SDS Section 12 (Tab "12 Ecological")
Quick start
Describe the effects of the product if released into the environment: its toxicity, its ability to accumulate and to degrade, and its ability to move through soil.
· None of the entry areas for this section are required by US-OSHA. However, completion is required for the EU/EEA, GB[1], and potentially other jurisdictions. Completion is highly recommended to ensure that the product is used in an environmentally responsible manner.
· Ensure that any environmental hazards listed on Tab "2 Hazards" (e.g., "Aquatic Acute 1", "Aquatic Chronic 2") also appear in suitable locations on this tab.
· Briefly summarize the available test data, including affected species, exposure levels, and other test conditions.
· List ecological information on the product, where available. If product information is unavailable, include available information on the components.
· Some data may be available by clicking on the Paste [t]oxicity items button, which will display a Toxicity items dialog. The dialog displays toxicity items from the Substances section of the program for the SDS components and (where available) the product itself.[2]
· The information here must be consistent with EU REACH registration material (UK REACH for GB SDSs), the Chemical Safety Report (if required[3]), and the GHS classifications for the product.
· For EU/EEA and GB safety data sheets:
o Provide bioaccumulation, persistence, and degradability information for each relevant substance in a product; and for by-products (hazardous transformation products) from degradation.
o Indicate if a particular property does not apply, is not available, is technically impossible to obtain, or if the results are inconclusive.
· For general guidance, refer to the Managing help box, below.
Toxicity (EU/EEA, GB required)
Provide acute and chronic toxicity information from tests performed on aquatic and/or terrestrial organisms, including (where available):
· Fish and crustaceans;
· Algae and other aquatic plants;
· Soil microorganisms;
· Environmentally relevant organisms, such as birds, bees, and plants.
If the product has an inhibitory effect on microorganism activity, discuss the possible impact on sewage treatment plants.
Persistence and degradability (EU/EEA, GB required)
Indicate the potential for the product and/or its components to degrade in the environment, through biodegradation or other processes, such as oxidation or hydrolysis. Provide test data if available.
For half-life data, indicate if the degradation results from conversion in soil to soluble inorganic compounds (mineralization). Identify products and/or components designated at "readily biodegradable".
Bioaccumulative potential (EU/EEA, GB required)
For individual components of the product, indicate the potential to accumulate in biological organisms, and to pass through the food chain. Include the octanol-water partition coefficient (Kow) and bioconcentration factors (BCFs) for the components, where available.
Mobility in soil (EU/EEA, GB required)
For individual components of the product, indicate the potential to move into the groundwater, or to move away from the site of release by other means. Evaluate the potential for mobility using (where available):
· Adsorption and/or leaching studies;
· Soil organic carbon – water partitioning coefficients (Koc);
· Surface tension;
· Known or predicted distributions to air, water, sediments, and other media ("environmental compartments").
Results of PBT and vPvB assessment (EU/EEA, GB required)
PBT refers to substances that are persistent, bioaccumulative, and toxic, and vPvB refers to substances that are very persistent and very bioaccumulative.
For the EU/EEA and GB, a PBT and vPvB assessment is part of the Chemical Safety Report. Where a Chemical Safety Report is required, this SDS entry area should indicate whether the product itself or any of its components is/are PBT or vPvB chemicals. Example statements might be:
“This mixture does not contain any substances that are assessed to be a PBT or a vPvB.”; or
"This product does not contain any substances classified as PBT or vPvB."
If the product or any of its constituents meets the PBT threshold, briefly summarize the rationale for the PBT designation.
The EPA presently identifies 16 chemicals considered to be PBT under the Toxics Release Inventory (TRI) Program.[4] However, US-OSHA guidance does not specify PBT and vPvB assessment as an area to be included on the SDS.
Endocrine disrupting properties (EU/EEA required)
Where applicable, briefly summarize the adverse effects on the environment due to the endocrine disrupting properties of the product and/or its components.
The EU provides criteria for evaluating endocrine disrupting properties in regulations (EU) 2017/2100 and (EU) 2018/605.
For substances with no endocrine disrupting properties that have the potential for affecting the environment, the EU recommends a brief statement similar to:
"This substance does not have endocrine disrupting properties with respect to non-target organisms as it does not meet the criteria set out in section B of Regulation (EU) No 2017/2100." [5]
Other adverse effects (EU/EEA, GB required)
For the product and/or individual components, identify where appropriate:
· Environmental fate;
· Ozone creation or depletion potential;
· Endocrine disruption potential;
· Global warming potential.
Distinguish clearly between information related to components and to the product as a whole.
