Screening Assessment for the Challenge

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4-[[3-[[2-Hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]benzenesulfonic acid, calcium salt (2:1)
(Pigment Red 247:1)

Chemical Abstracts Service Registry Number
43035-18-3

Environment Canada
Health Canada

July 2008

(PDF Version - 315 KB)

Table of Contents

• Synopsis
• Introduction
• Substance Identity
• Physical and Chemical Properties
• Sources
• Uses
• Releases to the Environment
• Environmental Fate
• Persistence and Bioaccumulation Potential
• Potential to Cause Ecological Harm
• Conclusions
• References
• Appendix 1: Robust Study Summaries

Synopsis

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1) (Pigment Red 247:1), Chemical Abstracts Service Registry Number 43035-18-3. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Pigment Red 247:1 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List (i.e., it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Pigment Red 247:1 is an organic substance used as a colour pigment in plastics, inks and paints, in the food and beverage sector, and as an inert ingredient in pesticides. In Canada, the only known use is in the plastics sector. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 100 and 1000 kg of the pigment were imported into the country in 2006 for use in the manufacturing of various coloured products.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in waste disposal sites. Assumptions and input parameters used in making these estimates are based on information obtained from a variety of sources including responses to regulatory surveys, Statistics Canada, manufacturers’ websites and technical databases. About 3% is estimated to be released to water, and negligible releases are predicted to air and soil. Pigment Red 247:1 presents very low experimental solubilities in water and octanol (< 200 µg/L). It is present in the environment primarily as micro-particulate matter that is not volatile and rather chemically stable, and it has a tendency to partition by gravity to sediments if released to surface waters, and to soils if released to air.

Based on its physical and chemical properties, Pigment Red 247:1 is expected to be persistent in the environment. However, new experimental data relating to its solubility in octanol and water suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. Therefore, this substance meets the persistence criterion but does not meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data for a chemical analogue and new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has a low acute toxicity to aquatic organisms.

For this screening assessment, a very conservative exposure scenario was selected whereby an industrial operation (user of the pigment) discharges to the aquatic environment. The predicted environmental concentration in water was many orders of magnitude below predicted no-effect concentrations calculated for fish and daphnids.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Based on the information available, Pigment Red 247:1 does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that have met the categorization criteria set out in the Act to determine whether these substances present or may present a risk to the environment or human health. Based on the results of a screening assessment, the Ministers can propose to take no further action with respect to the substance, to add the substance to the Priority Substances List (PSL) for further assessment, or to recommend that the substance be added to the List of Toxic Substances in Schedule 1 of the Act and, where applicable, the implementation of virtual elimination.

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

• met all of the ecological categorization criteria, including persistence (P), bioaccumulation potential (B) and inherent toxicity to aquatic organisms (iT), and were believed to be in commerce in Canada; and/or
• met the categorization criteria for greatest potential for exposure (GPE) or presented an intermediate potential for exposure (IPE), and had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity.

The Ministers therefore published a notice of intent in the Canada Gazette, Part I, on December 9, 2006 (Canada 2006), that challenged industry and other interested stakeholders to submit, within specified timelines, specific information that may be used to inform risk assessment, and to develop and benchmark best practices for the risk management and product stewardship of these substances identified as high priorities.

The substance Pigment Red 247:1 was identified as a high priority for assessment of ecological risk as it was found to be persistent, bioaccumulative and inherently toxic to aquatic organisms and is believed to be in commerce in Canada. The Challenge for Pigment Red 247:1 was published in the Canada Gazette on February 3, 2007 (Canada 2007a). A substance profile was released at the same time. The substance profile presented the technical information available prior to December 2005 that formed the basis for categorization of this substance. As a result of the Challenge, submissions of information were received.

Although Pigment Red 247:1 was determined to be a high priority for assessment with respect to the environment, it did not meet the criteria for GPE or IPE and high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Therefore, this assessment focuses principally on information relevant to the evaluation of ecological risks.

