m-Cresol - ipcs inchem

OECD SIDS
p-CRESOL
5. TOXICITY ID: 106-44-5
DATE: 24.05.2004
No. of generation : 2
studies
Doses : 0, 30, 175, 450 mg/kg bw
Control group : yes, concurrent vehicle
NOAEL parental : ca. 30 mg/kg bw
other: NOAEL (fertility) : ca. 450 mg/kg bw
Result : see freetext RS
Method : EPA OPP 83-4
Year : 1989
GLP : yes
Test substance : other TS: p-cresol, 98.93% pure
Remark : 25 rats/sex/dose (F0) were administered p-cresol in corn oil. Exposure
began 10 weeks prior to breeding and continued in the females throughout
mating, gestation and lactation.
25 randomly selected F1 pups/sex/dose were gavaged with the appropriate
concentration of p-cresol for 11 weeks and then bred to produce F2 litters
(dosing was continued throughout mating, gestation and lactation).
The F2 offspring were sacrificed at weaning.
Reproductive Indices: mating indices for males and females, fertility indices
for male and females, gestational index, live birth index, 4-day survival
index, 7-day survival index, 14-day survival index, 21-day survival index,
lactation index
Necropsy and pathology:
all F0 and F1 parental rats in all groups were subjected to a complete
necropsy ; 25 male and 25 female adults from the controls and from the
high dose groups were subjected to histopathology examination: pituitary,
vagina, uterus, ovaries. testes, epididymides, seminal vesicles, prostate
and other tissues with gross lesions identified as potentially treatment
related; any of thze above organs or tissues showing gross alterations
were also evaluated microscopically in other dose groups
A complete gross necropsy and histopathologic examination were
conducted for any parental rat dying on test
Gross necropsy included examination of the external surfaces, all orificwes,
cranila cavity, carcass, external and cut surfaces of the brain and spinal
cord, the thoracic,abdominal and pelvic cavities and their viscera, cervical
tissues and organs
a gross internal examination on any F1 and F2 pup appearing abnormal or
dying on test
Statistical methods:
Levene's test for equal variances,
analysis of variance (ANOVA),
t-test,
Kruskal-Wallis test,
Mann-Whitney U test
Fisher's exact test
Result : Mortality: 8/28 males and 5/25 females at 450 mg/kg bw; 1/25 females at
30 mg/kg bw
Clinical signs of toxicity
occurred in F0 and F1 males and females at 450 mg/kg bw/day and
included hypoactivity, ataxia, twitches, tremors, prostration, urine stains,
audible respiration, perinasal encrustation (not in F0 males), and perioral
wetness occurred at >= 175 mg/kg bw.
body weight:
F0 adult males, sign reduced (p