ICH Harmonised Tripartite Guideline.Detection of toxicity to reproduction for medicinal products, 1993.
2.
ICH Harmonised Tripartite Guideline, addendum Step 4 Draft 2. Detection of toxicity to reproduction for medicinal products, 1995.
3.
Heindel JJ and Chapin RE (1993) Methods in Toxicology Volume 3B. Female Reproductive Toxicology (series ed. CA Tyson and H Witschi). Academic Press Inc, pp. 404.
4.
Chapin RE, Phelps J.Recent advances in testicular cell culture: implications for toxicology. Toxic In Vitro1990; 4: 543-559.
5.
Aitken RJDevelopment of in vitro tests for human sperm function: a diagnostic tool and model system for toxicological analysis. Toxic In Vitro1990; 4: 560-569.
6.
Holloway AJ, Moore Hdm, Foster Pmd.The use of in vitro fertilisation to detect reductions in fertility of male rats exposed to 1,3-dinitrobenzene. Fund Appl Toxicol1990; 14: 113 -122.
7.
Spielmann H., Vogel R.Unique role of studies on pre-implantation embryos to understand mechanisms of embryotoxicity in early pregnancy. Crit Rev Toxicol1989; 20: 51-64.
8.
Carlsen E., Giwercman A., Keiding E., Skakkebaek NEEvidence for decreasing quality of semen during past 50 years. Br Med J1992; 305: 609-613.
9.
Giwercman A. , Carlsen E., Keiding N., Skakkebaek NEEvidence for increasing incidence of abnormalities of the human testis: a review. Env Health Persp (Suppl)1993; 101: 65 - 71.
10.
Sharpe RM, Skakkebaek NEAre oestrogens involved in falling sperm counts and disorders of the male reproductive tract?Lancet1993; 342: 125.
11.
Cohen J.Sperm counts: emergency or artifact. Biologist1995; 42: 248.
12.
Danish Epa.Male Reproductive Health and Environmental Chemicals with Oestrogenic Effects . Miljoproject No 290 1995.
13.
MRC Institute for Environmental Health (IEH)Assessement of Environmental Oestrogens: Consequences to Human Health and Wildlife. IEH Leicester1995.
14.
Giwercman A.Declining semen quality and increasing incidence of abnormalities in male reproductive organs - fact or fiction? Human Reprod 1995; 10: (Suppl 1): 158-164.
15.
Thigpen JE et al. The mouse bioassay for the detection of estrogenic activity in rodent diets: I A standardized method for conducting the mouse bioassay . Lab Anim Sci1987; 37: 596-601.
16.
Soto AM et al. An "in culture" bioassay to assess the estrogenicity of xeno-biotics (e-screen). In Chemically-induced Alterations in Sexual and Functional Development: The Wildlife/ Human Connection. (eds T Colborn and C Clement ). Adv Modern Environ Toxicol1992, pp. 295-309.
17.
Routledge EJ , Sumpter JPOestrogenic activity of surfactants and some of their degredation products using a recombinant yeast screen. Env Tox Chem1996; 15: 241-248.
18.
Ulbrich B., Palmer AKDetection of effects on male reproduction-a literature survey. J Am Coll Toxicol1995; 14: 293-327.
19.
Foster Pmd.The potential uses and misuses of compounds affecting spermatogenesis. Serono Symp Publ Raven Press1988; 50: 231-240.
20.
Li LH, Wine RN and Chapin RE2-Methoxyacetic acid (MAA)-induced spermatocyte apoptosis in human and rat testes, an in vitro comparison. J. Androl.1996; 17: 538-549.
21.
Hecht NBThe making of a spermatozoon: a molecular perspective. Dev Genetics1995; 16: 95 — 103.
22.
Hoffmann M-C. , Narisawa S., Hess RA, Millan JLImmortalization of germ cells and somatic testicular cells using the SV40 large T antigen. Exp Cell Res1992; 201: 417-435.
23.
Rassoulzadegan M. et al. Transmeiotic differentiation of male germ cells in culture. Cell1993; 75: 997 -1006.
24.
Fritz IBCell-cell interactions in the testis: a guide for the preplexed. In Biology of Mammalian Germ Cell Mutagenesis. (eds JW Allen, BA Bridges, MF Lyon, MJ Moses and LB Russel). pp. 19-34. Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York, 1995.
