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File No: STD/1106 26 April 2006 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Chemical in Crodazosoft DBQ This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at: Library Australian Safety and Compensation Council 25 Constitution Avenue CANBERRA ACT 2600 AUSTRALIA To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email [email protected] This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at: Street Address: Postal Address: TEL: FAX Website: Director NICNAS 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA. GPO Box 58, SYDNEY NSW 2001, AUSTRALIA. + 61 2 8577 8800 + 61 2 8577 8888 www.nicnas.gov.au TABLE OF CONTENTS FULL PUBLIC REPORT ....................................................................................................................................... 4 1. APPLICANT AND NOTIFICATION DETAILS .................................................................................... 4 2. IDENTITY OF CHEMICAL ................................................................................................................... 4 3. COMPOSITION....................................................................................................................................... 4 4. INTRODUCTION AND USE INFORMATION ..................................................................................... 5 5. PROCESS AND RELEASE INFORMATION ........................................................................................ 5 5.1. Distribution, transport and storage .................................................................................................. 5 5.2. Operation description ...................................................................................................................... 5 5.3. Occupational Exposure ................................................................................................................... 5 End use: ............................................................................................................................................................. 6 5.4. Release ............................................................................................................................................ 6 5.5. Disposal .......................................................................................................................................... 7 5.6. Public exposure ............................................................................................................................... 7 6. PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 7 7. TOXICOLOGICAL INVESTIGATIONS ............................................................................................. 10 7.1. Irritation – skin – in vitro ..................................................................................................................... 10 7.2 Irritation – Eye Irritancy Potential Utilizing the HET-CAM test. ......................................................... 10 7.3 Skin sensitisation – human volunteers – Repeated Insult Patch Test .................................................... 11 8. ENVIRONMENT ................................................................................................................................... 13 8.1. Environmental fate ........................................................................................................................ 13 8.1.1. Ready biodegradability ............................................................................................................ 13 8.1.2. Bioaccumulation ...................................................................................................................... 13 8.2. Ecotoxicological investigations .................................................................................................... 13 8.2.1. Acute toxicity to fish ................................................................................................................ 13 8.2.2. Acute toxicity to aquatic invertebrates ..................................................................................... 13 8.2.3. Algal growth inhibition test ..................................................................................................... 14 9. RISK ASSESSMENT ............................................................................................................................ 16 9.1. Environment ................................................................................................................................. 16 9.1.1. Environment – exposure assessment ........................................................................................ 16 9.1.2. Environment – effects assessment ........................................................................................... 16 9.1.3. Environment – risk characterisation ......................................................................................... 16 9.2. Human health ................................................................................................................................ 17 9.2.1. Occupational health and safety – exposure assessment ........................................................... 17 9.2.2. Public health – exposure assessment ........................................................................................ 17 9.2.3. Human health – effects assessment .......................................................................................... 17 9.2.4. Occupational health and safety – risk characterisation ............................................................ 19 9.2.5. Public health – risk characterisation......................................................................................... 19 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS ........................................................................................................................................................ 19 10.1. Hazard classification ..................................................................................................................... 19 10.2. Environmental risk assessment ..................................................................................................... 20 10.3. Human health risk assessment ...................................................................................................... 20 10.3.1. Occupational health and safety ............................................................................................ 