Report Generator User Manual - Part 1 (Principles of CSR
IUCLID 5
Guidance and Support
Report generator
CSR generation
User Manual
January 2014
Version 4.3
IUCLID 5 is developed by the European Chemicals
Agency in association with the OECD
Report Generator User Manual (CSR)
January 2014
PREFACE
The aim of this guidance document is to provide insight into what kind of information the Report
generator captures from IUCLID 5 records and optionally from Chesar (Chemical safety assessment
and reporting tool) in order to generate the Chemical Safety Report (CSR). The principle rules
underlying the automatic generation of a CSR rtf document are explained.
This guide also provides hints and tips on how to optimise data entry in the IUCLID 5 source records
in such a way that any manual revision work is limited to a minimum.
ORGANISATION OF THIS GUIDANCE DOCUMENT
This document is organised into the following two main parts:
Part I: Principles of CSR generation
Describes the general rules and format underlying the generation of a CSR template using the
Report Generator including examples and practical hints.
Part II: Specifications of the CSR Template
Provides the specifications of the CSR Template showing the IUCLID source fields and how
they are inserted in the CSR, together with specific rules where appropriate. The general rules
used are not re-iterated, but described in Part I.
DOCUMENT HISTORY
Version
Changes
4.3
Adaptation to Chesar synchronisation functionalities: minor changes to chapter 1.2, 1.3
and new chapters added (4.3 and 4.4)
4.2
Transfer of the CSR plug-in functions to the Report generator.
4.1
Minor changes of Specifications of the CSR Template (see Part II) as implemented in
CSR plug-in version 5.4.1.
Adaptation to the Chesar synchronisation functionalities, particulary added new chapters
"3 GENERATION OF THE CSR (EXCEPT SECTIONS 9 AND 10)" and
"4 GENERATION OF THE FULL CSR WHEN CHESAR ASSESSMENT IS AVAILABLE".
Deletion of part 0 to improve readability of the document. The information on the most
relevant changes made to the different CSR plug-in versions is now stored in the IUCLID
CSR plug-in release note document.
4.0
Adaptation to IUCLID 5.4
In addition, the Annotated CSR Template in Part II has been exchanged by the
Specifications of the CSR Template. An illustrative chemical safety report is available as
separate document from ECHA's website.
3.0
Adaptation to IUCLID 5.3
2.0
Addition of Part 0: Overview of the most relevant changes in this version.
Adaptation of Parts I and II to changes described in Part 0.
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Table of Contents
PART I: PRINCIPLES OF CSR GENERATION ................................................. 5
1 GENERAL INTRODUCTION ................................................................................. 5
1.1
CSR REQUIREMENTS UNDER REACH ............................................................................... 5
1.2
PURPOSE OF THE REPORT GENERATOR .............................................................................. 5
1.3
GENERAL PRINCIPLES OF THE CSR PREPARATION USING THE REPORT GENERATOR ......... 6
2 HOW TO INSTALL AND RUN THE REPORT GENERATOR........................................ 9
3 GENERATION OF THE CSR (EXCEPT SECTIONS 9 AND 10) .................................. 9
3.1
GENERATION OF OWN / JOINT CSR .................................................................................... 9
3.2
CSR PART A ...................................................................................................................... 9
4 GENERATION OF THE FULL CSR WHEN CHESAR ASSESSMENT IS AVAILABLE .... 10
4.1
CONSISTENCY OF THE SUBSTANCE PROPERTIES ............................................................... 10
4.2
SYNCHRONISATION OF THE USES BETWEEN CHESAR AND IUCLID SECTION 3.5 ............. 10
4.3
UPDATE
OF IUCLID SECTION 3.7.1 WITH THE EXPOSURE SCENARIO INFORMATION
EXTRACTED FROM CHESAR ....................................................................................................... 11
4.4
SYNCHRONISATION OF THE ENVIRONMENTAL ASSESSMENT FOR AGGREGATED SOURCES
BETWEEN CHESAR AND IUCLID SECTION 3.7.2 ........................................................................ 11
5 FORMAT AND GENERAL RULES UNDERLYING THE CSR GENERATION ............... 11
5.1
LAYOUT AND FORMAT OF THE CSR GENERATED ............................................................. 12
5.1.1
5.1.2
5.1.3
5.2
STRUCTURE ......................................................................................................................... 12
DOCUMENT FILE FORMAT .................................................................................................... 12
TABLE OF CONTENTS ........................................................................................................... 12
GENERAL RULES .............................................................................................................. 13
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
TEXT LABELS (PROMPTS) PRECEDING TRANSFERRED IUCLID VALUES ............................. 13
OUTPUT OF VALUE(S) CONCATENATED WITH TEXT ............................................................ 14
HANDLING INFORMATION CAPTURED FROM REPEATABLE BLOCKS OF FIELDS ................... 15
DISCARDING PICKLIST PHRASE "NO DATA" ......................................................................... 15
DISCARDING PICKLIST PHRASES "OTHER:", "OTHER .....:" ................................................... 15
HANDLING INFORMATION CAPTURED FROM TEXT FIELDS AND RICH TEXT AREAS ............. 16
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6 GUIDANCE ON SPECIFIC CSR SECTIONS B.1 TO B.3 ........................................ 16
6.1
CSR SECTION B.1 IDENTITY OF THE SUBSTANCE AND PHYSICOCHEMICAL PROPERTIES ... 16
6.2
CSR SECTION B.2 MANUFACTURE AND USES .................................................................. 16
6.3
CSR SECTION B.3. CLASSIFICATION AND LABELLING ..................................................... 16
7 GUIDANCE ON CSR SECTIONS B.4 TO B.7 (HAZARD ASSESSMENT) ................. 17
7.1
GENERAL APPROACH ....................................................................................................... 17
7.2
OVERVIEW TABLES FOR SUMMARISING THE RELEVANT STUDIES ..................................... 18
7.2.1
7.2.2
7.2.3
7.2.3.1
7.2.3.2
7.2.3.3
7.2.3.4
7.2.3.5
RULES FOR TRANSFERRING ENDPOINT STUDY RECORDS..................................................... 19
SORTING RULES ................................................................................................................... 19
ELEMENTS INCLUDED IN OVERVIEW TABLES ...................................................................... 20
INFORMATION ON METHOD (GUIDELINE, PRINCIPLES OF METHOD, SPECIFIC FIELDS) ................. 20
INFORMATION ON STUDY RESULTS ............................................................................................. 20
INFORMATION ON TEST MATERIAL IDENTITY.............................................................................. 20
ADMINISTRATIVE INFORMATION (RELIABILITY, PURPOSE FLAG, STUDY RESULT TYPE)............. 22
DATA SOURCE INFORMATION (BIBLIOGRAPHIC REFERENCES).................................................... 22
7.3
DATA WAIVING INFORMATION ........................................................................................ 23
7.4
INFORMATION ON TESTING PROPOSALS ........................................................................... 23
7.5
INFORMATION FROM ENDPOINT SUMMARIES ................................................................... 24
7.5.1
7.5.2
7.5.3
INFORMATION CAPTURED FROM IUCLID 5 ENDPOINT SUMMARIES ................................... 24
INFORMATION TO BE ADDED MANUALLY ............................................................................ 27
LIST OF REFERENCES ........................................................................................................... 27
8 SMART (CSR-ORIENTED) DATA ENTRY IN IUCLID 5....................................... 28
8.1
HOW TO GET INFORMATION ON THE TEST MATERIAL INTO THE CSR ............................... 28
8.2
HOW TO GET IMPORTANT METHODOLOGICAL INFORMATION INTO THE CSR ................... 31
8.3
HOW TO GET IMPORTANT INFORMATION ON STUDY RESULTS INTO THE CSR................... 33
8.4
HOW TO AVOID LENGTHY TEXTS IN CSR OVERVIEW TABLES .......................................... 34
9 ECHA GUIDANCE DOCUMENTS ...................................................................... 37
PART II: SPECIFICATIONS OF THE CSR TEMPLATE ................................. 38
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PART I: PRINCIPLES OF CSR GENERATION
1
GENERAL INTRODUCTION
1.1 CSR REQUIREMENTS UNDER REACH
As outlined in the ECHA Guidance on information requirements and chemical safety assessment,
Part F: Chemical Safety Report (ECHA 2008), the main goal of the chemical safety report (CSR) is to
document the chemical safety assessment (CSA), including its conclusions and results, with regard to
the standard elements of the CSA. The report should be readily understandable as a stand-alone
document. The principles applied, the assumptions made and the conclusions drawn should be
transparent. The key data should be easily identifiable without the need to revert to the underlying
data sets (i.e., the IUCLID 5 substance data set). In order to keep the CSR as concise as possible,
only the most relevant information reported in the technical dossier (IUCLID 5) is repeated.
