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years old should give a high probability of sexual maturity (1) but histopathology data at this laboratory has shown otherwise. This review of animal data from toxicology studies using sexually mature animals examines the parameters and factors involved in the determination of sexual maturation onset and completion. Discussions with suppliers, delivery, acclimatisation and pre-treatment investigations are included. The parameters reviewed include age, weight, physical characteristics of secondary development (e.g. descent and dimensions of testes, appearance of adult dentures), positive vaginal swabs and confirmed semen production and viability. Regular menstrual cycling, repeat viable semen sampling and assessment of hormone levels provide essential baseline data for intra-study/animal comparison, facilitating identification of toxicity and natural variability or progression of parameters. The results show that in isolation most of the parameters examined were open to interpretation as they were measured qualitatively. There was evidence that long-distance transport of the animals led to disruption of parameters measured at source. No individual parameter gave a clear determination of sexual maturity but repeated production of viable semen for males and a regular menstrual cycle for females provided the strongest evidence, accompanied by other parameters. Determination of sexual maturity in both sexes is a complex issue and many factors are involved. In conclusion, it is preferable to employ a weight of evidence approach using all available parameters to confirm sexual maturity in cynomolgus macaques.(1) Boyd Group Papers on the use of non-human primates in research and testing 2002 Paper 4. 1924 SERIAL COLLECTION OF CEREBROSPINAL FLUID VIA A SURGICALLY OR PERCUTANEOUSLY IMPLANTED CATHETER IN CYNOMOLGUS MONKEYS. J. K. Herman, R. Avery, M. Taschwer, P. Love, J. Fohey, M. Abdelhameed and W. Meier. Nonclinical Safety Assessment, Covance Laboratories, Madison, WI. Serial Cerebral Spinal Fluid (CSF) collection in primates was evaluated for studies involving test materials that are active in the central nervous system (CNS). Although exposure can be confirmed with a single cisternal CSF collection, this single point evaluation does not allow assessment of time profiles of exposure and must be conducted in anesthetized animals. The purpose of this study was to evaluated two procedures for placing an indwelling catheter in the lumbar intrathecal space for collecting serial CSF samples from unanesthetized animals. The two models evaluated were 1) a surgically implanted catheter placed in the lumbar intrathecal space via hemilaminectomy technique and 2) a percutaneously implanted catheter placed in the lumbar intrathecal space via a “through the needle” catheterization technique. Animals with the hemilaminectomy were allowed at least 1 week post surgery for recovery while animals with the percutaneous catheter were allowed 24 to 48 hours for recovery. Animals were then given either a single dose of vehicle or a commercially available glycine transport inhibitor via oral gavage at a dose level of 2 mg/kg. Blood and CSF were collected predose and 1, 2, 4, 8 and 24 hours post dose. There were no clinical signs or changes in body weight or body temperature associated with test article administration or the surgically implantation of the catheters. The time to maximum levels (Tmax) for the test article in the CSF was similar to the plasma Tmax although exposure (AUC) was approximately 10 fold lower in the CSF than in the plasma. In general, exposure assessments between the two catheterization techniques were similar, although the percutaneous approach tended to yield slightly higher values. In conclusion, serial collection of CSF from conscious, restrained primates is a valid method for determining test article exposure in the CNS and allows for comparisons between plasma exposure, CNS exposure and potential clinical signs or pathology changes. 1925 TEMPERATURE REGULATION AND THE ASSESSMENT OF TOXICITY. K. L. Hastings 1 and M. D. Green 2 . 1 Corporate Regulatory Affairs, sanofi-aventis, Bethesda, MD and 2 OVRR, DVRPA, U.S. FDA, Bethesda, MD. Temperature regulation is an important part of homeostatic regulation that influences many physiological and pharmacological systems. Factors involving body temperature involve both peripheral and centrally mediated physiological systems reflective of various classes of products making them potential responsive to a wide variety of drugs and biologicals. Changes in body temperature can be an important endpoint itself for example with certain classes of investigational products such as experimental vaccines. Additionally, body temperature may be a factor in the assessment of other endpoints of toxicological interest such as in vivo mutagenicity and exert on influence on the pharmacokinetics and pharmacodynamics of various drugs. Despite the potential value of measuring body temperature, this endpoint is infrequently determined in spite of the availability of sophisticated systems for its measurement. This presentation reviews the uses and tools presently available to examine body temperature for the assessment of toxicity. 