Post on 28-Mar-2015
transcript
Webinar for Inexperienced Registrants
Creation of the Substance Dataset and of the Registration Dossier
15.11.2010
Ricardo SimoesRicardo SimoesECHA – Registration & Dossier Submission UnitECHA – Registration & Dossier Submission Unit
2
Chapter 2 – IUCLID
What do you need to do in IUCLID? 1) Make sure you are using the same Legal Entity
(LE) in IUCLID and in Reach-IT and make it available for the IUCLID User that will
prepare the dossier Create and assign a “Site” to your LE
2) Preparing the Dossier EC inventory Reference substance Substance Dataset Dossier creation steps for Member dossier
3
Chapter 2 – IUCLID
Make sure you are using the same Legal Entity (LE) in IUCLID and in Reach-IT
4
Chapter 2 – IUCLID
make the LE available for the IUCLID User that will prepare the dossier
NOTE: You need to have Administrator rights in IUCLID to have access to the User Management menu!
5
Chapter 2 – IUCLID
make the LE available for the IUCLID User that will prepare the dossier
6
Chapter 2 – IUCLID
make the LE available for the IUCLID User that will prepare the dossier
-The user that will prepare the dossier can now login and confirm that the Legal Entity is available for him to use.
7
Chapter 2 – IUCLID
Create and assign a “Site” to your LE
8
Chapter 2 – IUCLID
Create and assign a “Site” to your LE
9
Chapter 2 – IUCLID
What do you need to do in IUCLID? 1) Make sure you are using the same Legal Entity
(LE) in IUCLID and in Reach-IT and make it available for the IUCLID User that will
prepare the dossier create and assign a “Site” to your LE
2) Preparing the Dossier EC inventory Reference substance Substance Dataset Dossier
10
Chapter 2 – IUCLID
Preparing the Dossier
11
Chapter 2 – IUCLID
Preparing the Dossier – The EC Inventory
12
Chapter 2 – IUCLID
Preparing the Dossier – The EC Inventory
13
Chapter 2 – IUCLID
Preparing the Dossier – The Reference Substance
14
Chapter 2 – IUCLID
Preparing the Dossier – The Reference Substance
15
Chapter 2 – IUCLID
Preparing the Dossier – The Reference Substance
16
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset
17
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset
18
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset
19
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset
1.1 Identification
1.2 Composition
1.3 Identifiers
3.3 Sites
11 Guidance on safe Use
13 Chemical safety report
BR STEP SUCCEDED
20
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset “1.2”
21
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset “1.3”
22
Chapter 2 – IUCLID
Preparing the Dossier – The Substance Dataset “3.3”
23
Chapter 2 – IUCLID
Preparing the Dossier – Guidance on safe use “11”
24
Chapter 2 – IUCLID
Preparing the Dossier – Chemical Safety Report “13”
25
Chapter 2 – IUCLID
Preparing the Dossier – Run the TCC Tool on your Substance Dataset
26
Chapter 2 – IUCLID
Preparing the Dossier – The Dossier Creation Wizard
27
Chapter 2 – IUCLID
Preparing the Dossier – The Dossier Creation Wizard
28
Chapter 2 – IUCLID
Preparing the Dossier – Run the TCC Tool on your dossier
29
Chapter 2 – IUCLID
Preparing the Dossier – Export the Dossier