20 10.3.2. Public health ........................................................................................................................ 20 11. MATERIAL SAFETY DATA SHEET ............................................................................................. 20 11.1. Material Safety Data Sheet ........................................................................................................... 20 11.2. Label ............................................................................................................................................. 20 12. RECOMMENDATIONS................................................................................................................... 20 12.1. Secondary notification .................................................................................................................. 22 13. BIBLIOGRAPHY ............................................................................................................................. 22 Created on 6/26/2015 7:05:00 AM Last Saved 6/29/2015 9:11:00 AM File No: STD/1106 26 April 2006 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Chemical in Crodazosoft DBQ This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at: Library Australian Safety and Compensation Council 25 Constitution Avenue CANBERRA ACT 2600 AUSTRALIA To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email [email protected] This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at: Street Address: Postal Address: TEL: FAX Website: Director NICNAS 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA. GPO Box 58, SYDNEY NSW 2001, AUSTRALIA. + 61 2 8577 8800 + 61 2 8577 8888 www.nicnas.gov.au 26 April 2006 NICNAS FULL PUBLIC REPORT Chemical in Crodazosoft DBQ 1. APPLICANT AND NOTIFICATION DETAILS APPLICANT(S) Croda Singapore Pte Ltd (trading as Croda Australia) (ABN: 34 088 345 457) Suite A1, Ground Floor, 44-46 Mandarin Street Villawood NSW 2163 NOTIFICATION CATEGORY Standard: Chemical other than polymer (more than 1 tonne per year). EXEMPT INFORMATION (SECTION 75 OF THE ACT) Data items and details claimed exempt from publication: Import volumes Chemical name CAS number Molecular and structural formulae Molecular weight Spectral data Percentage of notified chemical in final products VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT) Variation to the schedule of data requirements is claimed as follows: All toxicological testing All ecotoxicological testing PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S) None NOTIFICATION IN OTHER COUNTRIES Canada (low level notification under the Food and Drugs Act) 2. IDENTITY OF CHEMICAL OTHER NAME(S) Quaternium 91 (INCI name) MARKETING NAME(S) Crodazosoft DBQ (notified chemical is component of this mixture) METHODS OF DETECTION AND DETERMINATION METHOD Remarks 3. IR, titration for free amine. Copy of IR spectrum of Crodazosoft DBQ provided. COMPOSITION DEGREE OF PURITY FULL PUBLIC REPORT: STD/1106 Page 4 of 23 26 April 2006 NICNAS > 80% 4. INTRODUCTION AND USE INFORMATION MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS The notified chemical will be imported as 50% of Crodazosoft DBQ. MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS Year Tonnes 1 <1 2 <1 3 <1 4 <1 5 <1 USE Ingredient in hair care products. 5. PROCESS AND RELEASE INFORMATION 5.1. Distribution, transport and storage PORT OF ENTRY Sydney IDENTITY OF MANUFACTURER/RECIPIENTS Manufacturers of hair care products TRANSPORTATION AND PACKAGING The notified chemical will be transported into Australia by ship in 75 kg heat-sealed plastic bags. The notified chemical will be transported from the dockside to the manufacturing site at Hornsby, NSW, where it will be stored and formulated into hair care products. The finished hair care product will be packaged into 250 mL plastic bottles. These plastic bottled products are then packed in cardboard cartons before being transported by truck or van to hairdressing salons or to a port for export. 5.2. Operation description At the formulation site the hair care products are formulated in batch sizes of 18,000 kg. Crodazosoft DBQ containing 50% of the notified chemical is poured into stainless steel containers filled with solvent for dissolution. The resulting mixture is transferred under vacuum into a second sealed blending vessel where other components of the hair products are added. Prior to packaging, sampling and quality testing of the preparation is carried out in the laboratory. The formulated hair care products are then transferred to a hopper with a multiple head filler machine and automatically poured into 250 mL plastic bottles. The finished hair care products will contain < 1% of the notified chemical. The bottled products will be packed in cardboard cartons and will be exported or sent to distribution centres for hairdressing outlets . 5.3. Occupational Exposure Number and Category of Workers Category of Worker Storage and transport Transporting from dock to Manufacturer’s site for reformulation (loading/unloading trucks) FULL PUBLIC REPORT: STD/1106 Number Exposure Duration Exposure Frequency 2-4 2-3 hours/day 2 days/year Page 5 of 23 26 April 2006 NICNAS Manufacture of hair care products: Formulation, filling containers, cleaning and maintenance 6 8 hours/day 72 days/year Quality control 1 4 hours/day 20 days/year 2-4 1-2 hours/day 150 days/year ~ 1000 8 hours/day 300 days/year Transport and storage of formulated hair care products to end users (hair dressers) End use: Product application by hairdressers Exposure Details Transport and storage Warehousing and distribution of the notified chemical involves loading, unloading, moving and storing of packaged notified chemical and packaged hair care products. No exposure is expected except in the case of accident. Manufacture of hair care products The mixing vessels are enclosed and the filling machines are automated and fitted with local exhaust ventilation to capture any volatile or aerosol materials at the source. However, dermal and limited ocular exposure may occur when opening and closing the drums and when adding the notified chemical manually into mixing vessel, and connecting and disconnecting transfer and filling lines. Dermal exposure may also occur due to drips and spills and if containers are overfilled at the filling station. Skin contamination may occur when maintenance workers are cleaning equipment and during maintenance of equipment. Workers involved in the above activities wear personal protective equipment such as, overalls, safety glasses, safety