zilongwang/ReadingBank huggingface dataset:
Remarks in “High Production Volume (HPV) Challenge Program – Robust Summaries & Test Plans: Alkyl Sulfide, page 4, Table 1: Physical Properties of Representative Structures of Alkyl Sulfides as Modeled by EPIWIN”. Water Solubility (2) 0.5096 mg/L (10 chain thiol) ECOSAR v0.99 Remarks These results are calculated. Hydrolysis as a Function of pH Not determined. The notified chemical does not contain any functional groups considered to be hydrolysable. Partition Coefficient (n-octanol/water) (1) Not determined Remarks log Kow expected to be between 16 – 16.95 based on the analogue Alkenes, alpha, sulfurized. Cited in “High Production Volume (HPV) Challenge Program – Robust Summaries & Test Plans: Alkyl Sulfide, page 4, Table 1: Physical Properties of Representative Structures of Alkyl Sulfides as Modeled by EPIWIN”. Partition Coefficient (n-octanol/water) (2) log Pow = 6.1 (calculated) for tert-dodecanethiol Summary of data presented in IUCLID for tert-dodecanethiol. Partition Coefficient (3) log Kow = 5.12 (estimate) (10 chain thiol) KowWin – ECOSAR v0.99 Adsorption/Desorption Not determined Remarks log Koc is expected to be between 9.50 – 9.77 based on the analogue Alkenes, alpha, sulfurized. in “High Production Volume (HPV) Challenge Program – Robust Summaries & Test Plans: Alkyl Sulfide, page 4, Table 1: Physical Properties of Representative Structures of Alkyl Sulfides as Modeled by EPIWIN”. Dissociation Constant pKa = 9.0 – 11.0 (Aliphatic thiols) Test reports were not provided. Particle Size Not applicable as it is a liquid Point > 176.67oC Cleveland Remarks Cited in the MSDS for Base 18-V Flammability Limits Not determined. Remarks Not expected to be flammable based on use pattern. Autoignition Temperature Not determined. Remarks Not expected to autoignite based on use pattern. Explosive Properties Not determined.
alpha, sulfurized CAS No. Sulfide CAS No. CAS No. 68511-50-2 sulfurized CAS No. CAS No. 67124-09-8 25103-58-6 Acute Oral Acute Dermal Acute Inhalation Acute intraperitoneal Skin Irritation Eye Irritation Skin Sensitisation Repeat Dose Toxicity Genotoxicity in – Bacterial Reverse Mutation Genotoxicity in vitro Genotoxicity in vivo Development toxicity/Teratogenicity Endpoint and Result Assessment Conclusion Rat, acute oral LD50: 1-Propene, 2-methyl-, sulfurized: LD50 = 8600 mg/kg bw (male rats) 1-Propene, 2-methyl-, sulfurized: LD50 = 5.7 mL/kg (male rats) Pentene, 2,4,4-trimethyl-, sulfurized LD50 > 5000 mg/kg bw 2-Propanol, 1-(tert-dodecylthio)- LD50 > 5000g/kg bw (male and female) Low toxicity Low toxicity Low toxicity Low toxicity Rat, acute dermal: Alkenes, C15-18 alpha, sulfurized: LD50 > 2000 mg/kg bw Rabbit dermal: Pentene, 2,4,4-trimethyl-, sulfurized LD50 > 2000 mg/kg bw 2-Propanol, 1-(tert-dodecylthio)- LD50 > 2000 mg/kg bw Low toxicity Low toxicity Low toxicity
A cosmetic ingredients review panel concluded that magnesium stearate was not a mutagen in Salmonella typhimurium TA 1535, TA 1537, TA 1538 and Saccharomyces cerevisiae D4 with or with metabolic activation by liver and lung preparations from rats, mice and monkeys. 7.15. Chronic toxicity/carcinogenicity Lithium complex grease (80% (w/w) base oil, lithium 12-hydroxy stearate (7.5%), other additives (12%). Fifty mg of test material was applied twice weekly to the shorn interscapular region of C3H mice (50/sex). Positive controls were treated with 50 mg of a 0.05% solution of BaP in toluene and negative controls received toluene or were untreated. Applications were continued for 104 weeks or until a horny lesion on the surface of the skin grew to 1 mm3. Potential tumours were examined histologically. Species/Strain Mouse/C3H of Administration Dermal – non-occluded. Exposure Information Total exposure: 104 weeks Dose regimen: 2 days per week. Vehicle None. Group Number of mice with malignant tumours Number of mice with benign tumours Latent period (weeks) Untreated controls 46 males 50 females 0 1 0 2 Toluene controls 48 males 50 females 3 5 3 2 87 72 Test substance 47 males 50 females 0 1 2 0 67 82 BaP 46 males 49 females 21 45 5 2 48 49 The test substance was not a skin carcinogen. Developmental