zilongwang/ReadingBank huggingface dataset:
water solubility. Specific hydrolysis rates cannot be provided but reference was made to Streitwieser (1956) and Ingold (1969). Resulting hydrolysis species will be the mono-hydrolysed species of the diallyl carbonate component, carbon dioxide and allyl alcohol. With full hydrolysis, diethylene glycol will be formed as well. Partition Coefficient (n-octanol/water) log Pow at 20oC = 2.05-5.24 (calculated) (DAGC) ACD Labs Software Remarks No details of the report was provided. Weighted average of log Pow values was calculated to be 2.56 for the 3 main components. The Log Pow for diallyl diglycol carbonate was calculated to be 1.543 (EPIWIN/KOWWIN program). This program calculates log Kow contributions from individual molecular fragments and then summing up contributions. Adsorption/Desorption – screening test log Koc = 2.05-4.20 at 20C (calculated) (DAGC). ACD Labs Software Remarks No details of the report was provided. Weighted average of log Koc values was calculated to be 2.76 at 20C for the 3 main components of the notified substance. Dissociation Constant Not applicable Remarks Test was not performed. The notified polymer does not contain any functional groups which can undergo dissociation. Particle Size Not applicable – polymer is liquid Flash Point > Not specified Remarks The flash point for the notified chemical is derived from information contained in the MSDS (Great Lakes Chemical Corporation, 2001). The flash point of DAGC is 173 oC. Not specified Flammability Limits Not performed. Remarks Combustible but not expected to be flammable. Autoignition Temperature Not performed. Remarks Not expected to undergo autoignition. Explosive Properties Not performed. Remarks Not expected to have explosive properties. Reactivity Not performed. Remarks The notified chemical is not thermally stable and undergoes polymerisation when heated. 7a. TOXICOLOGICAL INVESTIGATIONS No toxicological data were submitted for the notified chemical. Robust summaries were submitted for the analogue Diallyl diglycol carbonate (CAS No. 142-22-3). These were compiled by the manufacturers PPG Industries Inc. and Great Lakes Chemical Corporation for the US EPA HPV Challenge program (Great Lakes and PPG, 2001).
Metabolic Activation Test Substance Concentration Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ≥333 ≥333 >5000 Negative Test 2 ≥333 >5000 Negative Present Test 1 ≥667 ≥333 >5000 Negative Test 2 ≥333 >5000 Negative Remarks - Results The test substance did not lead to an increase in the number of revertant colonies, either with or without S9 mix. Positive controls confirmed the sensitivity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. Microbiological Associates (1995) Genotoxicity – in vitro chromosome aberration test Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. EC Directive 92/69/EEC B.10 Mutagenicity - In Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Peripheral lymphocytes Metabolic Activation System Aroclor-1254 induced rat liver S9-mix Vehicle Dimethylsulphoxide Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period (hours) Harvest Time Absent Test 1A 33, 100, 133*, 180*, 240*, 333 24 24 Test 1B 133*, 180*, 240*, 333 48 48 Test 2 33, 100*, 133, 180*, 240*, 333 24 24 Present Test 1A 33*, 100*, 333* 3 24 Test 1B 333* 3 48 Test 2 33*, 100*, 333* 3 24 *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1A 333p ≥240 333 Negative Test 1B 333 333 Positive Test 2 ≥240 333 Negative Present Test 1A 333p >333 333 Negative Test 1B >333 333 Negative Test 2 >333 333 Negative
File No: STD/1271 November 2007 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Brown DER 8589 in NOVACRON® BLACK LS-N-01 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 Water Resources. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by appointment only at 334-336 Illawarra Road, Marrickville NSW 2204. This Full Public Report is also 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: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA. Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA. TEL: + 61 2 8577 8800 FAX + 61 2 8577 8888 Website: www.nicnas.gov.au Director NICNAS
Notified chemical (~59% purity) OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Chinese hamster Cell Type/Cell Line V79 cells Metabolic Activation System S9 mix derived from Phenobarbital induced Wistar rat liver. Vehicle Deionised water Remarks - Method No significant protocol deviations Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 75*, 150*, 300*, 600, 900, 1200 4 hr 18 hr Test 2 25, 50, 100*, 150, 200*, 250* 18 hr 18 hr Test 3 100, 150*, 200*, 250 28 hr 28 hr Present Test 1 12.5, 25, 50*, 100*, 150*, 200 4 hr 18 hr Test 2 12.5, 25, 50*, 100*, 150, 200* 4 hr 28 hr *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ~300 >1200 Negative Test 2 >250 >250 Negative Test 3 100-150 >250 Negative Present Test 1 100-150 >200 Positive Test 2 150-200 >200 Positive Remarks - Results In the presence of S9 mix the aberration rates (Test 1: 8.0% and 7.5%, respectively; Test 2: 19.5%) were biologically relevant and statistically significant increases were observed after treatment with 100 and 150 μg/mL (Test 1) and with 200 μg/mL (Test 2) compared to the solvent control (Test 1: 1%; Test 2: 1.5%). The notified chemical was clastogenic to Chinese hamster V79 cells treated in vitro under the conditions of the test. RCC Ltd Genotoxicity – in vivo Notified chemical (~59% purity) OECD TG 474 Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/NMRI Route of Administration Oral – gavage. Vehicle Deionised water Remarks – Method No significant protocol deviations. Dose mg/kg bw Number and Sex of Animals Sacrifice Time hours 0 6/sex 24 500 6/sex 24
