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Substance Profile for The Challenge
4-[[3-[[2-Hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]benzenesulfonic acid, calcium salt (2:1)
(Pigment Red 247) CAS No. 43035-18-3

Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) required the Minister of Health and Minister of the Environment to categorize the approximately 23 000 substances on the Domestic Substances List (DSL). Categorization involved identifying those substances on the DSL that are a) considered to be persistent (P) and/or bioaccumulative (B), based on criteria set out in the Persistence and Bioaccumulation Regulations (Government of Canada, 2000), and “inherently toxic” (iT) to humans or other organisms, or b) that present, to individuals in Canada, the greatest potential for exposure (GPE).

Further to this activity, the Act requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that meet the categorization criteria. A screening assessment involves a scientific evaluation of available information for a substance to determine whether the substance meets the criteria set out in section 64 of CEPA 1999. Based on the results of a screening assessment, the Ministers can propose taking no further action with respect to the substance, adding the substance to the Priority Substances List (PSL) for further assessment or recommending 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.

A number of substances have been identified by the Ministers as high priorities for action based on the information obtained through the categorization process. This includes substances:

  • that were found to meet all of the ecological categorization criteria, including persistence, bioaccumulation potential and inherent toxicity to aquatic organisms (PBiT), and that are known to be in commerce in Canada, and/or
  • that were found either to meet the categorization criteria for GPE or to present an intermediate potential for exposure (IPE), and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity.

Based on a consideration of the ecological and/or 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 and interpreting the results of an assessment, sufficient data are currently available to consider these substances as meeting the criteria under Section 64 of CEPA 1999.

As such, the Ministers have issued a Challenge to industry and other interested stakeholders through publication in Canada Gazette Part I December 9, 2006 to submit, within the timelines stated in the Challenge section of this document, below, specific information that may be used to develop and benchmark best practices for risk management and product stewardship.

4-[[3-[[2-Hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]benzenesulfonic acid, calcium salt (2:1) was 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 associated with this substance, is contained in Appendices I and II, respectively.

Substance Identity

For the purpose of this document, this substance will be referred to as Pigment Red 247.

CAS Registry Number
43035-18-3
Inventory names
Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1);
Bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphtyl]azo]-4-methylbenzoyl]amino]benzenesulfonate] de calcium (French);
calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate];
Calciumbis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzolsulfonat] (German);
bis[4-[[3-[[2-hidroxi-3-[[(4-metoxifenil)amino]carbonil]-1-naftil]azo]-4-metilbenzoil]amino]bencenosulfonato] de calcio (Spanish);
Calcium bis[4-[[3-[[2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulfonate];
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;
Pigment Red 247 ;
C.I. PIGMENT RED 247:1;
C.I. PIGMENT RED 247
Other names
Benzenesulfonic acid, 4-((3-((2-hydroxy-3-(((-4-methoxyphenyl)amino)carbonyl)naphth-1-yl)azo)-4-methylbenzoyl)amino)-, calcium salt 2:1;
C.I. 15915;
Pigment Red 247:1;
PV Fast Red HB;
PV Red HBTH;
PV Red HG
Chemical group
Discrete organics
Chemical sub-group
Monoazo Organic Color Pigments (Naphthol AS pigments III)
Chemical formula
C32H26N4O7S.1/2Ca
Chemical structure
Image of Chemical structure
SMILES
O=S(=O)(c3ccc(cc3)NC(=O)c4cc(c(cc4)C)N=Nc5c(c(cc2ccccc52)C(=O)Nc1ccc(cc1)OC)O)O[Ca]
Molecular mass
610.65 g/mol

Based on information submitted in response to a legal Notice published in 2006 under section 71 of CEPA 1999, Pigment Red 247 was not manufactured in Canada in 2005 in a quantity meeting the 100 kg reporting thresholds. One company reported importing up to 1,000 kg into Canada in 2005 for activities described as Wholesale Trade/Distribution of Chemical (except agricultural) and Allied Products. It can be used as colourants in printing inks, in rubber and plastic products, and in paints, lacquers and varnishes. It may also be present in pesticides as inert ingredients.

