Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) required the Minister of the Environment and the Minister of Health to categorize the approximately 23 000 substances on the Domestic Substances List (DSL) in order to identify the substances that

• are considered to be persistent (P) and/or bioaccumulative (B) under the Persistence and Bioaccumulation Regulations (Canada 2000) and inherently toxic (iT) to humans or other organisms; or
• present the greatest potential for exposure (GPE) to individuals in Canada.

The Act further requires the Minister of the Environment and the Minister of Health to conduct screening assessments of any substances that met the categorization criteria. A screening assessment involves a scientific evaluation of available information for a substance to determine whether the substance meets the definition of toxic set out in section 64 of CEPA 1999. Based on the results of a screening assessment, the Ministers can propose to

• take no further action with respect to the substance;
• add the substance to the Priority Substances List for further assessment; or
• recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of CEPA 1999 and, where applicable, the implementation of virtual elimination of releases to the environment.

Based on the information obtained through the categorization process, the Ministers identified a number of substances as high priorities for action. These included substances that

• met all of the ecological categorization criteria, including persistence, bioaccumulation potential and inherent toxicity to aquatic organisms (PBiT), and were known to be in commerce or to be of commercial interest in Canada; and/or
• met the categorization criteria for GPE or presented an intermediate potential for exposure (IPE) and had been identified as posing a high hazard to human health, based on available evidence on carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity.

Sufficient data are currently available to determine whether these substances meet the definition of toxic under section 64 of CEPA 1999, based on consideration of the ecological and human health concerns associated with these substances, and the requirement under section 76.1 of CEPA 1999 for the Ministers to apply a weight-of-evidence approach and the precautionary principle when conducting a screening assessment and interpreting its results.

The Ministers therefore published a notice of intent in the Canada Gazette, Part I, on December 9, 2006 (Canada 2006a) that challenges industry and other interested stakeholders to submit specific information that may be used to inform risk assessment and to develop and benchmark best practices for risk management and product stewardship, and to submit the information within the timelines referred to in “The Challenge” section of this document.

Resin acids and Rosin acids, hydrogenated, esters with glycerol has been identified as a high priority for action as it was found to be persistent, bioaccumulative and inherently toxic to aquatic organisms and is believed to be in commerce in Canada. The technical human health and ecological information that formed the basis for concern regarding this substance is presented in this document.

The Challenge

Respecting direction under section 76.1 of CEPA 1999, and in the absence of additional relevant information as a result of this Challenge, the Ministers are predisposed to conclude, based on a screening assessment, that this substance satisfies the definition of toxic under section 64 of CEPA 1999. As such, the Ministers are prepared to then recommend to the Governor in Council that this substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999, with the intent of initiating the development of risk management measures taking into account socio-economic considerations. If an act other than CEPA 1999 may be more appropriately used to control this substance, then the Ministers may recommend that this substance not be added to the List of Toxic Substances in Schedule 1 of CEPA 1999.

If it is determined that this substance meets the virtual elimination (VE) criteria in subsection 77(4) of CEPA 1999, then subsequent risk management activities will be based on the objective of eliminating the release of any measurable quantity of the substance to the environment.

In the absence of further information on existing management practices for a substance that meets the VE criteria, actions will be proposed based on the assumption of worst-case practices. The management actions being considered for this substance at this time include prohibition, through regulations, of the manufacture, use, sale, offer for sale and import of this substance, except for those activities controlled under the Pest Control Products Act (Canada 2002) or the Food and Drugs Act (Canada 1985).

Exceptionally, should no information be identified to indicate that this substance is in commerce in Canada, the Ministers may conclude, based on a screening assessment, that this substance does not satisfy the definition of “toxic” under section 64 of CEPA 1999 (except for substances for which it is concluded that there is some probability of harm at any level of exposure). However, given its properties, the concern remains that new activities for this substance that have not yet been identified or assessed under CEPA 1999 could nevertheless lead to it meeting the criteria set out in section 64 of the Act. Therefore, it would be recommended that this substance be subject to the significant new activity provisions specified under subsection 81(3) of the Act to ensure that any new manufacture, import or use of this substance in quantities greater than 100 kg/year is notified, and that ecological and human health risk assessments are conducted as specified in section 83 of the Act prior to the substance being introduced into Canada.

