Brief Profile

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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023. All other data parts (substance identity, C&L, key regulatory lists etc. are up to date).

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

AMLODIPINE STEP 3; UK-52,416

Brief Profile - Last updated: 27/10/2023 Print

Sub. description Substance description Substance description
The ’Substance description’ gives an overview of the main substance identifiers, substance classification, on-going regulatory activities, main uses of the substance and which registrants manufacture and/or import the substance. By summarising this information in a single page, ECHA aims to make this information accessible in a user-friendly way in line with the Agency’s goals and standards.
Data from all dossiers registered and the Classifications and Labelling Inventory (C&L) for the same substance are used to generate the Brief Profile. The information provided in the free-text fields is not published in the Brief Profiles.
The Brief Profile is automatically generated; information requirements under different legislative frameworks may, therefore, not be up-to-date or complete. For accuracy reasons, substance manufacturers and importers are responsible for consulting official sources. This Brief Profile is covered by the ECHA Legal Disclaimer.
Generating the Brief Profiles
The Brief Profile summarises the non-confidential data on substances as it is held in the databases of the European Chemical Agency (ECHA), including data provided by third parties. The Brief Profile is produced based on data in ECHA’s databases and maintained by the Agency, and therefore the Brief Profile as a dissemination tool falls under ECHA’s responsibility.
Due to the quantity of information and the number of chemicals, the Brief Profile is automatically generated based on the information available and is not manually verified. For sections such as substance use, chemical properties and the classification and labelling of substances, the quantity and quality of the information is the responsibility of manufacturers and importers. While the Agency tries to aggregate the information on chemicals in the best possible way, ECHA cannot check whether all the information provided by industry is free of errors.
Updates
Brief Profiles are updated regularly and new information is added when available. Since the source data can be updated at any time while the Brief Profiles are updated at intervals, a slight delay in the publication of information may occur.
The date of the last update corresponds to the publication date of the Brief Profile and not necessarily to the date in which the update occurred in the source data (registered dossiers, the C&L Inventory or a regulatory process).
Furthermore, updates in the source data may not always result in an update of the Brief Profile. For example, an update in a section of a dossier that is not displayed in the Brief Profile will not result in an update of the Brief Profile.
Dealing with Brief Profile errors
If you have any comments or suggestions, please contact ECHA using our contact form.
Sci. properties Scientific properties
Scientific properties
The ‘Scientific properties’ section gives an overview of summarised scientific data from registered dossiers. By summarising the endpoint study data, ECHA aims to make this information accessible in a user-friendly way in line with the Agency’s goals and standards.
All the source data on which the summaries on this page are based, is provided by industry and stored in the ECHA databases. Data from all dossiers registered for the same substance is used in the summarisation and aggregation process, as it is presumed that all data submitted by the registrants is relevant for the substance being registered. If the test material used is different from the substance being registered an indication will be provided. Please note that the information provided in the free-text fields is not published in the brief profiles.
Information in the ‘Scientific properties’ section is structured by substance properties, further broken down into endpoints. Each endpoint includes three information blocks:
- Study results – this information is collected from those endpoint study records provided by registrants of REACH dossiers which are flagged as Key or Weight of Evidence studies, and which have an indicated reliability (i.e. Klimisch score) of 1 or 2. Other types of studies are not processed for the Brief Profiles.
- Type of study provided – Provides an overview of the type of study records behind the presented results and data–waving justifications (e.g. key experimental study, Supporting QSAR study, etc.)
- Summary data – this information is collected from the endpoint summaries provided by registrants of REACH dossiers.
Note: Information presented in this section is generated as part of an automatic process, i.e. there is no manual verification or assessment of the correctness of the data. If no data is available in the registered substance dossiers, this will be indicated by a notification stating ‘Data not provided by the registrant’.
Summarisation and prioritisation of data
There are four methods to aggregate and summarise data, depending on the available data and endpoint. An icon is displayed to indicate the type of aggregation and summarisation performed:
- [R] Range of values – Range of results values (min-max) and range values of experimental condition(s) (min-max).
- [C] Concatenate distinct – Value types are ranked from most to least commonly provided, with a % attributed based on the count of total values provided.
- [M/C] Most conservative - Most conservative of all the data values provided, applying a precautionary principle (e.g. the lowest threshold or most hazardous statement)
- [P] Prioritisation – The result to be displayed is based on a set of criteria. For example, for endpoints related to (eco)toxicology four main types of criteria exist to prioritise the display of information: test species, dose descriptor, duration and measurement units. For Toxicology endpoint summaries two other criteria can be applied: Test type (Chronic, subchronic and subacute) and endpoint conclusion.
The precise data summarisation methods are specified per endpoint summary/study.
When more than one numerical result is available per endpoint the count is displayed between square brackets.
Units and data are normalised when possible and therefore the unit of measure/order of magnitude in the Brief Profile data may not correspond exactly to the one in the registered dossier. For temperature for example, data is standardised and displayed in Celsius (°C). For other data an order of magnitude logic might apply; e.g. 1 000 g will be displayed as 1 kg.
Processed studies and data-waiving
Due to the number of the substances and the associated information, substance data is processed and aggregated in an automatic process. Therefore, data has to fit the format and aggregation logic that is used for the Brief Profile.
Though the Agency aims to include as many studies as possible in the Brief Profile endpoint study results/summaries, those studies which do not fit the format or miss crucial information (such as measurement conditions) cannot be processed and therefore will not be included on this page. These study results can however be consulted when opening the source data.
The number of studies provided is indicated by ‘[x] studies submitted’, while the actual number of studies processed for the endpoint is indicated by ‘[x] studies processed’.
Data waiving
If only waived data is available for the substance, following justifications for data-waiving can be displayed in the Brief Profile:
- Study technically not feasible
- Study scientifically unjustified
- Exposure considerations
- Other justification
Excluded endpoints
Some endpoints are not included in the Brief Profile due to the use of free text and/or complex field(s) in the reporting of information, which cannot be easily summarised by an automatic algorithm. Please see the registered dossiers for substance information for the following endpoints:
- Particle size distribution
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- Additional physical-chemical information
- Mode of degradation in actual use
- Other distribution data
- Environmental data (monitoring data/field studies)
- Additional information on environmental fate and behaviour
- Toxicity to other aquatic organisms
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxicological information
- Skin irritation/corrosion (study results)
- Eye irritation (study results)
- Skin sensitisation (study results)
- Respiratory sensitisation (study results)
- Repeating dose toxicity oral/inhalation/dermal/other routes (study results)
- Toxicity to reproduction (study results)
- Developmental toxicity (study results)
- Toxicity to reproduction: other studies
- Specific investigations: other studies
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological information

Substance Description

Substance identity

Help

The ’Substance identity’ section links substance identification information from all databases that are maintained by ECHA. The substance identifiers – if available and not claimed confidential – displayed in the ’Substance identity’ section of the Brief Profile are:

EC name/number
IUPAC name/number
CAS number
Index number
Molecular formula
Smiles
InChI

In addition, information on the type of substance, origin, number and type of registered compositions and other places where the substance is listed are displayed in this section.

EC (European Community) name/number

The EC name and number are the official identifiers for substances within the European Union and can be found in the EC Inventory.

The EC Inventory is a combination of three independent European lists of substances from the previous EU chemicals regulatory frameworks (EINECS, ELINCS and the NLP-list). More information about the EC Inventory can be found here. If the substance has no EC number attributed, ECHA will attribute a list number. These numbers start with 6, 7, 8 or 9.

IUPAC name/number

An IUPAC name is based on the international standard chemical nomenclature set by the International Union of Pure and Applied Chemistry (IUPAC).

The IUPAC nomenclature is a systematic way of naming chemical substances, both organic and inorganic. In IUPAC nomenclature, prefixes, suffixes and infixes are used to describe the type and position of functional groups in the substance.

If more than one IUPAC name is available from REACH registered dossiers, all IUPAC names are displayed in ‘Other names’ section of the Brief Profile.

See the official IUPAC website for more information on the International Union of Pure and Applied Chemistry.

CAS (Chemical Abstract Service) registry number

The CAS number is the substance numerical identifier assigned by the Chemical Abstract Service, a division of the American Chemical Society, to substances registered in the CAS registry database. A substance may have more than one CAS number associated. In this case, the preferred CAS number is displayed first. More about CAS and the CAS registry can be found here.

Index number

The Index number is the identification code given to substances in Part 3 of Annex VI to the CLP Regulation ((EC) No 1272/2008). A distinct classification and labelling corresponds to each Index number.

The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y. ABC corresponds to the atomic number of the most characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number of the substance in the series ABC. VW denotes the form in which the substance is produced or placed on the market. Y is the check-digit calculated in accordance with the 10-digit ISBN method.

Molecular formula

The molecular formula identifies each type of element by its chemical symbol and identifies the number of atoms of each element found in one discrete molecule of the substance. If such information is available in ECHA’s database and is it not claimed confidential, the molecular formula and molecular structure will be displayed here.

