{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T08:04:30Z","timestamp":1777449870326,"version":"3.51.4"},"reference-count":12,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2006,8,1]],"date-time":"2006-08-01T00:00:00Z","timestamp":1154390400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Altern Lab Anim"],"published-print":{"date-parts":[[2006,8]]},"abstract":"<jats:p>Tonnage-based information requirements are specified in the proposal on the regulation on the Registration, Evaluation and Authorisation of Chemicals (REACH) in the European Union. The hazard assessment for toxic endpoints should be performed by using a tiered approach, i.e. as an information strategy (IS), starting with an evaluation of all of the data already available, including animal in vivo and in vitro data, and human evidence and case reports, as well as data from (Quantitative)-Structure Activity Relationships ([Q]SARs) or read-across, before any further testing is suggested. To contribute to the implementation of the REACH system, the Nordic countries launched two projects: 1) a review of currently used testing strategies, including a comparison with the REACH requirements; and 2) the development of detailed ISs for skin and eye irritation\/corrosion. The review showed that the ISs and classification criteria for the selected endpoints are inconsistent in many cases. In the classification criteria, human data and in vivo test results are usually the prerequisites. Other types of information, such as data from in vitro studies, can sometimes be used, but usually as supportive evidence only. This differs from the REACH ISs, where QSARs, read-across and in vitro testing are important elements. In the other part of the project, an IS for skin and eye irritation\/corrosion was proposed. The strategy was \u201ctested\u201d by using four high production volume (HPV) chemicals: hydrogen peroxide, methyl tertiary-butyl ether (MTBE), trivalent chromium, and diantimony trioxide, but only MTBE and trivalent chromium are dealt with in this paper. The \u201ctest\u201d revealed that in vivo data, human case reports and physical-chemical data were available and could be used in the evaluation. Classification could be based on the proposed IS and the existing data in all cases, except for the eye irritation\/corrosion of trivalent chromium. Weight-of-evidence analysis appeared to be a useful step in the ISs proposed, and including it in the REACH strategies should be considered. For these chemicals, few in vitro and (Q)SAR data were available \u2014 more of these data would be generated, if the relevant guidance and legislation on classification were updated.<\/jats:p>","DOI":"10.1177\/026119290603400408","type":"journal-article","created":{"date-parts":[[2019,4,9]],"date-time":"2019-04-09T05:04:15Z","timestamp":1554786255000},"page":"377-386","source":"Crossref","is-referenced-by-count":13,"title":["<i>In Vitro<\/i>\n                    Tests within the REACH Information Strategies"],"prefix":"10.1177","volume":"34","author":[{"given":"Kimmo","family":"Louekari","sequence":"first","affiliation":[{"name":"Finnish Institute of Occupational Health, Helsinki, Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirsi","family":"Sihvonen","sequence":"additional","affiliation":[{"name":"The National Product Control Agency (STTV), Helsinki, Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marko","family":"Kuittinen","sequence":"additional","affiliation":[{"name":"The National Product Control Agency (STTV), Helsinki, Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vibeke","family":"S\u00f8mnes","sequence":"additional","affiliation":[{"name":"The Norwegian Pollution Control Authority (SFT), Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2006,8,1]]},"reference":[{"key":"bibr1-026119290603400408","unstructured":"ECB (2004). TAPIR 3.3 \u2014 A Project for the Information Requirements of REACH. Final Report, August 2nd 2005. Lot 3: Scoping study on the Development of a Technical Guidance Document on Information Requirements on Intrinsic Properties of Substances (RIP 3.3-1). 76 pp. Ispra, Italy: European Chemicals Bureau, Joint Research Centre, European Commission."},{"key":"bibr2-026119290603400408","unstructured":"Nordic Council of Ministers (2005). Nordic Project on Information Strategies (NOIS) for Fulfilling Data Requirements under REACH (ANP 2005:754). Part 1 \u2014 Review of Current Testing\/Information Requirements. Final draft, February 2005. 61 pp. Copenhagen, Denmark: Nordic Council of Ministers. Website www.norden.org\/pub\/sk\/showpub.asp?pubnr=2005:754 (Accessed 29.12.05)."},{"key":"bibr3-026119290603400408","unstructured":"Nordic Chemicals Group (2005). Information Strategy for Skin and Eye Irritation\/corrosion. Nordic Project on Integrated Information Strategies. Step 2 project report (draft 18 April 2005). 131 pp. Copenhagen, Denmark: Nordic Council of Ministers."},{"key":"bibr4-026119290603400408","unstructured":"EC (2003). Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999\/45\/EC and Regulation (EC) {on Persistent Organic Pollutants} Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67\/548\/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals. 1328 pp. Brussels, Belgium: Commission of the European Communities. Website http:\/\/ec.europa.eu.enterprise\/reach\/overview_en.htm (Accessed 24.07.06)."},{"key":"bibr5-026119290603400408","unstructured":"EC (2003). Technical Guidance Document on Risk Assessment in support of Commission Directive 93\/67\/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488\/94 on Risk Assessment for existing substances, Directive 98\/8\/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Part I. European Commission Joint Research Centre. 311 pp. Ispra, Italy: European Chemicals Agency."},{"key":"bibr6-026119290603400408","unstructured":"ECB (2005). Manual of Decisions for Implementation of the Sixth and Seventh Amendments to Directive 67\/548\/EEC on Dangerous Substances (Directives 79\/831\/EEC and 92\/32\/EEC) Non-confidential Version. EUR 2051 EN, Updated Version of June 2005. 196 pp. Ispra, Italy: European Chemicals Agency."},{"key":"bibr7-026119290603400408","unstructured":"EEC (1967). Council Directive 67\/548\/EEC on the approximation of the laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances. 5 pp. Brussels, Belgium: The Council of the European Economic Community."},{"key":"bibr8-026119290603400408","unstructured":"GHS (2003). Globally Harmonized System on Classification and Labelling of Chemicals (GHS). 238 pp. New York, NY, USA and Geneva, Switzerland: United Nations. Website http:\/\/www.unece.org\/trans\/danger\/publi\/ghs\/ghs_rev00\/00files_e.html (Accessed 24.07.06)."},{"key":"bibr9-026119290603400408","unstructured":"OECD (2004). Manual for Investigation of HPV Chemicals. OECD Secretariat, September 2004. 24 pp. Paris, France: Organization for Economic Cooperation and Development. Website http:\/\/www.oecd.org\/document\/7\/0,2340,en_2649_34379_1947463_1_1_1_1,00.html (Accessed 24.07.06)."},{"key":"bibr10-026119290603400408","first-page":"431","volume":"32","author":"Louekari K.","year":"2004","journal-title":"ATLA"},{"key":"bibr11-026119290603400408","first-page":"351","volume":"33","author":"Kandarova H.","year":"2005","journal-title":"ATLA"},{"key":"bibr12-026119290603400408","first-page":"163","volume":"32","author":"Combes R.D.","year":"2004","journal-title":"ATLA"}],"container-title":["Alternatives to Laboratory Animals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/026119290603400408","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/026119290603400408","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:41:59Z","timestamp":1777380119000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/026119290603400408"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,8]]},"references-count":12,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2006,8]]}},"alternative-id":["10.1177\/026119290603400408"],"URL":"https:\/\/doi.org\/10.1177\/026119290603400408","relation":{},"ISSN":["0261-1929","2632-3559"],"issn-type":[{"value":"0261-1929","type":"print"},{"value":"2632-3559","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,8]]}}}