The value of historical control data-scientific advantages for pathologists, industry and agencies.

Abstract:

:Historical control tumor data are useful in the interpretation of long-term rodent carcinogenicity bioassays, especially to assess the occurrence of rare tumors and marginally increased tumor incidences. The major prerequisites to compare historical control data with studies under evaluation are the validity and consistency of the respective databases. The RITA (Registry of Industrial Toxicology Animal-data) database for historical data of tumors and pre-neoplastic lesions collects data according to highly standardized procedures including tissue sampling and trimming, histopathology according to internationally harmonized nomenclature and diagnostic criteria, and peer review. All lesions that are entered are unanimously diagnosed according to IARC (Intermational Agency for Research on Cancer)/WHO criteria. The validity of data is additionally confirmed by a complete peer review performed by a database pathologist. Equivocal diagnoses and selected cases are additionally submitted to a panel of RITA pathologists. In the RITA database, there are currently 10,896 rats from 106 studies with more than 17,604 primary tumors and 16,551 pre-neoplastic lesions. The RITA database for historical control data for Wistar and Sprague Dawley rats as well as for different mouse strains is briefly described. Based upon RITA background data, the survival rate of Wistar rats has been consistent over a period of 10 years. The occurrence of tumor-bearing animals also shows a stable percentage over a decade. Additionally, examples of how historical control data may support carcinogenic risk assessment in cases of rare tumors or marginally increased incidences of tumors and pre-neoplastic lesions are given.

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Deschl U,Kittel B,Rittinghausen S,Morawietz G,Kohler M,Mohr U,Keenan C

doi

10.1080/01926230252824743

subject

Has Abstract

pub_date

2002-01-01 00:00:00

pages

80-7

issue

1

eissn

0192-6233

issn

1533-1601

journal_volume

30

pub_type

杂志文章,评审
  • Gastrointestinal damage from nonsteroidal anti-inflammatory drugs.

    abstract::The mechanisms underlying the development of gastrointestinal (GI) damage by the NSAIDs differ considerably from drug to drug. Aside from environmental or intersubject influence (e.g., concurrent disease, physical or sociopsychologic stress, dietary and genetic status), the intrinsic pharmacokinetic and physicochemica...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/019262338801600218

    authors: Rainsford KD

    更新日期:1988-01-01 00:00:00

  • Mechanistic data and risk assessment of selected toxic end points of the thyroid gland.

    abstract::Many goitrogenic xenobiotics that increase the incidence of thyroid tumors in rodents exert a direct effect on the thyroid gland to disrupt one of several possible steps in the biosynthesis, secretion, and metabolism of thyroid hormones. This includes (a) inhibition of the iodine trapping mechanism, (b) blockage of or...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/019262339702500109

    authors: Capen CC

    更新日期:1997-01-01 00:00:00

  • 3,4,3',4'-tetrachlorobiphenyl-induced effects in the rat liver. I. Serum and hepatic retinoid reduction and morphologic changes.

    abstract::The distribution of 3,4,3',4'-tetrachlorobiphenyl (TCB), its effects on serum and hepatic retinoid, content and liver morphology were investigated in adult female WAG/Rij rats. Animals received a single intraperitoneal injection of either a corn oil vehicle, 15 or 200 mg TCB/kg body weight and were killed at 1, 3, 7, ...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262338901700308

    authors: Durham SK,Brouwer A

    更新日期:1989-01-01 00:00:00

  • Decreases in binding capacity of the mitochondrial 18 kda translocator protein accompany oxidative stress and pathological signs in rat liver after DMBA exposure.

    abstract::7,12-Dimethylbenz[a]anthracene (DMBA) presents a pollutant implicated in various toxicological effects. The aim of this experiment was to study the effects of DMBA administration on oxidative stress, histopathological signs, and 18 kDa translocator protein (TSPO) binding characteristics in rat liver. We also studied t...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623310379137

    authors: Dimitrova-Shumkovska J,Veenman L,Ristoski T,Leschiner S,Gavish M

    更新日期:2010-10-01 00:00:00

  • Lack of effects of viral sialoadenitis and depletion of epidermal growth factor on initiation of hepatic carcinogenesis in the rat.

    abstract::Sialodacryoadenitis (SDA) is a commonly-encountered coronaviral infection in laboratory rats that causes acute destruction of submandibular salivary glands. SDA results in depletion of salivary epidermal growth factor (EGF) and may thereby affect EGF-dependent cell growth processes. The purpose of this study was to de...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339101900210

    authors: Kemp DR,Percy DH,Hayes MA

    更新日期:1991-01-01 00:00:00

  • Generalized cellular hypertrophy is induced by a dual-acting PPAR agonist in rat urinary bladder urothelium in vivo.