Screening assessments under CEPA 1999 focus on information critical to determining whether a substance meets the criteria for defining a chemical as toxic as set out in section 64 of the Act, where

“64. [...] a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

Screening assessments examine scientific information and develops conclusions by incorporating a weight of evidence approach and precaution.

This screening assessment includes consideration of information on chemical properties, hazards, uses and exposure, including the additional information submitted under the Challenge. Data relevant to the screening assessment of this substance were identified in original literature, review and assessment documents, stakeholder research reports and from recent literature searches up to July 2007. Key studies were critically evaluated; modelling results may have been used to reach conclusions. When available and relevant, information presented in hazard assessment from other jurisdictions was considered. The screening assessment does not represent an exhaustive or critical review of all available data. Rather, it presents the most critical studies and lines of evidence pertinent to the conclusion.

This screening assessment was prepared by staff in the Existing Substances Programs at Health Canada and Environment Canada and incorporates input from other programs within these departments. Additionally, the draft of this screening assessment was subject to a 60-day public comment period. The critical information and considerations upon which the assessment is based are summarized below.

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Substance Identity

For the purpose of this document, this substance will be referred to as Pigment Red 247:1. This pigment belongs to the group of Naphthol AS Pigment Lakes. This is a Naphthol AS derivative that includes (i) the basic entity anilide of 2­hydroxy­3­naphthoic acid for Naphthol AS compounds and (ii) sulfonic acid functions providing a site for salt formation with metal cations, specifically calcium in the present case (Table 1; Herbst and Hunger 2004).

Table 1. Substance identity

Source: National Chemical Inventories (NCI), 2007: AICS (Australian Inventory of Chemical Substances); ASIA-PAC (Combined Inventories from the Asia-Pacific Region); ECL (Korean Existing Chemicals List); EINECS (European Inventory of Existing Chemical Substances); ENCS (Japanese Existing and New Chemical Substances); PICCS (Philippine Inventory of Chemicals and Chemical Substances); TSCA (Toxic Substances Control Act Chemical Substance Inventory).

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Physical and Chemical Properties

The pigment industry synthesizes organic pigments that have low to very low solubilities in nearly all solvents (i.e., < 1 mg L^-1 to < 0.01 mg L^-1). This arises from the desire of the industry to produce chemicals that will retain their colour for a long time and in any type of material. Low solubility is enhanced by designing chemicals that have strong interactive forces between molecules. For Naphthol AS Pigment Lakes, this is achieved by the introduction of sulfonic acid and/or carboxy groups forming insoluble polar salts with metal cations such as Ca, Ba, Sr or Mn (Herbst and Hunger 2004; Lincke 2003). The resulting intermolecular bonds, in turn, generate a crystal structure that is at the origin of the stability of organic pigments (Lincke 2003).

As for the majority of organic pigments, Naphthol AS Pigment Lakes generally do not exist as individual molecules but are principally particles in the submicron range. The pigment powder is typically composed of primary particles (i.e., the crystal lattice of a pigment ), aggregates and agglomerates. Manufacturers usually provide the physical specifications of their pigments which include the average particle size of the pigment powder (see Table 2). In doing so, users can determine which pigment is the most appropriate to color their product(s), since performance is chiefly controlled by the particle size distribution (Herbst and Hunger 2004).

Table 2 contains modelled and experimental physical and chemical properties of Pigment Red 247:1 that are relevant to its environmental fate. Modelled estimates for these properties, as well as for rate constants and environmental partitioning are typically generated using quantitative structure-activity relationship (QSAR) models. These models, in turn, base their predictions on the individual characteristics of the molecules. The modelled log K_ow of 7.46 (KOWWIN 2000) implies that the solubility of Pigment Red 247:1 is much higher in octanol than in water. Experimental solubility data, however, reveals that the substance is approximately equally soluble in the two solvents, indicating that the modelled partition coefficient is likely overestimated. The modelled estimate of log K_OW has therefore been disregarded for this assessment.

