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

More documents

Recommendations

Info

OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 156 ---- GROSS PATHOLOGY - ORGAN WEIGHTS (significant changes, test group vs control, absolute(abs) and/or relative(rel)): (1) 13-WEEK-TREATMENT: --Necropsy-bw: 298 g vs 345 g, --Right Kidney: (abs) 1.04g vs 1.13g , (rel) 3.50 vs 3.27 --Liver: (rel) 42.6 vs 34.9 --Spleen: (abs) 2.21g vs 0.73g, (rel) 7.43 vs 2.12 --Right Testis: (abs) 1.51g vs 1.59g, (rel) 5.07 vs 4.61 --Epididymis: (abs) 0.42g vs 0.477g (2) STOP-EXPOSURE+RECOVERY: --Necropsy-bw: 351g vs 389g --Right Kidney: (abs) 1.26g vs 1.38g --Spleen: (abs) 1.13g vs 0.81g, (rel) 3.23 vs 2.08 (3) 26-WEEK-TREATMENT: --Necropsy-bw: 316g vs 389g --Right KIdney: (abs) 1.26g vs 1.38g, (rel) 4 vs 3.6 --Liver: (rel) 45.7 vs 37.1 --Spleen: (abs) 2.84g vs 0.81g, (rel) 9 vs 2.1 --Right Testis: (rel) 4.8 vs 4.2 --Epididymidis: (abs) 0.43g vs 0.484g ---- HISTOPATHOLOGY (selected organs, significant changes: testgroup vs control (severity score: 1=minimal, 2=mild, 3=moderate, 4=marked) 1) 13-WEEK-TREATMENT --Liver, pigmentation, hemosiderin: 20/20 (1.0) vs 0/10 --Kidney: pigmentation: 20/20 (2.0) vs 0/10 --Urinary Bladder: --Transitional Epithelium Hyperplasia: 10/20 (2.2) vs 0/10 --Spleen: --Congestion: 20/20 (2.0) vs 0/10 --Hemapoietic cell proliferation: 20/20(2.0) vs 2/10(1.1) --Pigmentation, Hemosiderin: 20/20(1.6) vs 0/10 --Capsule, fibrosis: 20/20 (1.9) vs 0/10 2) STOP-EXPOSURE+RECOVERY --Liver, pigmentation, hemosiderin: 11/20 (1.0) vs 0/10 --Kidney: pigmentation, hemosiderin: 20/20 (1.1) vs 0/10 --Spleen: --Congestion: 20/20 (1.0) vs 0/10 --Pigmentation, hemosiderin: 18/20(1.0) vs 3/10(1.0) --Capsule, fibrosis: 20/20 (2.2) vs 0/10 --Capsule, lymphatic, angiectasis: 15/20 (1.7) vs 0/10 3) 26-WEEK-TREATMENT --Liver: --Pigmentation, hemosiderin: 20/20 (1.1) vs 0/10, --Foci/cm³tissue: 145 vs 17, --Mean volume(mm³) 0.017 vs 0.0 --Kidney: pigmentation, hemosiderin: 20/20 (2.2) vs 0/10 --Urinary Bladder: --Transitional epithelium hyperplasia 17/18 (2.0) vs 0/10 --Spleen --Congestion: 20/20 (2.0) vs 0/10 --Hematopoietic cell proliferation 20/20(1.9) vs 3/10(1.0) --Pigmentation, hemosiderin: 20/20/1.4) vs 3/10(1.0) --Capsule, fibrosis: 20/20 (2.7) vs 0/10 Test condition : ANIMALS - Age at study initiation: 45 days - Weight at study initiation: 153 g - Number of animals: controls: 20 rats; treated rats: 60 rats UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 ANIMAL MAINTENANCE Housing: 5/cage Time held before studies: 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/SIZE of STUDY GROUPS 1.) 13-weeks treatment: 10 control rats; 20 rats (o-toluidine hydrochloride) 2.) Stop-exposure-experiment: (13 week-treatment-period was followed by a 13-week recovery period) 20 rats (o-toluidine hydrochloride) 3.) 26-weeks treatment: 10 control rats; 20 rats (o-toluidine hydrochloride) CLINICAL OBSERVATIONS AND FREQUENCY: - Clinical signs: twice daily, reported weekly - Mortality: twice daily - Body weight: weekly - Food consumption: weekly NECROPSY AND HISTOLOGIC EVALUATIONS: Complete necropsies were performed on all rats exposed to 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 (first experiment) and at the end of the studies(second and third experiment). 