    abstract::Some developmental dual-acting PPARalpha/gamma agonists, such as ragaglitazar, have shown carcinogenic effects in the rodent urinary bladder urothelium after months-years of dosing. We examined early (precancerous) changes in the bladder urothelium of rats orally dosed with ragaglitazar, using a newly developed flow c...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1080/01926230500214657

    authors: Oleksiewicz MB,Thorup I,Nielsen HS,Andersen HV,Hegelund AC,Iversen L,Guldberg TS,Brinck PR,Sjogren I,Thinggaard UK,Jørgensen L,Jensen MB

    更新日期:2005-01-01 00:00:00

  • Flow cytometry in the preclinical development of biopharmaceuticals.

    abstract::Novel biomarkers are often required in the preclinical development of biopharmaceuticals in order to characterize pharmacologic and toxicologic effects and to establish pharmacodynamic and pharmacokinetic relationships. Flow cytometry is uniquely suited for measurement of these biomarkers. Large numbers of single cell...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/019262339902700107

    authors: Gossett KA,Narayanan PK,Williams DM,Gore ER,Herzyk DJ,Hart TK,Sellers TS

    更新日期:1999-01-01 00:00:00

  • Confocal laser scanning microscopy of oncogene localization in rainbow trout cell lines derived from normal and tumor tissue.

    abstract::We examined the localization and expression of the nuclear oncoprotein c-myc and the cytoplasmic membrane-associated oncoprotein c-ras in rainbow trout cell lines derived from both normal and tumor tissue in order to question whether c-myc and ras oncoprotein immunostaining was increased in cells derived from tumors c...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339602400310

    authors: Carter CA,Ellington WW,Van Beneden RJ

    更新日期:1996-05-01 00:00:00

  • Cardiovascular alterations in dogs treated with hydralazine.

    abstract::Groups of 5 male beagle dogs were treated orally with hydralazine tablets in gelatin capsules at a dose of 12 or 24 mg/kg twice a day (6 hours apart) for 2 consecutive days. Five male dogs treated with empty gelatin capsules served as untreated controls. Clinical findings and heart rate changes during treatment and te...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262338701500404

    authors: Mesfin GM,Shawaryn GG,Higgins MJ

    更新日期:1987-01-01 00:00:00

  • Proceedings of the 2018 National Toxicology Program Satellite Symposium.

    abstract::The 2018 annual National Toxicology Program Satellite Symposium, entitled "Pathology Potpourri," was held in Indianapolis, Indiana, at the Society of Toxicologic Pathology's 37th annual meeting. The goal of this symposium was to present and discuss challenging diagnostic pathology and/or nomenclature issues. This arti...

    journal_title:Toxicologic pathology

    pub_type:

    doi:10.1177/0192623318800734

    authors: Elmore SA,Carreira V,Labriola CS,Mahapatra D,McKeag SR,Rinke M,Shackelford C,Singh B,Talley A,Wallace SM,Wancket LM,Willson CJ

    更新日期:2018-12-01 00:00:00

  • A Brief Review of Infrequent Spontaneous Findings, Peculiar Anatomical Microscopic Features, and Potential Artifacts in Göttingen Minipigs.

    abstract::Minipigs are now used in greater numbers in contract research organizations (CROs) as well as in the pharmaceutical industry. Most CROs or pharmaceutical companies use the Göttingen minipig, which displays a number of important background lesions. This review will discuss some of the more infrequent minipig background...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/0192623315622423

    authors: McInnes EF,McKeag S

    更新日期:2016-04-01 00:00:00

  • The use of quantitative histological and molecular data for risk assessment and biologically based model development.

    abstract::In organs with diverse cell populations, it is not uncommon for one type of cell to respond while others are spared. Even in an organ with common cell types, such as hepatocytes within the liver, the population of cells may respond with different sensitivities for injury or for biochemical responses to toxicants. In t...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1080/01926230252824789

    authors: Andersen ME

    更新日期:2002-01-01 00:00:00

  • Evaluation of Magnesium-based Medical Devices in Preclinical Studies: Challenges and Points to Consider.

    abstract::Absorbable metallic implants have been under investigation for more than a century. Animal and human studies have shown that magnesium (Mg) alloys can be safely used in bioresorbable scaffolds. Several cardiovascular and orthopedic biodegradable metallic devices have recently been approved for use in humans. Bioresorb...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/0192623318816936

    authors: Chagnon M,Guy LG,Jackson N

    更新日期:2019-04-01 00:00:00

  • Regulatory Forum Opinion Piece*: An Experienced Pathologist Should Be Present at Necropsy for Novel Medical Device Studies.