1.2 PURPOSE OF THE REPORT GENERATOR
The Report Generator has been designed to assist in preparing a CSR. It generates the complete
structure of the CSR report including all main sections and subsections. In particular it:
Manages the information on part A of the CSR for own or joint CSRs.
Pre-fills the sections of part B, sections 1 to 8, for which information is captured in IUCLID 5.
When an exposure assessment and risk characterisation have been carried out using ECHA’s
1
Chemical safety assessment and reporting tool Chesar , adds the sections 9 and 10 of the
CSR as generated by Chesar after having checked that the data are consistent between the
two systems. It also enables the import of data on use description (IUCLID section 3.5), as
well as of an extract of exposure assessment data from Chesar to IUCLID (section 3.7).
The plug-in generates a CSR document as an rtf file (rich text format), which reflects the underlying
data base contained in the relevant IUCLID and, if applicable, Chesar datasets. Although possible,
editing of the generated CSR using any text processing program, should be limited to (rare) cases
where data cannot be edited upfront in the data source(s).
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1.3 GENERAL PRINCIPLES OF THE CSR PREPARATION USING THE REPORT
GENERATOR
The general principles of how the preparation of the CSR is supported by the Report Generator are
shown in the following schemes:
The capture of IUCLID 5 is controlled by a number of rules used to extract and transfer the most
relevant information and filter out less relevant information.
As shown in the graphical schema above, the Report Generator can be used in an iterative process.
That is, entries in the IUCLID 5 source fields can be optimised as appropriate. In this respect, the
cyclic improvement of the source data and re-run of the plug-in can be useful in
verifying that the appropriate information has been entered in IUCLID 5 and, if applicable,
Chesar, in the appropriate fields;
limiting any manual adaptations n the final CSR to cases where data cannot be edited upfront
in the data source(s).
Knowing beforehand what kind of IUCLID 5 information is used or not used by the plug-in may prompt
the IUCLID 5 user for a more anticipating, i.e. CSR-oriented, completion of the relevant fields (see
section 8. Smart (CSR-oriented) data entry in IUCLID 5).
The Report Generator handles also the import of the information generated by Chesar: the substance
properties and the uses available in Chesar are checked against the IUCLID ones. If the data are
similar in both systems the sections 9 and 10 are added to the CSR generated. In case there are
some uses already set in IUCLID, the Report Generator will overwrite them with the information
reported in Chesar (this is called “synchrionising the uses”)
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In addition, the Report Generator handles the import of an extract of exposure assessment information
generated by Chesar. Once the synchronisation with Chesar uses is completed in IUCLID (section
3.5), the Report Generator prompts the user to synchronise exposure assessment data (population of
IUCLID section 3.7.1) and report the environmental assessment for aggregated sources (IUCLID
section 3.7.2), as illustrated in the graphical scheme here below.
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Note:
The Report Generator is not a technical completeness check.
It cannot be guaranteed that all relevant information is captured and/or copied into the
appropriate CSR section. The user is responsible to verify that the relevant CSR
information is included, and if not, to update the CSR by updating the source records
and/or by modifying, supplementing or deleting any information in the CSR manually as
appropriate.
Be aware of the risk that any manual changes made to IUCLID 5-borne information in the
CSR may result in inconsistencies, if the IUCLID 5 records are not updated accordingly.
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HOW TO INSTALL AND RUN THE REPORT GENERATOR
A separate manual is available which gives guidance on how to install and run the plug-in.
Note: The CSR generation can only be used for an IUCLID 5 Substance or Dossier. If it
is desired to generate a preliminary CSR based on a Template, e.g. for internal review
purposes, the Template has to be assigned to a Substance first, which can then be
processed by the plug-in.
3
GENERATION OF THE CSR (EXCEPT SECTIONS 9 AND 10)
The Report Generator generates part A and part B sections 1 to 8 of the CSR in the standard case.
For that the user selects a substance or dossier and decides to "generate a CSR".
3.1 GENERATION OF OWN / JOINT CSR
The Report Generator allows the generation of two different types of Chemical Safety Report (CSR):
Own CSR or Joint CSR. This mainly impacts on the selection of uses that are described in section 2 of
the CSR. It has no impact on the information reported in any other sections related to the hazard
assessment. It also impacts on part A (see section 3.2).
In case the user decides to prepare its "Own" CSR, all uses flagged as "Use covered by an own CSR"
in field "Use coverage in CSR" of IUCLID section 3.5 will be reported in section 2.
In case the user instead decides to prepare a Joint CSR, only the uses flagged in IUCLID section 3.5
as "Use covered by a Joint CSR" (including those flagged as "Use covered by a Joint CSR but not a
lead own use") will be reported in section 2.
In case one or more uses do not report the information on the status (joint / own) the plug-in wizard
highlights them as "unflagged". All uses unflagged, will not be transferred to the Own or Joint CSR.
The assignment has to be done in IUCLID section 3.5.
Note: The option "all uses" can be choosen for populating CSR section 2.2 with all uses reported in
IUCLID section 3.5, regardless of whether and how they have been flagged. You should be very
careful when using this option, especially if some uses have been already identified as own or joint.
3.2 CSR PART A
The Report Generator manages also the so called part A of CSRs. Part A is divided in the following
three subsections:
-
1. Summary of risk management measures
-
2. Declaration that risk management measures are implemented
-
3. Declaration that risk management measures are communicated
All parts can be easily completed by the user in step 4 of the Report Generator dialog. For each of the
three subsections a rich text area is provided which can accommodate plain text, but also tables and
specific formatting of text entered. The text is stored internally within IUCLID. This means that every
time the user starts the generation of the CSR for a substance, for which he has previously entered
the information in part A, all text entered in the past is retrieved. Updates, if needed, can be done at
any time.
The Part A is specific to the type of CSR generated in terms of "Own CSR", "Joint CSR" or "All uses
CSR". In this way, for a single substance, up to three different sets of part A can be entered which are
linked to the respective selection made by the user.
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GENERATION OF THE FULL CSR WHEN CHESAR ASSESSMENT IS AVAILABLE
The Report Generator maintains the rules and features related to the transfer of the hazard
information from IUCLID to the CSR document (sections 1-8), adding the possibility to include the
exposure and risk characterisation information (CSR sections 9-10) as generated by ECHA’s
Chemical safety assessment and reporting tool Chesar. In order to ensure that the information used to
prepare Chesar’s exposure assessment and risk characterization is aligned to the one available in
IUCLID for the substance-dossier, the Report Generator checks the following:
-
Consistency of substance properties
-
Synchronisation of the uses of the substance
… as detailed in the following paragraphs.
4.1 CONSISTENCY OF THE SUBSTANCE PROPERTIES
If the user decides to prepare a full CSR, once having selected the relevant substance in IUCLID, he
will have to upload the Chesar CSR output file (*.zip) generated in Chesar Box 4. Once the file is
uploaded, the Report Generator checks that the substance properties reported in the Chesar file and
the ones available from IUCLID are consistent.