SMILES

SMILES is the acronym for Simplified Molecular Input Line Entry Specification, a chemical notation system used to represent a molecular structure by a linear string of symbols.

With standard SMILES, the name of a molecule is synonymous with its structure: it indirectly shows a two dimensional picture of the molecular structure. Since a two dimensional chemical structure can be drawn in various ways, there are several correct SMILES notations for one molecule.

The basis of SMILES is the representation of a valence model of a molecule. SMILES notations are comprised of atoms (designated by elemental symbols), bonds, parentheses (used to show branching), and numbers (used for cyclic structures).

InChI

InChI is an abbreviated name for IUPAC International Chemical Identifier, a chemical identifier developed and supported by the InChI Trust.

InChIs consist of text strings comprising different layers and sublayers of information separated by slashes (/). Each InChI string starts with the InChI version number followed by the main layer. This main layer contains sublayers for the chemical formula, atom connections and hydrogen atoms. Depending on the structure of the molecule the main layer may be followed by additional layers e.g. for charge, stereo–chemical and/or isotopic information.

Molecular structure

Molecular structure displayed in this section is based on InChI annotation from IUCLID reference substances database and stored in the ECHA database. The structure is a computer generated visualisation of the molecular structure derived from the InChI character string.

Type of substance

Registrants can identify their substance as being a mono-constituent substance, multi-constituent substance, UVCB, polymer or specify another type. If more than one type of substance is registered, both types will be displayed.

Origin

Registrants can identify the origin of their substance as being:

Element
Inorganic
Organic
Organometallic
Petroleum product
Other

If more than one type of substance is registered, both types will be displayed.

Registered compositions (additives and impurities)

The total number of non-confidential registered compositions submitted in REACH dossiers are displayed here. If there are additives and impurities relevant for the substance classification, these are also indicated.

Within the context of REACH, impurities are unintended constituents present in a substance as manufactured. It may, for example, originate from the starting materials or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance, it was not intentionally added. In most cases, impurities constitute less than 10% of the substance.

Additives are the constituents which have been intentionally added during the manufacturing process to stabilise the substance.

Substance listed

Provides information if the substance has been identified by one of the following previous EU chemicals regulatory frameworks:

EINECS (European INventory of Existing Commercial chemical Substances) List
ELINCS (European LIst of Notified Chemical Substances) List
NLP (No-Longer Polymers) List

EC / List name:
IUPAC name: 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Substance names and other identifiers

EC / List no.:: 413-410-3
CAS no.:: 88150-62-3
Index number:: 607-371-00-3
Molecular formula:: C28H27ClN2O7

SMILES:: CCOC(=O)C1=C(COCCN2C(=O)C3=C(C=CC=C3)C2=O)NC(C)=C(C1C1=CC=CC=C1Cl)C(=O)OC
InChI:: InChI=1/C28H27ClN2O7/c1-4-38-28(35)24-21(15-37-14-13-31-25(32)17-9-5-6-10-18(17)26(31)33)30-16(2)22(27(34)36-3)23(24)19-11-7-8-12-20(19)29/h5-12,23,30H,4,13-15H2,1-3H3
Type of substance:: Mono constituent substance
Origin:: Organic
Registered compositions:: 8
Of which contain:: 0 impurities relevant for classification; 0 additives relevant for classification
Substance Listed:: ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

Hazard classification and labelling

The ‘Hazard classification and labelling’ section shows the hazards of a substance through a standardised system of statements and pictograms, as has been established under CLP (Classification Labelling and Packaging) Regulation. The CLP Regulation makes sure that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union. The CLP Regulation uses the UN Global Harmonised System (GHS) and European Union Specific Hazard Statements (EUH).

This section searches three sources for information (harmonised classification and labelling (CLH), REACH registrations and CLP notifications). The source of the information is mentioned in the introductory sentence of the hazard statement.

More information about classification and labelling can be found in the Regulations section of ECHA website.

Please note:

The purpose of the information provided under this section is to highlight in a readable format the substance hazardousness. It does not represent a new labelling, classification or hazard statement. Other relevant information includes the following:

Substances may have impurities and additives that lead to different classifications. However, substance notifications in the Brief Profile are aggregated independently of the impurities and additives.
Hazard statements were adapted to improve readability and may not correspond textually to the hazard statements codes description in the European Union Specific Hazard Statements (EUH) or UN Global Harmonised System (GHS).

To see the full list of notified classifications and have more information on impurities and additives relevant to classification, you can consult the C&L Inventory.

Harmonised classification and labelling (CLH)

The Hazard classification and labelling section uses the signal word, pictogram(s) and hazard statements of the substance under the harmonised classification and labelling (CLH) as its primary source of information. Substance classifications under CLH are agreed at the Community level. Harmonisation is based on the substance’s physical, toxicological and eco-toxicological hazard assessment.

It is possible that the harmonisation is introduced through an amendment to the CLP Regulation. In that case, the ATP (Adaptation to Technical Progress) number is displayed. More information on CLH can be found here.

If the substance is classified under more than one CLH entry (e.g. disodium tetraborate EC no. 215–540–4, is covered by three harmonisations – 005–011–00–4; 005–011–01–1; 005–011–02–9), CLH information cannot be displayed in the Brief Profile as the differences between the CLH classifications require manual verification. If a substance is classified under multiple CLHs, a link to the C&L Inventory is provided to allow users to view CLH information manually, instead of having the information automatically generated in the Brief Profile.

Classification and labelling under REACH

Additional information on classification and labelling (C&L) – if available – is derived from REACH registration dossiers submitted by industry. This information has not been reviewed or verified by ECHA, and may change without prior notice. REACH registration dossiers have greater data requirements (support studies) than notifications under CLP. When submitted by the lead of a joint submission, the classifications may also reveal agreement between companies.

Notifications under the Classification, Labelling and Packaging (CLP) Regulation

If additional information derived from classification and labelling (C&L) notifications to ECHA under the CLP Regulation exists, this will be displayed below the information derived from harmonised classification and labelling and REACH registrations. These notifications can be provided by manufacturers, importers and downstream users. ECHA maintains the C&L Inventory, but does not review or verify the accuracy of the information.

For readability purposes, only the pictograms, signal words and hazard statements referred to in more than 5% of the notifications under CLP are displayed.

According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance may cause long lasting harmful effects to aquatic life.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance causes serious eye irritation, causes skin irritation and may cause respiratory irritation.

Breakdown of all 11 C&L notifications submitted to ECHA

Hazard classification & labelling graph

The chart displays the number of matching substance classifications (hazard class, categories and hazard statements) provided by manufacturers and importers under REACH and CLP notifications, as well as whether the substance is defined under harmonised classification and labelling (CLH).

The results of matching substance classifications are displayed in percentages of the total number of notifications. The bars indicate the number of matching classifications, i.e. the level of agreement, in substance classification between the REACH registrants (dark blue bar) and CLP notifiers (light blue bar), as well as between the notified classifications and the approved harmonised classification.

Harmonised classifications (√ - check mark)

The (√- check mark)-icon indicates the classification is defined under harmonised classification and labelling (in accordance with the CLP Regulation) and made obligatory at Community level to ensure an adequate risk management throughout the European Community.

REACH & CLP classifications (bar)

The dark blue bar illustrates the percentage of matching substance classifications provided by manufacturers and importers in a REACH registration dossier. Classifications under REACH have to be supported by data (support studies).
The light blue bar illustrates the percentage of matching substance classifications provided by manufacturers and importers in CLP notifications.

Divergent classifications and impurities

The physical state and form of a substance can play a significant impact when the hazards of a substance are assessed. REACH and/or CLP notifiers may classify a substance differently based on different studies or the way they access the data.

For example, substance impurities can constitute a valid reason for a different classification of the substance. Different compositions or impurity profiles often lead to different classifications. If impurities and/or additives have been identified, an informative sentence is displayed below the graphic.

Different classifications can also be due to technical errors made during the notification process.

To have more information on impurities relevant to classification you can consult the C&L Inventory entry for the substance, or the disseminated registration dossier.