The experimental solubilities in Table 2 have been determined using an aggressive approach with long contact times between pigment particles and the solvent, and a filtration step removing as much of the particulate matter in the suspension as possible. These studies have been critically reviewed, and although none reported using reference chemicals of known solubilities, they were determined to have a satisfactory degree of reliability for the present assessment.

Table 2. Physical and chemical properties for Pigment Red 247:1

NA: Not available;
^[1] not applicable.
^[2] An acid-base property is required for a chemical to be an uncoupler of oxidative phosphorylation (Ecological Effects Assessment section below). Values reported here are for the individual, solubilized molecule.

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Sources

Pigment Red 247:1 is not known to be formed in nature. In Canada, no manufacture of this pigment was reported in response to a CEPA section 71 survey notice for the 2006 calendar year in a quantity meeting the 100 kg reporting threshold. In total, two companies reported import of this substance, with one company in the 0–100 kg/year range and one company in the 100–1,000 kg/year range for use in the manufacturing of various coloured products.

Products containing Pigment Red 247:1 may enter in the country even if they are not identified as such in the section 71 survey. These quantities are currently not known. According to information from the United States Environmental Protection Agency (US EPA 2002), the import and production of Pigment Red 247:1 in that country was in the order of 4.5–225 tonnes per year in 1994, 1998 and 2002, but no import or production was reported in 1986 or 1990. The Substances in Preparations in Nordic Countries (SPIN) database indicates that consumption in Sweden from 1999 to 2004 was in the range of 2–6 tonnes per year (SPIN 2006).

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Uses

According to the submissions made under section 71 of CEPA 1999, the only known current use pattern code for Pigment Red 247:1 in Canada is as a colourant/pigment/stain/dye/ink (Environment Canada 2007a)  Pigment Red 247:1 does not have food packaging uses under the Food and Drug Act (Health Canada 2007a). Pigment Red 247:1 is a formulant in two pest control products registered for use in Canada under the Pest Control Products Act (Health Canada 2007b).  

Internationally, uses of Pigment Red 247:1 include:

• in plastics such as PVC, polystyrene, ABS, polyacetal and HDPE (CII 2007; Herbst and Hunger 2004);
• in polymers (Clariant 2007);
• as a colourant in printing inks in the areas of publishing, printing and reproduction of recorded media (SPIN 2000);
• as a colourant in paints, lacquers and varnishes in the areas of treatment and coating of fabricated metal products, machinery and equipment or in areas of construction industry (SPIN 2000);

Uses in Canada as a colourant/pigment/stain/dye/ink are considered to be similar to those identified above. 

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Releases to the Environment

The two companies that reported importing this substance in 2006 did not indicate any releases of this chemical to the environment.

Mass Flow Tool

To estimate potential release of the substance to the environment at different stages of its life cycle, a mass flow tool was used. Empirical data concerning releases of specific substances to the environment are seldom available. Therefore, for each identified type of use of the substance, the proportion and quantity of release to the different environmental media are estimated, as is the proportion of the substance chemically transformed or sent for waste disposal. Assumptions and input parameters used in making these estimates are based on information obtained from a variety of sources, including responses to regulatory surveys, Statistics Canada, manufacturers’ websites and technical databases. Of particular relevance are emission factors, which are generally expressed as the fraction of a substance released to the environment, particularly during its manufacture, processing and use associated with industrial processes. Sources of such information include emission scenario documents, often developed under the auspices of the Organisation for Economic Co-operation and Development (OECD) and default assumptions used by different international chemical regulatory agencies. It is noted that the level of uncertainty in the mass of substance and quantity released to the environment generally increase further down the life cycle. 

Results indicate that Pigment Red 247:1 can be expected to be found largely in waste management sites (94.5%), due to the eventual disposal of manufactured items containing it. The calculations assume that there is no release of the substance from these sites, although long-term releases may be possible. A small fraction of solid waste is incinerated, which is expected to result in the transformation of the substance. Based largely on information contained in OECD emission scenario documents for processing and uses associated with this substance, it is estimated that 0.1 percent and 3.2 percent of Pigment Red 247:1 may be released to air and water, respectively (Table 3).

