Prediction of in vivo embryotoxic effect levels with a combination of in vitro studies and PBPK modelling

Toxicology Letters

Volumn 165, Issue 1, 2006, Pages 79-87

  Verwei, Miriam ^a   van Burgsteden, Johan A ^a   Krul, Cyrille A M ^a   van de Sandt, Johannes J M ^a   Freidig, Andreas P ^a  

^a TNO   (Netherlands)

Author keywords

Alternative test method; Developmental toxicity; Embryonic stem cells; PBPK model

Indexed keywords

2 ETHOXYETHANOL; 2 METHOXYETHANOL; ACETIC ACID DERIVATIVE; ETHOXYACETIC ACID; FLUOROURACIL; METHOTREXATE; METHOXYACETIC ACID; RETINOIC ACID; UNCLASSIFIED DRUG;

ANIMAL CELL; ARTICLE; COMPUTER MODEL; CONTROLLED STUDY; EMBRYO; EMBRYO DEVELOPMENT; EMBRYONIC STEM CELL; EMBRYOTOXICITY; EXPOSURE; METABOLISM; MOUSE; NONHUMAN; PREDICTION; PRIORITY JOURNAL; RISK ASSESSMENT; RODENT;

ANIMAL TESTING ALTERNATIVES; ANIMALS; CELL LINE; CELL SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; EMBRYO; MICE; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS; RATS; RISK ASSESSMENT; STEM CELLS; TERATOGENS; TOXICITY TESTS;

RODENTIA;

EID: 33744995562     PISSN: 03784274     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.toxlet.2006.01.017     Document Type: Article

References (27)