The IUCLID substance properties checked by the plug-in are:
-
Main substance identifier (UUID) of the substance / dossier
-
IUCLID section 1.1 : Reference substance information (CAS information, IUPAC name,
molecular weight)
-
IUCLID section 2: PBT information (EPS 2.3)
-
IUCLID section 4: Physical form (EPS 4.1), Melting/Freezing point (EPS 4.2), Boiling point
(EPS 4.3), Relative density (EPS 4.4), Vapour pressure (EPS 4.6), Partition coefficient (EPS
4.7), Water solubility (EPS 4.8), Surface tension (EPS 4.10), Flash point (EPS 4.11),
Autoflammability (EPS 4.12), Viscosity (EPS 4.22)
-
IUCLID section 5: Biodegradation in water (EPS 5.2.1), Biodegradation in water and sediment
(EPS 5.2.2), Bioaccumulation (EPS 5.3.1), Adsorption/Desorption (EPS 5.4.1)
-
IUCLID section 6: Ecotoxicological information (EPS 6)
-
IUCLID section 7: Toxicological information (EPS 7)
1
In case of mismatch, the inconsistencies are listed. To proceed with the compilation of the full CSR the
2
user first will have to correct all differences and then start once again the CSR generation process.
Alternatively, he may decide to skip completely the generation of the full CSR and proceed with the
generation of the hazard part (section 1-8) with solely the data coming from IUCLID.
4.2 SYNCHRONISATION OF THE USES BETWEEN CHESAR AND IUCLID SECTION 3.5
To generate a consistent full CSR, all uses for which an Exposure Scenario (ES) exists, should be
listed in IUCLID section 3.5. When importing a "Joint CSA" from Chesar, the Report Generator will
replace (upon synchronisation) all the uses flagged as joint use, i.e. "Use covered by a Joint CSR" or
"Use covered by a Joint CSR but not a lead own use" by the uses described in Chesar and report
them as "Use covered by a Joint CSR". It will be up to the user to modify the flag in IUCLID 5 to "Use
covered by a Joint CSR but not a lead own use" when necessary.
1
Endpoint study summary
2
For that the user will have to check the IUCLID file and correct if necessary any data. Then he should import
the substance again in Chesar to synchronise the data in Chesar, and re-export the Chesar file.
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When importing a CSA from Chesar which is not "Joint CSA", then all the uses described in Chesar
will be reported in IUCLID as "own use" and replace the previously reported "own use".
Please be aware to avoid any unwanted deletion of previously entered data in section 3.5, that the
ideal situation is that this section at the moment of the synchronisation with Chesar is empty (or
alternatively backed-up).
To activate the transfer of information from Chesar to IUCLID section 3.5 the user has to click the
Synchronise button.
If the user decides not to proceed with the synchronisation of the uses, he can skip the step: in this
case, the report generator will generate a CSR containing only the information extracted from IUCLID
populating part A and part B sections 1 to 8.
4.3 UPDATE
IUCLID SECTION 3.7.1 WITH THE EXPOSURE SCENARIO INFORMATION
EXTRACTED FROM CHESAR
OF
Once the uses reported in Chesar are synchronised in section 3.5 of IUCLID, the report generator
plugin proposes the population of IUCLID section 3.7.1 with the exposure assessment information
extracted from a Chesar file. For each exposure scenario available in Chesar, the plugin creates a
new endpoint study that is re-named with the information available in the “label” field of the use
described in Chesar. All contributing scenarios for environment or/and workers/consumers linked to
the same use are added (as new repeatable blocks) to the corresponding section of the exposure
scenario in section 3.7.1. All conditions of use defined for a specific contributing scenario in Chesar,
are listed in IUCLID as consecutive repeatable blocks within the related contributing scenario added in
IUCLID.
To activate this transfer of information from Chesar to IUCLID section 3.7.1, the user has to click the
Synchronise button.
If the user decides not to proceed with the synchronisation of the exposure scenarios, he can skip it; in
this case the report generator will still generate a full CSR (part A and part B section 1-10).
4.4 SYNCHRONISATION OF THE ENVIRONMENTAL ASSESSMENT FOR AGGREGATED
SOURCES BETWEEN CHESAR AND IUCLID SECTION 3.7.2
As a last step in the synchronisation of information between Chesar and IUCLID, the report generator
plugin support the population of IUCLID section 3.7.2 with the information related to the environmental
assessment for aggregated sources extracted from Chesar.
To activate this transfer of information from Chesar to IUCLID section 3.7.2 the user has to click the
Synchronise button.
If the user decides not to proceed with this synchronisation, he can skip it; in this case the report
generator will still generate a full CSR (part A and part B section 1-10).
5
FORMAT AND GENERAL RULES UNDERLYING THE CSR GENERATION
In this section the general rules underlying the CSR generation are explained and exemplified. It is
demonstrated how the Report Generator works and what kind of IUCLID 5 information is generally
captured.
Note: All IUCLID 5 source fields are specified in PART II: SPECIFICATIONS OF THE
CSR TEMPLATE.
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5.1 LAYOUT AND FORMAT OF THE CSR GENERATED
5.1.1 Structure
The template for the CSR is structured according to section 7, Annex I of REACH, but provides a more
detailed breakdown into subsections as originally laid down in the template version of July 2008 made
available by the ECHA. Please note that this outline has been modified slightly in this version.
The plug-in generates the complete structure of the CSR report including all main and subsections
and, in particular, pre-fills the sections for which information can be captured from IUCLID 5, as
contained in structured format in (robust) study summaries or in endpoint summaries. That is, mainly
the CSR sections comprising the hazard assessment, basic information on manufacture and uses, as
well as classification and labelling, and - as added now - also section "8. PBT and vPvB assessment".
From plug-in version 5.4.1 the plug-in dialog provides the following options:
Manage the content of part A by entering or uploading (rich) text in step 4.
Create CSR sections B.1 - B.10 by selecting both an IUCLID substance (step 1) and a Chesar
export file for that substance (step 2);
Create CSR sections B.1 - B.8 by selecting only an IUCLID substance (step 1) and skipping
step 2. In this case only the headings of sections "B.9. Exposure assessment", and "B.10.
Risk characterisation" are output, except for section "9.0.1 Overview of uses and Exposure
Scenarios" which is populated with information captured from the field "Brief description of
use" of IUCLID section 3.5.
5.1.2 Document file format
The document can be created as XML DocBook format (Extensible Markup Language) or rich text
format (file extension rtf). The rtf format is a document file format used for cross-platform document
interchange. Most word processors are able to read and write RTF documents.
Note: Font defaults, style presets, table of contents and other functions may vary
according to defaults set in your word processing programme if you open rtf documents
with other than Microsoft Word/Microsoft Office versions. For instance, you may have to
change the standard font size from 12 to 10 pt in OpenOffice to avoid distorted
documents.
5.1.3 Table of contents
After the title page of the CSR, a table of contents is generated by the plug-in, which includes the page
numbers and hyperlinks that can be used to navigate to the bookmarked destinations.
Predefined styles are applied to headings (e.g CSR Heading 1) and the Word field code for TOC
(Table of Contents) is inserted by the Report Generator.
When a CSR is generated by the plug-in, only the headings "Table of contents" are printed and the
following message: "Please press CTRL+a and afterwards F9 to update the index.". As instructed, the
indexes are created if you
press the key combination CTRL+A (press and hold down the CTRL key and the press the A
key on the keyboard) to mark the entire document and then
press the F9 key on the keyboard.
Note: In practice, deleting or adding any headings should normally not occur, because
the format of the CSR is a standard format. However, if it is necessary to add or delete
any headings manually, it is recommended to copy and paste an existing heading and
update it as appropriate. The table of contents can be updated by pressing CTRL+A and
then the F9 key.
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5.2 GENERAL RULES
In this section the most important rules generally applied by the Report Generator are described.
