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

Data Submission Manual
Version: 3.1 6
4.3.4. Section 3.4 - Information on mixtures ................................................................................. 44
4.3.5. Section 3.5 - Life Cycle description ...................................................................................... 44
4.3.6. Section 3.6 - Uses advised against ...................................................................................... 47
4.3.7. Section 3.7 - Exposure scenarios, exposure and risk assessment ............................................ 47
4.4. Sections 4, 5, 6, 7 and 8 - Endpoint sections ........................................................................... 48
4.4.1. Background ...................................................................................................................... 48
4.4.2. Description of the approach to follow ................................................................................... 48
4.4.3. Adaptation of the standard testing regime ............................................................................ 52
4.4.4. Testing proposals .............................................................................................................. 57
4.4.5. Study results .................................................................................................................... 58
4.4.6. PNECs and DNELs ............................................................................................................. 65
4.5. Section 11 - Guidance on safe use ......................................................................................... 66
4.6. Section 13 - Assessment reports ............................................................................................ 67
4.7. Dossier header .................................................................................................................... 69
5. Technical Completeness Check (TCC) .................................................................................. 73
5.1. The TCC plug-in ................................................................................................................... 73
Annex 1 – Dossier endpoint matrix ......................................................................................... 76
Annex 2 – Information to provide in the block "Results and discussions" ............................... 85
Annex 3 – Dissemination of information and Confidentiality claims ........................................ 89
Annex 4 - Minimum information required for updating a registration under previous
Directive .................................................................................................................. 91
Annex 5 – Instructions on reporting uses in IUCLID 5.4 for lead, member and individual
registrants ............................................................................................................... 95
Table of Figures
Figure 1: Terminology of IUCLID 5 items ........................................................................... 10
Figure 2: Range fields ........................................................................................................ 10
Figure 3: Unit fields ............................................................................................................ 11
Figure 4: Selection of other in a list ................................................................................... 11
Figure 5: Detail level of endpoint study record ................................................................... 11
Figure 6: Repeatable blocks ............................................................................................... 12
Figure 7: IUCLID 5 view mode ........................................................................................... 12
Figure 8: Legal entity and third party in the substance identification block ....................... 16
Figure 9: Role in the supply chain ...................................................................................... 17
Figure 10: Type of substance ............................................................................................... 17
Figure 11: Reference substance ........................................................................................... 18
Figure 12: Substance identifier ............................................................................................ 19
Figure 13: Section 1.1 Molecular and structural information ................................................ 20
Figure 14: Substance composition block .............................................................................. 20
Figure 15: Concentrations .................................................................................................... 21