OF CONTENTS Full Public Report 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 4 6. HUMAN HEALTH IMPLICATIONS 5 6.1 Exposure assessment 5 6.1.1 Occupational exposure 6 6.1.2. Public exposure 6 6.2. Human health effects assessment 6 6.3. health risk characterisation 8 6.3.1. Occupational health and safety 8 6.3.2. Public health 9 7. ENVIRONMENTAL IMPLICATIONS 9 7.1. Environmental Exposure & Fate Assessment 9 7.1.1 Environmental Exposure 9 7.1.2 Environmental fate 10 7.1.3 Predicted Environmental Concentration (PEC) 10 7.2. Environmental effects assessment 11 7.2.1 Predicted No-Effect Concentration 11 7.3. Environmental risk assessment 11 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 12 Hazard classification 12 Human health risk assessment 12 Environmental risk assessment 12 Recommendations 12 Regulatory Obligations 13 Appendix A: Physical and Chemical Properties 15 Appendix B: Toxicological Investigations 18 B.1. toxicity – oral 18 B.2. Acute toxicity – dermal 18 B.3. Irritation – skin 19 B.4. Irritation – eye 19 B.5. Skin sensitisation 20 B.6. Repeat dose toxicity 20 B.6. Genotoxicity – bacteria 22 B.7. Genotoxicity – in vitro 22 B.8. Genotoxicity – in vivo 23 Appendix C: Environmental Fate and Ecotoxicological Investigations 25 C.1. Environmental Fate 25 C.1.1. Ready biodegradability 25 C.1.2. Inherent biodegradability 25 C.1.3. Potential for Bioaccumulation 26 C.2. Ecotoxicological Investigations 26 C.2.1. Acute toxicity to fish 26 C.2.2. Acute toxicity to aquatic invertebrates 27 C.2.3. Algal growth inhibition test 27 C.2.4. Inhibition of microbial activity 28 Bibliography 29
VI (high dose recovery) “ 1000 “ Mortality and time to death One at the mid dose was probably not treatment related as no deaths occurred at the high dose. Clinical Observations No relevant signs. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis No treatment-related changes. A reduction on blood cell count in high dose and high dose recovery females was slight, and was within the range of historical controls, it was considered not to be treatment related. Effects in Organs No effect of the test substance was noted on organ weights and there were no macroscopic or microscopic findings. The No Observed Effect Level (NOEL) was established as 1000 mg/kg bw/day in this study. CIT (2002f). 7.8. Genotoxicity - bacteria Notified chemical. OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, TA102. E. coli: WP2 uvrA. Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction. Concentration in Main Test a) With metabolic activation: 0 - 5000 µg/plate. b) Without metabolic activation: 0 - 5000 µg/plate. Vehicle DMSO Metabolic Activation Test Substance Concentration Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None 1250 None Test 2 “ “ Present Test 1 None “ 1250 “ Test 2 “ “ The notified chemical was not mutagenic to bacteria under the conditions of the test. CIT 7.9. Genotoxicity – in vitro
Partition Coefficient log Pow > 9.4 (temperature not specified) OECD TG 117 Partition Coefficient (n-octanol/water). Remarks HPLC Method. The dead time was determined by Thiourea. The column temperature was set as 30ºC. The partition coefficient has been test as Log Pow > 9.40 because the retention time was longer than that of 1-penyltridecane. High Pow is expected according to the low water solubility of the notified chemical. Safepharm (2007a) Adsorption/Desorption – screening test log Koc > 5.63 OECD TG 121 Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC). Remarks HPLC screening method was used. The dead time was determined by using formamide. Column temperature was set as 30˚C. Testing was carried out at neutral pH due to the absence of any possible dissociating functional groups in the notified chemical. The retention time of the notified chemical was longer than DDT. High Koc is expected from the high Pow and the low water solubility of the notified chemical. Safepharm (2007a) Flash Point 174 ± 2oC at 102.22 kPa EC Directive 92/69/EEC A.9 Flash Point. Remarks Closed cup method Safepharm Autoignition Temperature 366 ± 5oC EC Directive 92/69/EEC A.15 Auto-Ignition Temperature (Liquids and Gases). Safepharm (2007b)
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 425 Acute Oral Toxicity: Up-and-Down Procedure. Species/Strain Rat/Wistar Vehicle None Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. The notified chemical is of low toxicity via the oral route. RCC Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity. Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. LD50 >2000 mg/kg bw Remarks - Results No mortality, signs of toxicity, or adverse effects in organs were observed at the dose level of 2000 mg/kg bw. On test day 5, one animal displayed slight local erythema. The same animal also had slight scaling from day 5 to day 8. The notified chemical is of low toxicity via the dermal route. RCC (2007f) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand Number of Animals 1 male, 2 females Vehicle None Observation Period 10 days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations
Acute oral toxicity Component 1 Study 1 in rats Study 2 in rats Analogue 1 – in rats Study 2 – in rats Component 2 (a number of studies) LD50 > 5000 mg/kg bw (low toxicity) LD50 > 2000 mg/kg bw (low toxicity) LD50 > 21.5 ml/kg (low toxicity) LD50 > 2000 mg/kg (bw low toxicity) Slightly to low toxicity Acute dermal toxicity Component 2 (a number of studies) Low to moderate toxicity Acute inhalation toxicity Component 2 (a number of studies) Low to moderate toxicity Skin irritation Analogue Study 1 – Rabbit 2 – Rabbit Component 2 (a number of studies) Non-irritating Non-irritating Severely irritating to Corrosive Eye irritation Analogue Study 1 – Rabbit Study 2 – Rabbit Component 2 (a number of studies) Non-irritating Non-irritating Severely irritating Skin sensitisation Analogue In humans Component 2 (a number of studies) Non-sensitising Potential skin sensitiser (positive LLNA, but negative Guinea pig test and data) Repeat dose toxicity Component 1 Rat, diet repeat dose toxicity - 90 days Component 2 (a number of studies) NOAEL = 100 mg/kg bw/day NOAEL = 180 mg/kg bw/day Genotoxicity - bacterial reverse mutation Component 1 Ames Salmonella Assay Component 2 (a number of studies) Non-mutagenic Non-mutagenic Genotoxicity – in vitro Component 1 In – Mammalian cell gene test – mouse lymphoma L5178Y cells In vitro – Mammalian cytogenetic test – human Lymphocytes Component 2 (a number of studies) Non-mutagenic Non-clastogenic Non-genotoxic Carcinogenicity Component 2 (2 long-term oral studies) Non-carcinogenic
LD50 Study 1 – LD50 > 21.5 ml/kg Study 2 – LD50 > 2000 mg/kg bw Remarks – Results No information on signs of toxicity and effects in organs. The analogue is of low toxicity via the oral based on the limited information. Confidential reference 2 B.2. Irritation – skin Analogue (2 studies with limited information) 1 – not specified Study 2 – Regulation for the Enforcement of the Federal Hazardous Substances Act (Title 16, CFR 1500.40, 1500.41, 1500.42) Species/Strain Rabbit in both studies Remarks – Method No information is available. 1 – non-irritating 2 – non-irritating (Primary irritation index was 1.0) The analogue is non-irritating to skin based on the limited information. Confidential reference 2 B.3. Irritation – eye Analogue (2 studies with limited information) Species/Strain Rabbit in both studies Remarks – Method No other information is available. Study 1 – Non-irritating Study 2 – Non-irritating (very slight erythema in four rabbits) The analogue is non-irritating to the eye on the limited information. Confidential reference 2 B.4. Skin sensitisation Analogue (limited information) Not specified Species/Strain Humans Remarks – Method No other information is available. Non-sensitising There is no evidence of reactions indicative of skin sensitisation to the analogue under the conditions of the test (limited information available). Confidential reference 2 B.5. Repeat dose toxicity
Appendix A: Physical and Chemical Properties Softening Point 94.3oC ‘Ring & Ball Softening Point’ (internal test method) Eastman (reference details not provided) Density 970 kg/m3 at 25oC Pycnometer Eastman (reference details not provided) Solubility 4.87 x 10-5 g/L at 20 ± 0.5 oC (pH 6.0) OECD TG 105 Water Solubility. EC Directive 92/69/EEC A.6 Water Solubility. Remarks Flask Method with HPLC/UV analysis Springborn (2008a) Partition Coefficient log Pow = 4.29 at 20oC OECD 107 Partition Coefficient (n-octanol/water): Shake Flask Method with HPLC/UV analysis. Remarks No deviations from standard protocol. Springborn (2008b) Flash Point 183.9oC Pensky-Martens closed cup. Remarks Test report not available.
workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Disposal The notified chemical should be disposed of by landfill. Regulatory Obligations Secondary Notification This risk assessment is based on the information available at the time of notification. The Director may call for the reassessment of the chemical under secondary notification provisions based on changes in certain circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the notifier, as well as any other importer or manufacturer of the notified chemical, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified chemical is listed on the Australian Inventory of Chemical Substances (AICS). Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, importer or manufacturer: (1) Section 64(2) of the Act; if the function or use of the chemical has changed from an engine oil additive, or is likely to change significantly; the amount of chemical being introduced has increased from 500 tonnes, or is likely to increase, significantly; the chemical has begun to be manufactured in Australia; additional information has become available to the person as to an adverse effect of the chemical on occupational health and safety, public health, or the environment. The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required. No additional secondary notification conditions are stipulated. Material Safety Data Sheet The MSDS of the products containing the notified chemical provided by the notifier were reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.
