title: The testing of chemicals in the Syrian hamster embryo (SHE) cell transformation assay for assessment of carcinogenic potential.
abstract: The Syrian hamster embryo (SHE) cell transformation assay was used to test 28 chemical substances for their ability to induce morphologically transformed colonies. The purpose was to determine how well the assay method could be transferred from an experienced laboratory by including 18 chemicals previously evaluated and 10 new chemicals. Technical training was obtained in the experienced lab prior to testing. The assay was conducted at pH 6.7, a treatment period of 7 days was used, and single experiments were performed for each chemical. With this limited testing, 78% concordance with rodent bioassay results was obtained, and this high concordance would have increased if small, but statistically negative responses from single trials were overturned by positive data from repeat trials. Similarly, the results were highly concordant (90%) with the experienced lab results; only 2 chemical evaluations were discordant, and the use of repeat experiments would likely have eliminated these apparent disagreements. Thus, with appropriate training, the pH 6.7 SHE assay was successfully and reliably transferred.
authors.affiliation: Department of Product Safety, Regulations, Toxicology and Ecology, BASF Aktiengesellschaft, D-67056 Ludwigshafen, Germany. guenter.engelhardt@basf-ag.de
authors.forename: G
authors.initials: G
authors.lastname: Engelhardt
authors.forename: K-R
authors.initials: KR
authors.lastname: Schwind
authors.forename: B
authors.initials: B
authors.lastname: Mussler
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests / Q000379:methods*; D002273:Carcinogens / Q000633:toxicity*; D002471:Cell Transformation, Neoplastic / Q000187:drug effects*; D006224:Cricetinae; D015925:Cryopreservation; D004622:Embryo, Mammalian / Q000166:cytology; D005260:Female; D008647:Mesocricetus; D011237:Predictive Value of Tests; D011247:Pregnancy
chemical_list: D002273:Carcinogens