Water hazard class (WGK, UBA-Germany) (may be required in Germany)
Use the methodology in Appendix 1 of the German Ordinance on Facilities Handling Substances that are Hazardous to Water (AwSV) to select a water hazard classification (WGK) for the SDS product. This classification represents a level of hazard posed by the product if released into environmental waters.
You can click on the blue “Suggest” text link to perform and then display the program’s analysis and suggested classification for the product, in a dialog. (This is a preliminary feature.)
Results of a water hazard class (WGK) determination for the SDS product.
After you dismiss the dialog, the program places the suggested WGK class into the field immediately to the right of the blue “Suggest” text link. However, you can manually enter other values.
The analysis from the dialog will go into the Rationale field, further to the right (click on the magnifying glass icon to re-read the information).
NOTES:
1. The WGK class appears on this tab because it is an ecological parameter. To appear on the generated SDS, however, it must be listed in the Regulations table, in Section 15 (Regulatory information). If the program is successful in determining a suggested WGK class, it will offer to add or update a WGK class entry in the Regulations table, after you dismiss the “Suggest” dialog.
You can also add the program’s suggested WGK class directly into the Regulations table, using the Add button next to the table.
Water hazard class (WGK) for the SDS product, as entered into the Regulations table, on tab “15.1 Regulatory”.
2. An accurate WGK determination for an SDS product that is a mixture depends on having agency-prescribed WGK classifications for the individual components, on the “Ecological” tab of the respective Substance records’ entry forms.
For Substance records lacking a prescribed WGK value, you can click on the blue “Calculate class” text link (“Ecological” tab of the Substance entry form) to have the program estimate the WGK value. The methodology for this estimate is also from AwSV Appendix 1.
Determination of water hazard class (WGK) for a component, on the “Ecological” tab of the Substance entry form.
Next steps
Next, click on the “13 Disposal” tab.
Managing help
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· When automatic help is off, you can display or refresh this help window manually, by using the [Ctrl]-9 shortcut (“Background for this section”).[6]
· To get an overview:
o Take the Brief tour on how the SDS entry form works:
§ Entering SDS content
§ Navigating the form
§ Shortcuts and convenience features
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§ To start the tour, click on the Help button and select “Brief tour”.
o Watch the video on this tab (click on the Video button, if the label is in blue text).
o Navigate to Tab "1 Identification" and view or refresh the background help. Read the section, “Features common to most SDS form sections/tabs”.
· For brief tips, hover with your mouse over the object of interest.
· To get assistance on a particular field: Click into the field, then click on the Help button, and select “Guide this item” (shortcut: [Ctrl]-5).
· To get stepwise assistance for all areas on this tab: Click on the Help button and select “Guide this section” (shortcut: [Ctrl]-6).
· To learn additional details and requirements, including guidance from regulatory agencies (US-OSHA, UN, EU, and Health Canada), read the details section, starting immediately below.
SDS Section 12 (Tab "12 Ecological") — details
Contents
A4.3.12 SECTION 12: Ecological information
A4.3.12.6 Persistence and degradability
A4.3.12.7 Bioaccumulative potential
A4.3.12.9 Other adverse effects
SECTION 12: Ecological information
12.2 Persistence and degradability
12.3 Bioaccumulative potential
12.5 Results of PBT and vPvB assessment
12.6 Endocrine disrupting properties
Item 12: Ecological Information (header required; content optional):
I. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”, https://www.osha.gov/Publications/OSHA3514.html. NOTE: This section is optional under OSHA requirements.
This section provides information to evaluate the environmental impact of the chemical(s) if it were released to the environment. The information may include:
· Data from toxicity tests performed on aquatic and/or terrestrial organisms, where available (e.g., acute or chronic aquatic toxicity data for fish, algae, crustaceans, and other plants; toxicity data on birds, bees, plants).
· Whether there is a potential for the chemical to persist and degrade in the environment either through biodegradation or other processes, such as oxidation or hydrolysis.
· Results of tests of bioaccumulation potential, making reference to the octanol-water partition coefficient (Kow) and the bioconcentration factor (BCF), where available.
· The potential for a substance to move from the soil to the groundwater (indicate results from adsorption studies or leaching studies).
· Other adverse effects (e.g., environmental fate, ozone layer depletion potential, photochemical ozone creation potential, endocrine disrupting potential, and/or global warming potential).
II. UN guidance
From "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", 7th Ed., by Secretariat, United Nations Economic Commission for Europe (UNECE). ©2017, United Nations. Reprinted with the permission of the United Nations.
