zilongwang/ReadingBank huggingface dataset:
9.2.3. Human health - effects assessment 25 9.2.4. Occupational health and safety – risk characterisation 25 9.2.5. Public health – risk characterisation 26 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 26 10.1. Hazard classification 26 10.2. Environmental risk assessment 26 10.3. Human health risk assessment 26 10.3.1. Occupational health and safety 26 10.3.2. Public health 26 11. MATERIAL SAFETY DATA 26 11.1. Material Safety Data 26 11.2. Label 26 12. RECOMMENDATIONS 27 12.1. Secondary notification 27 13. BIBLIOGRAPHY 27
Species Daphnia magna (Crustacea) Exposure Period 48 hours Auxiliary Solvent Not reported Water Hardness 154 mg CaCO3/L Analytical Monitoring Not reported Remarks – Method Daphnia magna, less than 24 hours old, from a laboratory culture were exposed to the test item. No information was provided on the test concentrations. Test conditions included: temperature 18–22ºC; pH total hardness 154 mg CaCO3/L; dissolved oxygen 8.6 – 9.0 mg/L. No further information was provided on the test methods or procedures. LC50 > 1000 mg/L at 48 hours NOEC (or LOEC) Not reported. Remarks – Results No further information on the test results was provided. The test substance is very slightly toxic to Daphnia magna (Mensink et al. 1995). ECB (2000) 8.2.3. Algal growth inhibition test Fluid (DOT 4 type) No method description provided. Species Selenastrum capricornutum (Algae) Exposure Period 96 hours Concentration Range Nominal Not specified Concentration Actual Not specified Auxiliary Solvent Not specified Water Hardness Not specified Analytical Monitoring Not specified Remarks – Method Test parameters were: temperature 22–26ºC; pH 7.0–7.4; initial concentration of 500 cells/mL; illumination ~3000 lux; cell counts were made using a Coulter Counter. No further information was provided on the test methods or procedures. Remarks – Results EC50 (growth rate), 430 mg/L at 96 h. No further information on the test results was provided. The test substance is very slightly toxic to green algae (Mensink et al. 1995). ECB (2000) 8.2.4.1 Inhibition of microbial activity Borate Ester B DIN EN ISO 11348-2 (1999) – Luminescent bacteria test Inoculum Vibrio fischeri (Bacteria) Exposure Period 30 minutes Concentration Range Nominal Nine test concentrations in the range from 0.3 to 5.1 g/L, using dilution ratios of 1:2, 1:3, 1:4, 1:6, 1:8, 1:12, 1:16, 1:24, 1:32.
Topical challenge: undiluted main Number of Animals Test Group: 20 Control Group: 10 Induction Induction Concentration: undiluted Signs of Irritation None challenge phase 1st challenge Topical application: undiluted 2nd challenge Topical application: not conducted Remarks – Method Topical induction, elicitation, no positive control. No skin reactions were noted at challenge sites at any observation period (day 1-30). Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test Group 0 0 0 0 Control 0 0 0 0 was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Safepharm 7.7. Repeat dose toxicity Analogue. The method followed was that outlined in V, Part B, Method B7 in the EEC Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals No. 407, “Repeated Dose Oral Toxicity – Rodent: 28-day or 14 – day study”. Species/Strain Rat / Sprague-Dawley Route of Administration Oral – gavage. Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week; Post-exposure observation period: - All animals were killed and examined macroscopically on day 29. Vehicle Distilled water. Remarks – Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw/day Mortality I (control) 5 male, 5 female 0 (distilled water) 0 II (low dose) 5 male, 5 female 15 mg/kg/day 0 III (mid dose) 5 male, 5 female 150 mg/kg/day 0 IV (high dose) 5 male, 5 female 750 mg/kg/day 0 V (control recovery) VI (high dose recovery) Mortality and Time to Death No mortality was observed during treatment period.