Although no information is available on the volume of consumer products containing Pigment Red 247:1 that are imported into Canada, it is anticipated that the quantities of Pigment Red 247:1 that are released to the various environmental media would not be significantly different from those estimated here. However, the quantities sent for waste management would be higher if importation of these products were taken into consideration.

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Environmental Fate

The negligible modelled vapour pressure and a Henry's Law constant of ~0 Pa·m³/mol for Pigment Red 247:1 are consistent with the fact that it is a large and complex molecule (Baughman and Perenich 1988; Danish EPA 1998). This pigment is not expected to volatilize at environmentally realistic temperatures.

Because of its very low solubility in water, this pigment may be considered not available for aerobic biodegradation. In addition, direct contact with biota may probably not occur when the pigment is in materials.

Table 3. Estimated releases and losses of Pigment Red 247:1 to environmental media, chemical transformation and distribution to management processes, based on the Mass Flow Tool

^[1] For Pigment Red 247:1, information from the following OECD emission scenario documents was used to estimate releases to the environment and distribution of the substance as summarized in this table: (OECD 2006; 2004). Values presented for release to environmental media do not account for possible mitigation measures that may be in place in some locations (e.g., partial removal by sewage treatment plants). Specific assumptions used in derivation of these estimates are summarized in Environment Canada (2007b).
^[2] Applicable stage(s): production-formulation-industrial use-consumer use-service life of article/product-waste disposal.
^[3] Wastewater before any form of treatment

The particulate character of Pigment Red 247:1 should have a key influence on its fate in the environment. Its particle size and density, which is 44 percent greater than that of water (cf.: Wetzel 2001; Reynolds et al 1987), together with its chemical stability and low aqueous solubility, indicates that it will partition by gravity to sediments if released to surface waters and will tend to remain in soils if released to terrestrial environments.

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Persistence and Bioaccumulation Potential

Persistence

Jaffe (1996) has stated that once a pigment is incorporated into a matrix (e.g., plastic), it is expected to be durable and withstand the combined chemical and physical stresses of weather, solar radiation, heat, water and industrial pollutants.

Industries that manufacture pigments recognize that their substances are persistent. For example, the Color Pigments Manufacturers Association, Inc. (CPMA 2003) has indicated that pigments are designed to be durable or persistent in the environment in order to provide colour to finished coatings, inks and paints.

The environmental persistence of Naphthol AS Pigment Lakes, such as Pigment Red 247:1, in anoxic environments is an important area of uncertainty. Azo dyes are reported to be degraded in anoxic waters via anaerobic reduction of the azo bond (-N=N-: Van der Zee 2002). Naphthol AS Pigment Lakes have azo chromophores in their structure as well. However, no documentation has been found regarding a possible degradation potential of these pigments in aqueous media in the absence of oxygen. In principle, the crystal would have to dissolve first, releasing its constituent molecules. Then, the azo bonds in these molecules would be available for biotic reduction.

Based on the weight of evidence provided by the above-described literature, Pigment Red 247:1 is considered to meet the persistence criteria defined in the Persistence and Bioaccumulation Regulations (Canada 2000).

Bioaccumulation

There is a predictable relationship between K_ow and the bioconcentration factor in lipids (Mackay 1982). The ratio log (C_o/C_w) has been derived from the experimental solubilities of Pigment Red 247:1 in octanol (C_o) and water (C_w) (Table 2), and this experimentally derived ratio has been preferred over the model-derived log K_ow for this pigment. This approach is supported by the observation that partitioning into octanol is a good indicator of a substance’s potential to partition into the lipid phase of aquatic biota (Bertelsen et al. 1998) and, for pigments, the observation that a reduced solubility in octanol translates into a similarly reduced bioconcentration factor (BCF) and bioaccumulation factor (BAF) in an aquatic organism (Banerjee and Baughman 1991).