THE CHALLENGE

Based on the information presented in Appendix II of this document, it is expected that the screening assessment of this substance will conclude that it satisfies the definition of toxic under section 64 of CEPA 1999 in that it “may enter 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”. The substance will then be proposed for addition to the List of Toxic Substances in Schedule I of the Act and proposed for virtual elimination of releases to the environment.

Subsequent risk management activities will be based on the objective of eliminating the release of a measurable quantity of a PBiT substance to the environment. In the absence of further information on existing handling practices for these substances, proposed actions would be based on realistic worst case assumptions. At this time, prohibition is being considering 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 and/or the Food and Drugs Act.

Opportunity to Submit Information on P, B and iT Properties

Through the categorization exercise, available experimental aquatic toxicity information as well as experimental data on the potential for a substance to persist or bioaccumulate in the environment were collected prior 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 the categorization outcome on P, B, and iT form the basis for prioritizing this substance for action, and experimental data are preferred, interested parties have an opportunity to provide relevant experimental study information on the persistence, bioaccumulation, and inherent toxicity to aquatic organisms for this substance.

Efforts should focus on providing data for the endpoints for which quality experimental data does not already exist, as demonstrated by the information summarized in Appendix II 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 & Polymers”.[1]

Responses to this part of the challenge for this substance should be received at the address provided below by June 5, 2007.

Section 71 Notice

Information needed for improved decision-making with regard to risk assessment and management of this substance is being gathered using section 71 of CEPA 1999. This notice applies to any person who reported pursuant to the Canadian Environmental Protection Act, 1999 section 71 Notice with Respect to Selected Substances Identified as Priority for Action, published in the Canada Gazette, Part I, on March 4, 2006.

The 2006 information mandated through the notice relates to, among other things, quantity of the substance imported, manufactured or used, types of uses of the substance, and releases of the substance to the environment.

Copies of the section 71 notice and guidance on how to comply with it are available from the Government of Canada Chemicals Portal (www.chemicalsubstanceschimiques.gc.ca/en/index.html), or from the contact provided below.

Responses to the section 71 notice must be received at the address provided below by June 5, 2007.

Opportunity to Submit Additional Information on Current Uses and Existing Control Measures to Inform the Risk Management Approach for this Substance

The Ministers of Health and Environment are inviting the submission of additional information that is deemed beneficial by interested stakeholders, relating to the extent and nature of the management/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 invited in the following areas:

  • 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
  • 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 the challenge 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 Chemicals Portal (www.chemicalsubstanceschimiques.gc.ca/en/index.html), 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 June 5, 2007.

Request for Documents and Submission of Information

Documents and instructions may be requested from the following contact. Information in response to the above Challenge must be submitted to this address.

DSL Surveys Coordinator
Place Vincent Massey, 20th Floor
351 Saint Joseph 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

Appendix I
Human Health Information to Support the Challenge for
4-[[3-[[2-Hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]benzenesulfonic acid, calcium salt (2:1)
(Pigment Red 247) CAS No. 43035-18-3

Introduction

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 (GPE) and those among a subset of substances considered persistent (P) and/or bioaccumulative (B) that are also considered to be “inherently toxic” to humans.

In order to efficiently identify substances that represent the highest priorities for screening assessment, Health Canada developed and applied a Simple Exposure Tool (SimET) to the DSL to identify those substances that meet the criteria for GPE, Intermediate Potential for Exposure (IPE) or Low Potential for Exposure (LPE), and a Simple Hazard Tool (SimHaz) to identify those substances that pose a high or low hazard.

Pigment Red 247 is considered to meet the criteria for LPE under SimET and does not meet the criteria for high hazard under SimHaz. This document summarizes the currently available information on which the SimET and SimHaz results are based.

Exposure Information from Health Related Components of DSL Categorization

As mentioned above, SimET was developed and used to identify substances on the DSL considered to represent GPE. This approach was based on three lines of evidence: 1) the quantity in commerce in Canada, 2) the number of companies involved in commercial activities in Canada (i.e., number of notifiers), and 3) the consideration by experts of the potential for human exposure based on various use codes. The proposed approach was released for public comment in November 2003 and also enabled designation of substances as presenting an IPE or LPE, based on criteria for quantity and nature of use (Health Canada, 2003)

Results of the Application of SimET

Pigment Red 247 has been determined to be LPE based on a consideration of the DSL nomination information listed below.

