Help the Government of Canada organize its website!

Complete an anonymous 5-minute questionnaire. Start now.

Screening Assessment for The Challenge
Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]-2,4,6-trimethyl, disodium salt
(Acid Violet 48)

Chemical Abstracts Service Registry Number
72243-90-4


Environment Canada
Health Canada

February 2009

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, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]-2,4,6-trimethyl-, disodium salt (Acid Violet 48), Chemical Abstracts Service Registry Number 72243-90-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it was originally 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 Acid Violet 48 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. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Acid Violet 48 is a discrete organic chemical that is used in Canada and elsewhere as a colorant dye for textiles as well as a component in cleaning products. In Canada, this substance is primarily imported in already formulated cleaning products, and to a smaller degree, as a pure substance for integration into cleaning products or for use as an acid dye in textiles.

This substance is not naturally produced in the environment. Between 100 and 1000 kg of Acid Violet 48 were imported into Canada in 2006. Reported uses and the dispersive use patterns of this substance indicate that it could be released into the Canadian environment. It is predicted that most of this substance ends up in wastewater and to a lesser degree in waste disposal sites. Acid Violet 48 is not expected to be significantly present in other media.

Based on the review of the available empirical data for other similar dyes and the substance’s physical and chemical properties (particularly its existence as an anion in water), it is concluded that Acid Violet 48 does not have the potential to bioaccumulate to a significant extent in aquatic organisms. Furthermore, recently identified empirical and analogue acute aquatic toxicity values suggest that this substance is not highly hazardous to aquatic organisms. However, Acid Violet 48 does not degrade quickly in the environment and is expected to be persistent in water, soil and sediments. This substance has been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

For this screening assessment, reasonable worst case industrial and consumer use exposure scenarios were selected in which Acid Violet 48 is discharged into the aquatic environment. The predicted environmental concentration in water (PEC) was more than one order of magnitude below the predicted no-effect concentration (PNEC) for fish, pointing to a low risk to aquatic organisms.

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

Based on the information available, it is concluded that Acid Violet 48 does not meet any of the criteria set out in section 64 of CEPA 1999.

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; 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 those substances identified as high priorities.

The substance Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]-2,4,6-trimethyl-, disodium salt (hereafter referred to as “Acid Violet 48”) was identified as a high priority for assessment of ecological risk as it had been found to be persistent, bioaccumulative and inherently toxic to aquatic organisms and is believed to be in commerce in Canada. The Challenge for Acid Violet 48 was published in the Canada Gazette on August 18, 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 Acid Violet 48 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.

Under CEPA 1999, screening assessments 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

  1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
  2. constitute or may constitute a danger to the environment on which life depends; or
  3. constitute or may constitute a danger in Canada to human life or health.”

Screening assessments examine scientific information and develop conclusions by incorporating a weight-of-evidence approach and precaution as required under CEPA 1999. 

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 May 2008. Key studies were critically evaluated; modelling results may have been used to reach conclusions. When available and relevant, information presented in hazard assessments 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, a draft of this screening assessment was subject to a 60-day public comment period. While external comments were taken into consideration, the final content and outcome of the screening risk assessment remain the responsibility of Health Canada and Environment Canada. The critical information and considerations upon which the assessment is based are summarized below.

Substance Identity

Acid Violet 48 is defined by the Colour Index (CII 2002−) as a combination of multiple Chemical Abstracts Service Registration Numbers (CAS RN), including CAS RN 12220-51-8. However, for the purposes of the present report and the assessment of this substance, the common name Acid Violet 48 refers exclusively to the CAS RN 72243-90-4.

Table 1. Substance identity of Acid Violet 48

Chemical Abstracts Service Registry Number (CAS RN)

72243-90-4

DSL name1

Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-
[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]
-2,4,6-trimethyl-, disodium salt

National Chemical Inventories (NCI) names2

Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-
[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]
-2,4,6-trimethyl-, sodium salt (1:2)
(TSCA);
Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-
[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]
-2,4,6-trimethyl-, disodium salt (
AICS, PICCS, ASIA-PAC, NZIoC);
disodium 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulphonato-4-
(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthryl]amino]
-2,4,6-trimethylbenzenesulphonate
(EINECS);

Other names

3-({4-Amino-9,10-dihydro-9,10-dioxo-3-[sulfonato-4-
(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthryl}amino)
-2,4,6-trimethylbenzenesulfonate de disodium;

Sanolin Violet FBL; C.I. Acid Violet 48

Chemical group
(DSL stream)

Discrete organics

Chemical sub-group

Anthracenediones

Chemical formula Image of Chemical Structure CAS RN 72243-90-4
Chemical structure C37H38N2Na2O9S2
SMILES CC1=CC(=C(C(=C1NC2=CC(=C(C3=C2C(=O)
C4=CC=CC=C4C3=O)N)OC5=C(C=C(C=C5)
C(C)(C)CC(C)(C)C)S(=O)(=O)[O-])C)S(=O)(=O)
[O-])C.[Na+].[Na+]
Molecular mass 764.82 g/mol
1 DSL (Domestic Substance List)
2 Source: National Chemical Inventories (NCI) 2007: AICS (Australian Inventory of Chemical Substances); ASIA-PAC (Asia-Pacific Substances Lists); DSL (Canadian Domestic Substances List); EINECS (European Inventory of Existing Chemical Substances); NZIoC (New Zealand Inventory of Chemicals); PICCS (Philippine Inventory of Chemicals and Chemical Substances); TSCA (Toxic Substances Control Act Chemical Substance Inventory).

Physical and Chemical Properties

Few experimental physical and chemical data are available for Acid Violet 48.