1,3-Dimethyl-4-aminouracil (CD 19-0456) OECD TG 202 Daphnia sp. Immobilisation Test and Reproduction Test – static test. EC Directive 92/69/EEC C.2 Acute Toxicity for Daphnia - static test. Species Daphnia magna Exposure Period 48 hours Auxiliary Solvent None Water Hardness 250 mg CaCO3/L Analytical Monitoring HPLC analysis with UV/VIS-detection Remarks - Method A preliminary test was done to ascertain the concentration of the test material to be used. The study was conducted in duplicate with covered glass beakers containing 50 mL of test medium. Each beaker contained 10 daphnia (i.e. 20 daphnia per concentration), which were not fed during the study. The temperature, dissolved oxygen and pH were measured at the beginning and end of the study. Concentration mg/L Number of D. magna Number Immobilised Nominal Actual 24 h 48 h 0 (control) - 20 0 0 100 - 20 0 0 LC50 >100 mg/L at 48 NOEC (or LOEC) 100 mg/L at 48 hours Remarks - Results The test medium was a clear solution throughout the study. No abnormal behaviour or dead daphnia were observed during the study. The LC50 result indicates that under the Globally Harmonised System of Classification and Labelling of Chemicals the test substance is not classified as harmful to aquatic life. RCC Ltd (2001b) 8.2.3. Algal growth inhibition test 1,3-Dimethyl-4-aminouracil (CD 19-0456) OECD TG 201 Alga, Growth Inhibition Test. EC Directive 92/69/EEC C.3 Algal Inhibition Test. Species Algae (Scenedesmus subspicatus) Exposure Period 72 Concentration Range Nominal 100 mg/L Concentration Range Actual 103-104 mg/L Auxiliary Solvent None Water Hardness 24 mg CaCO3/L Analytical Monitoring HPLC analysis with UV/VIS-detection Remarks - Method The study consisted of 3 replicates per test concentration and 6 of the control. Erlenmeyer flask containing the solutions were inoculated with algal suspension to give a cell density of 10000 cell per mL of test medium. The flasks were covered, incubated in a temperature controlled water bath at 22-23oC and continuously illuminated. 72 hour EC50 > 100 mg/L
LD50 >2000 mg/kg bw Signs of Toxicity - Local No skin alterations at the application site were observed Signs of Toxicity - Systemic No systemic clinical signs of toxicity were observed. No test substance related effects on the body weight of animals were observed during the observation period. A slight loss of body weight observed in two female animals during the first observation period was considered a consequence of the semi-occlusive dressing. Effects in Organs The macroscopic examination at study termination revealed no organ abnormalities. The notified chemical is of low toxicity via the dermal RCC (1993b) 7.3. Acute toxicity – inhalation No test reports were submitted. 7.4. Irritation – skin Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White (SPF) Number of Animals 3 Vehicle Not used Observation Period 1, 24, 48 and 72 hours Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Remarks - Results No local signs of erythema or oedema were reported. The notified chemical is non-irritating to skin. RCC 7.5. Irritation – eye Notified chemical. OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 7 days Remarks - Method The observation period was extended to 7 days to examine the persistence of observed reactions. Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period
File No: STD/1058 30 July 2004 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Pergafast 201 This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at: Library National Occupational Health and Safety Commission 25 Constitution Avenue CANBERRA ACT 2600 AUSTRALIA To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163. This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at: Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA. Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA. TEL: + 61 2 8577 8800 FAX + 61 2 8577 8888. Website: www.nicnas.gov.au Director Chemicals Notification and Assessment
In Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. [Delete as appropriate] Remarks – Method No significant deviations from OECD TG 404 Acute Dermal Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0 0 N/A 0 Oedema 0 0 N/A 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks – Results No erythema, oedema or abnormal physical signs were noted during the observation period. The notified polymer is non-irritating to skin. [Delete as appropriate] MB Research Laboratories (1993c) 7.5. Irritation – eye Poly(oxy-1,2-ethanediyl), α, α', -[1,4-dimethyl-1,4-bis (higher level of ethoxylation than the notified polymer) (analogue) In House Species/Strain Rabbit/New Zealand White Number of Animals 6 Observation Period 21 days Remarks – Method After the 24 hour reading the eyes of all animals were examined with sodium fluorescein. No significant deviations from OECD TG 405 Acute Eye Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 2.2 3 21 days 1 Conjunctiva: chemosis 2.7 3 21 days 2 Conjunctiva: discharge 1.8 3 14 days 0 Corneal opacity 1.5 3 21 days 2 Iridial inflammation 0.8 1 14 days 0 *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals.