412 SOT 2011 ANNUAL MEETING 1926 APPLICATION OF THE DRIED BLOOD SPOT TECHNIQUE IN THE BIOANALYSIS OF SULPIRIDE. J. Legrand, T. Ameller, R. Forster, R. Michaud and S. Laurent. CIT, EVREUX Cedex, France. There has been much recent interest in the application of the Dried Blood Spot (DBS) technique in pharmacokinetics and toxicokinetics. In our facility, we have validated a bioanalytical method using the DBS approach for the determination of sulpiride in dog whole blood. Sulpiride is a second-generation antipsychotic molecule exhibiting bipolar functional groups. The DBS collection technique consisted of spotting 15.0μL droplets of whole blood samples containing sulpiride directly onto treated collection cards (GE-Whatman, DMPK cards type A®). After an appropriate drying time (at least 2 hours at room temperature), a small circular disc (3 mm wide) was punched out of the blood spot and immersed in methanol containing the Internal Standard (safinamide 0.20 μg/mL, 150 μL per sample). The samples were vortexed for 20 minutes at a moderate speed, the paper was removed from the solvent, and the extracts were evaporated (+35°C, 5 minutes) under a gentle stream of nitrogen. After reconstitution in organic solvent, the resulting mixture was transferred to LC-MS/MS for analysis (ESI positive mode). All the obtained results for sensitivity, linearity, reproducibility, selectivity and stability at room temperature fulfil the acceptance criteria described in current international guidelines. Specifically, no significant matrix effect or carry-over phenomenon was detected and precision and accuracy results were within ± 15%. Short-term stability was demonstrated after 69 hours of storage at room temperature and 114 hours at +4°C. A cross-validation between freshly prepared and overnight drying calibration curves and QC samples was also performed. Taking into account the practical advantages of the DBS technique (decreased number of required animals; lower collected blood volume; easier handling, shipping and storage), this method has been implemented for routine use in our facility for pre-clinical toxicocinetic/pharmacokinetic studies. 1927 INTRAVITREOUS ADMINISTRATION IN THE RABBIT AND MINIPIG. R. Forster, V. Haag, J. Legrand and B. Palate. CIT, EVREUX Cedex, France. Intravitreous administration to the eye brings drugs into direct access with the retina, and there has been much recent interest in the clinical use of this route of administration in the therapy of macular degeneration and other diseases. For the preclinical development of these approaches, intravitreous administration to laboratory animals is required. Over recent years, we have performed several hundred intravitreous administrations to rabbits, minipigs and other species. The formulations to be administered must have appropriate characteristics, including attention to physico-chemical properties such as pH and tonicity. Critical points in the administration technique concern adequate preparation of the animals, the volume and rate of administration, needle gauge and sterile technique. Attention should be given to the frequency of the administration in order to avoid problems of tolerability. Finally, in a small proportion of administrations, adverse findings such as inflammation may result in clinical and histopathological findings. Electroretinography may be used to provide an indication that administration or reactions to administration do not have an adverse impact on functionality. In this poster we present the technique of administration that we have used in the rabbit and minipig, and data on background findings and their frequency. Overall, when appropriate precautions are taken, this route of administration can be used routinely for preclinical studies in the rabbit and the minipig. 1928 ASSESSMENT OF COMMON PRECLINICAL VEHICLE FORMULATIONS USED IN DRUG DISCOVERY BY MAGNETIC RESONANCE SPECTROSCOPY (MRS). R. Sriram and S. Liachenko. Pfizer Inc., Groton, CT. Sponsor: M. Paule. To evaluate the effect of excipients in drug formulations MRS was utilized to monitor acute changes in creatine(Cr) levels in rats, which under normal physiological conditions is constant. By monitoring the level of total creatine(tCr) in vivo the potential untoward effects of seemingly inert vehicles can be measured. MRS was conducted on male SD rats under isoflurane using a 7T magnet. MRS signal was obtained from the hippocampus (64 cu mm voxel) by PRESS sequence with VAPOR water suppression (TE = 16.2 ms, TR = 3 s, NS = 512). After the baseline MRS scan, one of four different vehicles (2ml/kg) - saline (N = 4), or 1-2-97 (1% 1N HCl, 2% cremophor, 97% saline, N = 4), or DMA+PG (10% dimethyl acetamide (DMA), 45% propylene glycol (PG) and 45% saline, N = 9) or nanosuspension (0.025% sodium laurel sulfate and 2% poly-vinyl pyrrolidone in saline, N=4) was given subcutaneously, followed immediately by dynamic MRS scans. LCModel was used for tCr estimation. tCr (sum of phosphocreatine(PCr) and Cr) levels show a
statistically significant interaction (2 way repeated measures ANOVA) between time and excipients (p
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The Toxicologist Supplement to Toxi
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The Toxicologist Supplement to Toxi
