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m-Cresol - ipcs inchem

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OECD SIDS<br />

m- / p-CRESOL MIXTURE<br />

5. TOXICITY ID: 15831-10-4<br />

DATE: 24.05.2004<br />

Sex : male/female<br />

Strain : other: F334/N<br />

Route of admin. : oral feed<br />

Exposure period : 13 w<br />

Frequency of treatm. : continuously in feed<br />

Post exposure period : no<br />

Doses : 0, 1880, 3750, 7500, 15000, 30000 ppm (see RM)<br />

Control group : yes, concurrent no treatment<br />

NOAEL : 3750 ppm<br />

Method : other: see freetext ME<br />

Year : 1991<br />

GLP : yes<br />

Test substance : other TS: m-/p-cresol (60%:40% mixture)<br />

Method : SIZE OF STUDY GROUP:<br />

20 male and 20 female rats (10 of each group designated for<br />

clinical pathology studies)<br />

TIME HELD BEFORE STUDY: 12-13 days<br />

METHOD OF ANIMAL DISTRIBUTION:<br />

randomized for each sex on the basis of body weight into<br />

groups per sex<br />

DIET: NIH-07 rat ration<br />

ANIMAL ROOM ENVIRONMENT:<br />

temperature: 72° +/-3° F, humidity: 50 % +/-15 %,<br />

Fluorescent light: 12 hrs/day, room air changes: 10-12<br />

changes/hr<br />

TYPE AND FREQUENCY OF OBSERVATION:<br />

observed twice daily, body weight taken initially, weekly,<br />

and at termination, feed consumption by cage recorded twice<br />

weekly<br />

NECROPSY AND HISTOLOGIC EXAMINATION:<br />

necropsy performed on all animals. A complete<br />

histopathologic examination was conducted on all control<br />

animals, all animals in the highest dose group with at least<br />

60 % survivors at study termination, and all aninmals in<br />

higher dose groups inclusive of early deaths. The following<br />

organs and/or tissues were included in complete<br />

histopathological examinations, as well as any tissue<br />

masses, gross lesions, and associated regional lymph nodes:<br />

adrenals, aorta, bone (sternebrae, femur, or vertebrae,<br />

including marrow), brain, bronchi, clitoral gland,<br />

epididymis, oesophagus, heart, kidney, large intestines<br />

(caecum, colon,rectum), liver, lungs, lymph nodes<br />

(mesenteric), mammary glands, nasal cavity and turbinates,<br />

oral cavity, ovaries, pancreas, parathyroids, pharynx,<br />

pituitary, preputial gland, prostate, salivary glands,<br />

scrotal sac, seminal vesicles, skin, small intestine<br />

(duodenum, ileum, jejunum), spleen, stomach, testes, thymus,<br />

thyroid, tongue, trachea, tunica vaginalis, urinary bladder,<br />

uterus and Zymbal's glands. For lower level dose groups, all<br />

gross lesions and the following target organs were examined<br />

histopathologically: bone marrow, nasal mucosa, thyroid<br />

gland, uterus. Organ weights recorded for brain, liver,<br />

right kidney, thymus, heart, and lungs of all animals, and<br />

the right testis of all males.<br />

HAEMATOLOGIC, CLINICAL CHEMISTRY, and URINALYSIS<br />

determinations included.<br />

haematocrit, haemoglobin, red blood cell count, mean cell<br />

volume (only females), meam cell haemoglobin, mean cell<br />

haemoglobin concentration (only females), platelets,<br />

reticulocytes, white blood cell count, lymphocytes,<br />

354<br />

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