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全文: "Directive 67/548/EEC"
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  • A. BERLIN, E. BENNETT, M. Th. VAN DER VENNE
    The Journal of Toxicological Sciences
    1987年 12 巻 2 号 195-204
    発行日: 1987/05/25
    公開日: 2008/02/21
    ジャーナル フリー
  • Goh Choo Ta, Hiroshi Jonai, Mazlin Bin Mokhtar, Peter John Peterson
    Journal of Occupational Health
    2009年 51 巻 6 号 526-530
    発行日: 2009年
    公開日: 2009/12/18
    [早期公開] 公開日: 2009/10/16
    ジャーナル フリー
  • 城内 博, ククエコ マリア テレシータ, タ ゴー チヨウ
    労働科学
    2014年 90 巻 6 号 209-220
    発行日: 2014年
    公開日: 2016/07/25
    ジャーナル フリー
    化学品の分類および表示に関する世界調和システム(GHS)が2003年に国連勧告として発行された。その後多くの国々がこれの実施に取り組んでいるが,その時期や適用範囲は国によって異なる。フィリピン,マレーシアおよび日本での労働分野におけるGHSの実施状況を欧州連合および米国と比較した。調査,分析した内容は,所管官庁,適用法令,導入時期,罰則,分類対象化学品,適用除外項目などである。GHSの実施方法は国によって異なり,既存の法令に大きく左右されることが明らかになった。GHSは強制力を持たない勧告であり,適用にも柔軟性が認められていることがその理由として挙げられる。本調査結果は今後GHSを実施する国々に有益な情報になると考える。(図1,表1)
  • Goh Choo TA, Mazlin Bin MOKHTAR, Peter John PETERSON, Nadzri Bin YAHAYA
    Industrial Health
    2011年 49 巻 6 号 765-773
    発行日: 2011年
    公開日: 2011/12/16
    [早期公開] 公開日: 2011/10/20
    ジャーナル フリー
    The European Union (EU) and the World Health Organization (WHO) have applied different approaches to facilitate the implementation of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The EU applied the mandatory approach by gazetting the EU Regulation 1272/2008 incorporating GHS elements on classification, labelling and packaging of substances and mixtures in 2008; whereas the WHO utilized a voluntary approach by incorporating GHS elements in the WHO guidelines entitled ‘WHO Recommended Classification of Pesticides by Hazard’ in 2009. We report on an analysis of both the mandatory and voluntary approaches practised by the EU and the WHO respectively, with close reference to the GHS ‘purple book’. Our findings indicate that the mandatory approach practiced by the EU covers all the GHS elements referred to in the second revised edition of the GHS ‘purple book’. Hence we can conclude that the EU has implemented the GHS particularly for industrial chemicals. On the other hand, the WHO guidelines published in 2009 should be revised to address concerns raised in this paper. In addition, both mandatory and voluntary approaches should be carefully examined because the classification results may be different.
  • Stanislaw TARKOWSKI
    The Journal of Toxicological Sciences
    1987年 12 巻 2 号 185-194
    発行日: 1987/05/25
    公開日: 2008/02/21
    ジャーナル フリー
  • Noriyuki Morikawa, Katsuyasu Morota, Masakazu Suzuki, Hajime Kojima, Satoru Nakata, Hiroaki Konishi
    Alternatives to Animal Testing and Experimentation
    2005年 11 巻 1 号 68-78
    発行日: 2005/07/31
    公開日: 2012/02/29
    ジャーナル フリー
    During the last decade, ECVAM has supported formal validation studies on in vitro tests for predicting skin corrosivity, which included two of the in vitro tests employed human skin models, EPISKINTM and EpiDermTM. When skin models are used to evaluate skin irritancy and corrosivity, it is important that suitable chemical application procedures are utilized. We used several chemicals and evaluated their skin corrosivity using in vitro tests, evaluations using ECVAM experimental protocols and post-incubation methods that we have originally developed to predict skin irritancy, and compared the results. Vitrolife-Skin showed basic utility for corrosivity testing by both methods and it is possible to confidently predict skin corrosivity, provided that the appropriate chemical application procedures are used. In the future, human skin models will become very useful for purposes of predicting in vivo skin corrosivity of chemicals and for studying the mechanistic aspects of such corrosivity.