induction phase Induction Concentration: intradermal: 2% topical: 50% of Irritation Following intradermal injections with 2% test substance, 3/10 animals displayed slight or well-defined erythema. Following intradermal injection of 4% test substance with Freunds’ Complete Adjuvant (FCA), well-defined to severe erythema or necrosis were observed, and in the corresponding control animals, slight to moderate erythema were observed. Moderate erythema was observed in all animals, including the control group, following intradermal injection with FCA and water alone. Following epidermal application, some animals displayed scabbing, with one animal showing slight erythema and another animal showing severe erythema. Observations in the corresponding control groups were similar. Such reactions were considered to have been enhanced by treatment with SDS. challenge phase 1st challenge topical: 50% Remarks - Method 10% sodium dodecyl sulfate (SDS) was applied to the injection sites 24 hours prior to topical induction. The vehicle used for dilution of test substance was corn oil. Remarks - Results None of the animals were observed to have been sensitised. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. NOTOX (1999e) Repeat dose toxicity Notified chemical OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Wistar Crl: (WI) BR of Administration Oral – gavage Exposure Information Total exposure days: 28 days Dose regimen: 7 days per week Vehicle Propylene glycol Remarks - Method No significant protocol deviations. Dose mg/kg bw/day Number and Sex of Animals Mortality control 5 males, 5 females 0 50 5 males, 5 females 0 150 5 males, 5 females 1 1000 5 males, 5 females 0 Mortality and Time to One female treated with 50 mg/kg/day died following blood sampling on the day of scheduled necropsy. This was considered to be incidental. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis
NMR, IR, MS, elemental analysis, HPLC, GC Remarks Structure was confirmed by NMR, IR and Mass spectroscopy, levels of sodium, chlorine and sulphur by elemental analysis, impurities by HPLC and 2-propanol and n-hexane content by GC. 3. COMPOSITION > 90% None (>1% One impurity > 1% detected. None 4. INTRODUCTION AND USE INFORMATION (100%) 5 Imported as a powder in 20 kg plastic steel drums. (100%) 5 Year 1 2 3 4 5 Tonnes 3-10 3-10 3-10 3-10 3-10 Component of UV-curable inks and coatings. 5. PROCESS AND RELEASE INFORMATION 5.1. Distribution, Transport and Storage Melbourne Ciba Specialty Chemicals The notified chemical will be imported in sealed plastic bags within 20 kg steel drums with clip-lock rings. It will be delivered to the notifier’s warehouse and subsequently to ink and coating manufacturers who will ship inks and coatings to customers in 20 – 200 L steel drums. The notified chemical degrades in light and care must be taken to store in a cool, dark warehouse. Product storage requirements will be determined by components other than the notified chemical. 5.2. Operation Description
Present Test 1 5, 10*, 20*, 30*, 40, 60 4 h 18 h Test 2 3.1, 6.3, 12.5*, 25*, 50*, 100 4 h 28 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 23.4 ≥ 25 > 12.5 not observed Test 2 ≥ 10 > 25 not observed Present Test 1 46.9 > 30 60 not observed Test 2 ≥ 50 > 12.5 slight effect at 12.5 Remarks - Results The aberration rates of treated cells exclusive of gaps (0.5 – 3%) were close to those of the solvent controls (0 – 2.0%) and within the range of historical control data (0 – 4.0%). One statistically significant response (2.5% aberrant cells) was seen in one dose and condition: 12.5g/mL in experiment 2, 4 h/28 h only and is not considered biologically significant as the response was not dose related and aberration rates were within historical control data. Positive controls showed distinct increases in aberrant cells. The notified chemical was not clastogenic to Chinese Hamster V79 cells treated in vitro under the conditions of the test. RCC (2002s) 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Notified chemical OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Aerobic activated sludge. Exposure Period 28 days. Auxiliary Solvent None. Analytical Monitoring Inorganic Carbon analysis a Shimadzu TOC-500 Analyzer Remarks - Method Inoculum was aerated overnight in culture medium prior to the addition of test materials. Samples were collected from the first CO2 absorber vessel on Days 2, 5, 7, 9, 12, 14, 19, 23, 27, 28 and 29. On day 28 test vessels were treated with 1 mL of concentrated hydrochloric acid to drive of any inorganic carbonates formed. Test substance Sodium Benzoate Day % degradation Day % degradation 28 0 28 78.4
Appendix B: Toxicological Investigations Acute toxicity – oral Lumogen Black FK 4281 (50% notified chemical) in 0.5% CMC-solution OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Wistar Vehicle Doubly distilled water Remarks - Method No significant protocol deviations Number and Sex of Animals Dose mg/kg bw Mortality 3F 5000 0 3F 5000 0 LD50 >5000 mg/kg bw of Toxicity Impaired general state, dyspnoea, staggering and piloerection were observed from 3 to 5 hours after administration. Effects in Organs None observed. Remarks - Results The observed effects may reflect the large dose volume and are not necessarily indicative of absorption of the notified chemical. The notified chemical is of low toxicity via the oral BASF AG (2005d) Acute toxicity – inhalation Lumogen Black FK 4281 (50% notified chemical) OECD TG 403 Acute Inhalation Toxicity – Limit Test. Species/Strain Rat/Wistar Vehicle 1% Aerosil 200 Method of Exposure Oro-nasal exposure. Exposure Period 4 Physical Form aerosol (particulate). Particle Size 1.8 and 2.1 m (two independent samples) Remarks - Method No significant protocol deviations Number and Sex of Animals Concentration mg/L Mortality Nominal* Actual 5 per sex 24.7 5.1 1/10 *The nominal concentration was calculated from the amount of the notified chemical dosed into the dust generator and the supply air flow. LC50 >5.1 mg/L/4 hours Signs of Toxicity Mortality was observed in one female rat 3 hours after exposure. Common abnormalities noted during the study included increased respiratory rate, pulmonary respiratory sounds, hunched posture, smeared fur and black coloured faeces. Fur staining persisted until and including study day 14. All animals attempted to escape at the very beginning of exposure.
