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EC number: 203-398-6
CAS number: 106-44-5
There is no carcinogenicity bioassay or other chronic study available to assess the carcinogenic potential of p-cresol. However, for read across purposes, the recently published studies on carcinogenicity with m/p-cresol mixture (60:40; US Department of Health and Human services 2007) is considered.
Concentration in feed
0, 1,500, 10,000 or 15,000 ppm
equivalent to average daily doses of approximately 0, 70, 230, 720 mg/kg
15,000 ppm group: less than the control group
Survival rates : 33/50, 34/50, 33/50, 31/50
pelvis, transitional epithelium, hyperplasia (0/50, 0/50, 2/50, 8/50);
severity of nephropathy (1.4, 1.4, 1.7, 2.1)
goblet cell, hyperplasia (23/50, 40/50, 42/50, 47/50);
respiratory epithelium, hyperplasia (3/50, 17/50, 31/50, 47/50)
respiratory epithelium, metaplasia, squamous (0/50, 1/50, 8/50, 40/50);
inflammation (17/50, 19/50, 19/50, 28/50)
eosinophilic focus (14/50, 14/50, 13/50, 23/50)
renal tubule adenoma
--standard evaluation - 0/50, 0/50, 0/50, 3/50;
--standard and extended evaluations combined - 0/50, 0/50, 0/50, 4/50(8%)
Level of evidence of carcinogenic activity : equivocal evidence
Under the conditions of these 2-year studies (oral feed, 0, 1500, 5000
or 15000 ppm = equivalent to average daily doses of approx. 0, 720, 230,
or 720 mg/kg bw/day), there was equivocal evidence of carcinogenetic
activity of 60:40 m/p-cresol in male F344/N rats based on the marginally
increased incidence of renal tubule adenoma. The LOAEL(male rats) is
therefore 720 mg/kg bw/day.
No classification is required
There is no carcinogenicity bioassay or other chronic study available to
assess the carcinogenic potential of p-cresol.
However, for read across purposes, the recently published studies on
carcinogenicity with m/p-cresol mixture (60:40; US Department of Health
and Human services 2007) will be considered.
In 2007, US Health and Human Services published a Toxicity and
Carcinogenicity Study in which only male rats or only female mice were
fed m/p-cresol mixture over a period of two years without interim kill.
Neither absolute/relative organ weights nor blood biochemistry data were
reported so far. The report contains only histopathological data.
Male F344/N rats received in feed 0, 1500, 5000, or 15000 ppm (=
equivalent to daily doses of approx. 0, 70, 230 or 720 mg/kg bw/day) for
105 weeks. Under the condition of these 2-year studies, there was
equivocal evidence of carcinogenic activity on m/p-cresol based on the
4/50 male rats with renal tubular adenomas. The incidence of these
neoplasms was not significant but exceeded the historical control data
of the laboratory (1/297[feed studies]).
Female B6C3F1 mice received in feed 0, 1000, 3000, 10000 ppm (=
equivalent to dailydoses of approx. 0, 100, 300 or 1040 mg(kg bw/day)
for 104-105 weeks. Under the conditions of these 2-year studies there
was some evidence of carcinogenic activity of m/p-cresol mixture based
on the increased incidence of forestomach squamous cell papillomas.
However, there is no human counterpart for the rodent forestomach
(Proctor et al., Toxicol Sci 98, 313 -326, 2007). Therefore, the
forestomach squamous cell paplillomas are of minor significance for the
human situation. In addition, due to the corrosive property of the test
substance, chronic irritation is expected to be the mode of action.
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