It was determined at the Environment Canada-sponsored Quantitative Structure-Activity Relationship (QSAR) Workshop in 1999 that the inherent properties of many of the structural classes of dyes and pigments (including acid and disperse dyes) are not amenable to model prediction because they are considered “out of the model domain of applicability” (e.g., structural and/or property parameter domains) (Environment Canada 2000). As a result, the applicability of QSAR models to dyes and pigments is reviewed on a case-by-case basis. It has been considered inappropriate to use predictive quantitative structure-activity relationship (QSAR) models to determine many physical and chemical parameters of Acid Violet 48.

Consequently, available experimental data have been used, applying a “read-across” approach to determine the approximate physical and chemical properties of Acid Violet 48. The read-across values included in this screening assessment represent data available for compounds that share the same chemical class as Acid Violet 48, namely acid, ionic dyes. When possible, ranges of values are given in order to provide an indication of uncertainties.  

Table 2 contains experimental and read-across physical and chemical properties of Acid Violet 48 that are relevant to its environmental fate. 

Table 2. Physical and chemical properties for Acid Violet 48

Property Type Value Temperature
(°C)
Reference
Physical state Experimental Purple powder Room temperature Environment Canada 2008a
Experimental Violet granule, odourless n/a1 MSDS 2003
Decomposition point
(°C)
Experimental >200 n/a MSDS 2003
Read-across >250-300 n/a ETAD 1995
Vapour pressure (Pa) Read-across < 10-13 to 10-8 n/a ETAD 1995
Henry's Law constant
(Pa·m3/mol)
Calculated2 ~1.2 × 10-11 25  
Log Kow
(Octanol-water
partition coefficient)
(dimensionless)
Read-across <3 n/a ETAD 1995
Log Koc3
(Organic carbon-water
partition coefficient)
(dimensionless)
  n/a    
Water solubility
(mg/L)
Experimental 90 000 90 MSDS 2003
Experimental ~ 60 000 25 Clariant 2007
Read-across Readily soluble n/a ETAD 1995
pKa
(Acid dissociation constant)
(dimensionless)
  n/a    
1 n/a = not available
2 Calculated using the following physical and chemical properties: water solubility (WS), vapour pressure (VP) and molecular weight (MW), using the following formula: (VP/WS)MW. Water solubility at 60 000 mg/L and upper range limit of 10-8 Pa for vapour pressure were used in the calculation.
3 Highly soluble ionic substances such as acid dyes are not expected to undergo adsorption to solids as a function of the octanol-carbon partition coefficient (little or no solubility in n-octanol). However, acid dyes have been observed to have a high degree of adsorption to positively charged substrates; sulfonic acid groups of acid dyes react with the amide groups in fibres such as nylon, silk and wool. Dyes (including acid dyes) have been observed to adsorb to sediments, and be removed to sludge in sewer treatment plants via adsorption (ETAD 1995).

In addition, empirical toxicity data from two analogues: benzenesulfonic acid, 3,3'-[(9,10-dihydro-9,10-dioxo-1,4 anthracenediyl)diimino]bis[2,4,6-trimethyl-, disodium salt (CAS RN 4474-24-2) and 9,10-anthracenedione, 1,4-bis[(4-methylphenyl)amino]-, sulfonated, potassium salts (CAS RN 125351-99-7), listed in Table 3, were used in support of the weight of evidence.

Table 3. Structural analogues for Acid Violet 48

i. Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulfo-4-(1,1,3,3-tetramethyl
butyl)phenoxy]-1-anthracenyl] amino]-2,4,6-trimethyl-,disodium salt (CAS RN 72243-90-4)

ii.  Benzenesulfonic acid, 3,3'-[(9,10-dihydro-9,10-dioxo-1,4 anthracenediyl)diimino]bis[2,4,6-trimethyl-, disodium salt
(CAS RN 4474-24-2)

iii.  9,10-Anthracenedione, 1,4-bis[(4-methylphenyl)amino]-, sulfonated, potassium salts
(CAS RN 125351-99-7)

Image of Chemical Structure CAS RN 72243-90-4 Image of Chemical Structure CAS RN 4474-24-2 Image of Chemical Structure CAS RN 125351-99-7
  • CAS RN 125351-99-7 and 4403-90-1 are reasonable ecotoxicological analogues of CAS RN 72243-90-4 (Acid Violet 48) due to the similarities in the number and position of SO3 groups.
  • The presence of the NH2 group and an additional SO3 group (that does not have a defined position) are the two most relevant differences between the chemical structure of CAS RN 72243-90-4 and those of CAS RN 4403-90-1 and 125351-99-7.
  • CAS RN 4403-90-1 and 125351-99-7 are good analogues for toxicity of CAS RN 72243-90-4 (Acid Violet 48).

Sources

Acid Violet 48 is not naturally produced in the environment.

Recent information was collected through industry surveys conducted for the years 2005 and 2006 under a Canada Gazette notice issued pursuant to section 71 of CEPA 1999 (Canada 2006 and 2007b). This notice requested data on the Canadian manufacture, import and use of the substance.

In 2006, two companies reported importing this substance, and collectively they imported between 100 and 1000 kg of the substance. No companies reported manufacturing Acid Violet 48 above the prescribed reporting threshold of 100 kg/year in Canada. No companies reported using a total quantity greater than 1000 kg of the substance, whether alone, in a mixture, in a product or in a manufactured item, at any concentration in 2006. In the Declaration of Non-Engagement form associated with the section 71 survey for 2006, five companies reported a stakeholder interest in this substance.

In 2005, two companies reported importing a combined amount of this substance in the range of 100–1000 kg/year. No companies reported manufacturing Acid Violet 48 in quantities above the prescribed reporting threshold of 100 kg/year. No companies identified themselves as having a stakeholder interest in the substance.

It should be noted that an additional quantity of Acid Violet 48 likely enters Canada in imported products that were not identified in the section 71 surveys, either because the importer is not aware of its presence in manufactured items, or it is present in quantities below the 100 kg reporting threshold for the survey.