Section 71 Notice

Under the Challenge, information deemed necessary for improved decision making may be gathered by the Minister of Environment under section 71 of CEPA 1999. This information may be used to assess whether a substance is toxic or is capable of becoming toxic as defined under section 64 of CEPA 1999, or to assess whether to control, or the manner in which to control, a substance.

Among other things, the information mandated through the notices may relate to the quantity of the substance imported, manufactured, used, or released; concentrations; suppliers; customers; and types of uses of the substance.

Copies of the section 71 notice and guidance on how to comply with it are available from the Government of Canada Chemical Substances web site at www.chemicalsubstanceschimiques.gc.ca, or from the contact provided below.

Submission of additional data to inform screening assessment

The Minister of the Environment and the Minister of Health are now inviting the submission of additional information for consideration during the screening assessment of this substance. Data of the types described in the following paragraphs are considered most relevant, although other submitted information will be considered.

Data on persistence, bioaccumulation and toxicity to organisms

Through the categorization exercise required by CEPA 1999, available experimental data on persistence, bioaccumulation and toxicity to organisms were collected up to December 2005. Where acceptable experimental data were not available, quantitative structure activity relationships (QSARs) or read-across data were used to fill the data gaps.

Since experimental data are preferred, interested parties have an opportunity to provide new or additional relevant experimental study information on the persistence, bioaccumulation and potential for toxicity of this substance to organisms in different environmental compartments (air, water, sediment, soil), or on the physical and chemical properties values that were used as input to the QSAR models. Efforts should focus on providing data for the endpoints for which good quality experimental data do not already exist, as demonstrated by the information summarized in the “Ecological Information” and “Physical and Chemical Properties” sections of this document.

As submitted data will be evaluated for completeness and robustness, it is recommended that stakeholders follow the guidance for test protocols and alternative approaches for test data, as described in Section 8 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (Environment Canada 2006b).

Data on the substance’s toxicity to human health

Through the categorization exercise, the high health priorities for action were those substances identified by the Simple Hazard tool, which identified a potential high health hazard on the basis of classifications for cancer, genotoxicity, reproductive toxicity or developmental toxicity. The hazard classifications used were developed by national or international agencies, in which large numbers of substances have been classified for endpoint-specific hazard based on original review and critical evaluation of data, assessments of weight-of-evidence and extensive peer review. Interested parties have an opportunity to provide new or additional relevant experimental study information on the toxicity of the substance to human health which could inform the screening assessment.

Information submitted in response to the section 71 notice or as additional information on current uses and existing control measures (see section below) will also be considered when characterizing exposure potential.

Responses to this part of the Challenge for this substance should be received at the address provided below by the date indicated on the Government of Canada Chemical Substances web site (www.chemicalsubstanceschimiques.gc.ca).

Submission of additional information on current uses and existing control measures

To inform the risk management approach for this substance, the Minister of the Environment and the Minister of Health are inviting the submission of additional information that is deemed beneficial by interested stakeholders, relating to the extent and nature of the management and stewardship of substances listed under the Challenge.

Organizations that may be interested in submitting additional information in response to this invitation include those that manufacture, import, export or use this substance whether alone, in a mixture, in a product or in a manufactured item.

Additional information is being sought regarding

• import, manufacture and use quantities;
• substance and product use details;
• releases to the environment and spill management;
• current and potential risk management and product stewardship actions;
• existing legislative or regulatory programs controlling/managing the substance; and
• information to support the development of a regulatory impact assessment.

A questionnaire is available which provides a detailed template as an example for the submission of this information. Guidance on how to respond to this questionnaire is also available. Interested stakeholders are invited to provide available additional information, recognizing that not all questions in the questionnaire may be relevant to a particular substance, use or industrial sector.