Aquatic Chronic 4	H413
Eye Irrit. 2A	H319
Skin Irrit. 2	H315
STOT SE 3	H335
		0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Harmonised Classification

REACH registration dossiers notifications

CLP notifications

Properties of concern

The ‘Properties of concern’ section shows ECHA-assigned graphical indicators for certain substance properties that are regarded as critical for human health and/or the environment based on the information provided to the Agency. The following properties have been highlighted as critical:

C – This substance was identified as a carcinogenic (i.e. classified in Carcinogenicity categories 1A or 1B) in the EU harmonised classification and labelling and/or in a REACH registration dossier. More information about carcinogenicity here.
M – This substance was identified as Mutagenic (i.e. classified in Mutagenicity categories 1A or 1B) in the EU harmonised classification and labelling and/or by a REACH registration dossier. More information about mutagenicity here.
R – This substance was identified as toxic to reproduction (i.e. classified in reproductive toxicity categories 1A or 1B) in the EU harmonised classification and labelling and/or by a REACH registration dossier. More information about reproductive toxicity here.
Ss – This substance was identified as a skin sensitiser (i.e. classified in skin sensitisation categories 1, 1A or 1B) in the EU harmonised classification and labelling and/or by a REACH registration dossier. More information about skin sensitiser here.
Sr – This substance was identified as a respiratory sensitiser (i.e. classified in respiratory sensitisation categories 1, 1A or 1B) in the EU harmonised classification and labelling and/or by a REACH registration dossier. More information about respiratory sensitiser here.
PBT – This substance was identified as persistent, bioaccumulative and toxic (PBT) by at least one REACH registrant (i.e. it is PBT/vPvB). More information about persistent, bioaccumulative and toxic substances here.
POP – Recognised Persistent Organic Pollutant (POP): comes from an entry in the Annex I, II or III to the POPs Regulation and/or an entry in the Annex A, B or C to the Stockholm Convention. Under assessment as Persistent Organic Pollutant: is shown for substances that have been proposed for their inclusion in the Stockholm Convention and are under assessment, or for which a proposal is under preparation in the European Union. Note that proposals that have been set aside, either before their submission by the EU to the Convention, or by the POP Review Committee are still indicated as "Under assessment as POP".

The substance properties displayed in this section (with the exception of PBT properties) are derived from harmonised classification and labelling (CLH) and/or REACH registered dossier information. In case the substance classification is not harmonised and the substance is not registered the properties are derived from classifications provided in CLP notifications. PBT properties are derived from REACH registered substances dossiers.

Critical property indentification: Where less than 90% of the notifiers provide the same classification to derive the critical property, the border of this critical property icon is displayed as dashed.

Impurities or additives: When a specific critical property is associated with compositions with impurities and/or additives, the respective critical property icon has a * associated.

Please note: The icons in this section are only meant as visual indicators to help communicate information about the abovementioned critical properties. Unlike the pictograms in the ‘Classification and Labelling’ section, these icons are not determined by any legislative procedure and have the sole purpose of being informative in the context of InfoCards and Brief Profiles.

Regulatory context

The ‘Regulatory context’ section provides an overview of the regulatory activities that are related to the substance. For general information about any of the different regulations which currently fall under ECHA’s mandate please see the links below.

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
The REACH Regulation (1907/2006) entered into force on 1 June 2007. The regulation aims improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemical industry.

The REACH regulatory processes identified for the Brief Profile are:

Registration
- Pre-registration – indicated if the substance is included in the list of pre-registered substances. Pre-registration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached.
- Registration – indicated if there is at least one dossier registered and disseminated for the substance, how many non-confidential registrations are active and/or inactive and the type of submissions (joint and/or individual).
Evaluation
- Dossier evaluation – indicated if at least one registered dossier for the substance has been evaluated under REACH for compliance check or testing proposal evaluation and associated decision(s) published on the ECHA website.
- Substance evaluation – indicated if the substance is or was included in the Community rolling action plan (CoRAP). The CoRAP list includes substances that could pose a risk to human health or the environment and whose (potentially hazardous) properties are to be evaluated by the Member States in the next three years. After evaluation, proposals may be made for further regulatory action regarding the substance.
Authorisation
- Candidate List – indicates if the substance is included in the candidate list of substances of very high concern (SVHCs). The Candidate List includes substances that are subject to additional protocols and reporting obligations and which may eventually be included in the Authorisation list, further limiting their use.
- Authorisation list (Annex XIV) – indicates if the substance is included in the Authorisation List. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
Restriction
- Annex XVII (Restriction list) – indicates if the substance is included in the list of restrictions. The Restriction list describes the conditions for the manufacture, placing on the market or use of certain substances, either on their own or in mixtures or articles.

Persistent Organic Pollutants (POPs)
The POPs Regulation (EU) 2019/1021 entered into force on 15 July 2019, repealing the previous POPs Regulation (EC) No 850/2004. The regulation aims to protect human health and the environment by banning or severely restricting the production and use of persistent organic pollutants in the European Union.

The POPs regulatory processes identified for the Brief Profile are:

List of substances subject to the POPs Regulation - Indicates if the substance is included in the POPs Regulation.
List of substances proposed as POPs - Indicates if the substance has been proposed for its inclusion in the Stockholm Convention or if a proposal is under preparation in the European Union.

Classification, Labelling and Packaging (CLP)
The CLP Regulation (1272/2008) entered into force on 20 January 2009. The goal of CLP is to make sure that hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through a system of classifying and labelling of chemicals.

The CLP regulatory processes identified for the Brief Profile are:

Harmonised C&L– indicates if a European Union harmonised classifications and labelling has been assigned to the substance according to Annex VI to CLP and subsequent ATPs.
Notification – indicates that notified C&L’s have been submitted to ECHA for a substance.

Biocidal Products Regulation (BPR)

The BPR (528/2012) entered into force on 1 September 2013. The BPR addresses the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by regulating the active substances contained in a biocidal product.

The BPR regulatory processes identified for the Brief Profile are:

Active substance approval – indicates if the substance is an approved biocidal active substance.
Biocidal product authorisation – indicates if authorised biocidal products exist which use this substance as an active ingredient

Prior Informed Consent (PIC)
The PIC Regulation (649/2012) entered into force on 4 July 2014. PIC administers the import and export of certain hazardous chemicals and places obligations on companies who wish to export these chemicals to non-EU countries.

The PIC regulatory processes identified for the Brief Profile are:

Annex I – indicates if the substance is subject to PIC.
Annex V – indicates if the substance is prohibited from export.

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)

Registration

Pre-registration:: Substance pre-registered under REACH.
Registration:: This substance has 12 active registrations under REACH, 2 Joint Submission(s) and 3 Individual Submission(s).
Please see Registrants/Suppliers details.

Evaluation

Dossier Evaluation:
Substance Evaluation:

Authorisation

Candidate List:
Annex XIV (Authorisation List):

Restriction

Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

List of substances subject to the POPs Regulation:
List of substances proposed as POPs:

Classification Labelling & Packaging (CLP)

Harmonised C&L:: A European Union Harmonised Classification & Labelling has been assigned to this substance.
Seveso Annex I:
Notified C&L:: Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

The ’About this substance’ section provides an overview of the volume in which this substance is manufactured or imported to the European Economic Area (EU28 + Iceland, Liechtenstein and Norway). Data for calculating the ’total tonnage’ band is extracted from REACH registered dossiers for the last year reported on the tonnage manufactured or imported, unless the tonnage band has been claimed confidential. The ‘total tonnage’ band published does not necessarily reflect the registered tonnage band(s).

For more information on total tonnage band calculation please consult the Data submission manual.

Additionally, if available, information on the use of the substance and how consumers and workers are likely to be exposed to it can also be displayed here. The information is aggregated from REACH registered dossiers provided by industry through a use descriptor system based on five separate descriptor lists which in combination with each other form a brief description of use and exposure for certain life cycle stage.

The use information is displayed per relevant life cycle stage of the substance.

Manufacture stage includes processes by which the substance is manufactured from raw materials. Operations which are necessary for the handling of a substance on its own in the manufacturing for export or placing on the EU market are considered to be part of the manufacturing stage (e.g. filling into appropriate containers, storage or addition of stabiliser). If a substance is directly exported after manufacture, all activities with the substance will be reported under this stage.
Formulation or re-packing stage corresponds to specific activities meant to produce a mixture to be placed on the market. This means that during formulation, the substance is transferred and mixed with other substances. It corresponds to activities taking place at industrial sites. This stage also includes chemical distributorsâ activities such as repacking (which involves transfer of the substance).
End-use stage means the use of a substance as such or in a mixture (by professional workers (widespread uses), by consumers or at industrial sites), a last step before the end-of-life of the substance, namely before the substance is consumed in a process by reaction during use (including intermediate use), is emitted to waste streams or the environment or is included into an article.
(Article) service life stage means the period of time a substance incorporated into an article remains in service or in use. Articles containing the substance can be used or processed by consumers, by workers at industrial sites and/or by professional workers. This also includes processing of semi-finished articles by workers with the aim of producing finished articles or repair and maintenance work like for example sanding of surfaces.

Use Descriptors

The chemical product category (PC) describes the types of chemical products in which the substance is finally contained when it is supplied to end-users (by industrial, professional or consumer users). Examples include hydraulic fluids, perfumes and air care products. This category also describes uses as intermediate and under controlled conditions.
The sector of use category (SU) describes in which sector of the economy the substance is used. This includes mixing or re-packing substances at the formulator’s level as well as industrial, professional and consumer end-uses (e.g. building and construction work or manufacture of food products).
The process category (PROC) describes the application techniques or process types defined from the occupational perspective e.g. Industrial spraying, use in closed batch process (synthesis and formulation).
The environmental release category (ERC) describes the broad conditions of use from the perspective of release to the environment (e.g. if the use occurs in industrial setting, if it is indoor use in long-life materials with a low release rate (e.g. flooring, furniture, toys, etc).
The article category (AC) describes the type of article into which the substance has eventually been processed. This also includes mixtures in their dried or cured form (e.g. dried printing ink in newspapers; dried coatings on various surfaces).