toxicity/teratogenicity The teratogenic effect of lithium compounds has been reviewed by Leonard et al. (1995). A number of studies in various animal species have produced mixed results. Lithium carbonate given to mice over several days to produce serum levels comparable to those achieved in patients with manic depressive disorders did not result in any effects but dosages at a 6 times higher level caused malformations in the offspring. Many authors have reported that lithium given to women in the first trimester of pregnancy causes congenital defects, especially of the cardiovascular system. As a result registers of “lithium babies” have been set up. 8. ENVIRONMENT
FULL PUBLIC REPORT 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin, 6-oxide, sodium salt (ADK STAB NA-11) 1. APPLICANT AND NOTIFICATION DETAILS Marubeni Australia Ltd (ABN:53 000 329 699) 18 367 Collins St MELBOURNE VIC 3000 Standard: Chemical other than polymer (more than 1 tonne per year). 75 Data and details claimed exempt from publication: of the testing facilities End users of the notified chemical 24 Variation to the schedule of data requirements is claimed as follows: Dissociation constant, flashpoint, explosive properties, oxidising properties, inhalation study, induction of germ cell damage, 21 day Daphnia reproduction study, fish bioaccumulation study None. US PMN (1990), Canada (2002, listed on DSL 2003), (1985 Registration No. (5)-5864), EU listed on EINECS (286-344-4). 2. IDENTITY OF CHEMICAL 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin, 2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-, 6-oxide, sodium salt 2,4,8,10-Tetra(tert-butyl)-6 hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt Sodium-2,2-methylene bis(4,6-ditert-bethylphenyl)phosphate (SMBP) ADK STAB NA-11 ADK STAB NA-11 UH CAS 85209-91-2 C29H43O4P.Na INFORMATION CHEMICAL
11. MATERIAL SAFETY DATA SHEET 11.1. Material Safety Data Sheet The MSDS of the product containing the notified polymer provided by the notifier was in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 2003). It is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant. 11.2. Label The label for the product containing the notified polymer provided by the notifier was in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances (NOHSC 1994). The accuracy of the information on the label remains the responsibility of the applicant. 12. RECOMMENDATIONS Hazard Classification and Labelling Use the following risk phrases for products/mixtures containing the notified chemical: Conc 25%: R20/21/22; R34; R43; 25%> Conc 10%: R34; R43 10%> Conc 5%: R36/37/38; R43 5%> Conc 1%: R43 Products containing more than 1% notified chemical and available to the public must carry the following safety directions on the label: S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice S36 Wear suitable protective clothing S37 Wear suitable gloves S42 During spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer) S63 In case of accident by inhalation: remove casualty to fresh air and keep at rest. S64 If swallowed, rinse mouth with water, (only if the person is conscious) Health Surveillance As the notified chemical is a sensitiser, employers should carry out health surveillance for any worker who has been identified in the workplace risk assessment as having a significant risk of sensitisation. Sensitised workers should be advised not to further handle the notified polymer Occupational Health and Safety Employers should implement the following isolation and engineering controls to minimise occupational exposure to the notified chemical as mixed for use: enclosure of pumps and filling machines during repackaging to prevent exposure to aerosols; isolation of spray working areas where possible; exhaust ventilation during transfer of notified polymer from drum to mixing tank; good ventilation during preparation and application of coating solutions. Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical avoid skin and eye contact; avoid breathing spray;