In the U.S., between 10 000 and 500 000 pounds (4.54 to 22.7 tonnes) of Acid Violet 48 were reported to be manufactured and/or imported in each of the following years: 1986, 1990, 1994, 1998 (US EPA 2007). Acid Violet 48 was not reported to be manufactured or imported in the U.S. in 2002 (US EPA 2007). Acid Violet 48 is an existing chemical in Europe, but is not featured on the low or high production volume chemicals lists (ESIS 2008). Acid Violet 48 was in use in at least one of Denmark, Sweden, and Finland during 1999 to 2005 (SPIN 2007).

Uses

In 2006, one company imported the substance into Canada in a product (liquid laundry detergent) and this accounted for the majority of importation of the substance that was reported for that year. The use pattern code given by this company and the other importing companie was “Colorant – pigment – stain – dye – ink” and both companies appear to be wholesalers and distributors of chemicals.

In 2005, importing companies gave the NAICS codes for chemical wholesale and distribution, and “Textile and Fabric Finishing and Fabric Coating Mills”. 

In the U.S., Acid Violet 48 is indicated for use in textile mills products (CDC 2007) and is also registered as an inert pesticide formulant (US EPA 2004). Acid Violet 48 is not registered as a pesticide formulant in Canada (PMRA 2007). In Finland, Acid Violet 48 was used in the manufacture of textiles from 2002 to 2004 (SPIN 2007).

Releases to the Environment

No releases of Acid Violet 48 into the environment were identified. However, given the dispersive use of this substance in cleaning products, widespread release into the sewer is expected.

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 toward the end of the life-cycle. 

Table 4. Estimated releases and losses of Acid Violet 48 to environmental media, chemical transformation and distribution to management processes, based on the Mass Flow Tool1

Fate Proportion of
the mass
(%)
Major life cycle
stage involved
Released to receiving media:
  Soil 0.8 Consumer use
Air 0 n/a2
Sewer* 88.2 Consumer use,
formulation, manufacture
Chemically transformed 0 n/a
Transferred to waste disposal sites
(e.g., landfill, incineration)
11 Product-waste disposal
1For Acid Violet 48, information from the following OECD emission scenario documents was used to estimate releases to the environment and the distribution of the substance as summarized in this table: OECD 2004, 2006a and 2006b. Values presented for release to environmental media do not account for possible mitigation measures that may be in place at some locations (e.g., partial removal by sewage treatment plants). Specific assumptions used in the derivation of these estimates are summarized in Environment Canada 2007a.
2Not applicable.
* Wastewater before any form of treatment.

Mass Flow Tool results presented in Table 4 indicate that the majority of Acid Violet 48 (about 88%) is expected to be released into water (sewer), due to the wide dispersive consumer use, and through the formulation process into consumer products. A lesser amount (11%) is expected to be transferred to waste disposal sites. This substance is not expected to be chemically transformed. In addition, unless specific information on the rate or potential for release of the substance from landfills and incinerators is available, the Mass Flow Tool does not quantitatively account for releases from waste disposal sites into the environment. No such information has been identified for Acid Violet 48. It should be noted, however, that long-term releases from waste disposal sites may be possible. Finally, it is estimated that less than 1% of Acid Violet 48 may be released into soil and there are likely no releases of this substance into air.

Based on the above, wastewater will receive the greatest proportion of Acid Violet 48, as this substance is emitted during product manufacturing, processing and use. The release of Acid Violet 48 from imported cleaning products is expected when the products are used by consumers. The fate of unfixed dye released to sewers is unknown and will depend on the presence or absence of a sewage treatment plant.

Environmental Fate

As indicated by the Mass Flow Tool results, most of Acid Violet 48 is released into wastewater during the consumer use of manufactured products and formulation/manufacture processes associated with preparation of consumer end products. Therefore, discharge of Acid Violet 48 into water is the most relevant release scenario for Canada. When released into water, Acid Violet 48 will likely remain in this medium, due to its high water solubility (60 000–90 000mg/L). However, because they dissociate to form anions in water acid dyes have a high rate of fixation to positively charged substrates and can adsorb to positively charged particulates (e.g., nitrogen-containing particles), and consequently can settle out to bed sediments or wastewater treatment plant sludge (ETAD 1995). Acid Violet 48 may be applied to soil with wastewater treatment plant sludge used for soil enrichment. Sludge may also be deposited in landfills. Volatilization from dry or moist soil surfaces seems to be an unimportant fate process based upon the low estimated vapour pressure and Henry’s Law constant. If released to soil due to its high water solubility Acid Violet 48 may migrate to the water phase of soil (e.g., groundwater) or undergo surface runoff associated with particles.

Given the use in aqueous-based dye treatments and products, Acid Violet 48 will not be released to air and is not expected to partition to this compartment based on a very low Henry’s Law constant. Moreover, air is not considered to be a transport medium for dyes (including acid dyes), as these substances exhibit low or negligible volatility (ETAD 1995).

Persistence and Bioaccumulation Potential

Environmental Persistence

According to the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers, with some exceptions, dyes are considered essentially non-biodegradable under aerobic conditions (ETAD 1995). Repeated evaluation of ready and inherent biodegradability using accepted screening tests (see the OECD Guidelines for the Testing of Chemicals website) have confirmed this assumption (Pagga and Brown 1986; ETAD 1992). Based on the chemical structure of Acid Violet 48, there is no reason to suspect that biodegradation will be other than that described for dyes generally (ETAD 1995).

Inherent biodegradation of Acid Violet 48 was evaluated using a Zhan-Wellens test (Safepharm Laboratories 1991) using a mixed population of activated sewage sludge microorganisms. The results of this test indicated that Acid Violet 48 attained 18% degradation within 28 days and therefore cannot be considered inherently biodegradable. Furthermore the low degradation percentage (i.e., < 20%) indicates that the substance’s ultimate degradation half-life is likely to be > 180 days (Aronson et al. 2006), and that that primary degradation is also likely to be slow.

