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Commission Regulation (EC) No 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
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The test report must include the following:
Test substance:
physical nature and physicochemical properties, including water solubility limit,
chemical identification data (e.g. CAS Number), including purity.
Test species:
scientific name, clone (if known) and source.
Test conditions:
test procedure used (static, semi-static or flow-through),
date of start of the test and its duration,
test medium,
description of the experimental design: test vessels and covers, solution volumes, number of colonies and fronds per test vessel at the beginning of the test,
test concentrations (nominal and measured as appropriate) and number of replicates per concentration,
methods of preparation of stock and test solutions including the use of any solvents or dispersants,
temperature during the test,
light source, light intensity and homogeneity,
pH values of the test and control media,
test substance concentrations and the method of analysis with appropriate quality assessment data (validation studies, standard deviations or confidence limits of analyses),
methods for determination of frond number and other measurement variables, e.g. dry weight, fresh weight or frond area,
all deviations from this Testing Method.
Results:
raw data: number of fronds and other measurement variables in each test and control vessel at each observation and occasion of analysis,
means and standard deviations for each measurement variable,
growth curves for each concentration (recommended with log transformed measurement variable, see second paragraph in section 2.2.1),
doubling time/growth rate in the control based on the frond number,
calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates,
graphical representation of the concentration/effect relationship,
estimates of toxic endpoints for response variables e.g. EC50, EC10, EC20, and associated confidence intervals. If calculated, LOEC and/or NOEC and the statistical methods used for their determination,
if ANOVA has been used, the size of the effect which can be detected (e.g. the least significant difference),
any stimulation of growth found in any treatment,
any visual signs of phytotoxicity as well as observations of test solutions,
discussion of the results, including any influence on the outcome of the test resulting from deviations from this Testing Method.
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