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  • 1.
    Agerstrand, Marlene
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Kuester, A.
    Bachmann, J.
    Breitholtz, M.
    Ebert, I.
    Rechenberg, B.
    Ruden, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals2011Ingår i: Environmental Pollution, ISSN 0269-7491, E-ISSN 1873-6424, Vol. 159, nr 10, s. 2487-2492Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Ecotoxicity data with high reliability and relevance are needed to guarantee the scientific quality of environmental risk assessments of pharmaceuticals. The main advantages of a more structured approach to data evaluation include increased transparency and predictability of the risk assessment process, and the possibility to use non-standard data. In this collaboration, between the research project MistraPharma and the German Federal Environment Agency, a new set of reporting and evaluation criteria is presented and discussed. The new criteria are based on the approaches in the literature and the OECD reporting requirements, and have been further developed to include both reliability and relevance of test data. Intended users are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers. This approach intends to bridge the gap between the regulator and the scientist's needs and way of work.

  • 2.
    Bergman, Åke
    et al.
    Stockholms universitet.
    Hansson, Sven Ove
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Jakobsson,, Kristina
    Universitetssjukhuset Lund.
    Källén, Erland
    Stockholms universitet.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Giftfritt – en nyttig utopi2009Ingår i: Chemicalnet.seArtikel i tidskrift (Övrigt vetenskapligt)
  • 3. Beronius, A.
    et al.
    Hanberg, A.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Background paper on the risk assessment of Bisphenol A: Overview of previous risk assessments2010Ingår i: The joint FAO/WHO expert meeting to review toxicological and health aspects of bisphenol A, 2010Konferensbidrag (Övrigt vetenskapligt)
  • 4. Beronius, A.
    et al.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Hanberg, A.
    Improving the transparency of data evaluation in risk assessment of endocrine disrupting compounds-Implications from the bisphenol A case study2011Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 205, s. S256-S256Artikel i tidskrift (Övrigt vetenskapligt)
    Abstract [en]

    The complex biology and toxicology of endocrine disrupting compounds (EDCs) makes toxicity testing as well as evaluation of data for risk assessment difficult. Standardized test guidelines have previously been questioned as to their applicability for evaluating EDC toxicity. However, several guidelines have been updated and enhanced in an effort to better cover EDCs. Also, EDC toxicity is a very active research field and a lot of toxicological data are generated in research studies NOT conducted according to standardized guidelines. Our previous work indicates that differences in how the reliability and relevance of toxicity studies are judged may vary greatly between risk assessments of the same compound and may result in different conclusions about the size and nature of health risks. Further, the process of data evaluation is in many cases in-transparent. The purpose of this on-going study is to contribute to making health risk assessments of EDCs more transparent, systematic, and predictable. The investigation is conducted as a literature study using the EDC bisphenol A (BPA) for a case study. We scrutinize and compare the strengths and weaknesses of both guideline and non-guideline studies evaluating developmental neurotoxicity of BPA. One goal is to further assess the applicability of standardized guidelines in this case. Another aim is to propose improvements in the process of data reporting of non-guideline studies and recommend criteria for the evaluation of data in order to facilitate risk assessment of EDCs.

  • 5. Beronius, A.
    et al.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Hanberg, A.
    Garai, J.
    Håkansson, H.
    Assessing the risks of endocrine disrupting chemicals2009Ingår i: Endocrine disrupting chemicals in food / [ed] Ian Shaw, Woodhead Publishing Limited, 2009, s. 356-380Kapitel i bok, del av antologi (Övrigt vetenskapligt)
    Abstract [en]

    In this chapter, four European regulatory frameworks are compared concerning how they cope with identifying and risk assessing endocrine-disrupting chemicals. This comparison is performed by using four example chemicals, bisphenol A, dioxins, ethinyl estradiol and vinclozolin, representing four different regulatory categories. It is concluded that within these regulations, there are no general test requirements that specifically enable identification of endocrine disruptors, and there seem to be little conformity in the risk assessment processes even though the route of exposure and the mode of toxicity are similar. Further development of risk assessment guidance for endocrine disruptors requires continued cooperation between experimental scientists, risk assessors, regulators and industry.