In addition to the available empirical biodegradation data for Acid Violet 48, QSAR biodegradation models shown in Table 5 below were applied. Given the expected release into waste water, persistence was primarily examined using predictive QSAR models for biodegradation in water. Because these degradation models are structure-based, their results are considered reliable since chemicals of structural comparability to Acid Violet 48 are contained in their training sets. Acid Violet 48 does not contain functional groups expected to undergo hydrolysis (dyes are designed to be stable in aqueous conditions).

Table 5. Modelled data for persistence of Acid Violet 48

Model

Model and model basis

Result

 

Interpretation

Extrapolated half-life (days)

Extrapolation
reference
and/or source

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 1: Linear probability

-0.569

Does not biodegrade fast

n/a1

 

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 2: Non-linear probability

0

Does not biodegrade fast

n/a

 

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 3: Expert Survey (ultimate biodegradation)

0.869

Recalcitrant

180

US EPA 2002

720

Aronson et al. 2006

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 4: Expert Survey (primary biodegradation)

2.15

Months

60

US EPA 2002;
Aronson et al. 2006

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 5: MITI linear probability

-0.89

Does not biodegrade fast

> 60

Aronson et al. 2006

Biodegradation (aerobic)

BIOWIN 2000
Sub-model 6: MITI non-linear probability

0

Does not biodegrade fast

> 60

Aronson et al. 2006

Biodegradation (anaerobic)

BIOWIN 2000
Sub-model 7: Linear probability

-4.09

Does not biodegrade fast

n/a

 

Biodegradation

BIOWIN 2000
Overall Conclusion

no

Not ready biodegradable

n/a

 

Biodegradation (aerobic)

TOPKAT 2004
Probability
(MITI 1)

Out of acceptable domain

n/a

n/a

n/a

Biodegradation (aerobic)

CATABOL
c2004−2008
% BOD2
(OECD 301C)

0.6

Persistent
(< 20%)

> 182

Calculated from
BOD2 assuming
first-order-rate
kinetics

1 Not available.
2 Biochemical oxygen demand (BOD)

According to the results presented in Table 5, all the probability models (BIOWIN 1, 2, 5, 6 and 7) suggest this substance does not biodegrade rapidly. In fact, all probability results are less than 0.3, the cut-off suggested by Aronson et al. (2006) below which substances are expected to have a half-life > 60 days (based on the MITI probability models) and less than 0.5, the cut-off suggested by the model developers below which biodegradation is not considered to be fast. The half-life from the primary survey model (BIOWIN 4) result of “months” is suggested to mean approximately 60 days (US EPA 2002; Aronson et al. 2006), although the identity of potential degradation products is not known. The ultimate survey model (BIOWIN 3) result of “recalcitrant” is suggested to mean approximately 180 days by the US EPA (2002) and 720 days by Aronson et al. (2006). The substance is also not expected to degrade rapidly under favourable anaerobic conditions, as indicated by the model BIOWIN 7. The overall conclusion from BIOWIN (2000) is that this substance is not readily biodegradable.

Another ultimate degradation model, CATABOL, predicts only 0.6% biodegradation for Acid Violet 48 based on the OECD 301 28-day ready biodegradation test (% BOD), which has been suggested to mean likely persistent (Aronson and Howard 1999) and having a half-life in water of > 182 days (assuming first-order-rate kinetics). The model TOPKAT did not produce any acceptable results as the substance was out of its domain of applicability.

When the results of the BIOWIN models and CATABOL are considered, the weight of evidence suggests that the ultimate degradation half-life of Acid Violet 48 in water is > 182 days, which is consistent with what would be expected for a chemical with this structure. Although there is some potential for primary degradation, the estimated half-life is relatively long (months) and the nature of the degradation products is not known.

Using a 1:1:4 for a water:soil:sediment half-life extrapolation ratio (Boethling et al.1995), the ultimate degradation half-life in soil is also > 182 days and the half-life in sediments is > 365 days.

Based on the results of predictive modelling, Acid Violet 48 meets the persistence criteria for water and soil (half-life in soil and water ≥ 182 days) as well as sediments (half-life in sediments ≥ 365 days) as set out in the Persistence and Bioaccumulation Regulations (Canada 2000).

Potential for Bioaccumulation

Empirical data for bioaccumulation of Acid Violet 48 are not available. Furthermore, predictive QSAR models could not be used to estimate a reliable log Kow for Acid Violet 48 because they are structure-based models that do not account for the partitioning behaviour of this substance.

Anionic dyes such as Acid Violet 48 tend to be highly soluble in water (ETAD 1995). This is due to the presence of a sulfonic acid group, with additional sulfonic groups further increasing the molecule’s solubility. Acid Violet 48 has two sulfonic acid groups (see Table 1 for molecular structure).  

In fact, Acid Violet 48 is readily soluble in water (60 000 to 90 000 mg/L), as presented in Table 2. Studies performed by the Ecological and Toxicological Association of Dyes and Organic Pigment Manufacturers (ETAD) (Anliker et al. 1981; Anliker and Moser 1987), have demonstrated that ionic (hydrophilic) dyes such as Acid Violet 48 generally exhibit a log Kow value < 3 as well as a high water solubility (ETAD 1995). Consequently Acid Violet 48 is expected to have a low potential to bioaccumulate/bioconcentrate in aquatic biota.

It has been stated by ETAD (1995) that the molecular characteristics indicating the absence of bioaccumulation are a molecular weight of > 450 g/mol and a cross-sectional diameter of > 1.05 nm. Recent investigation by Dimitrov et al. (2002), Dimitrov et al. (2005) and the BBM (2008) suggests that the probability of a molecule crossing cell membranes as a result of passive diffusion declines significantly with increasing maximum cross-sectional diameter (Dmax). The probability of passive diffusion lowers appreciably when cross-sectional diameter is > ~1.5 nm and more significantly for molecules having a cross-sectional diameter of >1.7 nm. Sakuratani et al. (2008) have also investigated the effect of cross-sectional diameter on passive diffusion from a test set of about 1200 new and existing chemicals. They also observed that substances not having a very highly bioconcentration potential often have a Dmax (>2.0 nm) and an effective diameter (Deff) >1.1 nm.