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. SUPPLEMENTAL EVALUATION (see chapter 5.7: carcinogenicity) 26-week continuous treatment: liver samples were collected and examined for placental glutathione Stransferase-positive foci Conclusion : 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). In rats administered o-toluidine, spleen effects were induced and were also reflected by congestion and markedly increased spleen weights. During the recovery period of the stopexposure groups incidences of hemosiderin accumulation and hematopoiesis were decreased, but the capsular fibrosis did not resolve. Hyperplasia of the transitional epithelium in the urinary bladder was observed in rats did not increase in severity after 26 weeks of continuous exposure but completely regressed in the stop-exposure group during the recovery period. Reliability : (2) valid with restrictions only male rats used, only one dose group, no clinical chemical and UNEP PUBLICATIONS 157
Page 1 and 2:
OECD SIDS o-TOLUIDINE FOREWORD INTR
Page 3 and 4:
OECD SIDS o-TOLUIDINE 11. Comments:
Page 5 and 6:
OECD SIDS o-TOLUIDINE and transitio
Page 7 and 8:
OECD SIDS o-TOLUIDINE countries), e
Page 9 and 10:
OECD SIDS o-TOLUIDINE 1.3 Physico-C
Page 11 and 12:
OECD SIDS o-TOLUIDINE methylene-bis
Page 13 and 14:
OECD SIDS o-TOLUIDINE Table 3 Photo
Page 15 and 16:
OECD SIDS o-TOLUIDINE With adapted
Page 17 and 18:
OECD SIDS o-TOLUIDINE Table 8 Geoac
Page 19 and 20:
OECD SIDS o-TOLUIDINE polluted site
Page 21 and 22:
OECD SIDS o-TOLUIDINE depending on
Page 23 and 24:
OECD SIDS o-TOLUIDINE prepared from
Page 25 and 26:
OECD SIDS o-TOLUIDINE 3.1.2 Acute T
Page 27 and 28:
OECD SIDS o-TOLUIDINE 3.1.4 Sensiti
Page 29 and 30:
OECD SIDS o-TOLUIDINE Inhalation Th
Page 31 and 32:
OECD SIDS o-TOLUIDINE males or fema
Page 33 and 34:
OECD SIDS o-TOLUIDINE examination y
Page 35 and 36:
OECD SIDS o-TOLUIDINE Conclusion Th
Page 37 and 38:
OECD SIDS o-TOLUIDINE According to
Page 39 and 40:
OECD SIDS o-TOLUIDINE The lowest te
Page 41 and 42:
OECD SIDS o-TOLUIDINE 4.2 Terrestri
Page 43 and 44:
OECD SIDS o-TOLUIDINE 6 REFERENCES
Page 45 and 46:
OECD SIDS o-TOLUIDINE Bringmann G,
Page 47 and 48:
OECD SIDS o-TOLUIDINE Hecht SS, El-
Page 49 and 50:
OECD SIDS o-TOLUIDINE phase extract
Page 51 and 52:
OECD SIDS o-TOLUIDINE Stark M (1892
Page 53 and 54:
OECD SIDS o-TOLUIDINE I U C L I D D
Page 55 and 56:
OECD SIDS o-TOLUIDINE 1. GENERAL IN
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
OECD SIDS o-TOLUIDINE 2. PHYSICO-CH
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
OECD SIDS o-TOLUIDINE 3. ENVIRONMEN
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106: OECD SIDS o-TOLUIDINE 4. ECOTOXICIT
Page 129 and 130: OECD SIDS o-TOLUIDINE 5. TOXICITY I
Page 155: OECD SIDS o-TOLUIDINE 5. TOXICITY I
Page 207 and 208:
OECD SIDS o-TOLUIDINE 5. TOXICITY I
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
Page 223 and 224:
Page 225 and 226:
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Page 245 and 246:
Page 247 and 248:
Page 249 and 250:
Page 251 and 252:
Page 253 and 254:
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261 and 262:
Page 263 and 264:
Page 265 and 266:
Page 267 and 268:
Page 269 and 270:
Page 271 and 272:
Page 273 and 274:
Page 275 and 276:
OECD SIDS o-TOLUIDINE 6. REFERENCES
Page 277 and 278:
Page 279 and 280:
Page 281 and 282:
Page 283 and 284:
Page 285 and 286:
Page 287 and 288:
Page 289 and 290:
Page 291 and 292:
Page 293 and 294:
Page 295 and 296:
Page 297:
show all

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

Create successful ePaper yourself

Delete template?

Save as template?