A new set of BCF and BAF estimates for Pigment Red 247:1 has been obtained from quantitative structure-activity relationship (QSAR)-based bioaccumulation models, using the experimentally based value log C_o/C_w in place of the overestimated log K_ow by KOWWIN (2000). In addition, modelled BCF and BAF estimates have been obtained for a distant analogue of Pigment Red 247:1, namely Pigment Red 253 (CAS RN 85776-13-2), using a log (C_o/C_w) derived from experimental solubilities as well (Environment Canada 2007d). This analogue has half the molecular weight, but its solubilities in water and octanol similar to those of the pigment being assessed, and solubility is a key factor when determining an analogue for use in read-across (OECD 2007). For example, water and octanol solubilities of Pigment Red 253 are 8 and 202 µg/L, respectively (Study Submission 2007b; solubilities of Pigment Red 247:1 are given in Table 2). Table 4 shows that the new modelled BCF and BAF estimates are well below 100 for both Pigment Red 247:1 and the analogue, Pigment Red 253.

Thus, Pigment Red 247:1 is expected to present a low bioaccumulation potential because of its very limited affinity for the lipid phase of living organisms. Further support is provided by experimental determinations for six representative organic pigments all with BCF values of less than 100 wet wt (MITI 1992).

The above weight of evidence indicates that Pigment Red 247:1 does not meet the bioaccumulation criterion (BCF, BAF > 5000) as set out in the Persistence and Bioaccumulation Regulations (Canada 2000).

Table 4. Modelled bioaccumulation data for Pigment Red 247:1 and its analogue, Pigment Red 253

^[a] Pigment Red 247:1 and Pigment Red 253 have roughly similar solubilities in water and octanol

 

^[b] Default value for non-ionisable azo pigments.

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Potential to Cause Ecological Harm

A quantitative evaluation based on exposure and ecological effects was conducted for this pigment as part of the weight of evidence evaluation of its potential to cause harm.

First, a predicted environmental concentration (PEC) was determined based on an analysis of exposure pathways. Then, pertinent endpoint organisms were selected. For each endpoint organism, a conservative (reasonable worst-case) predicted no-effect concentration (PNEC) was derived. The PNEC is obtained by selecting the lowest critical toxicity value (CTV) for the organism of interest and dividing it by an application factor appropriate for the endpoint.

Ecological Exposure Assessment

No data have been found regarding concentrations of Pigment Red 247:1 in the Canadian environment. The mass flow tool estimated that nearly 94 percent of the mass of this pigment ends up in waste disposal facilities. Off-site chemical migration from these facilities is unlikely, or can be predicted to be minor, because of the negligible geochemical mobility of the pigment indicated by its very low solubility in water and in organic solvents. Consequently, it is anticipated that there are negligible releases associated with the waste management stage of this substance.

The mass flow tool estimated that up to about 3 percent of the total mass of Pigment Red 247:1 in use (22 kg in 2006) could be released to water. In addition, available industrial information suggested that these releases would be generated by industrial users who employed the pigment to manufacture other coloured products (Environment Canada 2007a). The Industrial Generic Exposure Tool – Aquatic (IGETA) was selected to model the reasonable worst-case discharge of an industrial operation (user of the pigment) to the aquatic environment. IGETA is a modelling tool developed by Environment Canada to estimate surface water concentrations. The tool models an industrial release scenario based on loading data from sources such as industrial surveys and knowledge of the distribution of industrial discharges in the country, and calculates a PEC. The maximum mass, per year, purchased by an industrial facility (1000 kg: Environment Canada 2007a) was used to calculate the loading rate for the PEC estimation. Based on the IGETA results, the PEC is 0.0056 mg/L in the receiving watercourse.

Ecological Effects Assessment

A – In the Aquatic Compartment

Although no experimental toxicity data were found for Pigment Red 247:1, there are experimental toxicity data available for Pigment Red 253, which is a distant analogue of Pigment Red 247:1 (Table 4, CAS RN 85776-13-2). Furthermore, predicted ecotoxicity values were obtained using the experimental log (Co/Cw) of Pigment Red 247:1 (0.20). These experimental and predicted toxicity data (Table 5a and 5b) are considered reliable and have been used in the weight of evidence approach to determine the aquatic toxicity potential of this pigment.