Nomination Information for DSL

Quantity in Commerce

The quantity reported to be manufactured, imported or in commerce in Canada during the calendar year 1986 was 1,000 kg

Number of Notifiers

The number of notifiers for the calendar years 1984-1986 was less than 4.

Use Codes and Description

The following DSL use codes have been identified for the substance:

13
Colourant - pigment/stain/dye/ink
85
Pigment, Dye and Printing Ink
86
Plastics

Hazard Information from Health Related Components of DSL Categorization

Simple Hazard Tool (SimHaz)

SimHaz is a tool that has been used to identify, among all of the approximately 23 000 substances on the DSL, those considered to present either high or low hazard to human health based on formalized weight of evidence criteria and/or peer review/consensus of experts. This tool has been developed through extensive compilation of hazard classifications of Health Canada and other agencies and consideration of their robustness based on availability of transparent documentation of both process and criteria (Health Canada, 2005).

Results of the Application of SimHaz

Pigment Red 247 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

SimET and SimHaz have been developed as robust tools for effectively identifying substances from the DSL considered to be human health related priorities for further consideration. It is recognized that they do not include 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.

References

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..
http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/existsub/exposure/greatest_potential_human_exposure-risque_exposition_humaine_e.pdf

Health Canada. 2005. Proposed Integrated Framework for the Health-Related Components of Categorization of the Domestic Substances List under CEPA 1999 http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/contaminants/existsub/framework-int-cadre_e.pdf

Appendix II
Ecological Information to Support The Challenge for
4-[[3-[[2-Hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]benzenesulfonic acid, calcium salt (2:1)
(Pigment Red 247) CAS No. 43035-18-3

The information in this document will form the basis of a screening assessment under section 74 of CEPA, 1999. Data relevant to an ecological screening assessment were identified in original literature, review documents, commercial and government databases prior to December 2005. Properties and characteristics may also have been estimated using Quantitative Structure Activity Relationship (QSAR) models. In addition, an industry survey was conducted for the year 2005 through a Canada Gazette Notice issued pursuant to section 71 of CEPA 1999 (Environment Canada, 2006). This Notice requested data on the Canadian manufacture and import of the substance.

Physical and chemical properties

There is no empirical physical-chemical property data available. Table 1 contains modelled physical-chemical properties of Pigment Red 247 which are relevant to its environmental fate.

Table 1. Physical and chemical properties

Property
Type
Value
Reference
Boiling point
Modelled
964.07 oC
MPBPWIN v1.41
Melting point
Modelled
349.84 oC
MPBPWIN v1.41
Vapour Pressure
Modelled
2.653 x 10-24 Pa/
1.99 x 10-26 mm Hg
MPBPWIN v1.41
Henry’s Law Constant
Modelled
2.358 x 10-23 atm-m3/mole
HenryWin v3.10
log Kow
Modelled
7.46
Kowwin v.1.67
log Koc
Modelled
6.36
PCKOCWIN v1.66
Water solubility
Modelled
4.45 x 10-05 mg/L
WSKOWWIN v1.41

Manufacture, Importation, and Uses

Manufacture and Importation

In Canada, no manufacture of Pigment Red 247 was reported in response to a CEPA section 71 survey notice for the 2005 calendar year in a quantity meeting the 100kg reporting threshold. In total, one company reported import of this substance in the 100-1,000 kg/year range (Environment Canada, 2006). Similar quantity was reported to the DSL during the calendar year 1986 (see Appendix I).

According to information from the US Environmental Protection Agency (EPA), the import/production of Pigment Red 247 was in the order of 4.5 – 225 tonnes in 1994, 1998, and 2002, but no consumption was reported in 1986 or 1990.

The Substances in Preparations in Nordic Countries (SPIN) database indicates that consumption in Sweden during 1999 – 2004 was in the range of 2 – 6 tonnes per year (SPIN, 2000).

