How are reproductive toxicity and developmental toxicity addressed in REACH dossiers?

Altex

Volumn 28, Issue 4, 2011, Pages 273-294

  Rovida, Costanza ^a   Longo, Fabiola ^b   Rabbit, Richard R ^a  

^a UNIVERSITY OF KONSTANZ   (Germany)

^b NONE

Author keywords

CLP; Developmental toxicity; REACH; Registration dossiers; Reproductive toxicity

Indexed keywords

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TESTING ALTERNATIVE; EMBRYO; EMBRYOTOXICITY; FEMALE; FERTILITY; HEALTH HAZARD; IN VITRO STUDY; IN VIVO STUDY; MALE; NONHUMAN; PRENATAL DEVELOPMENT; QUANTITATIVE STRUCTURE ACTIVITY RELATION; REPRODUCTIVE TOXICITY; REVIEW; RISK ASSESSMENT; STEM CELL; TOXICITY TESTING;

EID: 84455189560     PISSN: 09467785     EISSN: None     Source Type: Journal    
DOI: 10.14573/altex.2011.4.273     Document Type: Review

References (36)

1. Adler, S., Basketter, D., Creton, S., et al. (2011). Alternative (non-animal) methods for cosmetics testing: current status and future prospects - 2010. Arch. Toxicol. 85, 367-485.
2. Bremer, S., Pellizzer, C., Hoffmann, S., et al. (2007). The development of new concepts for assessing reproductive toxicity applicable to large scale toxicological programs. Curr. Pharm. Des. 13, 3047-3058. (Pubitemid 350130970)
3. CLP (2008). Regulations. 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. Official Journal of the European Union L 353, 1-1355.
4. Directive 67/548/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. Official Journal of the European Communities 196, 1-98.
5. ECHA (2008). Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance (428pp.). http://guidance.echa.europa.eu/docs/guidance-document/information-requirements- r7a-en.pdf?vers=20-08-08 (accessed 07.07.2011).
6. ECHA News Alert (2011). ECHA Refers a draft decision for one testing proposal to the Commission for the first time. ECHA/NA/11/45.
7. ECHA Press Release (2009). Clarification will avoid unnecessary animal tests, ECHA/PR/09/13. http://echa.europa.eu/doc/press/pr-09-13-animal-testing- carification-20090915.pdf (accessed 11.07.2011).
8. ECHA REACH Fact Sheet (2009). Information requirements for repeated dose toxicity and reproductive toxicity - substances over 100 (and 1000) tones. ECHA-09-FS-05-EN. http://echa.europa.eu/doc/reach/reach-factsheet-testing.pdf (accessed 10.07.2011).
9. ECHA Report (2011a). Evaluation under REACH progress report 2010, ECHA-11-R-001-EN. http://echa.europa.eu/doc/evaluation-under-reach-progress- report-2010-en.pdf (accessed 10.07.2011).
10. ECHA Report (2011b). The operation of REACH and CLP 2011, ECHA-11-R-003-EN. http://echa.europa.eu/publications/operation-reach-clp-2011- en.asp (accessed 10.07.2011).
11. ECHA Report (2011c). The use of alternatives to testing on animals for REACH regulation, ECHA-11-R-004-EN. http://echa.europa.eu/publications/ alternatives-test-animals-2011-en.asp (accessed 10.07.2011).
12. Fleischer, M. (2007). Testing costs and testing capacity according to the REACH requirements - Results of a survey of independent and corporate GLP laboratories in the EU and Switzerland. J. Bus. Chem. 4, 96-114.
13. 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. ATLA 32, 209-244. (Pubitemid 39517737)
14. Gilbert, N. (2010). Streamlined chemical tests rebuffed. Nature 463, 142-143.
15. Gilbert, N. (2011). Data gaps threaten chemical safety law. Nature 475, 150-151.
16. Hartung, T. (2009). Toxicology for the twenty-first century. Nature 460, 208-212.
17. Hartung, T. (2010). Food for thought ... on alternative methods for chemical safety testing. ALTEX 27, 3-14.
18. Hartung, T. and Rovida, C. (2009a). Chemical regulators have overreached. Nature 460, 1080-1081.