Y Coordinate Number For points only, the Y-coordinate is the decimal degree Latitude. This element is included to maintain backward compatibility with existing applications. Domain: +0.000000 through +999,999.999999 NUMBER 12, 6 No Identifier The horizontal reference for measuring locations on the surface. Domain: CAC – HARN – High Accuracy Reference Network HPGN – High Precision GIS Network / High Precision Geodetic Reference NAD27 – North American Datum of 1927 NAD83 – North American Datum of 1983 WGS84 – World Geodetic Survey of 1984 Business Rule: The are supported for the landmass and coastal waters; Oracle/Spatial does not presently support HPGN/HARN VARCHAR2 10 Yes Collector Name The name of the person taking the measurement. Domain: Formatted text Format Rule: where XXX = Last Name and Y = First letter of First Name VARCHAR2 30 No Collector Affiliation Name The agency or company for whom the collector works. Domain: Free form text VARCHAR2 30 No Collecting Program Identifier The DEP program which is obtaining the measurement. VARCHAR2 30 Yes
Domain: +0 through +99,999,999 Coordinate Accuracy Level Identifier The measured, estimated or deduced degree of correctness of the measurement. Domain: 1 = <0.02 meter (+/- 0.01 meter) 2 = 0.02 to 1.0 meter 3 = >1.0 meter to 10 meters 4 = >10 meters to 20 meters 5 = >20 meters to 50 meters 6 = >50 meters to 999.99 NUMBER 1 Yes Verification Method Identifier The method or mechanism used to verify the measurements. Refer to the section for a complete definition of Collection Method and information on expected collection cost and accuracy of these methods. Domain: ADDM – Address Matching AGPS – Autonomous GPS CALC – Calculated by GIS Software CSUR – Cadastral Survey DGPS – Differentially Corrected GPS DMAP – Digital Map Interpolation DPHO – Digital Aerial Photography with Ground Control GGPS – Geodetic Quality GPS LORN – Navigational Device MMAP – Manual Map Interpolation MPHO – Manual Aerial Photography with Ground Control OTHR – A Method Not Listed SATI – Satellite Imagery With Ground Control VARCHAR2 4 Yes
Latitude Measure Minutes Number GEOGRAPHIC_LOCATIONS GL LATITUDE_MM NUMBER 2 Latitude Measure Seconds Number GEOGRAPHIC_LOCATIONS GL LATITUDE_SS NUMBER 6,4 Longitude Measure Degrees Number GEOGRAPHIC_LOCATIONS GL LONGITUDE_DD NUMBER 3 Longitude Measure Minutes Number GEOGRAPHIC_LOCATIONS GL LONGITUDE_MM NUMBER 2 Longitude Measure Seconds Number GEOGRAPHIC_LOCATIONS GL LONGITUDE_SS NUMBER 6, 4 Elevation Number Elevation Datum Name Elevation Resolution Number Elevation Unit Name
OLOA 232E is slightly to moderate irritating to skin. Chevron Chemical Company (1972). 7.4 Irritation - eye OLOA 232E Similar to OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 6 Observation Period 7 days Remarks - Method None Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 0.9 2 7 days 1 Conjunctiva: chemosis 0.1 1 1 day 0 Conjunctiva: discharge 0.3 2 1 day 0 Corneal opacity 0 - - 0 Iridial inflammation 0 - - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results The mean Draize scores for redness, chemosis and discharge at 1 hour were 1.8, 1 and 1.5, respectively. OLOA 232E is slightly irritating to the eye. Chevron Chemical Company (1972). 7.5. Skin sensitisation (1) OLOA 232E OECD TG 406 Skin Sensitisation – Buehler method Species/Strain Guinea pig/Hartley preliminary study Not reported. main Number of Animals Test Group: 15 (low-dose) 15 (high-dose) Control Group: 10 (first challenge control) 10 (second challenge control) 10 (irritation control) induction phase Induction Concentration: topical: 5% in mineral oil (low dose 25% in mineral oil (high dose group) Signs of Irritation Number of animals showing skin reactions (Draize score 1) after inductions were listed below: Animal Number of Animals Showing Skin Reactions after 1st induction 5th induction 10th induction 24 h 48 h 24 h 24 h Test Group Low-dose 0/15 1/15 9/15 1/15
EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP & QA. Lesion Mean Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0.1 1 24 hours 0 Oedema 0 1 4 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results The primary irritation index (PII) was calculated as 0.3. OLOA 371 is slightly irritating to skin. Corning Hazleton Inc (1997c). 7.12. Irritation - eye OLOA 371 OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals Unrinsed eye 6 Rinsed eye group: 3 Observation Period 72 hours Remarks - Method GLP & QA. Rinsed eye group Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.7 0.3 0.3 2 48 hours 0 Conjunctiva: chemosis 0 0 0 - - 0 Conjunctiva: discharge 0 0 0 - - 0 Corneal opacity 0 0 0 - - 0 Iridial inflammation 0 0 0 - - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Unrinsed eye Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 0.6 2 48 hours 0 Conjunctiva: chemosis 0 - - 0 Conjunctiva: discharge 0 - - 0 Corneal opacity 0 - - 0 Iridial inflammation 0 - - 0
