zilongwang/ReadingBank huggingface dataset:
REFERENCE TRADE NAME VOLUME LTD/1769 Firmenich Limited Firwood Yes ≤ 1 tonne per annum Fragrance ingredient 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 Skin sensitisation (Category 1) H317 – May cause an allergic skin reaction Based 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: R43 May cause sensitisation by skin contact The environmental hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) is presented below. 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 2) H411 – Toxic to aquatic life with long lasting effects Human health risk assessment Under the conditions of the occupational settings described, the notified chemical is not considered to pose an unreasonable risk to the health of workers. When used at ≤ 1.0% in fine fragrances, ≤ 0.5% in other cosmetic products, and ≤ 1.5% in household products, the notified chemical is not considered to pose an unreasonable risk to public health. Environmental risk assessment On the basis of the PEC/PNEC ratio and the reported use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment. Recommendations Hazard Classification and Labelling The notified chemical should be classified as follows: Skin sensitisation (Category 1): H317 – May cause an allergic skin reaction The above should be used for products/mixtures containing the notified chemical, if applicable, based on the concentration of the notified chemical present and the intended use/exposure scenario. The Delegate (and/or the Advisory Committee on Chemicals Scheduling) should consider the notified chemical for listing on the SUSMP. Health Surveillance
Oxidising Properties Not determined Contains no functional groups that imply oxidative properties. For full details of tests on physical and chemical properties, refer to Appendix A. Reactivity The notified chemical is expected to be stable under normal conditions of use. Physical hazard classification Based on the submitted physico-chemical data depicted in the above table, 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 following table. Hazard classification Hazard statement Flammable Liquids (Category 3) H226 - Flammable liquid and vapour INTRODUCTION AND USE INFORMATION (100%) 5 The notified chemical will be imported into Australia either in neat form or as a component of fragrance formulation for reformulation. (100%) 5 Year 1 2 3 4 5 Tonnes ≤ 1 ≤ 1 ≤ 1 ≤ 1 ≤ 1 Sydney Manufacturer: Firmenich (outside Australia) Recipient: Firmenich Limited The notified chemical will be imported either in neat form, as a component of fragrance formulation for reformulation, or as a component of formulated end-use products. The notified chemical or products containing the notified chemical will be transported from the port of entry to the notifier’s warehouse facilities by road and will be delivered typically by road to clients’ facilities. The notified chemical will be used as a fragrance ingredient in cosmetics (≤ 0.5% in fine fragrances and ≤ 0.5% in other cosmetic products) and household products (≤ 5% in air fresheners and ≤ 0.5% in other household products). The processes for incorporating the imported notified chemical in neat form or as a component of fragrance preparations into end-use products will likely vary depending on the nature of the cosmetic and household products being formulated, and may involve both automated and manual transfer steps. However, in general, it is expected that the reformulation processes will involve blending operations that will be highly automated and occur in enclosed environments, followed by automated filling of the reformulated products into containers of various sizes. The finished products containing the notified chemical at ≤ 5% concentration may be used by consumers and professionals such as workers in beauty salons or cleaners. Depending on the nature of the product, these could be applied in a number of ways, such as by hand, using an applicator or sprayed.
SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE LTD/1772 Firmenich Ltd Pamplewood Yes ≤ 1 tonne per annum Cosmetic ingredient CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified chemical is not recommended for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). The environmental hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) is presented below. 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 1) H400 – Very toxic to aquatic life Chronic (Category 1) H410 – Very toxic to aquatic life with long lasting effects Human health risk assessment Under the conditions of the occupational settings described, 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. Environmental risk assessment On the basis of the PEC/PNEC ratio, maximum annual importation volume and assessed use pattern the notified chemical is not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical during reformulation processes: Avoid contact with skin and eyes A person conducting a business or undertaking at a workplace should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical during reformulation processes: Coveralls Impervious gloves Eye protection
SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE LTD/1794 Bralson Pty Ltd (trading as MotorActive) 1-Decanamine, N,N-dimethyl-, ND* ≤ 0.31 tonnes per annum Component of automotive wheel cleaner *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification As no toxicity data were provided, the notified chemical cannot be classified according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). Human health risk assessment Under the conditions of the occupational settings described, 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. Environmental risk assessment On the basis of the PEC/PNEC ratio and the reported use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical as introduced: Avoid eye contact Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards. A copy of the (M)SDS should be easily accessible to employees. If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation should be in operation. Disposal
1st challenge intradermal: none topical: 100, 50, 25, 10% 2nd challenge topical: None Remarks - Method 24 h prior to the topical challenge, 10% sodium lauryl sulphate in vaseline was applied to the skin, as the test article itself was non irritating. Results Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test Group 100 0 0 N/A N/A 0 0 N/A N/A Control Group 0 0 0 N/A N/A 0 0 N/A N/A Remarks - Results Conclusion There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test. Test Facility DST (2004b) Skin irritation- human volunteers (translation) Test Substance Notified polymer Method Single application patch test Study Design The test substance (0.01 g) was placed on a Finn Chamber (Epitest)) and patched to the inner side of forearm of each volunteer for 24 hours under occlusive conditions. At the end of 24 hours exposure period, the test sample was removed, and skin reactions were evaluated after 1 hour later and 24 hours later. Study Group 45 volunteers, 21 MF, 24 M; age range 22-56 Vehicle None Remarks - Method Results Remarks - Results 45 volunteers completed the study. In all volunteers, no reaction was observed 24 h or 48 h after removing the test samples, similarly, no reaction was observed in 48 hours after removing the test samples. Conclusion The test substance was non-irritating under the conditions of the test. Test Facility Japan Hair Science Association (2004) Genotoxicity – bacteria Test Substance Notified chemical Method OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation method Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, E. coli: WP2uvrA Metabolic Activation System Rat liver homogenate metabolising system, from rats induced with phenobarbitone/β-naphthoflavone. Concentration Range in Main Test 50, 150, 500, 1500 and 5000 μg/plate (With/without metabolic activation)
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. IDENTITY OF ANALOGUES 6 4. COMPOSITION 7 5. PHYSICAL AND CHEMICAL PROPERTIES 8 6. INTRODUCTION AND USE INFORMATION 8 7. HUMAN HEALTH IMPLICATIONS 9 7.1. Exposure Assessment 9 7.1.1. Occupational Exposure 9 7.1.2. Public Exposure 9 7.2. Human Health Effects Assessment 10 7.3. Human Health Risk Characterisation 11 7.3.1. Occupational Health and Safety 11 7.3.2. Public Health 11 8. ENVIRONMENTAL IMPLICATIONS 12 8.1. Environmental Exposure & Fate Assessment 12 8.1.1. Environmental Exposure 12 8.1.2. Environmental Fate 12 8.1.3. Predicted Environmental Concentration (PEC) 13 8.2. Environmental Effects Assessment 13 8.2.1. Predicted No-Effect Concentration 14 8.3. Environmental Risk Assessment 14 Appendix A: Toxicological Investigations 15 A.1. Acute toxicity – oral 15 A.2. Acute toxicity – dermal 15 A.3. Irritation – skin 16 A.4. Irritation – eye 16 A.5. Skin sensitisation – human volunteers (1) 16 A.6. Skin sensitisation – human volunteers (2) 17 A.7. Repeat dose toxicity 17 A.8. Genotoxicity – bacteria 19 A.9. Genotoxicity – in vitro 19 A.10. Comedogenicity 20 Appendix C: Environmental Fate and Ecotoxicological Investigations 22 C.1. Environmental Fate 22 C.1.1. Ready biodegradability 22 C.2. Ecotoxicological Investigations 23 C.2.1. Acute toxicity to aquatic invertebrates 23 BIBLIOGRAPHY 24
of 3 male rabbits. Test sites were observed for evidence of primary irritation at 1, 24, 48 and 72 hours post patch removal. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 2 2 1.7 2 ≥ 15 days 1 Oedema 0 0 0 0 0 0 * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well-defined erythema was evident at the treated site of all animals from 1 hour post application and sustained for the entire study period. Loss of elasticity was noted in one animal during the 48 hour observations but had subsided by day 15. Exfoliation was noted in all three animals during the second week of observations. There were no signs of toxicity in any of the test animals during the study. The notified chemical was irritating to rabbit skin. Huntingdon Life Sciences (2010a) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3F Observation Period 15 days Remarks - Method No significant protocol deviations. The purity of the test substance was recorded as 99.5%. A single application of 0.1 mL of the test material to the non-irrigated eye of three female rabbits. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1 0.7 1.3 2 < 15 days 0 Conjunctiva: chemosis 0 0 0.7 1 < 72 hours 0 Conjunctiva: discharge 0 0 0 2 < 24 hours 0 Corneal opacity 1 0.7 1 1 < 15 days 0 Iridial inflammation 0.3 0 0 1 < 48 hours 0 * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Installation of the notified chemical gave rise to a moderate initial pain response in the test animals. Crimson red conjunctival appearance was apparent in all three animals during the first 48 hours post installation, persisting in two animals at the 72 hour observations and in one animal on day 8. Slight to moderate