Precautionary measures and safe use

This section provides information on the recommended measures to minimise or prevent adverse effects resulting from exposure to a hazardous product, or improper storage or handling of a hazardous product. The recommendations are based on the precautionary statements provided in REACH registration dossiers.

If information on guidance on safe use is available in REACH registered dossiers, a link is displayed. Information in the guidance on safe use section consists of recommendations by a substance registrant(s) on the proper use of the substance in various situations. Examples include recommended measures on fire-fighting, transport, recycling and disposal.

More information on the use descriptor system can be found in ECHA’s Guidance Chapter R.12: Use Descriptor system of ECHA’s Guidance on information requirements and chemical safety assessment.

Please note:

Only non-confidential use descriptors are displayed and for readability purpose only use descriptors occurring in more than 5% of the total occurrences are displayed.

For a detailed overview on identified uses and environmental releases, please consult the detailed information from the registration dossiers.

Use descriptors were adapted from ECHA guidance to improve readability and may not correspond textually to descriptor codes description as in ECHA guidance chapter R.12: Use Descriptor system of ECHA Guidance on information requirements and chemical safety assessment.

Precautionary measures and guidance on safe use concern the use and handling of the specific substance, not of the presence of the substance in other articles or mixtures.

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General

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, for intermediate use only.

This substance is used by consumers, by professional workers (widespread uses), at industrial sites and in manufacturing.

Consumer Uses

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

Article service life

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

Widespread uses by professional workers

This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used for the manufacture of: chemicals.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation.

Release to the environment of this substance can occur from industrial use: as an intermediate step in further manufacturing of another substance (use of intermediates).

Formulation or re-packing

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

Uses at industrial sites

This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used for the manufacture of: chemicals.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, closed processes with no likelihood of exposure, transfer of chemicals at dedicated facilities, laboratory work and closed, continuous processes with occasional controlled exposure.

Release to the environment of this substance can occur from industrial use: as an intermediate step in further manufacturing of another substance (use of intermediates).

Manufacture

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, closed processes with no likelihood of exposure, transfer of chemicals at dedicated facilities, transfer of substance into small containers and laboratory work.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

Precautionary Measures and safe use

Precautions for using this substance have been recommended by its registrants under REACH, as follows:

Prevention statements

When handling this substance: avoid release to the environment.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

Registrant/suppliers

This section provides information on suppliers, importers or manufacturers of a substance (active and inactive) that have to register their substance under REACH.

Registration status
Status in REACH-IT	Displayed in Brief Profile
Active	Always as Active
Cease manufacture	Always as Inactive
Revoked registrations	Active/Inactive (pending). Due to ongoing appeals, all registrations flagged as revoked are published as Active pending the appeal outcome. When the appeal outcome is known, the registration will appear as Inactive
Annulled registrations	In the case of a merge between two companies having a registration for the same substance, the higher tonnage band registration is maintained as active, and the other registration is annulled. The annulled registration is still legally valid and considered as an active registration, because the registration number could be present on safety fata sheets and may already be communicated throughout the supply chain.

Under specific conditions, a registrant can claim confidentiality of their identity. If there is a confidentiality claim, an indication is provided with the tag [Confidential].

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Active

Borregaard AS, Hjalmar Wessels vei 6 1701 Sarpsborg Norway
EGIS Pharmaceuticals PLC, Keresztúri út 30-38 H-1106 Budapest Hungary
Ercros SA, Avenida Diagonal 593-595 08014 Barcelona Spain
Former NONS notifier unknown to ECHA - Contact the relevant Italian competent national authority., null
Former NONS notifier unknown to ECHA - Contact the relevant UK competent national authority., null
Gedeon Richter Plc., Gyomroi ut 19-21 1103 Budapest Hungary
Krka, d. d., Novo mesto, Smarjeska cesta 6 SI-8501 Novo mesto Slovenia
Lek Pharmaceuticals d.d., Verovskova 57 1526 Ljubljana Slovenia
MOEHS CATALANA, Cesar Martinell i Brunet 12 A 08191 Rubi Barcelona Spain
Pfizer Ireland Pharmaceuticals, n/a P43 X3336 Ringaskiddy Cork Ireland
Siemsgluss Ibérica, S.A., Pol. Ind. Sant Antoni, parcela 6, nave 2 08620 Sant Vicenç dels Horts Barcelona Spain

Inactive

Substance names and other identifiers

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Regulatory process names

3,5-Pyridinedicarboxylic acid, 4-(2-chlorophenyl)-2-((2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy)methyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester
AMLODIPINE STEP 3; UK-52,416

Other

3,5-Pyridinedicarboxylic acid, 4-(2-chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester
AMLODIPINE STEP 3; UK-52,416

Other

3-Ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-((2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy)methyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
AMLODIPINE STEP 3; UK-52,416

Other

3-Ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-(2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl)-6-methyl-3,5-pyridinedicarboxylate
AMLODIPINE STEP 3; UK-52,416

Other

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
AMLODIPINE STEP 3; UK-52,416

CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, General Product Safety Directive - Hazardous Substances, Waste Framework Directive, Annex III - Waste - Hazardous Properties

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

EC Inventory, Other

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
AMLODIPINE STEP 3; UK-52,416

REACH pre-registration, Other

4-(2-Chloroethyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-2-((2-phthalimidoethoxy)methyl)-1,4-dihydropyridine
AMLODIPINE STEP 3; UK-52,416

Other

4-(2-Chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-2-((2-phthalimidoethoxy)methyl)-1,4-dihydropyridine
AMLODIPINE STEP 3; UK-52,416

Other

Amlodipine besilate impurity A
AMLODIPINE STEP 3; UK-52,416

Other

Phthalimidoamlodipine
AMLODIPINE STEP 3; UK-52,416

Other

Phthaloylamlodipine
AMLODIPINE STEP 3; UK-52,416

Other

Translated names

3-etil 5-metil 4-(2-klorofenil)-1,4-dihidro-2-[2-(1,3-dihidro-1,3-diokso-(2H)izoindol-2-il)etoksimetil]-6-metil-3,5-piridindikarboksilat (sl)

C&L Inventory

3-etil-5-metil 4-(2-klórfenil)-1,4-dihidro-2-[2-(1,3-dihidro-1,3-dioxo-(2H)izoindol-2-il)-etoximetil]-6-metil-3,5-piridindikarboxilát (hu)

C&L Inventory

3-etil-5-metil-4-(2-chlorfenil)-1,4-dihidro-2-[2-(1,3-dihidro-1,3-diokso-(2H)izoindol-2-il)-etoksimetil]-6-metil-3,5-piridindikarboksilatas (lt)

C&L Inventory

CAS names

IUPAC names

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

C&L Inventory, Registration dossier

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

Registration dossier

3-ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

Registration dossier, Other

3-ethyl-5-methy 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl}-6-methyl-3,5-pyridinedicarboxylate

Registration dossier

3-O-ethyl 5-O-methyl 4-(2-chlorophenyl)-2-[2-(1,3-dioxoisoindol-2-yl)ethoxymethyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

Other

AL-II

Registration dossier

Phtalimido Amlodipine

Registration dossier

Phthaloyl Amlodipine

C&L Inventory

Trade names

12520460FTALOIL AMLODIPIN / PHTHALOYL AMLODIPINE

Registration dossier

Amlodipine FIA

Registration dossier

amplodipine step 3

Registration dossier

AN-06

Registration dossier

Ftalimido amlodipin

Registration dossier

UK-52,416

Registration dossier

Other names

Other identifiers

607-371-00-3

Index number

C&L Inventory

88150-62-3

CAS number

C&L Inventory, Registration dossier, Other, CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, General Product Safety Directive - Hazardous Substances, Waste Framework Directive, Annex III - Waste - Hazardous Properties

Scientific properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Appearance/physical state / colour

Appearance / physical state / colour

This section summarises appearance, physical state and colour property values from all registered dossiers held in the ECHA database for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

If more than one value is available, results are displayed as concatenated distinct values, ordered from most to least commonly provided, with the percentage of provided values appended. The percentage is based on the count of values provided.

Physical state

For substance’s physical state at 20°C and 1 013 hPa, registrants can classify their substance as:

Solid
Liquid
Gaseous

Form

For substance’s form, registrants can classify their substance as:

Aerosol dispenser: not specified
Aerosol dispenser: foam aerosol
Aerosol dispenser: spray aerosol
Gas
Gas: vapour
Gas under pressure: compressed gas
Gas under pressure: dissolved gas
Gas under pressure: liquefied gas
Gas under pressure: refrigerated liquefied gas
Liquid
Liquid: viscous
Liquid: volatile
Liquid – liquid: emulsion
Liquid – solid: mixture of
Semi–solid (amorphous): gel
Solid
Solid: bulk
Solid: compact
Solid: crystalline
Solid: fibres
Solid: filaments
Solid: flakes
Solid: granular
Solid: pellets
Solid: particulate/powder
Solid: nanomaterial, surface–treated
Solid: nanomaterial, no surface treatment
Solid: nanomaterial
Solid – liquid: aqueous solution
Solid – liquid: suspension
Solid – solid: alloy
Aerosol
Compact
Crystalline
Dispersion
Fibre
Filaments
Flakes
Liquefied gas
Nanomaterial
Particulates
Paste
Pellets
Powder
Refrigerated liquid
Suspension
Viscous
Other
No data

Odour

For substance’s odour, registrants can classify their substance as:

Ammonia-like
Biting
Characteristic of sulphur containing compounds
Characteristic of aromatic compounds
Faint
Garlic-like
Odourless
Pungent
Slight
Sweetish
Other

Type

For substance’s type, registrants can classify their substance as:

Element
Inorganic
Natural substance
Organic
Organometallic
Petroleum product
Other

Summary

Summary data is collected from the endpoint summary(ies) provided by registrants of REACH dossiers.