5.2.1 Text labels (prompts) preceding transferred IUCLID values
In the IUCLID 5 data entry forms, the data entry fields are specified by prompts, which are text labels
describing the kind of information expected to be entered (e.g. "Study result type"). In the overview
tables generated by the Report Generator, the following approach is used:
No text labels are printed if the kind of information transferred is self-explanatory in order to
keep the tables as concise as possible. Typical examples where the placeholders (Field label
set between inequality signs (<....>) in the specifications) are replaced by the field value
without any further preceding label include:
<Guideline>
<Principles of method if other than guideline>
<Reliability>
<Purpose flag>
<Study result type>
<Author> <Year>
Text labels are printed if they help understand the meaning of the information or to avoid
misinterpretation. Typical examples include:
Spectrum of substance: <Parameter>: <Value> <Unit> (<Remarks>)
Half-life (DT50): <DT50> (<Test condition>)
Please note that in such cases the label is for several subfields which in turn either come
without an extra text label, particularly if set in brackets (e.g. (<Test condition>)), or with extra
text labels as in the following example:
Test results: <Genotoxicity> for <Species/strain> (<Test system>); met. act.: <Metabolic
activation>; cytotoxicity: <Cytotoxicity>; vehicle controls valid: <vehicle controls valid>;
negative controls valid: <negative controls valid>; positive controls valid: <positive controls
valid>
If according to the specifications a text label is envisaged, it is not printed if no information is
available, that is, the corresponding IUCLID field is empty or contains a value that is ignored
(e.g. "no data").
Example:
o
If a value is available for <Endpoint conclusion> the following is printed:
Value used for CSA: Genetic toxicity: No adverse effect observed (negative)
o
If no value is available for <Endpoint conclusion> nothing is printed
Text labels are not necessarily identical with those used in the corresponding IUCLID fields.
For instance the text label "Planned study period" is used instead of the IUCLID label "Study
period".
In some exceptional cases, the text label is printed even though no value is available. This is
done where the completion of a source field is required as the field "Study period" in the case
of test proposals or the fields "Data waiving" and "Justification for data waiving" in the case of
data waivers.
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Examples:
o
Testing proposal
Information requirement: Aquatic bioaccumulation
Proposed test guideline: OECD Guideline 305
Species: Alburnus sp.
Planned study period:
o
Data waiving
Information requirement: Long-term toxicity testing on fish
Reason:
Justification:
5.2.2 Output of value(s) concatenated with text
Some items consist of value(s) captured from IUCLID field(s) preceded and/or followed by default text.
In such cases any default text is only printed if the related value is available. Otherwise it is ignored.
Examples:
Example 1:
o
Specification: Value used for CSA: <Melting / freezing point> <Unit> at 101.3 kPa
o
Output in CSR if values are available: Value used for CSA: 255 °C at 101.3 kPa
o
Output in CSR if no values are available: nothing is printed
Example 1:
o
Specification:
Test results:
<Genotoxicity> for <Species/strain> (<Test system>); met. act.: <Metabolic
activation>; cytotoxicity: <Cytotoxicity>; vehicle controls valid: <vehicle controls valid>;
negative controls valid: <negative controls valid>; positive controls valid: <positive
controls valid>
o
Output if all values are available:
Test results:
negative for Chinese hamster lung fibroblasts (V79); met. act.: with and without;
cytotoxicity: no ; vehicle controls valid: yes; negative controls valid: yes; positive
controls valid: yes
o
Output in CSR if no values are available for "Metabolic activation", "Cytotoxicity" and
"vehicle controls valid":
Test results:
negative for Chinese hamster lung fibroblasts (V79); negative controls valid: yes;
positive controls valid: yes
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5.2.3 Handling information captured from repeatable blocks of fields
In IUCLID 5, most results data are included in repeatable blocks of fields, which are grouped in a
dialog box and usually displayed in tabular form on the data entry screen. The Report Generator
concatenates all or selected subfields according to specific rules, as illustrated in the following
screenshots:
Note: For technical reasons, several pieces of information (e.g. <Remarks>) are set in
parentheses, as it would otherwise be difficult to set them apart by punctuation marks.
5.2.4 Discarding picklist phrase "no data"
In many IUCLID 5 picklist (drop-down list) fields, the phrase "no data" can be chosen. By convention,
this phrase is not transferred to the CSR as this would cause confusion or give false meanings. For
instance, if no text label is provided, the plain text "no data" would not be understood.
5.2.5 Discarding picklist phrases "other:", "other .....:"
The picklist phrases "other:" or "other guideline:" are also ignored. However, the free text entered next
to the list field is indeed transferred.
Example:
o
Specification: <Test type> (<Route of administration>)
o
Input (IUCLID values): "Test type = other: 20 days (satellite group); "Route of
administration = oral: drinking water"
o
Output in CSR: 20 days (satellite group) (oral: drinking water)
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5.2.6 Handling information captured from text fields and rich text areas
In IUCLID 5, different text field types are provided. Information captured from these fields is handled
as follows:
6
Single-line text field: The content of these fields is transferred without any changes.
Multi-line text field: The content of these fields is transferred as is including line breaks. Only in
some cases the latter my be removed.
Rich text (html) area: allows to specify fonts, colours, bullets, and other text attributes and to
insert tables. The Report Generator keeps most of the formatting including tables.
GUIDANCE ON SPECIFIC CSR SECTIONS B.1 TO B.3
The general rules outlined in the preceding section 5.2 General rules apply where applicable.
6.1 CSR SECTION B.1 IDENTITY OF THE SUBSTANCE AND PHYSICOCHEMICAL
PROPERTIES
Specific guidance notes:
Table "Physicochemical properties":
Information is captured from the relevant endpoint summaries, but not from endpoint
study records.
For guidance on the use of endpoint summary information see section 7.5 Information
from endpoint summaries.
Data waiving: see section 7.3 Data waiving information.
Testing proposal: see section 7.4 Information on testing proposals.
6.2 CSR SECTION B.2 MANUFACTURE AND USES
The tables in the IUCLID 5 sections "3.1 Technological process", "3.5 Life Cycle description" and "3.6
Uses advised against" have been revised in IUCLID version 5.4. The Report Generator has been
updated accordingly.
6.3 CSR SECTION B.3. CLASSIFICATION AND LABELLING
This CSR section is broken down into two subsections.
Specific guidance notes on subsection "3.1 Classification and labelling according to CLP / GHS":
To distinguish the C&L information transferred from multiple records the heading "Substance:
<Name>" is inserted. Make sure that this field is completed appropriately. As a fallback, the
heading "Substance: <Reference substance name>" is inserted.
Specific guidance notes on subsection "3.2 Classification and labelling according to DSD / DPD":
Make sure that the field "Status" in IUCLID 5 section 2.2 is completed with the relevant
phrase, i.e., "67/548/EEC annex 1" or "67/548/EEC self classification" or "other:+free text", as
this information is used as target trigger. If this field is left blank, any record is transferred to
the CSR section "3.2.3 Other classification(s)".
To distinguish the C&L information transferred from multiple records the heading "Chemical
name: <Name>" or, if not available, the heading "Substance: <Reference substance name>"
is inserted in CSR sections "3.1 Classification and labelling in Annex I of Directive
67/548/EEC" and "3.2.2 Self classification(s)".
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In CSR section "3.2.3 Other classification(s)", each C&L information starts with the heading
"Status: <Status>" if the corresponding IUCLID 5 field is populated with "other:+free text". If
this field is blank, the heading "Status: >>>??? IUCLID 5 field empty!<<<" is printed in order to
alert the user that this field should be updated.
GUIDANCE ON CSR SECTIONS B.4 TO B.7 (HAZARD ASSESSMENT )
The general rules outlined in section 5.2 General rules apply where applicable.
7.1 GENERAL APPROACH
The Report Generator was designed by taking into account the general requirements outlined in
the relevant ECHA guidance documents ECHA (2008), ECHA (2012a) and ECHA (2012b) (see
9. ECHA Guidance documents).
The following approach is applied for generating the hazard assessment sections:
Overview tables are generated for summarising all relevant and possibly relevant studies as
requested in the ECHA guidance documents:
Present the key information provided in the IUCLID 5 dataset in a brief table format
and reference, rather than repeat the details (cf. ECHA 2008).