Appendix B: Toxicological Investigations Acute toxicity – oral Analogue 1 OECD TG 401 Acute Oral Toxicity – Limit Test. EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) – Limit Test. Species/Strain Rat/Wistar Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 (M) 2000 0 2 5 (F) 2000 0 LD50 >2000 mg/kg bw of Toxicity The male animals did not show any signs of toxicity for the duration of the study (14 days). However, one female animal had slightly reddish coloured nose after 4-24 hours. No further symptoms were observed up to 14 days. Effects in Organs No special finding was noticed in male animals. In female animals, one animal had hydrometra, was not thought to be test-substance related. Remarks - Results All animals gained weight by the end of the study (Day 14). However, weight gain was more pronounced in male animals. The notified polymer is of low toxicity via the oral route. Institute for Toxicology (1989a) Acute toxicity – dermal Analogue 2 EC Directive 79/831/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Type of dressing occlusive Remarks - Method Only the summary of the test report was provided in English and details of any protocol deviations are not available. Five rats per sex were tested at one dose level. Number and Sex of Animals Dose mg/kg bw Mortality I 5 M / 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local No signs of local toxicity were observed. Signs of Toxicity - Systemic No signs of systemic toxicity were observed. Effects in Organs No pathological findings. The test substance is of low toxicity via the dermal route.
File No: STD/1338 September 2009 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Polymer in Infineum R408 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, Water, Heritage and the Arts. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by appointment only at , Marrickville NSW 2204. This Full Public Report is also 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: MARRICKVILLE NSW 2204, . Postal Address: GPO NSW 2001, . TEL: + 61 2 8577 8800 FAX + 61 2 8577 8888 Website: www.nicnas.gov.au Director NICNAS
COMPOSITION > 95% Unknown (>1% Unknown None PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20ºC and 101.3 kPa: Liquid Property Value Data Source/Justification Melting Point/Freezing Point Not determined Will be imported in solution Boiling Point 431oC at 101.3 kPa IUCLID (2001) Density 1003 kg/m3 at 15.6oC IUCLID (2001) Vapour Pressure 6.7 × 10-8 kPa at 25oC Estimated with EPIWIN (US EPA, 2003) Water Solubility ≤ 1.1 ppm Estimated based on the water solubility of 1.1 ppm for an analogue (6PPD) that contains two less carbon atoms in the aliphatic chain (IUCLID, 2000). Hydrolysis as a Function of pH t½ = 3-4 hours at pH 7 Estimated based on the analogue 6PPD. The notified chemical may react rapidly with the oxygen in water (IUCLID, 2000). Partition Coefficient (n-octanol/water) log POW ≥ 5.4 Estimated based on the calculated value of 5.4 for the analogue chemical 6PPD (IUCLID, 2000). Adsorption/Desorption Not determined Expected to absorb strongly to soil from water based on the high POW and the presence of the amine groups in the molecule. Dissociation Constant Not determined The notified chemical contains aromatic amines which are expected to show their typical basicity within the environmental pH range of 4-9. Flash Point Not determined Imported as a component (0.3 ppm) of an extremely flammable solution. Flammability Not determined Imported as a component (0.3 ppm) of an extremely flammable solution. Autoignition Temperature Not determined Imported as a component (0.3 ppm) of an extremely flammable solution. Explosive Properties Not expected to be explosive The structural formula contains no explosophores. Fat Solubility 100% Measured OECD 116 (IUCLID, 2001) Discussion of Properties
Irritation – skin 40-55% notified chemical in glycerin OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Number of Animals 3 F Vehicle None Observation Period 72 Type of Dressing Semi-occlusive. Remarks - Method No deviations from the protocol. Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 0 - 0 Oedema 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No skin reactions were observed in all treated animals. The test substance is non-irritating to the skin. Frey-Tox (2007c) Irritation – eye 40-55% notified chemical in glycerin OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 F Observation Period 72 hours Remarks - Method No deviations from the protocol. Conjunctiva: discharge was not recorded. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0 0.3 0.3 1 < 48 h 0 Conjunctiva: chemosis 0 0 0 0 - 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results One hour after the application of the test substance all tested animals showed some hyperaemic conjunctival blood vessels. 24 h after the application of the test substance some hyperaemic conjunctival blood vessels were still observed at two animals, whereas one animal did not show any ocular reactions. 48 h and 72 h after the application of the test substance all animals were free of any signs of eye irritation.
