Abstract
In 2007, a new European chemicals legislation was implemented: Regulation (EC) No. 1907/2006, also known as “REACH.” It obliges companies to take the main responsibility for the valid information on the safe use of the chemicals they manufacture and/or place on the European market. So they must, for example, register their chemicals at the European Chemicals Agency (ECHA) and submit extensive substance-related registration dossiers containing information on the substances’ intrinsic hazardous properties and documentation of their risk assessment. REACH regulates the registration and evaluation process as well as the authorization and restriction procedure. In addition, classification, labeling, and packaging of chemicals apply in accordance with Regulation (EC) No. 1272/2008 (“CLP Regulation”). It implements almost completely the provisions of the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS) into European legislation and will fully replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC) by 2015. According to both the old and the new classification system, teratogenic chemicals are classified as developmental toxicants, with developmental toxicity falling within the hazard class of reproductive toxicity. REACH as well as the CLP Regulation provide several procedures in which reproductive toxicants take a special position because their harmful effects are considered particularly serious. Teratogenic substances are not explicitly named by these legal texts but, as they constitute as developmental toxicants a hazard differentiation of reproductive toxicity, they are implicitly always included by the provisions.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
EEC (1967) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Off J Eur Union 196:1–98
EC (1999) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Off J Eur Commun L200:1–68
EU (2008) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Off J Eur Union L353:1–1355
UN (2011) Globally harmonized system of classification and labelling of chemicals (GHS), 4th edn. United Nations, New York, eISBN 978-92-1-054745-1
ECVAM (2002) Method Validation > Scientifically validated methods > Reproductive toxicity. http://ecvam.jrc.it/. Accessed 28 Jan 2012
Genschow E, Spielmann H, Scholz G et al (2004) Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests. Altern Lab Anim 32:209–244
Spielmann H, Genschow E, Brown NA et al (2004) Validation of the rat limb bud micromass test in the international ECVAM validation study on three in vitro embryotoxicity tests. Altern Lab Anim 32:245–274
Piersma AH, Genschow E, Verhoef A et al (2004) Validation of the postimplantation rat whole-embryo culture test in the international ECVAM validation study on three in vitro embryotoxicity tests. Altern Lab Anim 32:275–307
ECETOC (2002) Guidance on evaluation of reproductive toxicity data. Monograph No. 31. ISSN-0773-6347-31
Lee YE, Byun SK, Shin S et al (2008) Effect of maternal restraint stress on fetal development of ICR mice. Exp Anim 57:19–25
Hemm RD, Arslanoglou L, Pollock JJ (1977) Cleft palate following prenatal food restriction in mice: association with elevated maternal corticosteroids. Teratology 15:243–248
EU (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Off J Eur Union L396:1–849
EC (2009) JRC Scientific and technical reports. European list of notified chemical substances (ELINCS) in support of Directive 92/32/EEC, the 7th amendment to Directive 67/548/EEC. EUR 23923 EN-2009
EC (2002) European inventory of existing commercial chemical substances (EINECS). http://esis.jrc.ec.europa.eu/index.php?PGM = ein. Accessed 29 Oct 2011
ECHA (2011) Guidance on Registration. Version 1.6, Jan 2011. ECHA-11-G-03-EN
Cooper RL, Lamb JC, Barlow SM et al (2006) A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol 36:69–98
ECETOC (2008) Triggering and waiving criteria for the extended one-generation reproduction toxicity study. Document No. 45. http://www.ecetoc.org/technical-documents. Accessed 28 Jan 2012
