The SDA Alternatives Program Phase III: Comparison of in Vitro Data with Animal Eye Irritation Data on Solvents, Surfactants, Oxidizing Agents, and Prototype Cleaning Products

Bagley, Daniel M.; Booman, K.A.; Bruner, Leon H.; Casterton, Phillip L.; Demetrulias, J.; Heinze, John E.; Innis, J. David; McCormick, W. C.; Neun, David J.; Rothenstein, Arthur S.; Sedlak, Richard

doi:10.3109/15569529409037519

Cited by 25 publications

(16 citation statements)

References 13 publications

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“…• Alternative to vertebrate animals or cells for testing cleaning products for eye irritation (e.g., Bagley et al 1994). 3.…”

Section: Inmentioning

confidence: 99%

Mapping the Germ-Line and Somatic Genomes of a Ciliated Protozoan,Tetrahymena thermophila

Orias¹

1998

Genome Res.

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Ciliates are among the very few eukaryotes in which the powers of molecular biology, conventional genetics, and microbial methodology can be synergistically combined. Because ciliates also are distant relatives of vertebrates, fungi, and plants, the sequencing of a ciliate genome will be of import to our understanding of eukaryotic biology. Tetrahymena thermophila is the only ciliate in which a systematic genetic mapping of DNA polymorphisms has begun. Tetrahymena has many biological features that make it a specially or uniquely useful experimental system for fundamental research in cell and molecular biology and for biotechnological applications. A key factor in the usefulness of Tetrahymena is the speed, facility, and versatility with which it can be cultivated under a wide range of nutrient conditions, temperature, and scale. This article describes the progress made in genetically and physically mapping the genomes of T. thermophila: the micronuclear (germ-line) genome, which is not transcriptionally expressed, and the macronuclear (somatic) fragmented genome, which is actively expressed and determines the cell's phenotype. Introduction to the Ciliated ProtozoaTetrahymena is a member of the Ciliated Protozoa, a monophyletic group of unicellular eukaryotes, whose biology was reviewed recently in Hausmann and Bradbury (1996). The ciliates diverged earlier than plants and fungi in the evolutionary line leading to the vertebrates (see Pace 1997). Yet the ciliates possess a typical eukaryote life cycle, with conventional meiosis and biparental fertilization through the union of haploid gametes. While retaining unicellularity, ciliates exhibit evolutionary advances reminiscent of features of multicellular eukaryotes. For example, ciliates possess vegetative growth restricted to the diploid phase of their life cycle; extensive compounding of cellular structure that has led to the evolution of macroscopically observable unicells; elaborate structural differentiations accompanied by complex morphogenetic mechanisms; internal fertilization through direct exchange of gamete nuclei; and nuclear dimorphism, that is, the possession of differentiated germ-line and somatic nuclei, described below.The possession of two related but functionally differentiated genomes within one cell is a diagnostic ciliate feature. The germ-line genome is carried in the diploid micronucleus (MIC), whereas the somatic genome is contained in the polyploid macronucleus (MAC). MIC and MAC differentiate from mitotic descendants of the fertilization nucleus formed during conjugation, the sexual stage of the life cycle (Fig. 1). MAC differentiation is accompanied by chromosome fragmentation and thousands of other DNA rearrangements (Prescott 1994;Coyne et al. 1996). These rearrangements, which are developmentally programmed and site-specific, reconfigure the genome extensively. Nuclear differentiation results in a MIC that is not transcriptionally expressed and an actively expressed MAC that determines the cell's phenotype. The nuclear dualism of the...

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“…• Alternative to vertebrate animals or cells for testing cleaning products for eye irritation (e.g., Bagley et al 1994). 3.…”

Section: Inmentioning

confidence: 99%

Mapping the Germ-Line and Somatic Genomes of a Ciliated Protozoan,Tetrahymena thermophila

Orias¹

1998

Genome Res.

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“…Studies performed under the auspices of the Soap and Detergent Association (Bagley et al, 1994) also indicate that the CAMVA produced good correlations with the Draize eye irritation test (correlation coefficient = -0.91); the correlation was not affected by alkaline test materials. All 7-2 test products were correctly classified as irritants or nonirritants according to Federal Hazardous Substances Act criteria.…”

Section: (1985)mentioning

confidence: 84%

“…Lessening the quantity of test material 10-fold (from the 0.1 ml required in the Draize eye irritation procedure) has also become an acceptable modification (Lambert et al, 1993). Studies with 22 test materials conducted by the Soap and Detergent Association (Bagley et al, 1994) have shown that a 93% correlation exists between results from this low-volume eye test and the Draize eye irritation test. Other in vivo testing procedures have included examining corneal thickness (Kennah et al, 19896) and evaluating corneal nerve irritation (Beuerman et al, 1992).…”