R22: Harmful if swallowed R41: Risk of serious eye damage R43: May cause sensitisation by skin contact Use the following risk phrases for products/mixtures containing the notified chemical: 25%: R22: Harmful if swallowed 10%: R41: Risk of serious eye damage 5% conc 10%: R36: Irritating to eyes 1%: R43: May cause sensitisation by skin contact The National Drugs and Poisons Standing Committee (NDPSC) should consider the notified chemical for listing on the SUSDP. Products containing more than the percentage specified of notified chemical and available to the public must carry the following warning statements and safety directions on the label: 5%: Irritant, Avoid contact with eyes 1%: (Repeated) exposure may cause sensitisation, Avoid contact with skin; Wear protective gloves when mixing or using Any percentage: Breathing spray mist is harmful and may cause an asthma-like reaction, Avoid breathing spray mist. Occupational Health and Safety Employers should implement the following engineering controls to minimise occupational exposure to the notified chemical as introduced and in formulated products: Local exhaust ventilation should be employed at sites of potential dust cloud or aerosol generation. Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical as diluted for use and in formulated products: Cleaning by should be conducted in areas of good general ventilation Spills should be cleaned up promptly and placed in containers for disposal Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical as introduced, as diluted for use, and in formulated products: Respiratory protection against imported powders where dust can be generated or in the absence of local exhaust ventilation; Impervious gloves; Safety goggles or face shields Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards. Atmospheric monitoring should be conducted periodically by formulators of cleaning products to measure workplace concentrations of dust during formulation of the notified chemical. A copy of the MSDS should be easily accessible to employees. If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Environment
Concentration (% w/w) in dimethyl sulphoxide Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 5 1166.97 1.77 10 1153.09 1.75 25 943.13 1.43 Vehicle control: Dimethyl sulphoxide 659.94 Not applicable Concentration (% v/v) in acetone/olive oil 4:1 Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Positive control: -hexylcinnamaldehyde 5 - 2.8 10 - 2.3 25 - 5.5 - proliferative response not provided Remarks - Results No deaths occurred. Blue staining of the fur was noted in all test animals during the study. No signs of systemic toxicity were noted during the study. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. Safepharm Laboratories (2003i) 7.7. Repeat dose toxicity Notified chemical Similar to OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. Species/Strain Rat/Wistar Route of Administration Oral – gavage Exposure Information Total exposure days: 28 days; Post-exposure observation period: 14 days (high dose and control groups) Vehicle Water Remarks - Method Additional 14-day recovery groups were also included for high dose and control groups. Group Number and Sex of Animals Dose mg/kg bw/day Mortality I (control) 5/sex 0 0 II (low dose) 5/sex 100 0 III (mid dose) 5/sex 300 0 IV (high dose) 5/sex 1000 0 V (control recovery) 5/sex 0 0 VI (high dose recovery) 5/sex 1000 0 Mortality and Time to Death No mortalities were observed.
Tools The group for Enterprise Tools encompasses those applications that are above the level of individual applications, or are components used by any application within the Agency. These include applications used by the development community (such as the DEP Technical Wiki) and Enterprise Tools such as Security Components which all registered users may need. Security Groups Security groups have been established to further limit access to the Portlets. The following security groups have been established for the FDEP enterprise: Divisional Services The security groups for Divisional Services will be “DIV_” and the Division Acronym. DIV_ARM Access granted to staff of the Division of Air Resource Management. DIV_SL Access granted to staff of the Division of State Lands. DIV_WASTE Access granted to staff of the Division of Waste Management. DIV_DWRM Access granted to staff of the Division of Water Resource Management. DIV_DEAR Access granted to staff of the Division of Environmental Assessment and Restoration. DIV_GEO Open to the public, no security required. Enterprise Services The security groups for Enterprise Services will be “SVC_” and the short name of the functional area SVC_AUTH Links to access permitting and registration applications. SVC_COMP Links to access compliance and enforcement applications. SVC_DOC to access Oculus. SVC_FIN Links to access financial management applications. SVC_GIS Links to access GIS applications and tools. SVC_NATUR Links to access Recs and Parks applications.
Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 male, 5 female 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local None of Toxicity - Systemic None Effects in Organs No test-related changes were noted at necroscopy. Remarks - Results No microscopic examination of tissues was carried out. The notified chemical is of low toxicity via the dermal route. Eastman Kodak (2004l) 7.4. Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/Albino (Hra: (NZW)SPF) Number of Animals 3 Vehicle The test substance was moistened with water. Observation Period 72 h Type of Dressing Occlusive/Semi-occlusive. Remarks - Method At the end of the 4 h exposure period the application site was rinsed with running water. Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 0 - 0 Oedema 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No of irritation were evident at any time during the study. The notified chemical is non-irritating to skin. Eastman (2003i) 7.5. Irritation - eye 7.5.1 Eye Irritation in vivo Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/Albino (Hra: (NZW)SPF) Number of Animals 3 Observation Period 72 h Remarks - Method 0.1g of the notified chemical was administered as received, as a brown powder. Three additional rabbits were treated similarly, except that the eyes were immediately irrigated with running distilled water.