In addition to the key studies, information available in other studies could also be used
by the registrant as supporting information or as part of a weight of evidence approach
(cf. ECHA 2012a).
Note: The IUCLID 5 fields "Conclusions" and "Executive summary" are not addressed by
the Report Generator, which is in line with the ECHA guidance that the description of key
information should preferably be done in tabular form.
In the previous version of the Report Generator data waiving information was captured only
where REACH foresees this possibility (cf. ECHA 2012b). In the updated version data waiving
records from each endpoint section are transferred.
The same holds true for information on testing proposals: In the updated version any record
containing the field "Study result type = experimental study planned" is transferred.
The conclusions from the hazard assessment should be presented in the relevant endpoint
summaries of IUCLID 5 which is then transferred to the relevant CSR subsections (cf. ECHA
2008).
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7.2 OVERVIEW TABLES FOR SUMMARISING THE RELEVANT STUDIES
The following screenshots illustrate the way an overview table is generated.
(i) Specification of an overview table in this document
(ii) Example of overview table generated by the Report Generator
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The following approach is applied for generating overview tables:
An overview tables is generated if at least one endpoint study record is available in the
IUCLID 5 dataset that fulfils the selection criteria specified in the section 7.2.1 Rules for
transferring endpoint study records which follows below.
Each overview table is preceded by a default statement such as "The results of studies on
skin irritation are summarised in the following table.".
7.2.1 Rules for transferring endpoint study records
The general rules apply as outlined in the section 5.2 General rules, subsections:
Only endpoint study records are captured fulfilling the following selection criteria:
Criterion #1: Field "Purpose flag" is populated, i.e. the record is flagged as "key study",
"supporting study", "weight of evidence" or "disregarded study". Please note: Records with no
entry in this IUCLID field are not captured by the Report Generator.
Criterion #2: Only in some special cases an additional IUCLID field is used to trigger the
transfer to a given target section in the CSR. For instance, records in IUCLID sections 7.10.1,
7.10.2, 7.10.3 and 7.10.5 can only be processed if the target section is indicated in the field
"Endpoint addressed".
7.2.2 Sorting rules
Data from multiple endpoint study records of the same source section
When data from multiple records are inserted in a CSR table, the order is controlled by the following
sort rules:
(I.) Endpoint-specific criteria (if applicable): (1) e.g. freshwater; (2) e.g. saltwater; (3) etc
(II.) Field "Purpose flag" = (1) "key study"; (2) "supporting study"; (3) "weight of evidence"; (4)
disregarded study.
(III.) Additional endpoint-specific rules where appropriate. For instance, studies on acute toxicity with
rats are always sorted first, followed by studies with other species (Sort rule: Field "Species" = (1)
"rat"; (2) <> "rat").
(IV.) If multiple records fulfill the same combination of sorting criteria (e.g. several key studies of type
freshwater), the order of records used in the source IUCLID 5 is adhered to.
Note: In the tables of "Human information" sections (Table # "Exposure-related
observations on ... in humans"), the primary sort rule is determined by the source section
for technical reasons. This means that any relevant records from section 7.10.1 are
inserted first, followed by those from 7.10.2, etc.
Data from multiple fields within the same endpoint study record
Data from multiple fields or blocks of fields are normally ordered as entered in the IUCLID 5 source
field(s), unless specific sorting criteria apply. For instance, any NO(A)EL values from repeated dose
toxicity studies are sorted first, followed by other effect levels such as LO(A)ELs.
Example sort rule for multiple "Effect levels": Field "Endpoint" = (1) "no NOAEL identified"; (2)
"NOAEL"; (3) "NOEL"; (4) "LOAEL"; (5) "LOEL"; (6) "BMD05"; (7) "BMD10" ; (8) "BMD:" ; (9) any other
or empty.
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7.2.3 Elements included in overview tables
7.2.3.1 Information on method (Guideline, Principles of method, specific fields)
In the column "Method", the key information is inserted, which includes specific descriptors such as
Test type, Species, Route of administration, Exposure duration and the following generic descriptors:
Guideline:
Printed if available without any preceding text label (prompt), e.g.
OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test)
The following picklist phrases from field "Test guideline: Qualifier" are ignored:
"according to", "no guideline followed", "no guideline available", and "no guideline
required".
The phrase "equivalent or similar to" is printed, e.g.
equivalent or similar to OECD Guideline 473 (In vitro Mammalian Chromosome
Aberration Test).
Principles of method if other than guideline:
Printed if available without any preceding text label (prompt)
Exception: Nothing is printed if the field "Guideline" is populated in parallel, thus
clearly distinguishing between guideline studies and non-guideline studies.
7.2.3.2 Information on study results
In the column "Results", the most relevant study results and conclusions are inserted. In most cases
structured fields are extracted, e.g. "Effect levels" or "Interpretation of results". In some cases multi
line free text fields (up to 2000 characters capacity) or text areas are addressed in addition or
exclusively. In these cases, manual intervention may be necessary to ensure that the tables contain
only brief descriptions of the relevant information. See also section 8.4 How to avoid lengthy texts in
CSR overview tables.
Examples:
Several CSR sections: Field "Principles of method if other than guideline"
CSR section "5.1 Toxicokinetics": Fields "Doses / concentrations", "Details on in vitro test
system (if applicable)".
Several CSR sections: The "Results" column of Table "Exposure-related observations on ... in
humans" includes information from the following free text fields: "Results", "Results of
examinations", "Outcome of incidence".
7.2.3.3 Information on test material identity
In the column "Remarks", the identity of the test material used in the study is inserted under the
following conditions:
Print "Test material (<Identifier_sec_1.1>): <Identity_sec_1.1>" if the "Test material
identity" can be identified as being the same as that defined in section 1.1, either as based on
the comparison of standard identifiers (EC name, IUPAC name, CAS name, CAS number, or
EC number) or if "yes" is indicated in the field "Identity of test material same as for substance
defined in section 1 (if not read-across)". The latter condition has no bearing in the case of
referenced records (i.e. either records pasted as reference to the source record or records
inherited from an "Inherit Template").
As a rule always the same identifier is captured from section 1.1 and printed according to the
priority EC name, IUPAC name, CAS name, CAS number, or EC number.
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Print "Test material (<Identifier>): <Identity>" (actual test material ID specified in the record)
if the "Test material identity" cannot be identified as being the same as that defined in section
1.1. The following cases can occur:
The "Test material identity" based on standard identifiers is different from that defined
in section 1.1. In this case one standard identifier is printed according to the priority
EC name, IUPAC name, CAS name, CAS number, or EC number.
No standard identifiers are available, but only non-standard identifier(s). In this case
one non-standard identifier is printed according to the priority Common name, TSCA,
other:.
Note: If the only available identifier is "other:", but with no text entered in the
associated text field, this is handled as if the field "Identifier" was left blank.
If read-across is identified as triggered by the phrase "read-across ..." in the field "Study result
type" add the following additional default text "(See endpoint summary for justification of
read-across)" after "Test material (<Identifier>): <Identity>".
In any ambiguous cases (as far as they can be identified), an error message is printed to
advice the user that the underlying IUCLID source fields should be updated, i.e.
Test material: >>>??? ID is the same as in section 1.1, although "no" is indicated in
field "Identity of test material same as for substance defined in section 1 (if not readacross)" [only in case of non-referenced records]
Test material: >>>??? ID not the same as in section 1.1, although "yes" is indicated in
field "Identity of test material same as for substance defined in section 1 (if not readacross)"<<< [only in case of non-referenced records]
Test material: >>>??? ID missing in IUCLID<<<
">>>??? Read-across is indicated in field "Study result type" although test material is
same as in section 1.1.<<<"
>>>??? Read-across is indicated in field "Study result type", although the test material
is not specified.<<<
Test material: >>>??? Inconsistent identities: <Identifier>n same, but <Identifier>m
not same as in section 1.1<<< [If "no" is indicated in the field "Identity of test material
same as for substance defined in section 1 (if not read-across)".]