19. Hartung, T. and Rovida, C. (2009b). That which must not, cannot be... a reply to the ECHA and EDF responses to the REACH analysis of animal use and costs. ALTEX 26, 307-311.
20. Hewitt, M., Ellison, M. C., Enoch, S. J., et al. (2010). Integrating (Q)SAR models, expert systems and read-across approaches for the prediction of developmental toxicity. Reprod. Toxicol. 30, 147-160.
21. Höfer, T., Gerner, I., Gundert-Remy, U., et al. (2004). Animal testing and alternative approaches for the human health risk assessment under the proposed new European chemicals regulation. Arch. Toxicol. 78, 549-564. (Pubitemid 39591625)
22. IEH Report (2001). Testing requirements for proposals under the EC white paper "strategy for a future chemicals policy."Institute for Environment and Health. http://www.cranfield.ac.uk/health/researchareas/ environmenthealth/ieh/ieh%20publications/w6.pdf (accessed 22.07.2009).
23. Klimisch, H. J., Andreae, M., and Tillmann, U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharmacol. 25, 1-5. (Pubitemid 27117571)
24. Marx-Stoelting, P., Adriaens, E., Ahr, H. J., et al. (2009). A review of the implementation of the Embryonic Stem Cell Test (EST). The report and recommendations of an ECVAM/ReProTect. ATLA 37, 313-328.
25. Pedersen, F., de Bruijn, J., Munn, S. and van Leeuwen, K. (2003). Assessment of additional testing needs under REACH - effects of (Q)SARs, risk based testing and voluntary industry initiatives. JRC Report EUR 20863.
26. REACH (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. http://home.kpn.nl/reach/downloads/reachtestingneedsfinal.pdf (accessed 05.11.2011). Official Journal of the European Union L 396, 1-849.
27. Regulation 134/2009 (2009). Commission Regulation (EC) No 134/2009 of 16 February 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI. Official Journal of the European Union L 46, 3-5.
28. Regulation 340/2008 (2008). Commission Regulation (EC) No 340/2008of 16 April 2008on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union L 107, 6-26.
29. Regulation 440/2008 (2008). Council Regulation (EC) No 440/2008of 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). Official Journal of the European Union L 142, 1-739.
30. 4). ALTEX 26, 187-208.
31. Rovida, C. (2010). Food for thought ... why no new in vitro tests will be done for REACH by registrants. ALTEX 27, 175-183.
32. RPA and Statistics Sweden (2002). Assessment of the impact of new regulations in the chemicals sector. Final Report prepared for European Commission, DG ENTR. http://ec.europa.eu/enterprise/reach/docs/whitepaper/bia- report-2002-06-en.pdf (accessed 05.09.2011)
33. Schenk, B., Weimer, M., Bremer, S., et al. (2010). The RePro- Tect Feasibility Study, a novel comprehensive in vitro approach to detect reproductive toxicants. Reproductive Toxicology 30, 200-218.
34. Seiler, A. and Spielmann, H. (2011). The validated embryonic stem cell test to predict embryotoxicity in vitro. Nat. Protoc. 6, 961-978.
35. van der Jagt, K., Munn, S.,Tørsløv,J., and de Bruijn, J. (2004). Alternative approaches can reduce the use of test animals under REACH. Addendum to the report: Assessment of additional testing needs under REACH Effects of (Q)SARS, risk based testing and voluntary industry initiatives. JRC Report EUR 21405 EN. http://publications.jrc.ec.europa.eu/repository/bitstream/ 111111111/8790/1/EUR%2021405%20EN.pdf (accessed 27.07.2011).
36. West, P. R., Weir, A. M., Smith, A. M., et al. (2010). Predicting human developmental toxicity of pharmaceuticals using human embryonic stem cells and metabolomics. Toxicol. Appl. Pharmacol. 247, 18-27.