Acid Violet 48 has a molecular weight of 764.82 g/mol (see Table 1); this characteristic does not indicate a bioaccumulation capability of this substance if molecular weight is used as the only parameter. An Environment Canada (2007b) report points out that there are no clear relationships for establishing strict molecular size cut-offs for assessing bioaccumulation potential. However, the report does not dispute the notion that a reduction in uptake rate can be associated with increasing cross-sectional diameter as demonstrated by Dimitrov et al. (2002, 2005). The maximum diameter of Acid Violet 48 and its conformers ranges from 0.54 to 2.04 nm (BBM 2008) suggesting that a potential for a reduced uptake rate and in vivo bioavailability exists with this dye.

The weight of evidence indicates that Acid Violet 48 does not meet the bioaccumulation criteria (BCF, BAF ≥ 5000) as set out in the Persistence and Bioaccumulation Regulations (Canada 2000).

Potential to Cause Ecological Harm

Ecological Effects Assessment

There are few suitable empirical ecotoxicity data available for Acid Violet 48; therefore, analogue data were also considered. Two structural analogues of Acid Violet 48 are presented in Table 3. Based on the available experimental evidence and the properties of the relevant functional groups of Acid Violet 48, this substance is not expected to cause harm to aquatic organisms at low concentrations (e.g., acute LC50 > 1 mg/L) (see Table 6).

A - In the Aquatic Compartment

Aquatic toxicity predictions for Acid Violet 48 obtained using predictive QSAR models were considered unreliable and are not included. These models lack the ability to accurately estimate log Kow for this substance.

Limited suitable toxicity data exist for Acid Violet 48. Therefore, in addition, analogue data for two anthracendione dyes, CAS RN 4474-24-2 and CAS RN 125351-99-7, are employed in the discussion of the aquatic toxicity of this substance.

Table 6. Empirical data for aquatic toxicity

CAS RN Test organism Type of test Endpoint Value
(mg/L)
Reference
4474-24-2 Rainbow trout
(Oncorhynchus
mykiss
)
Acute LC501 75 Environment
Canada 2007c
125351-99-7 Guppy
(Poecilia
reticulate
)
Acute LC50 14.3 Häner 1996
72243-90-4 Rainbow trout
(Oncorhynchus
mykiss
)
Acute 48 hr LC50 ~ 33 MSDS 2003
Rainbow trout
(Oncorhynchus
mykiss
)
Acute 96 hr LC50 > 10 and
< 100
Environment
Canada 2008a
Bacteria
(species
unspecified)
Respiratory
Inhibition Test,
OECD No. 209
50% inhibition > 100 Van Dijk 1988
1LC50 - Lethal concentration affecting 50% of the test population.

Two toxicity studies in rainbow trout for Acid Violet 48 were obtained (Table 6). They indicate an acute LC50 value of > 10 mg/L. It should be noted, however, that the experimental and methodological details were not available for these studies. Therefore, they are considered very limited and are not presented as the only weight of evidence for the aquatic toxicity of Acid Violet 48. However, since results of these studies appear to support the existing knowledge about ionic dyes such as Acid Violet 48, they were found acceptable for presentation in this report.

Experience with new dyes at Environment Canada and the United States Environmental Protection Agency (US EPA) Office of Pollution Prevention and Toxics (OPPT) has shown that, in general, the number of sulfonic acid groups determines potential for toxicity of a substance. Dyes with one or two sulfonic acid groups have been shown to exhibit moderate to high acute toxicity (< 1–10 mg/L), while dyes with more than two sulfonic acid groups have shown low acute (> 100 mg/L) and chronic (> 10 mg/L) toxicity to most aquatic biota (Environment Canada 2003). Acid Violet 48 contains two sulfonic acid groups and thus the analogue data, also for dyes with two sulfonic acid groups, are considered a good approximation of the expected effects of Acid Violet 48 on aquatic organisms.

Studies for two analogue anthracendione acid dyes, CAS RN 4474-24-2 and CAS RN 125351-99-7, presented in Table 6, show LC50 values > 10 mg/L in two fish species, O. mykiss and P. reticulate. Both of these analogue dyes have two sulfonic acid groups, indicating a potential for moderate to high acute toxicity (Environment Canada 2003). However, the experimental results for these analogues suggest that Acid Violet 48 is likely to be only moderately toxic to aquatic organisms.

Both the available empirical ecotoxicity information for Acid Violet 48 and its chemical analogues indicate that this substance is not likely to cause harm to aquatic organisms at low concentrations (e.g., acute LC50 > 1 mg/L).

B - In Other Environmental Compartments

Effects studies for non-aquatic non-human organisms were not found for Acid Violet 48. As such, effect levels for this substance have not been estimated for soil and sediments. However, Acid Violet 48 could be released to soil from waste disposal or transferred to sediment after release to water. Therefore, it would have been preferable to have had toxicity data for soil and sediment-dwelling organisms.

Ecological Exposure Assessment

No information concerning the concentration of Acid Violet 48 in the environmental media (air, water, soil, sediment) in Canada has been identified. Therefore, environmental concentrations of this substance are estimated using models.

Environment Canada conducted quantitative comparison of exposure and of ecological effects for Acid Violet 48 as a further indication of its potential to cause ecological harm. In this context, Environment Canada estimated that approximately 76% of Acid Violet 48 is imported inside cleaning products, 12% is formulated into cleaning products in Canada, and 12% is used as an acid dye for textiles. These estimates are based on information gathered from the CEPA 1999 section 71 notice for the 2006 calendar year (Canada 2007b). In that year, Acid Violet 48 was imported into Canada by two companies with a total quantity in the range of 100−1000 kg/year for use in cleaning products and as textile dyes (Environment Canada 2008a).