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1 BIODEGRADABLE MATERIALS FOR TISSU
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that genetic toxicology data are ge
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well-orchestrated lung inflammation
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scribed in the literature. We have
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years ago). We will illustrate how
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involved in the biodegradation proc
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stem cells but rather a treatment i
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additional compound showed agreemen
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82 COMPARISON OF 3H-THYMIDINE INCOR
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irritants. While in practice these
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alleles are especially vulnerable t
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109 CD4+ T CELL INTRINSIC TNF RECEP
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118 TO STUDY THE SIGNAL TRANSDUCTIO
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PAHs, such as dioxins, are prevalen
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containing substituents and/or hydr
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146 COMPUTATIONAL MODELING FOR QT P
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suggest that the combination of too
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164 TRANSLOCATOR PROTEIN (18 KDA) (
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function as a metal binding protein
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laboratory has demonstrated that NR
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known. The aim of this study was to
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from 5 to 28 days in duration) in e
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positive cells, caspase-3 activatio
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creased level in the 46 kDa preproe
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invasiveness at concentrations repr
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thracene (DMBA,50 μg in acetone, a
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247 CO-CARCINOGENESIS OF N, N- DIET
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sponds to the endosomal dsRNA that
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ODD in both WT (maximum 177% of con
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Lastly, using p53siRNA cells, p53 w
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its receptor Mpl to exert its funct
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294 LOW LEVEL OF LEAD CAN INDUCE PH
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lunar surface presented potential h
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lar about cellular export mechanism
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DNA in the kidney medulla, grandula
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5.00 and 7.50 mg/kg/day by oral gav
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events and carcinogenesis. Here we
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tinization of cells of the hair fol
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358 CHARACTERIZATION OF GENOME-WIDE
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RNAi were also performed to identif
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376 A FUNCTIONAL CROSSTALK BETWEEN
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UGT1A gene induction, while this re
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tivity, specifically peroxisome pro
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and cytotoxic effects; however, its
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histone deacetylase that is necessa
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ment. Paradoxically, buthionine sul
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drug leflunomide and its major (A77
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442 GENE EXPRESSION AND MORPHOLOGIC
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451 INHIBITION OF THE MITOCHONDRIAL
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460 SULFORAPHANE PREVENTS ACETAMINO
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drophilic/lipophilic balance. Other
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pharmacokinetic and toxicological p
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489 USE OF ‘OMICS DATA TO IMPROVE
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498 APPLICATION OF AGE-SPECIFIC ADJ
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507 A DOSE VOLUME TOLERABILITY STUD
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involved the use of an acute inflam
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sorption in the gastrointestinal (G
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(ABC) transporters actively transpo
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545 BEHAVIORAL EFFECTS OF REPIN IN
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a blood pressure phenotype that res