Appendix C: Environmental Fate and Ecotoxicological Investigations Ecotoxicological Investigations Acute toxicity to fish Notified polymer Static Acute Toxicity Test with Feathead Minnows following ABC Protocol No. 7601 Species Fathead Minnows (Pimephales promelas) Exposure Period 96 hours Auxiliary Solvent Not reported Water Hardness 130 - 142 mg CaCO3/L Analytical Monitoring None reported Remarks – Method The test was conducted according to the guidelines above. However, the study was not in compliance with good laboratory practice (GLP) principles. No significant deviations from the test guidelines were reported. The above stated test guideline is very similar to OECD TG 203. Nominal Concentration (mg/L) Number of Fish Cumulative Mortality(96 h) 48h 72h 96h Control 10 0 0 0 100 10 0 0 0 180 10 0 0 0 320 10 0 0 0 560 10 0 0 0 1000 10 0 0 0 LC50 > 100 mg/L at 96 hours. NOEC 100 mg/L at 96 hours. Remarks – Results All validity criteria for the test were satisfied. The 96 h LC 50 was determined based on visual observations. The MSDS reported the LC50 value of the test substance was > 1000 mg/L. The notified polymer is not harmful to fish ABC (1996)
Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ˃ 5,000 - - Negative Test 2 - ˃ 5,000 - Negative Present Test 1 ˃ 5,000 - - Negative Test 2 - ˃ 5,000 - Negative Remarks - Results No toxic effects or no substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the notified chemical at any dose level, neither in the presence nor absence of metabolic activation. In test 2, slight toxic effects were observed at 5,000 µg/plate in strains TA 1535 and TA 1537 with metabolic activation. The study authors concluded that there was no tendency of higher mutation rates with increasing concentrations of the notified chemical in the range below the generally acknowledged border of biological significance. The positive controls (sodium azide, 2-aminoanthracene, methyl methane sulfonate) showed a distinct increase in induced revertant colonies, confirming the efficacy of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. RCC Ltd (2003t) Genotoxicity – in vitro mammalian chromosome aberration test Notified chemical (approximately 92% in purity) OECD TG 473 In vitro Mammalian Chromosome Aberration Test. EC Directive 2000/32/EC B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test. Species/Strain Chinese Hamster Cell Type/Cell Line V79 Metabolic Activation System S9 fraction Phenobarbital/β-naphthoflavone induced rat liver Vehicle Deionised water Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period (hrs) Harvest Time (hrs) Absent Test 1 10, 20*, 40*, 60*, 80, 100 4 18 Test 2 5, 10*, 20*, 40*, 60, 80 18 18 Test 3 20*, 40, 60, 80 28 28 Present Test 1 10, 20, 40*, 60*, 80*, 100 4 18 Test 2 10*, 20*, 40*, 60, 80, 100 4 28 *Cultures selected for metaphase analysis.
SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE LTD/1820 Allnex Australia Pty Ltd & Fujifilm Australia Pty Ltd Polymer in Ebecryl 80 ND* ≤15 tonne/s per annum Component of UV cured ink *=Not Determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified polymer is not recommended for hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia. Human health risk assessment Provided that the recommended controls are in place to limit exposure, under the conditions of the occupational settings described the notified polymer is not considered to pose an unreasonable risk to the health of workers. When used in the proposed manner, the notified polymer is not considered to pose an unreasonable risk to public health. Environmental risk assessment On the basis of the PEC/PNEC ratio and the reported use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety A person conducting a business or undertaking at a workplace should implement the following isolation and engineering controls where possible to minimise occupational exposure to the notified polymer; Enclosed, automated processes Local exhaust ventilation A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure to the notified polymer; Avoid contact with skin and eyes Avoid inhalation Clean up any spills or soiled personal protective equipment promptly A person conducting a business or undertaking at a workplace should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified polymer; Coveralls Impervious gloves Goggles Respiratory protection if inhalation exposure may occur Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.