  • Hajime Kojima, Tomoko Ando, Katsuhiro Inagaki, Mahito Ohhira, Tadashi Kosaka, Yosuke Nakamura, Hisashi Torishima, Noriyuki Morikawa, Jun Kanno, Mami Kuboki, Michiru Genno, Masaru Nokata, Takanori Harada, Takashi Morimoto, Isao Yoshimura, Yasuo Ohno
    Alternatives to Animal Testing and Experimentation
    2008年 13 巻 1 号 36-44
    発行日: 2008/01/31
    公開日: 2012/01/23
    ジャーナル フリー
    As shown in OECD test guidelines 430 and 431, the human skin epidermal assay and Transcutaneous Electrical Resistance Test (TER) were validated and peer reviewed as an alternative method to corrosivity testing; however, these methods have not been used widely in Japan. The problems related to techniques and evaluation are not clear. Therefore, we performed a validation study of EPI-200 (EpiDermTM), a 3-dimensional cultured epidermal model and Vitrolife-SkinTM, a 3-dimensional cultured skin model made in Japan as a catch-up validation trial of alternatives for skin corrosivity testing using 13 chemicals including a positive control: 10% potassium hydroxide solution in Japan. From the obtained data, we identified the potential of utilizing these models to evaluate the corrosivity of a chemical.
  • 高梨 ルミ, 浦野 紘平, 小林 剛
    環境科学会誌
    2002年 15 巻 1 号 23-33
    発行日: 2002/01/31
    公開日: 2010/06/28
    ジャーナル フリー
     本研究では,定量的な毒性強度の情報がない有害化学物質についても,優先的に環境安全管理を進めるべき物質を適切に選択したり,毒性情報を専門家以外に平易に伝える1)ことができるようにするため,前報2)で示した定量的な毒性強度によるランク分け方法の続報として,人に対する長期毒性を示す確からしさの程度(確度)の情報からランクを決定する方法を提案して考察した。長期毒性としては,国際的な機関,日本または米国の政府機関,および専門家機関等から信頼できる確度隋報が入手できる発がん性,生殖毒性とこれらを補う変異原性,および感作性を対象とし,人に対して明確な影響がある物質をAランク,影響がある可能性が高い物質をBランク,可能性がある物質をCランクに分類する方法を提案して1332物質(群)のランク分けを行った。また,各毒性でランク分けされた物質(群)数とそれらの相互関係,および前報で定量1青報をもとにランク分けされた物質(群)数との関係,およびPRTR対象物質との関係などを考察した。
  • Horst Spielmann
    Alternatives to Animal Testing and Experimentation
    2005年 11 巻 2 号 89-100
    発行日: 2005/11/30
    公開日: 2012/03/01
    ジャーナル フリー
    A short description of the history of the 3Rs concept is given, which was developed as the scientific concept to refine, reduce and replace animal experiments by Russel and Burch more than 40 years ago. In addition, the legal framework in Europe for developing alternatives to animal experiments is given and the current status of in vitro systems in pharmacology and toxicology is described including an update on metabolising systems. The decrease in experimental animal numbers during the past decade in Europe is illustrated by the situation in Germany and the contribution of international harmonisation of test guidelines on reducing animal numbers in regulatory testing is described. A review of the development of the principles of experimental validation is given and the 3T3 NRU in vitro phototoxicity test is used as an example for a successful validation study, which led to the acceptance of the first in vitro toxicity test for regulatory purposes by the OECD. In addition, a promising QSAR approach to identify the skin irritation potential of chemicals is described, which was developed at the BfR and is proposed for regulatory acceptance after critical evaluation by the European Commission. Finally, the currently accepted alternative methods for standardisation and safety testing of drugs, biologicals and medical devices are summarised.
  • Vladimir MURASHOV, Paul SCHULTE, Charles GERACI, John HOWARD
    Industrial Health
    2011年 49 巻 3 号 280-296
    発行日: 2011年
    公開日: 2011/06/14
    [早期公開] 公開日: 2011/03/01
    ジャーナル フリー
    A number of reports have been published regarding the applicability of existing regulatory frameworks to protect consumers and the environment from potentially adverse effects related to introduction of nanomaterials into commerce in the United States and the European Union. However, a detailed comparison of the regulatory approaches to worker safety and health in the USA and in the EU is lacking. This report aims to fill this gap by reviewing regulatory frameworks designed to protect workers and their possible application to nanotechnology.