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and inhalation exposure system that
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and lethality associated with these
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position, on vascular reactivity an
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therefore more accurate and reprodu
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commercial chrysotile product that
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elative to their controls. ST-depre
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ats. The majority of the studies fo
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in the China Jintan Child Cohort St
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corneum thickness, cellular epiderm
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645 EVALUATION OF THE IN VITRO EPIS
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654 TCDD ADSORBED ONTO NATURAL AND
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tion revealed no test article-relat
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671 INFLAMMATION AND TISSUE DAMAGE
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model, ethanol was found to inhibit
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689 ENHANCED SUPPRESSIVE FUNCTION O
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NAC + LPS yielded different levels
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707 LIFE-STAGE PBPK MODELS FOR MULT
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downstream of the apical endpoint o
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726 UPDATED ALUMINUM PHARMACOKINETI
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global parameter sensitivity analys
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and renal inflammation induced by 2
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754 PLASMA, URINE, AND TISSUE CONCE
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cently characterized transporter OA
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exposure system was developed from
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lood cell mass and decrease in urin
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practical alternatives to MC in non
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imals dosed with 167 mg/kg THU alon
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and organ weights, clinical signs a
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yet is induced in most bladder and
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830 RISK ASSESSMENT OF THE SPILL: C
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knowledgebase creation. Results are
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852 UNDERSTANDING STRUCTURAL AND PH
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for integrating epidemiology and an
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motor activity, including age of th
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y partial purification of urine (fr
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pacity for self-renewal and may dif
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sue. The depth of our analysis led
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910 IMPLEMENTING CALIFORNIA’S GRE
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concentrations in six tissues and b
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934 THE FDA’S LIVER TOXICITY KNOW
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943 GENOME-WIDE DNA METHYLATION DIF
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membrane localization and subsequen
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trols, respectively. Subtoxic and t
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survival using both smoking regimes
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as non-, weak, moderate, or strong
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988 NNK-INDUCED CYTOKINE ALTERATION
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group (one-way ANOVA, p90 % viabili
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ered as an organ involved in xenobi
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Transport of CPZ across the Caco-2
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estrous cycle and sexual behavior d
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mRNA expression levels. Collectivel
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1043 THE EFFECTS OF ENDOCRINE DISRU
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1052 MONO-2-ETHYLHEXYL PHTHALATE IN
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Results: MC was variable within and
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UtSMCs. Phosphorylation of FoxO1 wa
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nonpregnant and pregnant diabetic m
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1089 PFOA-INDUCED LIVER EFFECTS IN
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events in the liver. AZD9056 was ev
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The peppermint oil caused a concent
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OA did not affect food consumption.