USA, Canada, EU, China and Philippines IDENTITY OF CHEMICAL IDM Ketal Operanide CAS 823178-41-2 4H-Indeno[4,5-d]-1,3-dioxole, 3a,5,6,7,8,8b-hexahydro-2,2,6,6,7,8,8-heptamethyl- 2,2,6,6,7,8,8-Heptamethyl-4,5,6,7,8,8b-hexahydro-3ah-indeno[4,5-d][1,3]dioxole C17H28O2 264.40 Da Reference NMR, IR, GC, MS, UV spectra were provided. COMPOSITION > 95% Chemical Name 4H-Inden-4-one, 1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl- CAS No. 33704-61-9 Weight % < 2 Hazardous Properties H303 – may be harmful if swallowed, H319 – causes serious eye irritation, H315 – causes skin irritation, H317 – may cause an allergic reaction (> 1% None None PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 ºC and 101.3 kPa: clear yellow liquid Property Value Data Source/Justification Freezing Point < -20 °C Measured Boiling Point 280 °C at 103 kPa Measured Density 974 kg/m3 at 20 °C Measured Vapour Pressure 1.1×10-3 kPa at 25 °C Measured Water Solubility 4.61 × 10-3 g/L at 20 °C Measured
GUJARAT NATIONAL LAW UNIVERSITY APPLICATION FORM FOR SETTLEMENT OF LTC ADVANCE (To be submitted after availing the LTC facility) Name of the Employee Designation Type of LTC (Home town/Anywhere in India) Travel Entitlement Persons in respect of whom LTC availed*. S. No. Name Age Relationship with the Employee Occupation Amount of Advance taken ₹ * As a proof of journey performed, the Employee has to produce a valid ticket/boarding pass(s). In case of ticket booked by IRCTC, the General Administration /HR Section has to verify the validity of PNR no. 7. Details of fare and journey (s) performed by the Employee and the members of his/her family*. Departure Arrival Distance in Kms Mode of Travel & class of used Fare per person(₹) Total number of persons travelled Date From (Name of the place) Date To (Name of the place) Total Particulars of journey (s) for which higher class of accommodation used than the one to which the Employee is entitled:
SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE LTD/1841 Croda Singapore Pte Ltd Polymer in KERAVIS PE NT-LQ-(WD) / KERAVIS PE-(WD) / KERAVIS-(WD) (INCI Name: Hydrolyzed Vegetable Protein PG-Propyl Silanetriol) ND* ≤ 1 tonne per annum Component of cosmetic products *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified polymer is not recommended for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). Human health risk assessment Under the conditions of the occupational settings described, the notified polymer is not considered to pose an unreasonable risk to the health of workers. When used in the proposed manner, the notified polymer is not considered to pose an unreasonable risk to public health. Environmental risk assessment On the basis of use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety No specific engineering controls, work practices or personal protective equipment are required for the safe use of the notified polymer itself. However, these should be selected on the basis of all ingredients in the formulation. Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards. A copy of the (M)SDS should be easily accessible to employees. If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation should be in operation. Disposal off
saline (PBS) and then incubated with MTT bromide) for 3 hours at 37 °C (5% carbon dioxide, ≥ 90% humidity). Following overnight extraction at room temperature, the optical densities were determined (570 nm). Positive control samples (0.3% Triton X-100) were applied to the tissues in triplicate and exposed for 5 min, 15 min and 1 hr. Six replicates of the negative control (corn oil) were applied to tissues and exposed for 1 hour only. Samples were then treated the same as the test substance. The test substance was considered by the study authors to be an irritant if the ET50 value (exposure time required to reduce cell viability by 50%) was < 2 hour. Quality Assurance statement included. Test material Exposure period Mean OD570 of triplicate tissues Relative mean Viability (%) ET50 Value Negative control 1 1.709 100 - Test substance (20%) 20 min 1.866 109 > 2 hr 1 hr 1.849 108 3 hr 1.849 108 Test substance (2%) 20 min 1.631 95 > 2 hr 1 hr 1.786 105 3 hr 1.706 100 Positive control 5 min 1.474 86 21 min 15 min 1.123 66 1 hr 0.263 15 OD = optical density Remarks - Results Tissue viability after exposure to the test substance at 20% or 2% concentration was not reduced to ≤ 50% in any of the exposure periods. The positive control performed as expected. The test substance was considered to be non-irritating to the eye under the conditions of the test. CPT (1998b) A.11. Irritation – eye (1) Analogue 1 Similar to OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 6 (Males and Females) Observation Period 72 hours Remarks - Method Test substance (0.1 mL) was instilled in the right eye (left eye remained untreated and acted as a control) and the eye remained unwashed. Eyes were examined 24 hours after exposure. Scoring was based on the Draize method (1944). No GLP statement provided. Remarks - Results None of the animals exhibited an adverse effect to the test substance.