  • 6. Beronius, Anna
    et al.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Hanberg, Annika
    Håkansson, Helen
    Health risk assessment procedures for endocrine disrupting compounds within different regulatory frameworks in the European Union2009Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, nr 2, s. 111-122Artikel i tidskrift (Refereegranskat)
    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.

  • 7. Beronius, Anna
    et al.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Håkansson, Helen
    Hanberg, Annika
    Risk to all or none? A comparative analysis of controversies in the health risk assessment of Bisphenol A2010Ingår i: Reproductive Toxicology, ISSN 0890-6238, E-ISSN 1873-1708, Vol. 29, nr 2, s. 132-146Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Bisphenol A (BPA) is an endocrine disruptor for which health risk assessment has proven controversial. Conclusions regarding health risks of BPA vary between assessments from "there is no risk to any part of the population" to "there is risk to the entire population". We have carried out a literature study investigating what might be the scientific and/or policy-related reasons for these differences. Ten risk assessments for BPA were scrutinized and several factors were compared between assessments, including estimations of exposure levels, identification of critical study and NOAEL, assessment factors and significance attributed to reports of low-dose effects. Differences in conclusions were mainly influenced by the evaluation of low-dose effects and the uncertainties surrounding the significance of these data for health risk assessment. The results illustrate the impact of differences in risk assessment policy and expert judgment on the risk assessment process and highlight the importance of transparency in this process.

  • 8.
    Beronius, Anna
    et al.
    Karolinska Inst, Stockholm, Sweden.
    Willighagen, Egon
    Maastricht Univ, Maastricht, Netherlands .
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Hanberg, Annika
    Karolinska Inst, Stockholm, Sweden.
    Factors influencing developmental neurotoxicity study outcome in the bisphenol A case2012Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, s. S128-S129Artikel i tidskrift (Övrigt vetenskapligt)
  • 9. Breitholtz, M.
    et al.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Hansson, Sven Ove
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Bengtsson, B. E.
    Ten challenges for improved ecotoxicological testing in environmental risk assessment2006Ingår i: Ecotoxicology and Environmental Safety, ISSN 0147-6513, E-ISSN 1090-2414, Vol. 63, nr 2, s. 324-335Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    New regulations, in particular the new European chemicals legislation (REACH), will increase the demands on environmental risk assessment (ERA). The requirements on efficient ecotoxicological testing systems are summarized, and 10 major issues for the improvement of ERA practices are discussed, namely: (1) the choice of representative test species, (2) the development of test systems that are relevant for ecosystems in different parts of the world, (3) the inclusion of sensitive life stages in test systems, (4) the inclusion of endpoints on genetic variation in populations, (5) using mechanistic understanding of toxic effects to develop more informative and efficient test systems, (6) studying disruption in invertebrate endocrine mechanisms, that may differ radically from those we know from vertebrates, (7) developing standardized methodologies for testing of poorly water-soluble substances, (8) taking ethical considerations into account, in particular by reducing the use of vertebrates in ecotoxico logical tests, (9) using a systematic (statistical) approach in combination with mechanistic knowledge to combine tests efficiently into testing systems, and (10) developing ERA so that it provides the information needed for precautionary decision-making.

  • 10. Breitholtz, Magnus
    et al.
    Eriksson, Johan
    Green, Nicholas
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Testing and risk assessment of persistent and bioaccumulating chemical substances - Improvements within REACH?2006Ingår i: Human and Ecological Risk Assessment, ISSN 1080-7039, E-ISSN 1549-7860, Vol. 12, nr 4, s. 782-805Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    In the proposed new European chemicals regulations - the REACH system - the improved control of persistent and bioaccumulating substances is stated as one of the tasks being of particular importance. In this article, the reliability and validity of the scientific basis for identification of persistent ( P), bioaccumulating ( B), and toxic ( T) substances, and for assessing the risks that these substances may pose, are discussed. We have used the European Union risk assessment of pentabromodiphenyl ether, PentaBDE ( CAS 32534-81-9) as a study case in the analysis. It is concluded that for PBT substances there is room for development both with regard to test methodology and with regard to risk assessment procedures.

