Fact sheet glossary for LSPC
In the fact sheets for substances on the OSPAR List of Substances of Possible Concern, available information is compiled on e.g. intrinsic properties, exposure, legislation.
Experimental data have been collected from the Nordic Substance Database (NSDB), in which data from many different sources (e.g. IUCLID (International Uniform Chemical Information Database), AQUIRE (Aquatic Toxicity Information Retrieval), scientific literature, etc.) have been included. Additional data have also been provided by industry and other NGOs (non-governmental organisations).
Estimated data by QSAR (Quantitative Structure Activity Relationships) determination have been collected from databases in Denmark and the Netherlands.
Section 1: Identification
The identification of the substance is presented by including the Chemical Abstracts Service number (CAS No) and the numbers of the European Inventory of Existing Commercial Chemical Substances or the European List of Notified Chemical Substances (EINECS/ELINCS).
In this section also information on the reason why the respective substance has been initially selected e.g. fulfilment of the PBT-criteria, equivalent level of concern (safety net), or potential for endocrine disrupting properties is given.
Information is also provided on whether the substance has already been selected in the OSPAR List of Chemicals for Priority Action, which Contracting Party acts as a lead country for the preparation of an OSPAR background document for this substance and what the state of progress is in developing these documents.
Sections 2-6: properties
For most of the substances, available experimental and QSAR data are presented in sections 2-6, however the data situation is not exhaustive and not all data sources have been available; therefore, the fact sheets do not claim to be complete.
However, for substances for which a validation of data has been performed (i.e. substances for which an EU risk assessment in the framework of Council Regulation 793/93/EEC has been finalised or is close to finalisation), only validated values are given. This is indicated in the columns "Source/Reference"/"Remarks" as ‘RAR’ (Risk Assessment Report available) together with the indication who is the responsible EU rapporteur country. Other available data, e.g. QSAR data, are not presented in the fact sheets for those substances. For substances, for which Industry has provided data, a reference is made in this column as ‘Industry data’.
With respect to the validated experimental data collected under Council Directive 91/414/EC concerning the placing of plant protection products on the market, not all data could be included due to a lack of accessibility of these data (this data is confidential and not published yet).
As a matter of policy, plausible experimental data have been used for selecting the substance in the List of Substances of Possible Concern rather than QSAR data.
However, where experimental data were not available for a particular end point for either P, B or T, then appropriate QSAR estimations have been used as a basis for including a substance into the list.
The data points and values leading to the inclusion in the List of Substances of Possible Concern are highlighted in yellow in the fact sheet.
1. Explanation to the different columns in the fact sheets
describes the parameters and the units used for values given in the column "Value";
gives the parameter value in standardised unit for the parameter (i.e. mg/l for aquatic toxicity, % degradation for biodegradation, etc.);
identifies the sources and or the reference from which the values have been selected. Where no original reference has been identified, a reference to the respective source is given. In most cases the source was the EU database IUCLID or a national database of a Contracting Party;
includes additional information, e.g. conclusions or judgements related to the parameter values reported.
2. Basis for experimental data
The basis for experimental data in the fact sheets are laboratory test results which were mainly obtained from the Nordic Substance Database (NSDB), in particular for the intrinsic properties ‘biodegradation’, ‘aquatic toxicity (acute and chronic)’, ‘mammalian toxicity (acute and chronic)’ and ‘liability to bioaccumulate’.
Ready biodegradation refers to the property of a substance which reaches the required pass levels of 60% carbon dioxide evolution or oxygen demand, or 70 % dissolved organic carbon removal within 28 days in standard biodegradation tests. Inherent biodegradation refers to test conditions which are designed to promote biodegradation.
The liability to bioaccumulate can be deduced either from the logKow value (logarithm of the octanol-water partitioning coefficient) or from the BCF value (bioconcentration factor giving the distribution of the substances between the tissue and the surrounding water).
Aquatic toxicity values are expressed either as acute effect or lethal concentrations, (EC/LC50 values indicate concentrations of a substance which causes 50% mortality in test organisms (or otherwise affected)) or as chronic concentrations (NOEC stands for No Observed Effect Concentration).
Detailed descriptions of these properties and how their determination is carried out can be found at http://esis.jrc.ec.europa.eu/ in the Technical Guidance Document on risk assessment for new notified substances and for existing substances (TGD).
3. Basis for modelled data
QSAR data are available for most of the substances on the list of possible concern. More than half of the substances of possible concern were initially selected on the basis of QSAR-data. The QSAR data are mainly provided by the Danish EPAs’ QSAR database. In most cases estimates were made by commercially available QSAR-models, however, a few models have been developed by the Danish EPA. Many of the estimates have been calculated by using the Estimations Programs Interface for Windows (EPIWIN). Detailed descriptions can be found at www.syrres.com.
Biodegradation (subsection 3.6)
For the estimation of the biodegradation probability, specific subprograms from the EPIWIN package have been used. The Biodegradation Probability Program (BIOWIN) estimates the probability for the rapid aerobic biodegradation of an organic chemical in the presence of mixed populations of environmental micro-organisms. BIOWIN 1 refers to a linear model, that indicates if a substance is not rapidly biodegradable in terms of a probability score. BIOWIN 3 is developed using data from specific test systems (MITI-test for ready biodegradability). A substance is readily biodegradable if it biodegrades within the time of the test (usually 28 days). BIOWIN 3 provides for estimates for the time required to achieve primary and ultimate biodegradation, and refers to an expert survey model, that indicates the time scale for ultimate biodegradation e.g. in weeks or months. A substance is considered
Readily biodegradable if :
BIOWIN 1 > 0.5
Not readily biodegradable if :
BIOWIN 1 < 0.5
Not inherently biodegradable if :
BIOWIN 1 < 0.15 and BIOWIN 3 < 2.2
Furthermore, estimates based on the ‘H. Loonen’s Simca Fragment linear and non-linear model’ are given (Syracuse Corp. version). Estimates < 0.5 indicate that a substance is not readily biodegradable.