TABLE OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 3 4. INTRODUCTION AND USE INFORMATION 3 5. PROCESS AND RELEASE INFORMATION 4 5.1. Distribution, transport and storage 4 5.2. Operation description 4 5.3. Occupational exposure 4 5.4. Release 5 5.5. Disposal 5 5.6. Public exposure 5 6. PHYSICAL AND CHEMICAL PROPERTIES 5 7. TOXICOLOGICAL INVESTIGATIONS 7 7.1. Acute toxicity – oral 8 7.2. toxicity – dermal 8 7.3. toxicity – inhalation 9 7.4. Irritation – skin 9 7.5. Irritation – eye 9 7.6. Skin sensitisation 10 7.7. Repeat dose toxicity 10 7.8. Genotoxicity – bacteria 11 7.9. Genotoxicity – in 12 8. ENVIRONMENT 13 8.1. Environmental fate 13 8.1.1. Ready biodegradability 13 8.1.2. Bioaccumulation 13 8.2. Ecotoxicological investigations 14 8.2.1. Acute toxicity to fish 14 8.2.2. Acute toxicity to aquatic invertebrates 14 8.2.3. Algal growth inhibition test 15 8.2.4. Inhibition of microbial activity 16 9. RISK ASSESSMENT 16 9.1. Environment 16 9.1.1. Environment – exposure assessment 17 9.1.2. Environment – effects assessment 17 9.1.3. Environment – risk characterisation 17 9.2. Human health 17 9.2.1. Occupational health and safety – exposure assessment 17 9.2.2. Public health – exposure assessment 18 9.2.3. health – effects assessment 18 9.2.4. Occupational health and safety – risk characterisation 18 9.2.5. Public health – risk characterisation 19 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 19 10.1. Hazard classification 19 10.2. Environmental risk assessment 19 10.3. Human health risk assessment 19 10.3.1. Occupational health and safety 19 10.3.2. Public health 19 11. MATERIAL SAFETY DATA 19 11.1. Material Safety Data Sheet 19 11.2. 19 12. RECOMMENDATIONS 19 12.1. Secondary notification 20 13. BIBLIOGRAPHY 21
Remarks – Results Slight erythema occurred in treated skin areas of the 3 rabbits 1 hour after application only. No symptoms of systemic toxicity were observed and no mortality occurred. Yellow staining was observed throughout the study. The notified chemical is non-irritating to skin. NOTOX B.V (1999m). 7.5. Irritation – eye Notified chemical OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 h Remarks – Method No significant protocol deviations Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.3 0.3 0.3 2 <48h 0 Conjunctiva: chemosis 0 0 0 1 <24h 0 Conjunctiva: discharge 0 0 0 1 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 1 <24h 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks – Results Iridal irritation occurred in one animal 1 hour after installation only. Conjunctival irritation consisted of redness, chemosis and discharge which completely resolved within 48 hours in all animals. No staining of ocular tissues was reported. The notified chemical is non-irritating to the eye. NOTOX B.V (1999n). 7.6. Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation - Maximisation test. EC Directive 96/54/EC B.6 Skin Sensitisation - Maximisation test. Species/Strain Guinea pig/ Dunkin Hartley preliminary study Maximum Non-irritating Concentration: intradermal: <2% topical: 5% main study Number of Animals Test Group: 10 Control Group: 5 induction Induction Concentration: intradermal injection 2% in water/ 2% in FCA:Water 1:1 topical application 20% in vaseline
Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.33 0.67 0 2 3 days 0 Conjunctiva: chemosis 0 0 0 0 0 0 Conjunctiva: discharge Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The notified chemical is slightly irritating to the eye. Huntingdon Life Sciences 7.5. Skin sensitisation Notified chemical. OECD TG 406 Skin Sensitisation – maximisation test. EC Directive 96/54/EC B.6 Skin Sensitisation - maximisation. Species/Strain Guinea pig/Dunkin-Hartley. preliminary study Maximum Non-irritating Concentration: intradermal: 5% (w/v) topical: 65% (w/v) main study Number of Animals Test Group: 10 Control Group: 5 induction phase Induction Concentration: intradermal: 5% (w/v) topical: 65% (w/v) Signs of Irritation None due to notified chemical. challenge phase 1st challenge topical: 32.5% (w/v), 65% (w/v) Remarks - Method No significant deviations from protocol. Remarks - Results No sensitisation reactions were observed in any animal at either challenge concentration at either 24 or 48 hours after patch removal. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Huntingdon Life Sciences (2002f). 7.7. Repeat dose toxicity Notified chemical. OECD TG 407 Repeated Dose 28-day Oral Toxicity in Rodents. OPPTS 870.3050, July 2000. Species/Strain Rat/Crl: CD SD IGS BR. Route of Administration Oral – gavage. Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week. Vehicle Corn oil.