shoes and PVC or disposable latex gloves. Quality Control/Maintenance Limited dermal exposure to small quantities may occur during sampling and testing or during machine maintenance. To minimise exposure workers will wear laboratory coats, safety glasses and rubber gloves. End-use in hairdressing salons The bottled products will be sent to distribution centres for storage until distribution to retail or hairdressing outlets. Except in the case of accident, workers handling the finished product during distribution and retail would not be exposed to the notified chemical because of the closed containers, and even in the case of spills, the small packaging size and the low concentration of the notified chemical in the finished products would limit exposure. Intermittent dermal exposure to hairdressers is likely to occur when applying the hair care products to the hair of customers in salons, as gloves will probably not be used for this process. Based on similar products, the quantity used per application will be approximately 14 grams. Repeated exposure may occur through use of the product on different customers. Some accidental ocular exposure may occur. Inhalation exposure is not expected. The low concentration of the notified chemical in the hair care products (< 1%) will reduce the exposure of hairdressers. 5.4. Release RELEASE OF CHEMICAL AT SITE The notified chemical will not be manufactured in Australia. Local operations will include transport and storage, formulation, filling and packaging. FULL PUBLIC REPORT: STD/1106 Page 6 of 23 26 April 2006 NICNAS Release during transport Release to the environment may occur in the unlikely event of an accident during transport or an accidental spill. The notified chemical will be transported to Australia by ship in 75 kg heat-sealed plastic bags and will be transported directly to the formulation site. Release during formulation During the formulation of the hair care products up to 10 kg per annum of the notified chemical will be released into the environment as a result of residual in import containers, spills and equipment cleaning. Subsequent water washes will pass to interceptor pits where the settled material will be collected and disposed of to landfill. Wastewater will be used for gardening or recycled in the plant for other processing activities. Import containers will be rinsed and disposed off to landfill. The rinsate will be collected and disposed off to a liquid waste facility by licensed contractor. RELEASE OF CHEMICAL FROM USE Since the notified chemical will be used in hair care products, majority of the import volume is expected to be released to sewer. However, the notifier has indicated that 90% of the formulated products will be exported. Therefore, at the maximum rate of import rate ~100 kg per annum of the notified chemical is expected to be disposed of to sewers Australia wide. It is expected that up to 5 kg per annum of the notified polymer will be disposed of to landfill in empty product containers. 5.5. Disposal The plastic bags containing residual notified chemical will be disposed of to landfill. The plastic bottles in which the hair product will be sold to consumers and the residues they contain will be disposed of in domestic landfill or recycled. The majority of the notified chemical used in hair care products domestically will ultimately be disposed of to sewer. Spilt material will be contained by absorbent, placed into containers and disposed in landfill. 5.6. Public exposure The notified chemical will be used in the manufacture of wash-off hair care products. Public exposure will be widespread and will result through salon use of hair care products containing < 1% of notified chemical. It is expected that approximately 14 grams will be used per application and that application may occur up to once weekly. While deliberate dermal contact will occur and accidental eye contact may also occur, inhalation exposure is not expected. Public exposure during transport and storage is unlikely unless the packaging is breached. 6. PHYSICAL AND CHEMICAL PROPERTIES Physico-chemical properties are based on Crodazosoft DBQ, containing 50% of the notified chemical. Appearance at 20oC and 101.3 kPa Light yellow waxy solid with mild fatty amine odour. Melting Point 60-70 oC METHOD Not provided Boiling Point Not determined. Density Not determined Vapour Pressure Not determined. Remarks Given the ionic nature (quaternary ammonium salt) of the notified substance and FULL PUBLIC REPORT: STD/1106 Page 7 of 23 26 April 2006 NICNAS its high molecular weight it is anticipated that it will have a low vapour pressure. Water Solubility Remarks Not determined. It is not possible to measure the water solubility. The notified chemical contains aliphatic hydrocarbon chains coupled to a polar end group. This constitution indicates that the material will have surfactant properties and will form micelles in solution. Hydrolysis as a Function of pH Remarks The notified chemical contains an amide group, which may undergo hydrolysis at extreme temperatures and pH conditions. Partition Coefficient (n-octanol/water) Remarks Not Determined Based on the anticipated surface activity the substance would be expected to strongly adsorb to sediments. Quaternary ammonium compounds are known to react with dissolved organic carbon in water to form part of the sediments, and become completely inactivated on contact with soils (Nabholz JV, Miller P, Zeeman M, 1993). They have also been shown to adsorb on a wide variety of materials (Boethling RS, Lynch DG, 1992). Dissociation Constant Remarks Not determined. Contains quaternary ammonium groups that will be fully dissociated in an aqueous environment. The pH of Crodazosoft DBQ ranges from 6-8. Particle Size Remarks Not determined. The notified chemical is in a form of waxy solid flakes with diameter of 6-10mm. Flash Point Remarks Not determined. Flash point is not applicable as the notified chemical is in solid form. No solid flammability testing was conducted. Flammability Limits Remarks Not applicable The notified chemical is in solid form. Autoignition Temperature Remarks Not Determined The notified polymer has surface active properties. Thus, a reliable partition coefficient cannot be obtained. The notified chemical would be expected to partition to surfaces. Adsorption/Desorption Remarks Not determined Not determined. Not expected to self-ignite. Explosive Properties Remarks Not expected to be explosive Reactivity Remarks Under normal conditions the notified chemical is stable. The notified chemical is FULL PUBLIC REPORT: STD/1106 Page 8 of 23 26 April 2006 NICNAS incompatible with strong oxidising agents. Hazardous polymerization of the notified chemical will not occur. Hazardous decomposition products of the notified chemical are: oxides of carbon, nitrogen and sulphur. FULL PUBLIC REPORT: STD/1106 Page 9 of 23 26 April 2006 7. NICNAS TOXICOLOGICAL INVESTIGATIONS Toxicological data provided for Crodazosoft DBQ containing approximately 50% of the notified chemical are summarised in the table below. Endpoint and Result Assessment Conclusion Skin Irritation – in vitro (The MatTEK Corporation EpiDerm™ Skin Model In Vitro Toxicity Testing System) Skin Sensitisation, Human Volunteers, Repeated Insult Patch Test Eye Irritation – in vitro (HET-CAM test) Expected in vivo dermal irritancy potential in the moderate to mild range. When diluted with water to 5% was non-irritating and non-sensitising under the conditions of the test. Non-irritating as 5% solution. 