Suitability of the limit dose in evaluating reproductive toxicity of substances and preparations

International Journal of Toxicology

Volumn 26, Issue 3, 2007, Pages 183-195

  Schneider, Klaus ^a,d   Oltmanns, Jan ^a   Van Gelder, Rainer ^b   Gebel, Thomas ^c  

^a Forschungs und Beratungsinstitut Gefahrstoffe   (Germany)

^b BG Institute for Occupational Safety and Health (BGIA)   (Germany)

^c FEDERAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH   (Germany)

^d NONE   (Germany)

Author keywords

Classification; Limit Dose; Preparations; Reproductive Toxicity; Workplace

Indexed keywords

AEROSOL; ARTICLE; CONCENTRATION (PARAMETERS); CORRELATION ANALYSIS; EXPOSURE; HAZARD ASSESSMENT; HUMAN; OCCUPATIONAL EXPOSURE; REPRODUCTIVE TOXICITY; WORKPLACE;

AIR POLLUTANTS, OCCUPATIONAL; DATABASES, FACTUAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; OCCUPATIONAL EXPOSURE; REPRODUCTION; SKIN ABSORPTION; THRESHOLD LIMIT VALUES; WORKPLACE;

EID: 34250372453     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1080/10915810701352564     Document Type: Article

References (56)