Note:
The approach described above takes into account:
- that the fields "Identity of test material same as for substance defined in section 1 (if not
read-across)") and "Test material identity" are not filled in automatically anymore, when a
record is created, as was done in previous IUCLID versions.
- that according to the ECHA Submission Manual #5 (ECHA 2012), it is not required to fill
in the field "Test material identity", if the field "Identity of test material same as for
substance defined in section 1 (if not read-across)" is populated with "yes", except for
referenced records (or records inherited from an Inherit Template). Since the latter cannot
be edited in the target dataset, it cannot be excluded that the value entered in this field in
the source dataset (i.e. "yes" or "no") gives a wrong meaning in the target dataset.
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7.2.3.4 Administrative information (Reliability, Purpose flag, Study result type)
In the column "Remarks", the following administrative information is given:
Reliability: The value from the corresponding source field is inserted.
Purpose flag: The value from the corresponding source field is inserted, i.e., either "key
study", "supporting study", "weight of evidence" or "disregarded study".
Study result type: The value from the corresponding source field is inserted, i.e., either
"experimental result", "estimated by calculation", "read-across based on grouping of
substances (category approach)", "read-across from supporting substance (structural
analogue or surrogate)", "(Q)SAR" or free text (if "other:" is selected). "robust study summary"
Note:
In IUCLID 5.2, the new phrase "disregarded study" has been added to the picklist in the
field "Purpose flag" allowing to explicitly indicate that a study is not used as key study
although showing critical results. In the first version of the Report Generator, such studies
were identified based on the workaround "checkbox 'robust study summary' selected
AND field 'Purpose flag' empty". This workaround has been abandoned, because records
may also be flagged as 'robust study summary', but not with the intention to flag them as
"disregarded study".
The phrase "experimental study planned" in field "Study result type" triggers the transfer
of the relevant information to the corresponding part "Testing proposal" (see section
7.4 Information on testing proposals).
7.2.3.5 Data source information (Bibliographic references)
In the column "Reference", the bibliographic reference captured from IUCLID 5 is inserted according to
the following rules:
The values of the fields "Author" + "Year" are printed. In case of missing information either of
the following default texts is inserted:
- >>>Author missing<<<
- >>>Author + Year missing<<<
The concatenated value "Author" + "Year" is truncated if it exceeds 75 characters. This is to
avoid very lengthy citations.
A lower case letter "a, b, c, etc." is inserted after the year (e.g. Smith H 1999a) if the
combination "Author + Year" appears in otherwise differing bibliographic references.
At the end of the CSR a list of full references is printed, as described in section 7.5.3 List of
references.
Note: The plug-in can identify duplicates (i.e., identical contents in all subfields of
"Reference") only if identical spelling and format is used. For instance, if the same author
or authors have been entered with even slight different spelling or punctuation, they are
identified as different citations. Example:
Smith E (1999)
Smith E. (1999) [period after first name initial]
Smith, E. (1999) [comma after last name; period after first name initial]
Even if all other bibliographic data were identical, three citations would be printed in the
list of references (see 7.5.3 List of references).
Bibliographic references are often copied from other sources using different formats. It is
recommended to update at least those references in IUCLID 5 that could otherwise not
be identified easily in the CSR.
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7.3 DATA WAIVING INFORMATION
Data waiving information is captured based on the following rules:
Data waiving records from each endpoint section are transferred to the corresponding section
of the CSR. Please note: In the previous version of the Report Generator data waiving
information was captured only where REACH foresees this possibility (cf. ECHA 2012b).
If the field "Data waiving" is populated, this field and the field "Justification for data waiving"
are captured and inserted under the CSR heading "Data waiving". As a second criterion the
field "Purpose flag" must be empty.
If, in the same endpoint study record, "Data waiving" is indicated and "Purpose flag" is
populated, the data waiving information is ignored, while the relevant study summary
information is transferred to the overview table.
Note: This approach reflects the TCC and the Data Submission Manual #5 (ECHA 2012)
according to which "an individual Data waiving record should stand alone and not be
mixed with other data such as existing study summaries".
Since multiple data waivers are possible for a given endpoint, each data waiving information
starts with the heading "Information requirement: <Description of endpoint>", e.g.
Data waiving
Information requirement: Respiratory sensitisation
If several different data requirements can occur, additional information is provided with this
heading, e.g. the "Type of study", "Route of administration", etc., e.g.
Data waiving
Information requirement: in vitro mammalian cell micronucleus test (chromosome
aberration)
7.4 INFORMATION ON TESTING PROPOSALS
Information on testing proposals is captured based on the following rules:
Testing proposal records from each endpoint section are transferred to the corresponding
section of the CSR. Please note: in the previous version of the Report Generator testing
proposal information was captured only where REACH foresees this possibility (cf. ECHA
2012b).
If the field "Study result type" contains the phrase "experimental study planned", the values of
the following fields are captured and inserted under the CSR heading "Testing proposal":
Guideline
Specific fields characterising the study design, e.g. Study type, Type of method, Test
organisms (species).
Principles of method if other than guideline
Study period
Since testing proposals for several different data requirements are possible, the heading
"Information requirement: <Description of endpoint> [additional information as appropriate,
e.g. the "Type of study", "Route of administration", etc., ]" is printed, e.g.
Testing proposal
Information requirement: Developmental toxicity / teratogenicity (oral: gavage)
Proposed test guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Species: rat (Wistar)
Planned study period: As soon as possible after ECHA’s approval.
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7.5 INFORMATION FROM ENDPOINT SUMMARIES
In the hazard assessment part of the CSR, the human health hazard, physicochemical hazard and
environmental hazard should be assessed and reported in the endpoint summaries in IUCLID 5.
7.5.1 Information captured from IUCLID 5 endpoint summaries
In the IUCLID 5 Endpoint sections 4 to 10, Endpoint summary records can be created, which can be
used to give an appraisal of all data compiled in a given Endpoint section. Hence, an endpoint
summary addresses, in a very condensed form, the most relevant and reliable data or provides a
weight of evidence evaluation based on several studies.
Endpoint summary records can also be created at a higher level, i.e., for main sections. At the highest
level of the main sections "6. Ecotoxicological Information" and "7. Toxicological information", specific
summary templates are provided for recording more integrated information, i.e. PNECs and DNELs,
respectively, and other hazard conclusions including relevant input parameters.
The relevant endpoint summary information is printed either under the heading "Discussion" or in a
subsection titled "Summary and discussion of ...", as illustrated in the screenshot example below.
Note: In IUCLID 5 Substance or Template datasets, only one endpoint summary record
per section can be created. However, multiple endpoint summary records can occur in a
Substance dataset in the following cases:
(i) If a Template has been assigned to a Substance and in both datasets an endpoint
summary record was created for the same IUCLID 5 section.
(ii) If an IUCLID 4 dataset was migrated to IUCLID 5, multiple records mapped to an
endpoint summary appear as multiple endpoint summary records in IUCLID 5.
(iii) If another endpoint summary record of another IUCLID substance dataset is copied to
the IUCLID-built in clipboard and pasted to a dataset already containing an endpoint
summary record.
The Report Generator captures all endpoint summary records. It is up to the user to
update the IUCLID 5 dataset and ensure that any multiple endpoint summary records are
cleared.
The following fields are captured from endpoint summaries, if available:
Field "Discussion": The information from this field is inserted in the CSR normally after the
heading "Discussion". As an exception, in section "B.1.3 Physico-chemical properties", it is
transferred to the overview table.
In this IUCLID 5 field, the assessment made for the given endpoint should be described,
including the rationale for the choice of the key study(ies). This includes a discussion of the
key information identified and in some instances of studies which are considered to be
unreliable, but give critical results. A discussion as to why they were discarded in favour of
other studies should then be included. Vice versa, a weight of evidence analysis based on
less reliable data should be justified.