Copies of the questionnaire and associated guidance are available from the Government of Canada Chemical Substances web site (www.chemicalsubstanceschimiques.gc.ca) or from the contact provided below.

Responses to this part of the Challenge for this substance should be received at the address provided below by the date indicated on the Government of Canada Chemical Substances web site (www.chemicalsubstanceschimiques.gc.ca).

Requests for documents and submission of information

The following contact is to be used to request documents and instructions, and to submit information in response to the Challenge.

DSL Surveys Coordinator
Fontaine Building, 8th Floor
200 Sacré-Cœur Boulevard
Gatineau QC K1A 0H3
Tel.: 1-888-228-0530 / 819-956-9313
Fax: 1-800-410-4314 / 819-953-4936
Email: DSL.surveyco@ec.gc.ca

Substance Identity

For the purposes of this document, resin acids and rosin acids, hydrogenated, esters with glycerol will be referred to as HRGE which has been derived from the inventory name hydrogenated rosin glycerine ester.

Table 1. Substance identity for HRGE

Chemical Abstracts Service Registry Number (CAS RN)	65997-13-9
DSL name	Resin acids and Rosin acids, hydrogenated, esters with glycerol
National Chemical Inventories (NCI) names1	Resin acids and Rosin acids, hydrogenated, esters with glycerol (TSCA, EINECS, AICS, ECL, PICCS, ASIA-PAC, NZIoC) Hydrogenated rosin glycerin ester (ENCS) Resin acids and rosin acids ester of glycerol, hydrogenated (PICCS) Rosin, hydrogenated, glycerol ester (PICCS)
Other names	A 100; Elkan A 120; Ester Gum H; Foral 69; Foral 85; Foral 85E; Foral 85-55WKX; Foralyn 90; Glycerides, rosin, hydrogenated; Glycerol ester of partially hydrogenated wood rosin, Hydrogenated rosin glycerine; Hydrogenated rosin, disproportionated rosin, glycerol ester; KE 100; Pinecrystal KE 311; Resin acids, hydrogenated, esters with glycerol; Rikatac F 85; Rikatac SE 7; Rosin, hydrogenated, ester with glycerol; Staybelite Ester 10; Staybelite Ester 10.55WK; Staybelite Ester 10E; Staybelite Ester 5; Staybelite Ester 5E; Staybelite Ester 5E-JQ; Staybelite Ester 610; Super Ester A 100; Wood rosin, hydrogenated, ester with 1,2,3-propanetriol
Chemical group (DSL Stream)	Biological UVCB2
Major chemical class or use	Resin acids and Rosin acids; Glycerides
Major chemical sub-class	Esters
Chemical formula	Variable
Representative structure used to run the estimation model 2
Representative SMILES2,3 used to run the estimation model	CC12C(CCC3C2CCC(C3)C(C)C)C(C(OCC(CO)O)=O)(CCC1)C
Molecular mass	Variable

¹National Chemical Inventories (NCI). 2007: AICS (Australian Inventory of Chemical Substances); ASIA-PAC (Asia-Pacific Substances Lists); ECL (Korean Existing Chemicals List); EINECS (European Inventory of Existing Commercial Chemical Substances); ENCS (Japanese Existing and New Chemical Substances); PICCS (Philippine Inventory of Chemicals and Chemical Substances); NZIoC (New Zealand Inventory of Chemicals); and TSCA (Toxic Substances Control Act Chemical Substance Inventory).
²This substance is a UVCB (Unknown or Variable Composition, Complex Reaction Products, or Biological Materials); i.e., it is not a discrete chemical and thus may be characterized by a variety of structures. To assist with modelling, the structure and corresponding SMILES presented here were chosen to represent the substance
³Simplified Molecular Input Line Entry System

Physical and Chemical Properties

Table 2 below contains modelled physical-chemical properties of HRGE that are relevant to its environmental fate.