  • 11.
    Ding, Qian
    et al.
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Malkiewicz, Katarzyna
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Hansson, Sven Ove
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Are the new Chinese chemicals regulations catching up with REACH?2012Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169Artikel i tidskrift (Övrigt vetenskapligt)
  • 12. Eriksson, J.
    et al.
    Gilek, M.Rudén, ChristinaKTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Regulating Chemical Risks: European and Global Challenges2010Samlingsverk (redaktörskap) (Refereegranskat)
    Abstract [en]

    This important contribution to the scientific understanding of chemical risk regulation offers a coherent, comprehensive and updated multidisciplinary analysis, written by leading experts in toxicology, ecotoxicology, risk analysis, media and communication, law, and political science. The text focuses in particular on the new European REACH regime and its nature, causes and consequences. It examines the regime in the context of the interplay between science and policy, the role of the media, human health, and the environment. Other regulatory systems at both domestic and international levels are also studied, including the UNs Globally Harmonised System (GHS) for chemical labelling, as well as developments in the U.S. In addition, readers will find analyses of a number of new and still largely uncharted regulatory systems, along with in-depth assessments of their complexity and transnational nature.

  • 13.
    Gilek, Michael
    et al.
    Sodertorn Univ, SE-14189 Huddinge, Sweden..
    Eriksson, Johan
    Sodertorn Univ, SE-14189 Huddinge, Sweden..
    Rudén, Christina
    KTH.
    Introduction2010Ingår i: Regulating Chemical Risks: European and Global Challenges Introduction, SPRINGER , 2010, s. 1-5Kapitel i bok, del av antologi (Refereegranskat)
  • 14.
    Hansson, Sven Ove
    et al.
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Malkiewicz, Katarzyna
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och historia.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och historia.
    Assessment factors for extrapolation from short-time to chronic exposure-Are the REACH guidelines adequate2009Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 189, s. S243-S243Artikel i tidskrift (Övrigt vetenskapligt)
  • 15.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Molander, Linda
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    The substitution principle2011Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 59, nr 3, s. 454-460Artikel i tidskrift (Refereegranskat)
    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.

  • 16.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    A Risk-Neutral Default for Chemical Risk Management2008Ingår i: American Journal of Industrial Medicine, ISSN 0271-3586, E-ISSN 1097-0274, Vol. 51, nr 12, s. 964-967Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    In many risk management decisions concerning industrial chemicals, including decisions on classification and labeling, lack of toxicity data is interpreted as (or has the same implications as) absence of toxicity In other words, if the toxicity of a chemical is unknown, it is treated as having no or low toxicit) This practice is difficult to defend from a decision-theoretical point of view. We apply standard decision theory to toxicity data and investigate an alternative approach in which substances with unknown properties are treated as if they had the average toxicity among tested substances in the group to which they belong. An index of acute toxicity is proposed and then used to define a risk-neutral hazard default that can be applied to industrial chemicals for which no specific information on acute toxicity is available. It is proposed that such a risk-neutral approach is preferable to the current practice of treating substances with unknown acute toxicity in the same manner as substances that can reasonably be assumed to have no such harmful properties. The risk-neutral approach could be generalized to other toxicological endpoints. Am. J. Ind. Med. 51:964-967, 2008.

  • 17.
    Hansson, Sven Ove
    et al.
    KTH, Tidigare Institutioner, Infrastruktur.
    Rudén, Christina
    KTH, Tidigare Institutioner, Infrastruktur.
    A science-based strategy for chemicals control2004Ingår i: Industry and Environment, ISSN 0378-9993, Vol. 27, nr 2-3, s. 12-18Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    A number of suggestions are made in this article for amending the data requirements of the proposed European chemicals control system, REACH. These data requirements are shown to be insufficient for applying current criteria to classify substances according to their adverse effects. Use of production volume as a priority-setting criterion for data acquisition is questioned. Three alternative priority-setting mechanisms are proposed: chemical properties of the substance; results from lower tier testing; and incentives for voluntary testing. A new classification category ("insufficiently investigated") is also proposed. Substances in this category would be identified with a warning label.