As Acid Violet 48 is used in industrial facilities and can be released to water, Environment Canada’s Industrial Generic Exposure Tool – Aquatic (IGETA) was employed to estimate a conservative substance concentration in a generic water course receiving industrial effluents (Environment Canada 2008b).

The generic scenario is designed to provide these estimates based on conservative assumptions regarding the amount of chemical processed and released, the number of processing days, the sewage treatment plant removal rate and the size of the receiving watercourse. 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 predicted environmental concentration (PEC).

The PEC for Acid Violet 48 was calculated based on a use quantity of 1000 kg/year for a single facility (based on the high end of the range 100−1000 kg/year range reported (Environment Canada 2008a)). It was assumed that 5 % of this quantity was lost to water during handling and processing, that 0% was removed in an STP and that the STP discharged into a generic small river. The equation and inputs used to calculate the PEC in the receiving watercourse are described in Environment Canada (2008c).

The water PEC, resulting from industrial releases, is 0.0056 mg/L (Environment Canada 2008c).

Mega Flush, Environment Canada’s spreadsheet model for estimating down-the-drain releases from consumer uses, was also employed to estimate the potential substance concentration in multiple water bodies across Canada receiving sewage treatment plant effluents to which consumer products containing the substance may have been released (Environment Canada 2008d). The spreadsheet model is designed to provide these estimates based on conservative assumptions regarding the amount of chemical used and released by consumers. By default, we assume losses from use to be 100%, consumer use of the substance to be over 365 days/year, and the flow rate used at all sites was conservatively chosen to be the 10th percentile value for the receiving water body. Primary and secondary STP removal rates of 42% and 66% respectively were used, which were obtained from the SimpleTreat STP model (SimpleTreat 1997). PEC estimates were made for approximately 1000 release sites across Canada, which account for all of the major STPs in Canada.

The equation and inputs used to calculate the predicted environmental concentration (PEC) of Acid Violet 48 in the receiving water bodies are described in Environment Canada (2008e). The scenario was run assuming a use quantity of 1000 kg/year based on the high end of the 100−1000kg/year range reported (Environment Canada 2008a).

Using this scenario, the tool estimates that the PEC in the receiving water bodies ranges from 5.3x10-3 to 7.2x10-3 mg/L (Environment Canada 2008e).

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 precaution as required under CEPA 1999. Particular consideration has been given to potential for environmental exposure, persistence, bioaccumulation, and potential to cause toxicity.

Acid Violet 48 is determined to be persistent based on experimental and modelled biodegradation data. However Acid Violet 48 does not have the potential to bioaccumulate significantly in aquatic organisms based on the review of the available empirical data for other similar dyes and the substance’s physical and chemical properties (particularly its existence as an anion in water). Furthermore, recently identified empirical and analogue acute aquatic toxicity data suggest that this substance is only moderately hazardous to aquatic organisms.

Risk quotients were calculated as ratios of predicted environmental concentrations (PECs) to the predicted no-effect concentration (PNEC). The PNEC value was obtained using the LC50 value of 33 mg/L for rainbow trout exposed to Acid Violet 48 (see Table 2) and dividing by an assessment factor of 100 to account for both the inter/intra-species variability in sensitivity and extrapolation from a laboratory estimated acute effect concentration to a chronic no effect concentration in the field.

Dividing the industrial PEC of 0.0056 mg/L by this PNEC yields a conservative risk quotient that is well below 1 (0.017) and a more than 50-fold margin of safety. This indicates that industrial releases of Acid Violet 48 pose little risk to aquatic organisms.

Similarly PECs for exposures resulting from down-the-drain releases using a moderately conservative consumer-use MegaFlush scenario were well below the predicted no-effect concentration (PNEC) at all sites examined (i.e., all risk quotients < 1). This indicates that down-the-drain consumer releases of Acid Violet 48 also pose little risk to aquatic organisms.

Considering these findings and given that this chemical is imported in relatively low quantities, it is concluded that Acid Violet 48 is unlikely to be causing ecological harm in Canada.

Uncertainties in Evaluation of Ecological Risk

The evaluation of physical and chemical properties, persistence, bioaccumulation potential and aquatic toxicity of Acid Violet 48 based on the available information presented in this document is considered to be relatively robust. However, the general lack of empirical studies designed specifically for this substance required the use of predictive models, analogues and read-across data to evaluate its properties.

The lack of supporting evidence from empirical studies is a source of uncertainty in the evaluation of certain physical and chemical properties as well as in the bioaccumulation assessment.

There are also uncertainties due to the lack of information on environmental concentrations in Canada (e.g., monitoring data) for Acid Violet 48. Consequently some conservative assumptions were made when using models to estimate concentrations near point sources. 

Although it is possible that the total mass of the substance in commerce has been underestimated - because of its unreported presence in down-the-drain consumer products imported into Canada – any releases associated with such uses would be spread over wide areas and the resulting exposure concentrations should thus be lower than those resulting from industrial releases and thus are also expected to pose little risk.

In addition, based on the anticipated release pattern for the substance as well as its potential for persistence in soil and sediment, the significance of exposure in these media is not addressed. Indeed, the only effects data identified apply primarily to pelagic aquatic exposures. In the exposure assessment, the predicted environmental concentration (PEC) values for Acid Violet 48 account for concentrations in water only, and thus exposure through soils, suspended solids and sediments is not considered. However given the relatively low amounts of this substance imported into Canada and its relatively low toxicity to aquatic organisms, Acid Violet 48 is likely to pose little risk to either soil or sediment-dwelling organisms in Canada.

Conclusion

Based on the information presented in this screening assessment, it is concluded that Acid Violet 48 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.