Juveniles of Daphnia magna were exposed to Pigment Red 253 for 24 hours under static conditions (Study Submission 2007c; Table 5a). The pH was maintained at 8, the temperature was kept at 20±1°C and dissolved oxygen ranged between 7.6 and 9.2 mg/L. An experimental treatment consisted of 20 specimens placed in a 50-mL glass beaker. Seven test concentrations were established, using three replicates per test. The chemical was not measured during the test. The EC₅₀ (immobilization) was estimated to be 990.7 mg/L, with a 95 percent confidence interval (CI) of 475.7-6076 mg/L.

No information was provided on how the test solutions were prepared. Therefore, it is not known with certainty if the toxicity test was conducted at saturation (i.e., the maximum concentration of the substance that can be achieved under the test conditions). However, high loadings (up to 1000 mg/L) were used and only 10 percent immobilization was observed up to a concentration of 500 mg/L.

The degree of reliability of this study was deemed satisfactory for the present assessment. Notably, a reference toxicant was used and good laboratory practices (GLP) were followed.

In another study, young carp (Cyprinus carpio) were exposed to Pigment Red 253 for 96 hours under static conditions (Environment Canada 2007f; Table 5a). The pH was maintained between 7.4 and 8.1, the temperature oscillated between 21.6 and 22.2°C and dissolved oxygen ranged between 6.5 and 8.8 mg/L. The test water had a hardness of ~ 240 mg CaCO₃/L. The experiment consisted of ten fish placed in a 15-L glass tank. Six test concentrations were established. The chemical was not measured during the test. The LC₅₀ was estimated to be 172 mg/L, with a 95 percent CI of 126-230 mg/L.

No information was provided on how test solutions were prepared. Therefore, it is not known with certainty if the toxicity test was conducted at saturation. However, high loadings (up to 400 mg/L) were used and no toxic response was recorded up to a concentration of 90 mg/L.

The degree of reliability of this study was deemed satisfactory for the present assessment.

Aquatic toxicity predictions, recalculated using log (C_o/C_w), were obtained using the ECOSAR Program (ECOSAR 2004), which is based on the assumption that Pigment Red 247:1 has a narcotic mode of action (MOA). However, the ASTER (1999) model predicted the MOA to be the “uncoupling of oxidative phosphorylation” for this pigment, in addition to narcosis. An application factor of 100 (Environment Canada 2003) was therefore applied to extrapolate from baseline toxicity to this more toxic MOA. It should be noted that the above MOAs were predicted for the solubilized molecule (i.e., Table 1). Table 5b presents these modelled ecotoxicity data.

The model data are all well above the estimated water solubility of the substance, and therefore are consistent with the reported no effects at saturation.

Table 5a. Experimental aquatic toxicity values for Pigment Red 247:1

^[1] Immobilization

Table 5b. Modelled aquatic toxicity values for Pigment Red 247:1

 

B – In Other Media

No empirical or predicted effects data for non-aquatic organisms were identified for this compound. However, given the current release scenarios and quantities used in Canada, exposures through soils, suspended solids and sediment are not likely to be significant at this time.

Characterization of Ecological Risk

The approach taken in this ecological screening assessment was to examine the available scientific information and develop conclusions based on a weight of evidence approach and using the precautionary principle as required under section 76.1 of CEPA 1999. Particular consideration has been given to risk quotient analysis, persistence, bioaccumulation, toxicity, sources and fate in the environment.

Pigment Red 247:1 is determined to be persistent based on published evidence. However it has been determined not to be bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations of CEPA 1999 (Canada 2000), based on observations of its very low solubility in octanol, low modelled BCFs and low experimental BCFs determined for a number of analogous organic pigments (MITI 1992).