Uses

There are 4 categories of potential uses for Pigment Red 247 that have been identified or suggested in Canada and worldwide:

  1. Pigment for colouring printing inks - used in the areas of publishing, printing, and reproduction of recorded media (SPIN, 2000).
  2. Paint, lacquers and varnishes - used in the areas of treatment and coating of fabricated metal products, machinery and equipment, or in areas of construction industry (SPIN, 2000).
  3. Colorant in manufacture of rubber and plastic products. Pigment Red 247 is contained in polyethylene terephthlate articles, including dual-ovenable trays (US Food and Drug Administration, 2006).
  4. Inert Ingredients in pesticides (USEPA, 2004).

Similar uses were reported to the DSL during the calendar year 1986 (see Appendix I).

Releases, Fate, and Presence in the Environment

Releases

Pigment Red 247 is not naturally produced in the environment. Data concerning the environmental releases of the pigment in Canada are not available. Since the pigment is not manufactured in Canada, the possible release to waste water effluent during the production phase is negligible. According to its major applications in printing inks, paints, and as plastic colorants, Pigment Red 247 may be released to the environment in a dispersive manner (Environment Canada 2006). It is assumed that the predominant release route is through weathering of such products, and to landfills at the end of their life cycle. The de-inking process for paper recycling and residue rinse during the processing phase could lead to release through wastewater treatment plants (STPs). The STP effluents and leaching from landfill may lead to soil and ground water exposure.

Fate

The high log Kow and Koc values indicate this substance will likely partition to soil and sediments. Indeed, the results of the Level III Fugacity modelling indicates that if this pigment is released equally to the three major environmental compartments (air, water, and soil), it will partition in water, soil, and sediments, with the latter two being the predominant compartments (Table 2), where the chemical has been indicated to persist (see Table 3).

Table 2. Results of the Level III fugacity modelling (EPIWIN V3.12)


Fraction of Substance Partitioning to Each Medium (%)
Substance Released to:
% in Air
% in Water
% in Soil
% in Sediment
Air (100%)
0.25
0.19
85.10
14.50
Water (100%)
0.00
1.30
0.00
98.70
Soil (100%)
0.00
0.00
99.8
0.19
Air, water, soil (33.3% each)
0.02
0.73
44.00
55.30

If the substance is released solely to air, a vapour pressure of 2.65 x 10-24 Pa and Henry’s Law constant of 2.36 x 10-23 atm-m3/mole indicates its partitioning to air will be negligible. The major two media where these substances will partition will be soil and sediment (> 99 %) and a very small amount of the pigment will partition in water (~ 0.45 %) due to the substance’s low water solubility.

If released to soil, Pigment Red 247 is expected to have extremely high adsorptivivity to soil (i.e. expected to be immobile) based upon estimated log Koc of > 6. Volatilization from dry or moist soil surfaces seems to be an unimportant fate process based upon the low estimated Henry's Law constant and vapour pressure. Therefore, if released to soil, Pigment Red 247 will mainly partition in this environmental compartment, which can be illustrated by the results of the Level III fugacity modelling (Table 2).

If released into water, Pigment Red 247 is expected to strongly adsorb to suspended solids and sediment based upon extremely high values of estimated Koc. Volatilization from water surfaces is expected to be an unimportant fate process based upon this compounds’ estimated Henry's Law constant. Thus, if water is a receiving medium, this pigment is expected to mainly partition in sediments and, to some extent, in water (Table 2). Pigment Red 247 is expected to persistent in water with half-life of more than 182 days according to the model prediction (BIOWIN v4.02, Ultimate survey, Table 3).

Presence in the Environment

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

Evaluation of P, B and iT Properties

Environmental persistence

Once released into the environment, Pigment Red 247 appears to be relatively persistent in water, soil and sediments. The Level III Fugacity model indicates negligible partitioning of the substance in air. For the small amount of the pigment that may partition in air, the predicted atmospheric oxidation half-life of 0.387 day (Table 3) suggests that in air, it seems to be rapidly oxidized. The pigment is not expected to react, or react appreciably, with other photo oxidative species in the atmosphere, such as O3 and NO3, nor is it likely to degrade via direct photolysis. Therefore, it is expected that reactions with hydroxyl radicals will be the most important fate process in the atmosphere for the substance. With a half-life of less than half a day via reactions with hydroxyl radicals, Pigment Red 247 is not persistent in air.

