o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals
o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals
o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals
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OECD SIDS o-<strong>TOLUIDINE</strong><br />
5. TOXICITY ID: <strong>95</strong>-<strong>53</strong>-4<br />
DATE: 07.01.2005<br />
CONTROLS<br />
---Subcutaneous fibromas and fibrosarcomas: 0/16--18/23(significant)-<br />
21/24(significant)--18/111<br />
---transitional cell carcinomas of the urinary bladder<br />
0/16--3/23-4/24--5/111<br />
---Multiple tumours<br />
3/16--6/23-8/24(significant)--14/111<br />
There were 6 cases where a fibroma or a fibrosarcoma occurred along with<br />
a transitionalcell carcinoma of the bladder.<br />
In 8 instances pituitary or adrenal adenomas were seen along with<br />
subcutaneous tumours(no details specified)<br />
Test condition : TEST ORGANISMS<br />
- Age: 6-8 weeks<br />
Acclimation period: 2 weeks<br />
- Number of animals: 25 per group<br />
ADMINISTRATION /EXPOSURE<br />
- Diet: purina certified rodent diet<br />
- Doses:<br />
Doses were chosen based on prelimminary 30-day feeding study followed<br />
by a 2-week recovery period (no further information)<br />
---Initially 8000, 16000 ppm (approximately 600, 1200 mg/kg bw/day) over<br />
feeding period of 3 months,<br />
---Reduction of doses after 3 months because weight gain was by 10 %<br />
below that observed in the concurrent controls:<br />
4000, 8000 ppm (approximately 300, 600 mg/kg bw/day)<br />
OBSERVATIONS:<br />
body weights<br />
NECROPSY:<br />
Animals which died during the first 6 month of treatment were discarded<br />
without necropsy.<br />
A complete gross necropsy was done on all animals which died after 6<br />
month on test or were killed at the end of the study.<br />
Tissues were fixed, sectioned, and stained by hematoxylin and eosin.<br />
HISTOPATHOLOGY<br />
Histopathological examinations were done on all grossly abnormal organs,<br />
tumor masses, lung, liver, spleen, kidney, adrenal, heart, bladder, stomach,<br />
intestines, reproductive organs, and pituitaries.<br />
STATISTICS<br />
Statistical analysis of tumors found was performed using the Fisher exact<br />
testwith Bonferroni correction.<br />
Reliability : (2) valid with restrictions<br />
Study doesn't meet the criteria of today and is reported in brief<br />
Flag : Critical study for SIDS endpoint<br />
13.07.2004 (354) (355) (356) (357) (150)<br />
Species : rat<br />
Sex : male/female<br />
Strain : Fischer 344<br />
Route of admin. : oral feed<br />
Exposure period : 104 Wochen<br />
Frequency of treatm. : continuously<br />
Post exposure period : none<br />
Doses : 0, 3000, 6000 ppm (approximately 0, 225, 450 mg/kg bw/day)<br />
Result : positive<br />
Control group : yes, concurrent no treatment<br />
Method : other: Carcinogenesis bioassay see also freetext TC<br />
Year : 1979<br />
GLP : no data<br />
Test substance : other TS: o-Toluidine hydrochloride, purity: >99 %<br />
<strong>UNEP</strong> PUBLICATIONS 243