Table 2. Physical and chemical properties for HRGE

¹Values and units in brackets represent those originally reported by the authors or estimated by the models.

Sources and Uses

DSL nomination information (1984–1986)

Quantity in commerce

The quantity reported to be manufactured, imported or in commerce in Canada during the calendar year 1986 was over 10 000 000 kg.

Number of notifiers

The number of notifiers for the calendar years 1984–1986 was fewer than 4.

Use codes and description

The following DSL use codes have been identified for HRGE:

4 - Adhesive/binder/sealant/filler
21 - Formulation component
30 - Paint/coating additives
52 - Adhesive and Sealant Production

Recent manufacture and importation information

Elsewhere, this substance has been identified as a High Production Volume (HPV) chemical by the Organisation for Economic Co-operation and Development (OECD 2004), the US Environmental Protection Agency (US EPA 2009), and the International Congress & Convention Association (ICCA 2005). According to information from the US EPA, the import/production of HRGE was in the range of  >100–500 M pounds or 45-226 K tonnes in 1986. The import/production decreased to 10-50 M pounds or 5-23 K tonnes in 1990, 1994, following by a temporary decreased in 1998 to 10-500 K pounds or 5-23 tonnes to finally reach again in 2002 to 10-50 M pounds or 5-23 K tonnes (US EPA 2009).

Human Health Information

Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Health Canada undertook to categorize all substances on the Domestic Substances List (DSL) to identify those representing the greatest potential for human exposure and those among a subset of substances considered persistent (P) and/or bioaccumulative (B) that are also considered to be inherently toxic to humans.

To efficiently identify the DSL substances that represented the highest priorities for screening assessment from a human health perspective, Health Canada developed and applied two tools. It used a simple exposure tool (SimET) to identify those substances that met the criteria for greatest potential for exposure (GPE), intermediate potential for exposure (IPE), or lowest potential for exposure (LPE). It also used a simple hazard tool (SimHaz) to identify those substances that posed a high or low hazard.

Exposure information from health-related components of DSL categorization

Simple Exposure Tool (SimET)

SimET was developed and used to identify substances on the DSL considered to represent GPE. This approach was based on three lines of evidence:

• the quantity in commerce in Canada;
• the number of companies involved in commercial activities in Canada (i.e., number of notifiers); and
• the consideration by experts of the potential for human exposure based on various functional use codes.

The proposed approach was released for public comment in November 2003. It permitted substances to be designated as representing a GPE, IPE or LPE, based on criteria for quantity and nature of use (Health Canada 2003).

Results of the application of SimET

HRGE has been determined to be IPE based on a consideration of the DSL nomination information listed in the “Sources and Uses” section.

Hazard information from health-related components of DSL categorization

Simple Hazard Tool (SimHaz)

SimHaz is used to identify, among all the approximately 23 000 DSL substances, those considered to present an either high or low hazard to human health based on formalized weight-of-evidence criteria and/or peer review and expert consensus. The tool was developed through an extensive compilation of the hazard classifications of Health Canada and other agencies and through a consideration of the robustness of the classifications based on the availability of transparent documentation of both process and criteria. The identification of the substances considered potential high health hazards were based on hazard classifications for cancer, genotoxicity, reproductive toxicity or developmental toxicity (Health Canada 2005).

Results of the application of SimHaz

HRGE has not been classified for hazard by any of the agencies considered under the SimHaz tool and therefore does not meet the criteria for high hazard under SimHaz.

Uncertainties in human health information

SimET and SimHaz were developed as robust tools for effectively identifying which DSL substances were considered to be human health priorities and as such called for further consideration. It is recognized that both these tools disregard a number of elements normally considered in a human health risk assessment, such as a comprehensive characterization of exposure and hazard, a comparison of exposure metrics to hazard metrics and a detailed analysis of uncertainties.

Ecological Information

Prior to December 2005, data relevant to an ecological screening assessment were identified in original literature, review documents and commercial and government databases. Properties and characteristics may also have been estimated using quantitative structure activity relationship (QSAR) models. The information presented here has not been updated to reflect more recent predictive methods or additional empirical data.