Ecotoxicity (subsection 5.6)
In the initial selection, a fish NOEC (No Observed Effect Concentration) is given, calculated as the lethal body burden NOEC, based on the EPIWIN bioconcentration estimate (BCFWIN) and assuming a ratio of 10 between the acute toxicity result and the chronic test result (A:C = 10:1). Two new multicase models to determine the acute toxicity developed by the Danish EPA have also been used: a EC50 acute toxicity model for Daphnia, and a LC50 acute toxicity model for fish (fathead minnow).
Mammalian toxicity (subsection 6)
Mammalian toxicity endpoints have been calculated using the model TOPKAT 5.0 (the quantitative structure toxicity relationships (QSTRs) model approach). However, for the endpoints ‘reprotoxicity’ and ‘chronic toxicity’, the Danish EPA QSAR database contains selected test results. In the factsheet, a ‘+’ denotes a positive indication, which is further qualified by ‘C’ if calculated, or ‘T’ if based on test results.
In general, for information related to QSAR-data, the contact person at the Danish EPA is: Henrik Søren Larsen (e-mail address:email@example.com).
4. Explanation/comments to the different lines in the fact sheet:
indicates whether the substance is selected on the basis of experimental data (NSDB), modelled data (QSAR) or via the safety net. The number in parentheses shows which selection category developed in the DYNAMEC Mechanism applies to the substance as indicated in the table given below. The different cut-off values for P, B and T in these selection categories indicate a certain differentiation of the intrinsic properties and provide an indication of the likely degree of concern. The Selection Category V criteria (similar to the international harmonised classification system for substances hazardous to health or the environment) was the basic screen with the least stringent PBT values used for selecting a substance, and all the substances on the list meet Selection Category V. Selection Category I resembles the characterisation criteria for POP-like substances;
Following the selection of substances using the above criteria, OSPAR subsequently refined the persistency criteria to a half life of 50 days, with alternatives if half-life data is not available and several substances were subsequently de-selected from the list on this basis. These revised criteria will be used in any future iteration of the list.
Safety net: if the data indicate that the PBT criteria are not fulfilled, or if they are not available, the substance was included in the List of Substances of Possible Concern based on information giving rise to an equivalent level of concern;
BM (biomagnification): the substance is included in the list due to its ability to accumulate through the food chain;
ED (endocrine disruption): the substance is considered to be a potential endocrine disruptor. As no criteria for identifying endocrine disruptors have been developed so far, all potential endocrine disruptors on the OSPAR List of Candidate Substances (part A and B) in the 1998 OSPAR Strategy with regard to Hazardous Substances, were consequently included in the List of Substances of Possible Concern;
gives information on the market volume range at EU level (IUCLID, or Information from Risk Assessment Report, or additional information provided by industry) or for the Nordic markets (NPR). A high production volume chemical (HPVC) is defined as a chemical being produced or imported in quantity of at least 1000 tonnes per year in EU by at least one Industry. A low production volume chemical (LPVC) is a chemical which has been produced or imported in EU with a tonnage >10t/y but never more than 1000 t/y;
gives information on the main use of the substance, based on the same kind of sources as in line 7.1;
gives information on the use of the substance in articles;
Line 7.4 and 7.5:
gives information on representative environmental concentrations (monitored or modelled) at EU level;
gives information on whether the substance is included in Annex I to Council Directive 67/548/EEC on classification and labelling of dangerous substances. The figures given refer to the Risk-phrases assigned to the substance according to this Directive. The full explanation of the Risk-phrases can be found at: http://esis.jrc.ec.europa.eu/;
gives information on whether the substance is covered by the risk assessment programme under Council Regulation 793/93/EEC. Status for the work on the substance can be found at http://esis.jrc.ec.europa.eu/;
gives information on whether the substance is included in the list of priority substances under European Parliament and Council Directive 2000/60/EEC establishing a framework for Community action in the field of water policy. At present water quality standards and emission controls for these substances are under preparation;
gives information on whether the substance is included in Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and products;
gives information on whether the substance is included in the Annex to Council Directive 76/464/EEC on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community;
gives information on whether the substance is included in Annex I to Council Directive 94/414/EEC concerning placing of plant protection products on the market;
gives information on whether the substance is included in Council Directive 98/8/EEC on biocides(http://esis.jrc.ec.europa.eu/);
gives information on whether the substance is included in the program on hazard assessment for high production volume chemicals under OECD (http://www.oecd.org);
gives information on whether the substance is included in other possible risk assessment programmes.
 The NSDB was distributed by the Nordic Countries as a CD-ROM to the OSPAR Contracting Parties in March 2000. It is available from the Nordic Council of Ministers and can be downloaded from their website: www.norden.org. If you need further information on, and access to, the database, the contact person at the Swedish Chemicals Inspectorate is: Mr Bert-Ove Lund (e-mail address: Bert_Ove.Lund@kemi.se).
 PBT: hazardous intrinsic properties of persistence, liability to bioaccumulate and toxicity
 Substances inducing changes in the hormonal system causing adverse health effects in an organism or its progeny
 See Briefing Document on the work of DYNAMEC and the Dynamic Mechanism for the Selection and Prioritisation of Hazardous Substances (published on the OSPAR website in 2000 under "publications")
 Carcinogenic, mutagenic or reprotoxic substances
 Cut-off Values for the Selection Criteria of the OSPAR Dynamic Selection and Prioritisation Mechanism for Hazardous Substances (Reference number: 2005-9; published on the OSPAR website under "measures")