  • Kazuhiro Sato, Tomohiro Umemura, Taro Tamura, Yukinori Kusaka, Toshiko Ido, Kohji Aoyama, Atsushi Ueda, Kohichi Harada, Keiko Minamoto, Takemi Otsuki, Kunihiko Yamashita, Tatsuya Takeshita, Eiji Shibata, Kunio Dobashi, Satomi Kameo, Muneyuki Miyagawa, Masaaki Kaniwa, Takahiko Yoshida, Tetsuhito Fukushima, Kohtaro Yuta
    Alternatives to Animal Testing and Experimentation
    2010年 15 巻 3 号 124-130
    発行日: 2010/12/31
    公開日: 2011/02/21
    ジャーナル フリー
    New respiratory sensitization positive/negative prediction models with discriminant functions were generated and parameter analyses were discussed on the basis of QSAR technology. Samples used in this research were selected from the list of European Chemical Bureau (ECB): R42, R42/43 for positive samples (respiratory sensitizers) and from the classification results of the Japanese Inter-ministerial Committee for negative respiratory sensitizers (controls). A total of 214 compounds (61 positive sensitizers and 153 negative sensitizers) were used in this study. Parameters were generated from 2-D and 3-D structures of compound. All of the approximately 800 parameters generated were reduced to 12 parameter set by feature selection. Various linear and non-linear discriminant analysis methods were applied using the parameter set. All data analyses were performed using ADMEWORKS/ ModelBuilder software. Perfect classification ratios (100%) were achieved using Iterative Least Squares (ILS) and AdaBoost. The highest prediction ratio of 97.2% by leave-one-out cross-validation was achieved with Support Vector Machine (SVM). This model is applicable to initial prediction of respiratory sensitization.
  • Taku Nishijo, Masaaki Miyazawa, Kazutoshi Saito, Yuki Otsubo, Hideyuki Mizumachi, Hitoshi Sakaguchi
    The Journal of Toxicological Sciences
    2019年 44 巻 1 号 23-34
    発行日: 2019年
    公開日: 2019/01/08
    ジャーナル フリー HTML
    電子付録

    Cosmetic ingredients often comprise complex mixtures, such as botanical extracts, which may contain skin sensitizing constituents. In our previous study for the sensitivity of the evaluations of skin sensitizing constituents in mixtures using the binary in vitro test battery with KeratinoSensTM and h-CLAT, some sensitizers showed higher detection limits in in vitro test methods than in murine local lymph node assays (LLNA). Thus, to minimize the uncertainty associated with decreased sensitivity for these sensitizers, a risk assessment strategy was developed for mixtures with negative results from the binary test battery. Assuming that the no expected sensitization induction level of mixtures (mixture NESIL) can be derived for mixtures with negative in vitro test results, we assessed 146 sensitizers with in vitro and LLNA data according to the assumption of indeterminate constituents in mixtures. Finally, we calculated 95th percentile probabilities of mixture NESILs and derived dermal sensitization thresholds for mixtures (mixture DST) with negative in vitro test results of 6010 μg/cm2. Feasibility studies indicated that this approach was practical for risk assessments of products in the cosmetic industry. This approach would be a novel risk assessment strategy for incorporating the DST approach and information from in vitro test methods.