Short description of key information: The information from this field is normally inserted in
the CSR after the default statement
"The following information is taken into account for any hazard / risk assessment:".
In section "B.1.3 Physico-chemical properties", it is transferred to the overview table.
In this IUCLID 5 field a short description of the most relevant endpoint data should be
included, i.e., the most relevant details, e.g. the test guideline used, test organism and
exposure duration, and the key results. Also several key studies can be referenced,
particularly if several data requirements are discussed, e.g., in vitro vs. in vivo or gene
mutation vs. chromosome aberration in the section "7.6 Genetic toxicity". In general, the
characterisation of the endpoint data should be kept as concise as possible and not repeat
verbatim the narrative in the field "Discussion".
Examples:
Melting point: 54.6-55.8 °C at 1,013 hPa (OECD 102)
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Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in
28 days; 0 - 1% (HPLC) in 28 days (OECD 301C)
Genetic toxicity: In vitro gene mutation (Ames test): S. typhimurium TA 100, TA 1535:
positive with and without metabolic activation (equivalent to OECD 471)
Key value for chemical safety assessment: The information from field(s) subsumed under
this heading is inserted in the endpoint-related CSR summary subsections after the text label:
"Value used for CSA:", e.g. Value used for CSA: 255 °C at 101.3 kPa
In addition, the key values from the toxicological endpoints are used to generate the table
"Available dose-descriptor(s) per endpoint as a result of its hazard assessment" in the CSR
section "5.11.1. Overview of typical dose descriptors for all endpoints".
Note: In the IUCLID 5 endpoint summaries, only a minimum number of structured and
hence, searchable fields are provided as "Key value". This has been foreseen for the use
of estimation tools. Key values are intended to condense the data summarised in the field
"Short description of key information" to one single numeric value or concluding remark
(e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided,
only a clear value can be entered, that is, no range and no less than or greater than
qualifiers.
Justification for classification or non-classification: The information from this field, if
available, is inserted in the CSR after the heading "Justification for classification or non
classification".
The registrant has to determine the classification and labelling of the substance (cf. ECHA
2012a). The rationale for the decision for a classification can be clearly documented in each of
the relevant endpoint summary sections. For example the classification for the environment
should be justified under the endpoint summary for ecotoxicological information, the
classification for physico-chemical properties and human health should be justified under the
relevant endpoint summary (e.g. under acute toxicity, flammability, etc.).
If the information is inadequate to decide whether a substance should be classified for a
particular end-point, the registrant shall indicate and justify the action or decision he has taken
as a result. He should also indicate for each endpoint for which no classification is proposed
whether this is based on conclusive data, inconclusive data or lack of data.
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Example illustrating the transfer of IUCLID inforamtion from an endpoint summary to the CSR
The information from endpoint summaries of the main ecotoxicological and toxicological sections is
transferred as follows:
IUCLID 5 section "7. Toxicological information": The relevant information is transferred
to the CSR section "B.5.11.2. Selection of the DNEL(s) or other hazard conclusions for
critical health effects":
The DNEL(s)/DMEL(s) or qualitative hazard conclusions are transferred to the tables
"Hazard conclusions for workers" and "Hazard conclusions for the general population"
together with the information from the fields "Most sensitive endpoint" and "Route of
original study".
The information from the field "Justification and comments" is inserted as Footnotes
("Further explanation on hazard conclusions") after these tables.
The tables "Further explanation on DNEL derivation for workers" and "Further
explanation on DNEL derivation for the general population" are populated with data
captured from the fields "DNEL derivation method", "Dose descriptor starting point"
and all fields describing assessment factors (AF).
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The information from the fields "Discussion - Workers" and "Discussion - General
population" is inserted after these tables.
IUCLID 5 section "6. Ecotoxicological Information": The relevant information is
transferred to CSR section "B.7.6. PNEC derivation and other hazard conclusions":
All PNEC values and/or qualitative hazard conclusions are transferred to the table
"Hazard assessment conclusion for the environment", together with "Assessment
factor:", "Extrapolation method" and "Justification for (no) PNEC .... derivation".
The information from the field "Environmental classification justification" is inserted
under the heading "Environmental classification justification".
The information from field "Discussion" is inserted at the end of CSR section
B.7.6 after the heading "General discussion".
7.5.2 Information to be added manually
With the Report Generator for IUCLID 5.4.1 all relevant CSR elements of section B are automatically
completed with IUCLID 5 data except for the following items:
Section 9: EXPOSURE ASSESSMENT, if no Chesar data are selected in step 2 of the Report
Generator (except for the information from the fields "Brief description of use process" for all
identified uses in IUCLID section 3.5 which is transferred to the CSR table "Brief description of
the use process for all identified uses" in section "9.0. Introduction".)
Section 10: RISK CHARACTERISATION, if no Chesar data are selected in step 2 of the
Report Generator
Note: With plug-in version 5.4.1 a Chesar export file can be uploaded in step 2 so that
the complete CSR, including sections 9 and 10, can be generated.
In the following sections notes are inserted if the target section cannot be located
automatically by the Report Generator. Manual intervention may be required in rare cases:
o
4.4. Secondary poisoning
o
7.2.1. Toxicity to soil macro-organisms
o
7.2.4. Toxicity to other terrestrial organisms
o
7.3. Atmospheric compartment
Plug-in version 5.4.1 also provides the option to manage the content of CSR part A by entering or
uploading (rich) text.
7.5.3 List of references
At the end of the CSR a list of full references is printed according to the following rules:
The references are sorted lexicographically, i.e., alphabetically.
In the case of ambiguous references, the lower case letter inserted after the year of any
citations ("Author + Year") is also inserted in the full reference.
In the case that either the field "Author" or "Author" and "Year" is/are empty, the default text
>>>Author missing<<< or >>>Author + Year missing<<< is inserted.
Note:
As set out in section 7.2.3.5 Data source information (Bibliographic references), the plugin can identify dublettes (i.e., identical contents in all subfields of "Reference") only if
identical spelling and punctuation is used in all subfields of a reference.
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As the references are sorted lexicographically, references with the same first author are
not necessarily sorted by the year. For instance, the following output would occur:
- Smith A, Cochran S, Adrian V. (2000)....
- Smith A. et al. (1984)....
- Smith A., Walace W. and Adrian V. (1989)....
8
SMART (CSR-ORIENTED) DATA ENTRY IN IUCLID 5
In this section, hints are given on how to reduce any manual update work, after running the Report
Generator, by taking into account what kind of IUCLID 5 information is used or not used by the plug-in.
As can be seen from the Specifications (see PART II: SPECIFICATIONS OF THE CSR
TEMPLATE), only selected IUCLID 5 fields are addressed by the Report Generator. With a few
exceptions, rather unspecific text fields are not captured, such as fields of the type "Details on ..." or
the rich text area "Any other information on materials and methods incl. tables", "Any other information
on results incl. tables" or "Overall remarks". Otherwise too much text would compromise the
readability of the overview tables.
CSR-oriented data entry in IUCLID 5 is driven by the question of what pieces of information should
occur in the CSR table. In the following subsections, some examples are presented which illustrate the
before-and-after look of CSR tables depending on the completion of relevant IUCLID 5 fields. Although
the examples are taken from selected endpoint sections, the principles of the guidance given can be
applied to other sections as well. In brief, the tips given by these examples can be summarised as
follows:
Use an appropriate "Results" field that is captured by the plug-in for specifying the purity or
composition of the test material, if relevant for the judgement of the study results.
Avoid empty "Method" cells in CSR overview tables. In the case of non-guideline studies, fill in
the field "Principles of method if other than guideline" and, if provided, other fields addressed
by the plug-in. (Note that this is partly also required by the TCC tool.)
Avoid empty "Results" cells in CSR overview tables. Enter results that do not seem to fit into
structured field(s) in a "Remarks" field or another adequate field. See examples in section
"4.3. How to get important information on study results into the CSR".
