Data Submission Manual 5: How to complete a - ECHA - Europa

Data Submission Manual
For dossiers above 10 tonnes: for the specific case of the endpoint acute toxicity
three IUCLID 5 sections (7.2.1 "Acute Toxicity: oral", 7.2.2 "Acute toxicity:
inhalation" and 7.2.3 "Acute toxicity: dermal") will be checked for completeness. If
one of them is not relevant, this should be indicated by creating a data waiver for
the non-relevant route(s).
Further information on this IUCLID-REACH endpoint study mapping is provided in Annex
1 of this document (see column "Specific rules for IUCLID-REACH relationships different
to a one to one relationship").
In cases where more than one study is provided for one endpoint then it is
recommendable to create an endpoint summary to summarise and highlight the main
points of your endpoint study records. These endpoint summaries can be created by
making a right click on the specific IUCLID 5 endpoint (endpoint summaries are indicated
with a blue symbol ). However, these endpoint summaries will not be checked for
completeness except the general one for section 6 "Ecotoxicological information" and the
general one for section 7 "Toxicological information" (i.e. where the PNEC and DNEL
should be reported).
Further information on how to complete these two endpoint summaries is provided in the
"PNECs and DNELs" chapter 4.4.6 of this document.
Please note that the generation of a Chemical Safety Report (CSR) by means of
the CSR plug-in can only be accomplished if the appropriate endpoint summaries
are provided.
The approach described above results in the following practical scheme (Figure 47).
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