Newly acquired empirical data for a chemical analogue, as well as modelled aquatic toxicity results, also suggest that this pigment is not very harmful, showing a low acute toxicity for aquatic organisms (LC₅₀/EC₅₀ > 100 mg/L). There is uncertainty that effect concentrations are greater than the solubility of the compound. For this, the OECD (2000) guidance for the evaluation of sparingly soluble substances has been considered. This protocol suggests that the product be tested at saturation and that an adequate separation technique be used to separate particulate from dissolved forms. It is currently the best available approach for the evaluation of these types of substances.

Since Pigment Red 247:1 is considered a persistent but not bioaccumulative substance, a quantitative evaluation of exposure and ecological effects was conducted as part of the weight of evidence evaluation of this pigment’s potential to cause harm.

In view of the limited amount of empirical Canadian exposure data, the IGETA model was used, along with industrial information, to estimate worst-case PECs. Three categories of organisms were considered for derivation of PNECs: fish, daphnids and algae. An application factor of 100 was used to extrapolate from acute to chronic effects, and from laboratory species to different species in the field. CTVs and PNECs are based on the most conservative effect values and are presented in Table 6. The resulting risk quotients are in all cases much less than 1, suggesting the substance is unlikely to be present at concentrations that could cause harm to aquatic organisms.

Table 6. Summary of values used for the risk characterization of Pigment Red 247:1

Given the high persistence of the substance in the environment, chronic exposure is likely to occur. However, in view of its low acute toxicity, and taking into account its relatively low solubility (112 µg/L) and its low bioaccumulation potential, long-term environmental exposure to the substance is not expected to cause adverse effects to aquatic organisms.

Considering these findings and given that this chemical is imported in relatively low quantities, it is concluded that Pigment Red 247:1 is unlikely to be causing ecological harm in Canada.

Uncertainties in Evaluation of Ecological Risk

This section summarizes the key uncertainties associated with the risk assessment of Pigment Red 247:1.

Long-term stability of Pigment Red 247:1 in anoxic sediments, as well as in anoxic layers in the soil column of waste disposal sites, is largely unknown.

Nanoscale materials are informally defined as substances having at least one dimension less than 100 nm. There is increasing evidence to the effect that nanoparticles can be absorbed by non-specific biouptake pathways such as pinocytosis (Leroueil et al. 2007). Organic pigments, such as Pigment Red 247:1, typically have a certain proportion of their particle size spectra in the nanoparticle range (e.g., Table 2). Presently, the bioaccumulation mechanisms and potential of these particles is poorly understood, as is the nature of the relationship between their bioaccumulation and their toxicity. Furthermore, certain less commonly considered environmental fate processes may have an important influence on the propensity of the pigment nanoparticles to be taken up by biota (e.g., importance of aggregation in nature: Wiesner et al. (2006)).

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Conclusion

Based on the information presented in this screening assessment, it is concluded that Pigment Red 247:1 is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. Similarly, it is concluded that Pigment Red 247:1 is persistent but does not meet the criterion for bioaccumulation as set out in thePersistence and Bioaccumulation Regulations (Canada 2000).

Therefore it is concluded that Pigment Red 247:1 does not meet the definition of toxic as set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999. 

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References

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Appendix 1: Robust Study Summaries

Evaluation of experimental data using Kollig's approach^[*]

^[*] Kollig, H.P. 1988. Criteria for evaluating the reliability of literature data on environmental process constants. Toxicol. Environ. Chem. 17: 287-311.
^[**] The reliability code for ecotoxicological studies of DSL categorization is used.

Evaluation of experimental data using Kollig's approach^[*]

^[*] Kollig, H.P. 1988. Criteria for evaluating the reliability of literature data on environmental process constants. Toxicol. Environ. Chem. 17: 287-311.
^[**] The reliability code for ecotoxicological studies of DSL categorization is used.

Robust Study Summaries Form and Instructions: Aquatic iT

Robust Study Summaries Form and Instructions: Aquatic iT