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Interim report on the genetic and animal toxicity testing of SRC-I products, intermediates, and waste materials. Appendix E. Subchronic dermal studies reports

Technical Report ·
OSTI ID:6821177
The objective of this study was to determine the dosage levels to be employed in a 13-week toxicity study in rats. A maximum tolerated dose was not achieved in the conduct of this study. Dermal irritation at the site of application and a decreased body weight gain attributed to the application of the test article, First Stage Middle Distillate (SRC) were both observed at the low dosage level, 312 mg/kg/day. Compound related observations which were noted at higher dosage levels included dermal irritation, decreased body weight gain, compound related pharmacotoxic signs, and mortality. Test article related macroscopic changes consisting of erythema, thickening, coriaceousness, and ulcerations were observed at the application site of all dosage groups exposed to First Stage Middle Distillate (SRC) for 4 weeks. Neither systemic changes nor changes indicative of a manner of death were observed. The objective of this study was not achieved as a maximum tolerated dose was not obtained, however, an additional 2-week dose-range finding study in rats has been scheduled to augment the findings of this study. A further similar test to the above is described. Similarly, two range finding dermal teratology studies with middle distillate are described. The 1000 and 2000 mg/kg/day treatment groups displayed marked increases in the mean number of postimplantation losses and corresponding decreases in the number of viable fetuses compared to values for the control group. (LTN)
Research Organization:
International Coal Refining Co., Allentown, PA (USA)
DOE Contract Number:
AC05-78OR03054
OSTI ID:
6821177
Report Number(s):
DOE/OR/03054-50-App.E; ON: DE84013330
Country of Publication:
United States
Language:
English