Reliable experimental ecotoxicological and environmental fate data are available for less than 5% of UVCBs on the DSL. It is estimated that modelled data will probably be produced for approximately 60-70% of UVCBs. While experimental and modelled data are not available for all UVCBs on the DSL, a category approach was developed to identify small groups of substances with similar structure and/or physico-chemical properties. It is expected that the ecotoxicity and environmental fate of the substance within such sub-groups would be relatively similar. Therefore, where data (either experimental or modelled) were available from substances from the sub-group, these data were used to determine the P, B and iT profiles of the whole sub-group.There are two other similar chemicals on the DSL to resin acids and rosin acids, hydrogenated, esters with glycerol: resin acids and rosin acids, hydrogenated esters with pentaerythritol (CAS 64365-17-9), and resin acids and rosin acids, hydrogenated esters with triethylene glycol (CAS 68648-53-3). Therefore, a category approach for them has been used for their categorization.

Releases, Fate and Presence in the Environment

Releases

No information concerning release of HRGE to the environment has been identified.

 Fate

HRGE is characterized by low water solubility (0.12 mg/L), negligible vapour pressure (6.1 × 10^-9 Pa), moderate log K_oc (3.04), and negligible Henry’s Law Constant (5.9 × 10^-4 Pa·m³/mol). Thus, there is potential for partitioning to each of the air, soil, sediment and water compartments, depending on the compartment of release and the rates of partitioning relative to other fate processes such as advection and degradation.

The results of the Level III-fugacity modelling indicate that if the chemical is released equally to the three major environmental compartments (air, water and soil), it will mainly partition into soil and sediment and to a lesser degree water (see Table 3). HRGE is expected to persist in these media (see Table 4a and 4b in the “Environmental Persistence” section).

Table 3: Results of the Level III fugacity modelling (EPIWIN 2004)

If released to air, a low amount of the substance is expected to remain in air (see Table 3 above). Based upon the negligible modelled vapour pressure of 6.1 × 10^-9 Pa and Henry's Law constant of 5.9 × 10^-4 Pa·m³/mol indicate that HRGE has limited potential to reach the air compartment. Therefore, if released solely to air, it will not tend to remain in this compartment; the major two compartments in which this substance will partition will be soil and sediment (~97 %, see Table 3 above).

If released into water, HRGE is expected to strongly adsorb to suspended solids and sediment based upon a moderate estimated log K_oc value of  ~3.04. Volatilization from water surfaces is expected to be an unimportant fate process based upon this compound's estimated Henry's Law constant. Thus, if water is a receiving medium, HGRE is expected to mainly partition into sediment and remain in water (see Table 3 above).

If released to soil, HRGE is expected to be relatively immobile based upon its estimated log K_oc. Volatilization from moist soil surfaces seems to be an unimportant fate process based upon its estimated Henry's Law constant. This chemical is not likely to volatilize from dry soil surfaces given its very low vapour pressure. Therefore, if released to soil, HRGE will mainly remain in this environmental compartment, which is illustrated by the results of the Level III-fugacity modelling (see Table 3 above).

Presence in the Environment

No monitoring data relating to the presence of this substance in environmental media (air, water, soil, sediment) have yet been identified.

Evaluation of P, B and iT Properties

Environmental Persistence

A category approach was developed for categorization to maximize the use of limited data for HRGE and other resin acids and rosin acids, hydrogenated, esters that are classified as UVCBs.

The Level III-fugacity model indicates partitioning of the substance mainly into water, soil and sediment (see Table 2). Once released into the environment, HRGE appears to be relatively persistent in the environment, mainly in water, soil and sediment(see Tables 4a and 4b below).

Empirical biodegradation data are not available for HRGE.  Data for the analogue resin acids and rosin acids, hydrogenated esters with pentaerythritol (HRPE) (CAS 64365-17-9) show only 3% biodegradation over 28 days in a ready-biodegradation test (Kelly 2002) (Table 4a) which suggests that the half-life in water is longer than 182 days (6 months) and that the substance is considered to persist in that environmental compartment.