Mean OD550 of duplicate tissues Relative mean viability (%) Mean OD550 of duplicate tissues Relative mean viability (%) Negative control 1.834 100 1.773 100 Test substance 1.634 89 1.726 97 Positive control 0.395 22 0.304 17 OD = optical density Remarks - Results The test substance showed no corrosive effects. The positive and negative controls gave satisfactory results, confirming the validities of the test systems. The notified chemical was non-corrosive to the skin under the conditions of the test. Bioservice (2012c) Irritation – skin (in vitro) Notified chemical OECD TG 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Method EPISKIN-SM™ Reconstructed 3D Human Epidermis Model Vehicle Distilled water Remarks - Method The test substance (10 mg) was applied to the tissues (pre-moistened with 5 µL distilled water) in triplicate. Following exposure periods of 15 minutes (room temperature) and 1 hour (room temperature; test 2), the tissues were rinsed, treated with MTT bromide] and then incubated at 37 °C for 3 hours. In a preliminary test the test substance was shown not to directly reduce MTT. Positive and negative controls were run in parallel with the test substance: Negative control (NC): phosphate buffered saline Positive control (PC): 5% sodium dodecyl sulphate in distilled water Test material Mean OD550 of triplicate tissues Relative mean Viability (%) SD of relative mean viability Negative control 1.233 100 4.8 Test substance 1.259 102.1 5 Positive control 0.096 7.8 0.4 OD = optical density; SD = standard deviation Remarks - Results The test substance showed no irritation effects. The positive and negative controls gave satisfactory results, confirming the validities of the test systems. The notified chemical was non-irritating to the skin under the conditions of the test. Bioservice (2012d) Irritation – eye (in vitro)
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. COMPOSITION 5 4. PHYSICAL AND CHEMICAL PROPERTIES 5 5. INTRODUCTION AND USE INFORMATION 6 6. HUMAN HEALTH IMPLICATIONS 7 6.1. Exposure Assessment 7 6.1.1. Occupational Exposure 7 6.1.2. Public Exposure 7 6.2. Human Health Effects Assessment 8 6.3. Human Health Risk Characterisation 8 6.3.1. Occupational Health and Safety 8 6.3.2. Public Health 8 7. ENVIRONMENTAL IMPLICATIONS 8 7.1. Environmental Exposure & Fate Assessment 8 7.1.1. Environmental Exposure 8 7.1.2. Environmental Fate 9 7.1.3. Predicted Environmental Concentration (PEC) 9 7.2. Environmental Effects Assessment 9 7.2.1. Predicted No-Effect Concentration 9 7.3. Environmental Risk Assessment 9 Appendix A: Toxicological Investigations 10 A.1. Acute toxicity – oral 10 BIBLIOGRAPHY 11
The positive controls produced satisfactory responses, thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains. The notified chemical was not mutagenic to bacteria under the conditions of the test. WIL (2013) Genotoxicity – in vitro Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Lymphocytes/peripheral Metabolic Activation System S9 fraction from phenobarbitone/β-naphthoflavone-induced rat liver Vehicle Dimethyl sulfoxide Remarks - Method No significant deviations from the OECD guidelines. A preliminary range finding study was conducted to measure the solubility and cytotoxic effects of test substance. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 1*, 10*, 100, 120*, 140 and 160 3 h 24 h Test 2 3, 10, 30, 50*, 75* and 100* 24 h 24 h 3*, 10, 30*, 50, 75* and 100 48 h 48 h Present Test 1 1*, 10, 100*, 120, 140* and 160 3 h 24 h Test 2 3, 10, 30, 50*, 100*, 150* and 200 3 h 48 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity Precipitation Genotoxic Effect Absent Test 1 ≥ 120 ≥ 160 Negative Test 2 (24 h) ≥ 100 > 100 Negative Test 2 (48 h) ≥ 75 > 100 Negative Present Test 1 ≥ 160 ≥ 160 Negative Test 2 > 150 ≥ 200 Negative Remarks - Results No statistically significant increase in the frequency of cells with chromosomal aberrations, polyploid cells or cells with endoreduplicated chromosomes was seen at any dose levels, with and without metabolic activation. The positive and negative controls produced satisfactory responses confirming the validity of the test system. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. WIL (2014k)
Appendix B: Toxicological Investigations Irritation – eye (in vitro isolated chicken eye test) Notified chemical OECD TG 438 Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants Vehicle None Remarks - Method The purity of the test substance was reported as 95.2%. The test substance was directly administered to the isolated chicken eyes. The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t = 0) and approximately 30 minutes after the post-treatment rinse. Positive control: imidazole Negative control: saline (0.9% w/w sodium chloride) Test Substance Observation Value ICE Class Mean maximum corneal swelling at up to 75 min 1% I Mean maximum corneal swelling at up to 240 min 1% I Mean maximum corneal opacity 0.67 II Mean fluorescein retention 1.00 II Overall ICE Class 1 × I, 2 × II Positive Control Observation Value ICE Class Mean maximum corneal swelling at up to 75 min 1% I Mean maximum corneal swelling at up to 240 min 6% II Mean maximum corneal opacity 3.83 IV Mean fluorescein retention 2.67 IV Overall ICE Class 1 × II, 2 × IV Negative Control Observation Value ICE Class Mean maximum corneal swelling at up to 75 min 0% I Mean maximum corneal swelling at up to 240 min 0% I Mean maximum corneal opacity 0.00 I Mean fluorescein retention 0.00 I Overall ICE Class 3 × I Remarks - Results The test substance and the positive control (imidazole) were stuck on the surface of the cornea. Gentle rinsing with 20 mL saline was performed at each observation time point. The surface of the cornea was not cleared 240 minutes after the post-treatment rinse. The notified chemical was not corrosive or a severe eye irritant under the conditions of the test. The notified chemical also was not considered as a non-irritant and an in vivo study was required for classification. CiToxLAB (2014g) Irritation – eye Notified chemical