1. Anon. White Paper on a Strategy for a Future Chemicals Policy (2001), Commission of the European Communities, Brussels. http://europa.eu.int/comm/environment/chemicals/whitepaper.htm
2. Anon., 2003. Directive 2003/15/EC of the European Parliament and of the council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the member states relating to cosmetic products. http://europa.eu.int/eurolex/pri/en/oj/dat/2003/1_06620030311en 00260035.pdf.
3. Barber B.J., Schultz T.J., and Randlett D.L. Comparative analysis of protein content in rat mesenteric tissue, peritoneal fluid and plasma. Am. J. Physiol. Gastrointest. Liver Physiol. 258 (1990) G714-G718
4. Bremer S., and Hartung T. The use of embryonic stem cells for regulatory developmental toxicity testing in vitro-the current status of test development. Curr. Pharm. Des. 10 (2004) 2733-2747
5. Bremer S., Pellizzer C., Coecke S., Paparella M., and Catalani P. Detection of the embryotoxic potential of cyclophosphamide by using a combined system of metabolic competent cells and embryonic stem cells. ATLA 30 (2002) 77-85
6. Bremer S., Cortvrindt R., Daston G., Eletti B., Mantovani A., Maranghi F., Pelkonen O., Ruhdel I., and Spielmann H. Reproductive and developmental toxicity. ATLA 33 Suppl. 1 (2005) 183-209
7. Brown N.A. Selection of test chemicals for the ECVAM international validation study on in vitro embryotoxicity tests. ATLA 30 (2002) 177-198
8. Clewell III H.J., Andersen M.E., Wills R.J., and Latriano L. A physiologically based pharmacokinetic model for retinoic acid and its metabolites. J. Am. Acad. Dermatol. 36 (1997) S77-S85
9. DeJongh J., Verhaar H.J.M., and Hermens J.L.M. A quantitative property-property relationship (QPPR) approach to estimate in vitro tissue-blood partition coefficients or organic chemicals in rats and humans. Arch. Toxicol. 72 (1997) 17-25
10. Doe J.E. Ethylene glycol monoethyl ether and ethylene glycol monoethyl ether acetate teratology studies. Environ. Health Perspect. 57 (1984) 33-41
11. Gargas M.L., Tyler T.R., Sweeney L.M., Corley R.A., Weitz K.K., Mast T.J., Paustenbach D.J., and Hays S.M. A toxicokinetic study of inhaled ethylene glycol monomethyl ether (2-ME) and validation of a physiologically based pharmacokinetic model for the pregnant rat and human. Toxicol. Appl. Pharmacol. 165 (2000) 53-62
12. Gargas M.L., Tyler T.R., Sweeney L.M., Corley R.A., Weitz K.K., Mast T.J., Paustenbach D.J., and Hays S.M. A toxicokinetic study of inhaled ethylene glycol ethyl ether acetate and validation of a physiologically based pharmacokinetic model for rat and human. Toxicol. Appl. Pharmacol. 165 (2000) 63-73
13. Genschow E., Spielmann H., Scholz G., Seiler A., Brown N., Piersma A., Brady M., Clemann N., Huuskonen H., Paillard F., Bremer S., and Becker K. The ECVAM international validation study on in vitro embryotoxicity tests: results of the definitive phase and evaluation of prediction models. ATLA 30 (2002) 151-176
14. Genschow E., Scholz G., Brown N., Piersma A., Brady M., Clemann N., Huuskonen H., Paillard F., Bremer B., Becker K., and Spielmann H. Development of prediction models for three in vitro embryotoxicity tests. In Vitro Mol. Toxicol. 13 (2000) 51-65
15. Grafton T.F., Bazare J.J., Hansen D.K., and Sheehan D.M. The in vitro embryotoxicity of 5-fluorouracil in rat embryos. Teratology 36 (1987) 371-377
16. Gülden M., and Seibert H. In vitro-in vivo extrapolations: estimation of human serum concentrations of chemicals equivalent to cytotoxic concentrations in vitro. Toxicology 189 (2003) 211-222
17. Hanley T.R., Yano B.L., Nitschke K.D., and John J. Comparison of the teratogenic potential of inhaled ethylene glycol monomethyl ether in rats, mice and rabbits. Toxicol. Appl. Pharmacol. 75 (1984) 409-422
18. Heuer J., Graeber I.M., Pohl I., and Spielmann H. Culture system for the differentiation of murine embryonic stem cells-a new approach to in vitro testing for embryotoxicity and for developmental immunotoxicology. In: Fracchia G.N. (Ed). European Medicines Research (1994), IOS Press, Amsterdam 134-145
19. Heuer J., Graeber I.M., Pohl I., and Spielmann H. An in vitro embryotoxicity assay using the differentiation of embryonic mouse stem cells into haematopoietic cells. Toxicol. In Vitro 8 (1994) 558-587
20. INVITTOX protocol 113. Embryonic stem cell test. http://ecvam-sis.jrc.it/IP1685/published/main_ 113.html (accessed 2003).
21. Jordan R.L., Wilson J.G., and Schumacher H.J. Embryotoxicity of the folate antagonist methotrexate in rats and rabbits. Teratology 15 (1976) 73-80
22. Kanamitsu S.I., Ito K., Okuda H., Ogura K., Watabe T., Muro K., and Sugiyama Y. Prediction of in vivo drug-drug interactions based on mechanism-based inhibition from in vitro data: in hibition of 5-fluorouracil metabolism by (E)-5-(2-bromovinyl)uracil. Drug Metab. Dispos. 28 4 (1999) 467-474
23. Kamm J.J. Toxicology, carcinogenicity, and teratogenicity of some orally administered retinoids. J. Am. Acad. Dermatol. 6 (1982) 652-659
24. OSHA. Occupational exposure to 2-methoxyethanol, 2-ethoxyethanol and their acetates (glycol ethers); proposed rule. 29 CFR Part 1910 58 54 (1993) 15526-15632
25. Shuey D.L., Lau C., Logsdon T.R., Zucker R.M., Elstein K.H., Narotsky M.G., Setzer W., Kavlock R.J., and Roger J.M. Biologically based dose-response modeling in developmental toxicology: biochemical and cellular sequelae of 5-fluorouracil exposure in the developing rat. Toxicol. Appl. Pharmacol. 126 (1994) 129-144
26. Spielmann H., Pohl I., Döring B., Liebsch M., and Moldenhauer F. The embryonic stem cell test (EST), an in vitro embryotoxicity test using two permanent mouse cell lines: 3T3 fibroblasts and embryonic stem cells. In Vitro Toxicol. 10 (1997) 119-127
27. Zhao R., and Goldman I.D. Resistance to antifolates. Oncogene 22 (2003) 7431-7457