o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 242 GLP : yes Test substance : other TS: o-Toluidine hydrochloride, purity: 100 % Remark : For general toxicity: See also Chapter 5.4 Result : LIVER: Foci/cm³ tissue: 145 versus 17 in samples of control rats mean volume (mm³): 0.017 versus 0.0 in samples of control rats Test condition : TEST ORGANISMS - Age: 45 days - Weight at study initiation: 153 g - Number of animals: control rats: 10; 20 rats treated with o-toluidine hydrochloride ANIMAL MAINTENANCE Housing: 5/cage Time held before study start: 9 days Diet: NIH-07 Open Formula Diet ad libitum Water: ad libitum Room air: temperature: 72°F, humidity: ca. 50 %, 10 room air changes per hour fluorescent light: 12 hour day cycle ADMINISTRATION / EXPOSURE rats were fed with o-toluidine hydrochloride for 26 weeks CLINICAL OBSERVATIONS AND FREQUENCY: see chapter 5.4 NECROPSY AND HISTOPATHLOGICAL EVALUATION: see chapter 5.4 SUPPLEMENTAL EVALUATION liver samples were collected and examined for placental glutathione Stransferase-positive foci STATISTICAL METHODS: The number of placental glutathione S-transferase PGST) - positive foci per cubic centimeter of liver and the volume fraction of liver occupied by PGST-positive foci were analyzed with Wilcoxon's rank sum test (Conover, 1971) Reliability : (2) valid with restrictions special investigation: only 1 dose used, only male rats; treatment time was to short for a general carcinogenicity investigation Flag : Critical study for SIDS endpoint 24.05.2004 (157) Species : rat Sex : male Strain : other: CD Route of admin. : oral feed Exposure period : 18 months Frequency of treatm. : continuously Post exposure period : 6 months Doses : 3 months: 8000, 16000 ppm (approx. 600, 1200 mg/kg bw/day); 15 months: 4000, 8000 ppm (approx. 300, 600 mg/kg bw/day) Result : positive Control group : yes, concurrent no treatment Method : other: see freetext TC Year : 1972 GLP : no data Test substance : other TS: o-Toluidine hydrochloride, purified by treatment with charcoal, purity controlled by thin layer chromatography (no further data) Result : o-toluidine was carcinogenic in all groups. CONCURRENT CONTROL--LOW DOSE-HIGH DOSE--POOLED UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 CONTROLS ---Subcutaneous fibromas and fibrosarcomas: 0/16--18/23(significant)- 21/24(significant)--18/111 ---transitional cell carcinomas of the urinary bladder 0/16--3/23-4/24--5/111 ---Multiple tumours 3/16--6/23-8/24(significant)--14/111 There were 6 cases where a fibroma or a fibrosarcoma occurred along with a transitionalcell carcinoma of the bladder. In 8 instances pituitary or adrenal adenomas were seen along with subcutaneous tumours(no details specified) Test condition : TEST ORGANISMS - Age: 6-8 weeks Acclimation period: 2 weeks - Number of animals: 25 per group ADMINISTRATION /EXPOSURE - Diet: purina certified rodent diet - Doses: Doses were chosen based on prelimminary 30-day feeding study followed by a 2-week recovery period (no further information) ---Initially 8000, 16000 ppm (approximately 600, 1200 mg/kg bw/day) over feeding period of 3 months, ---Reduction of doses after 3 months because weight gain was by 10 % below that observed in the concurrent controls: 4000, 8000 ppm (approximately 300, 600 mg/kg bw/day) OBSERVATIONS: body weights NECROPSY: Animals which died during the first 6 month of treatment were discarded without necropsy. A complete gross necropsy was done on all animals which died after 6 month on test or were killed at the end of the study. Tissues were fixed, sectioned, and stained by hematoxylin and eosin. HISTOPATHOLOGY Histopathological examinations were done on all grossly abnormal organs, tumor masses, lung, liver, spleen, kidney, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries. STATISTICS Statistical analysis of tumors found was performed using the Fisher exact testwith Bonferroni correction. Reliability : (2) valid with restrictions Study doesn't meet the criteria of today and is reported in brief Flag : Critical study for SIDS endpoint 13.07.2004 (354) (355) (356) (357) (150) Species : rat Sex : male/female Strain : Fischer 344 Route of admin. : oral feed Exposure period : 104 Wochen Frequency of treatm. : continuously Post exposure period : none Doses : 0, 3000, 6000 ppm (approximately 0, 225, 450 mg/kg bw/day) Result : positive Control group : yes, concurrent no treatment Method : other: Carcinogenesis bioassay see also freetext TC Year : 1979 GLP : no data Test substance : other TS: o-Toluidine hydrochloride, purity: >99 % UNEP PUBLICATIONS 243
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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