25.
Takayama S. et al. A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders induced by drugs in rats. J Am Coll Toxicol1995; 14: 266-292.
26.
Evenson DPFlow cytometry of acridine orange stained sperm is a rapid and practical method for monitoring occupational exposure to genotoxicants. In Monitoring of Occupational Genotoxicants (ed. M Sorsa and H Norrpa). pp 121-132. Alan R Liss, New York, 1986.
27.
Anderson D. , Dobrzynska MM, Basaran N.The effects of various genotoxins and reproductive toxins in human lymphocytes and sperm in the comet assay. Teratogenesis, Carcinogenesis, Mutagenesis1997; 17: 29-43.
28.
Chapin RE, Heindel JJMethods in Toxicology Volume 3A. Male Reproductive Toxicology (series ed. CA Tyson and H Witschi). pp. 389. Academic Press Inc, 1993.
29.
Chapin RE et al. Methods for assessing rat sperm motility. Reprod Toxicol1993; 6: 267-273.
30.
Freeman SJ, Brown NASub-mammalian and sub-vertebrate models in teratogenicity screening. In In Vitro Methods in Toxicology (ed CK Atterwill and CE Steele) , pp. 391-409. Cambridge University Press, 1987.
31.
Atterwill CK, Steele CE In Vitro Methods in Toxicology. pp. 458. Cambridge University Press, Cambridge, 1987.
32.
Villneuve DC , Koeter Hbwm, Becking GCProceedings of The International Workshop On In Vitro Methods In Reproductive Toxicology-Ottawa, Canada, 19-20 May 1992. Reproductive Toxicology1993; 7: Suppl. 1.
33.
Wang Y-L., Brown NAExpression patterns of Hox-B1, -B2 and Krox 20 in triazole-treated rat embryos suggest thombomere reduction and loss. Teratology1994; 49: 380.
34.
Wood H., Pall G., Morriss-Kay G.Exposure to retinoic acid before or after the onset of somitogenesis reveals separate effects on rhombormeric segmentation and 3' HoxB gene expression domains. Development1994; 120: 2279-2286.
35.
Marshall H. et al. Retinoic acid alters hindbrain Hox code and induces transformation of rhombomeres 2/3 into a 4/5 identity. Nature1992; 360: 737-741.
36.
Flint OP, Orton TCAn in vitro assay for teratogens with cultures of rat embryo midbrain and limb-bud cells. Toxicol Appl Pharmacol1984 ; 76: 383-395.
37.
Piersma AH et al. Interlaboratory evaluation of embryotoxicity in the postimplantation rat embryo culture. Reprod Toxicol1995; 9: 275-280.
38.
Brown NA et al. Screening chemicals for reproductive toxicity: the current alternatives. The report and re-commendations of an ECVAM/ETS workshop (ECVAM workshop 12). A.T.L.A.1995; 23: 868 -882.
39.
Laschinski G. , Vogel R., Spielmann H.Cytotoxicity test using blastocyst-derived euploid embryonal stem cells: A new approach to in vitro teratogenesis screening. ReproductiveToxicology1991; 5: 57-64.
40.
Heuer J., Bremer S., Pohl I., Spielmann H.Development of an in vitro embryotoxicity test using murine embryonic stem cell cultures. Toxic In Vitro1993; 7: 551 -556.
41.
Newall DR, Beedles KEThe stem-cell test: a novel in vitro assay for teratogenic potential. Toxic In Vitro1994; 8: 697-701.
42.
Newall DR, Beedles KEThe stem-cell test, an in vitro assay for teratogenic potential: results of a blind trial with 25 compounds. Toxic In Vitro1996; 10: 229-240.
43.
Newall DR and Beedles KE. Unpublished data.
44.
Slotkin TA, Lav C., Lapi SE and Seidler FJCan intracellular signalling pathways predict developmental abnormalities. Sensitivity of the adenylyl cyclase/c-fos proto-oncogene cascade to β-adrenergic agonists and glucocorticoids in foetal rat. Biomarkers1: 115 -122.
45.
Hooghe RJ, Ooms D.Use of the fluorescence-activated cell sorter (FACS) for in vitro assays of developmental toxicity. Toxic In Vitro1995 ; 9: 349-354.