Physical state at 20°C and 1013 hPa

For substance’s physical state at 20°C and 1013 hPa, registrants can classify their substance as:

Solid
Liquid
Gaseous

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data–waving justifications.

Study results

7 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study	1	1
Weight of evidence
Other		5

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Melting/freezing point

Study results

4 studies submitted
1 study processed

R Melting / freezing point: 150 °C @ 100.1 kPa [1]

Type of Study provided

Studies with data
Key study	1
Supporting study		1
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Boiling point

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Density

Study results

3 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study	1
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Vapour pressure

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Partition coefficient

Study results

3 studies submitted
1 study processed

R Log Pow: 4.9 @ 30 °C and pH 6.79 [1]

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Water solubility

Study results

4 studies submitted
1 study processed

R Water solubility (mass/vol.): 17 mg/L @ 20 °C and pH 7.18 [1]

Type of Study provided

Studies with data
Key study	2
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Solubility in organic solvents / fat solubility

Study results

3 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Surface tension

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Flash point

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Auto flammability

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Flammability

This section summarises the flammability values from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

If more than one value is available, results are displayed as concatenated distinct values, ordered by most to least commonly provided, with the % of provided values appended. The % is based on count of values provided.

Applicant’s summary and conclusion – Interpretation of results. Registrants can register their substance flammability as:

Extremely flammable aerosols (Cat. 1)
Flammable gases (Cat.1)
Flammable solids (Cat.1)
Pyrophoric liquids (Cat.1)
Pyrophoric solids (Cat. 1)
Self-heating substances and mixtures (Cat. 1)
Substances or mixtures which in contact with water release flammable gases which may ignite spontaneously (Cat.1)
Flammable aerosols (Cat.2)
Flammable gases (Cat.2)
Flammable solids (Cat.2)
Self-heating substances and mixtures (Cat.2)
Substances or mixtures which in contact with water release flammable gases which may ignite spontaneously (Cat.2)
Non-flammable aerosols (Cat.3)
Substances or mixtures which in contact with water releases flammable gases (Cat.3)
Chemically unstable gases (Cat.A)
Chemically unstable gases (Cat.B)
GHS criteria not met
Not classified based on GHS criteria
Extremely flammable
Extremely flammable liquefied gas
Substances and mixtures which in contact with water emit flammable gases
Contact with water liberates highly flammable gases
Highly flammable
Flammable
Pyrophoric
Spontaneously flammable in air (pyrophoric)
Non–flammable
Non flammable (based on GHS criteria)
No information available
Not classified

Note: Registrants can also select ‘other’ as the flammability value for their substance. If so, the data provided is not processed for the Brief Profile.

Summary

Registrants can register their substance’s flammability as:

Extremely flammable
Extremely flammable liquefied gas
Contact with water liberates highly flammable gases
Highly flammable
Flammable
Spontaneously flammable in air (pyrophoric)
Non–flammable

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

4 studies submitted
1 study processed

C Interpretation of results: Non flammable (100%) [1]

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		3

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Explosiveness

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Oxidising

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Oxidation reduction potential

Data not provided by the registrant

pH

Study results

1 study submitted
1 study processed

R pH: 6.78 @ 20.4 °C and 10 g/L [1]

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other

Data waiving
no waivers

No summary exists for this scientific endpoint

Dissociation constant

Data not provided by the registrant

Viscosity

Data not provided by the registrant

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results

1 study submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				1

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

This section summarises the values related to the screening tests for biodegradation in water from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

If more than one numerical result is available per endpoint, the range of results (min-max) and range of experimental conditions will be presented (RANGE method).

If more than one picklist value is available per endpoint, results are displayed as concatenated distinct values, ordered by most to least commonly provided, with the % of provided values appended. The % is based on count of values provided.

BOD5 provides substance information on the substance’s BOD5 values displayed in O2 (milli)gram per gram test material.

COD provides substance information on the substance’s COD values displayed in O2 (milli)gram per gram test material.

BOD5*100/COD provides substance information on the substance’s BOD5*100/COD values displayed in O2 (milli)gram per gram test material.

BOD5/COD ratio provides substance information on the substance’s BOD5/COD ratio values displayed in O2 (milli)gram per gram test material.

BOD5/ThOD ratio provides substance information on the substance’s BOD5/ThOD ratio values displayed in O2 (milli)gram per gram test material.

BOD5*100/ThOD provides substance information on the substance’s BOD5*100/ThOD values displayed in O2 (milli)gram per gram test material.

ThOD provides substance information on the substance’s ThOD values displayed in O2 (milli)gram per gram test material.

Note: Registrants can also select ‘other’ as the unit of measure. If so, the data provided is not processed for the Brief Profile.

Applicant’s summary and conclusion – Interpretation of results provides information on the substance’s biodegradation properties in water and can be registered by the registrants by one or more of the following picklist options:

Readily biodegradable
Readily biodegradable but failing the 10-day window
Inherently biodegradable
Inherently biodegradable, fulfilling specific criteria;
Inherently biodegradable, not fulfilling specific criteria
Not inherently biodegradable
Not readily biodegradable
Under test conditions no biodegradation observed

Note: Registrants can also select ‘other’ as picklist option for describing the biodegradation values of the substance in water. If so, the data provided is not processed in the Brief Profile.

Summary

Biodegradation in water provides information on the substance’s biodegradation properties in water and can be registered by the registrants by one or more of the following picklist options:

Readily biodegradable
Readily biodegradable but failing the 10-day window
Inherently biodegradable
Inherently biodegradable, fulfilling specific criteria;
Inherently biodegradable, not fulfilling specific criteria
Under test conditions no biodegradation observed

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

5 studies submitted
1 study processed

C Interpretation of results: Not readily biodegradable (100%) [1]

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		4

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results

1 study submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				1

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Predicted No-Effect Concentration (PNEC)

If more than one numerical result is available per endpoint, the range of results (min-max) will be presented (RANGE method).

Hazard to aquatic organisms provides information on the substance’s hazard assessment conclusion regarding aquatic organisms.

Manufacturers and importers can provide the following information in the registration dossier:

Freshwater/marine water/intermittent:

PNEC aqua, displayed in milligram per litre.
No data: aquatic toxicity unlikely
No data available: testing technically not feasible
No hazard identified

Sewage treatment plant (STP)

PNEC STP, data displayed in milligram per litre.
No data: aquatic toxicity unlikely
No data available: testing technically not feasible
No emission the STP expected
No hazard identified

Sediment freshwater/marine water

PNEC sediment, data displayed in milligram per kilo sediment (dry weight).
No or insufficient data available at present
No exposure of sediment expected
No data available: testing technically not feasible
No hazard identified

Hazard for Air provides information on the substance’s hazard assessment conclusion related to air.

Data is generally standardised and displayed in milligram per litre/cubic metre.

Manufacturers and importers can provide the following information in the registration dossier:

PNEC air
Hazard related to composition of atmosphere identified
No hazard identified

Hazard for terrestrial organisms provides information on the substance’s hazard assessment conclusion related to terrestrial organisms/soil.

Data is generally standardised and displayed in milligram per kilo soil (dry weight).

Manufacturers and importers can provide the following information in the registration dossier:

PNEC soil
No or insufficient data available at present
No exposure of soil expected
No data available: testing technically not feasible
No hazard identified

Hazard for predators provides information on the substance’s hazard assessment conclusion related to predators/secondary poisoning.

Data is generally standardised and displayed in in milligram per kilo of food.

Manufacturers and importers can provide the following information in the registration dossier:

PNEC oral
No potential for bioaccumulation
No potential to cause toxic effects if accumulated (in higher organisms) via the food chain
No or insufficient data available at present
No data available: testing technically not feasible

Data not provided by the registrant

Short–term toxicity to fish

Study results

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results

3 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Long–term toxicity to aquatic invertebrates

This section summarises the values related to long term toxicity to aquatic invertebrates from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

Displayed are the RANGES of min – max of the PRIORITISED value(s) within the five highest priority groupings of provided data. Data is generally standardised and displayed in milligram per litre or molar per litre.

The availability of additional data beyond the five results displayed is indicated by (…).

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (longer prioritised over shorter).