Density 1,150 kg/m3 at 21.3 °C Method A3 of Commission Directive 92/69/EEC Remarks Gas comparison pycnometer SafePharm (2008a) Vapour Pressure < 2.3 x 10-8 kPa at 25 °C Method A4 of Commission Directive 92/69/EEC Remarks Vapour pressure balance SafePharm (2008b) Water Solubility 260-270 g/L at 20 °C EC Council Regulation No 440/2008 A.6 Water Solubility. Remarks Flask Method. The standard A6 Method was not applicable to this test material due to high indeterminable saturation levels. SafePharm (2008a) Surface Tension 53.0 mN/m at 25 °C Method A.5 of Commission Directive 92/69/EEC Remarks Concentration: 1.008 mg/mL; ISO 304 ring method SafePharm (2008a) Particle Size OECD TG 110 Particle Size Distribution/Fibre Length and Diameter Distributions. Range (m) Mass (%) < 100.0 76.4 < 10.0 3.41 < 5.5 1.42 < 2.4 0.88 < 1.61 0.64 < 0.307 0.51 Remarks Cascade Impactor SafePharm (2008a) Flammability Not highly flammable Method A10 of Commission Directive 92/69/EEC Remarks Notified chemical failed to ignite within required time frame SafePharm (2008b) Autoignition Temperature > 316 °C Method A16 of Commission Directive 92/69/EEC Remarks Notified chemical failed to ignite below its melting temperature. SafePharm (2008b) Explosive Properties Predicted negative
BIBLIOGRAPHY Boethling, RS, Nabholz, JV (1997). “Environmental Assessment of Polymers under the US Toxic Substances Control Act”, in: Hamilton, JD, Sutcliffe, R (ed). Ecological Assessment of Polymers: Strategies for product stewardship and regulatory programs. Van Nostrand Reinhold, New York CIR (2012a) Safety Assessment of Trimoniums as Used in Cosmetics. International Journal of Toxicology, 31 (Supplement 3): 296S-341S CIR (2012b) CIR Precedents - Aerosols (September, 2012) Cosmetic Ingredient Review Institut de la Corrosion (2014) Determination of the Corrosiveness of a Solution in the Presence of Steel and Aluminium Alloy - Solution: “LCE 14004” (Test Report No PV/249/14, August, 2014) France, Institut de la Corrosion (Unpublished report submitted by the notifier) NOHSC (2004) Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, Canberra, AusInfo NTC (2007) Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG code), 7th Edition, National Transport Commission, Commonwealth of Australia. SWA (2012) Code of Practice: Managing Risks of Hazardous Chemicals in the Workplace, Safe Work Australia, United Nations (2009) Globally Harmonised System of Classification and Labelling of Chemicals (GHS), 3rd revised edition. United Nations Economic Commission for Europe (UN/ECE), <http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html> US EPA (2015) High Molecular Weight Polymers in the New Chemicals Program. (Accessed 28 April 2016)
Limited: Synthetic polymer with Mn 1,000 Da. 75 Data items and details claimed exempt from publication: chemical name, other names, CAS number, molecular and structural formulae, molecular weight, analytical data, degree of purity, polymer constituents, residual monomers, impurities, additives/adjuvants, use details, manufacture/import volume and site of manufacture/reformulation. None TSCA 2012, CEPA 2014 and China. IDENTITY OF CHEMICAL RC-8370 (product containing the notified polymer) (MW) Number Average Molecular Weight (Mw) > 1,000 Da COMPOSITION > 95% PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 ºC and 101.3 kPa: Clear liquid (polymer solution) Property Value Data Source/Justification Boiling Point 78 °C (M)SDS* Density 0.99 kg/m3 (M)SDS* Vapour Pressure 2.53 kPa (M)SDS* Water Extractability > 2% Measured Hydrolysis as a Function of pH < 10% after 5 days at 50 C for pH 4, pH 7 and pH 9 Analogue data Partition Coefficient (n-octanol/water) log Pow = 1.3–4.0 at 20 °C Analogue data Adsorption/Desorption Not determined Despite the low log POW, the notified polymer is expected to adsorb strongly to soils and sludge sediments due to the presence of the potential cationic functionality Dissociation Constant Not determined Contains potential cationic functionalities. Therefore, the notified polymer is expected to be ionised at the environmental pH range of 4–9. Flash Point -9 °C (M)SDS* Flammability Flammable liquid. Vapours may form explosive mixtures with air (RC-8370 solution) (M)SDS* Autoignition Temperature 404 °C (M)SDS* Explosive Properties Not determined for the notified polymer. RC-8370 solution has explosive properties, as in lower explosion limit of 1% and higher explosion limit of 11%. Notified polymer contains no pyrophoric groups Oxidising Properties Not determined Notified polymer contains no functional
7.1.3. Predicted Environmental Concentration (PEC) The predicted environmental concentration (PEC) has not been calculated as release of the notified polymer to the aquatic environment will be limited based on its reported use pattern. 7.2. Environmental Effects Assessment No ecotoxicity data were submitted. However, it should be noted that some functional groups of the notified polymer are potentially cationic which are considered a concern to aquatic organisms. However, this effect is not significant given minimal release of the notified polymer to the aquatic environment is expected from the proposed use pattern. 7.2.1. Predicted No-Effect Concentration The Predicted No-Effect Concentration (PNEC) has not been calculated as no significant release of the notified polymer to the aquatic environment is expected from the proposed use pattern. 7.3. Environmental Risk Assessment The risk quotient (Q = PEC/PNEC) for the notified polymer has not been calculated as release to the aquatic environment in ecotoxicologically significant quantities is not expected based on its reported use pattern as a component of industrial coating. The majority of the notified polymer will be disposed of to landfill as a cured polymer matrix in coated articles. The notified polymer bound in coated articles is unlikely to be bioavailable or mobile in this form. On the basis of the assessed use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment.