Only a summary of the study was reviewed. Other than information provided above, no details of the method used was provided Remarks – Results The average weight, length and rate of development of the injected rats showed no significant variations compared to the control. Other than the information above, no detailed results were provided. Test data has not been reviewed. Due to insufficient information it is not possible to establish a No Observed Adverse Effect (NOAEL) in this study. European Chemicals Bureau (2000) 7.8. Genotoxicity – bacteria Maleic acid & Remarks - Method The following information was provided for five bacterial mutation assays. Only a summary of studies was reviewed. Other than information provided below, no details of the method used was provided Method Species/Strain Metabolic activation Result not provided not provided with and without negative not provided Salmonella typhimurium TA 100 no data negative not provided Escherichia coli Sd-4-73 no data negative Not provided Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100 with and without negative preincubation method Salmonella typhimurium TA97, TA98, TA102, TA104 with and without negative Remarks - Results Other than the information above, no detailed results were provided. Test data has not been reviewed. The test substance was not mutagenic to bacteria the conditions of these tests. European Chemicals Bureau (2000) 7.9.1 Genotoxicity – in vitro DNA synthesis inhibition test Maleic Acid Cell Type/Cell Line Human Fibroblasts, YH-1 cells Metabolic Activation System Polychlorinated biphenyl induced rat S9 fraction Vehicle Eagle’s minimum essential medium (MEM) supplemented with 10% fetal calf serum. Remarks - Method Basic method details are as follows:
8. ENVIRONMENT 8.1. Environmental fate 8.1.1. Ready biodegradability Notified chemical Testing methods for new chemical substances, Kanpogyo No.5, Planning and coordination Bureau, Environment Agency, Yakuhatu No. 615, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, and 49 Kikyoku No. 392, Basic Industries Bureau, Ministry of International Trade and Industry, Japan. Inoculum Mixture of activated sludge from 10 locations in Japan Exposure Period 28 days Auxiliary Solvent None Analytical Monitoring HPLC and BOD Remarks - Method The concentration of the test substance used was 100 mg/L. The medium was inoculated with micro-organisms derived from the activated sludge. Five treatment groups were established in the system: a control consisting of sludge with reference (aniline), sludge with test substance (triplicate), water with the test substance and a blank. The % biodegradation of the test substance was measured by BOD and HPLC on days 7, 14, 21 and 28. The results of the BOD and HPLC determinations are shown below. Test substance Aniline Day % Degradation Day % Degradation HPLC BOD 7 6 0 7 59 14 6 0 14 71 21 4 0 21 73 28 6 0 28 74 Remarks - Results The test substance was neither soluble in water nor in sludge at the initiation of cultivation. At the completion of the cultivation, transformation was not observed compared with the initiation of cultivation for test substance in water. The test solutions were cloudy and the growth of the sludge was not observed at the completion of the cultivation. The test substance was stable during the cultivation based on the HPLC of the test substance before the start and after the termination of the cultivation. The reference substance underwent 74% biodegradation after 28 days thus validating the test. The test substance is considered to be not readily biodegradable. Kurume Research Laboratories 8.1.2. Inherent biodegradability Notified chemical OECD guideline 302D for testing of chemicals: ‘Inherent biodegradability – Concawe test (October 2001), using a pre-exposed inoculum.
in the one printer. The use of one cartridge is likely to occur over a period of time. Therefore exposure is likely to be episodic rather than continuous. Overall the exposure from the notified chemical in air immediately after printing could vary with a number of factors. 35 9.2.2. Public health – exposure assessment 35 9.2.3. Human health – effects assessment 35 9.2.4. Occupational health and safety – risk characterisation 36 9.2.5. Public health – risk characterisation 37 10. CONCLUSIONS – ASSESSMENT OF CONCERN FOR THE ENVIRONMENT AND HUMANS 37 10.1. Hazard classification 37 10.2. Environmental risk assessment 37 10.3. Human health risk assessment 37 10.3.1. Occupational health and safety 37 10.3.2. Public health 38 11. MATERIAL SAFETY DATA SHEET 38 11.1. Material Safety Data Sheet 38 11.2. Label 38 12. RECOMMENDATIONS 38 12.1. Secondary notification 39 13. BIBLIOGRAPHY 39
