m-Cresol - ipcs inchem

OECD SIDS
m- / p-CRESOL
Conclusion:
The instillation of undiluted m- or p-cresol into the rabbit eye according to the Draize method
resulted in extreme irritation with the risk of serious eye damage.
3.1.4 Sensitisation
m-Cresol:
There is no study available using m-cresol.
p-Cresol:
A modified Draize test was performed on 10 guinea pigs (males and females). Preliminary irritation
studies were performed to determine the suitable concentrations: the intradermal injection challenge
concentration was a 0.1 % solution and the application challenge concentration was a 10 %
solution. p-cresol did not induce sensitization in guinea pigs (Sharp 1978).
Human data:
A maximization test was conducted on 25 volunteers using a 4 % concentration of p-cresol in
petrolatum. The maximization test involved an induction phase of 5 consecutive 48-hr covered
patch tests, sometimes separated by 24-hr periods of treatment with a mild irritant, followed 10 - 14
days later by a 48-hr challenge patch using the same concentration. There were no sensitization
reactions in any of the volunteers (Kligman 1972).
m/p-Cresol:
In a study in which a 7.5 % solution of a mixture of m- and p-cresol in acetone was repeatedly
applied to the skin of guinea pigs, sensitization was not observed (DECOS, 1998).
Conclusion:
There is no indication of a sensitizing effect of p-cresol and m/p-cresol from a limited guinea pig
study and a limited human study. No sensitization test was available for m-cresol. In a survey article
hypersensitivity reactions of some individuals to cresol (isomer unspecified) have been mentioned
(Deichmann and Keplinger 1981).
3.1.5 Repeated Dose Toxicity
Oral application
Regenerative changes in the nasal epithelia as a result of the irritant effects were the predominant
signs of toxicity following repeated dosing of rats and mice with p-cresol or with the 60:40 m/pcresol
with the feed in 28-day and 13-week studies. At minimum effect levels of 1000 ppm in the
diet (mouse, ca. 200 mg/kg bw/day) and 3000 ppm in the diet (rat, ca. 250 mg/kg bw/day), the liver
was the target organ for the toxic action of m-cresol, p-cresol and the 60:40 m/p-cresol mixture. A
dose-dependent increase in liver weight was observed, but histopathological effects or changes of
parameters indicative of liver toxicity were seen with p-cresol at high doses only. In the 13-week
feeding study with m/p-cresol transitory increases in serum total bile acids, alanine
aminotransferase and sorbitol dehydrogenase near the start of the study suggested that
hepatocellular injury with a decrease in hepatocellular function may have occurred and regressed in
the course of the study. Kidney weights were increased in male mice after feeding p-cresol for 28
days at 3000 ppm (469 mg/kg bw/day), and lengthened estrous cycles were noted in rats fed with
the m/p-cresol at 7500 ppm (509 mg/kg bw/day) in the 13-week study. In feeding studies bone
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