7.1. Irritation – skin – in vitro TEST SUBSTANCE Crodazosoft DBQ METHOD The MatTek Corporation EpiDerm™ Skin Model In Vitro Toxicity Testing System Tissue Sample – Normal human epidermal keratinocytes cultured to form a multilayered, highly differentiated model of the human epidermis. Cell viability is determined by the activity of mitochondrial succinate dehydrogenase, which reduces a yellow, water-soluble, tetrazolium salt to a purple, insoluble formazan derivative. The amount of reduction is determined by spectrophotometry. Species/Strain Remarks – Method The cell layer is incubated with test substance and controls in microplates, extracted and the absorbance read at 570 nm. RESULTS Test Article Crodazosoft DBQ (100%* - 1hr) (100%* - 4.5 hr) (100%* - 20 hr) System Percent Inhibition EpiDerm Conclusion ~ 5 hr Moderate to mild ~ 2.9 Moderate 2 47 86 Triton X 100 EpiDerm (1% - 1 hr) (1% - 4.5 hr) (1% - 20 hr) *Moistened with 100 microliters of distilled water. Remarks – Results ET-50 22 63 95 The ET-50 is a measure of 50% cell viability. The irritation guidelines were according to the MatTek corporation. CONCLUSION Under the conditions of this test, the results indicate that Crodazosoft DBQ has an expected in vivo dermal irritancy potential in the moderate to mild range. The reference article, 1% Triton X 100, has an expected in vivo dermal irritancy potential in the moderate range. TEST FACILITY Consumer Products Testing (2002) 7.2 Irritation – Eye Irritancy Potential Utilizing the HET-CAM test. FULL PUBLIC REPORT: STD/1106 Page 10 of 23 26 April 2006 NICNAS TEST SUBSTANCE Crodazosoft DBQ (5% in distilled water) METHOD Fresh, fertile, White Leghorn eggs that were 7 days old were incubated for 10 days were used in this study. A cut in the large end of each egg where the air sack is located was made in the eggs. The shell was then removed down to the shell-membrane junction. The inner egg membrane was then hydrated with a warm, physiological saline solution. The saline was removed after 2 to 5 minute exposure. Remarks – Method The test or reference article at a dosage of 0.3ml of a liquid or 0.3g of a solid was administered to each of 4 chorioallantoic membranes (CAM). After 20 seconds the test or control material was rinsed from each CAM with saline. Observation periods were 0.5 seconds, 2 and 5 minutes. Previous studies have shown that the CAM of the hen’s egg is more sensitive to liquid irritants than is the rabbit eye. Therefore, the CAM results of the test article at a specific concentration equate to Draize results for the test article at 2 tomes that concentration. RESULTS Results show that Crodazosoft DBQ (5% solution) is non-irritating under the conditions of the test.. CONCLUSION Under the conditions of the test, the results indicate that Crodazosoft (5% distilled water) at 1%, 2% and 10% would have practically no irritation potential in vivo. (The CAM results for the test article at 0.5%, 1% and 5% are equivalent to Draize results for the test article at 1%, 2% and at 10%). TEST FACILITY Consumer Product Testing (2003) 7.3 Skin sensitisation – human volunteers – Repeated Insult Patch Test TEST SUBSTANCE Crodazosoft DBQ, (5% aqueous) METHOD Study Design The Repeated Insult (semi-occlusive) Patch Test (RIPT) Study Group Vehicle Induction Procedure Rest Period Challenge Procedure RESULTS Remarks – Results Fifty-four females and 7 males, ranging in age from 20 to 69 years completed the study. Water The upper back between the scapulae was administered with 0.2 ml of the test substance under a semi-occlusive patch 3 times per week for a total of 9 applications. Induction patches were removed after 24 hours. Two weeks A challenge patch was applied to a virgin site close to the induction site. Challenge sites were scored 24 and 72 hours post-application. All observations were within normal limits throughout the study. CONCLUSION A Repeated Insult Patch Test was conducted using Crodazosoft DBQ diluted with water to 5% under semi-occlusive dressing. The notified chemical was non-irritating and non-sensitising under the conditions of the test. TEST FACILITY RCTS (2002) In addition, published data (IUCLID 2000, CIR 1990, CIR 1991, CETOX 2001) on the following chemicals were used to provide information for other endpoints: Betaines, Imidazoline derivatives and FULL PUBLIC REPORT: STD/1106 Page 11 of 23 26 April 2006 NICNAS Distearyldimethylammonium chloride (DSDMAC). Results for the studies for the above mentioned analogues are provided in the table below. Endpoint Rat, acute oral Test Substance Result and Assessment Conclusion Betaines Low toxicity, LD50 > 2000 mg/kg bw Imidazoline derivatives Low toxicity, LD50 > 2000 mg/kg bw Distearyldimethylammoniumchloride (DSDMAC) DSDMAC 97+/- 1% pure, max. 3% water: Betaines: concentrations >10%: Low toxicity, LD50 > 2000 mg/kg bw Imidazoline derivatives: concentrations >10%: Slightly irritating DSDMAC 97+/- 1% pure, max. 3% water: Betaines: concentrations > 10% Non-irritating Imidazoline derivatives: concentrations > 10% Moderately to severely irritating Distearyldimethylammoniumchloride (DSDMAC) 97+/- 1% pure, max. 3% water: Betaines Irritating No evidence Skin sensitisation - Repeat Insult patch test (nonOcclusive): Imidazoline derivatives: Not sensitising Guinea pig, skin sensitisation - MagnussonKligman maximization test: (90% DSDMAC, ~5% isopropanol, ~5% water): Not sensitising Rat, gavage repeat dose toxicity - 28 days. (90% DSDMAC, ~5% isopropanol, ~5% water): NOAEL: 100mg/kg/bw LOAEL: 500 mg/kg bw Rabbit, Dermal repeat dose toxicity – 28 days (~ 75% DSDMAC, ~ 25% Isopropanol and