zilongwang/ReadingBank huggingface dataset:
Harlan (2009o) (Notified chemical) Assessment of the inhibitory effect on the respiration of activated sewage sludge (Project No. 0161/0692, September, 2009). , Harlan laboratories Limited (Unpublished report submitted by the notifier). Harlan (2010) (Notified chemical) Twenty-Eight Day Repeated Dose Oral (Gavage) Toxicity Study in the Rat (Project number: 0161/0688, March, 2010), , Harlan Laboratories Limited (Unpublished report submitted by the notifier). NOHSC (1994) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)]. National Occupational Health and Safety Commission, , Australian Government Publishing Service. NOHSC (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2nd edition [NOHSC:2011(2003)]. National Occupational Health and Safety Commission, , Australian Government Publishing Service. NOHSC (2004) Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, , AusInfo. NTC (National Transport Commission) 2007 Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG code), 7th Edition, Commonwealth of Australia. SCCP (2006) Notes of Guidance for testing of Cosmetic Ingredients and Their Safety Evaluation (6th revision) European Commission - Scientific Committee on Cosmetic Products. United Nations (2009) Globally Harmonised System of Classification and Labelling of Chemicals (GHS), 3rd revised edition. United Nations Economic Commission for (UN/ECE), <http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html >. US EPA (2009) Estimations Program Interface Suite™ for Microsoft® Windows, v 4.00. United States Environmental Protection Agency. , <> Accessed 2011, Jan 28.
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 LTD/1509 Estee Lauder Pty Ltd 2-Butenedioic acid (2E)-, esters (INCI Name: Di-C12-15 Alkyl Fumarate) Yes ≤ 1 tonne per annum Component of cosmetic products 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 following table. 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(s): R43: May Cause sensitisation by skin contact 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 ≤ 10% in body lotion, ≤ 6% in other leave-on cosmetic products and ≤ 10% in rinse-off cosmetic products, the notified chemical is not considered to pose an unreasonable risk to public health. Environmental risk assessment On the basis of 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 following should be used for products/mixtures containing the notified chemical: Conc. ≥ 1%: H317 The Delegate (and/or the Advisory Committee on Chemicals Scheduling) should consider the notified chemical for listing on the SUSMP. Occupational Health and Safety If beauty care professionals are frequently applying cosmetic products containing the notified chemical to clients, employers should implement the following safe work practices to minimise occupational exposure of workers to the notified chemical: Avoid contact with skin
File No: LTD/1511 March 2011 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Ethyl Safrascenate 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: Level 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
of small package sizes and will subsequently be transported to retail outlets. The notified chemical will be used as a fragrance ingredient in a variety of cosmetic, toiletry and household products. It will be present at a maximum concentration of 1% in fine perfumes, and a maximum of 0.025% in other products. The fragrance preparations containing the notified chemical (up to 10%) will be reformulated into end use products in . The reformulation process typically involves blending operations that will be highly automated and enclosed and will not usually involve manual handling by workers. The final products (up to 1% notified chemical) will then be transferred to smaller containers typically using automated filling processes. The final consumer products will be distributed to retail outlets and sold to the public. HUMAN HEALTH IMPLICATIONS Exposure assessment 6.1.1 Occupational exposure Number and Category of Workers Category of Worker Number Exposure Duration (hours/day) Exposure Frequency (days/year) Transport workers 4 Unknown unknown Mixer 5 4 2 Drum handling 5 4 2 Drum cleaning 8 4 2 Maintenance 5 4 2 Quality control 1 0.5 1 Packaging 10 4 2 Salon workers 100 1 300 Exposure Details Occupational exposure to the notified chemical will mainly occur at the reformulation plants where the imported containers of fragrance mixtures containing the notified chemical (at a maximum of 10%) will be opened and used. Dermal, ocular and inhalation exposure of workers to fragrance mixtures containing the notified chemical may occur during handling of the drums, weighing and charging to the blending vessel, mixing in open vessels (which may occur in some facilities), during cleaning operations, sampling or analysis tasks, and transfer to end-use containers. Exposure to the notified chemical is expected to be lowered by the mainly automated and enclosed processes used, and the ventilation likely to be in place. Personal protective equipment (gloves, eye and respiratory protection etc) used by workers will reduce exposure if mixing occurs in open vessels. Workers in hair and beauty salons may experience extensive dermal exposure during application of products containing the notified chemical at up to 0.025% by hand. Such professionals may use some personal protective equipment (such as gloves) to minimise repeated exposure, and good hygiene practices are expected to be in place. Exposure of such workers is expected to be of a similar or higher level than that experienced by consumers using products containing the notified chemical. 6.1.2. Public exposure
workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Public Health Products marketed to the public containing the notified polymer should not recommend application by spraying. Disposal The notified polymer should be disposed of to landfill. Emergency procedures Spills or accidental release of the notified polymer should be handled by physical containment, collection and subsequent safe disposal. 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, other importer or manufacturer: (1) Under Section 64(1) of the Act; if the polymer has a number-average molecular weight of less than 1000; additional information becomes available as to the sensitisation or corrosion/irritation potential of the notified polymer. (2) Under Section 64(2) of the Act; if the function or use of the polymer has changed from as a component of coatings and paint (<30%) for both industrial and DIY uses, or is likely to change significantly; the amount of polymer being introduced has increased from 200 tonnes/annum, or is likely to increase, significantly; the polymer has begun to be manufactured in Australia; additional information has become available to the person as to an adverse effect of the polymer 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. Material Safety Data Sheet The MSDS of the product containing the notified polymer provided by the notifier was reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.
8. CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the information provided, the notified polymer is classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)] with the following risk phrase: Xn; R42 May cause sensitisation by inhalation and The classification of the notified polymer using the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations 2009) is presented below. This system is not mandated in and carries no legal status but is presented for information purposes. Hazard category Hazard statement Respiratory sensitisation 1 May cause allergy or asthma symptoms or breathing difficulties if inhaled 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 Based on the reported use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment. Recommendations Hazard Classification and Labelling Safe Work Australia, should consider the following health hazard classification for the notified polymer: Conc. ≥ 1%: R42 may cause sensitisation by inhalation Health Surveillance As the notified polymer contains isocyanate functional groups, employers should carry out health surveillance for any worker who has been identified in the workplace risk assessment as having a history of isocyanate sensitivity, asthma or other pulmonary condition and who may be adversely affected by isocyanate exposure. Occupational Health and Safety Employers should implement the following isolation and engineering controls to minimise occupational exposure to the notified polymer during reformulation and use of products containing the notified polymer: Ventilation systems including local exhaust ventilation when inhalation exposure could occur, where possible. Automated processes, where possible. Ventilated spray booths during spray application, where possible. Spray application to occur in well-ventilated areas when spray booths cannot be used.
Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 5000 > 2000 ≥ 1500 negative Test 2 5000 ≥ 1500 ≥ 1500 negative Present Test 1 5000 > 2000 ≥ 1500 negative Remarks - Results Preliminary toxicity assay Precipitation was observed at concentrations ≥ 1500 µg/mL. Substantial toxicity was observed at 5000 µg/mL with and without S9 activation and with a 4-hour exposure, and without activation with a exposure. Main study There was an absence of a concentration-related increase in mutant frequency. The notified polymer was not clastogenic to mouse lymphocytes treated in vitro under the conditions of the test. BioReliance (2008)
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, other importer or manufacturer: (1) Under Section 64(1) of the Act; if the polymer has a number-average molecular weight of less than 1000; the concentration of the polymer in diesel fuel is >0.05%. or (2) Under Section 64(2) of the Act; if the function or use of the polymer has changed from an additive in diesel fuel, or is likely to change significantly; the amount of polymer being introduced has increased from 30 tonnes per annum, or is likely to increase, significantly; the polymer has begun to be manufactured in ; additional information has become available to the person as to an adverse effect of the polymer 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. Material Safety Data Sheet The MSDS of the notified polymer provided by the notifier was reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.