Prioritisation by dose descriptor:

NOEC
LOEC
EC10
LC10
IC10
EC50
LC50
IC50
EL10
EL50
LL10
LL50
NOELR
LOELR

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

EC10 / LC10 or NOEC for freshwater invertebrates provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested freshwater invertebrates or the no observed effect concentration for freshwater invertebrates. Values are presented in (nano/ micro/milli)gram per litre and/or (nano/ micro/milli)molar per litre.

EC10 / LC10 or NOEC for marine water invertebrates provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested marine water invertebrates or the no observed effect concentration for marine water invertebrates. Values are presented in (nano/ micro/milli)gram per litre and/or (nano/ micro/milli)molar per litre.

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

1 study submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study
Supporting study
Weight of evidence
Other				1

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Toxicity to aquatic algae and cyanobacteria

This section summarises the values related to toxicity to aquatic algae and cyanobacteria from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

The availability of additional data beyond the five results displayed is indicated by (…).

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (longer prioritised over shorter).

Prioritisation by dose descriptor:

EC50
IC50
NOEC
LOEC
EC10
IC10
EC20
EC5
EC0
EC100
IC100
EC90
EL0
EL5
EL10
EL20
EL50
EL90
EL100
NOELR
LOELR

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

LC50 for freshwater algae provides substance information on the substance’s lethal concentration for 50% of the freshwater algae in the test, displayed in generally milligram per litre.

LC50 for marine water algae provides substance information on the substance’s lethal concentration for 50% of the marine water algae in the test, generally displayed in milligram per litre.

EC10 / LC10 or NOEC for freshwater algae provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested freshwater algea or the no observed effect concentration for freshwater algae. Values are generally displayed in milligram per litre.

EC10 / LC10 or NOEC for marine water algae provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested marine water algae or the no observed effect concentration for marine water algae. Values are generally displayed in milligram per litre.

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

4 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		3

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Toxicity to aquatic plants other than algae

This section summarises the values related to toxicity to aquatic plants (other than algae) from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

Displayed are the RANGES of min – max of the PRIORITISED value(s) within the five highest priority groupings of provided data. Data is generally standardised and the displayed in milligram per litre or molar per litre.

The availability of additional data beyond the five results displayed is indicated by (…).

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (longer prioritised over shorter).

Prioritisation by dose descriptor:

EC50
IC50
NOEC
LOEC
EC10
IC10
EC20
EC5
EC0
EC100
IC100
EC90
EL0
EL5
EL10
EL20
EL50
EL90
EL100
NOELR
LOELR

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

EC/LC50 for freshwater plants provides substance information on the substance’s effect concentration or lethal concentration for 50% of the freshwater plants in the test, generally displayed in milligram per litre.

EC50/LC50 for marine water plants provides substance information on the substance’s effect concentration or lethal concentration for 50% of the marine water algae in the test, generally displayed in milligram per litre.

EC10 / LC10 or NOEC for freshwater plants provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested freshwater plants or the no observed effect concentration for freshwater plants. Values are generally displayed in milligram per litre.

EC10 / LC10 or NOEC for marine water plants provides substance information on the substance’s effect concentration/lethal concentration for 10% of the tested marine water plants or the no observed effect concentration for marine water plants. Values are generally displayed in milligram per litre.

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicity to microorganisms

Data not provided by the registrant

Sediment toxicity

This section summarises the values related to toxicity to sediment toxicity from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (in hours, longer prioritised over shorter).

Prioritisation by dose descriptor:

NOEC
LOEC
EC10
LC10
LD10
EC50
LC50
LD50
EC0
LC0
LD0
EC100
LC100
LD100
LR10
LR50
LR0
LR100

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

EC/LC50 for freshwater sediment provides substance information on the substance’s effect concentration or lethal concentration for 50% of the model organisms feeding off the freshwater sediment, generally displayed in milligrams per kilogram sediment (dry weight).

EC50/LC50 for marine sediment provides substance information on the substance’s effect concentration or lethal concentration for 50% of the model organisms feeding off the marine sediment, generally displayed in milligrams per kilogram sediment (dry weight).

EC10 / LC10 or NOEC for freshwater sediment provides substance information on the substance’s effect concentration/lethal concentration for 10% of the model organisms feeding off the freshwater sediment or the no observed effect concentration for of the model organisms feeding off the freshwater sediment. Values are generally displayed in milligrams per kilogram (dry weight).

EC10 / LC10 or NOEC for marine sediment provides substance information on the substance’s effect concentration/lethal concentration for 10% of the model organisms feeding off the marine sediment or the no observed effect concentration for of the model organisms feeding off the marine sediment. Values are generally displayed in milligrams per kilogram (dry weight).

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

This section summarises the values related to toxicity to soil macroorganisms (except arthropods) from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

The availability of additional data beyond the five results displayed is indicated by (…).

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (in hours, longer prioritised over shorter). Thirdly the display of data is prioritised by units.

Prioritisation by dose descriptor:

NOEC
LOEC
EC10
LC10
LD10
EC50
LC50
LD50
EC0
LC0
LD0
EC100
LC100
LD100
LR10
LR50
LR0
LR100

Prioritisation by units (dry weight):

Mg/cm2
g/ha

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

EC10 / LC10 or NOEC for marine sediment provides substance information on the substance’s effect concentration/lethal concentration for 10% of the model organisms feeding off the marine sediment or the no observed effect concentration for of the model organisms feeding off the marine sediment. . Values are generally displayed in measured in (nano/ micro/milli)gram per kilogram (dry weight).

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicity to terrestrial arthropods

This section summarises the values related to toxicity to (terrestrial) arthropods from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

Displayed are the RANGES of min – max of the PRIORITISED value(s) within the five highest priority groupings of provided data. Data is generally displayed in milligrams per kilogram in the case of soil (dry/wet weight), or gram per hectare. Otherwise data is displayed reported as provided by the registrant(s).

The availability of additional data beyond the five results displayed is indicated by (…).

Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (longer prioritised over shorter). Thirdly the display of data is prioritised by unit.

Prioritisation by dose descriptor:

NOEC
LOEC
EC10
LC10
LD10
EC50
LC50
LD50
EC0
LC0
LD0
EC100
LC100
LD100
LR10
LR50
LR0
LR100

Prioritisation by unit:

soil dw (g/ha and mg/cm²)
soil ww; (g/ha and mg/cm²)
µg per animal
mL/ha; mg/kg bw
mg/kg diet
ppm
mg/kg dung dw

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

Short-term EC50 or LC50 for soil dwelling arthropods provides substance information on the substance’s effect concentration or lethal concentration (short term) for 50% of the soil dwelling arthropods in the test, generally displayed in milligram per kilo soil (dry weight).

Long-term EC10 or LC10 or NOEC for soil dwelling arthropods provides substance information on the substance’s effect concentration or lethal concentration (long term) for 10% of the soil dwelling arthropods in the test, or the no observed effect concentration for soil dwelling arthropods. Values are generally displayed in milligram per kilo soil (dry weight).

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicity to terrestrial plants

This section summarises the values related to toxicity to (terrestrial) plants from all registered dossiers for the substance.

If more than one numerical result is available per endpoint, the range of results (min-max) and range of experimental conditions will be presented (RANGE method).

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

Prioritisation by dose descriptor:

NOEC
LOEC
EC10
LC10
EC50
LC50
EC0
EC25
EC100
LC0
LC25
LC100
ER0
ER10
ER25
ER50
ER100

Prioritisation by units:

soil dw (g/ha, kg/ha and lbs/acre).
soil ww (g/ha, kg/ha and lbs/acre).

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

Short-term EC50 or LC50 for terrestrial plants provides substance information on the substance’s effect concentration or lethal concentration (short term) for 50% of the terrestrial plants in the test, generally displayed in milligram per kilo soil (dry weight).

Long-term EC10 or LC10 or NOEC for terrestrial plants provides substance information on the substance’s effect concentration or lethal concentration (long term) for 10% of the terrestrial plants in the test, or the no observed effect concentration for terrestrial plants. Values are generally displayed in milligram per kilo soil (dry weight).

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicity to soil microorganisms

This section summarises the values related to toxicity to soil microorganisms from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

The availability of additional data beyond the five results displayed is indicated by (…).

Prioritisation by dose descriptor:

NOEC
EC10
EC25
EC50
EC100
EC0
ER0
ER10
ER25
ER50
ER100

Prioritisation by units:

Soil dw (g/ha, kg/ha and lbs/acre).
Soil ww (g/ha, kg/ha and lbs/acre).

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

If more than one numerical result is available per endpoint, the range of results (min-max) and range of experimental conditions will be presented (RANGE method).

Short-term EC50 or LC50 for soil microorganisms provides substance information on the substance’s effect concentration or lethal concentration (short term) for 50% of soil microorganisms in the test, generally displayed in milligram per kilo soil (dry weight).

Long-term EC10 or LC10 or NOEC for soil microorganisms provides substance information on the substance’s effect concentration or lethal concentration (long term) for 10% of the soil microorganisms in the test, or the no observed effect concentration for soil microorganisms. Values are generally displayed in milligram per kilo soil (dry weight).