A4.3.12 SECTION 12: Ecological information
A4.3.12.1 The information that shall be provided in this section is to enable evaluation of the environmental impact of the substance or mixture if it were released to the environment. This information can assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measures, and transport.
A4.3.12.2 A concise but complete and comprehensible description of the various ecotoxicological (environment) properties, and the available data used to identify those properties, should be provided. The basic properties, for which data should be provided, are:
(a) Toxicity;
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects.
These properties should always be listed on the SDS. Species, media, units, test duration and test conditions should be clearly indicated. (If data for any of these properties are not available, they should still be listed on the SDS with a statement that data are not available).
A4.3.12.3 Some ecotoxicological properties are substance specific, i.e. bioaccumulation, persistence and degradability. The information should therefore be given, where available and appropriate, for each relevant ingredient of the mixture (i.e. those which are required to be listed in Section 3 of the SDS).
A4.3.12.4 Provide also a short summary of the data given under A4.3.12.5 to A4.3.12.9 in relation to the hazard classification criteria. Where data are not available for classification, this should be clearly stated on the SDS for each basic property concerned. Additionally, if data are available showing that the substance or mixture does not meet the criteria for classification, it should be stated on the SDS that the substance or mixture has been evaluated and, based on available data, does not meet the classification criteria. Additionally, if a substance or mixture is found to be not classified for other reasons, for example, due to technical impossibility to obtain the data, or inconclusive data, this should be clearly stated on the SDS.
A4.3.12.5 Toxicity
Information on toxicity can be provided using data from tests performed on aquatic and/or terrestrial organisms. This should include relevant available data on both acute and chronic aquatic toxicity for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on other organisms (including soil micro-and macro-organisms) such as birds, bees and plants, should be included when available. Where the substance or mixture has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants should be mentioned.
A4.3.12.6 Persistence and degradability
Persistence and degradability is the potential for the substance or the appropriate constituents of a mixture to degrade in the environment, either through biodegradation or other processes, such as oxidation or hydrolysis. Test results relevant to assess persistence and degradability should be given where available. If degradation half-lives are quoted it must be indicated whether these half-lives refer to mineralization or to primary degradation. The potential of the substance or certain constituents (see also A4.3.12.8) of a mixture to degrade in sewage treatment plants should also be mentioned.
A4.3.12.7 Bioaccumulative potential
Bioaccumulation is the potential for the substance or certain constituents of a mixture to accumulate in biota and, possibly, pass through the food chain. Test results relevant to assess the bioaccumulative potential should be given. This should include reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), if available.
A4.3.12.8 Mobility in soil
Mobility in soil is the potential of a substance or the constituents of a mixture, if released to the environment, to move under natural forces to the groundwater or to a distance from the site of release. The potential for mobility in soil should be given where available. Information on mobility can be determined from relevant mobility data such as adsorption studies or leaching studies. For example, Koc values can be predicted from octanol/water partition coefficients (Kow). Leaching and mobility can be predicted from models..
NOTE: Where real data on the substance or mixture is available this data will take precedence over models and predictions.
A4.3.12.9 Other adverse effects
Information on any other adverse effects to the environment should be included where available, such as environmental fate (exposure), ozone depletion potential, photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.
III. European Union guidance
From: "COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)". Official Journal of the European Union, 26.6.2020.
SECTION 12: Ecological information
This section of the safety data sheet shall provide information to enable evaluation of the environmental impact of the substance or mixture where it is released to the environment. Subsections 12.1 to 12.7 of the safety data sheet shall provide a short summary of the data including, where available, relevant test data and clearly indicating species, media, units, test duration and test conditions. This information may assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measures and transport. If it is stated that a particular property does not apply (because the available data shows that the substance or mixture does not meet the criteria for classification) or if information on a particular property is not available, the reasons shall be indicated. Additionally, if a substance or mixture is not classified for other reasons (for example, due to the technical impossibility of obtaining the data or to inconclusive data) this should be clearly stated on the safety data sheet.
Some properties are substance specific, i.e. bioaccumulation, persistence and degradability, and that information shall be given, where available and appropriate, for each relevant substance in the mixture (i.e. those which are required to be listed in section 3 of the safety data sheet and are hazardous to the environment or PBT/vPvB – substances). Information shall also be provided for hazardous transformation products arising from the degradation of substances and mixtures.
The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.
Where reliable and relevant experimental data are available, that data shall be provided and take precedence over information obtained from models.
12.1 Toxicity
Information on toxicity using data from tests performed on aquatic and/or terrestrial organisms shall be provided when available. This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on soil micro- and macroorganisms and other environmentally relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or mixture has inhibitory effects on the activity of microorganisms, the possible impact on sewage treatment plants shall be mentioned.
