m-Cresol - ipcs inchem

OECD SIDS
m-CRESOL
5. TOXICITY ID: 108-39-4
DATE: 24.05.2004
Reference :
Type : other: subchronic
Species : Rat
Sex : male/female
Strain : other: CD
Route of admin. : Gavage
No. of animals : 20
Vehicle : other: corn oil
Exposure period : 90 day(s)
Frequency of treatm. : Daily
Doses : 0, 50, 150, 450 mg/kg bw/day
Control group : yes, concurrent vehicle
Observation period : 13 weeks during dosing
Result : see freetext RE
Method : other: see freetext ME
Year : 1986
GLP : no data
Test substance : other TS: no data on purity
Method : 10 male and 10 female CD rats/treatment group received corn oil solutions
of 50, 175 or 600 mg/kg bw /day by gavage once daily for 13 weeks. 20
male and 20 female CD rats received corn oil alond to serve as
control.Rats were observed for body weight gain, food consumption,
clinical signs.
Signs of neurobehavioral toxicity were documented during pretreatment, 1
and 6 hours after dosing on study day 1 and prior dosing on study days 2,
7, 14, 30, 60 and 90 including salivation, urination, tremors, piloerection,
diarrhea, pupil size, pupil response, lacrimation, hypothermia, vocalization,
exophthalmus, palpebral closure, convulsions (type and severity),
respiration (rate and type), impaired gait, positional passivity, locomotor
activity, stereotypy, startle response, righting reflex, performance on a wire
maneuver, forelimb grip strength, positive geotropism, extensor thrust, limb
rotation, tail pinch reflex, toe pinch reflex, hind limb splay.
gross and histopathologic examination
Result : Mortality: control: 1 female (2.5 %), 450 mg-gr: 1 female (5 %), gross and
histopathologic examination: aspiration or inhalation of the TS, pulmonary
edema
body weight gain comparable to control
mean food consumption, 450 mg-gr., males and females: significantly less
than control during the initial portion of the study
clinical signs: dose related in incidence: salivation, myotonus, tremors,
urine wet abdomen, hypoactivity, rapid respiration
neurobehavioral toxicity:
450 mg-group, males and females: initial part of the study: incidence of
palpebral closure, rales, laboured respiration; at study termination, females:
significantly increased urination.
Other differences from controls with regard to behavioral tests were
evaluated as sporadic in nature by the authors (no further details given).
necropsy:
brain weights of treated animals comparable to controls; gross and
microscopic examination of tissues revealed no lesions which were
attributable to treatment
Reliability : (2) valid with restrictions
limited documentation (only study summary available)
Flag : Critical study for SIDS endpoint
05.02.2004 (163) (112) (164)
5.10 EXPOSURE EXPERIENCE
156
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