p-Tert-Butylphenol - UNEP Chemicals

OECD SIDS P-TERT-BUTYLPHENOL
Results: Rats were administered with or without N-Methyl-N’-nitro-Nnitrosoguanidine
(MNNG) at 150 mg/kg b.w. by stomach tube and given
diet containing p-t-butylphenol or basal diet one week later.
[Without MNNG pretreatment] Decrease in the final body weight and
increase in relative liver and kidney weights were observed in p-tbutylphenol
treated rats. Histological changes observed in the forestomach
were hyperplasia (14/15, 0/10 for treated and control), papilloma (1/14,
1/15), carcinoma in situ (0/15, 0/15), and squamous cell carcinoma (0/15,
0/10). No tumors were observed in the other organs examined such as the
esophagus and intestines.
[With MNNG pretreatment] Decrease in the final body weight and increase
in relative liver and kidney weights were observed in p-t-butylphenol treated
rats. Grossly, small papillary or polypoid tumours were found in the
forestomach of control rats, while very large single or multiple tumor masses
occupied the forestomach in treated rats. Histological changes observed in
the forestomach were hyperplasia (20/20, 19/19 for treated and control),
papilloma (19/20, 13/19), carcinoma in situ (8/20, 11/19), and squamous
cell carcinoma (15/20, 5/19). Squamous cell carcinoma in treated group
was significant change, compared to control group. Leiomyosarcoma was
induced in one treated rat. As histological change of the glandular stomach,
adenocarcinoma of fundic region was only observed in one of treated rats.
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 %
Reference: Hirose et al.: 1988
*5.8 TOXICITY TO REPRODUCTION
Type: Fertility [ ]; One-generation study [ ]; Two-generation study [ ];
Other [X]
Species/strain: Rats/Crj:CD (SD)
Sex: Female [ ]; Male [ ]; Male/Female [X]; No data [ ]
Route of Administration: Oral (gavage)
Exposure period: Male: 44 days
Female: from 14 days before mating to day 3 of lactation
Frequency of treatment:
Post exposure observation period:
Premating exposure period: male: 14 days, female: 14 days
Duration of the test:
Doses: 0 (Vehicle), 20, 60, 200 mg/kg/day
Control group: Yes [X]; No [ ]; No data [ ]; 0.5% aqueous methyl cellulose
Concurrent no treatment [ ]; Concurrent vehicle [X]; Historical [ ]
NOEL Parental: 200 mg/kg/day
NOEL F1 Offspring: 200 mg/kg/day
NOEL F2 Offspring:
Results: There were no treatment related toxic effects on pregnant and lactating
females or their offspring.
Method: OECD Combined Repeat Dose and Reproductive/Developmental Toxicity
Screening Test
GLP: Yes [X] No [ ] ? [ ]
Test substance: purity: 99.9%
UNEP Publications 117