1. Anonymous. 2001. Begründungen zu Arbeitsplatzgrenzwerten: Allgemeiner Staubgrenzwert. www.baua.de, accessed May 2006.
2. Anonymous. 2005. Specific concentration limits for borates. Unpublished manuscript, The Netherlands, September 2005.
3. AGS, Ausschuss für Gefahrstoffe. 2006a. TRGS 900 - Arbeitsplatzgrenzwerte. www.baua.de, accessed May 2006.
4. AGS, Ausschuss für Gefahrstoffe. 2006b. TRGS 901 - Begründungen und Erläuterungen zu Grenzwerten in der Luft am Arbeitsplatz. www.baua.de, accessed May 2006
5. Anundi, H., M.-L. Lind, L. Friis, N. Itkes, S. Langworth, and C. Edling. 1993. High exposures to organic solvents among graffiti removers. Int. Arch. Occup. Environ. Health 65:247-251.
6. Antti-Poika, M., J. Heikkila, and L. Saarinen. 1990. Cardiac arrhythmias during occupational exposure to fluorinated hydrocarbons. Br. J. Ind. Med. 47:138-140.
7. Armstrong, S. R., and L. C. Green. 2004. Chlorinated hydrocarbon solvents. Clin. Occup. Environ. Med. 4:481-496.
8. Boucher, R., C. Hanna, G. M. Rusch, D. Stidham, E. Swan, and M. Vazquez. 2003. Hepatotoxicity associated with overexposure to 1,1-dichloro-2,2,2- trifluoroethane (HCFC-123). Am. Ind. Hyg. Assoc. J. 64:68-79.
9. Brooke, I., J. Cocker, J. I. Delic, M. Payne, K. Jones, N. C. Gregg, and D. Dyne. 1998. Dermal uptake of solvents from the vapour phase: An experimental study in humans. Ann. Occup. Hyg. 42:531-540.
10. Brouwer, D. H., C. M. Lansink, J. W. Cherrie, and J. J. van Hemmen. 2000. Assessment of dermal exposure during airless spray painting using a quantitative visualisation technique. Ann. Occup. Hyg. 44:543-549.
11. Caldwell, D. J., T. W. Armstrong, N. J. Barone, J. A. Suder, and M. J. Evans. 2000. Hydrocarbon solvent exposure data: Compilation and analysis of the literature. Am. Ind. Hyg. Assoc. J. 61:881-894.
12. Choi, Y. H., N. Kim, Y. S. Seo, S. J. Choi, J. O. Yang, E. Y. Lee, S. Y. Hong, and H. S. Lee. 2003. ARF requiring hemodialysis after accidental perchloroethylene ingestion. Am. J. Kidney Dis. 41:E11.
13. Clewell, H. J., J. Teeguarden, T. McDonald, R. Sarangapani, G. Lawrence, T. Covington, R. Gentry, and A. Shipp. 2002. Review and evaluation of the potential impact of age- and gender-specific pharmacokinetic differences on tissue dosimetry. Crit. Rev. Toxicol. 32:329-389.
14. Corley, R. A., D. A. Markham, C. Banks, P. Delorme, A. Masterman, and J. M. Houle. 1997. Physiologically based pharmacokinetics and the dermal absorption of 2-butoxyethanol vapor by humans. Fundam. Appl. Toxicol. 39:120-130.
15. Dean, B. S., and E. P. Krenzelok. 1992. Clinical evaluation of pediatric ethylene glycol monobutyl ether poisonings. J. Toxicol. Clin. Toxicol. 20:557-563.
16. Doe, J., A. Boobis, A. Blacker, V. Dellarco, N. Doerrer, C. Franklin, J. Goodman, J. Kronenberg, R. Lewis, E. McConnell, T. Mercier, A. Moretto, C. Nolan, S. Padilla, W. Phang, R. Solecki, L. Tilbury, van B. Ravenzwaay, and D. Wolf. 2006. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. Crit. Rev. Toxicol. 36:37-68.
17. Edling, C., C.-G. Ohlson, G. Ljungkvist, A. Oliv, and B. Söderholm. 1990. Cardiac arrhythmia in refrigerator repairmen exposed to fluorocarbons. Br. J. Ind. Med. 47:207-212.
18. Egeland, G. M., T. F. Bloom, T. M. Schnorr, R. W. Hornung, A. J. Suruda, and K. K. Wille. 1992. Fluorocarbon 113 exposure and cardiac dysrhythmias among aerospace workers. Am. J. Ind. Med. 22:851-857.
19. Estill, C. F., and A. B. Spencer. 1996. Case study: Control of methylene chloride exposures during furniture stripping. Am. Ind. Hyg. Assoc. J. 57:43-49.
20. European Commission (EC). 2002. Technical Notes for Guidance. Human Exposure to Biocidal Products - Guidance on Exposure Estimation. Part 2. http://ecb.jrc.it/
21. European Commission (EC). 2003. Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances and Directive 98/8/EC of the European Parliament and of the Council Concerning the Placing of Biocidal Products on the Market. Joint Research Centre, Institute for Health and Consumer Protection, European Chemicals Bureau, Ispra, Italy.
22. European Commission (EC). 2005. Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances and Directive 98/8/EC of the European Parliament and of the Council Concerning the Placing of Biocidal Products on the Market, Human Health Risk Characterisation, Revised Chapter, Final Draft. Joint Research Centre, Institute for Health and Consumer Protection, European Chemicals Bureau, Ispra, Italy.
23. European Chemicals Bureau (ECB). 1998. Letter from BAuA to JRC, ECB, dated 29 September 1998. "Concentration limits for substances classified as toxic to reproduction/developmental toxicity in preparations", distributed by ECB at October 1998 to CMR WG meeting, document ECBI/19/95 Add 18.
24. European Chemicals Bureau (ECB). 2003. Concentration limits for substances classified as toxic to reproduction/developmental toxicity in preparations, N-METHYLPYRROLIDONE (NMP), document ECBI/47/02 Add 13, Dec. 22, 2003/fg-cg0059.
25. Fujino, A., T. Satoh, T. Takebayashi, H. Nakashima, H. Sakurai, T. Higashi, H. Matumura, H. Minaguchi, and T. Kawai. 1992. Biological monitoring of workers exposed to acetone in acetate fibre plants. Br. J. Ind. Med. 49:654-657.
26. Gabriel S. 2006. The BG Measurement System for Hazardous Substances (BGMG) and the Exposure Database of Hazardous Substances (MEGA). Int. J. Occup. Saf. Ergon. 12:101-104.
27. Imberti, R., I. Preseglio, M. Imbriani, S. Ghittori, F. Cimino, and A. Mapelli. 1995. Low flow anaesthesia reduces occupational exposure to inhalation anaesthetics. Acta Anaesthesiol. Scand. 39:586-591.
28. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 1997. ICH Harmonised Tripartite Guideline: Addendum to "Dose Selection for Carcinogenicity Studies of Pharmaceuticals" - Addition of a Limit Dose and Related Notes. Recommended for Adoption at Step 4 of the ICH Process on 17 July 1997 by the ICH Steering Committee 1997.
29. Kezic, S., K. Mahieu, A. C. Monster, and F. A. de Wolff. 1997. Dermal absorption of vaporous and liquid 2-methoxyethanol and 2-ethoxyethanol in volunteers. Occup. Environ. Med. 54:38-43.
30. Kezic, S., A. C. Monster, J. Krüse, and M. M. Verberk. 2000. Skin absorption of some vaporous solvents in volunteers. Int. Arch. Occup. Environ. Health 73:415-422.
31. Kiesswetter, E., M. Blaszkewicz, R. R. Vangala, and A. Seeber. 1994. Acute exposure to acetone in a factory and ratings of well-being. Neurotoxicology 15:597-601.
32. Krafczyk, J., J. Gmehling, and K. Fischer. 2000. Empfehlungen zur thermodynamischen Behandlung komplexer Multikomponentensysteme in Zusammenhang mit Expositionsabschätzungen. In: Bewertung und Fortentwicklung der Regelsetzung: Anwendbarkeit der TRGS 440. Teil 2, Forschungsvorhaben F 1706, ed. BAuA, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 153-163. Dortmund: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin.
33. Krysinska-Traczyk, E., C. Skórska, Z. Prazmo, J. Sitkowska, G. Cholewa, and J. Dutkiewicz. 2004. Exposure to airborne microorganisms, dust and endotoxin during flax scutching on farms. Ann. Agric. Environ. Med. 11:309-317.
34. Martin, J. L., and D. J. Caldwell. 2004. Evaluation of a sampling method for the measurement of occupational exposures to ethylene. J. Occup. Environ. Hyg. 1:363-370.
35. Meier, A., M. Jost, M. Rüegger, R. Knutti, and C. Schlatter. 1995. Narkosegasbelastung des Personals in der Kinderanästhesie. Anaesthesist 44:154-162.
36. Nieuwenhuijsen, M. J., H. Kruize, and M. B. Schenker. 1998. Exposure to dust and its particle size distribution in California agriculture. Am. Ind. Hyg. Assoc. J. 59:34-38.
37. Oppl, R., F. Kalberlah, P. G. Evans, and J. J. van Hemmen. 2003. A toolkit for dermal risk assessment and management: an overview. Ann. Occup. Hyg. 47:629-640.
38. Phillips, A. M., and A. N. I. Garrod. 2001. Assessment of dermal exposure - Empirical models and indicative distributions. Appl. Occup. Environ. Hyg. 16:323-328.
39. Schneider, K., J. Oltmanns, and M. Hassayer. 2004. Allometric principles for interspecies extrapolation in toxicological risk assessment-empirical investigations. Reg. Tox. Pharm. 39:334-347.
40. Shih, T. S., S. H. Liou, C. Y. Chen, and J. S. Chou. 1999. Correlation between urinary 2-methoxy acetic acid and exposure of 2-methoxy ethanol. Occup. Environ.l Med. 56:674-678.
41. Shih, T.-S., P.-Y. Wang, C.-Y. Chen, T. J. Smith, and Y.-P. Hu. 2000. Measurement of percutaneous uptake of 2-methoxy ethanol vapor in humans. J. Occup. Environ. Med. 42:475-482.
42. Simpson, J. C. G., R. M. Niven, C. A. C. Pickering, L. A. Oldham, A. M. Fletcher, and H. C. Francis. 1999. Comparative personal exposures to organic dusts and endotoxin. Ann. Occup. Hyg. 43:107-115.
43. Smith, T. A., G. Parker, and T. Hussain. 2000. Respiratory symptoms and wheat flour exposure: A study of flour millers. Occup. Med. 50:25-29.
44. Soden, K. J. 1993. An evaluation of chronic methylene chloride exposure. J. Occup. Med. 35:282-286.
45. Solecki, R., L. Davies, V. Dellarco, I. Dewhurst, van M. Raaij, and A. Tritscher. 2005. Guidance on setting of acute reference dose (ARfD) for pesticides. Food Chem. Toxicol. 43:1569-1593.
46. Tay, P., J. Pinnagoda, C. T. Sam, S. F. Ho, K. T. Tan, and C. N. Ong. 1995. Environmental and biological monitoring of occupational exposure to 1,1,1-trichloroethane. Occup. Med. 45:147-150.
47. Theurl, A., H. J. Battista, and W. Fritzer. 1989. Akzidentelle Glykolvergiftung. Wien. Med. Wochenschr. 139:390-395.
48. Tsuruta, H. 1996. Skin absorption of solvent mixtures effect of vehicles on skin absorption of toluene. Ind. Health 34:369-378.
49. Van Gelder, R., ed. 2005. BGIA MEGA exposure database (Focus on BGIA's work, No. 0207e, 4/2005). Sankt Augustin, Germany: BG Institute for Occupational Safety and Health (BGIA).
50. Van Hemmen, J. 2004. RISKOFDERM, Risk Assessment for Occupational Dermal Exposure to Chemicals, EU Research Project, QLK4-CT-1999-01107, Final report and Deliverable 43 (Final report of work part 3), March 2004
51. Verma, D. K., D. M. Johnson, M. L. Shaw, and K. Tombe. 2001. Benzene and total hydrocarbons exposures in the downstream petroleum industries. Am. Ind. Hyg. Assoc. J. 62:176-194.
52. Vermeire, T., H. Stevenson, M. N. Pieters, M. Rennen, W. Slob, B. C. Hakkert, 1999. Assessment factors for human health risk assessment: a discussion paper. Crit. Rev. Toxicol. 29:439-490.
53. Vincent, R., P. Poirot, I. Subra, B. Rieger, and A. Cicolella. 1994. Occupational exposure to organic solvents during paint stripping and painting operations in the aeronautical industry. Int. Arch. Occup. Environ. Health 65:377-380.
54. Wiesner, G., M. Harth, R. Szulc, W. Jurczyk, P. Sobczynski, K. H. Hoerauf, J. Hobbahn, and K. Taeger. 2001. A follow-up study on occupational exposure to inhaled anaesthetics in Eastern European surgeons and circulating nurses. Int. Arch. Occup. Environ. Health 74:16-20.
55. Winek, C. L., W. W. Wahba, and J. M. Edelstein. 1990. Sudden death following accidental ingestion of chlormequat. J. Anal. Toxicol. 14:257-258.
56. Williams, A. C., and B. W. Barry. 2004. Penetration enhancers. Adv. Drug Deliv. Rev. 56:603-618.