Testing REACH draft technical guidance notes for conducting chemical safety assessments-The experience of a downstream user of a preparation

Regulatory Toxicology and Pharmacology

Volumn 51, Issue 2, 2008, Pages 168-180

  Gade, Anne Lill ^a,b   Øvrebø, Steinar ^b,c   Hylland, Ketil ^b,d  

^a JOTUN A S   (Norway)

^b UNIVERSITY OF OSLO   (Norway)

^c NATIONAL INSTITUTE OF OCCUPATIONAL HEALTH   (Norway)

^d NORWEGIAN INSTITUTE FOR WATER RESEARCH   (Norway)

Author keywords

Case study; DNEL; Exposure scenarios; PNEC; Preparations; Protective coatings; REACH

Indexed keywords

ARTICLE; CASE STUDY; CHEMICAL INDUSTRY; COMPUTER PROGRAM; EXPOSURE; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; OCCUPATIONAL EXPOSURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT;

ENVIRONMENTAL EXPOSURE; EUROPEAN UNION; GUIDELINES AS TOPIC; HAZARDOUS SUBSTANCES; HUMANS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RISK ASSESSMENT; SOFTWARE; TOXICITY TESTS;

EID: 46549084253     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2008.04.001     Document Type: Article

References (63)

1. Aasmuth T., Lyytimäki J., Hildèn M., Lindholm M., and Münier B. What do experts and stakeholders think about chemical risks and uncertainties. The Finnish Environment 22 (2007) 117. http://www.ymparisto.fi/download.asp?contentid=71173&lan=EN Available from:
2. Ahrens, A., 2006. Development of a Technical Guidance Document for preparing the Chemical Safety Report (REACH Implementation Project 3.2-2), p. 1. Available from: .
3. Atrion, 2007. Chemmate Software, data link regularly updated on eco and human toxicological data from U.S. Environmental Protection Agency, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory. Available from: .
4. Breitholtz M., Rudèn C., Hansson S.O., and Bengtsson B.-E. Ten challenges for improved ecotoxicological testing in environmental risk assessment. Ecotoxicol. Environ. Safe. 63 (2006) 324-335
5. Cassee F.R., Groten J.P., van Bladeren P.J., and Feron V.J. Toxicological evaluation and risk assessment of chemical mixtures. Crit. Rev. Toxicol. 28 (1998) 73-101
6. Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (text with EEA relevance). OJ L 142, pp. 47-50. Available from: .
7. Concurrent Technologies Corporation and Toxicology Excellence for Risk Assessment (TERA), 1998, ITER database. Report on: propylene glycol monomethyl ether (PGME). Available from: .
8. 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, OJ L, 16.08.1967, pp. 1-98. Available from: .
9. Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJ L 154 (5.6.1992), pp. 1-29. Available from: .
10. Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). OJ L 131 (5.5.1998), pp. 11-23. Available from: .
11. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. OJ L 119, pp. 24-26. Available from: .
12. Creely K.S., Tickner J., Soutar A.J., Hughson G.W., Pryde D.E., Warren N.D., Rae R., Money C., Phillips A., and Cherrie J.W. Evaluation and further development of EASE model 2.0. Ann. Occup. Hyg. (Oxford, UK) 49 2 (2005) 135-145. http://annhyg.oxfordjournals.org/cgi/reprint/49/2/135 Available from:
13. Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. OJ L 123 (24.4.1998), pp. 1-63. Available from: .
14. 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. OJ L 200 (30.07.1999), pp. 1-68. Available from: .
15. Ecetoc, 2003. European Centre for Ecotoxicology and Toxicology of Chemicals. Software tool for risk assessments. Available from: .
16. European Chemicals Bureau, 1999a. Allanou, R., Hansen, BG., van der Bilt, Y. Public availability of data on EU high production volume chemicals. Ispra, Italy. Available from: .
17. European Chemicals Bureau, 1999b. Recommendation of the Scientific Committee on Occupational Exposure Limits for 1-Methoxypropan-2-ol. SEG/SUM/38 final March 1999. Available from: .
18. European Chemicals Bureau, 2000a. IUCLID Dataset-1-Methoxypropan-2-ol (PGME). 58 pp. Available from: .
