts of metals. The release of molybdenum from the Mo powder generally increased with pH and was influenced by the fluid composition. The mixed iron and molybdenum surface oxide of the FeMo powder acted as a barrier both at acidic and weakly alkaline conditions. These findings underline the importance of the surface oxide characteristics for the bioaccessibility of metal alloys.

  • 12.
    Nordberg, Anna
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology.
    Towards more efficient testing strategies - analyzing the efficiency of toxicity data requirements in relation to the criteria for classification and labelling2008In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 50, no 3, p. 412-419Article in journal (Refereed)
    Abstract [en]

    This contribution is based on the assumption that the aim of toxicity testing as required by chemicals legislation is to identify as many chemicals of concern to human health and the environment as possible, given a limited amount of resources allocated to testing. Based on this assumption we propose a method for the optimization of test systems for industrial chemicals, based on the calculation of efficiency ratios for tests and test systems. The efficiency ratio of a toxicity test depends on the monetary cost of performing the test and the probability that the test will identify a chemical of concern, as estimated by the rules for classification and warning labelling. Efficiency ratios are estimated based on the results of basic standardized toxicity testing for acute toxicity, subacute toxicity, irritation and sensitization of 1409 industrial chemicals notified in the European Union between 1994 and 2004. This careful evaluation of the regulatory consequences of testing indicated that many of these substances are classified based on short-term testing of acute toxicity, irritation and sensitization and that most of the substances classified due to a 28-day study were also classified based on short-term testing. These results indicate that, within the classification and labelling system, it is currently more efficient to perform short-term testing of a larger number of substances rather than to perform subacute toxicity studies on substances already tested for acute toxicity.

  • 13.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Principles and practices of health risk assessment under current EU regulations2006In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 44, no 1, p. 14-23Article in journal (Refereed)
    Abstract [en]

    Risk assessments serve as the foundation of regulatory decision-making on whether to take actions to reduce (or otherwise manage) a toxicological or ecotoxicological risk or not. To understand the complex process that leads from the generation of scientific data, via risk assessment to risk management decision-making, close studies of the scientific basis and risk assessment methods must be undertaken. This paper consists of two main parts. In the first part the principles of the European Union process for risk assessments, as defined by legislations and official guidelines, are briefly outlined. In the second part the actual workings of this system are exemplified by the results from case studies of the risk assessment processes for trichloroethylene and for acrylamide. The analysis and comparison of these two cases illustrates: (1) that generation of a large amount of data does not ensure consensus among risk assessors, (2) that controversy can regard different levels of detail, (3) that controversy can arise at different organizational and theoretical levels, (4) that risk assessments may be subject to (public) criticism even if the experts agree, and (5) that scientific controversies have a significant policy component.

  • 14. Rudén, Christina
    The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments2001In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 34, no 1, p. 3-16Article in journal (Refereed)
    Abstract [en]

    This paper reports the results from a detailed study on how risk assessments of chemicals are actually made. The study is performed by comparing 29 cancer risk assessments made of one and the same chemical substance, namely, trichloroethylene. In this paper, the conclusions that are drawn in these risk assessment documents are described, and differences between the conclusions are explored. This is made within the framework of a proposed cancer risk assessment index. The selection of scientific data for risk assessment purposes is analyzed and the different risk assessors' interpretations and evaluations of individual primary data are compared. It is concluded that the data sets utilized by the trichloroethylene risk assessors are surprisingly incomplete and that biased data selection may have influenced some of the risk assessors' conclusions. Different risk assessors often interpret and evaluate one and the same study in different ways. There are also indications of both interpretation bias and evaluation bias for some of the risk assessors.

  • 15. Rudén, Christina
    The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments - The trichloroethylene example2002In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 35, no 1, p. 80-94Article in journal (Refereed)
    Abstract [en]

    The purpose of this paper is to explore how risk assessors actually use mechanistic data in carcinogen risk assessment and to discuss how the handling of scientific uncertainty may affect the outcome of the risk assessment. The analysis is performed by comparing 29 trichloroethylene risk assessment documents in general and 2 of these, namely the ECETOC (1994, Trichloroethylene: Assessment of Human Carcinogenic Hazard, Technical Report No. 60) and the OECD/EU (1996, Initial Assessment Report for the 4th SIAM (Screening Information Data Set Initial Assessment Meeting), May 1996: Trichloroethylene, sponsor country, United Kingdom [Draft]), in more detail. It is concluded that in this example the ECETOC required less evidence for considering a carcinogenic mechanism irrelevant to humans than did the OECD/EU risk assessors. There are examples of when two risk assessors have selected different primary data for their argumentation and also examples of how one and the same primary publication was interpreted differently. Biased data selection and evaluation of primary data that correlate to the risk assessor's overall conclusions have also been identified. The general comparison of all 29 TCE risk assessment documents indicates that the assessment of scientific uncertainty in the mechanistic data affects the overall conclusions.