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

This section summarises the values related to toxicity to mammals (other above-ground organisms) from all registered dossiers for the substance.

More information on processable studies and data-waiving is available in the section help of the ‘Scientific properties’ header.

Study results

The availability of additional data beyond the five results displayed is indicated by (…).
Processable data is prioritised by the toxicity descriptor type (see list below) and subsequently further prioritised by duration (longer prioritised over shorter). Thirdly the display of data is prioritised by units.

Prioritisation by dose descriptor:

NOEC
EC50
LC50
LD50
EC100
LC100
LD100
EC0
LC0
LD0
LR50
LR0
LR100
ER50
ER0
ER100

Prioritisation by units

Soil dw (g/ha and mg/cm²)
Soil ww; (g/ha and mg/cm²)
µg per animal
mL/ha; mg/kg bw
mg/kg diet
ppm.
mg/kg dung dw

Note: Registrants can also select ‘other’ as the dose descriptor type or unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

Short-term EC50 or LC50 for mammals provides substance information on the substance’s effect concentration or lethal concentration (short term) for 50% of mammals in the test, generally displayed in milligram per kilo food.

Long-term EC10 or LC10 or NOEC for mammals provides substance information on the substance’s effect concentration or lethal concentration (long term) for 10% of the mammals in the test, or the no observed effect concentration for mammals. Values are generally displayed in milligram per kilo food.

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Data not provided by the registrant

Toxicological information

This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Derived No- or Minimal Effect Level (DN(M)EL)

This section provides information on the derived no- or minimal effect level (DN(M)EL), the level of exposure above which a human should not be exposed to a substance.

When more than one summary is provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

When more than one result is available per endpoint the ‘worst case’ or most conservative of all the data values provided are displayed, applying a precautionary principal. The aim is to display the lowest values reported as causing the most adverse effects, and hence the broadest possible safety margins for the substance.

Inhalation exposure provides information on the substance’s hazard assessment conclusions regarding inhalation exposure.

Registrant can provide information on the long and acute/short term exposure for both systemic and local effects of inhalation exposure of workers and/or general population by selecting one of the following hazard assessment conclusions:

DNEL (Derived No-Effect Level)
DMEL (Derived Minimum Effect Level) - not included for short–term effects
Other toxicological threshold
High hazard (no threshold derived)
Medium hazard (no threshold derived)
Low hazard (no threshold derived)
Insufficient data available (further information necessary)
Hazard unknown (no further information necessary)
No hazard identified
Hazard unknown but no further hazard information necessary as no exposure expected

Prioritisation of display occurs based on the order above. If a threshold is derived, the type of hazard assessment conclusion is displayed and the registered threshold is reported in (nano/micro/milli)gram per cubic metre. If more than one DNEL/DMEL is available the most conservative (i.e. the lowest numerical data) is displayed.

Information on the most sensitive study can be provided by the registrants as:

Acute toxicity
Repeated dose toxicity
Effect on fertility
Developmental toxicity/teratogenicity
Neurotoxicity
Immunotoxicity
Sensitisation (skin)
Sensitisation (respiratory tract)
Carcinogenicity
Skin irritation/corrosion
Irritation (respiratory tract)
Genetic toxicity

Dermal exposure provides information on the substance’s hazard assessment conclusions regarding dermal exposure (for workers).

See ‘Data for workers – Inhalation exposure’, with the following additional hazard assessment conclusion in the case of short term:

‘No DNEL required: short term exposure controlled by conditions for long-term’ is added

The registered threshold is generally displayed in milligrams per kilogram per bodyweight per day.

Data for workers – eye exposure provides information on the substance’s hazard assessment conclusions regarding eye exposure (for workers).

Registrant can provide information on eye exposure by selecting one of the following hazard assessment conclusions:

High hazard (no threshold derived)
Medium hazard (no threshold derived)
Low hazard (no threshold derived)
Hazard unknown (no further information necessary)
No hazard identified
Hazard unknown but no further hazard information necessary as no exposure expected

Data for general population – eye exposure provides information on the substance’s hazard assessment conclusions regarding eye exposure (for the general population).

Registrant can provide information on eye exposure as mentioned above for ‘Data for workers – eye exposure.’

Data not provided by the registrant

Toxicokinetics, metabolism, and distribution

Study results

Study data: basic toxicokinetics

3 studies submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Study data: basic toxicokinetics

Studies with data
Key study
Supporting study
Weight of evidence
Other				3

Data waiving
no waivers

Study data: dermal absorption

0 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: dermal absorption

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Acute toxicity

This section displays the values related to acute toxicity from all registered dossiers for the substance.

Study results - oral

Displayed are the RANGES of min – max of the PRIORITISED value(s) within the five highest priority groupings of provided data. Data is generally displayed in milligram per kilo bodyweight. The availability of additional data beyond the five results displayed is indicated by (…).

Results

Processable data for study results is prioritised by test species (see list below) and subsequently further prioritised by the dose descriptor.

Prioritization by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Prioritisation by dose descriptor type:

LD50
LD50 cut-off
Discriminating dose
LD0
LD100
LDLo
Approximate LD50

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Applicant’s summary and conclusion – Interpretation of results (oral). Registrants can choose from the following (picklist) conclusions:

Category 1 based on GHS criteria
Category 2 based on GHS criteria
Category 3 based on GHS criteria
Category 4 based on GHS criteria
Category 5 based on GHS criteria
Study cannot be used for classification
GHS criteria not met
Extremely toxic
Very toxic
Highly toxic
Toxic
Moderately toxic
Slightly toxic
Toxicity category I
Toxicity category II
Toxicity category III
Toxicity category IV
Toxicity category V
Practically nontoxic
Harmful
Relatively harmless
Not classified
Other

Displayed is the MOST CONSERVATIVE of the value(s) provided, ranking in the order as above.

Note: Registrants can also select ‘other’ as the picklist conclusion. If so, the data provided is not processed for the Brief Profile.

Study results - dermal

Results

See information under ‘Study results oral’.

Applicant’s summary and conclusion – Interpretation of results (dermal). See information under ‘Applicant’s summary and conclusion – interpretation of results (oral)’.

Study results - Inhalation

Results

Processable data for study results is prioritised by test species (see list below) and subsequently further prioritised by the dose descriptor. Within each of these categories, data is prioritised further by duration (in hours), with longer prioritised over shorter.

Prioritization by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Prioritisation by dose descriptor type:

LC50
LC50 cut-off
Discriminating conc.
LC0
LC1
LC100
LCLo

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Applicant’s summary and conclusion – Interpretation of results (inhalation). See information under ‘Applicant’s summary and conclusion – interpretation of results (oral)’.

Study results - other routes

Results

Processable data for study results is prioritised by test species (see list below) and subsequently further prioritised by the dose descriptor.

Prioritization by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Prioritization by the dose descriptor type:

EC50
LC50
LD50
EC0
LC0
LD0
EC100
LC100
LD100
LCLo
LDLo

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary

Displayed in all cases is the MOST CONSERVATIVE of the value(s) provided, ranking in the order as above, i.e. the minimum numerical value associated with the highest priority picklist item.

Oral route provides substance information on the substance’s acute toxicity via the oral route. Registrants can choose from the following picklist endpoint conclusions:

Adverse effect observed
No adverse effect observed
No study available

If an adverse effect is observed, data can be provided as LD 50 or discriminating dose, displayed here in milligrams per kilogram bodyweight.

Dermal route provides substance information on the substance’s acute toxicity via the dermal route. Registrants can choose from the following picklist endpoint conclusions:

Adverse effect observed
No adverse effect observed
No study available

If an adverse effect is observed, data can be provided as LD 50 or discriminating dose, displayed here in milligrams per kilogram bodyweight.

Inhalation route provides substance information on the substance’s acute toxicity via the inhalation route. Registrants can choose from the following picklist endpoint conclusions:

Adverse effect observed
No adverse effect observed
No study available

If an adverse effect is observed, data can be provided as LD 50 or discriminating concentration, displayed here in milligram per cubic metre.

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

oral

5 studies submitted
2 studies processed

P/RResults: approx. LD50 2 000 mg/kg bw (rat) [2]
M/CInterpretations of results: Not classified [2]

Type of Study provided

oral

Studies with data
Key study	2
Supporting study
Weight of evidence
Other		3

Data waiving
no waivers

inhalation

0 studies submitted
0 studies processed

No data available

inhalation

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

dermal

2 studies submitted
0 studies processed

No automatically processable data submitted

dermal

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

other routes

0 studies submitted
0 studies processed

No data available

other routes

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Irritation / corrosion

Study results

Study data: skin

4 studies submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Study data: skin

Studies with data
Key study	2
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Study data: eye

4 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: eye

Studies with data
Key study	2
Supporting study
Weight of evidence
Other		2

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Sensitisation

Study results

Study data: skin

4 studies submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Study data: skin

Studies with data
Key study	1
Supporting study	1
Weight of evidence
Other		2

Data waiving
no waivers

Study data: respiratory

0 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: respiratory

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Repeated dose toxicity

This section displays the values related to repeated dose toxicity from all registered dossiers for the substance.