  • 18.
    Hansson, Sven Ove
    et al.
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Rudén, ChristinaKTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    BETTER CHEMICALS CONTROL WITHIN REACH2004Samlingsverk (redaktörskap) (Refereegranskat)
  • 19.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Evaluating the risk decision process2006Ingår i: Toxicology, ISSN 0300-483X, E-ISSN 1879-3185, Vol. 218, nr 03-feb, s. 100-111Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    In order to ensure that risk assessment and risk management serve their purposes efficiently, it is essential to systematically evaluate actual practices. In this overview, it is proposed that such evaluation studies constitute an important field Of Study that should be recognized as a Subdiscipline of regulatory toxicology with its own research issues and its own methodologies. Previous Such evaluation studies are summarized. Methods are described that can be used for comparing different risk assessments of one of the same substance, for checking the consistency of harmonized classifications with the available data, for assessing the actual margin of safety (i.e. size Of Uncertainty factors) in exposure limits, and for comparing different lists of exposure limits. In conclusion, some important problem areas for future evaluation studies are pointed out.

  • 20.
    Hansson, Sven Ove
    et al.
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Rudén, Christina
    Improving the incentives for toxicity testing2003Ingår i: Journal of Risk Research, ISSN 1366-9877, E-ISSN 1466-4461, Vol. 6, nr 1, s. 3-21Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The legal systems for the classification and labelling of chemical substances have an incentives structure that discourages rather than encourages companies to test their products. This is shown in a logical analysis of the European classification system and also in an analysis of recent changes in the classification of individual substances. Finally two methods to improve the incentives structure are proposed and discussed: the introduction of negative clauses that allow new information to lead to less strict classifications, and a new danger-class and a symbol (a question mark) that indicates serious lack of data.

  • 21.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Improving the Scientific Basis for Decisions in the REACH System2005Ingår i: European Proposal for Chemicals Regulation: REACH and Beyond, Les Actes IDDRI no 2, Paris 2005 / [ed] Claire Weill, 2005Konferensbidrag (Refereegranskat)
  • 22.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Priority-Setting in the REACH System2006Ingår i: Toxicological Sciences, ISSN 1096-6080, E-ISSN 1096-0929, Vol. 90, nr 2, s. 304-308Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Due to the large number of chemicals for which toxicological and ecotoxicological information is lacking, priority setting for data acquisition is a major concern in chemicals regulation. In the current European system, two administrative priority-setting criteria are used, namely novelty (i.e., time of market introduction) and production volume. In the proposed Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system, the novelty criterion is no longer used, and production volume will be the main priority-setting criterion for testing requirements, supplemented in some cases with hazard indications obtained from QSAR modelling. This system for priority setting has severe weaknesses. In this paper we propose that a multicriteria system should be developed that includes at least three additional criteria: chemical properties, results from initial testing in a tiered system, and voluntary testing for which efficient incentives can be created. Toxicological and decision-theoretical research is needed to design testing systems with validated priority-setting mechanisms.

  • 23.
    Hansson, Sven Ove
    et al.
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    Filosofi och historia, KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    REACH: What has been achieved and what needs to be done?2010Ingår i: Regulating Chemical Risks: European and Global Challenges / [ed] Johan Eriksson, Michael Gilek, and Christina Rudén, Springer, 2010, s. 71-83Kapitel i bok, del av antologi (Refereegranskat)
  • 24.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, ChristinaKTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Science for a safe chemical environment2005Samlingsverk (redaktörskap) (Refereegranskat)
  • 25.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    The substitution Principle2007Rapport (Övrigt vetenskapligt)
  • 26.
    Hansson, Sven Ove
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Towards, a theory of tiered testing2007Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 48, nr 1, s. 35-44Artikel i tidskrift (Refereegranskat)
    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.

  • 27.
    Ingre-Khans, E
    et al.
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Rudén, Christina
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Breitholtz, M
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Chemical risks and consumer products: The toxicity of shoe soles2010Ingår i: Ecotoxicology and Environmental Safety, ISSN 0147-6513, E-ISSN 1090-2414, Vol. 73, nr 7, s. 1633-1640Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The European chemicals legislation, REACH, aims to ensure a high level of protection of human health and the environment. However, chemicals included in consumer products are covered only to a very limited extent even though they constitute the main source of chemical emissions. Shoes are large volume products and the overall aim of the present study was to study the ecotoxicological effects of three types of shoe soles and relate these effects to chemical emissions to the aquatic environment. The shoe soles were abraded and leached in water for 29 days and the alga Ceramium tenuicorne and the crustacean Nitocra spinipes were exposed to different concentrations of the leachate. Chemical analyses were performed to determine the chemical contents of the leachate. The main conclusions are that the shoe soles contain substances that are toxic to both test organisms, and that the toxicity is mainly explained by the presence of zinc. The estimated concentration of zinc from shoe soles in storm water runoff is low, but it still contributes to the overall load of chemicals and metals in the environment. The outlined test procedures may, in our view, provide a useful screening tool for assessing the risk that chemicals in consumer articles pose to the environment.