It is therefore concluded that Acid Violet 48 does not meet the definition of “toxic” as set out in section 64 of CEPA 1999. Additionally, Acid Violet 48 does not meet criteria for bioaccumulation potential but meets criteria for persistence as set out in the Persistence and Bioaccumulation Regulations (Canada 2000).

References

Anliker R, Clarke EA, Moser P. 1981. Use of the partition coefficient as an indictor of bioaccumulation tendency of dyestuffs in fish. Chemosphere 10(3):263-274.

Anliker R., Moser P. 1987. The limits of bioaccumulation of organic pigments in fish: their relation to the partition coefficient and the solubility in water and octanol. Ecotoxicol Environ Saf 13(1):43-52.

[BBM] Baseline Bioaccumulation Model. 2008. Gatineau (QC): Environment Canada, Existing Substances Division. [Model developed based on Dimitrov et al. 2005].

[BIOWIN] Biodegradation Probability Program for Windows [Estimation Model]. 2000. Version 4.02. Washington (DC): US Environmental Protection Agency, Office of Pollution Prevention and Toxics; Syracuse (NY): Syracuse Research Corporation. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

Boethling, RS, Howard, PH, Beauman, JA, Larosche, ME 1995. Factors for intermedia extrapolations in biodegradability assessment. Chemosphere 30(4): 741-752.

Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33. Canada Gazette. Part III. vol. 22, no. 3. Available from: http://canadagazette.gc.ca/partIII/1999/g3-02203.pdf

Canada. 2000. Canadian Environmental Protection Act: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March, 2000, SOR/2000-107, Canada Gazette. Part II, vol. 134, no. 7, p. 607-612. Available from: http://canadagazette.gc.ca/partII/2000/20000329/pdf/g2-13407.pdf

Canada, Dept. of the Environment, Dept. of Health. 2006. Canadian Environmental Protection Act, 1999: Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment. Canada Gazette, Part I, vol. 140, no. 49, p. 4109–4117. Available from: http://canadagazette.gc.ca/partI/2006/20061209/pdf/g1-14049.pdf

Canada, Dept. of the Environment, Dept. of Health. 2007a. Canadian Environmental Protection Act, 1999: Notice of third release of technical information relevant to substances identified in the Challenge. Canada Gazette, Part I, vol.141, no. 33, p.2375−2379. Available from: http://canadagazette.gc.ca/partI/2007/20070818/pdf/g1-14133.pdf

Canada, Dept. of the Environment. 2007b. Canadian Environmental Protection Act, 1999: Notice with respect to Batch 3 Challenge substances. Canada Gazette, Part I, vol. 141, no. 33, p. 2379−2394. Available from: http://canadagazette.gc.ca/partI/2007/20070818/pdf/g1-14133.pdf

[CDC] Centres for Disease Control and Prevention (US). 2007. National Occupational Survey conducted from 1981 to 1983 [Internet]. CAS RN 72243-90-4. Atlanta (GA): Centres for Disease Control and Prevention, National Institute for Occupational Safety and Health. [cited 2008 April]. Available from: www.cdc.gov/noes/noes1/x9739sic.html

[CII] Colour Index International [database on the Internet]. 2002-. 4th Ed. Bradford (UK) : Society of Dyers and Colourists; Research Triangle Park (NC): American Association of Textile Chemists and Colorists. [cited 2008 April]. Available from: http://www.colour-index.org/

Clariant. 2007. Product Data Sheet: Dyes for Detergents [Internet]. Muttenz (CH): Clariant. Sanolin Violet FBL, Acid Violet 48. [cited 2008 Feb 14]. Available from: http://www.clariant.com/C1256A2A001CDFF0/wvbysalesrange/
AD94D9A2F88285EDC1256B1B00366A74

Dimitrov S, Dimitrova N,Walker J, Veith G, Mekenyan O. 2002. Predicting bioconcentration potential of highly hydrophobic chemicals. Effect of molecular size. Pure and Appl Chem 74(10): 1823-1830.

Dimitrov S, Dimitrova N, Parkerton T, Comber M, Bonnell M, Mekenyan O. 2005. Base-line model for identifying the bioaccumulation potential of chemicals. SAR QSAR Environ Res 16(6):531–554.

Environment Canada. 2000. Chemicals Evaluation Division. Environmental Categorization for Persistence, Bioaccumulation and Inherent Toxicity of Substances on the Domestic Substances List Using QSARs. Final Report. Environment Canada. July.

Environment Canada. 2003. Guidance Manual for the Categorization of Organic and Inorganic Substances on Canada 's Domestic Substance List: Determining Persistence, Bioaccumulation Potential, and Inherent Toxicity to Non-Human Organisms [CD-ROM]. 124 p. Gatineau (QC): Environment Canada, Existing Substances Division. Available on request.

Environment Canada. 2007a. Assumptions, limitations and uncertainties of the mass flow tool for Acid Violet 48, CAS RN 72243-90-4. Internal draft document. Available from: Environment Canada, Existing Substances Division, Ottawa, KIA 0H3.

Environment Canada. 2007b. Review of the limitations and uncertainties associated with use for molecular size information when assessing bioaccumulation potential. Unpublished Final Report. Gatineau (QC): Environment Canada, Existing Substances Division. Available on request.

Environment Canada. 2007c. Data for Batch 2 substances collected undertheCanadian Environmental Protection Act, 1999, Section71:Notice with respect to certain Batch 2 Challenge substances. Prepared by: Environment Canada, Health Canada, Existing Substances Program.

Environment Canada. 2008a. Data for Batch 3 substances collected underCanadian Environmental Protection Act, 1999, Section71: Notice with respect to Batch 3 Challenge substances. Prepared by: Environment Canada, Health Canada, Existing Substances Program.

Environment Canada. 2008b. Guidance for conducting ecological assessments under CEPA, 1999: science resource technical series, technical guidance module: the Industrial Generic Exposure Tool – Aquatic (IGETA). Working document. Gatineau (QC): Environment Canada, Existing Substances Division.