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1126 PERSISTENT DEVELOPMENTAL ARYLH
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1135 BACH2 BINDING TO Prdm1 AS A ME
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The purpose of this project was to
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one marrow. Since Chk1 is an attrac
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1163 THE MRNA AND MIRNA PROFILE OF
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have now compared the IC50 values b
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1181 ELUCIDATION OF FACTORS DETERMI
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enced by pre-exposure to cigarette
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if abnormal PF was associated with
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weight (P=0.016) and small for gest
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portant cause of death, compared to
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posure groups. However, the differe
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Naphthalene is routinely analyzed i
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1245 SEASONAL CHARACTERIZATION OF H
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1255 URINARY T, T MUCONIC ACID LEVE
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modating a reliable data evaluation
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enzoquinone generate ROS and arylat
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teins (e.g. C3, 4, and 5, APOB, VDB
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1293 TRANSFORMING GROWTH FACTOR BET
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mation was decreased to the same le
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1312 EVALUATION OF THE SENSITIVITY
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luted OFR and CRL. Culture media ex
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urinary TCPy levels, blood and brai
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activity. The dose-response curves
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mice, each with 4 dose groups. One
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exposure to both ATR and DACT has a
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third tetratricopeptide repeats (TP
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7d. 28d after TMT injury there was
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subunits. Each cell type was treate
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1394 COMPARATIVE EFFECTS OF METHYLM
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1403 GENOTOXICITY AND PRE-NEOPLASTI
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vated only in high-dose-treated ani
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1421 DOSE-RESPONSE OF NAPHTHALENE-I
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cisplatin; 1.2-, 1.9- and 2.9-fold
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Day 11 and started to recover on Da
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1448 DEVELOPMENT OF A METHOD FOR QU
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1457 GLOBAL GENE PROFILING REVEALS
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cluding mouse and human macrophage,
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model of lung inflammation and host
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1484 NANOTOXICOLOGY AND NANOHEALTH
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throughput in vitro approach was us
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1502 IMMUNOLOGICAL ASPECTS OF AN AN
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(CIA) and the Streptococcal cell wa
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sitizers were 100% concordant among
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1530 MINIMAL RISK LEVELS FOR STYREN
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ical groups in the field of regulat
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vitro with this potentially insect-
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their performance on toxicological
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need for a better understanding of
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1577 AN IN VITRO MODEL SYSTEM FOR A
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gene expression post-transcriptiona
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1595 GENE EXPRESSION PROFILE OF RAT
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to confirm a hepatotoxic property o
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1613 AN INVESTIGATION OF THE CLEARA
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its nuclear translocation was reduc
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were collected from TK animals at d
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egulated targets were selected for
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U/L after tetracycline. Minocycline
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peri-pubertal FasL-/- mice show a d
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showed similar levels of apoptosis
Page 365 and 366: 1676 TWO BIOMARKERS FOR EVALUATION
Page 367 and 368: motifs selected. This system was ap
Page 369 and 370: 1693 VOC SERUM LEVELS IN THE GENERA
Page 371 and 372: 1702 DOES THE CLOCK MAKE THE POISON
Page 373 and 374: those with high nickel content are
Page 375 and 376: isk assessment. However, unique cha
Page 377 and 378: model of APAP metabolism and glutat
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Page 381 and 382: posure, blood chemistry was analyze
Page 383 and 384: elated to oxidative stress by measu
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Page 389 and 390: ways as chemical stressors and, the
Page 391 and 392: toxicity of nanomaterials relates s
Page 393 and 394: 1815 MEASURING COMPOUND SELECTIVITY
Page 395 and 396: 1825 EFFECTS OF METABOLISM BY INTES
Page 397 and 398: cyanoacetic acid increased 2-3 fold
Page 399 and 400: 1845 IS THE PROMISCUITY OF THE ARYL
Page 401 and 402: crorarray analysis. RT-PCR results
Page 403 and 404: are a family of phase-II biotransfo
Page 405 and 406: ous labs. As a result of positive s
Page 407 and 408: down the doses may produce more tox
Page 409 and 410: spectively. Below 100 mg/l of gemfi
Page 411 and 412: 1900 GENERATION OF PRECISION CUT LI
Page 413 and 414: iomarkers or observation of lesions
Page 415: creased reticulocytes and lymphocyt
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Page 421 and 422: NPC and sinonasal cancer in neighbo
Page 423 and 424: showed incidences of lung and nasal
Page 425 and 426: utylbenzenes, exhibited most simila
Page 427 and 428: 1975 DIFFERENTIAL MODULATION OF CYP
Page 429 and 430: organic As to MMA(V) and a lower ca
