Improving the Value of Standard Toxicity Test Data in REACH

Breitholtz, Magnus; Lundström, Elin; Dahl, Ulrika; Forbes, Valery E.

doi:10.1007/978-90-481-9428-5_6

Cited by 3 publications

(2 citation statements)

References 41 publications

(46 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The development of new test standards is costly and may take up to 10 to 15 years [8] and since pharmaceuticals are a diverse group of substances when it comes to how they affect biological processes it is unlikely that new standards that would cover all relevant endpoints, could be developed in the near future.…”

Section: Testing For Environmental Effects Caused By Pharmaceutical Smentioning

confidence: 99%

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

2011

Self Cite

View full text Add to dashboard Cite

Background: Standard test data are still preferred and recommended for regulatory environmental risk assessments of pharmaceuticals even though data generated by non-standard tests could improve the scientific basis of risk assessments by providing relevant and more sensitive endpoints. The aim of this study was to investigate if non-standard ecotoxicity data can be evaluated systematically in risk assessments of pharmaceuticals. This has been done by evaluating the usefulness of four reliability evaluation methods, and by investigating whether recently published non-standard ecotoxicity studies from the open scientific literature fulfill the criteria that these methods propose.Results: The same test data were evaluated differently by the four methods in seven out of nine cases. The selected non-standard test data were considered reliable/acceptable in only 14 out of 36 cases. Conclusions: The four evaluation methods differ in scope, user friendliness, and how criteria are weighted and summarized. This affected the outcome of the data evaluation. The results suggest that there is room for improvements in how data are reported in the open scientific literature. Reliability evaluation criteria could be used as a checklist to ensure that all important aspects are reported and thereby increasing the possibility that the data could be used for regulatory risk assessment.

show abstract

Section: Testing For Environmental Effects Caused By Pharmaceutical Smentioning

confidence: 99%

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

2011

Self Cite

View full text Add to dashboard Cite

show abstract

“…Standardization of TGs, however, is a slow and costly process in the sense that many predefined steps need to be followed, often in an iterative way: thorough presentation of the need for the test; preparation of TGs; intra-and interlaboratory calibration; reporting/revision; refinement of proposed TG, and final evaluation [2][3][4]. The slowness of the process is often related to the number of intra-and interlaboratory calibrations, revisions, and refinement of proposed TGs.…”

Section: Introductionmentioning

confidence: 99%

An individual‐based modeling approach for evaluation of endpoint sensitivity in harpacticoid copepod life‐cycle tests and optimization of test design

Preuß

Brinkmann

Lundström

et al. 2011

Enviro Toxic and Chemistry

Self Cite

View full text Add to dashboard Cite

In the present study, an individual-based model for Nitocra spinipes was developed and used to optimize the test design of a proposed Organisation for Economic Co-operation and Development test guideline for harpacticoid copepods. The variability between individuals was taken into account, based on measured data, leading to stochastic model output. Virtual experiments were performed with the model to analyze the endpoint sensitivity and the effect of number of replicates and inspection intervals on statistical power. The impact of mortality was evaluated; most sublethal effects could not be determined if the mortality was ≥70%. Most sensitive to mortality was the determination of effects on brood size, for which the statistical power was reduced at 10% mortality. Our simulations show that increasing the number of replicates from 72 to 96 or 144 has little impact on the statistical power, whereas 25 replicates disallow relevant endpoint detection. Furthermore, it was demonstrated that the proposed 1D inspection interval can be shifted to a 3D interval, without losing statistical power. It was demonstrated that developmental endpoints have a higher statistical power than reproductive endpoints in the current test design. The present study highlights the usefulness of individual-based models for optimizing the experimental design. The use of such models in the development of standard test guidelines will lead to a faster and less resource-demanding process.

show abstract

Complexities and Conflicts in Controlling Dangerous Chemicals

Kuraj¹

Preventing Environmental Damage From Products

View full text Add to dashboard Cite

Improving the Value of Standard Toxicity Test Data in REACH

Cited by 3 publications

References 41 publications

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

An individual‐based modeling approach for evaluation of endpoint sensitivity in harpacticoid copepod life‐cycle tests and optimization of test design

Complexities and Conflicts in Controlling Dangerous Chemicals

Contact Info

Product

Resources

About