water) LOAEL: 4mg/kg bw Genotoxicity - bacterial reverse mutation Betaines: Non mutagenic Imidazoline derivatives: Non mutagenic DSDMAC (90% DSDMAC, ~5% isopropanol, ~5% water): Non mutagenic Non clastogenic Rat, acute dermal Rabbit, skin irritation Rabbit, eye irritation Guinea pig, skin sensitisation - MagnussonKligman maximization test: Genotoxicity – in vitro Cytogenetic assay DSDMAC FULL PUBLIC REPORT: STD/1106 Low toxicity, LD50 > 2000 mg/kg bw Moderately irritating Irritating Page 12 of 23 26 April 2006 NICNAS 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. Ready biodegradability TEST SUBSTANCE Notified chemical METHOD Inoculum Exposure Period Auxiliary Solvent Analytical Monitoring Remarks - Method OECD TG 301 D Ready Biodegradability: Closed Bottle Test. Domestic waste water treatment plant secondary effluent 28 d Not specified Reference substance – sodium benzoate Treatments - nutrient medium and inoculum - test substance (10 mg) - reference substance (2 mg) - toxicity control (test substance 10 mg and reference substance 2 mg). All treatments were done in duplicate. RESULTS Day 4 7 11 14 18 21 25 28 Test substance % Degradation 5.9 10.1 13.0 14.2 15.4 14.1 19.2 19.7 Remarks - Results Sodium Benzoate Day % Degradation 4 7 70.2 11 80.2 14 67.2 18 21 25 28 87.9 Toxicity Control Day % Degradation 4 7 141.0 11 163.8 14 164.5 18 21 25 28 220.7 The degradation of the toxicity control is based on the theoretical oxygen demand of the reference substance alone. Hence, the greater than 100% degradation figures as a result of degradation of the test substance in the toxicity control. As this is present in 5 times the amount of the reference substance the oxygen consumed in degrading a small percentage of this inflates the percentage degradation of the reference substance. CONCLUSION The test substance is not considered to be readily biodegradable. TEST FACILITY Vizon SciTec (2005) 8.1.2. 8.2. 8.2.1. Bioaccumulation The relatively high molecular weight and charged nature of the notified substance indicate that unlikely to bioaccumulate (Connell 1989). Ecotoxicological investigations Acute toxicity to fish Not Provided 8.2.2. Acute toxicity to aquatic invertebrates FULL PUBLIC REPORT: STD/1106 Page 13 of 23 26 April 2006 NICNAS TEST SUBSTANCE Notified chemical METHOD OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction Test - static. EC Directive 92/69/EEC C.2 Acute Toxicity for Daphnia - static. Daphnia magna 48 hours None Dilution water specified as moderately hard (80-110 mg CaCO3/L) Species Exposure Period Auxiliary Solvent Water Hardness Analytical Monitoring Remarks - Method The test was conducted using water soluble fractions (WSFs) at five nominal loading levels with each loading level done in quadruplicate. WSFs were prepared by stirring fixed weights of the test substance in dilution water for ~24 h at 22-23°C, settling for ~1 h and siphoning the from the centre of the solution. The siphoned solution was then filtered through a 0.45 µm acetate filter before adding to test vessels. A WSF control was prepared in an analogous manner without the addition of the test substance. Water quality measurements (conductivity, temperature, pH and dissolved oxygen) were conducted throughout the study and were within acceptable ranges. No analysis of the test material was performed. RESULTS Concentration mg/L Nominal Actual Lab Control WSF Control 0.34 0.57 1.49 2.94 5.83 EL50 LOEL Remarks - Results Number of D. magna 20 20 20 20 20 20 20 Number Immobilised 24 h 48 h 0 0 0 0 0 10 20 10 20 20 20 20 20 20 0.57-1.49 mg/L at 24 hours 0.42 (95% CI 0.28-0.54) mg/L at 48 hours 0.34 mg/L at 48 hours Zinc sulphate heptahydrate was used as a reference toxicant with an LC50 of 0.56 (95% CI 0.21-0.78) mg/L Zn2+. The results are quoted in terms of the nominal loading level. The 48 h EL50 and 95% confidence intervals were calculated using the probit method and ToxCalcTM (Version 5.0.18; Tidepool Scientific Software). CONCLUSION The test substance is highly toxic to daphnia (Mensink et al. 1995). As this is an effect loading based on a WSF, with no analysis of the test solution, the actual result could be much lower. TEST FACILITY Vizon SciTec (2005) 8.2.3. Algal growth inhibition test TEST SUBSTANCE Notified chemical METHOD OECD TG 201 Alga, Growth Inhibition Test. EC Directive 92/69/EEC C.3 Algal Inhibition Test. Selenastrum capricornutum 72 hours Nominal: 0.17, 0.60, 1.17, 3.00, 6.63 mg/L None Not specified Species Exposure Period Concentration Range Auxiliary Solvent Water Hardness FULL PUBLIC REPORT: STD/1106 Page 14 of 23 26 April 2006 Analytical Monitoring Remarks - Method NICNAS WSFs were prepared in an analogous manner to the daphnia study described above with the exception that test media was passed through a 0.2 µm Naglene filter unit prior to exposing test organisms. Water quality measurements (conductivity, temperature, pH and dissolved oxygen) were conducted throughout the study and were within acceptable ranges. No analysis of the test material was performed. RESULTS EL50 mg/L 0.32 (0.17-0.60) Remarks - Results NOEL mg/L 0.17 LOEL mg/L 0.60 For the test material, an obvious all-or-none response was observed, where there was no growth inhibition at the lowest nominal loading rate and 100% growth inhibition at the higher loading rates (≥0.60 mg/L). Zinc sulphate heptahydrate was used as a reference toxicant with an EC50 of 0.038 mg/L Zn2+. CONCLUSION The test material is highly toxic to algae (Mensink et al. 1995) . As this is an effect loading based on a WSF, with no analysis of the test solution, the actual result could be much lower. TEST FACILITY Vizon SciTec (2005) FULL PUBLIC REPORT: STD/1106 Page 15 of 23 26 April 2006 NICNAS 9. RISK ASSESSMENT 9.1. Environment 9.1.1. Environment – exposure assessment During formulation of the hair care products the notifier estimates that up to 10 kg per annum of notified polymer will be released into the environment as a result of residues in import containers, spills and equipment cleaning. Subsequent water washes will pass to interceptor pits where the settled material will be collected and disposed of in landfill. Treated wastewater will be released to sewer. In a worst case based on maximum annual imports of 1 tonne per annum, 10% (90% or products exported) of which is released to sewer and assuming that none is removed during sewage treatment processes, assuming a national population of 20,100,000 and that each person contributes an average 200 L/day to overall sewage flows, the predicted concentration for release to ocean and river on a nationwide basis are 0.007 and 0.07 g/L, respectively. Amount of entering sewer annually Population of Australia 100 kg 20.1 million Amount of water used per person per day Number of days in a year Estimated PECOcean 0.007 g/L Estimated PECRiver 0.07 g/L 200 L 365 The plastic import drums containing residual notified polymer (up to 10 kg per annum) will be disposed of to landfill. The bottles in which the hair product will be sold to consumers and the residues they contain (up to 5 kg per annum) will be disposed of either in domestic landfill or recycled. The majority of the notified chemical will be incorporated into hair products and as such will almost completely be released to the environment. 