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 266 ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): Complete necropsies were performed on all rats exposed to o-nitrotoluene or o-toluidine hydrochloride for 13 weeks, 13 weeks with 13 weeks of recovery, or 26 weeks. The right kidney, liver, spleen, right testis, and epididymis of all control rats and 10 of 20 rats from each exposure group were weighed. Histopathologic evaluations were performed on all rats at the 13-week interim evaluation and at the end of the studies. The following tissues were examined in all groups: epididymides (three portions of each), gross lesions, liver, right kidney, spleen, and testes. The urinary bladder was also examined in rats administered o-toluidine hydrochloride for 13 or 26 weeks. STATISTICAL METHODS: ANALYSIS OF LESION INCIDENCES The Fisher exact test (Armitage, 1971; Gart et al., 1979), a procedure based on the overall proportion of lesion-bearing animals, was used to evaluate histopathologic lesion data. ANALYSIS OF CONTINUOUS VARIABLES Organ and body weight data, which have approximately normal distributions, were analyzed with the parametric multiple comparison procedures of Dunnett (1955). Reliability : (2) valid with restrictions not according to the current guideline for fertility assessment Flag : Critical study for SIDS endpoint 02.06.2004 (157) 5.9 SPECIFIC INVESTIGATIONS 01.12.2003 5.10 EXPOSURE EXPERIENCE Type of experience : other: Biological monitoring Remark : Incidence rates of bladder cancer among workers at a chemical plant in western New York were compared with those of the population of New York State (excluding New York City). Among all 1749 workers at the plant, 13 cases of bladder cancer were observed versus 3.61 expected. Among the 708 workers who worked in areas in wich o-toluidine and aniline were used, 7 cases were observed versus 1.08 expected. Further studies on method evaluations for biomonitoring workers at chemical plants on urine excretion and hemoglobin-adducts. Reliability : (2) valid with restrictions basic data given Flag : Critical study for SIDS endpoint 03.06.2004 (384) (385) (386) (387) (388) (389) (390) (391) Type of experience : other: Biological monitoring Remark : Blood samples from 73 workers from a factury producing plastic ware. Method development to measure hemoglobin adducts of over 30 arylamines. From the measured Hb-adduct levels the daily dose which were then compared to rodent carcinogenic potency data. The index for o-toluidine was 0.3%. UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 Investigations at workes in a dystaff facility (USA). Urine samples were taken before and after a work shift for 12 probably exposed workers and 8 presumably unexposed workers, and analyzed. Nine of the 12 personal time weighted average air measurement for the likley to have been exposed group had detectable levels of o-toluidune. None of the nonexposed group had detectable levels of o-tuluidine. Average urinary concentrations of o-toluidine were about eight times higher among exposed than probably unexposed workers. Reliability : (4) not assignable method evaluation 03.06.2004 (392) (393) (394) (395) Type of experience : other: Hemoglobin adducts in humans Remark : Hemoglobin adducts of 15 aromatic amines were determined in nonsmokers and smokers living in Turin, Italy. Blood samples from 25 nonsmokers and 61 smokers were examined. There was an increase of o-toluidine-HB adducts in smokers 310 pg/g HB versus 188 pg/g in nonsmokers. Reliability : (2) valid with restrictions Method evaluation for routinely monitoring of HB adducts in humans, basic data available Flag : Critical study for SIDS endpoint 03.06.2004 (396) (397) Type of experience : Health records from industry Remark : The study examined 868 of the 906 workers employed in the dyestuff industry in Italy between 1922 and 1970. Mortality in the years 1946-1976 was determined and compared with the totale male population. 5 cases of death caused by bladder cancer were reported in a subgroup of 53 workers in the rosaline and safranine T production who were exposed to a mixture of toluene, o-nitrotoluene, o-toluidine and 4,4-methylene-bis-(2methylaniline) (3 death) or 4,4-methylene-bis-(2-methylaniline, onitrotoluene, aniline, rosaniline and safranine (2 death) Reliability : (4) not assignable exposure against a mixture of substances (aromatic amines), no concentrations given Flag : Critical study for SIDS endpoint 18.02.2004 (398) Type of experience : Health records from industry Remark : concentrations of 40 ppm (176 mg/m3) o-Toluidin in the atmosphere for more than 60 minutes caused severe toxic effects in persons, 10 ppm (44 mg/m3) lead to symptoms of illness and concentration in the atmosphere greater than 5 ppm (22 mg/m3) indicate unsatisfactory conditions. Test substance : o-, m-, p-toluidine, isomer not specified Reliability : (2) valid with restrictions exposure against a mixture of toluidine isomeres Flag : Critical study for SIDS endpoint 18.02.2004 (399) Type of experience : Health records from industry Remark : 98 cases of bladder cancer were observed among industrial workers between 1903 and 1955. Most of this persons had been exposed to 2naphthylamine, either alone or together with other aromatic amines; in addition, 11 cases were mentioned for which the exposure had involved UNEP PUBLICATIONS 267
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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