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 254 Body weight were similar to controls. No tumors induced Test condition : TEST ORGANISMS - Age: 8 weeks - Weight at study initiation: 110 g - Number of animals: 15 ADMINISTRATION / EXPOSURE - Duration of test/exposure: 87 / 52 weeks - Type of exposure: subcutan - Post exposure period: approx. 30 weeks - Vehicle: peanut oil CLINICAL OBSERVATIONS AND FREQUENCY - Clinical signs: once a week after injection - Body weight: yes, no data on frequency - Mortality: no data on frequency ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): - All remaining animals were killed after 87 experimental weeks. Upon necropsy, gross lesions and representative samples of major organs were fixed in 10% buffered formalin and processed for microscopic evaluation. Reliability : (4) not assignable documentation insufficient for assessment and meets not the criteria of today 03.06.2004 (367) (356) Species : other: hamster; mammalian cell transformation assay Sex : Strain : other: Chinese hamster ovary (CHO) cells and Syrian hamster embryo cells Route of admin. : Exposure period : Frequency of treatm. : Post exposure period : Doses : 0.0, 0.1, 0.25, 0.5 µl/ml in culture medium Result : negative Control group : yes Method : other: cell transformation assay according Pienta et al., 1977 Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : No induction of cell transformation was observed for o-toluidine No cytotoxicity was observed. The positive controls were functional. Test condition : Treatment: Test compounds were dissolved in DMSO and the stock solutions were added to the cells in roller bottles. The compound were added 4h after seeding the cells and the treatment occurred over 4 consecutive days. Metabolic activation of the compounds was achieved by cocultivation with irradiated primary syrian hamster embryo cells. Determination of cell-transforming frequencies The transformed phenotype of CHO cells consistes out of colonies in agar that show an INvasive Growth in Agar (INGA). The transformed colonies were counted and the frequency was calculated by dividing the number of transformed clones by the total number pf clones in agar. B(a)P and EMS served as positive controls. Reliability : (2) valid with restrictions UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 no data on GLP and the purity of the test substance 25.05.2004 (173) (368) Species : other: hamster; mammalian cell transformation assay Sex : Strain : other: Syrian hamster embryo (SHE) cells Route of admin. : Exposure period : Frequency of treatm. : Post exposure period : Doses : 0, 9, 11, 13, 15, 17, 19 mM Result : Control group : yes Method : other: Adenovirus (SA7) transformation assay as prescribed by Casto, B.C. (1973): Progr. Esp. Tumor Res. 18, 166-198 Year : 1985 GLP : no data Test substance : other TS: o-toluidne, no data on purity Result : o-Toluidine was tested over a narrow dose range because preliminary cytotoxicity experiments indicated a sharp toxicity breakpoint. Enhancement of virus transformation was observed at 15, 13, and 9 mM. This enhancement was independent of cytotoxicity at 15 and 9 mM. In Experiment 2 a similar dose range was employed and a similar cytotoxicity was produced, but no activity was detected using an alternate pool of primary embryo cells. Test condition : o-toluidine was tested for the ability to enhance the potency of adenovirus (SA7) to transform Syrian hamster embryo (SHE) cells: For determination of the enhancement ratio, the transforming frequency obtainde from virus and chemically treated cells was devided by the transforming frequency obtained from cells inoculated with the virus only. Statistical significance was deterimined from a table of critical ratios constructed from Poisson distribution tables of significance developed by Lorenz. Priliminary test for cytotoxicity of o-toluidine on SHE cells were performed: concentrations resulting in >=50 % cytotoxicity was seledted as the highest concentration As positive controls served B(a)P and 1,2-Dichloroethane(DCE) Reliability : (4) not assignable special study 25.05.2004 (369) Species : other: hamster; mammalian cell transformation assay Sex : Strain : other: Syrian hamster embryo cells Route of admin. : Exposure period : Frequency of treatm. : Post exposure period : Doses : (1) 0, 100, 300 µg/ml culture medium (2) 0, 20, 100 µg/ml culture medium (3) 0, 300, 500 µg/ml culture medium (4) 0, 100, 300 µg/ml culture medium Result : positive Control group : yes Method : other: according Berwald and Sachs, 1965 Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : transformation frequency [%]: UNEP PUBLICATIONS 255
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OECD SIDS o-TOLUIDINE FOREWORD INTR
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OECD SIDS o-TOLUIDINE 6 REFERENCES
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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