9.1.2. Environment – effects assessment The notified chemical is highly toxic to both daphnia (EL50 0.42 mg/L) and algae (EL50 0.32 mg/L). As only two toxicity endpoints are available a PNEC of 0.32 µg/L has been determined from the endpoint for the most sensitive organism and applying an assessment factor of 1000. Concerns above (see section 8.2) that toxicity may be even higher should be noted. 9.1.3. Environment – risk characterisation The intended use pattern of the notified chemical is expected to result in the majority of the chemical used in Australia being eventually released to the environment. However, this will be in dilute manner as the notified chemical contained within the hair care products will be released from domestic use at low concentrations. The risk of the release of 10% imported notified chemical during use in hair care products can be estimated by determining the aquatic risk quotient (RQ = PEC/PNEC). Removal by STP PNEC Risk Quotient (RQ) Ocean 0% 0.07 µg/L 0.02 0.32 g/L River 0% 0.007 µg/L 0.2 0.32 g/L The values of the worst case risk quotients for the aquatic environment are less than 1, for both marine and fresh water organisms, indicating an acceptable risk to the aquatic compartment. While in a sewage system some adsorption could occur, this could be offset by the doubt that the toxicity results may be underestimated. FULL PUBLIC REPORT: STD/1106 PEC Page 16 of 23 26 April 2006 NICNAS In landfill the notified polymer has the potential to be mobile in both terrestrial and aquatic comportments. However, over time it is expected to adsorb to soil and sediments and degrade slowly through biotic and abiotic processes to give water and oxides of carbon and nitrogen. The charged nature of the notified polymer indicates its potential to bioaccumulate will be low (Connell 1990). Therefore, the environmental exposure and overall environmental risk from the notified chemical is expected to be acceptable, noting that release to fresh water constitutes only about 25% of total Australian release. However, if local consumption rises above 1 tonne the chemical would need to be reassessed with the provision of all tests for physical and chemical properties and ecotoxicity including repeated daphnia and algae test with measured concentrations and a chronic daphnia study as per schedule requirements. 9.2. 9.2.1. Human health Occupational health and safety – exposure assessment Transport & Storage Occupational exposure to the notified chemical during its transport and storage, or of finished products containing < 1% notified chemical, is only likely in the event of accidental container spillage involving breach of packaging. Exposure in these circumstances is expected to be infrequent and limited by use of appropriate personal protective equipment (PPE) during cleanup operations. Reformulation and packaging Worker exposure to the notified chemical at 50% or less during reformulation into hair care products may occur when weighing the notified chemical and adding it to the mixing vessel, and also during sampling for QA testing. Any exposure is expected to be primarily dermal. Ocular exposure is less likely because the chemical is supplied as solid pellets, however this may also occur as a result of spills or as secondary to skin contamination. Inhalation exposure is not expected to occur in these processes. Exposure to products containing < 1% of the notified chemical during mixing and filling operations is expected to be low, as the concentration is low, and exposure is limited by engineering and PPE controls. End-use in salons Repeated dermal and possibly ocular exposure to hairdressers can occur when products containing < 1% of the notified chemical are dispensed and applied to customers’ hair. Exposure could be limited by use of gloves and safe work practices. However it is not expected that gloves will be worn during shampooing. Inhalation exposure should not occur, as use spray products have not been proposed. 9.2.2. Public health – exposure assessment Public exposure to wash-off hair care products containing < 1% of the notified chemical is expected, through use of conditioners in hairdressing salons. The main potential route of exposure would be dermal, through application to the scalp. Some accidental ocular exposure is also possible. The frequency of salon treatment for individual clients may be up to once weekly. An estimate of exposure is as follows: Product Application Application Retention % Notified Exposure to Quantity Frequency per Factor Chemical Notified Chemical (g/application)* Day (%)* in Product (mg/kg bw/day)** conditioner 14.0 0.14 1 1 0.003 *data from EU SCCNFP (Scientific Committee on Cosmetic Products and Non-food products intended for Consumers) (SNCNFP, 2003) ** assuming 60kg body weight 9.2.3. Human health – effects assessment FULL PUBLIC REPORT: STD/1106 Page 17 of 23 26 April 2006 NICNAS Toxicological data are not available on the notified chemical itself. In vitro skin irritation and eye irritation studies and a human repeat insult patch test were carried out on Crodazosoft DBQ containing approximately 50% of the notified chemical. Information on other endpoints has been obtained for other surfactant classes that have general structural resemblances to the notified chemical. Toxicokinetics, metabolism and distribution. No specific information was provided on the toxicokinetics, metabolism or distribution of the notified chemical. Acute toxicity. On the basis of data provided, the notified chemical is expected to have low acute oral and dermal toxicity. Irritation and Sensitisation. From in vitro testing of Crodazosoft DBQ, it is expected to be moderately irritating to the skin, and this is consistent with the effects of other amphoteric and cationic surfactants. Crodazosoft DBQ was not irritating at 5% in a human repeat insult patch