Table 4a. Empirical data for persistence

Since few experimental data on the degradation of hydrogenated esters of rosins and resins are available, a QSAR-based weight-of-evidence approach (Environment Canada 2007) was also applied using the degradation models shown in Table 4b below.

Table 4b. Modelled data for persistence

¹Limits were derived from the emprical half-life in water using the extrapolation factors of Boethling et al (1995): t_{1/2 water} : t_{1/2 soil} : t_{1/2 sediment} = 1:1:4.

In air, a predicted atmospheric oxidation half-life value of 0.237 days (see Table 4b above) demonstrates that this chemical is likely to be rapidly oxidized. The compound is not expected to react with other photo-oxidative species in the atmosphere, such as O_3. Therefore, it is expected that reactions with hydroxyl radicals will be the most important fate process in the atmosphere for HRGE. With a half-life of 0.237 days via reactions with hydroxyl radicals, HRGE is considered not persistent in air.

In water, based on the modelled probability for biodegradation values and hydrolysis (see Table 4b above) and applying the QSAR-based weight-of-evidence approach, the substance’s degradation half-life in water is ³ 182 days. Thus, this substance is considered to be persistent in that environmental compartment.

Based on the calculated half-lives for soil and sediment in Table 4b, it may be concluded that HGRE is expected to be persistent in soil and sediment.

Thus the empirical and modelled data (see Tables 4a and 4b above) demonstrate that HGRE meets the persistence criteria in water, soil and sediment (half-lives in soil and water ≥ 182 days and half-life in sediment ≥ 365 days), but does not meet the criteria forair (half-life criteria of ³ 2 days) as set out in the Persistence and Bioaccumulation Regulations (Canada 2000).

In addition, the long-range transport potential (LRTP) of HRGE from its point of release to air is estimated to be low according to the model prediction presented in Table 4c below. The TaPL3 model was used to estimate characteristic travel distance, defined as the maximum distance traveled by 63 percent of the substance; or in other words, the distance that 37 percent of the substance may travel beyond. Beyer et al. (2000) have proposed characteristic travel distances of > 2000 km as representing high LRTP, 700–2000 km as moderate, and < 700 km as low. Based on the result shown in Table 4c, this substance is not expected to reach areas far from its emission sources.

Table 4c. Model Predicted Characteristic Travel Distance (CTD)

Potential for bioaccumulation

The modelled log K_ow value for HRGE suggests that this chemical has potential to bioaccumulate in the environment (see Table 2).

Since no experimental data on the bioaccumulation factor (BAF) and/or the bioconcentration factor (BCF) of HRGE were available, a QSAR-based weight-of-evidence approach (Environment Canada 2007) was applied using the BAF and BCF models shown in Table 5 below.

Metabolism information for this substance was not available, nor was it considered in the BAF models.

The modified Gobas BAF middle trophic-level model for fish (no metabolism) predicted a bioaccumulation factor (BAF) of 49 678 L/kg, indicating that HRGE has the potential to bioconcentrate and biomagnify in the environment. The results of BCF model calculations also provide weight-of-evidence to support the high bioaccumulation potential of this substance.

Table 5. Modelled data for bioaccumulation

The results of predictive modelling suggest that the substance meets the bioaccumulation criterion (BCF, BAF > 5000) as set out in the Persistence and Bioaccumulation Regulations (Government of Canada 2000).

Ecological Effects

A - In the Aquatic Compartment

There are no experimental data available for aquatic toxicity for HRGE nor are there for the two other resin acids and rosin acids within HRGE’s UVCB sub-group. Therefore, predictive models were used to estimate the potential for aquatic toxicity. Table 6 contains predicted ecotoxicity values that were considered as reliable and were used in the QSAR weight-of-evidence approach for aquatic toxicity (Environment Canada 2007).

