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