Full Public Report Magnesium, bromo(hexahydro-2H-azepin-2-onato-.kappa.N1)- APPLICANT AND NOTIFICATION DETAILS Plastral Pty Ltd (ABN 68 000 144 132) HILLSDALE NSW 2036 Standard: Chemical other than polymer (more than 1 tonne per year). 75 Data items and details claimed exempt from publication: Purity, Import volume, Additives/adjuvants. 24 Variation to the schedule of data requirements is claimed as follows: Boiling Vapour pressure, Water solubility, Hydrolysis as a function of pH, Partition coefficient, Adsorption/desorption, Dissociation constant, Flash point, Autoignition temperature, Explosive properties, Acute toxicity – inhalation, Skin irritation, Ready biodegradability and Bioaccumulation. , , , IDENTITY OF CHEMICAL Nyrim C1 Catalyst (10-25% notified chemical) Magnesium, bromo(hexahydro-2H-azepin-2-onato-.kappa.N1)- Bromo(hexahydro-2H-azepin-2-onato-N) magnesium 1-azanidacycloheptan-2-one; magnesium (+2) cation; bromide name) 2H-Azepin-2-one, hexahydro-, magnesium complex Magnesium, bromo(hexahydro-2H-azepin-2-onato)- Magnesium, bromo(hexahydro-2H-azepin-2-onato-N)- epsilon.-Caprolactam magnesium bromide Bromocaprolactam magnesium Caprolactam magnesium bromide CAS 17091-31-5 C6H10BrMgNO
TABLE OF CONTENTS Full Public Report 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 5 6. HEALTH IMPLICATIONS 6 7. ENVIRONMENTAL IMPLICATIONS 10 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 12 Appendix A: Physical and Chemical Properties 15 Appendix B: Toxicological Investigations 17 Appendix C: Environmental Fate and Ecotoxicological Investigations 19 Bibliography 22
SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS SUBSTANCE INTRODUCTION VOLUME USE STD/1360 The Chemours Company (Australia) Pty Ltd Diversey Australia Pty Limited IMCD Australia Limited Anderson Dry-Treat Trust & Salmon Dry-Treat Trust Rohm & Haas Australia Pty Ltd Polyfluorinated Chemical in Capstone® FS-60, Capstone® FS-61, Capstone® FS-63 and Capstone® ST 300 Yes ≤ 6 tonnes per annum Component of paints and coatings, and tile products and commercial floor finishes CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified chemical is recommended for hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia. The recommended hazard classification is presented in the table below. Hazard classification Hazard statement Acute Toxicity (Category 1) H330 – Fatal if inhaled on the available information, the notified chemical is recommended for hazard classification according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) with the following risk phrase: R26 Very toxic by inhalation The environmental hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) is presented Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes. Hazard classification Hazard statement Acute (Category 2) H401 – Toxic to aquatic life Chronic (Category 1) H410 – Very toxic to aquatic life with long lasting effects health risk assessment Provided that the recommended occupational control measures are adhered to, the notified chemical is not considered to pose an unreasonable risk to the health of workers. When used in the proposed manner, the notified chemical is not considered to pose an unreasonable risk to public health. However, the notified chemical is a potential precursor of perfluorohexanoic acid (PFHxA), which is persistent in the environment. Due to the environmental distribution of PFHxA resulting from the use pattern of the notified chemical, secondary human exposure to PFHxA via the environment may occur. The notified chemical is replacing a longer chain perfluorinated substance, which will result in secondary human exposures to
Adsorption/Desorption – screening test log Koc < 1.32 OECD TG 121 Estimation of the Adsorption Coefficient (Koc) on Soil and Sewage Sludge using High Performance Liquid Chromatography (HPLC). Remarks The mixture of the reference was dissolved in CH3OH/H2O 65/35% v/v rather than the guideline ratio of 55/45%. This deviation would not have affected the outcome of the test. LAUS GmbH (2008a) Flash Point 224.5 oC at 101.3 kPa EC Directive 92/69/EEC A.9 Flash Point. Remarks Sticky paste test item. Defitraces (2003e)
File No: STD/1363 January 2011 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT 1-Dodecanaminium, N-(2-hydroxy-3-sulfopropyl)-N,N-dimethyl-, inner salt (INCI: Lauryl hydroxysultaine) 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 Sustainability, Environment, Water, Population and Communities. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by appointment only at Level 7, , Surry Hills NSW 2010. This Full Public Report is also 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: 7, , SURRY HILLS NSW 2010, . Postal Address: GPO NSW 2001, . TEL: + 61 2 8577 8800 FAX + 61 2 8577 8888 Website: www.nicnas.gov.au Director NICNAS