BIBLIOGRAPHY NOHSC (1994) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)]. National Occupational Health and Safety Commission, , Australian Government Publishing Service. NOHSC (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2nd edition [NOHSC:2011(2003)]. National Occupational Health and Safety Commission, , Australian Government Publishing Service. NOHSC (2004) Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, , AusInfo. NTC (National Transport Commission) 2007 Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG code), 7th Edition, Commonwealth of Australia United Nations (2009) Globally Harmonised System of Classification and Labelling of Chemicals (GHS), 3rd revised edition. United Nations Economic Commission for (UN/ECE), <http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html >. US EPA (2010) Interpretive Assistance Document for Assessment of Polymers. US EPA Sustainable Futures Assessment Summary Updated April 2010. Available online [9 October 2011]: .
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 LTD/1558 PPG Industries Australia Pty Ltd Polymer B in CA1000 ND* ≤ 3 tonnes per annum Component of sealants *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification As no toxicity data were provided, the notified polymer cannot be classified according to 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 the assessed use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified polymer: Avoid contact with skin Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified polymer: Coveralls Gloves Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards. A copy of the MSDS should be easily accessible to employees. If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)] workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Surveillance
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley CD, 5M/5F Vehicle None Remarks - Method No significant protocol deviations Remarks - Results There were no mortalities observed LD50 >2,000 mg/kg bw Signs of Toxicity None Effects in Organs None The notified chemical is of low toxicity via the oral route. Safepharm (1996c) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle None Observation Period 14 days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations 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 1.3 2 2 <14 days 0 Oedema 1.3 0.7 1.7 2 <14 days 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 and very slight to slight oedema were noted at up to the day 7 observation. These effects were resolved by the day 14 observation. Crust formation preventing an accurate erythema reading was noted at a single treated site at the day 7 observation. Moderate desquamation was noted at the treated site of 2 animals at day 7 and slight desquamation was noted at the sites of all animals at the end of the observation period. The notified chemical is irritating to the skin. Safepharm (1996d) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion.
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 4 1. APPLICANT AND NOTIFICATION DETAILS 4 2. IDENTITY OF CHEMICAL 5 3. COMPOSITION 5 4. PHYSICAL AND CHEMICAL PROPERTIES 5 5. INTRODUCTION AND USE INFORMATION 6 6. HUMAN HEALTH IMPLICATIONS 6 6.1. Exposure Assessment 6 6.1.1. Occupational Exposure 6 6.1.2. Public Exposure 7 6.2. Human Health Effects Assessment 7 6.3. Human Health Risk Characterisation 7 6.3.1. Occupational Health and Safety 7 6.3.2. Public Health 7 7. ENVIRONMENTAL IMPLICATIONS 7 7.1. Environmental Exposure & Fate Assessment 7 7.1.1. Environmental Exposure 7 7.1.2. Environmental Fate 8 7.1.3. Predicted Environmental Concentration (PEC) 8 7.2. Environmental Effects Assessment 9 7.2.1. Predicted No-Effect Concentration 9 7.3. Environmental Risk Assessment 9 Appendix A: Physical and Chemical Properties 10 BIBLIOGRAPHY 12 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 LTD/1583 Canon Australia Pty Ltd CIM-27 ND* ≤1 tonnes per annum Component of inkjet printer ink *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification As no toxicity data were provided, the notified chemical cannot be classified according to 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
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 LTD/1587 Rohm & Haas Australia Pty Ltd and Dow Chemical () Ltd Polymer in Acusol 420N ND ≤ 100 tonnes per annum Component of dishwashing and laundry products *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available data the notified polymer is not classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(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 the PEC/PNEC ratio and the assessed 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 MSDS should be easily accessible to employees. If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)] workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Disposal The notified polymer should be disposed of to landfill. Emergency procedures Spills or accidental release of the notified polymer should be handled by physical containment, collection and subsequent safe disposal. Regulatory Obligations
