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Priority setting strategies for regulatory testing of industrial chemicals
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology.
2007 (English)Licentiate thesis, comprehensive summary (Other scientific)
Abstract [en]

For the majority of the estimated 70,000 industrial chemical substances available on the European market today there is not enough information to enable a reasonably complete assessment of the risks that they might pose to man and the environment. Any strategy for the generation of additional data for these substances should aim at making testing as efficient as possible taking into account environmental and health protection, time, monetary cost and animal welfare. To achieve this, appropriate priority setting rules are needed.

The main criterion currently used for regulatory priority setting for testing of industrial chemicals is production volume; the higher the production volume, the more information is required. This was also the main criterion in the former legislation, preceding REACH (Registration, Evaluation and Authorisation of Chemicals). The aim of this thesis is to evaluate other priority setting criteria and their implications for risk management, in particular classification and labelling.

The first paper in this thesis includes a study of the efficiency ratio for some of the tests required for the notification of new substances, i.e. the ratio between the likelihood that the test will lead to a classification, and the monetary cost of performing the test. The efficiency ratio was determined for the standard tests for acute oral toxicity, irritation, sensitisation and subacute toxicity using data from 1409 new chemicals notified in Europe between 1994 and 2004. The results of this investigation suggest that, given limited resources for testing, it is more efficient to perform acute toxicity tests on a larger number of substances rather than to perform additional subacute toxicity studies on the substances already tested for acute toxicity.

The second paper included in this thesis, reports the results from a comparative study of the bioaccumulating properties of substances being (a) classified as carcinogenic, mutagenic and/or toxic to reproduction (CMR-substances), or (b) classified as acutely toxic or (c) unclassified. The purpose of this investigation was to evaluate potential consequences of prioritising bioaccumulating chemicals for evaluation and testing, as this is one of the strategies prescribed in REACH. The results of this study suggest that bioaccumulating substances are neither over- nor underrepresented among the CMR-substances. This result lends support to the use of the bioconcentration factor for priority setting.

The studies reported in this thesis utilize existing data on classification of substances as an indicator of the outcome of the risk assessment process, relating priority setting methods to the risk management measures that they give rise to. To the best of my knowledge there are still only very few studies published that address the issue of priority setting in chemicals control using this approach, and in my view there is need for more studies of priority setting methods and a further development of priority setting strategies that are science-based.

Place, publisher, year, edition, pages
Stockholm: KTH , 2007. , 18 p.
Keyword [en]
risk assessment, risk management, regulatory toxicology, test strategies, prioritisation, REACH, industrial chemicals
National Category
History of Technology
Identifiers
URN: urn:nbn:se:kth:diva-4554ISBN: 978-91-7178-808-5 (print)OAI: oai:DiVA.org:kth-4554DiVA: diva2:12830
Presentation
2007-12-06, Seminarierummet, 231, Avd för Filosofi, Teknikringen 78B, 100 44 STOCKHOLM, 10:00
Opponent
Supervisors
Note
QC 20101115Available from: 2007-11-25 Created: 2007-11-25 Last updated: 2010-11-15Bibliographically approved
List of papers
1. Towards more efficient testing strategies - analyzing the efficiency of toxicity data requirements in relation to the criteria for classification and labelling
Open this publication in new window or tab >>Towards more efficient testing strategies - analyzing the efficiency of toxicity data requirements in relation to the criteria for classification and labelling
2008 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 50, no 3, 412-419 p.Article in journal (Refereed) Published
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.

Keyword
testing strategies, classification, efficiency ratio, acute toxicity, subacute toxicity
National Category
History of Technology
Identifiers
urn:nbn:se:kth:diva-7719 (URN)10.1016/j.yrtph.2008.01.012 (DOI)000255996700014 ()2-s2.0-41949135938 (Scopus ID)
Note
Uppdaterad från submitted till published(20101115) QC 20101115Available from: 2007-11-25 Created: 2007-11-25 Last updated: 2010-11-15Bibliographically approved
2. The usefulness of the bioconcentration factor as a tool for priority setting in chemicals control
Open this publication in new window or tab >>The usefulness of the bioconcentration factor as a tool for priority setting in chemicals control
2007 (English)In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, no 168, 113-120 p.Article in journal (Refereed) Published
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.

Keyword
priority setting, bioaccumulation, risk assessment, chemicals control, REACH, test strategies, tiered testing
National Category
History of Technology
Identifiers
urn:nbn:se:kth:diva-7720 (URN)10.1016/j.toxlet.2006.11.004 (DOI)000244059300003 ()2-s2.0-33846020570 (Scopus ID)
Note
QC 20101115Available from: 2007-11-25 Created: 2007-11-25 Last updated: 2010-11-15Bibliographically approved

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