Repeat dose toxicity Not determined Genotoxicity - bacterial reverse mutation Non mutagenic Genotoxicity – in vitro Not determined Cytotoxicity study (ISO Elution Method) No evidence of cell lysis or toxicity 7.1. (a) Acute toxicity – oral Zonatac Alternate #1 (ASL 5263) Study 8219A 10/30/84 Stated as OECD method. Analogous to TG 401 Acute Oral Toxicity – Limit test Species/Strain Rat/Sprague-Dawley Vehicle Corn oil Remarks – Method Gavage Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 10.0 g/kg None LD50 > 10.0 g/kg bw of Toxicity Diarrhoea in 5/5 males and 2/5 females, which reversed by day 3. Salivation in 3/5 males and 1/5 females on day 1 only. Wet abdomen in 3/5 males and 3/5 females, which reversed by day 3. 1/5 males experience hair loss and a sore on a hind leg from day 6 onwards. Reduced activity and increased respiratory rate in 1/5 females was observed from day 4 to end of the observation period. Effects in Organs The female rat in persistent clinical signs were observed was found at necropsy to have abscessed lobes of the lung which adhered to the rib cage. Remarks – Results Abscessed lung in 1/5 females and hair loss/sore on leg in 1/5 males are likely to be unrelated to the test substance. The notified chemical is of low acute toxicity via the oral route. Food and Drug Research Laboratories (1984a) 7.1. (b) toxicity – oral Zonatac Alternate #1 Lite (ASL 5264) Study 8219B 10/30/84 Method analogous to OECD TG 401 Acute Oral Toxicity – Limit test. Species/Strain Rat/Sprague-Dawley Vehicle Corn oil 25% solution Remarks – Method Gavage. Observations carried out to Day 15. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 10g/kg None
169.65 Reference IR, Ion Pair Liquid Chromatography spectra were provided. COMPOSITION 99% Chemical Name Methanamine, N,N-dimethyl-, Hydrochloride (1:1) (Trimethylamine Hydrochloride). CAS No. 593-81-7 Weight % 0.0002% Hazardous Properties R36/37/38 (>1% Chemical Name 1-Propanaminium, 3-chloro-, 1,3-dihydroxy-N,N,N-trimethyl-, chloride. (3-chloro-1,3-Dihydroxypropyltrimonium Chloride) CAS No. Unknown Weight % 0.0045% Chemical Name Water CAS No. 7732-18-5 Weight % 44.46 to 54.34% Chemical Name Ethanol, 2-phenoxy CAS No. 122-99-6 Weight % 0.36 to 0.44% Hazardous Properties Xn; R22 Xi; R36 Chemical Name Benzoic acid, 4-hydroxy-, methyl ester CAS No. 99-76-3 Weight % 0.18 to 0.22% PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20ºC and 101.3 kPa: White crystalline solid at 20oC. Property Value Data Source/Justification Melting 88oC Measured Boiling Point 282oC at 100.07 kPa Measured Density 1290 kg/m3 at 22oC Measured Vapour Pressure <6.7 x 10-7 kPa at 25oC Measured Water Solubility 838-861 g/L at 20oC Measured Hydrolysis as a Function of pH Not determined The notified chemical is not expected to hydrolyse over the environmental pH (4–9) based on the absence of readily hydrolysable functional groups Partition Coefficient log Pow = 1.15 at 22.7oC Measured
Notified chemical The potential of the notified chemical to cause serious damage to the eye/mucous membranes was assessed by a single topic application of 0.3 mL of the undiluted test substance and 0.3 mL of a 10% test substance solution in olive oil to the chorionallantoic membrane () of fertilised and incubated hen eggs. Three eggs per test substance concentration were observed until unambiguous irritation reactions were detected. The occurrence of vascular injury or intravascular coagulation in response to the test substance was recorded. Concentration: Egg-No.: Time (seconds) until appearance of: Grading of effects: Haemorrhagia: Coagulation: Haemorrhagia: Coagulation: Undiluted test substance 1 64 64 1 2 2 53 53 1 2 3 51 51 1 2 Mean: n = 3 56 56 1 2 Concentration: Egg-No.: Time (seconds) until appearance of: Grading of effects: Haemorrhagia: Coagulation: Haemorrhagia: Coagulation: 10% test substance in oil 1 30 30 1 2 2 36 36 1 2 3 41 41 1 2 Mean: n = 3 36 36 1 2 Positive controls Concentration: Egg-No.: Time (seconds) until appearance of: Grading of effects: Haemorrhagia: Coagulation: Haemorrhagia: Coagulation: 0.1 M NaOH 1 20 40 2 2 2 28 42 2 2 Mean: n = 2 24 41 2 2 Concentration: Egg-No.: Time (seconds) until appearance of: Grading of effects: Haemorrhagia: Coagulation: Haemorrhagia: Coagulation: 10% sodium dodecyl sulfate 1 22 41 2 2 2 21 35 2 2 Mean: n = 2 22 38 2 2 Remarks - Results The undiluted test substance caused moderate (grade 2) intravascular coagulation and slight (grade 1) haemorrhagia in all eggs after 51-64 seconds. The 10% test substance solution in olive oil caused moderate intravascular coagulation and slight haemorrhagia in all eggs after 30-41 seconds. The notified chemical is severely irritating to the eye the test conditions. BASF SE (2009f) - Skin sensitisation – local lymph node assay (LLNA) Notified chemical