, and . IDENTITY OF CHEMICAL Accelerator 2950 CH (≤70% notified polymer) Mn <500 Da Reference IR and GPC spectra were provided. COMPOSITION >90% Hazardous Impurities/Residual Monomers One hazardous impurity/residual monomer is present at a level above the concentration cut-off for classification. The impurity is present at a concentration of ≥1% and may result in sensitisation by skin contact (R43 classification). PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 ºC and 101.3 kPa: Yellow liquid* Property Value Data Source/Justification Freezing Point -41.9 oC Measured Boiling Point Decomposition at ~240 oC at 101.3 kPa Measured Density* 970 – 1,050 kg/m3 at 20 oC MSDS Vapour Pressure* 1x10-4 kPa at 20 oC MSDS Water Solubility ≥466.9 g/L Measured Hydrolysis as a Function of pH Not determined No hydrolysable groups present. Partition Coefficient (n-octanol/water) log Kow = 0.99 Measured Adsorption/Desorption log Koc = 1.21 at 25 C Estimated for a representative low molecular weight oligomer using KOCWIN v2.00 (US EPA 2009). Expected to sorb to soil and sludge based on presence of cationic functionality. Dissociation Constant pKa ~10 Based on data from analogous compounds. Flash Point* >100 oC (closed cup) MSDS Autoignition Temperature Not determined Not expected to autoignite under normal conditions based on the flash point. Explosive Properties Not determined There are no chemical groups within the structure that imply explosive properties. Oxidising Properties Not determined There are no chemical groups within the structure that imply oxidative properties. *For imported product containing ≤70% notified polymer. Discussion of Properties For full details of tests on physical and chemical properties, refer to Appendix A.
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 6 1. APPLICANT AND NOTIFICATION DETAILS 6 2. IDENTITY OF CHEMICAL 7 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 7 5. INTRODUCTION AND USE INFORMATION 8 6. HUMAN HEALTH IMPLICATIONS 9 7. ENVIRONMENTAL IMPLICATIONS 14 BIBLIOGRAPHY 16
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 LTD/1609 BASF Australia Ltd Polymer in Lutensit Z 96-70% ND* ≤ 10 tonnes per annum Additive for use in laundry cleaning products *ND = not determined CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification As no toxicity data were provided, the notified polymer 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 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 Hazard Classification and Labelling 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 MSDS should be easily accessible to employees. If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)] workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Disposal The notified polymer should be disposed of to landfill.
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/1616 BASF Australia Ltd Glycols, 1,2-, ethoxylated propoxylated (INCI name: PPG-1-PEG-9 Lauryl Glycol Ether) Yes ≤ 1 tonne per annum Component of cosmetic products CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified polymer 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 Skin Irritation (Category 2) H315 – Causes skin irritation Eye Irritation (Category 2A) H319 – Causes serious eye irritation Based on the available information, the notified polymer is recommended for hazard classification according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004), with the following risk phrase(s): R36: Irritating to eyes R38: Irritating to skin 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 Toxicity (Category 2) H401 - Toxic to aquatic life Chronic Toxicity (Category 3) H412 - Harmful to aquatic life with long lasting effects 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 at ≤ 2% in leave-on cosmetic products and ≤ 3% in rinse-off cosmetic products, 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 assessed use pattern, the notified polymer is not considered to pose an unreasonable risk to the environment. Recommendations Hazard Classification and Labelling The notified polymer should be classified as follows: Skin Irritation (Category 2): H315 – Causes skin irritation
File No: LTD/1623 November 2012 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) PUBLIC REPORT CIM-21 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 Public Report may be inspected at our NICNAS office by appointment only at Level 7, , Surry Hills NSW 2010. This 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: Level 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