Rat, acute oral Notified chemical low toxicity, LD50 16,900 – 22,400 mg/kg bw Rat, acute dermal 2-Pyrrolidone low toxicity, LD50 > 2000 mg/kg bw Rat, inhalation 2-Pyrrolidone Not highly toxic, LC50 > 0.28 mg/L/8 h Rabbit, skin irritation Notified chemical non-irritating Rabbit, eye irritation Notified chemical slightly irritating Guinea pig, skin sensitisation test. Notified chemical no evidence of sensitisation Rat, repeat dose oral toxicity – 90 days. 2-Pyrrolidone NOAEL 207 mg/kg bw/day Genotoxicity – bacterial reverse mutation a) Notified chemical non mutagenic Genotoxicity – bacterial reverse mutation b) Notified chemical mutagenic Genotoxicity – bacterial reverse mutation c) Notified chemical mutagenic Genotoxicity – bacterial reverse mutation d) Notified chemical mutagenic Genotoxicity – in vitro Sister Chromatid Exchange Assay Notified chemical weakly clastogenic Genotoxicity – in vitro Chromosome Aberration Test Notified chemical not clastogenic Genotoxicity – in vitro Mammalian Cell Gene Mutation Test Notified chemical weakly clastogenic Genotoxicity – in vitro Mammalian Cell Transformation Assay Notified chemical not clastogenic Genotoxicity – in vivo Mammalian Erythrocyte Micronucleus Test 2-Pyrrolidone non genotoxic 7.1 Toxicity Oral 7.1.1 Acute toxicity – oral a) Notified chemical Species/Strain Rat/Wistar Vehicle Remarks – Method A one page summary of the study was supplied. The rats were fasted for approximately 18 hours prior to administration of the test material. The material was given orally by intubation on a g/kg basis. Following treatment the animals were returned to their cages and food and water were freely available. The rats were observed for signs of toxicity and pharmacological effects for 14 days following treatment. Necropsies were inadvertently not performed. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 10 male 5000 2 2 10 male 7120 0 3 10 male 10,140 0 4 10 male 14,430 0
None USA Accession # 169632) 2. IDENTITY OF CHEMICAL HP-877 (solvent solution of the notified polymer) CAS None allocated Gel Permeation Chromatography (GPC) Remarks The molecular weight distribution was determined by GPC. 3. COMPOSITION > 98% All residual monomers and hazardous impurities are expected to be present the relevant cut-offs for classification of the notified polymer as a hazardous substance. extreme heat conditions, eg. fire, the polymer would burn emitting oxides of carbon. The film will very slowly deteriorate under the action of UV from sunlight, but from experience this is insignificant over the average life of a car (20 years). There is no loss of monomers, additives or impurities from the notified polymer during the life of the car. 4. INTRODUCTION AND USE INFORMATION (100%) 5 The notified chemical will not be manufactured in Australia, but will be imported as a component in the polymer solution HP-877 at a concentration of 65%. (100%) 5 Year 1 2 3 4 5 Tonnes 1-3 3-10 3-10 3-10 3-10 The notified polymer will be formulated in Australia into finished automotive spray paints. It will be spray applied by robots and operators onto car bodies and then baked to form part of the paint finish of the car. 5. PROCESS AND RELEASE INFORMATION 5.1. Distribution, transport and storage
OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria. incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, E. coli: WP2uvrA Metabolic Activation System 10% rat liver S9 Concentration Range in Main Test a) With metabolic activation: 15-5000 b) Without metabolic activation: 15-5000 µg/plate Vehicle tetrahydrofuran Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None 500, 1500 µg/plate None Present Test 1 None None 500, 1500 None Remarks - Results Negative controls were similar to historical values. Positive controls confirmed the sensitivity of the test system. The notified polymer was not mutagenic to bacteria under the conditions of the test. SafePharm (2002a) 7.10. Genotoxicity – in vivo 51% notified polymer in mineral oil. OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Rat/Crl:CD-1(ICR)BR Route of Administration Intraperitoneal injection Vehicle Arachis oil Remarks - Method In a preliminary range-finding test, there was no marked difference in toxicity to males or females. Therefore, males only were used for the main study. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours I (vehicle control) 6/male 0 24 I (vehicle control) 6/male 0 48 II (low dose) 6/male 500 24 III (mid dose) 6/male 1000 24 IV (high dose) 6/male 2000 24 IV (high dose) 6/male 2000 48 V (positive control, CP) 6/male 50 24 CP=cyclophosphamide. Doses Producing Toxicity None. Genotoxic Effects No statistically significant increases in the frequency of micronucleated PCEs in any of the test groups when compared to the control groups.
TABLE OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. INTRODUCTION AND USE INFORMATION 4 5. PROCESS AND RELEASE INFORMATION 4 5.1. Distribution, transport and storage 4 5.2. Operation description 4 5.3. Occupational exposure 5 5.4. Release 6 5.5. Disposal 6 5.6. Public exposure 6 6. PHYSICAL AND CHEMICAL PROPERTIES 6 7. TOXICOLOGICAL INVESTIGATIONS 11 7.1. Acute toxicity – oral 11 7.2. toxicity – dermal 11 7.3. Acute toxicity – inhalation 12 7.4. Irritation – skin 12 7.5. Irritation – eye 12 7.6. Skin sensitisation – mouse local lymph node assay (LLNA) 13 7.7. Repeat dose toxicity - oral 14 7.8. Genotoxicity – bacteria 19 7.9. Genotoxicity – in vitro 19 7.10. Genotoxicity – in vivo 20 8. ENVIRONMENT 21 8.1. Environmental fate 21 8.1.1. biodegradability 21 8.1.2. Bioaccumulation 22 8.2. Ecotoxicological investigations 22 8.2.1. Acute toxicity to fish 22 8.2.2. Acute toxicity to aquatic invertebrates 23 8.2.3. Algal growth inhibition test 24 8.2.4. Inhibition of microbial activity 25 9. RISK ASSESSMENT 26 9.1. Environment 26 9.1.1. Environment – exposure assessment 26 9.1.2. Environment – effects assessment 27 9.1.3. Environment – risk characterisation 27 9.2. Human health 28 9.2.1. Occupational health and safety – exposure assessment 28 9.2.2. Public health – exposure assessment 29 9.2.3. Human health – effects assessment 29 9.2.4. Occupational health and safety – risk characterisation 29 9.2.5. Public health – risk characterisation 30 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 30 10.1. Hazard classification 30 10.2. Environmental risk assessment 30 10.3. Human health risk assessment 30 10.3.1. Occupational health and safety 30 10.3.2. Public health 30 11. MATERIAL SAFETY DATA SHEET 31 11.1. Material Safety Data Sheet 31 11.2. Label 31 12. RECOMMENDATIONS 31 12.1. Secondary notification 32 13. BIBLIOGRAPHY 33