Table 3. Modelled persistence data for Pigment Red 247

Medium
Fate Process
Degradation Value
Degradation Endpoint
Reference
Air
atm-oxidation
0.387
half-life (days)
AOPWIN v1.91
Water/soil
Biodegradation
182
half-life (days)
BIOWIN v4.02, 
Ultimate survey
Water/soil
Biodegradation
0
probability
BIOWIN v4.02, MITI Linear Probability
Water/soil
Biodegradation
0
probability
BIOWIN v4.02, MITI Non-linear Probability
Water/soil
Biodegradation
0
probability
TOPKAT v6.1

For estimating degradation in water, soil and sediment, a QSAR weight-of-evidence approach (ESD, 2006a) was applied using the models shown in Table 3. Based on these results shown in the table, the estimated timeframes for biodegradation indicate that Pigment Red 247 can be considered as persistent in water and soil. This substance is not expected to hydrolyse.

To extrapolate to a half-life in sediments, an approach has been developed using Boethling’s extrapolation factors (BIOWIN v4.02), which involves extrapolating the half life in sediment from that estimated for water (t1/2 water : t1/2 sediment = 1:4). Therefore, in sediments, the half-life for Pigment Red 247 is expected to exceed 728 days.

The long-range transport potential (LRTP) of this pigment from its point of release to air is estimated to be low according to the model prediction presented in Table 4. The TaPL3 model was used to estimate Characteristic Travel Distance (CTD), defined as the maximum distance traveled by 63% of a substance; or in other words, the distance that 37% of the substance may travel beyond. Beyer et al (2000) have proposed CTD’s of >2000 km as representing high LRTP, 700-2000 km as moderate, and <700 km as low. Based on the result shown in Table 4, Pigment Red 247 is expected to remain primarily in the areas close to its emission sources.

Table 4. Model Predicted Characteristic Travel Distance (CTD) for Pigment Red 247

Characteristic Travel Distance
Model (Reference)
474 km
TaPL3 (CEMC, 2003)

The modelled data (Table 3) demonstrate that Pigment Red 247 meets the persistence criteria (half-life in soil and water ≥ 182 days, in sediments ≥365 days) as set out in the Persistence and Bioaccumulation Regulations (Government of Canada 2000).

Potential for bioaccumulation

There is no empirical bioaccumulation data available for this substance. The modelled log Kow value for Pigment Red 247 indicates that this substance has the potential to bioaccumulate in the environment.

The Modified GOBAS BAF middle trophic level model produced BAF values from 3890451 L/kg wet weight, indicating that this substance has the potential to bioconcentrate and biomagnify in the environment. The GOBAS BCF and BCF OASIS models also provide a weight-of-evidence to support the bioconcentration potential of the substance.

Table 5. Modelled bioaccumulation data

Test Organism
Endpoint
Value wet wt
Reference
Fish
BAF
3890451 L/kg
Gobas BAF T2MTL (Arnot & Gobas, 2003)
Fish
BCF
20893 L/Kg
Gobas BCF T2LTL (Arnot & Gobas, 2003)
Fish
BCF
30903 L/kg
OASIS, 2005
Fish
BCF
10 L/kg*
BCFWIN v2.15    

* Default value for non-ionisable azo pigments.

The modelled bioaccumulation values do not take into account the metabolism potential of the substance. Studies on structurally similar Naphthol AS pigments demonstrated negligible metabolism of these pigments (Danish EPA, 1998).

The weight of evidence indicates that Pigment Red 247 meets the bioaccumulation criterion (BCF, BAF ≥ 5000) as set out in the Persistence and Bioaccumulation Regulations (Government of Canada 2000).

Ecological Effects

In the Aquatic Compartment

There is no empirical ecotoxicity data available for this substance. The models suggest that this substance causes harm to aquatic organisms at relatively low concentrations (e.g., acute LC50 < 1 mg/L).

