Page 35 - CITDBooklet

Guide on the application of REACH Regulation

■ It was a scoring system for reliability, particularly for ecotoxicology and health studies;
however it may be extended to physicochemical and environmental fate and
pathway studies.

■ Klimisch et al. (1997), developed a scoring system which can be used to categorize
the reliability of a study as follows:

■ 1 = reliable without restrictions: “studies or data...generated according to generally
valid and/or internationally accepted testing guidelines (preferably performed
according to GLP) or in which the test parameters documented are based on a
specific (national) testing guideline...or in which all parameters described are closely
related/comparable to a guideline method.”

■ 2 = reliable with restrictions: “studies or data...(mostly not performed according to
GLP), in which the test parameters documented do not totally comply with the specific
testing guideline, but are sufficient to accept the data or in which investigations
are described which cannot be subsumed under a testing guideline, but which are
nevertheless well documented and scientifically acceptable.”

■ 3 = not reliable: “studies or data...in which there were interferences between the
measuring system and the test substance or in which organisms/test systems were
used which are not relevant in relation to the exposure (e.g., unphysiologic pathways
of application) or which were carried out or generated according to a method which
is not acceptable, the documentation of which is not sufficient for assessment and
which is not convincing for an expert judgment.”

■ 4 = not assignable: “studies or data....which do not give sufficient experimental details
and which are only listed in short abstracts or secondary literature (books, reviews,
etc.).

■ What studies should be valued?
■ From a quality perspective and taking ‘Klimisch’ ratings as a model, only studies with

a reliability rating of 1 or 2 should normally qualify for financial compensation.
■ Reports in categories (3) “not reliable” and (4) “not assignable” can therefore

effectively be deselected from a valuation procedure whenever higher reliability
studies are available.

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