7. TOXICOLOGICAL INVESTIGATIONS Toxicological tests were performed on products containing analogous chemicals Endpoint and Result Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, acute dermal LD50 >2000 mg/kg bw low toxicity Rat, acute inhalation not performed Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation –non-adjuvant test. limited evidence of sensitisation Rat, repeat dose dermal toxicity – 28 days. NOAEL > 1000 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic Genotoxicity – in vitro mammalian chromosome aberration test non genotoxic Genotoxicity – in vivo mammalian bone marrow chromosome aberration test non genotoxic 7.1. Acute toxicity – oral Analogous chemical. OECD TG 401 Oral Toxicity – Limit Test. Species/Strain Rat/Crl:CD BR Vehicle None. Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity No signs of toxicity observed. Effects in Organs No abnormalities observed. Remarks - Results No significant protocol deviations. The analogue chemical is of low toxicity via the oral EBS (1997a) 7.2. Acute toxicity – dermal Analogous chemical. OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rabbit/New Zealand White Vehicle None. Type of dressing Occlusive. Remarks - Method No significant protocol deviations.
EC Directive 92/69/EEC A.14 Explosive Properties. US, EPA OPPTS Method 830.6316 Remarks The notified chemical contains no chemical groups that would imply explosive properties, therefore the result has been predicted negative. Safepharm (2004b) Oxidizing Properties Not expected to be oxidising. EC Directive 92/69/EEC A.17 Oxidizing Properties (Solids). Remarks The notified chemical contains no chemical groups that would imply oxidising properties, therefore the result has been predicted negative. Safepharm (2004b) 7. TOXICOLOGICAL INVESTIGATIONS Endpoint Result and Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, dermal LD50 > 2000 mg/kg bw low toxicity Rabbit, skin irritation non-irritating Rabbit, eye irritation severely irritating Mouse, skin sensitisation – local lymph node assay no evidence of sensitisation Rat, repeat dose oral toxicity – 28 days. NOAEL= 150 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic in two separate studies Genotoxicity – in vitro chromosomal aberration test non genotoxic in two separate studies 7.1. Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague-Dawley (CD) Vehicle Arachis oil BP Remarks - Method A correction factor was applied to account for substance purity. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 6 females 2000 0/6 LD50 >2000 mg/kg bw of Toxicity The only clinical sign observed was blue staining of faeces and urine. There were no signs of systemic toxicity. Effects in Organs Dark liver in 3 females; dark grey liver in the remaining animals. Remarks - Results None. The notified chemical is of low toxicity via the oral route. SafePharm (2004d) 7.2. Acute toxicity – dermal
Oral administration of the notified chemical to rats by gavage for a period of 28 days consecutively, resulted in treatment-related but non-adverse changes in either sex at the high dose and in males treated with the mid dose or low doses. There was no effect of treatment in females treated with mid or low doses. A clear No Observed Effect Level (NOEL) for treatment-related histopathological changes was not established in respect of renal changes in mid or low dose treated males but the NOEL in females was considered to be 150 mg/kg/day. Treatment-related changes seen in male rats treated with mid or low doses were consistent with well-documented condition known as hydrocarbon nephropathy. This only occurs in male rats and is not indicative of a hazard to human health. Furthermore, the effects seen in animals treated with the high dose were confined to minimal clinical observations and adaptive, reversible liver and thyroid changes. Therefore the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day. SafePharm Laboratories Limited (2004g) 7.7. Genotoxicity – bacteria Notified chemical OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test Bacteria. Species/Strain S. typhimurium: TA1535, TA1537, TA98, E. Coli:WP2 uvrA Metabolic Activation System S9 mix from liver homogenate of Arochlor 1254 induced rats Concentration Range in Main Test a) With metabolic activation: 50 to 5000 µg/plate. b) Without metabolic activation: 50 to 5000 µg/plate. Vehicle Dimethyl sulfoxide Remarks - Method A preliminary assay was carried out to determine the toxicity of the test substance. The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 g/plate. The main test was conducted at concentrations ranging from 50 to 5000 g/plate. There was no visible decrease in the bacterial lawn both in the presence and absence of S9 activation.Test conducted in accordance with GLP standards. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None None None Present Test 1 None None None None