Test substance Sodium Benzoate Day % Degradation Day % Degradation 1 - 1 - 3 0 3 65 7 0 7 78 10 0 10 86 14 0 14 91 21 0 21 92 28 0 28 93 Remarks – Results The toxicity control attained 68% degradation after 14 days confirming that the test substance was not inhibitory to activated sludge bacteria. The reference substance showed the expected degradation profile, confirming the suitability of the inoculums and the validity of the test conditions. The deviations to protocol are not expected to significantly alter the outcome of the test. The notified chemical is not inherently biodegradable RCC Ltd (2008o) Ecotoxicological Investigations Acute toxicity to fish Notified chemical OECD TG 203 Fish, Acute Toxicity Test – Semi- static EC Directive 92/69/EEC C.1 Acute Toxicity for Fish – Semi- static Species Zebra fish (Brachydanio rerio) Exposure Period 96 hours Auxiliary Solvent None Water Hardness 125 mg CaCO3/L Analytical Monitoring HPLC Remarks – Method Following a range-finding test a limit test was conducted in accordance with the guidelines above and with GLP compliance. No deviations to protocol were reported. Concentration mg/L Number of Fish Mortality Nominal Actual 3 h 24 h 48 h 72 h 96 h Control 0 7 0 0 0 0 0 100 98-104 7 0 0 0 0 0 LC50 > 100 mg/L at 96 hours (based on nominal concentration) NOEC > 100 mg/L at 96 hours (based on nominal concentration) Remarks – Results The analytically determined mean test item concentration in the test medium at the start and the end of the test medium renewal periods of 24 hours was 98 and 104% of the nominal value, respectively. Under the test conditions, the test substance was stable during the test period of 96 h. Therefore, all reported results are related to the nominal concentration. All validity criteria for the test were satisfied. The notified chemical is not harmful to fish Harlan Laboratories (2009h)
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical (purity >87%) OECD TG 420 Oral Toxicity – Fixed Dose Procedure. EC Directive 92/69/EEC B.1 bis Acute toxicity (oral) fixed dose method. Species/Strain Rat/Wistar Vehicle Arachis oil BP Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality I 1 F 300 0 II 1 F 2000 0 III 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity There were no deaths and no sign of systemic toxicity. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals showed expected gains in bodyweight. Pale faeces were noted in one animal at the 4-hour, day 1 and day 2 observations. The notified chemical is of low toxicity via the oral route. Harlan Laboratories Ltd (2010e) Acute toxicity – dermal Notified chemical (purity >87%) OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Wistar Vehicle None Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality I 1 M 2000 0 II 1 F 2000 0 III 4 M 2000 0 IV 4 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local Increased respiratory rate and/or hunched posture were noted in two animals. Signs of Toxicity - Systemic There were no deaths and no signs of systemic toxicity were noted. Effects in Organs No abnormalities were in any animal at necropsy. Remarks - Results
Infra red Spectrophotometry Remarks DSM Resins bv, Analytical Department (2003) 3. COMPOSITION >99% Not available None expected 4. INTRODUCTION AND USE INFORMATION (100%) 5 The notified polymer is imported in 25 kg bags or boxes at a concentration of 100%. The reformulated powder coating containing the notified polymer at a concentration of 8% will be transported to professional spray painters in 25 kg bags or boxes. (100%) 5 Year 1 2 3 4 5 Tonnes 25 25 25 25 25 The notified polymer will be used a component of industrial powder coatings. 5. PROCESS AND RELEASE INFORMATION 5.1. Distribution, Transport and Storage Non-Confidential The notified polymer will be reformulated as a component of a powder coating at several sites in Australia. At present only one Victorian reformulator has been identified however up to 5 reformulators may use the notified polymer in the future. The reformulation sites are all located in metropolitan Sydney or Melbourne except for one located in Bowral NSW. The reformulated powder coating product will be distributed for use by professional spray painters throughout Australia. The notified polymer is not a classified as a Dangerous Good under the Australian Code for the Transport of Dangerous Goods by Road and Rail. Coatings containing the notified polymer are also not classified as Dangerous Goods. The notified polymer in its pure form and the powder coating containing the notified chemical at 8% will be transported in 25 kg plastic bags or boxes. The notified polymer is imported in shipping containers by sea and transported in both concentrated and reformulated forms by road and rail. 5.2. Operation Description The notified polymer is imported in 25 kg containers and transported to up to five reformulating sites within Victoria and NSW.