typhimurium strain TA98 in the presence of S-9 only, under the conditions of the test. Covance Laboratories Ltd (2010) Genotoxicity – in vitro Notified Polymer (72.7%) OECD TG 487 Draft guideline for In vitro Mammalian Cell Micronucleus Test. Species/Strain Human Cell Type/Cell Line Lymphocyte cells Metabolic Activation System S-9 Aroclor 1254 Vehicle Purified water Remarks - Method The test method used by notifier is in line with the OECD test guideline. The negative control was sterile purified water. The positive controls used were mitomycin C, cyclophosphamide and vinblastine. A correction factor of 1.376 was applied to all concentrations to account for the purity value of 72.7%. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 10, 20*, 40*, 60, 80*, 100, 120, 140*, 160, 180, 200, 250 3 24 Test 2 5, 10*, 20, 30*, 40, 50*, 60*, 70, 80, 90, 100, 120 24 24 Present Test 1 50, 100*, 125*, 150*, 175, 200, 225, 250, 275, 300, 350, 400 3 24 *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test (>60%) Cytotoxicity in Main Test (>60%) Precipitation Genotoxic Effect Absent Test 1 ≥233 ≥160 >250 Negative Test 2 ≥84 ≥60 >400 Negative Present Test 1 ≥389 ≥175 >120 Negative Test 2 Remarks - Results Statistically significant increases in the number of MNBN (micronucleated binucleate) cells were seen at the highest concentration tested following 3+21 hour and 24+0 hour treatments, in the absence of metabolic activation. These increases were discounted because they only occurred in one of two replicate cultures. No statistically significant increases in the number of MNBN cells were seen in other test groups The notified polymer did not induce micronuclei in cultured human peripheral blood lymphocytes treated in vitro under the conditions of the test.
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/1648 Firmenich Limited 2-Propen-1-ol, (2E)- 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 Acute toxicity (Category 4) H302 – Harmful if swallowed 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: R22 Harmful if swallowed 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 aquatic toxicity (Category 2) H401 – Toxic to aquatic life Human health risk assessment Under the conditions of the occupational settings described, provided that control measures are in place to minimise worker exposure, including the use of automated processes, ventilation systems and PPE (coveralls, impervious gloves, eye protection), the notified chemical is not considered to pose an unreasonable risk to the health of workers. Based on the available information, when used at ≤ 0.17% in deodorants, ≤ 0.32% in fine fragrances, ≤ 0.5% in body lotion, ≤ 0.44% in other leave-on cosmetic products and ≤ 1% in rinse-off cosmetic products and 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 assessed 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:
Consumer Product Testing Inc (1986) Irritation – skin (in vivo) (2) Notified chemical Similar to OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3M Vehicle - Observation Period 7 days Type of Dressing Not stated Remarks - Method Tabular summary only provided, and the test period was not specified. Remarks - Results No erythema or oedema was observed at the 24, 48 or 72 h observations. The notified chemical was non-irritating to the skin under the conditions of the study. Cosmeer (1995) Irritation – eye (1) Notified chemical Similar to OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals Observation Period Remarks - Method Tabular summary only provided. Observation period was 7 days. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctival effects 0.3 0.3 0.7 4 < 72 h 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 Conjunctival effects were not distinguished as redness, chemosis or discharge. Severe conjunctival effects were seen at 1 h, which had reduced to slight effects at 24 h, and resolved by 72 h in all animals. The notified chemical is slightly irritating to the eye. Cosmeer (1995) Skin sensitisation – mouse local lymph node assay (LLNA) Notified chemical OECD TG 429 Skin Sensitisation: Local Lymph Node Assay EC Directive 2004/73/EC B.42 Skin Sensitisation (Local Lymph Node Assay)
7.2.1. Predicted No-Effect Concentration A Predicted No-Effect Concentration (PNEC) was not calculated as no ecotoxicological data were submitted and there will be very low potential for aquatic exposure. 7.3. Environmental Risk Assessment A Risk Quotient (RQ = PEC/PNEC) is unable to be quantified as a PEC and PNEC were not calculated. There is no significant aquatic release of the notified polymer anticipated based on the reported use pattern. Moreover, after curing, the majority of the imported quantity of notified polymer will be incorporated into the adhesive matrix and is not expected to be mobile, bioavailable nor readily biodegradable. The notified polymer contains functionality that may slowly degrade over extended periods of time to form potentially persistent and/or bioaccumulative highly halogenated fragments. However, based on the incorporation of the notified polymer into the adhesive matrix and the expected limited environmental exposure and mobility of the articles formed using the notified polymer, the potential release of highly hydrogenated fragments is expected to be limited. On the basis of the assessed use pattern, the notified polymer is not considered to pose an unreasonable short-term risk to the environment. However, due to the potential release of possibly persistent and/or bioaccumulative highly halogenated fragments, the long-term environmental implications are unknown.