Avoid lengthy texts in CSR overview tables by entering only the most relevant details in CSRrelated fields, but including any comprehensive narratives in text areas such as "Any other
information on results incl. tables" which is normally not captured for the CSR.
Note: It may be sensible to describe any peculiars of a study in the IUCLID 5 endpoint
summary instead of directly in the overview table in the CSR. However, the requirement
set out by REACH should be adhered to, i.e., the key data should be easily identifiable in
the CSR without the need to revert to the underlying data sets (i.e., the IUCLID 5 data
set). See 1.1 CSR requirements under REACH.
8.1 HOW TO GET INFORMATION ON THE TEST MATERIAL INTO THE CSR
Data on the purity or composition of the test material are normally entered in the IUCLID 5 field
"Details on test material". This field is not captured by the Report Generator, which is no problem if the
test material used in a study is equivalent to the specification given in IUCLID 5 section 1.1. However,
in case the results data would be ambiguous without indicating the specification of the test material
used, it should be specified in an appropriate "Remarks" or other field.
Note: The TCC tool (cf. ECHA 2012) allows specifying the test material identity either in
the field block "Test material identity" or the field "Details on test material". Since the latter
is not captured by the Report Generator, it is highly recommended to use the field block
"Test material identity" for the intended purpose and to enter only additional details in
field "Details on test material" such as purity.
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Example: IUCLID 5 section "7.2.1 Acute toxicity: oral"
The specification of the overview table for the CSR section "5.2.1.1 Acute toxicity: oral" is as follows:
Assuming that a product containing the submission substance as active ingredient was used as test
material in the sample study summarised in the screenshot below, the effect level presented would
ambiguously indicate whether it is based on the product or the active ingredient included in the
product.
This shortcoming can be overcome by specifying the test material in the IUCLID 5 subfield "Remarks"
of the repeatable field block "Effect levels". It can even be useful to indicate both effect levels, i.e., the
one based on the product and the one based on the active ingredient, as shown in the following
screenshots:
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Note: In the environmental and human health sections of IUCLID 5 the repeatable field
block "Effect concentrations" or "Effect levels" has been with the subfield "Conc. based
on" or "Based on", which allows selecting this kind of information from a picklist (e.g. test
mat. or act. ingr.). Additional explanations (e.g. 12% act. ingr.") can be entered in the
supplementary text field associated with this field and/or in the "Remarks" field.
Example: IUCLID 5 section "6.1.3 Short-term toxicity to aquatic invertebrates"
The specification of the overview table for the CSR section "7.1.2.1 Short-term toxicity to aquatic
invertebrates" is as follows:
In the field block "Effect concentrations" of all environmental toxicity sections of IUCLID 5, the distinct
subfield "Conc. based on" is provided for specifying whether the result is based on the "test mat." or
"act. ingr.". In addition further details, e.g. the concentration of the active ingredient, can be entered in
the supplementary remarks field, if they are important for the judgment of the study results.
The first example in the following screenshot shows an EC50 based on the active ingredient with no
further details on the test material. In the second example, the concentration of the active ingredient
had been entered in the supplementary remarks field and appears in the CSR table set between
parentheses (circled).
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8.2 HOW TO GET IMPORTANT METHODOLOGICAL INFORMATION INTO THE CSR
Example: IUCLID 5 section "5.1.1 Phototransformation in air"
The specification of the overview table for the CSR section "4.1.1.2.1. Phototransformation in air" is as
follows:
The first screenshot below shows the summary of an estimation study where information is missing in
the column "Method". The reason is that all methodological information was obviously entered in fields
that are not addressed by the Report Generator, e.g. "Any other information on materials and methods
incl. tables". In addition, the results data presented may also benefit from additional information.
While such a minimal approach may be acceptable for summarising less relevant studies, some more
basic information should appear in the CSR for key studies or studies used for weight of evidence
evaluation. Filling in the fields "Principles of method if other than guideline" and "Estimation method (if
used)" and "Test condition" (in field block "Dissipation half-life") would improve the output, as
illustrated by the following screenshots:
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8.3 HOW TO GET IMPORTANT INFORMATION ON STUDY RESULTS INTO THE CSR
Example: IUCLID 5 section "5.1.2 Hydrolysis"
The specification of the overview table for the CSR section "5.1.2 Hydrolysis" is as follows:
The first screenshot below shows the summary of a study where information is missing in the column
"Results".
The reason for the missing information is that the result was entered in the rich text area "Any other
information on results incl. tables" in narrative form: "The test substance was not stable under test
conditions and hydrolysed completely (100 %) within 8 hours at pH 7 and 20°C."
Although the result "100 % hydrolysis within 8 hours at pH 7 and 20°C" seems not fit into one of the
source fields specified in the table above, it can be documented using an appropriate "Remarks" field.
As shown in the following screenshot, the field block "Dissipation half-life" was used and the
information "100 % hydrolysis after 8 h" was entered in the subfield "Remarks".
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Another possibility would be to use the field block "Total recovery of test substance (in %)" and enter
"0" in subfield "%Recovery" and the conditions in the relevant subfields "pH", "Temp." and "Duration".
It could also be considered to enter a half-life value of "< 8 h" and add the actual result in the
"Remarks" field as done above.
Note: In most cases, at least one field is available that can be used to enter free text for
documenting any results that would not fit into structured field(s). If no "Remarks" field is
provided, you may use the "other:" option of an appropriate list field.
8.4 HOW TO AVOID LENGTHY TEXTS IN CSR OVERVIEW TABLES
In some cases, IUCLID 5 fields are captured by the Report Generator that allow for the entry of
comprehensive texts. However, in a CSR table, rather concise texts should be included. This can be
achieved by entering only the most relevant details in the CSR-related fields, but including any
comprehensive narratives in text areas of the type "Details on ..." or the rich text areas "Any other
information on materials and methods incl. tables" and "Any other information on results incl. tables".
Example: IUCLID 5 section "7.5.1 Repeated dose toxicity: oral"
The specification of the overview table for the CSR section "5.6.1.1 Repeated dose toxicity: oral" is as
follows:
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In the following screenshot example, very lengthy text appears in the "Results" column, because the
detailed results were entered in the subfield "Basis for effect level / Remarks" instead of the field
"Details on results".
Unless the user prefers to edit any CSR tables manually, the revision work can be reduced by entering
only the most important results in those IUCLID 5 text fields that are addressed by the Report
Generator, as shown in the following screenshot:
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Example: IUCLID 5 section "7.1.1 Basic toxicokinetics"
The following screenshots show the specification of the overview table for the CSR section "5.1.1 Nonhuman information (Toxicokinetics)":
CSR-oriented data entry means
entering the most relevant results in the repeatable field block "Main ADME results" (select
either "absorption", "distribution in tissues", "metabolism" and/or "excretion" from the picklist of
field "Type") and using the multiline text fields "Details on ..." only for recording any further
details that should not necessarily occur in the CSR table.
entering comprehensive narratives, structured with the relevant subheadings, in the rich text
area "Remarks on results including tables".
Note: In the Report Generator for IUCLID 5.4 text fields "Details on absorption", "Details
on distribution in tissues" and "Details on excretion" have been added. However, these
fields are only captured if no information is provided in "Main ADME results".
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ECHA GUIDANCE DOCUMENTS
The following ECHA guidance documents have been cited in this document:
ECHA (2008) Guidance on Information Requirements and Chemical Safety Assessment. Part
F: Chemical Safety Report. May 2008. European Chemicals Agency, Helsinki.
ECHA (2012a) Guidance on Registration. May 2012. European Chemicals Agency, Helsinki.
ECHA (2012b) Data Submission Manual No. 5. How to complete a Technical Dossier for
Registrations and PPORD Notifications. Version 3.0. July 2012. European Chemicals Agency,
Helsinki.
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PART II: SPECIFICATIONS OF THE CSR TEMPLATE
Available as a separate document
38
European Chemicals Agency
IUCLID 5 Guidance and Support
Report Generator - CSR
User Manual
January 2014 version 4.3
http://iuclid.eu
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