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

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%.
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