Table 6. Modeled aquatic toxicity values for Pigment Red 247

Organism
Endpoint
Duration
Concentration (mg/L)
Reference
Fish
LC50
96 h
0.269901
ASTER, 1993  
Fish
LC50
14 d
0.007787936
ECOSAR v.0.99h

A range of aquatic toxicity predictions were obtained from the various QSAR models considered. Table 6 lists those predictions that were considered reliable and were used in the QSAR weight-of-evidence approach for aquatic toxicity (ESD, 2006a). These results indicate that Pigment Red 247 is highly hazardous to aquatic organisms (i.e. acute LC/EC50 ≤ 1.0 mg/L).

In Other Media

No effects studies for non-aquatic non-mammalian organisms were found for this compound.

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 (Government of Canada, 2000) together with evidence of commercial activity provides a significant indication of its potential to be entering the environment under conditions that may have harmful long term ecological effects (ESD, 2006b). Substances that are persistent remain in the environment for a long time, 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. Evidence that a substance is both highly persistent and bioaccumulative, when taken together with other information (such as evidence of toxicity at relatively low concentrations, and evidence of uses and releases) may therefore be sufficient to indicate that the substance has the potential to cause ecological harm.

The volume of Pigment Red 247 imported into Canada was in the range of one tonne per year. The quantities of the pigment contained in imported printing and painted materials, coloured plastics, etc. are not available. The dispersive use of the pigment indicates potential for releases into the Canadian environment. Once released in the environment, because of its resistance to degradation, Pigment Red 247 will remain in water, sediment and soil for a long period of time . As it persists in the environment, it will likely bioaccumulate and may be biomagnified in trophic food chains. It has also demonstrated relatively high toxicity. This information suggests that Pigment Red 247 has the potential to cause ecological harm in Canada.

Uncertainties

The uncertainties exist in the conclusions reached in this document because all P, B, iT evaluations are based on model data. There were no empirical studies available relating to the persistence, bioaccumulation and toxicity of the pigment. The information on environmental concentration or monitoring data in Canada and long term low level exposure of Pigment Red 247 is also lacking.

The experimental or predicted concentrations, associated with inherent toxicity for aquatic organisms, may have an additional source of uncertainty in some situations, e.g. where these concentrations exceed the solubility of the chemical in water (either experimental or predicted). Given that concentrations for both the toxicity and water solubility often vary considerably (up to several orders of magnitude), it is acknowledged that these uncertainties exist.

Regarding toxicity, based on the predicted partitioning behaviour of the substance, the significance of soil and sediments as important media of exposure is not well addressed by the effects data available. Indeed, the only effects data identified apply primarily to pelagic aquatic exposures, although the water column may not be the medium of primary concern based on partitioning estimates.

There is also uncertainty associated with basing the overall conclusion that Pigment Red 247 may be causing ecological harm, solely on information relating to its persistence, bioaccumulation, relative toxicity and use pattern. Typically quantitative risk estimates (i.e., risk quotients or probabilistic analyses) are important lines of evidence when evaluating a substance’s potential to cause environmental harm. However, when risks for persistent and bioaccumulative substances such as this pigment are estimated using such quantitative methods, they are highly uncertain and are likely to be underestimated (ESD, 2006b). Given that long term risks associated with persistent and bioaccumulative substances cannot at present be reliably predicted, quantitative risk estimates have limited relevance. Furthermore, since accumulations of such substances may be widespread and are difficult to reverse, a conservative response to uncertainty (that avoids underestimation of risks) is justified.

References

AOPWIN v1.91. 2000. U.S. Environmental Protection Agency.
http://www.epa.gov/oppt/exposure/pubs/episuite.htm

Arnot, J.A. and Gobas, F.A.P.C. 2003. A Generic QSAR for Assessing the Bioaccumulation Potential of Organic Chemicals in Aquatic Food Webs. QSAR Comb. Sci. 22(3): 337-345.

ASTER. 1993. Assessment Tools for the Evaluation of Risk. U.S. Environmental Protection Agency. Environmental Research Laboratory, Duluth, MN.
http://www.epa.gov/med/Prods_Pubs/aster.htm

BCFWIN. 2000. Version 2.15. U.S. Environmental Protection Agency. http://www.epa.gov/oppt/exposure/pubs/episuite.htm

Beyer, A., Mackay, D., Matthies, M., Wania. F, and Webster, E. 2000. Assessing Long-Range Transport Potential of Persistent Organic Pollutants. Environ. Sci. Technol. 34 (4): 699-703.