Table 6. Modelled data for aquatic toxicity

⁺Above HRGE’s water solubility
¹LC₅₀ – The concentration of a substance that is estimated to be lethal to 50% of the test organisms.
²EC₅₀ - The concentration of a substance that is estimated to cause some toxic sublethal effect on 50% of the test organisms.

A range of aquatic toxicity predictions were obtained from the various QSAR models considered. These results indicate that the substance is potentially highly hazardous to aquatic organisms (i.e., acute LC/EC₅₀ ≤ 1.0 mg/L)

B - In Other Environmental Compartments

No suitable ecological effects studies were found for this compound in media other than water.

Potential to cause ecological harm

Evidence that a substance is highly persistent and bioaccumulative as defined in the Persistence and Bioaccumulation Regulations of CEPA 1999 (Canada 2000), when taken together with potential for environmental release or formation and potential for toxicity to organisms, provides a significant indication that it may be entering the environment under conditions that may have harmful long-term ecological effects. Substances that are persistent remain in the environment for a long time after being released, increasing the potential magnitude and duration of exposure. Substances that have long half-lives in mobile media (air and water) and partition into these media in significant proportions have the potential to cause widespread contamination. Releases of small amounts of bioaccumulative substances may lead to high internal concentrations in exposed organisms. Highly bioaccumulative and persistent substances are of special concern, since they may biomagnify in food webs, resulting in very high internal exposures, especially for top predators.

The information collected to date thus suggests that the relatively large importation volumes of HRGE into Canada, along with its dispersive uses, indicate potential for releases into the Canadian environment. Once released into the environment, because of its resistance to degradation, it will remain in water, sediment and soil for a long time. Because it persists in the environment, and because of its lipophilic character, it will likely bioaccumulate and may be biomagnified in trophic food chains. It has also demonstrated potential for relatively high toxicity to aquatic organisms. This information suggests that HRGE has the potential to cause ecological harm in Canada.

Uncertainties in ecological information

This substance profile outlines uncertainties in ecological information in order to help focus attention on those areas where it may be particularly desirable to submit additional data in the context of the Challenge.

Gaps in available experimental data were largely filled during categorization through the use of QSARs. While there are uncertainties associated with the use of QSAR models to estimate chemical and biological characteristics, the approaches used allowed meaningful interpretation of the information, as well as the identification of those substances that are priorities for further actions. For HRGE, there were little or no experimental data for ecotoxicity, degradation and bioaccumulation identified during categorization, and QSARs were used to estimate them. Additionally, values for all key physical and chemical properties (log K_ow, water solubility, Henry’s Law constant), which are used as input to the QSAR models, have also had to be estimated.

It is also noted that, with regards to ecotoxicity, categorization primarily focused on the collection and generation of data on the inherent toxicity of substances to organisms in the pelagic aquatic environment. The release and partitioning behaviour of this substance can result in the exposure of organisms living in other media (air, soil, sediment). No data on potential effects on such organisms have been identified.

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Environment Canada. 2007. Guidance for Conducting Ecological Assessments under CEPA, 1999: Science Resource Technical Series, Draft Module on QSARs. Draft document prepared by Environment Canada, Existing Substances Division. Available on request.
                           
[EPIWIN] Estimation Programs Interface for Microsoft Windows [suite of Estimation Models]. 2004. Version 3.12. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

Health Canada. 2003. Proposal for priority setting for existing substances on the Domestic Substances List under the Canadian Environmental Protection Act, 1999: greatest potential for human exposure [Internet]. Ottawa (ON): Health Canada, Bureau of Environmental Contaminants, Safe Environments Programme, Existing Substances Division. 73 p. Available from: http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/exposure/greatest_potential_human_exposure-risque_exposition_humaine-eng.pdf

Health Canada. 2005. Proposed integrated framework for the health-related components of categorization of the Domestic Substances List under CEPA 1999 [Internet]. Ottawa (ON): Health Canada, Bureau of Environmental Contaminants, Safe Environments Programme, Existing Substances Division. 63 p. Available from: http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/contaminants/existsub/framework-int-cadre-eng.pdf