19. European Chemicals Bureau, 2000b. IUCLID Dossier-Aromatic Hydrocarbons. 18.02.2000, 182 pp. Available from: .
20. European Chemicals Bureau, 2000c. IUCLID dataset xylene (18.02.2000), 100 pp. Available from: .
21. European Chemicals Bureau, 2000d. IUCLID dataset zinc powder (18.02.2000), 100 pp. Available from: .
22. European Chemicals Bureau, 2002. Summary of SCOEL recommendations. PGME, Available from: .
23. 2 with addendum. Second Priority List, EUR 21171 EN. 43, 162 pp. Available from: .
24. European Chemicals Bureau, 2005. European Union System for the Evaluation of Substances (EUSES), version 2.0.3. Available from: .
25. European Chemicals Bureau, 2006. European Union Risk Assessment Report 1-Methoxypropan-2-ol (PGME) Part I-Environment. Fourth Priority List, vol. 66. EUR 22474 EN. ISSN 1018-5593. Office for Official Publications of the European Communities, Luxembourg. ©European Communities. Available from: .
26. European Chemicals Bureau, 2007a. REACH Interim Projects. Final reports. Available from: .
27. European Chemicals Bureau, 2007b. ARONA NETWORK ON EXPOSURE SCENARIOS. First Workshop on 14th of February 2006, 2nd workshop on 9th June 2006, 3rd workshop on 7th and 8th of November 2006, and 4th workshop on 26th and 27th of March 2007. Available from: .
28. European Chemical Industry Council (co-ordinator), 2005a. CSA Scoping Studies. WP2-1A: Development of the Concept of Chemical Safety Assessment. WP1-1B: Development of a Flexible CSA Structure. WP2-1B: Development of New Risk Assessment Elements. Final Eeport. Service Contract Nos. 22551-2004-12 F1SC ISP BE and 22552-2004-12 F1SC ISP BE. Available from: .
29. European Chemical Industry Council (co-ordinator), 2005b. Considerations on Safety Data Sheets and Chemical Safety Assessments of Preparations. Final report. Service Contract Nos. 22551-2004-12 F1SC ISP BE and 22552-2004-12 F1SC ISP BE. Available from: .
30. European Chemical Industry Council, 2007. The European Chemical Industry Councils position on REACH second reading in the EP. Available from: .
31. European Communities, 2007. EU Research on Environment and Health-Results from projects funded by the Fifth Framework Programme. ISBN 978-92-79-05359-7, 236 pp. Available from: .
32. European Council of Paint, Varnish, Printing Ink and Artist's Colors Industry, 2005. Imagine a world without colour. Available from: .
33. Exxon Mobile, 2003. United States-Material Safety Data Sheet No 92957652-Solvesso 100 (27.02.2003), 9 pp. Available from: .
34. Fernandez, R.A,. Cladrowa, S., Rumar, R., Tarancon-Estrada, M., Olsson, B., Witzani, H., Zucht, G., 2004. European Classification and Labelling Inspections of Preparations, including Safety Data Sheets (ECLIPS). Final report. Published by the ECLIPS Working Group, CLEEN Secretariat, 64 pp. Available from: .
35. Fuller, H.B., 2003. Material Safety Data Sheet. Epoxy resin (26.02.2003). Available from: .
36. Groten J.P., Butler W., Feron V.J., Kozianowski G., Renwick A.G., and Walker R. An analysis of the possibility for health implications of joint actions and interactions between food additives. Regul. Toxicol. Pharmacol. 31 (2000) 77-91
37. Hansen H., DeRosa C.T., Pohl H., Fay M., and Mumtaz M.M. Public health challenges posed by chemical mixtures. Environ. Health Perspect. 106 (1998) 1271-1280
38. Hamilton J.D., Daggett D.A., and Pittinger C.A. The role of professional judgment in chemical hazard assessment and communication. Regul. Toxicol. Pharmacol. 46 (2006) 84-92
39. Hazard Communication Resources Committee Society for Chemical Hazard Communication, 1999. Published research on the comprehensibility of chemical hazard warning labels and material Safety Data Sheets, 4 pp. Available from: .
40. Health and Safety Executive, 2003. HSE-books-HSG 193. COSHH Essentials. Easy Steps to Control Chemicals (October 2003), ISBN 0717627373. Available from: .
41. Innochem, 2006: Innovation in response to new regulations of materials in a life cycle, functional and holistic perspective. Available from: .