BIOWIN. 2000. Version 4.02. U.S. Environmental Protection Agency. http://www.epa.gov/oppt/exposure/pubs/episuite.htm

CEMC (Canadian Environmental Modelling Centre) 2003. TaPL3 v. 3.00 model. Released September 2003. Trent University, Peterborough, Ontario. www.trentu.ca/academic/aminss/envmodel

CEPA 1999. Canadian Environmental Protection Act, 1999. 1999, c. 33. C-15.31. [Assented to September 14th, 1999]. http://laws.justice.gc.ca/en/C-15.31/text.html

Danish EPA. 1998. Survey of azo-colorants in Denmark: Consumption, use, health and environmental aspects. Ministry of Environment and Energy, Denmark.

ECOSAR 2004. Version 0.99h. U.S. Environmental Protection Agency. http://www.epa.gov/oppt/exposure/pubs/episuite.htm

Environment Canada. 2003. Guidance Manual for the Categorization of Organic and Inorganic Substances on Canada’s Domestic Substances List. Existing Substances Branch, Environment Canada, Gatineau, Canada, 124 p.

Environment Canada. 2006. Data collected pursuant to subsection 71(1) of the Canadian Environmental Protection Act, 1999 and in accordance with the published notice “Notice with respect to Selected Substances identified as Priority for Action”, Canada Gazette, Part 1, Vol. 140, No. 9.

EPIWIN. 2000. Version 3.12 U.S. Environmental Protection Agency.
http://www.epa.gov/oppt/exposure/pubs/episuite.htm

ESD (Existing Substances Division) 2006a. Guidance Module on "Quantitative Structure-Activity Relationships (QSARs)". Guidance for Conducting Ecological Risk Assessments Under CEPA 1999: Science Resource Technical Series, Environment Canada, Internal document available on request.

ESD (Existing Substances Division) 2006b. Issue paper on "Approach to Ecological Screening Assessments for Existing Substances that are both Persistence and Bioaccumulative". Environment Canada. The document may be obtained from the CD entitled "CEPA DSL Categorization: Overview and Results", that is periodically released by the Existing Substances Division, and is also available on request.

Government of Canada. 2000. Persistence and Bioaccumulation Regulations (SOR/2000-107). Canada Gazette, v. 134. Available at http://www.ec.gc.ca/CEPARegistry/regulations/detailReg.cfm?intReg=35 (accessed August, 2006).

HENRYWIN. 2000. Version 3.10. U.S. Environmental Protection Agency.
http://www.epa.gov/oppt/exposure/pubs/episuite.htm

KOWWIN. 2000. Version 1.67. U.S. Environmental Protection Agency.
http://www.epa.gov/oppt/exposure/pubs/episuite.htm

MPBPWIN. 2000. Version 1.41. U.S. Environmental Protection Agency.
Information available to http://www.epa.gov/oppt/exposure/pubs/episuite.htm

Oasis Forecast. 2005. Version 1.20. Laboratory of Mathematical Chemistry. Bourgas, Bulgaria. Information available at
www.oasis-lmc.org

PCKOCWIN. 2000. Version 1.66. U.S. Environmental Protection Agency.
http://www.epa.gov/oppt/exposure/pubs/episuite.htm

SPIN (Substances in Preparations in Nordic Countries) database. 2000. Available at http://www.spin2000.net

USEPA. 2004. Inert Ingredients Ordered Alphabetically by Chemical Name - List 3 Updated August 2004. Available at http://www.epa.gov/opprd001/inerts/inerts_list3name.pdf

Topkat. 2004. Version 6.1. Accelrys, Inc.
http://www.accelrys.com/products/topkat/index.html

US Food and Drug Administration, 2006. Available at http://www.cfsan.fda.gov/~dms/opa-torx.html

WSKOWWIN. 2000. Version 1.41. U.S. Environmental Protection Agency.


[1] “Guidelines for the Notification and Testing of New Substances: Chemicals & Polymers (version 2005)”, Government of Canada, Available from http://www.ec.gc.ca/substances/nsb/eng/cp_guidance_e.shtml


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.

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