positive control test was conducted not provided in the study report. induction phase Induction Concentration: intradermal: 20% topical: 20% Signs of Irritation None challenge phase Challenge topical: 20% Remarks - Method Only 3 animals were used for the test. Freund’s Complete Adjuvant was used. A 10% solution of sodium dodecyl sulfate was applied to the skin during the induction phase. Remarks - Results No skin reaction was observed in any test animals during the induction phase and 24 h and 48 h after challenge. There was no evidence of reactions indicative of skin sensitisation to the test substance under the conditions of the test. Confidential Genotoxicity – bacteria Analogue Method similar to OECD TG 471 Bacterial Reverse Mutation Test. Pre incubation procedure Species/Strain S. typhimurium: TA98 and TA100 Metabolic Activation System S9 fraction in Main Test a) With metabolic activation: 5-5,000 µg/plate b) Without metabolic activation: 5-5,000 µg/plate Vehicle Dimethyl sulfoxide Remarks - Method Only one test was conducted. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity Precipitation Genotoxic Effect Absent ≥ 2,000 > 5,000 Negative Present ≥ 2,000 > 5,000 Negative Remarks - Results Cytotoxicity was observed in bacterial strain TA100 only. The positive controls gave satisfactory results confirming the validity of the strain and S9 mix. The test substance was not mutagenic to bacteria under the conditions of the test. Confidential
Appendix A: Physical and Chemical Properties Freezing Point < -50 °C OECD TG 102 Melting Point/Melting Range. Remarks Determined using a crystallising apparatus. Givaudan (2004a) Boiling Point 251 °C at 101.3 kPa (extrapolated) OECD TG 103 Boiling Point. OECD TG 104 Vapour Pressure. Remarks Dynamic method. The normal boiling point was extrapolated from the temperature/pressure relationship. Givaudan (2004b) Density 1,022 kg/m3 at 20 °C OECD TG 109 Density of Liquids and Solids. Remarks Oscillating densitimeter method Givaudan (2005) Vapour Pressure 1.2 × 10-3 kPa at 20 °C OECD TG 104 Vapour Pressure. Remarks Static method Notox (2004a) Water Solubility 0.446 g/L at 20 °C OECD TG 105 Water Solubility. Remarks Flask Method Givaudan (2004c) Partition Coefficient log Pow = 2.9 OECD TG 117 Partition Coefficient (n-octanol/water). Remarks Reverse Phase HPLC Method Givaudan (2004d) Flash Point 120 °C at 101.3 kPa EC Council Regulation No 440/2008 A.9 Flash Point. Remarks Closed cup method Givandan (2004e)
Remarks Concentration: 90% saturated aqueous solution Dr U Noack-Laboratorien (2014b) Flash Point 148 °C at 101 kPa EC Council Regulation No 440/2008 A.9 Flash Point. Remarks Closed cup method Consilab (2014c) Autoignition Temperature 255 °C EC Council Regulation No 440/2008 A.15 Auto-Ignition Temperature (Liquids and Gases). Consilab (2014d)
ANSWER: Do you know why this resident had additional record review area listed than Bugs Bunny or Cruella De Vil? ANSWER: Did you mark harm or IJ for this resident? ANSWER: Did you mark any MDS discrepancies? What was your response for each area? ANSWER: In order to complete the sample selection process for your initial pool residents, you will have to answer just the concerns noted below. You can leave all other areas blank (for this exercise only!). Atom Ant (3) The resident is non-interviewable. Mark the following areas for further investigation: Pressure ulcers (RR) since the resident developed a Stage 2 pressure ulcer on his coccyx in the facility. It is now a Stage 1 PU. Restraint (RO) – has self-releasing seat belt in w/c. Falls (RO) – not wearing non-skid socks, normal socks Fred Flintstone (13) The resident is interviewable. Mark the following areas for further investigation: Infections (RI) – said was admitted for therapy after surgery but has developed an infection in his incision. Rehab (RI) – not getting rehab since I can’t put weight on my leg right now. ADL Decline (RI) – has needed more help getting dressed since getting weaker. James Bond (52) The resident is interviewable. Mark the following areas for further investigation: Nutrition (RO and RI) – didn’t eat breakfast. Said he’s lost weight. No interventions discussed with him. Insulin/AC (RI) – not sure they are checking his BS when they are supposed to. BS fluctuate. Catheter (RO) – Tubing dragging on the floor under the w/c. Pressure Ulcer (RI) – developed pressure ulcer in the facility after w/c cushion went missing for a couple days. They tell me it’s a Stage 3. Hospitalization (RI) – have gone to the hospital because of my wound and breathing issues.