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 4 5.4. Release 6 5.5. Disposal 7 5.6. Public exposure 7 6. PHYSICAL AND CHEMICAL PROPERTIES 7 7. TOXICOLOGICAL INVESTIGATIONS 11 7.1. Acute toxicity – oral 11 7.2. Acute toxicity – dermal 11 7.4. Irritation – skin 11 7.5. Irritation – eye 13 7.6. Skin sensitisation 13 7.7. Repeat dose toxicity 14 7.8. Genotoxicity – bacteria 17 7.9. Genotoxicity – in vitro 18 8. ENVIRONMENT 19 8.1. Environmental fate 19 8.1.1. Ready biodegradability 19 8.1.2. Bioaccumulation 19 8.2. Ecotoxicological investigations 20 8.2.1. Acute toxicity to fish 20 8.2.2. Acute/chronic toxicity to aquatic invertebrates 20 8.2.3. Algal growth inhibition test 21 8.2.4. Inhibition of microbial activity 22 9. RISK ASSESSMENT 22 9.1. Environment 22 9.1.1. Environment – exposure assessment 22 9.1.2. Environment – effects assessment 23 9.1.3. Environment – risk characterisation 23 9.2. Human health 23 9.2.1. Occupational health and safety – exposure assessment 23 9.2.2. Public health – exposure assessment 23 9.2.3. Human health – effects assessment 23 9.2.4. Occupational health and safety – risk characterisation 23 9.2.5. Public health – risk characterisation 24 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 24 10.1. Hazard classification 24 10.2. Environmental risk assessment 24 10.3. health risk assessment 24 10.3.1. Occupational health and safety 24 10.3.2. Public health 24 11. MATERIAL SAFETY DATA SHEET 24 11.1. Material Safety Data Sheet 24 11.2. 25 12. RECOMMENDATIONS 25 12.1. Secondary notification 25 13. BIBLIOGRAPHY 25
There were no test item related effects on clinical observations in pups or pup body weights. Pregnancy ratios were 11/12, 10/12, 10/11 and 11/12 for the 0, 100, 500, and 1000 mg/kg groups, respectively. A summary of other reproductive outcomes (means/litter) are provided in the table below: The No Observed (Adverse) Effect (NO(A)EL) was established as 1000 mg/kg bw/day in this study, based on the maternal and developmental toxicity results reported in this study. Cited in OPPT (2003). 7.12T. Toxicity to reproduction – one generation study Analogue (purity 100%) OECD TG 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. Species/Strain Rat/Crl:CD®BR Male and female/12 per sex per dose group Route of Administration Oral – gavage Exposure Information exposure days: 14 days premating through 4-day lactation period (approximately 50 days). Exposure levels: 0, 100. 500, 1000 mg/kg bw/day Vehicle Methyl cellulose (0.5%). Remarks – Method Statement of GLP included. No full study report provided. Group Number and Sex of Animals Dose mg/kg bw/day Mortality 1 12 males, 12 females 0 None reported 2 12 males, 12 females 100 None reported 3 12 males, 12 females 500 None reported 4 12 12 females 1000 None reported Mortality and Time to None reported. Effects on Parental (P) animals: There were no significant differences between the control and treated rats with respect to the reproductive performance of male or female rats which included mating index and fertility indices, gestation length, number of implantation sites, sex ratio, gestation ratio, percentage of pups born alive, and number of pups surviving to day 4 of lactation. Effects on 1st Filial Generation (F1) There were no test item related effects on clinical observations in pups or pup body weights. Remarks - Results A summary of reproductive outcomes are provided in the table below:
Number of Animals 3 Observation Period 8 days. Remarks - Method No protocol deviations. 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 2 1 2 72 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. Remarks - Results None. The notified chemical is slightly irritating to the eye. (HLS, 2004f). 7.6. Skin sensitisation – mouse local lymph node assay (LLNA) Notified chemical. Species/Strain Mouse/CBA/Ca Vehicle 4:1 oil Remarks - Method No protocol deviations. Concentration (% w/v) Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Test Substance 0 (vehicle control) 460.9 5 545.7 1.2 10 1244.4 2.7 25 458.0 1.0 Positive Control (HCA) 0 136.7 10 208.4 1.5 25 478.6 3.5 50 800.5 5.9 Remarks - Results The positive control data was at the low end of the of historical data. was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (HLS, 2004g). 7.7. Repeat dose toxicity Notified chemical.