  • 山本 昭子, Christina E. COWAN, Drew C. McAVOY, Eun NAMKUNG
    環境科学会誌
    1997年 10 巻 2 号 129-139
    発行日: 1997/05/31
    公開日: 2011/03/01
    ジャーナル フリー
     新規および既存の化学物質の環境安全性を判断するには,環境リスクアセスメントの手法が用いられる。環境リスクアセスメントでは,排出環境における物質の挙動と影響を予測する必要がある。挙動予測では,生物が暴露される物質濃度を推定する。排出経路を把握し,物質が環境中に排出されたあと最終的にどうなるかを理解したうえで環境濃度が推定される。本稿では,複数の排出経路が関わる場合の化学物質の環境濃度を予測する数学モデルを検討した。洗剤製品の成分として広く用いられている直鎖アルキルベンゼンスルホン酸塩(LAS)のデータと,多摩川流域における消費者製品の排出経路に関する情報を用いてケーススタディを行った。
  • Masashi TSUNODA, Takamasa KIDO, Sachiyo MOGI, Yumiko SUGIURA, Eriko MIYAJIMA, Yuichiro KUDO, Tatenao KUMAZAWA, Yoshiharu AIZAWA
    Industrial Health
    2014年 52 巻 5 号 439-444
    発行日: 2014年
    公開日: 2014/10/27
    [早期公開] 公開日: 2014/07/29
    ジャーナル フリー HTML
    Glass wool and continuous glass filaments have been used in industry. We examined the irritability of those among Japanese. A patch test was performed on 43 volunteers for the followings: glass wool for non-residential use with and without a urea-modified phenolic resin binder, that for residential use with and without the binder, and continuous glass filaments with diameters of 4, 7, 9, and 13 µm. Materials were applied to an upper arm of each volunteer for 24 h. The skin was observed at 1 and 24 h after the removal. At 1 h after removal, slight erythema was observed on the skin of a woman after the exposure to glass wool for residential use without the binder. Erythema was observed on the skin of another woman at 1 h after a 24-h exposure to glass wool for non-residential use without the binder. There were no reactions at 24 h after the removal. The low reactions in the patch test suggested that the irritability caused by glass wool, irrespective of a resin component, could be induced mechanically, and that the irritability caused by continuous glass filaments with resin could be slight and either mechanical or chemical.
  • Tomoe MURAKAMI, Tsunehiro OYAMA, Toyohi ISSE, Masanori OGAWA, Takuya SUGIE, Toshihiro KAWAMOTO
    Environmental Health and Preventive Medicine
    2007年 12 巻 2 号 56-65
    発行日: 2007年
    公開日: 2007/04/24
    ジャーナル フリー
    In this study, we aim to compare the criteria for sensitizers among national organizations in various countries and international organizations, and to specify whether each Pollutant Release and Transfer Register (PRTR)-designated chemical substance is a sensitizer by each organization. The definition of sensitizing chemicals and the designation of respective sensitizers according to the PRTR law, Japan Society for Occupational Health (JSOH), American Conference of Governmental Industrial Hygienists (ACGIH), European Union (EU), and Deutsche Forschungsgemeinshaft (DFG) were studied. Of the 435 PRTR-designated chemical substances, 15 are listed as sensitizers according to the PRTR law, 16 as sensitizers of the airway and 21 as sensitizers of the skin by JSOH, 12 as sensitizers (no discrimination) by ACGIH, 19 (airway) and 85 (skin) by EU, and 15 (airway) and 43 (skin) by DFG. Only 9 substances were designated as sensitizers by all these organizations. The variation in the designation of sensitizers is accounted for by the differences in the classification criteria and grouping of chemical substances. JSOH limits the definition of sensitizers to substances that induce allergic reactions in humans and uses only human data. Other organizations utilize not only human evidence but also appropriate animal tests. In addition, EU designates an isocyanate as a sensitizer except those for which there is evidence showing that they do not cause respiratory sensitivity. The worldwide enforcement of the globally harmonized system (GHS) of classification and labeling of chemicals could promote not only the consistent designation of sensitizers among national and international organizations, but also the development of testing guidelines and classification criteria for mixtures.
  • Valerie Zuang, Thomas Hartung
    Alternatives to Animal Testing and Experimentation
    2005年 11 巻 1 号 15-26
    発行日: 2005/07/31
    公開日: 2012/02/29
    ジャーナル フリー
    ECVAM was created in 1991 further to Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes which prescribes to use alternative methods whenever possible. As a service of the EU Joint Research Centre, ECVAM has pioneered the validation process and became a proactive facilitator for effective animal protection, especially in the field of regulatory toxicology. The field of alternatives is currently driven by the expectations from both cosmetics and chemicals policies: The 7th amendment to the Cosmetics Directive published in 2003 foresees to phase out animal experiments completely within 10 years. A timetable for the phasing out of the individual animal tests published by the European Commission in September 2004 had been supported by a task-force of stakeholders chaired by ECVAM. The legislation is reinforced by an immediate testing ban for finished products and for all the human health effects, for which alternative methods have been validated by ECVAM. Furthermore, a testing ban and a marketing ban, which cannot be postponed, apply in 6 years for topical and acute systemic toxicity, while the animal tests for all the other human health effects should be phased out in 10 years with a possible postponement by codecision procedure.