Appendix A: Toxicological Investigations A.1. Acute toxicity – oral Analogue 3 OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle Water Remarks - Method Test substance administered as a 10% (w/v) suspension. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 M, 5 F 2000 0/10 LD50 > 2000 mg/kg bw Signs of Toxicity None observed. Effects in Organs None observed. Remarks - Results All animals gained the expected amount of body weight. One male (1/5) regurgitated the test substance immediately after exposure. No other clinical signs observed. The notified chemical is of low toxicity via the oral route. Pharmakon (1995) A.2. Irritation – skin Analogue 3(100%) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 3 Male Vehicle None. Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP compliant. Test substance was melted in a sheet and applied as a square of 2.5 cm x 2.5 cm (approximately 2 g). Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 < 24 hours 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 Very slight erythema was observed in 2/3 animals at the 1 hour observation. No other adverse effects were observed. The test substance is slightly irritating to the skin. Chrysalis (1997)
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. COMPOSITION 5 4. PHYSICAL AND CHEMICAL PROPERTIES 5 5. INTRODUCTION AND USE INFORMATION 6 6. HUMAN HEALTH IMPLICATIONS 7 6.1. Exposure Assessment 7 6.1.1. Occupational Exposure 7 6.1.2. Public Exposure 7 6.2. Human Health Effects Assessment 8 6.3. Human Health Risk Characterisation 8 6.3.1. Occupational Health and Safety 8 6.3.2. Public Health 8 7. ENVIRONMENTAL IMPLICATIONS 9 7.1. Environmental Exposure & Fate Assessment 9 7.1.1. Environmental Exposure 9 7.1.2. Environmental Fate 9 7.1.3. Predicted Environmental Concentration (PEC) 9 7.2. Environmental Effects Assessment 10 7.2.1. Predicted No-Effect Concentration 10 7.3. Environmental Risk Assessment 11 BIBLIOGRAPHY 12
File No: LTD/1957 May 2017 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) PUBLIC REPORT Polymer in D 600 G This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (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 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 Energy. This 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: Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, 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
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 6 1. APPLICANT AND NOTIFICATION DETAILS 6 2. IDENTITY OF CHEMICAL 6 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 7 5. INTRODUCTION AND USE INFORMATION 8 6. HUMAN HEALTH IMPLICATIONS 9 6.1. Exposure Assessment 9 6.1.1. Occupational Exposure 9 6.1.2. Public Exposure 9 6.2. Human Health Effects Assessment 9 6.3. Human Health Risk Characterisation 10 6.3.1. Occupational Health and Safety 10 6.3.2. Public Health 11 7. ENVIRONMENTAL IMPLICATIONS 11 7.1. Environmental Exposure & Fate Assessment 11 7.1.1. Environmental Exposure 11 Appendix A: Physical and Chemical Properties 14 Appendix B: Toxicological Investigations 15 B.1. Acute toxicity – oral 15 B.2. Acute toxicity – dermal 15 B.3. Irritation – skin 16 B.4. Irritation – eye 16 B.5. Skin sensitisation 17 B.6. Repeat dose toxicity 18 B.7. Genotoxicity – in vitro 20 B.8. Genotoxicity – in vitro 21 Appendix C: Environmental Fate and Ecotoxicological Investigations 23 C.1. Environmental Fate 23 C.2. Ecotoxicological Investigations 23 C.2.1. Acute toxicity to fish 23 C.2.2. Acute toxicity to aquatic invertebrates 24 C.2.3. Algal growth inhibition test 25 BIBLIOGRAPHY 26