  • 28.
    Levin, Rikard
    et al.
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Hansson, Sven Ove
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Rudén, Christina
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Indicators of uncertainty in chemical risk assessments2004Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 39, nr 1, s. 33-43Artikel i tidskrift (Refereegranskat)
    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.

  • 29. Lindblom, L
    et al.
    Clausen, J
    Edvardsson Björnberg, Karin
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Hayenhielm, M
    Fröding, Barbro
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Nihlén Fahlquist, Jessica
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Palm, Elin
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Rudén, Christina
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    Wikman, P
    Hansson, Sven Ove
    KTH, Tidigare Institutioner, Teknik- och vetenskapshistoria.
    How Agencies inspect: A comparative study of inspection policies in eight Swedish government agencies2003Rapport (Övrigt vetenskapligt)
  • 30.
    Malkiewicz, Katarzyna
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Andersson, Patrik
    Nordberg, Anna
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Bergman, Åke
    Hansson, Sven Ove
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Human experts' judgment of chemicals reactivity for identification of hazardous chemicals2009Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 189, s. S243-S243Artikel i tidskrift (Refereegranskat)
  • 31.
    Malkiewicz, Katarzyna
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Hansson, Sven Ove
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Assessment factors for extrapolation from short-time to chronic exposure-Are the REACH guidelines adequate?2009Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 190, nr 1, s. 16-22Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Due to the relative scarcity of long-term toxicity data, assessment factors for extrapolation from relatively short to chronic exposures have an important role in the risk assessment of chemicals. A recent REACH guidance document includes recommended default assessment factors that cover subacute-subchronic, subchronic-chronic, and subacute-chronic extrapolations. The recommended assessment factors are smaller than in most previous proposals, since they are calibrated to achieve central estimates (50th percentile of the target distribution) rather than a higher percentile such as the 95th, as has been more common. These assessment factors are nevertheless presented as representing a "widely agreed level of conservatism", a statement that may lead to misunderstandings of what is achieved by using them in a risk assessment. Assessment factors have been based on evidence from animal studies with different designs, in particular with focus on different endpoints. Our re-analysis of experimental data shows that using mortality as an endpoint leads to smaller assessment factors than if the factors are derived from corresponding ratios for non-lethal toxicity.

  • 32.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Beronius, Anna
    Karolinska Inst, Stockholm, Sweden.
    Hanberg, Annika
    Karolinska Inst, Stockholm, Sweden.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Endpoints and dose-response relationships of low-dose studies of Bisphenol A2012Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, s. S130-S130Artikel i tidskrift (Övrigt vetenskapligt)
  • 33.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Breitholtz, M.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Missing links in the regulatory chain controlling life cycle emissions of hazardous chemicals from articles2011Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 205, s. S243-S243Artikel i tidskrift (Övrigt vetenskapligt)
    Abstract [en]

    It is widely acknowledged that the management of risks associated with chemicals in articles, including consumer products, needs to be improved.

    The purpose of the present study is to empirically analyze to what extent European legislations that control emissions of hazardous chemicals from articles during different life cycle phases are coherent or not. To illustrate this, the regulation of a number of case-study chemicals, used in various consumer products and in high volumes, is scrutinized. This analysis identifies missing regulatory links between the rules that are relevant for the use phase and the rules applicable to the waste phase. With the exception of the RoHS directive, a clear connection to the rules for waste is missing in the regulatory system. Clear links are also missing between the rules regulating chemical emissions during the articles’ life cycle and maximum environmental concentration limits set for sludge, soil and surface water. The Waste Directive, the WEEE Directive, and the Water Framework Directive refer to EU environmental and waste policies. These policies state that environmental damage should be rectified at source. The lack of connection between the rules regulating different phases of an article's life cycle makes these objectives difficult to fulfill. These legislative gaps will encourage end-of-pipe solutions, rather than actions to manage the source of the problem. We argue that it is necessary to minimize the input of hazardous chemicals into articles, so that waste and other end-products can be recovered and used without harming human health or the environment.