    abstract::Necropsies conducted to support medical device development may be conducted in facilities that do not have the infrastructure in place to support Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) studies and for a variety of reasons they may be conducted without a pathologist present at necropsy. Howev...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623315617035

    authors: Nikula KJ,Funk K

    更新日期:2016-01-01 00:00:00

  • High hematocrit resulting from administration of erythropoiesis-stimulating agents is not fully predictive of mortality or toxicities in preclinical species.

    abstract::We conducted a retrospective analysis of publicly available preclinical toxicology studies with erythropoiesis-stimulating agents (ESAs) to examine common adverse events in rats, Beagle dogs, and cynomolgus monkeys. Mortality and/or thrombotic events were reported sporadically in a subset of studies and attributed to ...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/0192623313486317

    authors: Andrews DA,Pyrah IT,Boren BM,Tannehill-Gregg SH,Lightfoot-Dunn RM

    更新日期:2014-01-01 00:00:00

  • Regulatory forum opinion piece: obligatory microscopic examination of intermediate dose groups in non-rodent toxicity studies--is it necessary?

    abstract::In non-rodent toxicity studies supporting pharmaceutical or chemical product registration, the value of histopathology evaluation of all tissues from all animals from all dose groups is an ongoing discussion topic among pathologists. This manuscript documents an examination of this topic through a retrospective review...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623312439642

    authors: Weddle DL,Mahrt CR,Schmidt SP

    更新日期:2012-07-01 00:00:00

  • Myelodysplasia: differentiating neoplastic from nonneoplastic syndromes of ineffective hematopoiesis in dogs.

    abstract::In the context of human hematopathology, the terms myelodysplasia and Myelodysplastic Syndromes (MDS) are applied to disorders of hematopoiesis that are clonal, neoplastic, and, in most forms, manifested as ineffective hematopoiesis with characteristic morphologic abnormalities in multiple cell lines. Studies of human...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1080/01926230390177659

    authors: Blue JT

    更新日期:2003-01-01 00:00:00

  • Previously Diagnosed Reticulum Cell Hyperplasia in Decalcified Rat Bone Marrow Stain Positive for Ionized Calcium Binding Adapter Molecule 1 (Iba1): A Monocytic/Macrophage Cell Marker.

    abstract::Reticulum cell hyperplasia (RCH) was a term used for many years by the National Toxicology Program (NTP) to describe a certain non-neoplastic bone marrow lesion of rats. Retrospective microscopic evaluation of RCH lesions and immunohistochemistry analyses were performed to reassess and further characterize these lesio...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623319890610

    authors: Cora MC,Janardhan KS,Jensen H,Clayton N,Travlos GS

    更新日期:2020-02-01 00:00:00

  • Antisense oligonucleotide therapies: the promise and the challenges from a toxicologic pathologist's perspective.

    abstract::Many antisense oligonucleotides (ASOs) from several classes of molecules are currently in drug development. Despite over 20 years of pharmaceutical research, few ASOs have been marketed due to problems with clinical efficacy or preclinical toxicologic challenges. However, a number of recent developments have renewed i...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/0192623314551840

    authors: Frazier KS

    更新日期:2015-01-01 00:00:00

  • Characterization of the promoting activity of thiobenzamide on liver carcinogenesis.

    abstract::To characterize the promoting activity of thiobenzamide (TB), a thiono-sulfur-containing xenobiotic, rats of both sexes were treated with the compound for 4 or 8 weeks after an initiating dose of diethyl-nitrosamine. The number, area (volume), and phenotypic complexity of the enzyme-altered hepatocyte foci were studie...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262338601400314

    authors: Malvaldi G,Chieli E,Saviozzi M

    更新日期:1986-01-01 00:00:00

  • Adaptive parotid gland hypertrophy induced by dietary treatment of GSE in rats.

    abstract::In a 13-week feeding toxicity study of grape skin extract (GSE) performed previously, 5.0% GSE showed diffuse hypertrophy and basophilia in rat parotid glands. To clarify whether the change in the parotid glands was an adverse effect of GSE, 6-week-old male F344 rats were fed a diet containing 5.0% GSE or were adminis...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623313512429

    authors: Inoue K,Morikawa T,Matsuo S,Tamura K,Takahashi M,Yoshida M

    更新日期:2014-08-01 00:00:00

  • The significance of hepatic microsomal enzyme induction and altered thyroid function in rats: implications for thyroid gland neoplasia.

    abstract::Hepatic microsomal enzymes play an important role in thyroid hormone homeostasis. Glucuronidation of thyroxine is the rate limiting step in the biliary excretion of thyroxine in the rat; the monodeiodinases are important in the conversion of T4 to T3 and reverse T3 and subsequent deiodinations. Phenobarbital is known ...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章,评审

    doi:10.1177/019262338901700206

    authors: McClain RM

    更新日期:1989-01-01 00:00:00

  • Dose-dependent renal tubular toxicity of harman and norharman in male F344 rats.