Section: S Christian and R M Dienermentioning

confidence: 96%

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Soaps and Detergents: Alternatives to Animal Eye Irritation Tests

Christian

Diener

1996

Journal of the American College of Toxicology

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An extensive computer search was conducted, and a comprehensive overview of the current status of alternatives to animal eye irritation tests was obtained. A search of Medline and Toxline databases (1988 to present) was supplemented with references from sources regarding in vitro eye irritation. Particular attention was paid to soap and detergent products and related ingredients. Eighty-five references are included in the review; the in vitro assays are categorized, and their predictive values for assessing acute ocular irritation are evaluated and compared with the Draize rabbit eye irritation assay and with each other. The present review shows that the increased activity of scientists from academia, industry, and regulatory agencies has resulted in substantial progress in developing alternative in vitro procedures and that a number of large, interlaboratory evaluations and international workshops have assisted in the selection process. However, none of these methodologies has obtained acceptance for regulatory classification purposes. Conclusions drawn from this review include that (a) no single in vitro assay is considered capable of replacing the Draize eye irritation test; (b) the chorioallantoic membrane vascular assay (CAMVA) or the hen egg test-chorioallantoic membrane test (HET-CAM), the chicken or bovine enucleated eye test, the neutral red and plasminogen activation assays for cytotoxicity, and the silicon microphysiometer appear to have the greatest potential as screening tools for eye irritation: and (c) choosing a specific assay or series of assays will depend on the type of agent tested and the impact of false-negative or falsepositive results. New assays will continue to be developed and should be included in future evaluations, when sufficient data are available.

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“…In support of alternative test development, there have been numerous major programs by industry and government which have evaluated diverse test systems for their ability to predict Draize test data. A number of these programs (Bagley et al, 1994;Balls et ai, 1995;Gettings et al, 1996;Sina et al, 1995) have included tests based on animal ocular tissue (bovine cornea, chicken and rabbit enuceated eye, rabbit corneal cells, both primary and cell line) or nonocular human cell cultures (keratinocytes, dermal fibroblasts). A test based on human ocular tissue was not represented in these or other similar evaluations, and this underscored the current general lack of human ocular cellbased models for supporting the assessment of ocular irritancy.…”

mentioning

confidence: 99%

Evaluation of a Human Corneal Epithelial Cell Line as an in Vitro Model for Assessing Ocular Irritation

Kruszewski¹,

Walker²,

DiPasquale³

1997

Toxicol Sci

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A human corneal epithelial cell line, 10.014 pRSV-T (HCE-T cells), has been used to develop a three-dimensional in vitro model of the human comeal epithelium (HCE-T model). HCE-T cells form a stratified culture when grown at the air-liquid interface on a collagen membrane in serum-free medium. This model served as the basis for assays which supported the ocular irritancy assessment of water-soluble test substances. In vitro assays used were transepithelial permeability to sodium fluorescein (TEP) and transepithelial electrical resistance (TER). These measured alterations in the barrier function of this comeal epithelial equivalent Barrier function is a well-developed property in the HCE-T model that supports the mechanistic relevance of these assays. In vitro data, averaged from replicate assays, were compared to respective Drake rabbit eye irritation data from the publicly available ECETOC and CTFA databases using linear regression with Pearson's correlation analysis. For chemicals, Pearson's correlation coefficients, r, from comparisons of Draize maximum average scores (MAS) to TEP and TER data were 0.71 and 0.55, respectively. For product formulations, Pearson's correlation coefficients from comparisons of Draize MAS to TEP and TER data were 0.86 and 0.80, respectively. Data indicated that barrier function alterations in the HCE-T model correlated with ocular irritancy and comeal toxicity. While the irritancy of the chemicals tested was effectively assessed only by the TEP assay,

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The SDA Alternatives Program Phase III: Comparison of in Vitro Data with Animal Eye Irritation Data on Solvents, Surfactants, Oxidizing Agents, and Prototype Cleaning Products

Cited by 25 publications

References 13 publications

Mapping the Germ-Line and Somatic Genomes of a Ciliated Protozoan,Tetrahymena thermophila

Mapping the Germ-Line and Somatic Genomes of a Ciliated Protozoan,Tetrahymena thermophila

Soaps and Detergents: Alternatives to Animal Eye Irritation Tests

Evaluation of a Human Corneal Epithelial Cell Line as an in Vitro Model for Assessing Ocular Irritation

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