Примери за използване на Read-across на Английски и техните преводи на Български
{-}
-
Colloquial
-
Official
-
Medicine
-
Ecclesiastic
-
Ecclesiastic
-
Computer
Grouping of substances and read-across.
Failure to include read-across in the operative part of the data to be considered(12).
Grouping of substances and read-across.
Grouping of substances and applying read-across are possible adaptations to information requirements.
This approach is called read-across.
Grouping of substances and read-across is one of the most commonly used alternative approaches for filling data gaps in registrations submitted under REACH.
Justification for grouping of substances and read-across.
You also need to explain why you are applying this category or read-across approach to the registered substance and the endpoint in question.
For each standard information requirement that applies,registrants must indicate whether they are making an adaptation using read-across, and they must justify its use.
ECHA is now using the RAAF to make sure that assessing grouping and read-across used for human health endpoints under dossier evaluation is consistent and transparent.
It may also include read-across from chemical analogues and homologues,(Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks.
Alternatives to test data(e.g. QSAR, read-across, in vitro).
Part 1: An Introductory Note which provides background information on read-across including general considerations and addresses shortcomings commonly identified by ECHA when evaluating registration dossiers.
Predictions based on information from structurally related substances(read-across and chemical categories);
It may also include read-across from chemical analogues and homologues,(Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks.
The use of test data across companies and read-across within a group of substances;
When experts apply the RAAF in read-across, it will result in a structured assessment of the strengths and weaknesses of the read-across and identify possible shortcomings in the documentation, scientific reasoning and/or supporting evidence.
Additional useful information may come from structural alerts and read-across from structurally related substances.
The grouping of substances and read-across offer a possibility for adaptation of the standard information requirements of the REACH Regulation, with the conditions for using grouping and read-across approaches to fulfil information requirements set in Annex XI, 1.5.
In some cases, instead of test data, you can also consider waivers,non-testing methods and read-across, if they are scientifically justified.
Grouping of substances and read-across approach Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or‘category' of substances.
This publication also provides insights for registrants making use of expertise in read-across on how to assess, and improve where they can, their explanations of why and how read-across can be used.
The main objective of the Toolbox is to allow the user to use(Q)SAR methodologies to group chemicals into categories andto fill data gaps by read-across, trend analysis and(Q)SARs.
Whereas the failure to explicitly include read-across as part of the consideration of all available data is not consistent with the existing classification system for CMR substances as laid down in Regulation(EC) No 1272/2008, which explicitly includes read-across; .
Information on the hazardous properties of substances may, in accordance with Annex XI to Regulation(EC) No 1907/2006, be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models orby the use of grouping or read-across.
Such an approach should not only consider the quality and reliability of the data on genotoxicity itself, but also take into account other relevant data that may be available, such as physico-chemical characteristics,structure-activity relationships(including structural alerts for genotoxicity and read-across from structurally related substances), bioavailability, toxicokinetics and metabolism, and the outcomes of any repeated-dose toxicity and carcinogenicity studies.
In particular, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models orfrom information from structurally related substances(grouping or read-across).”.
The information supplied for the purpose of evaluation of chemicals as regards human toxicity in particular must be obtained whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models orfrom information from structurally related substances(grouping or read-across).