    abstract::The renal toxicity of harman and norharman, administered for 2 or 4 weeks at dietary levels of 1,000, 500, or 0 parts per million (ppm), was investigated in 6-week-old male F344/DuCrj rats. Although rats fed 1,000 ppm harman or norharman, but not the 500 ppm level, demonstrated marked body weight retardation from 1 we...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339202000206

    authors: Hagiwara A,Asakawa E,Kurata Y,Sano M,Hirose M,Ito N

    更新日期:1992-01-01 00:00:00

  • Passive role of articular chondrocytes in quinolone-induced arthropathy in guinea pigs.

    abstract::The role of articular chondrocytes and matrix degrading enzymes such as collagenase and neutral protease in the pathogenesis of quinolone-induced cartilage degeneration was investigated in immature guinea pigs. Articular cartilage from nalidixic acid (NA) treated guinea pigs was examined for the presence of protease a...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339001800209

    authors: Bendele AM,Hulman JF,Harvey AK,Hrubey PS,Chandrasekhar S

    更新日期:1990-01-01 00:00:00

  • Sex-related differences in mast cell activity and doxorubicin toxicity: a study in spontaneously hypertensive rats.

    abstract::Clinically, girls appear to be more sensitive than boys to the cardiotoxic effects of doxorubicin, whereas the opposite may be true for adults. To identify and characterize potential sex-related differences, adult male and female spontaneously hypertensive rats (SHR; some ovariectomized [OVX]) received 1 mg/kg of doxo...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623313482778

    authors: Zhang J,Knapton A,Lipshultz SE,Cochran TR,Hiraragi H,Herman EH

    更新日期:2014-01-01 00:00:00

  • Histopathologic approaches to chemical toxicity using primary cultures of dissociated neural cells grown in chamber slides.

    abstract::Morphologic lesions have received only limited attention as in vitro endpoints of toxicity. In the present work, "tissue" and cell morphology of control and toxicant-treated primary dissociated cerebrocortical cell cultures from fetal mice were examined using phase-contrast and bright-field microscopy. In untreated co...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339302100506

    authors: Bolon B,Dorman DC,Bonnefoi MS,Randall HW,Morgan KT

    更新日期:1993-09-01 00:00:00

  • Automated and semiautomated analysis of rat alkaline phosphatase isoenzymes.

    abstract::A semiautomated quantitative assay for rat serum alkaline phosphatase (ALP) isoenzyme determination was developed, incorporating selective precipitation of bone alkaline phosphatase (BALP) with wheat germ lectin and differential inhibition with levamisole for determination of intestinal alkaline phosphatase (IALP). Th...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/019262339402200607

    authors: Hoffmann WE,Everds N,Pignatello M,Solter PF

    更新日期:1994-11-01 00:00:00

  • Summary of panel discussion: past, present and future of toxicologic pathologists and the contributions to hazard identification and molecular mechanisms of action.

    abstract::One of the major roles for the toxicologic pathologists now and into the future will be to determine the biologic significance of chemically induced biochemical and molecular alterations detected in whole tissue homogenates or cell cultures. The biologically significant effects will then require further analysis to de...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1080/019262301301418973

    authors: Miller RT,Davis BJ

    更新日期:2001-01-01 00:00:00

  • Toxicity profiles in rats treated with tumorigenic and nontumorigenic triazole conazole fungicides: Propiconazole, triadimefon, and myclobutanil.

    abstract::Conazoles are a class of azole based fungicides used in agriculture and as pharmaceutical products. They have a common mode of antifungal action through inhibition of ergosterol biosynthesis. Some members of this class have been shown to be hepatotoxic and will induce mouse hepatocellular tumors and/or rat thyroid fol...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1080/01926230601047808

    authors: Wolf DC,Allen JW,George MH,Hester SD,Sun G,Moore T,Thai SF,Delker D,Winkfield E,Leavitt S,Nelson G,Roop BC,Jones C,Thibodeaux J,Nesnow S

    更新日期:2006-01-01 00:00:00

  • Early stellate cell activation and veno-occlusive-disease (VOD)-like hepatotoxicity in dogs treated with AR-H047108, an imidazopyridine proton pump inhibitor.

    abstract::Dogs treated with AR-H047108, an imidazopyridine potassium competitive acid blocker (P-CAB), developed clinical signs of hepatic dysfunction as well as morphologically manifest hepatotoxicity in repeat-dose toxicity studies. An investigative one-month study was performed, with interim euthanasia after one and two week...

    journal_title:Toxicologic pathology

    pub_type: 杂志文章

    doi:10.1177/0192623308320802

    authors: Berg AL,Böttcher G,Andersson K,Carlsson E,Lindström AK,Huby R,Håkansson H,Skånberg-Wilhelmsson I,Hellmold H

    更新日期:2008-07-01 00:00:00