OECD (2011) Test No. 443: Extended one-generation reproductive toxicity study. OECD, Paris. doi:10.1787/9789264122550-en
OECD (2001) Test No. 414: Prenatal developmental toxicity study. OECD, Paris. doi:10.1787/9789264070820-en
OECD (1983) Test No. 415: One-generation reproduction toxicity study. OECD, Paris. doi:10.1787/9789264070844-en
OECD (2001) Test No. 416: Two-generation reproduction toxicity study. OECD, Paris. doi:10.1787/9789264070868-en
OECD (1995) Test No. 421: Reproduction/developmental toxicity screening test. OECD, Paris. doi:10.1787/9789264070967-en
OECD (1996) Test No. 422: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test. OECD, Paris. doi:10.1787/9789264070981-en
OECD (2007) Test No. 426: Developmental neurotoxicity study. OECD, Paris. doi:10.1787/9789264067394-en
ECHA (2010) Chapter R.8: Characterisation of dose (concentration)-response for human health. Guidance on information requirements and chemical safety assessment. ECHA-2010-G-19-EN
Schneider K, Oltmanns J, Hassauer M (2004) Allometric principles for interspecies extrapolation in toxicological risk assessment—empirical investigations. Regul Toxicol Pharmacol 39:334–347
Klimisch H-J, Andreae M, Tillmann U (1996) A systemic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25:1–5
BAuA (2008) Exposure estimate at the workplace—EMKG-Expo-Tool. http://www.reach-clp-helpdesk.de/en/Exposure/Exposure.html;jsessionid=24C63680B506E9958E22B9B8D07C6E23.2_cid246. Accessed 28 Jan 2012
ECETOC (2012) Targeted risk assessment tools. http://www.ecetoc.org/tra. Accessed 28 Jan 2012
SZW (2012) Stoffenmanager 4.5. https://www.stoffenmanager.nl/default.aspx. Accessed 28 Jan 2012
Eurofins (2012) Toolkit dermal exposure and risk management (RiskOfDerm Toolkit). Version A 1.11 UK-03/2004. http://www.eurofins.com/product-testing-services/services/research--development/projects-on-skin-exposure-and-protection/riskofderm---skin-exposure-and-risk-assessment/download-of-riskofderm-toolkit.aspx. Accessed 28 Jan 2012
ECHA (2010) Guidance on the preparation of dossiers for harmonised classification and labelling. ECHA-10-G-03-EN
ECHA (2010) CLH report format with explanations. http://echa.europa.eu/documents/10162/17218/clh_report_format_expl_201005_en.pdf. Accessed 29 Jan 2012
ECHA (2007) Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern. http://echa.europa.eu/documents/10162/17230/svhc_en.pdf. Accessed 29 Jan 2012
ECHA (2012) Candidate list table. http://echa.europa.eu/web/guest/candidate-list-table. Accessed 29 Jan 2012
ECHA (2010) General approach for prioritisation of substances of very high concern. http://echa.europa.eu/documents/10162/17232/axiv_priority_setting_gen_approach_20100701_en.pdf. Accessed 29 Jan 2012
ECHA (2011) Guidance on the preparation of an application for authorisation. Version 1. ECHA-11-G-01-EN
ECHA (2011) Guidance on the preparation of socio-economic analysis as part of an application for authorisation. Version 1. ECHA-11-G-02-EN
EC (1976) Council Directive of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (76/769/EEC). Off J Eur Commun L262:201–203
ECHA (2007) Guidance for the preparation of an Annex XV dossier for restrictions. http://echa.europa.eu/documents/10162/17233/restriction_en.pdf. Accessed 29 Jan 2012
ECHA (2008) Guidance on socio-economic analysis--restrictions. http://echa.europa.eu/documents/10162/17233/sea_restrictions_en.pdf. Accessed 29 Jan 2012
ECHA (2010) Practical guide 3: How to report robust study summaries. ECHA-10-B-06-EN
EU (2008) Council regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Eur Union L142:1–739
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Prutner, W. (2013). Hazard and Risk Assessment of Teratogenic Chemicals Under REACH. In: Barrow, P. (eds) Teratogenicity Testing. Methods in Molecular Biology, vol 947. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-131-8_34
Download citation
DOI: https://doi.org/10.1007/978-1-62703-131-8_34
Published:
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-62703-130-1
Online ISBN: 978-1-62703-131-8
eBook Packages: Springer Protocols