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Page 433 and 434: 3T3-L1 cells to low-levels of arsen
Page 435 and 436: 2011 IDENTIFICATION OF A NOVEL VX M
Page 437 and 438: This work was supported by Cooperat
Page 439 and 440: 2029 EFFICACY OF ENDOTRACHEAL ADMIN
Page 441 and 442: Diazepam injections and its combina
Page 443 and 444: 2047 ESTERASE ACTIVITIES AND HEMOST
Page 445 and 446: nanoparticle-induced toxicity progr
Page 447 and 448: house, were iv infused into rats ov
Page 449 and 450: een explored. This study investigat
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Page 453 and 454: egg yolk collected from turtles inh
Page 455 and 456: consistency of results in both expe
Page 457 and 458: 2111 CYTOCHROME P450 3A5 GENOTYPE I
Page 459 and 460: esidues of organophosphates or thei
Page 461 and 462: manganism. Recent work from our lab
Page 463 and 464: Aβ1-40 in CSF and hippocampus in P
Page 465 and 466: 2147 CATALASE MANIPULATIONS MODIFY
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ation based on real-world exposure
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NPs. Aggregation of citrate-stabili
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2175 THE ROLE OF SURFACE CHEMISTRY
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seen rapid uptake in biological ima
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effect on uterine weight or vaginal
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dicating widespread exposure. While
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components into the liver parenchym
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2223 ISOLATION AND DETECTION OF RIC
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stored (-20 celsius degree). The co
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2241 DDA, A BIOMARKER FOR ENVIRONME
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2249 INTERACTION BETWEEN DIETARY SE
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2258 PHARMACOKINETICS, EXCRETION BA
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2267 SENSITIVE AND SPECIFIC FLUORES
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2276 METABOLISM AND DISPOSITION OF
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ment of hypertension in companion a
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for the propyl series can be used f
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2304 IN VITRO EXPOSURE AND EVALUATI
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2313 THE SYNERGISTIC EFFECT OF SODI
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genes that play a crucial role in M
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2330 THE ROLE OF TRANSFORMING GROWT
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ined following up to 96 h continuou
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effect doses obtained with the rat
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diated transcriptional response of
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docrine disruptor activities of EDC
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individuals. Week 6 results were qu
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functionality of photosystem II and
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wild mice (Mus musculus) from areas
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2406 TOXICITY AND BIOACCUMULATION O
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Isocitric acid is the acid in the h
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2425 EFFECTS OF FUMONISINS IN ETHAN
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centration(μg/g) were: 5.1-95.3; 2
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2445 AUTOPHAGY IN DEVELOPMENT: A LI
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sures to inhaled Mn in dust. Nevert
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2466 CRITICAL EVALUATION OF ANIMAL
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elationships predict that resting r
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2489 COMPARATIVE TOXICITY OF BIODIE
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2497 TRANSCRIPTIONAL REGULATION OF
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2506 TOXICOLOGICAL CONSIDERATIONS O
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launched with the aim of developing
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forms mRNA expression levels were a
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2534 CUTANEOUS WOUND HEALING IN THE
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wells (0, 1, 5, 10, 25, 50, 100, an
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2553 AN ORGANOTYPIC MICROLIVER PLAT
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serum-free media. At 24 hrs, the gr
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2572 INCREASED ARSENIC BIOACCESSIBI
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nology to develop improved methods.
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tuna, swordfish, or mako shark (3.5
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nificantly reduce circulating thyro
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grouped into 9 observation periods
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histopathological or biochemical ev
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exhibited a hyperactive phenotype,
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the search of effective drugs for e
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2644 COVALENT BINDING OF 14 C 2-MET
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aries targeting all transcription f
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(p 9 weeks) and CSC phenotype acqui
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2673 IMMUNE-MEDIATED VASCULAR INJUR
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for risk identification and charact
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to control toxicant delivery in tob
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Author Index (Continued) The numera
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Keyword Index (Continued) Arsenite
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Keyword Index (Continued) Covalent
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Keyword Index (Continued) flow cyto
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Keyword Index (Continued) innate im
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Keyword Index (Continued) nanoparti
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Keyword Index (Continued) preservat
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Keyword Index (Continued) Thrombocy
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Toxicological Sciences The Official
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