Where experimental data are not available, the supplier shall consider whether reliable and relevant information obtained from models can be provided.
For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be included..
12.2 Persistence and degradability
Degradability is the potential for the substance or the appropriate substances in a mixture to degrade in the environment, either through biodegradation or other processes, such as oxidation or hydrolysis. Persistence is the lack of demonstration of degradation in the situations defined in Sections 1.1.1 and 1.2.1 of Annex XIII. Test results relevant to assess persistence and degradability shall be given where available. If degradation half- lives are quoted it must be indicated whether these half-lives refer to mineralisation or to primary degradation. The potential of the substance or certain substances in a mixture to degrade in sewage treatment plants shall also be mentioned.
Where experimental data are not available, the supplier shall consider whether reliable and relevant information obtained from models can be provided.
This information shall be given where available and appropriate, for each individual substance in the mixture, which is required to be listed in section 3 of the safety data sheet.
12.3 Bioaccumulative potential
Bioaccumulative potential is the potential of the substance or certain substances in a mixture to accumulate in biota and, eventually, to pass through the food chain. Test results relevant to assess the bioaccumulative potential shall be given. This shall include reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), or other relevant parameters related to bioaccumulation, if available.
Where experimental data are not available, it shall be considered whether model predictions can be provided.
This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in section 3 of the safety data sheet.
12.4 Mobility in soil
Mobility in soil is the potential of the substance or the components of a mixture, if released to the environment, to move under natural forces to the groundwater or to a distance from the site of release. The potential for mobility in soil shall be given where available. Information on mobility in soil can be determined from relevant mobility data such as adsorption studies or leaching studies, known or predicted distribution to environmental compartments, or surface tension. For example, soil adsorption coefficient (Koc) values can be predicted from Kow. Leaching and mobility can be predicted from models.
This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in section 3 of the safety data sheet.
12.5 Results of PBT and vPvB assessment
Where a chemical safety report is required, the results of the PBT and vPvB assessment as set out in the chemical safety report shall be given.
12.6 Endocrine disrupting properties
Information on adverse effects on the environment caused by endocrine disrupting properties shall be provided where available, for the substances identified as having endocrine disrupting properties in subsection 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for the environment
12.6 Other adverse effects
Information on any other adverse effects on the environment shall be included where available, such as environmental fate (exposure), photochemical ozone creation potential, ozone depletion potential or global warming potential.
IV. Health Canada guidance
From: "Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations, WHMIS 2015 Supplier Requirements", Cat.: H129-64/1-2016E-PDF. December 2016. ©2016, Her Majesty the Queen in Right of Canada, as represented by the Minister of Health. The acronym "HPR" refers to the Canadian Hazardous Products Regulations.
Item 12: Ecological Information (header required; content optional):
As per subsection 4(2) of the HPR, the content of the specific information elements may be omitted as long as the item number and heading appear on the SDS. Environmental hazards are outside the scope of the HPR. If provided, this section offers information to evaluate the environmental impact of the product if it were released to the environment. The information may include:
· Data from toxicity tests performed on aquatic and/or terrestrial organisms, where available (e.g., acute or chronic aquatic toxicity data for fish, algae, crustaceans, and other plants; toxicity data on birds, bees, plants)
· Whether there is a potential for the product to persist and degrade in the environment either through biodegradation or other processes, such as oxidation or hydrolysis
· Results of tests of bioaccumulation potential, making reference to the octanol-water partition coefficient (Kow) and the bioconcentration factor, where available
· The potential for the product to move from the soil to the groundwater (indicate results from adsorption studies or leaching studies) or to a distance from the site of release
· Other adverse effects (e.g., environmental fate (exposure), ozone layer depletion potential, photochemical ozone creation potential, endocrine disrupting potential, and/or global warming potential)
[rev. 7.9.2024]
[1] Endocrine disrupting properties (entry area) is not presently required for a GB-type SDS.
[2] In the future, you can facilitate SDS completion by adding toxicology and environmental toxicology information for your commonly used ingredients to the Toxicity items dialog.
[3] Required for substances (i.e., products) subject to REACH registration that are produced or imported by individual companies/entities in quantities of 10 metric tons or more per year, with specified exceptions. Refer to Article 14 of Regulation (EC) 1907/2006.
[4] Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA).
[5] "Guidance on the compilation of safety data sheets, Version 4, December 2020". Helsinki: European Chemicals Agency, 2020. Section 3.12 (SDS SECTION 12: Ecological information).
[6] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.