Evaluation of substances

Matthies M, Berding V, Beyer A (2004) Probabilistic uncertainty analysis of the European union system for the evaluation of substances multimedia regional distribution model. Environ Toxicol Chem 3(10) 2494—2502... 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

Figure 2.1 presents a flow chart that outlines a plan for the initial theoretical hazard evaluation of substances and reaction masses. This approach may be applied to evaluate the potential hazard of the substance on theoretical grounds provided that the molecular structure of the specific chemical is known. 

In the experimental evaluation of substances for carcinogenesis based on experimental results of studies in a nonhuman species at some relatively high dose or exposure level, an attempt is made to predict the occurrence and level of tumorogenesis in humans at much lower levels. In this chapter we will examine the assumptions involved in this undertaking and review the aspects of design and interpretation of traditional long-term (lifetime) animal carcinogenicity studies as well as some alternative short-term models. 

The systematic evaluation of substance properties and predictable or actual exposure patterns over the entire life-time of a substance within the scope of risk assessment is as yet a relatively recent instrument, for which harmonised scientific rales were created in the EU for the first time in 1997 in the form of the Technical Guidance Documents (TGD). An essential element in this range of instruments is how to deal with shortcomings in knowledge. Wherever information is missing, standardised worst-case scenarios are conceived taking into account appropriate safety factors . If under these worst-case assumptions a rele-... 

The European Union System for the Evaluation of Substances (FUSES) is a decision-support instrument, which enables government authorities, research institutes, and chemical companies to carry out rapid and efficient exposure assessments for chemical substances (ECB 2007). 

EUSES European Union System for the Evaluation of Substances... 

Folkers K, Hakanson R, Horig J, Xu JC, Leander S (1984) Biological evaluation of substance P antagonists. Br J Pharmacol 83 449-456... 

The removal of xylan by the xylanase appeared more pronounced in T than in Si. This is in disagreement with microdensitometrical evaluations of substance losses in cell walls of spruce- and pinewood holocellulose reported by Boutelje and co-workers (5,6). They found that the hydrolysis of xylan by xylanase treatment occurred mainly in the S2 layer the Si and in some cases also the S3 (T) layer appeared not to be affected. In the same way, they showed that the Si layer is more resistant to cellulolytic attack than the other cell wall layers. 

Evaluation of Substances Without Reference Values From the IRK/AOLG Ad-hoc Working Group... 

SimpleBox was created as a research tool in environmental risk assessment. Simple-Box (Brandes et al. 1996) is implemented in the regulatory European Union System for the Evaluation of Substances (EUSES) models (Vermeire et al. 1997) that are used for risk assessment of new and existing chemicals. Dedicated SimpleBox 1.0 applications have been used for integrating environmental quality criteria for air, water, and soil in The Netherlands. Spreadsheet versions of SimpleBox 2.0 are used for multi-media chemical fate modeling by scientists at universities and research institutes in various countries. SimpleBox models exposure concentrations in the environmental media. In addition to exposure concentrations, SimpleBox provides output at the level of toxic pressure on ecosystems by calculating potentially affected fractions (PAF) on the basis of species sensitivity distribution (SSD) calculus (see Chapter 4). 

Vermeire TG, Jager DT, Bussian B, Devillers J, den Haan K, Hansen B, Lundberg I, Niessen H, Robertson S, Tyle H, van der Zandt PTJ. 1997. European Union system for the evaluation of substances (EUSES) principles and structure. Chemosphere 34 1823-1836. 

For additives, on the other hand, the list is a partial list currently comprising 289 substances fully evaluated by the SCF whose toxicological characteristics do not necessitate the imposition of any restriction on use other than the overall migration limit. 204 additional substances, fully evaluated by the SCF and 185 of which require a restriction on their use according to the SCF, will be added to the list before long. All of the more important information on the evaluation of substances is to be found in the document entitled Synoptic which is to be distributed on the Internet (address http //cpf.jrc.it/webpack/). 

Bum et al. (1952) described the evaluation of substances, which affect gastric secretion using perfusion of the stomach in anesthetized cats. 

Many models are available for calculating exposure, but the European Union System for the Evaluation of Substances (EUSES) is the most commonly used in the EU. Variations in human populations across Member States are considered in terms of body weight, diet, and activities [133]. Consideration is also given to susceptible individuals such as children and the elderly [133]. More specific models are used in conjunction with EUSES to assess occupational dermal exposure (DERMAL), occupational inhalation (EASE) and consumer exposure (CONSEXPO) (see [134]). 

Environment Institute, Joint Research Centre - European Commission, European Chemicals Bureau, EUSES, European Union System for the Evaluation of Substances, EUR 17308, Ispra (Varese), Italy, 1997. 

RIVM (1998). Uniform System for the Evaluation of Substances 2.0 (USES 2.0), RIVM Report No. 679102.044, Ministry of Housing, Spatial Planning and the Environment (VROM), Ministry of Health, Welfare and Sports (VWS), Bilthoven, The Netherlands. 

This theoretical example of a QSAR assessment is presented to exhibit FDA s current approach to using S AR as a tool in the safety evaluation of substances proposed for use as food contact materials. If anthrafurin (1,6-dihydroxy anthraquinone CASRN 117-12-4 Fig. 7.3) were expected to be an impurity in a food contact material, an immediate initial concern would be raised due to reports in the literature of positive results in the bacterial reverse mutation assay and other in vitro genetic toxicity tests. A literature search did not identify relevant carcinogenicity data for anthrafurin. 

The quality and consistency of the data are important. Evaluation of substances or mixtures related to the material being classified should be included, as should site of action and mechanism or mode of action study results. Both positive and negative results are assembled together in a single weight of evidence determination. 

Aromoline and ten other bisbenzylisoquinoline alkaloids were evaluated in the in vitro histamine release inhibition assay. This assay is one of the basic tests that is used in the evaluation of substances for antiallergic effects. The order of potency of inhibitory effect of those bisbenzylisoquinoline alkaloids that have been isolated from Thalictrum species was as follows homoaromoline > aromoline > isotetrandrine > obaberine > tetrandrine. Berbamine and oxyacanthine were found to have no inhibitory effect [178]. 

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