None IDENTITY OF CHEMICAL Supermol L Supermol L-LQ-(RB) CAS 161308-02-7 Hexanedioic acid, polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol, decanoate isooctadecanoate octanoate Adipic acid, oligomeric reaction products with decanoic acid, isooctadecanoic acid, octanoic acid and pentaerythritol Pentaerythrityl Isostearate/Caprate/Caprylate/Adipate (INCI name) C18 H36 O2 . x C10 H20 O2 . x C8 H16 O2 . x (C6 H10 O4 . C5 H12 O4)x > 1,000 Da Reference GPC, IR and UV spectra were provided. COMPOSITION > 90% PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 ºC and 101.3 kPa: Amber/yellow liquid Property Value Data Source/Justification Melting Point/Freezing Point Not determined The Polymer is liquid at ambient temperature Boiling Point > 200 °C Statement by notifier Density 0.981 at 25°C Statement by notifier Vapour Pressure Not determined Expected to be low on the basis of the high molecular weight (>1000). Water Solubility 1.28 x 10-35 g/L Calculated using WSKOW v1.42 (US EPA, 2011). Hydrolysis as a Function of pH t½ = 16.78 and 1.68 minutes at pH 7 and 8 respectively. Calculated using HYDROWIN v2.00 (US EPA, 2011). Partition Coefficient (n-octanol/water) log Kow = 31.87 Calculated using KOWWIN v1.68 (US EPA, 2011). Adsorption/Desorption log Koc = 17.96 Calculated using KOCWIN v2.00 (US EPA, 2011). Dissociation Constant Not determined No dissociable functionality. Flash Point > 100 °C (open cup) (M)SDS Autoignition Temperature Not determined Expected to be high on the basis of the flash point. Explosive Properties Not determined Contains no functional groups that would imply explosive properties. Oxidising Properties Not determined Contains no functional groups that would imply oxidising properties.
Appendix A: Physical and Chemical Properties Pour Point -12 °C OECD TG 102 Melting Point/Melting Range. Remarks An automatic apparatus, ASTM D 5950 was used. The apparatus detects the lowest temperature at which movement of the sample occurs. Integrated (2013a) Boiling Point 342 – 450 °C at 101.3 kPa Thermogravimetric analysis Remarks A thermogravimetric analysis was used to determine the weight change as a function of temperature. Integrated (2013a) Density 918 kg/m3 at 20 °C OECD TG 109 Density of Liquids and Solids. Remarks The density was determined using a pycnometer. Harlan (2013a) Density 917.3 kg/m3 at 20 °C OECD TG 109 Density of Liquids and Solids. Remarks The density was determined using an oscillating densitometer. Integrated (2013a) Vapour Pressure 5.161 x 10-7 kPa at 20 °C Maxwell-Bonnell method Remarks The vapour pressure was computed using the Maxwell-Bonnell calculation in conjunction with a correlation from distillation data (software by Simulation Sciences ProVision, v.10). Integrated (2013a) Solubility < 2.5 × 10-5 g/L OECD TG 105 Water Solubility Remarks A turbidity measurement technique was used to determine the water solubility of the test substance. The test substance was dissolved in tetrahydrofuran, and various amounts were spiked into water. As the concentration of the test substance reached its solubility limit, the insoluble material caused turbidity and was measured by an ultraviolet-visible (UV-Vis) spectrophotometer. Integrated (2013a) Partition Coefficient (n-octanol/water) log Pow = 10 – 14 OECD TG 117 Partition Coefficient (n-octanol/water). Remarks A high performance liquid chromatography (HPLC) was used for reverse phase analysis using a Zorbax XDB-C18 column, a UV detector for the calibrants, and an evaporative light scattering detector for the test material. A mobile phase of 75% tetrahydrofuran/25% water was used at a flow rate of 1.0 mL/min. Four reference substances with known log Kow values (cited from literature sources) ranging from 4.9 to 10.2 were used to