[HENRYWIN] Henry’s Law Constant Program for Microsoft Windows [Estimation Model]. 2000. Version 3.10. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation.  Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[HYDROWIN] Hydrolysis Rates Program for Microsoft Windows [Estimation Model]. 2000. Version 1.67. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[ICCA]  International Council of Chemical Associations. 2005. Website of the Global Initiative on High Production Volume (HPV) Chemicals.[cited December 2005 – January 2006].
http://www.cefic.org/activities/hse/mgt/hpv/hpvinit.htm

Kelly CR.  2002.  Rosin, esters with pentaerythritol, CAS No. 8050-26-8; rosin, esters with glycerol, CAS No. 8050-31-5; rosin, esters with diethylene glycol, CAS No. 68153-38-8; rosin, methyl esters, CAS No. 68186-14-1; rosin, hydrogenated, esters with pentaerythritol, CAS No. 64365-17-9; rosin, hydrogenated, glycerol ester, CAS No. 65997-13-9; determination of ready biodegradability by the Modified Sturm Test.  Tranet, Scotland: Inveresk Research.  Report No. 21732.  As cited in US EPA 2005.

[KOWWIN] Octanol-Water Partition Coefficient Program for Microsoft Windows [Estimation Model]. 2000. Version 1.67. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[TaPL3] Long Range Transport and Persistence Level III model [Internet]. 2000. Version 2.10. Peterborough (ON): Trent University, Canadian Environmental Modelling Centre.  Available from: http://www.trentu.ca/academic/aminss/envmodel/models/TaPL3.html

[MPBPWIN] Melting Point Boiling Point Program for Microsoft Windows [Estimation Model]. 2000. Version 1.41. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[NCI] National Chemical Inventories [database on a CD-ROM]. 2007.  Issue 1. Columbus (OH): American Chemical Society, Chemical Abstracts Service. [cited January 2008]. Available from: http://www.cas.org/products/cd/nci/require.html

[OASIS Forecast] Optimized Approach based on Structural Indices Set [Estimation Model]. 2005. Version 1.20. Bourgas, Bulgaria: Laboratory of Mathematical Chemistry. Available from: http://oasis-lmc.org/?section=software

[OECD] Organisation for Economic Co-operation and Development. 2004. The 2004 OECD list of high production volume chemicals [Internet]. Paris (FR): OECD, Environment Directorate. [cited 2006 January]. Available from: http://www.oecd.org/dataoecd/55/38/33883530.pdf

[PCKOCWIN] Organic Carbon Partition Coefficient Program for Windows [Estimation Model]. 2000. Version 1.66. Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[U.S. EPA] U.S. Environmental Protection Agency. 2005.  High Production Volume (HPV) Challenge—Robust Study Summaries and Test Plans:  Rosin Esters—Revised Summaries [internet].  Washington (DC):  prepared for the US EPA by the Pine Chemicals Association.  Available from:  http://www.epa.gov/chemrtk/pubs/summaries/rosnstrs/c13552rr2.pdf

[US EPA] US Environmental Protection Agency. 2009. Inventory update reporting, previously collected data: Non-confidential production volume information submitted by companies under the 1986,1990,1994,1998, and 2002 Inventory Update Reporting Regulation: Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol, CAS RN 64365-17-9 [Internet]. Washington (DC): US Environmental Protection Agency; [cited 2009 May 22]. Available from:  http://www.epa.gov/opptintr/iur/tools/data/index.htm
 
[WSKOWWIN] Water Solubility for Organic Compounds Program for Windows [Estimation Model]. 2000. Version 1.41 Washington (DC): U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. [cited January 2003]. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

Disclaimer: Although care has been taken to ensure that the information found on this website accurately reflects the requirements prescribed in the Canadian Environmental Protection Act (1999), you are advised that, should any inconsistencies be found, the legal documents, printed in the Canada Gazette, will prevail.