title: p-Chloroaniline, t-butylhydroquinone, and methyl carbamate: Rat in vivo comet test, JaCVAM trial phase 4.2.
abstract: As part of the Japanese Center for the Validation of Alternative Methods (JaCVAM)-initiative international validation study of in vivo rat alkaline comet assay, we examined p-Chloroaniline, t-butylhydroquinone, and methyl carbamate. All test materials and controls were dosed orally by gavage. p-Chloroaniline produced a statistically significant increase in the mean and median % tail intensity which was also outside of the historical control range in the liver and stomach of Sprague-Dawley rats. t-Butylhydroquinone caused a statistically significant increase in the mean % tail intensity in the liver and stomach and a statistically significant increase in the median % tail intensity in the liver; however, these results are not considered to be biologically significant as all values obtained fell within the current vehicle historical control range and within the negative control range for mean % tail intensity set by the Validation Management Team (VMT) as a requirement for an acceptable assay. Methyl carbamate did not induce a statistically significant change in the mean or median % tail intensity in either liver or stomach.
authors.affiliation: Huntingdon Life Sciences, Woolley Road, Huntingdon, Cambs PE284HS, UK. Electronic address: barfielw@ukorg.huntingdon.com.
authors.forename: William
authors.initials: W
authors.lastname: Barfield
authors.affiliation: Huntingdon Life Sciences, Woolley Road, Huntingdon, Cambs PE284HS, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: Burlinson
mesh_terms: D000814:Aniline Compounds / Q000633:toxicity*; D000818:Animals; D002219:Carbamates / Q000633:toxicity*; D020552:Comet Assay / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006873:Hydroquinones / Q000633:toxicity*; D008099:Liver / Q000187:drug effects; D008297:Male; D051381:Rats; D017207:Rats, Sprague-Dawley; D013270:Stomach / Q000187:drug effects
chemical_list: D000814:Aniline Compounds; D002219:Carbamates; D006873:Hydroquinones; C036868:methyl carbamate; C018855:2-tert-butylhydroquinone; C004658:4-chloroaniline
keywords: Comet assay; JaCVAM; Methyl carbamate; p-Chloroaniline; t-Butylhydroquinone