  • 34.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Breitholtz, Magnus
    Stockholm University.
    Andersson, Patrik L.
    Umeå University.
    Rybacka, Aleksandra
    Umeå University.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Are chemicals in articles an obstacle for reaching environmental goals? - Missing links in EU chemical management2012Ingår i: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 435, s. 280-289Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    It is widely acknowledged that the management of risks associated with chemicals in articles needs to be improved. The EU environmental policy states that environmental damage should be rectified at source. It is therefore motivated that the risk management of substances in articles also takes particular consideration to those substances identified as posing a risk in different environmental compartments. The primary aim of the present study was to empirically analyze to what extent the regulation of chemicals in articles under REACH is coherent with the rules concerning chemicals in the Sewage Sludge Directive (SSD) and the Water Framework Directive (WFD). We also analyzed the chemical variation of the organic substances regulated under these legislations in relation to the most heavily used chemicals. The results show that 16 of 24 substances used in or potentially present in articles and regulated by the SSD or the WFD are also identified under REACH either as a substance of very high concern (SVHC) or subject to some restrictions. However, for these substances we conclude that there is limited coherence between the legislations, since the identification as an SVHC does not in itself encompass any use restrictions, and the restrictions in REACH are in many cases limited to a particular use, and thus all other uses are allowed. Only a minor part of chemicals in commerce is regulated and these show a chemical variation that deviates from classical legacy pollutants. This warrants new tools to identify potentially hazardous chemicals in articles. We also noted that chemicals monitored in the environment under the WFD deviate in their chemistry from the ones regulated by REACH. In summary, we argue that to obtain improved resource efficiency and a sustainable development it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles.

  • 35.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Narrow-and-sharp or broad-and-blunt - Regulations of hazardous chemicals in consumer products in the European Union2012Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 62, nr 3, s. 523-531Artikel i tidskrift (Refereegranskat)
    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.

  • 36.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Ågerstrand, Marlene
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    WikiPharma: A database with environmental effect data for pharmaceuticals2010Ingår i: Towards sustainable pharmaceuticals in a healthy society, Stockholm: MistraPharma , 2010, s. 98-147Kapitel i bok, del av antologi (Övrigt vetenskapligt)
  • 37.
    Molander, Linda
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Ågerstrand, Marlene
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals2009Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, nr 3, s. 367-371Artikel i tidskrift (Refereegranskat)
    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.

  • 38.
    Nordberg, Anna
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    The usefulness of the bioconcentration factor as a tool for priority setting in chemicals control2007Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, nr 168, s. 113-120Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The implementation of the REACH system will lead to the creation of a single, uniform legislation for industrial chemicals in Europe. An important aim of this legislation is to generate toxicity data for previously untested chemicals. Testing tens of thousands of chemicals can however not be done in one step, and criteria for priority setting is therefore an essential part of the proposed REACH system. In this study we investigate potential consequences of using bioaccumulation (B) data as a tool for priority setting in chemicals control. The results of this investigation suggests that the use of data for the bioconcentration factor (BCF, as an estimation of B) at first tier will not introduce bias towards a particular type of toxicity (i.e. carcinogenicity, reproductive toxicity or mutagenicity) in the priority setting process.

  • 39.
    Nordberg, Anna
    et al.
    KTH.
    Rudén, Christina
    KTH.
    Towards developing efficient testing strategies - Analyzing the decision relevance of different toxicity tests2006Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 164, s. S78-S79Artikel i tidskrift (Övrigt vetenskapligt)
  • 40.
    Nordberg, Anna
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Hansson, Sven Ove
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Towards more efficient testing strategies - analyzing the efficiency of toxicity data requirements in relation to the criteria for classification and labelling2008Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 50, nr 3, s. 412-419Artikel i tidskrift (Refereegranskat)
    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.