test (RIPT). Crodazosoft DBQ at 5% was not irritating in a HET-CAM test, designed to test the potential for eye irritation. Similar surfactant categories demonstrate moderate to severe eye irritation characteristics. Skin sensitisation was not observed in a human repeat insult patch test using 5% Crodazosoft DBQ. However, a structurally related chemical previously assessed by NICNAS was classified as a skin sensitiser based on the results of skin sensitisation studies in guinea pigs. In addition, although betaines did not cause skin sensitisation in a guinea pig maximisation test, various instances of contact allergy in this surfactant groups have been reported. Observed reactions were linked to the presence of impurities. (CETOX, 2001). Repeated Dose Toxicity. A cationic surfactant had a NOAEL of 100 mg/kg/bw day and LOAEL of 500 mg/kg bw/day in a rat 28-day oral study and the LOAEL in a rat 28-day dermal study (based on local effects) was 4 mg/kg bw/day. It is not possible to determine a NOAEL/LOAEL for the notified chemical based on this information. Other toxicological data Data on the analogue groups suggests that the notified chemical would not be mutagenic. No information was available from the notified chemical or analogues regarding potential carcinogenicity or toxicity to reproduction. The notifier advised that no adverse health effects of the chemical had been observed from its use in a hair product overseas. Hazard classification for health effects. Based on limited data relevant to skin irritation, the notified chemical is classified as R38: Irritating to skin. An R41 classification (Risk of serious eye damage) for the notified chemical is considered appropriate, based on the characteristics of similar surfactant categories. The HET-CAM study carried out tested only a dilute form of the chemical. (The HET-CAM test method is not yet validated. The EU national regulatory authorities accept positive outcomes from this test method for classifying and labelling severe irritants (R41). Where a negative result is obtained, an in vivo test is subsequently required, as the HET-CAM test method has not been shown to adequately discriminate between eye irritants and non-irritants. For the detection of ocular corrosives and severe irritants it is recommended that all test substances should be evaluated undiluted unless dilution is justified. (ICCVAM, 2004).) On the basis of the skin sensitising potential of a structurally related chemical and contact allergy observed in some cationic surfactants, the notified chemical is classified as R43 (May cause sensitisation by skin contact) as a precautionary measure. Although the RIPT on dilute (5%) Crodazosoft DBQ was did not show sensitisation, as the conditions of this test have not been FULL PUBLIC REPORT: STD/1106 Page 18 of 23 26 April 2006 NICNAS maximised, the skin sensitisation potential of the notified chemical cannot be discounted. In addition, the notified chemical is a reaction mixture and not fully characterised. Sensitisation can occur in some cationic surfactants and can be caused by impurities. Based on the available data, the notified chemical is classified as a hazardous substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC 2004). 9.2.4. Occupational health and safety – risk characterisation The notified chemical has the potential to cause irritation to the skin, skin sensitisation and serious damage to the eyes. Workers that have the potential for exposure to the notified chemical at a concentration of 50% include transport and storage workers, QA chemists and production personnel. Exposure and hence the risk of irritation/sensitisation is most likely for production personnel during the transfer of the notified chemical to the mixing vessels. Due to the possible risk of skin irritation/sensitisation the following personal protective equipment should be worn: chemical resistant industrial clothing (coveralls) and impermeable gloves. Although the notified chemical is introduced as solid pellets, therefore limiting the potential for ocular exposure due to the potential for severe eye irritation, protective eyewear should also been worn as a precaution. The risk to transport and storage workers and QA chemists is expected to be low due to the limited predicted exposure. However, in order minimise the risk of adverse irritancy/sensitisation effects, similar PPE to that described above should be worn. Following formulation of the hair conditioner, there is the potential for exposure to up to 1% notified chemical. At this concentration, the notified chemical is below the cut off for classification as a skin and eye irritant and skin sensitiser according to NOHSC Approved Criteria for Classifying Hazardous Substances. Therefore, the risk of an adverse irritant/sensitisation response from exposure to the notified chemical at this concentration is considered to be low. This is supported by the results from the human repeat insult patch test. Overall, the risk to workers following formulation including salon workers is expected to be low due to the low exposure predicted, although the risk of sensitisation in sensitive individuals cannot be ruled out. 9.2.5. Public health – risk characterisation Although dermal exposure (through the scalp) and accidental ocular exposure to the notified chemical could occur during use of hair conditioner, due to the low concentration of the notified chemical in the hair conditioner and the fact that the product is rinsed from the scalp shortly after application, the risk of an adverse irritant/sensitisation response is considered to be low, however, the risk of sensitisation in sensitive individuals cannot be ruled out. 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 10.1. Hazard classification Based on the limited toxicological data for the notified chemical, it is not possible to classify the notified chemical as a hazardous substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). However, based on the in vitro skin irritation study, the data provided for other surfactant classes and classification of similar chemicals, the following classification and labelling details should apply: R38 Irritating to skin R41 Risk of serious damage to eyes R43 May cause sensitisation by skin contact and FULL PUBLIC REPORT: STD/1106 Page 19 of 23 26 April 2006 NICNAS As a comparison only, the classification for skin irritation/environmental hazards of the notified chemical using the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations, 2003) is presented below. This system is not mandated in Australia and carries no legal status but is presented for information purposes. Skin corrosion/irritation Acute hazards to the aquatic environment Hazard category 2 1 Hazard statement Causes skin irritation Very toxic to aquatic life 10.2. Environmental risk assessment On the basis of the PEC/PNEC ratio, the chemical is not considered to pose a risk to the environment based on its reported use pattern at the proposed low level of domestic release. 