Webinar for Inexperienced Registrants Creation of the Substance Dataset and of the Registration...

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Transcript of Webinar for Inexperienced Registrants Creation of the Substance Dataset and of the Registration...

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

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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

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Chapter 2 – IUCLID

Make sure you are using the same Legal Entity (LE) in IUCLID and in Reach-IT

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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!

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Chapter 2 – IUCLID

make the LE available for the IUCLID User that will prepare the dossier

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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.

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Chapter 2 – IUCLID

Create and assign a “Site” to your LE

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Chapter 2 – IUCLID

Create and assign a “Site” to your LE

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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

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Chapter 2 – IUCLID

Preparing the Dossier

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Chapter 2 – IUCLID

Preparing the Dossier – The EC Inventory

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Chapter 2 – IUCLID

Preparing the Dossier – The EC Inventory

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Chapter 2 – IUCLID

Preparing the Dossier – The Reference Substance

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Chapter 2 – IUCLID

Preparing the Dossier – The Reference Substance

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Chapter 2 – IUCLID

Preparing the Dossier – The Reference Substance

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset

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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

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset “1.2”

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset “1.3”

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Chapter 2 – IUCLID

Preparing the Dossier – The Substance Dataset “3.3”

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Chapter 2 – IUCLID

Preparing the Dossier – Guidance on safe use “11”

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Chapter 2 – IUCLID

Preparing the Dossier – Chemical Safety Report “13”

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Chapter 2 – IUCLID

Preparing the Dossier – Run the TCC Tool on your Substance Dataset

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Chapter 2 – IUCLID

Preparing the Dossier – The Dossier Creation Wizard

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Chapter 2 – IUCLID

Preparing the Dossier – The Dossier Creation Wizard

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Chapter 2 – IUCLID

Preparing the Dossier – Run the TCC Tool on your dossier

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Chapter 2 – IUCLID

Preparing the Dossier – Export the Dossier