42. Jotun, 1994. Coating Manual. Jotun Protective Coatings, 3500/0538842.
43. Koch L., and Ashford N.A. Rethinking the role of information in chemicals policy; implications for TSCA and REACH. J. Clean. Products 14 (2006) 31-36
44. Krishnan K., and Brodeur J. Toxic interactions among environmental pollutants: corroborating laboratory observations with human experience. Environ. Health Perspect. 102 (1994) 11-17
45. Kulp P., Sattler B., Blayney M., and Sherwood T. Comprehensibility of material safety data sheets. Am. J. Ind. Med. 23 (1993) 135-141
46. McCarty L.S., and Borgert C.J. Review of the toxicity of chemical mixtures: theory, policy, and regulatory practice. Regul. Toxicol. Pharmacol. 45 (2006) 119-143
47. Oxford University, 2005. Safety data sheet-1-methoxy-2-propanol EU (24.08.2005). Available from:
48. Phillips C.C., Wallace B.C., Hamilton C.B., Pursey R.T., Petty G.C., and Bayne C.K. The efficacy of material safety data sheets and worker acceptability-managing and providing information on chemicals. J. Safe. Res. 30 (1999) 113-122
49. Regulations (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. Available from: .
50. RIVM, 1996. Health Canada: assessment of xylene. Available from: .
51. Rudèn C., and Hansson O. Improving REACH. Regul. Toxicol. Pharmacol. 44 (2006) 33-42
52. Seed J., Brown R.P., Olin S.S., and Foran J.A. Chemical mixtures: current risk assessment methodologies and future directions. Regul. Toxicol. Pharmacol. 22 (1995) 76-97
53. Seki A., Takehara H., Takigawa T., Hidehira T., Nakayama S., Usami M., Uchida G., and Kira S. Use of material safety data sheets at workplaces handling harmful substances in Okayama, Japan. J. Occup. Health 43 (2001) 95-100
54. Total Petrochemicals, 2005. Safety data sheet, mixed xylenes, version 7.03 (22.02.2005), 10 pp. Available from: .
55. Umicore, 2005. Safety data sheets. Zinc metal pigment, 6 pp (30.06.2005). Available from: http://www.zincdiecasting.umicore.com/infos/DownloadCenter/MSDS/UnitedKi ngdom/MaterialSafetyDataSheet-Zamak-Zinc-Alloys_UK-English_UMS.pdf>.
56. UNEP, 2001. OECD Screening Information DataSet (SIDS) High Production Volume Chemicals (processed by UNEP Chemicals). Initial assessment profile 1-methoxypropan-2-ol. Available from: .
57. UNEP, 2006. OECD Screening Information DataSet (SIDS) High Production Volume Chemicals (processed by UNEP Chemicals). Inert reassessment-propylene glycol monomethyl ether (PGME), CAS Reg. No. 107-98-2. Available from: .
58. United States National Library of Medicine (NLM), 1996. International Toxicity Estimates for Risk (ITER) database. Toxicology excellence for risk assessment (TERA): toxicological information-xylene. Available from: .
59. US-EPA, 1986. The Agency for Toxic Substances and Disease Registry (ATSDR) developed jointly with the U.S. Environmental Protection Agency (EPA)-Toxicological profile of xylene based on requirements in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) [42 U.S.C. 9601 et seq.], as amended by the Superfund Amendments and Reauthorization Act (SARA) [Pub. L. 99-499]. Agency Contacts (Chemical Managers): Mike Fay, Ph.D.; John F. Risher, Ph.D.; Jewell D. Wilson, Ph.D. Available from: .
60. US-EPA, 2007. Integrated Risk Information System (IRIS)-Ethylbenzene, 19 pp (last updated January 25th, 2007). Available from: .
61. Van Veen, M.P, 2001. Consexpo 3.0. Consumer exposure and uptake models, RIVM rReport 612810011.
62. VCI, 2004. Exposure Categories: Targeted Protection of Humans and the Environment. A Concept for the Safe Use of Chemicals by Characterising and Communicating their Risks for the Implementation of REACH, proposed by the Chemical Industry. Verband der Chemischen Industrie e.V. Available from: .
63. WHO, 1999. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, vol. 71. Re-Evaluation of Some Organic Chemicals (e.g. xylenes), Hydrazine and Hydrogen Peroxide. Available from: .