    The legislation for chemicals (REACH) is only emerging. It foresees data requirements for more than 30.000 substances produced at levels above 1 ton per year. Extensive in vivo data requirements are expected for a core of about 6.000 substances with highest production and concern. Alternative meth-ods shall first be considered throughout the testing and be predominantly used for the largest group of chemicals, namely those produced between 1-10 tons per year. A Commission proposal as to the legislation has been handed to the European Parliament and Council, and is currently under consultation.
    ECVAM has restructured its services directly targeting the animal tests to be replaced by in vitro and in silico approaches. Given the short time-lines to make available and implement validated methods, ECVAM is offering to steer the process of making validated alternatives available by bundling the inputs of stakeholders and by involving regulators in the process at an early stage. Steering groups com-posed of ECVAM's senior staff and complemented by external experts carry out the project management, which coordinates the various inputs. The collaboration with various stakeholders has also been reinforced. A series of activities including the initiation of three Integrated Projects have put the tailored development and validation of alternative methods on a new scale.
  • J.Thomson Bruce, 長谷川 和俊
    安全工学
    1990年 29 巻 4 号 303-307
    発行日: 1990/08/15
    公開日: 2017/09/30
    ジャーナル フリー
  • Laurent GRIDELET, Philippe DELBECQ, Laurent HERVÉ, Pierre BOISSOLLE, Dominique FLEURY, Sophie KOWAL, Guillaume FAYET
    Industrial Health
    2015年 53 巻 1 号 56-68
    発行日: 2015年
    公開日: 2015/02/05
    [早期公開] 公開日: 2014/10/17
    ジャーナル フリー
    A new approach to assess the risks inherent in the implementation of powders, including nanomaterials, has been developed, based on the OHB (Occupational Hazard Band) method which is widely spread in the chemical industry. Hazard classification has not been modified; only the control of exposure has been worked at. The method applies essentially to the prevention of the exposures to airborne materials, whatever their particle size. The method considers exposure based on seven parameters which take into account the characteristics of the materials used, their emission potential, the conditions of use, as well as classic parameters of exposure characterization like duration and frequency. The method is a pragmatic exploitation of the state-of-art and of available data, bearing in mind that a lot of them are not easily accessible to factory operators. The result of the reflection is then positioned on a hazard versus exposure matrix from which 4 levels of priority of action are defined, as in the classical OHB method used to manage pure chemical risk. This approach fills a gap in terms of risk assessment and avoids jeopardizing all that has been set up for years, while introducing new elements of decision making accessible to all operators.
  • 環境省環境管理局
    大気環境学会誌
    2005年 40 巻 5 号 A41-A63
    発行日: 2005/09/10
    公開日: 2011/11/08
    ジャーナル フリー
  • 山本 毅
    日本画像学会誌
    2007年 46 巻 3 号 185-191
    発行日: 2007年
    公開日: 2007/06/13
    ジャーナル フリー
    With aim of preventing damage to human health caused by environmental pollution from chemical substances, Notification Systems of New Chemical Substances have been implemented in nine countries.
    Manufacturers or importers are required to notify new chemical substances in advance of the manufacture and the import provided that the new chemical substances are not listed in the existingchemical substances Inventory.
    As notification systems in major nations, the following regulations are outlined with points to note for researchers in business corporations in this article:
    Japan;The Chemical Substances Control Law (Law concerning the evaluation of chemical substances and regulation of their manufacture, etc.) and Industrial Safety and Health Law Article 57-3 (Investigation of Toxicity of Chemical Substances)
    China;Provisions on the Environmental Administration of New Chemical Substances
    EU;the REACH (Registration, Evaluation and Authorisation of Chemicals) Regulation
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