  • 16.
    Rudén, Christina
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Improving REACH2006In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 44, no 1, p. 33-42Article in journal (Refereed)
    Abstract [en]

    The European Commission has proposed a new system for chemicals control, the REACH system. The objectives of REACH with respect to risk assessment call be summarized in the form of two overarching goals. First, REACH aims at improved knowledge about the properties and the uses of individual chemical substances. Secondly, REACH is intended to increase the speed and efficiency of the risk assessment process and to make producers and importers of chemicals responsible for this process. The implementation of the REACH proposal will lead to increased availability of toxicological information but not to the extent that would be needed to achieve a Sound scientific basis for risk assessment of individual substances. In this paper, we propose certain amendments of the Current REACH proposal. The Purpose of these proposals is to improve priority-setting and testing strategies and to simplify the risk assessment procedures.

  • 17.
    Schenk, Linda
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Awareness and understanding of occupational exposure limits in Sweden2013In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 65, no 3, p. 304-310Article in journal (Refereed)
    Abstract [en]

    The efficiency of a risk management tool, such as occupational exposure limits (OELs), partly depends on the responsible parties' awareness and understanding of it. The aim of this study was to measure the awareness and understanding of OELs at Swedish workplaces and to collect opinions on their use and function. Through a web-based questionnaire targeting workers that are exposed to air pollutants or chemicals, and persons working with occupational health and safety or in management at workplaces where workers are exposed to air pollutants or chemicals 1017 responses were collected. The results show that awareness and understanding of Swedish OELs is low among workers, as well as managers and occupational health and safety employees. Statistically significant, but small, differences were found depending on the size of the company and the position in the company. Based on the results, it is recommended that authorities and the social partners target this lack of awareness and understanding regarding OELs. Also, other tools to ascertain a safe working environment with regards to chemicals exposure might be useful for Swedish workplaces.

  • 18.
    Schenk, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Gilek, Michael
    Occupational Exposure Limits: A Comparative Study2008In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 50, no 2, p. 261-270Article in journal (Refereed)
    Abstract [en]

    Occupational exposure limits (OELs) are used as an important regulatory instrument to protect workers' health from adverse effects of chemical exposures. The OELs mirror the outcome of the risk assessment and risk management performed by the standard setting actor. In this study we compared the OELs established by 18 different organisations or national regulatory agencies. The OELs were compared with respect to: (1) what chemicals have been selected and (2) the average level of exposure limits for all chemicals. Our database contains OELs for a total of 1341 substances; of these 25 substances have OELs from all 18 organisations while more than one-third of the substances are only regulated by one organisation. The average level of the exposure limits has declined during the past 10 years for 6 of the 8 organisations in our study for which historical data were available; it has increased for Poland and remained nearly unchanged for Sweden. The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland. The scientific or policy-related motivations for these differences remain to be analysed.

  • 19.
    Westerholm, Emma
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Schenk, Linda
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Comparative analysis of toxicological evaluations for dermal exposure performed under two different EU regulatory frameworks2014In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 68, no 1, p. 51-58Article in journal (Refereed)
    Abstract [en]

    Dermal exposure to chemicals is highly relevant in relation to the use of cosmetic products, both in consumers and in individuals exposed occupationally. Regulatory frameworks exist within the EU to limit the dermal exposure of the general population and workers to chemicals in general, as well as to limit the use of certain substances in cosmetic products. The objective of the study was to investigate and compare toxicological evaluations of dermal exposure performed under current regulatory frameworks. The publicly disseminated hazard information under the respective regulatory frameworks was compiled and compared for the five substances resorcinol, p-phenylenediamine, p-aminophenol, N-phenyl-p-phenylenediamine, and diethylene glycol monoethyl ether. A low consistency between evaluations was observed in respect to data coverage and cited dose descriptors. No systematic differences over all five substances were identified from the viewpoint of dermal hazard assessment. The critical effect and corresponding systemic effect dose descriptor was identical for two substances, differed somewhat for two other (a factor of 2-2.5). For N-phenyl-p-phenylenediamine a critical effect was only identified under REACH.

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  • rtf