Study results oral

Processable data for study results is prioritised by dose descriptor type (see list below) and subsequently further prioritised by the test species. Thirdly the display of data is prioritised by units.

The availability of additional data beyond the five results displayed is indicated by (…).

Prioritization by dose descriptor type:

NOAEL
LOAEL
NOEL
LOEL
BMD05
BMDL05
BMDL10
BMC05
BMCL05
BMCL10
no NOAEL identified

Note: Registrants can also select ‘BMD’, ‘BMC’, ‘dose level’ and ‘conc. level’ as the dose descriptor. If so, the data provided is not processed for the Brief Profile.

Prioritisation by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Prioritisation by units:

mg/kg bw/day (nominal/actual dose received)
mg/kg diet
mg/L drinking water
mg/kg bw (total dose)
ppm

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Study results inhalation

Displayed are the RANGES of min – max of the PRIORITISED value(s) within the five highest priority groupings of provided data. Data is generally displayed in milligram per litre air.

The availability of additional data beyond the five results displayed is indicated by (…).

Prioritization by dose descriptor type:

NOAEL
LOAEL
NOEL
LOEL
NOAEC
NOEC
LOAEC
LOEC
BMD05
BMDL05
BMDL10
BMC05
BMCL05
BMCL10
no NOAEL identified
no NOAEC identified

Note: Registrants can also select ‘BMD’, ‘BMC’, ‘dose level’ and ‘conc. level’ as the dose descriptor. If so, the data provided is not processed for the Brief Profile.
Prioritization by test species:

See ‘Study results oral: Prioritization by test species’

Prioritisation by unit:

mg/L air (combining mg/L air, mg/L air (nominal), mg/L air (analytical), mg/m³ air, mg/m³ air (nominal), mg/m³ air (analytical))
ppm (combine ppm, ppm (nominal), ppm (analytical), mg/kg bw/day (actual dose received)

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Study results dermal

See ‘Study results Oral’, except:

Prioritisation by unit:

mg/kg bw/day (combining mg/kg bw/day (nominal), mg/kg bw/day (actual dose received) and mg/kg bw/day)
mg/kg bw (total dose)
mg/cm² per day (combining mg/cm² per day, mg/cm² per day (nominal), mg/cm² per day (analytical))

Note: Registrants can also select ‘other’ as the test species, dose descriptor type and/or the unit of measure. If so, the data provided is not processed for the Brief Profile.

Summary oral – systemic effects

Processable data for the summary is prioritised by test species (see list below) and subsequently further prioritised by the dose descriptor. Displayed is the most conservative of the prioritised value(s). If more than one result with the same value, data is further prioritised by test type and endpoint conclusion.

Data is generally displayed in milligrams per kilogram bodyweight per day.

Prioritization by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Prioritisation by descriptor type:

NOAEL
LOAEL
T25
BMDL05
BMD05
BMDL10

Prioritisation by test type:

Chronic
Subchronic
Subacute

Prioritisation by endpoint conclusion:

Adverse effect observed
No adverse effect observed
No study available / no study available (further information necessary)

Summary dermal - systemic effects

See ‘Summary oral systemic effects’

Summary dermal - local effects

See ‘Summary oral systemic effects’, except:

Unit of measure: mg/cm2

Summary inhalation - systemic effects

See ‘Summary oral Route’, except:

Unit of measure: mg/m3

Prioritisation by dose descriptor type:

NOAEC
LOAEC
BMCL05
BMC05
BMCL10
T25

Summary inhalation - local effects

‘See Summary inhalation systemic effects’

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

Study data: oral

2 studies submitted
0 studies processed

No automatically processable data submitted

Type of Study provided

Study data: oral

Studies with data
Key study
Supporting study
Weight of evidence
Other				2

Data waiving
no waivers

Study data: inhalation

0 studies submitted
0 studies processed

No data available

Study data: inhalation

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Study data: dermal

0 studies submitted
0 studies processed

No data available

Study data: dermal

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Genetic toxicity

Study results

Study data: in vitro

8 studies submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Study data: in vitro

Studies with data
Key study	1
Supporting study
Weight of evidence
Other		7

Data waiving
no waivers

Study data: in vivo

0 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: in vivo

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

This section displays the values related to reproductive toxicity from all registered dossiers for the substance.

Study results

Study results are not processed for carcinogenicity in the context of Brief Profiles due to the use of complex field(s) to report the information, which cannot be easily summarised by an automatic algorithm.

Summary effect on fertility oral route

Processable data for study results is prioritised by test species (see list below) and subsequently further prioritised by the dose descriptor. Displayed is the most conservative of the prioritised value(s). If there is more than one result with the same value, data is further prioritised by test type and endpoint conclusion.

Data is generally displayed in milligrams per kilogram bodyweight per day.
Prioritization by test species:

Rat
Mouse
Dog
Cat
Cattle
Gerbil
Guinea pig
Hamster (combine hamster, Armenian; hamster, Chinese and hamster, Syrian)
Hen
Miniature swine
Monkey
Pig
Primate
Rabbit
Sheep

Note: Registrants can also select ‘other’ as the test species. If so, the data provided is not processed for the Brief Profile.

Prioritisation by descriptor type:

NOAEL
LOAEL
T25
BMDL05
BMD05
BMDL10

Prioritisation by test type:

Chronic
Subchronic
Subacute

Prioritisation by endpoint conclusion:

Adverse effect observed
No adverse effect observed
No study available / no study available (further information necessary)

Summary effect on fertility dermal route

See ‘Summary effect on fertility oral route’

Summary effect on fertility inhalation route

See ‘Summary effect on fertility oral route’, except:

Dose descriptor prioritization:

NOAEC
LOAEC
BMCL01
BMC05
BMCL10

Measurement units: mg/m3

Summary developmental toxicity oral route

See ‘Summary effect on fertility oral route’

Summary developmental toxicity dermal route

See ‘Summary effect on fertility oral route’

Summary developmental toxicity inhalation route

See ‘Summary effect on fertility oral route’, except:

Dose descriptor prioritization:

NOAEC
LOAEC
BMCL01
BMC05
BMCL10

Measurement units: mg/m3

Type of study provided

This section provides an overview of the type of study records behind the presented results and – if applicable - data waving justifications.

Study results

Study data: reproduction

1 study submitted
0 studies processed

Study data not processed for brief profile

Type of Study provided

Study data: reproduction

Studies with data
Key study
Supporting study
Weight of evidence
Other				1

Data waiving
no waivers

Study data: developmental

0 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: developmental

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Study data: other studies

0 studies submitted
0 studies processed

Study data not processed for brief profile

Study data: other studies

Studies with data
Key study
Supporting study
Weight of evidence
Other

Data waiving
no waivers

Summaries

0 summaries submitted
0 summaries processed

No data available

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant

The brief profile is based on non-confidential data contained in ECHA’s databases at the time of generation. Please be aware that as additional data is submitted to ECHA, the brief profile will also be updated to reflect the new situation. All data remain the property of its respective owners.
Note that the brief profile is an automatically generated summary and that not all available data may be displayed. The content is subject to change without prior notice. The information has not been reviewed or verified by ECHA or any other authority. The Agency thus cannot guarantee the correctness of the information displayed. The identification of applicable legislative frameworks is done automatically and without manual verification. Therefore this does not constitute official and legally binding information. To confirm if a substance is covered by a specific legislative framework the official publication should be consulted.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take any responsibility whatsoever for any copyright or other infringements that may be caused by using the information. This brief profile is covered by the ECHA Legal Notice.

Brief Profile

Brief Profile

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Diss Brief Profile

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

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Excluded endpoints

Substance Description

Substance identity

EC (European Community) name/number

IUPAC name/number

CAS (Chemical Abstract Service) registry number

Index number

Molecular formula

SMILES

InChI

Molecular structure

Type of substance

Origin

Registered compositions (additives and impurities)

Substance listed

Hazard classification & labelling

Please note:

Harmonised classification and labelling (CLH)

Classification and labelling under REACH

Notifications under the Classification, Labelling and Packaging (CLP) Regulation

Breakdown of all 11 C&L notifications submitted to ECHA

Properties of concern

Regulatory context

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)

Registration

Evaluation

Authorisation

Restriction

Persistent Organic Pollutants Regulation (POPs)

Classification Labelling & Packaging (CLP)

Biocidal Products Regulation (BPR)

Prior Informed Consent (PIC)

European Union Observatory for Nanomaterials (EUON)

About this substance

Prevention statements

Disposal statements

Registrants/suppliers

Substance names and other identifiers

Scientific properties

Physical and chemical properties

Appearance/physical state / colour

Study results

Summary

Study results

Type of Study provided

Summaries

Melting/freezing point

Study results

Type of study provided

Study results

Type of Study provided

Summaries

Boiling point

Study results

Summary

Type of study provided

Study results

Type of Study provided

Summaries

Density

Study results

Summary

Type of study provided

Study results

Type of Study provided

Summaries

Vapour pressure

Study results

Summary