Environment Canada. 2008c. IGETA report: CAS 72243-90-4, 2008-07-16. Unpublished report. Gatineau (QC): Environment Canada, Existing Substances Division.

Environment Canada. 2008d. Guidance for conducting ecological assessments under CEPA, 1999: science resource technical series, technical guidance module: Mega Flush consumer release scenario. Preliminary draft working document. Gatineau (QC): Environment Canada, Existing Substances Division.

Environment Canada. 2008e. Mega Flush report: CAS RN 722-43-90-4,  2008-05-22. Unpublished report. Gatineau (QC): Environment Canada, Existing Substances Division.

[ESIS] European Substances Information System [database on the Internet]. 2008. Version 5.10. European Chemical Bureau (ECB). [cited 2008 April]. Available from: http://ecb.jrc.it/esis

[ETAD] Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers. 1992. ETAD project E3020-data summary (disperse dyes). Unpublished results summary. Submitted to Environment Canada, Existing Substances Division by ETAD in May 2008.

[ETAD] Ecological and Toxicological Association of Dyes and Organic Pigments Canadian Affiliates, Dayan J, Trebitz H, consultants. 1995. Health and environmental information on dyes used in Canada. Unpublished report submitted to Environment Canada, New Substances Division. On the cover: An overview to assist in the implementation of the New Substances Notification Regulations under the Canadian Environmental Protection Act.

Häner A (BMG Engineering Ltd.). 1996. Sandolan Gruen MF-BL: 96-hour toxicity study to Poecilia reticulata (Guppy). Muttenz (GH): Clariant International Ltd. Report No.: 512-96.17 p. Internal study requested by Environment Canada, Existing Substances Division.

[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. [Jan 2008]. Available from: www.epa.gov/oppt/exposure/pubs/episuite.htm

[MSDS] Material Safety Data Sheet [Internet]. 2003. St-Laurent (QC): Clariant (Canada) Inc. Sanolin Violet FBL, CAS RN 72243-90-4. [cited 2007 Jan 18]. Available from: http://www.msdsonline.com. Restricted access.

[NCI] National Chemical Inventories [database on CD-ROM]. 2007. Issue 2. Columbus (OH): American Chemical Society. [cited 2008 March]. Av ailable from: http://www.cas.org/products/cd/nci/index.html

[OECD] Organisation for Economic Co-operation and Development. 2004. Draft Emission Scenario on Textile manufacturing wool mills [Internet]. ENV/JM/EEA(2004)8/1/REV, JT00175156 [cited 2008 Feb]. Prepared by Environment Canada, New Substances Division. Available from: http://www.oecd.org/dataoecd/2/47/34003719.pdf

[OECD] Organisation for Economic Co-operation and Development. 2006a. Emission Scenario Document on Adhesive Formulation. Revised Draft. ENV/JM/EEA(2006)2, JT03213460. Prepared by US Environmental Protection Agency.

[OECD] Organisation for Economic Co-operation and Development. 2006b. Emission Scenario Document on Coating Industry (paints, lacquers, varnishes). Draft document. ENV/JM/EEA(2006)12, JT03213540. Prepared by UK Environment Agency.

[PMRA] Pest Management Regulatory Agency. 2007. Regulatory Note REG 2007-04: PMRA list of formulants [Internet]. Ottawa (ON): Health Canada, Pest Management Regulatory Agency. CAS RN 72243-90-4; [cited 2008 April]. Available from: http://www.pmra-arla.gc.ca/english/pdf/reg/reg2007-04-e.pdf

Safepharm Laboratories. 1991. Assessment of inherent biodegradability, Zahn-Wellens test [CAS RN 72243-90-4]. Derby (UK) : Safepharm Laboratories. Report No.: S0052/E328. 3p. Unpublished report submitted to Environment Canada, Existing Substances Division by Clariant in April 2008.

SimpleTreat, version 3.0. Software program developed by The National Institute for Public Health and the Environment (RIVM) for sewage treatment plant removal predictions, released 1997, available from Jaap Struijs, The National Institute for Public Health and the Environment (RIVM), Laboratory for Ecological Risk Assessment, PO Box 1, 3720 BA Bilthoven, The Netherlands, Email: j.struijs@rivm.nl

[SPIN] Substances in Products in Nordic Countries [database on the Internet]. 2007. Financed by the Nordic Council of Ministers, Chemical group. [cited 2008 April]. Available from: http://195.215.251.229/Dotnetnuke/Home/tabid/58/Default.aspx

[TOPKAT] Toxicity Prediction Program [Internet]. 2004. Version 6.2. San Diego (CA): Accelrys Software Inc. Available from: http://www.accelrys.com/products/topkat/index.html

[US EPA] US Environmental Protection Agency. 2004. Complete List of Other (intert) Ingredients Permitted in Pesticide Products, Inert ingredients ordered by CAS number [Internet]. Washington (DC): U.S. EPA. CAS RN 72243-90-4; [cited 2008 Feb 29]. Available from: http://www.epa.gov/opprd001/inerts/completelist_inerts.pdf

[US EPA] US Environmental Protection Agency. 2007. Inventory Update Reporting, Past IUR Data, Non-confidential Production Volume Information submitted by companies under the 1986,1990,1994,1998, and 2002 Inventory Update Reporting Regulation, CAS RN 72243904 [Internet]. Washington (DC): US EPA; [cited 2007 Feb 28]. Available from: http://www.epa.gov/oppt/iur/tools/data/2002-vol.htm

Van Dijk A. 1988. Assessment of the acute toxicity of Sandolan Walkviolett N-FBL 180% on aerobic waste-water bacteria. Switzerland : RCC Umweltchemie. Study Project No. 216696. 12 p. Unpublished study submitted to Environment Canada, Existing Substances Division by Clariant in April 2008.