  • 41.
    Roos, Vendela
    et al.
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Gunnarsson, L.
    Fick, J.
    Larsson, D. G. J.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Prioritising pharmaceuticals for environmental risk assessment: Towards adequate and feasible first-tier selection2012Ingår i: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 421, s. 102-110Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The presence of pharmaceuticals in the aquatic environment, and the concerns for negative effects on aquatic organisms, has gained increasing attention over the last years. As ecotoxicity data are lacking for most active pharmaceutical ingredients (APIs), it is important to identify strategies to prioritise APIs for ecotoxicity testing and environmental monitoring. We have used nine previously proposed prioritisation schemes, both risk- and hazard-based, to rank 582 APIs. The similarities and differences in overall ranking results and input data were compared. Moreover, we analysed how well the methods ranked seven relatively well-studied APIs. It is concluded that the hazard-based methods were more successful in correctly ranking the well-studied APIs, but the fish plasma model, which includes human pharmacological data, also showed a high success rate. The results of the analyses show that the input data availability vary significantly: some data, such as logP, are available for most API while information about environmental concentrations and bioconcentration are still scarce. The results also suggest that the exposure estimates in risk-based methods need to be improved and that the inclusion of effect measures at first-tier prioritisation might underestimate risks. It is proposed that in order to develop an adequate prioritisation scheme, improved data on exposure such as degradation and sewage treatment removal and bioconcentration ability should be further considered. The use of ATC codes may also be useful for the development of a prioritisation scheme that includes the mode of action of pharmaceuticals and, to some extent, mixture effects.

  • 42.
    Rudén, Christina
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Acrylamide and cancer risk - expert risk assessments and the public debate2004Ingår i: Food and Chemical Toxicology, ISSN 0278-6915, E-ISSN 1873-6351, Vol. 42, nr 3, s. 335-349Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    This study has two parts. In the first part, fourteen carcinogen risk assessments of acrylamide made by different expert groups during the years 1976-2002 are compared in terms of their overall conclusions and their use of primary data. In the second part, the public debate on acrylamide and cancer risks and the questioning of the expert risk assessment, that arose as a reaction to the identification of this substance in staple food is discussed. In the first part it is shown that the expert risk assessors concur to a large degree about the assessment of the acrylamide potential to cause cancer. Three risk assessors have concluded that acrylamide is neither carcinogenic to humans nor to animals, while eleven risk assessors have concluded that acrylamide is carcinogenic in animals and is likely to be carcinogenic in humans. The differences in the overall conclusions seem to a large extent be explained by an evolving database. The risk assessors agree considerably on how to interpret and evaluate the available primary data, but the coverage of the available references is low. These results are also compared to those previously published on risk assessments of trichloroethylene. In the second part the arguments used in the public debate to question the expert risk assessment are summarized and it is argued that they are not based on the principles generally accepted in toxicological risk assessment.

  • 43.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    Evaluation of carcinogen risk assessments and the role of evidence-based toxicology in chemicals control2008Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 180, s. S17-S17Artikel i tidskrift (Refereegranskat)
  • 44. Rudén, Christina
    Interpretations of primary carcinogenicity data in 29 trichloroethylene risk assessments2001Ingår i: Toxicology, ISSN 0300-483X, E-ISSN 1879-3185, Vol. 169, nr 3, s. 209-225Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    This paper explores to what extent interpretations of individual primary carcinogenicity data differ between different risk assessors, and discusses possible reasons for such differences as well as their impact on the overall risk assessment conclusions. For this purpose 29 different TCE carcinogenicity risk assessments are used as examples. It is concluded that the TCE risk assessors surprisingly often interpret and evaluate primary data differently. Two particular reasons for differences in data interpretation are discussed: different assessments of statistics, and different assessments of whether the results obtained in bioassays have toxicological relevance. Differences in the interpretation and evaluation of epidemiological data are also explored and discussed.

  • 45.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Principles and practices of health risk assessment under current EU regulations2006Ingår i: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 44, nr 1, s. 14-23Artikel i tidskrift (Refereegranskat)
    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.

