Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

42 Data Submission Manual Version: 2.0
For more instructions on the selection of these codes, please consult the Guidance on the
application of the CLP criteria which can be found on the ECHA website.
For the “Specific target organ toxicity - Single exposure” and “Specific target organ
toxicity - Repeated exposure” hazard classes, you have to indicate in the field “Affected
organs” the primary target organs. It is recommended to include no more than three
primary target organs for practical reasons and because the classification is for specific
target organ toxicity. If more target organs are affected it is recommended that the
overall systemic damage should be reflected by the phrase “damage to organs” (
Figure 50).
If the affected organ is unknown indicate “unknown” it in the field “Affected
organs”.
The route of exposure should only be specified if it is conclusively proven that no
other route of exposure causes the hazard. Supporting evidence can be attached
to section 13 of IUCLID 5 in a separate endpoint study record (unless it is already
specified in Annex VI to the CLP Regulation or justified in the SDS provided by the
supplier).
Two routes of exposure can be specified. This means that in case all three routes
of exposure cause the hazard, the route of exposure field shall remain empty.
Figure 50: Specify the affected organ
For “Specific target organ toxicity – single” and “Specific target organ toxicity –
repeated” either the three fields “Hazard category” and “Hazard statement” and
“Affected organs” should be filled in, or the field “Reason for no classification”
should be filled in (
Figure 50).
Substances which have a harmonised classification, or are fulfilling the criteria for
classification, as carcinogenic, mutagenic, reproductive toxicants or substances
fulfilling the criteria for STOT-SE or STOT-RE Category 1 do not qualify for an
alternative chemical name.
5.7.2.3. Classification – Specific concentration limit
Harmonised classification has to be applied: if your substance has harmonised specific
concentration limit(s), you shall specify it in this IUCLID 5 block (
Figure 51).
If you propose to set specific concentration limit(s) under the strict condition of Article
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