10.3. Human health risk assessment 10.3.1. Occupational health and safety Production Personnel There is Moderate Concern to occupational health and safety under the conditions of the occupational settings described due to the potential for skin sensitisation. All other workers There is Low Concern to occupational health and safety under the conditions of the occupational settings described. 10.3.2. Public health There is No Significant Concern to public health when used in the proposed manner 11. MATERIAL SAFETY DATA SHEET 11.1. Material Safety Data Sheet The MSDS for Crodazosoft DBQ provided by the notifier was in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 2003). It is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant. 11.2. Label The label for Crodazosoft DBQ provided by the notifier was in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances (NOHSC 1994). The accuracy of the information on the label remains the responsibility of the applicant. 12. RECOMMENDATIONS REGULATORY CONTROLS Hazard Classification and Labelling Use the following risk phrases for products/mixtures containing the notified chemical: conc>20%: R38; R41; R43 10%<conc<20%: R41; R43 5%<conc<10%: R36; R43 1%<conc<5%: R43 FULL PUBLIC REPORT: STD/1106 Page 20 of 23 26 April 2006 NICNAS Use the following safety phrases for products/mixtures containing the notified chemical: S24 Avoid skin contact (conc >1%) S25 Avoid contact with eyes (conc >10%) S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice (conc >10%) S37 Wear suitable gloves (conc >1%) S39 Wear eye/face protection (conc >10%) Health Surveillance As the notified polymer is a potential skin sensitiser, employers should carry out health surveillance for any worker who has been identified in the workplace risk assessment as having a significant risk of sensitisation. CONTROL MEASURES Occupational Health and Safety Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical as introduced: Avoid contact with skin and eyes Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical as introduced: Protective eyewear, chemical resistant industrial clothing (coveralls) and impermeable gloves; Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards. A copy of the MSDS should be easily accessible to employees. If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Public Health As the notified chemical is a potential skin sensitiser, NICNAS must be advised of any customer reported adverse health effects from use of products containing the notified chemical as they occur. Environment The following control measures should be implemented by end users to minimise environmental exposure during use of the notified chemical: Do not allow material or contaminated packaging resulting from spills to enter drains, sewers or water courses. Disposal The notified chemical should be disposed of to landfill. Emergency procedures Gross spills/release of the notified chemical should be contained by sand or inert FULL PUBLIC REPORT: STD/1106 Page 21 of 23 26 April 2006 NICNAS powder and earth. Collect and seal in properly labelled drums for disposal in landfill. 12.1. Secondary notification The Director of Chemicals Notification and Assessment must be notified in writing within 28 days by the notifier, other importer or manufacturer: (1) Under Section 64(1) of the Act; if the release of the notified chemical to the Australian aquatic environment exceeds 1000 kg per annum; or Crodazosoft DBQ (containing 50% notified chemical) is used either in wash-off products at > 2% or in leave in products. or (2) Under Section 64(2) of the Act: if any of the circumstances listed in the subsection arise. The Director will then decide whether secondary notification is required. For the two conditions described under subsection 64 (1) the following information will need to be submitted if a secondary notification is required: all physicochemical and ecotoxicity tests required under the schedule including repeated daphnia and algae tests with measured concentrations and a chronic daphnia study as per schedule requirements (increase in release volume). evidence that the notified chemical is unlikely to cause skin sensitisation at that concentration or exposure duration (increase in concentration/use in leave in products). 13. BIBLIOGRAPHY Boethling RS and Lynch DG (1992) Quaternary Ammonium Surfactants, pp 146-176. In, Hutzinger, O. & de Oude, N.T. (eds), Handbook of Environmental Chemistry, Vol 3: Part F, Anthropogenic Compounds: Detergents, Springer-Verlag, Berlin.\ CIR (1990) Final report on the Safety Assessment of Cocoamphoacetate, Cocoamphodiacetate, and Cocoamphodipropionate. The Cosmetic Ingredient Review. 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Experiment reference no.: V03-0113-3, for Croda Inc, Edison, New Jersey. The Consumer Product Testing Co., Fairfield, New Jersey, USA (unpublished report provided by notifier). CETOX (2001) Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products. Environment Project No. 615 2001. MiljØ-og Energi-ministeriet, Danmark. Centre for Integrated Environment and Toxicology (CETOX) Accessed at http://www.mst.dk/udgiv/publications/2001/87-7944-596-9/pdf/87-7944-597-7.pdf IUCLID (2000) IUCLID Data Set Existing Chemical ID: 107-64-2 Dimethyldioctadecylammonium chloride European Chemicals Bureau (2000). FULL PUBLIC REPORT: STD/1106 Page 22 of 23 26 April 2006 NICNAS ICCVAM (2004) The Interagency Coordinating Committee on the Validation of Alternative Methods: Test Method Evaluations. 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RCTS Code No: 1122.1249, Reliance Clinical Testing Services, Inc., Irving, Texas, USA (unpublished report provided by notifier). United Nations (2003) Globally Harmonised System of Classification and Labelling of Chemicals (GHS). United Nations Economic Commission for Europe (UN/ECE), New York and Geneva. Vizon Scitec (2005) Final Report: Ecotoxicity and environmental fate of [Notified Chemical] (lot # DBQ-1016; sample date 7/8/2004), Viz0n SciTec Inc. Vancouver Canada. Unpublished report supplied by the notifier. FULL PUBLIC REPORT: STD/1106 Page 23 of 23