The notified polymer 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 polymer is not 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. INTRODUCTION AND USE INFORMATION (100%) 5 The notified polymer will be imported into Australia as a component of a finished product at ≤ 50% concentration in an aqueous solution. (100%) 5 Year 1 2 3 4 5 Tonnes < 1 < 1 1-2 1-2 2-5 Sydney The notified polymer will be imported in finished aqueous products in a purpose designed 10 L “cartridge” (plastic bag/bladder inside a cardboard box) fitted with a valve for connection to printer intake port. The products containing the notified polymer will be transported by road from the dockside to the notifier’s warehousing facility for storage prior to being distributed to the end–users’ facilities. The notified polymer will be used as a component of paper treatment products for printing applications at ≤ 50% concentration. The notified polymer will be imported as a component of paper treatment products at ≤ 50% concentration, which will be sold to end-users in the same form in which they are imported. The operators at the end use site will unscrew the valve opening and insert a tube into the cartridge. The solution will be pumped directly from the cartridge into the printer. The solution will be deposited on the print head prior to deposition of ink onto the paper surface and will be air-dried prior to the paper leaving the printer. The product will only be used for commercial scale printing and will not be available to the public. HUMAN HEALTH IMPLICATIONS 6.1. Exposure Assessment 6.1.1. Occupational Exposure Category of Workers Category of Worker Exposure Duration (hours/day) Exposure Frequency (days/year) Transport and storage 0.5-1 12 End-use printing operators 8 200 End-use service technicians 1 200 Transport and storage workers may come into contact with the notified polymer (≤ 50% concentration) only in the event of accidental rupture of containers.
Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ≥ 7.82 > 8 ≥ 2 Negative Test 2 ≥ 62.5 > 8 ≥ 1 Negative Present Test 1 ≥ 62.5 > 16 ≥ 1 Negative Test 2 > 16 ≥ 4 Negative Remarks - Results The test substance did not induce any statistically significant increases in the frequency of cells with aberrations in any of the exposure groups. The test substance is not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Harlan (2012e)
Appendix B: Toxicological Investigations All studies were conducted using a mixture of the notified chemicals. Acute toxicity – oral Notified chemicals (isomers present at: trans- 32.1% and cis- 60.3%) OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/ Wistar (RccHanTM:WIST) Vehicle Arachis oil BP (300 mg/kg bw) or none (2,000 mg/kg bw). Remarks - Method No significant protocol deviations. GLP Compliance. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3F 300 0/3 2 3F 2,000 0/3 3 3F 2,000 0/3 LD50 > 2,000 mg/kg bw Signs of Toxicity Clinical observations seen in animals treated at 2,000 mg/kg bw included piloerection (3/6 animals) and hunched posture (6/6 animals). One of these animals was seen to additionally exhibit ptosis, ataxia, lethargy and laboured, noisy and gasping respiration. This animal was still showing signs at the end of the observation period. Signs of toxicity were observed in all other animals from 1 hour to 4 hours post dosing only. No signs of systemic toxicity were noted in any animals treated at 300 mg/kg bw. Effects in Organs No macroscopic abnormalities were seen at necropsy in any of the test animals. Remarks - Results All test animals showed body weight gains during the study period, except for one animal treated at 2,000 mg/kg bw, which showed weight loss during the first week, but gained weight during the second week of observation. This was the same animal which showed additional signs of toxicity throughout the study period. The mixture of notified chemicals is of low toxicity via the oral route. Harlan (2013d) Acute toxicity – dermal Notified chemicals (isomers present at: trans- 32.1% and cis- 60.3%) OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/Wistar (RccHanTM:WIST) Vehicle None. Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP Compliance. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 per sex 2,000 0/10