p-Tert-Butylphenol - UNEP Chemicals

OECD SIDS P-TERT-BUTYLPHENOL
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or nestic downward growth beyond the muscularis mucosa. No abnormal
findings were observed in liver, kidneys, cheek pouch, lung, pancreas and
urinary bladder.
Method: Other
GLP: Yes [ ] No [X] ? [ ]
Test substance: purity: > 95 %
Remarks: [ 3 H]thymidine incorporation study was also conducted together with this
study. See Section 5.10.A.
Reference: Hirose et al.: 1986
(d)
Species/strain: Fischer 344 rats
Sex: Female [ ]; Male [X]; Male/Female [ ]; No data [ ]
Route of Administration: Oral (feed)
Exposure period: 51 weeks
Frequency of treatment:
Post exposure observation period: 1 week
Dose: 15 g/kg diet (calculated daily dose as 420 g of body weight and 30 g/day of
food consumption: 1.07 g/kg b.w.)
Control group: Yes [X]; No [ ]; No data [ ];
Concurrent no treatment [X]; Concurrent vehicle [ ]; Historical [ ]
Results: Decrease in the final body weight and increase in relative liver and kidney
weights were observed in treated rats. Histological changes observed in the
forestomach were hyperplasia (14/15, 0/10 for treated and control rats,
respectively) but papilloma (1/14, 1/15), carcinoma in situ (0/15, 0/15) and
squamous cell carcinoma (0/15, 0/10) were no changes. No tumors were
observed in the other organs examined such as the esophagus and
intestines.
Method: Other
GLP: Yes [ ] No [X] ? [ ]
Test substance: purity: > 95 %
Remarks: Major purpose of this study was to examine the promoting property of
phenolic antioxidants including p-t-butylphenol by two-stage protocol. The
result was given at section 5.7.
Reference: Hirose et al.: 1988
*5.5 GENETIC TOXICITY IN VITRO
A. BACTERIAL TEST
(a)
Type: Bacterial gene mutation assay
System of testing: S. typhimurium TA98, TA100, TA1535, TA1537
E. coli WP2 uvrA
Dose: -S9 mix: 0, 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate (TA100, TA1535,
TA98, TA1537), 0, 31.3 - 1000 µg/plate (WP2)
+S9 mix: Same as -S9 mix.
Metabolic activation: With [ ]; Without [ ]; With and Without [X]; No data [ ]
S9: Rat liver, induced with phenobarbital and 5,6-benzoflavone
Plate/test 3
Number of replicates: 2
Results:
Cytotoxicity conc: With metabolic activation: 500 µg/plate (five strains)
Without metabolic activation: 500 µg/plate (TA100, TA1535, TA1537) 1000
µg/plate (WP2 and TA98)
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