ATLA 25.5, September 1997

//ATLA 25.5, September 1997

Book Reviews

Bob Combes, Michael Garle, Anthony J. Frew and Rob Crilly

CRC has a long history of producing comprehensive toxicology texts, and the present volume is no exception. The volume is arranged into 22 chapters, many by single authors, covering all the principal types of toxicity endpoints, and with individual treatments of the major target organs. There are also chapters on clinical toxicology, metabolism and toxicokinetics, as well as four chapters on regulatory issues, and one on risk assessment. The extensive appendices of tables containing information such as analytical chemistry data, details of solvents, and a directory of contract research laboratories with their expertise and services, are especially useful.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:26:23+00:00

Defined Structural and Performance Criteria would Facilitate the Validation and Acceptance of Alternative Test Procedures

Michael Balls

The developers of new test procedures tend to want them to be tightly defined, so that they can gain their specific acceptance in the face of real or imagined competition, either for commercial reasons or to ensure that they gain the personal recognition they may deserve. However, it has become clear that this attitude is not in the interests of in vitro toxicology in general and may delay, or even prevent, the acceptance and application of scientifically relevant and reliable new approaches.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:26:23+00:00 Tags: |

News & Views

ATLA Staff Writer

Eurobarometer Forecasts Continued Unsettled Weather for Biotechnology
Call for Research Proposals
Canadian Statistics on Animal Use
Wasted Lives
International Course on Laboratory Animal Science
Shorter Dog Studies in Prospect
Corrections to ATLA
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:26:23+00:00 Tags: |

ECVAM News & Views

ATLA Staff Writer

Call for Laboratories to Participate in the Formal Validation of Three In Vitro Embryotoxicity Tests
The ECVAM International Validation Study on In Vitro Tests for Skin Corrosivity: Statement on the Outcome of the Validation Study by the Management Team and Sponsors
Eye Irritancy Initiatives
A Meeting of Representatives of European National Centres (or Equivalent) on Alternatives
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:26:23+00:00 Tags: |

The Validation of Toxicological Prediction Models

Graeme Archer, Michael Balls, Leon H. Bruner, Rodger D. Curren, Julia H. Fentem, Hermann-Georg Holzhütter, Manfred Liebsch, David P. Lovell and Jacqueline A. Southee

An alternative method is shown to consist of two parts: the test system itself; and a prediction model for converting in vitro endpoints into predictions of in vivo toxicity. For the alternative method to be relevant and reliable, it is important that its prediction model component is of high predictive power and is sufficiently robust against sources of data variability. In other words, the prediction model must be subjected to criticism, leading successful models to the state of confirmation. It is shown that there are certain circumstances in which a new prediction model may be introduced without the necessity to generate new test system data.
You need to register (for free) to download this article. Please log in/register here.

Letter from the NCA

Jan van der Valk

During the twenty-fifth ECVAM workshop, on the “Current Status and Future Developments of Databases on Alternative Methods”, which was held in Neubiberg, Germany on 12–15 September 1996, it was recognised that good information exchange is essential in promoting alternatives to animal experiments. We therefore welcome the opportunity of writing a regular column in ATLA on news of alternatives in The Netherlands. We will inform readers of the latest developments and activities at the Netherlands Centre Alternatives to Animal Use (NCA), the Dutch Alternatives to Animal Experiments Platform, and other organisations in The Netherlands.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:26:23+00:00 Tags: |

Nephrotoxicity Testing In Vitro: The Current Situation

Jean-Paul Morin, Marc E. De Broe, Walter Pfaller and Gabriele
Schmuck

An ECVAM task force on nephrotoxicity has been established to advise, in particular, on the follow-up to recommendations made in the ECVAM workshop report on nephrotoxicity testing in vitro. Since this workshop was held, in 1994, there have been several improvements in the techniques used. For example, the duration of renal slice viability, and the maintenance of functional activities in slices, have been improved by using dynamic incubation systems with higher oxygen tensions and more-appropriate cell culture media. Highly differentiated primary cultures of pig, human and rabbit proximal tubule cells have been established by using specific cell isolation procedures and/or selective culture media. To date, the most comparable phenotypic expression and transepithelial transport capacities to proximal tubules in vivo have been obtained with primary cultures of rabbit proximal tubule cells which are grown on bicompartmental supports; in this system, transepithelial substrate gradients are generated and the transepithelial transport of both organic anions and cations is highly active. This in vitro system has been selected by ECVAM for further evaluation and prevalidation. Industrial needs in the area of nephrotoxicity testing have been identified, and recommendations are made at the end of this report concerning possible future initiatives.
You need to register (for free) to download this article. Please log in/register here.

In Vitro Versus In Vivo Propagation of Monoclonal Antibodies: A Test Case for the Effectiveness of Swedish Ethical Review Committees

Ulrika Hansson

In descriptions of the Swedish system for the control of animal experiments, it is often implied that the system guarantees that the animals are not subjected to unnecessary suffering and that available alternative methods are used. A study was carried out to examine applications for the use of the ascites method for monoclonal antibody production during 1995 and 1996. The data show that approval was given to all the applications received, with scanty justification. Thus, public reassurance that the Swedish system prevents the unnecessary use of animals is undermined by these findings.
You need to register (for free) to download this article. Please log in/register here.

Good Laboratory Practice and Study Management for the Validation of In Vitro Toxicity Studies

Robin Cooper-Hannan

The principles of Good Laboratory Practice (GLP) are designed to help ensure the proper management and conduct of studies. GLP compliance demonstrates to regulatory authorities that studies were undertaken in a manner which promotes confidence in the data and reporting. Formal validation of in vitro toxicity studies is being recommended as an interlaboratory activity. Study management of interlaboratory studies in compliance with GLP is discussed. This includes: a) a clearly defined management, with responsibility for the GLP compliance of participating laboratories; b) one Study Director, who represents the single point of study control and who overviews study procedures and data, to ensure that procedures laid down in the protocol are being followed; and c) Principal Investigators, who may be appointed at some, or all, of the participating laboratories to facilitate supervision and communications with the Study Director.
You need to register (for free) to download this article. Please log in/register here.

In Vitro Cytotoxicity of Textile Dyes and Extracts of Dyed/Finished Fabrics

Päivi Kopponen, Mirkka Asikainen, Riitta Törrönen, Kaisa Klemola, Jyrki Liesivuori and Sirpa Kärenlampi

The aim of this study was to investigate whether an in vitro test can give an indication of the overall toxicity of fabric extracts, and whether this toxicity correlates with the toxicity of the dyes and finishes used. Thirteen textile dyes and dyed/finished cotton fabrics were tested by using the Hepa-1 cytotoxicity test. Black sulphur and two blue reactive dyes were the most toxic, with IC50 (the concentration at which the total protein content was 50% of the protein content of non-exposed cells) values of 40–65μg/ml. The least toxic dyes, the black and yellow mix reactive dyes, had IC50 values of 825μg/ml and 703μg/ml, respectively. There was no correlation between the toxicities of the dyes and the fabric extracts; the extract from naphtholdyed fabric was the most cytotoxic. These results strongly support the hypothesis that the toxicity of a fabric extract cannot be predicted directly from the toxicity of the dye itself. The results also showed that flame-retardant and water/soil-repellent finishes can alter the cytotoxicity. In vitro tests, as exemplified by the Hepa-1 cytotoxicity test, could provide useful information for developing new ecotextiles.
You need to register (for free) to download this article. Please log in/register here.