  • 46.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    Re: Am J Ind Med 44 : 204-213, 2003. Response to the letter to the editor from Vickie L. Wells (ACGIH)2005Ingår i: American Journal of Industrial Medicine, ISSN 0271-3586, E-ISSN 1097-0274, Vol. 47, nr 5, s. 464-466Artikel i tidskrift (Refereegranskat)
  • 47.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi.
    REACH is but the first step-on the need to improve testing and risk assessment for industrial chemicals2009Ingår i: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 189, s. S249-S249Artikel i tidskrift (Refereegranskat)
  • 48.
    Rudén, Christina
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria.
    Science and policy in risk assessments of chlorinated ethenes2006Ingår i: Living In A Chemical World: Framing The Future In Light Of The Past / [ed] Mehlman, MA; Soffritti, M; Landrigan, P; Bingham, E; Belpoggi, F, 2006, Vol. 1076, s. 191-206Konferensbidrag (Refereegranskat)
    Abstract [en]

    In this article the use of data obtained from standardized experimental methods, for example, as specified in OECD guidelines for the testing of chemicals, epidemiology data, and mechanism data obtained from nonstandardized experimental methods in carcinogen risk assessment is scrutinized using the most recent risk assessments made by International Agency for Research on Cancer (IARC), the MAK(MAK)Kommission, World Health Organization (WHO), European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), and American Conference of Governmental Industrial Hygienists (ACGIH) for the four chlorinated ethenes as examples. The analysis shows that there was little controversy among these risk assessors about the interpretation of standardized animal data. On the other hand, they differ in their interpretation of epidemiology data, in particular in their assessment of statistical significance including the use of meta-analyses, and in quality evaluation of studies initiated on the basis of a priori concerns for carcinogenicity. The selection of mechanism data for species extrapolation is diverse among these risk assessors. Furthermore, in some cases they refrain from transparently motivating significant claims about mechanisms of toxicity by avoiding to give (explicit) references to the sources of information forming the basis of these claims or conclusions. This practice is not according to the scientific standards that should be required of a risk assessment document, and it makes it difficult to follow the argumentation and consequently to scrutinize the scientific accuracy of the conclusions drawn. In this article it is concluded that in some of these risk assessment documents, the use of mechanism data is not according to the scientific standards that should be required. It is furthermore concluded that if the use of mechanism data in these documents are representative of risk assessments in general, then there is an urgent need for further development and implementation of quality criteria for the use of mechanism data in species extrapolation.

  • 49.
    Rudén, Christina
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Science and transscience in carcinogen risk assessment - The European Union regulatory process for trichloroethylene2003Ingår i: Journal of toxicology and environmental health. Part B, Critical reviews, ISSN 1093-7404, E-ISSN 1521-6950, Vol. 6, nr 3, s. 257-277Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    This is a study of carcinogen risk assessment of the chlorinated solvent trichloroethylene within the European Union existing substances program and the classification and labeling process. The focus is on the most active and influential participants of this process, namely, those from the United Kingdom, Germany, and Sweden, and from industry. The member state and other experts have different opinions regarding the appropriate classification of trichloroethylene for mutagenicity (no classification or category 3) and carcinogenicity (category 3, 2, or 1). In this article these differences are described, as well as how the primary carcinogenicity and mutagenicity data have been interpreted and evaluated by these participants. It is concluded that underlying the different assessments are disagreements about issues that to some degree lie outside the scope of purely scientific considerations.

  • 50.
    Rudén, Christina
    KTH, Tidigare Institutioner                               , Teknik- och vetenskapshistoria.
    Scrutinizing ACGIH risk assessments: The trichloroethylene case2003Ingår i: American Journal of Industrial Medicine, ISSN 0271-3586, E-ISSN 1097-0274, Vol. 44, nr 2, s. 207-213Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background The American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit values (TLVs)for occupational exposure to chemicals and physical agents have been very influential in the setting of occupational exposure limits in many countries. Methods Three ACGIH risk assessments of the chlorinated solvent trichloroethylene (TCE) [ACGIH (1989): 5th edition; ACGIH (1992): 5th edition. Revised Vol II; ACGIH (1996): Suppl. 6th edition] are compared to 26 other risk assessments made of the same chemical substance. The documents are compared in terms of their overall conclusions and the data selected for assessment. Results It is shown that these ACGIH risk assessment documents were based on incomplete and biased data sets. Conclusions The data on which the ACGIH [ACGIH (1996): Suppl. 6th edition] base their TCE risk assessment do not adequately reflect the available scientific knowledge about TCE toxicity and carcinogenicity. This may have influenced their conclusion that TCE is not carcinogenic in either animals or humans which stand out compared to contemporary risk assessments.

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