Plaque A broad papule, or confluence of papules equal to or greater then 1 cm; an elevated, plateau-like lesion greater in its diameter than in its depth (i.e. psoriasis). Polycystic Ovarian Syndrome/Disease (PCOS/PCOD) A condition in a woman's ovaries or adrenal glands produce more male hormones than normal, possibly resulting in the development of cysts (fluid-filled sacs) on the ovaries. Women who are obese are more likely to have PCOS. Women with PCOS are at increased risk of developing diabetes and heart disease. Post-Exposure Prophylaxis (PEP) A preventative medical treatment started immediately after a high-risk exposure to a pathogen such as HIV to prevent infection and development of the disease. To be effective PEP for HIV must be taken within 72 hours of exposure and consists of 2-3 antiretroviral medications taken for 28 days. Pre-Exposure Prophylaxis (PrEP) A preventative medical treatment used before exposure to a disease causing agent to prevent rather than treat or cure a disease. PrEP most commonly refers to an HIV-prevention strategy that uses antiretroviral medications to protect high-risk HIV-negative people from acquiring HIV. Pruritus Sensation that causes the desire or reflex to scratch; itchiness. Lice The crab louse (Pthirus pubis), also known as the pubic louse, is a tiny insect that is an obligate ectoparasite of humans. It is typically found in the pubic hair, but may also live on other areas of coarse hair, including the eyelashes. They cannot jump and feed exclusively on blood. They are spread through sexual contact as well as when infested bed sheets, clothing, or towels are shared. Females lay 3 eggs a day and the eggs take 6-8 days to hatch. Itching is the main symptom of pubic lice. Skin may be irritated, and a rash may develop from extensive scratching and digging. Pubic lice can be treated with a medicated shampoo. Purulent Producing or containing pus. Pustule A small circumscribed elevation on the skin containing pus.
Endpoint and Result Assessment Conclusion Rat, acute oral Low toxicity, LD50 > 2000 mg/kg bw Rabbit, acute dermal Low toxicity, LD50 > 9ml/kg bw Rat, acute inhalation Not determined Rabbit, skin irritation Moderately irritating Rabbit, eye irritation Non-irritating Guinea pig, skin sensitisation - Guinea pig maximisation test by Magnusson and Kligman No evidence of sensitisation. Rat, oral repeat dose toxicity - 28 days. NOEL > 200 mg/kg bw/day Genotoxicity – Ames Test Non mutagenic Genotoxicity – in vitro Chinese hamster lung fibroblasts (V79 cells) Non genotoxic Genotoxicity – in based on analogue data: Non mutagenic 7.1. toxicity – oral Notified chemical OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Wistar Vehicle Water Remarks – Method No deviation from protocol Administration by gavage (5 mL/kg) Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/male 2000 Nil 2 5/female 2000 Nil LD50 > 2000 mg/kg bw Signs of Toxicity No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. All animals showed body weight gain during the study period. Effects in Organs Macroscopic examination of all animals at the end of the study revealed no gross abnormalities. Remarks – Results The notified chemical is of low toxicity via the oral C.V. (1987) 7.2. Acute toxicity – dermal Notified chemical (Summary only provided) Not Species/Strain Rabbit/New Zealand White Vehicle Undiluted Type of dressing Remarks – Method The test was conducted by exposing a large surface of the skin to 0 (control), 5, 10 or 100% of the material in an amount of 9 ml/kg body weight of the rabbits during 24 hours. Each of the doses was applied to 2 male and 2 female rabbits. In each dose group one male and one female received material on intact skin, while the other male and female was treated on the superficially damaged skin. After exposure, the animals were observed for a period of 14 days. Body weights and intake of food and water were recorded. At day 14 blood samples were collected for
Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 5004 0 LD50 >5004 mg/kg bw Signs of Toxicity None Effects in Organs None Remarks - Results None The analogous chemical is of low toxicity via the oral route. Pharmakon (1997a) 7.2. Acute toxicity – dermal Analogue B OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle None Type of dressing Semi-occlusive Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2006 0 LD50 >2006 mg/kg bw Signs of Toxicity - Local None of Toxicity - Systemic One treated female showed low body weight gain, however, this is likely incidental. Effects in Organs None Remarks - Results None The analogous chemical is of low toxicity via the dermal route. Pharmakon (1997b) 7.3. Acute toxicity – inhalation Not performed. 7.4. Irritation – skin Analogue C 0.5 mL of test substance was applied to three clipped, intact areas on the back of each of six rabbits for four hours under occlusive dressings. After exposure, the exposed areas were wiped with mineral oil. Irritation was scored at 1, 24, 48 and 72 hours and 7 and 14 days, using a modified Draize scoring method. Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 14 days Type of Dressing Occlusive Remarks - Method None
The analogue chemical was not mutagenic to bacteria under the conditions of the test. Covance Laboratories Inc (1998e) – bacteria Analogue D OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 97/69/EC Mutagenicity – Reverse Mutation Test using Bacteria. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100 E. coli: WP2uvrA Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction Concentration Range in Main Test a) With metabolic activation: 100, 250, 500, 1000, 5000, µg/plate b) Without metabolic activation: 100, 250, 500, 1000, 5000, 10000 µg/plate Vehicle None 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 ≥ 1000μg/plate None Test 2 None ≥ 1000μg/plate None Present Test 1 None None ≥ 1000μg/plate None Test 2 None ≥ 1000μg/plate None Remarks - Results Positive control substances had the appropriate response. Negative controls were within historical limits. The analogous chemical was not mutagenic to bacteria under the conditions of the test. CHV (1997) 7.12. Genotoxicity – in vitro Analogue A OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line Human lymphocytes Metabolic Activation System Aroclor 1254 induced rat liver S9fraction. Vehicle DMSO Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 34.7, 49.5, 70.7, 101, 144*, 205*, 293*, 419, 598, 854, 1220, 1740, 2480, 3540, 5050 μg/mL 3 h 22 h Test 2 12.5, 25, 50, 100, 150*, 200*, 250*, 300, 350, 400 μg/mL 19.3 h 22 h Test 3 12.5, 25*, 50*, 100*, 150, 200, 250, 300, 350, 400 μg/mL 43.3 h 46 h Present
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 4 5.4. Release 5 5.5. Disposal 5 5.6. Public exposure 5 6. PHYSICAL AND CHEMICAL PROPERTIES 5 7. TOXICOLOGICAL INVESTIGATIONS 8 7.1. Acute toxicity – oral 8 7.2. Acute toxicity – dermal 8 7.3. Acute toxicity – inhalation 9 7.4a. Irritation – skin 9 7.4b. Irritation – skin 10 7.5. Irritation – eye 11 7.6. Skin sensitisation 11 7.7. Repeat dose toxicity - inhalation 12 7.8. Genotoxicity – bacteria 14 7.9. Genotoxicity – in 14 8. ENVIRONMENT 15 8.1. Environmental fate 15 8.1.1. Ready biodegradability 15 8.1.2. Bioaccumulation 16 8.2. Ecotoxicological investigations 17 8.2.1. Acute toxicity to fish 17 8.2.2. toxicity to aquatic invertebrates 17 8.2.3. Algal growth inhibition test 18 9. RISK ASSESSMENT 19 9.1. Environment 19 9.1.1. Environment – exposure assessment 19 9.1.2. Environment – effects assessment 19 9.1.3. Environment – risk characterisation 20 9.2. Human health 20 9.2.1. Occupational health and safety – exposure assessment 20 9.2.2. Public health – exposure assessment 20 9.2.3. Human health – effects assessment 20 9.2.4. Occupational health and safety – risk characterisation 21 9.2.5. Public health – risk characterisation 21 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 21 10.1. Hazard classification 21 10.2. Environmental risk assessment 21 10.3. Human health risk assessment 21 10.3.1. Occupational health and safety 21 10.3.2. Public health 21 11. MATERIAL SAFETY DATA 21 11.1. Material Safety Data Sheet 21 11.2. Label 22 12. RECOMMENDATIONS 22 12.1. Secondary notification 22 13. BIBLIOGRAPHY 23
File No: STD/1210 March 2007 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin, 6-oxide, lithium salt This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Water Resources. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at: Library Australian Safety and Compensation Council 25 Constitution Avenue CANBERRA ACT 2600 AUSTRALIA To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email ascc.library@dewr.gov.au 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
Metabolic Activation System S9 mix. Vehicle dimethylsulfoxide Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Expression Time Selection Time Absent Test 1 24, 32, 42, 56, 75 4 hours 48 hours 10 – 12 days. Test 2 18, 24, 32, 42, 56 4 hours 48 hours 10 – 12 days. Test 3 12, 15, 19, 24, 30 4 hours 48 hours 10 – 12 days. Present Test 1 24, 32, 42, 56, 75 4 hours 48 hours 10 – 12 days. Test 2 24, 32, 42, 56, 75 4 hours 48 hours 10 – 12 days. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent >75 Test 1 24 - + Test 2 24 - + Test 3 12 - + Present > 75 Test 1 42 - + Test 2 24 - + Remarks - Results Maximum mutation frequency was 26.8 x 10-4 at 24 µg/mL in the absence of S9 and 24.6 x 10-4 at 56 µg/mL in the presence of S9. The notified chemical was mutagenic to Mouse lymphoma L5178Y cells treated in vitro under the conditions of the test. Zeneca (1996h). 7.10. Genotoxicity – in vivo ITC 826 Concentrate. OECD TG 474 Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/CD-1. Route of Administration Oral – gavage. Vehicle Deionised water. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours 1 5/sex 0 24 and 48 hours 2 5 200 24 and 48 hours 3 5 females 320 24 and 48 hours 4 5/sex CP, 65 24 hours CP = cyclophosphamide. Doses Producing Toxicity 320 mg/kg bw (males), 500 mg/kg/bw (females). Genotoxic Effects A statistically significant increase in micronucleus frequency at the 24 hour time point for females was apparently due to a low control value as confirmed by a further analysis of female vehicle controls.
FULL PUBLIC REPORT Chemical 1 in Lugafast AN 1. APPLICANT AND NOTIFICATION DETAILS BASF Australia Ltd (ABN 62 008 437 867) 500 Princes Highway, Noble Park Vic 3174 Standard: Chemical other than polymer (more than 1 tonne per year). 75 Data items and details claimed exempt from publication: Chemical Name Other Names CAS number Structural Formula Molecular Formula Spectral data Purity Identity of toxic and hazardous impurities and % weight Identity of non-hazardous impurities and % weight Identity of additives/adjuvants and % weight Import volume Customer names and identity of sites 24 Variation to the schedule of data requirements is claimed as follows: Adsorption/Desorption Particle Size Flash point Acute Inhalation Toxicity Induction of germ Cell Damage Bioaccumulation None USA, EU 2. IDENTITY OF CHEMICAL Lugafast Black AN (Dye product containing approx 25-35% notified chemical) – related to STD/1239 (Chemical 2 in Lugafast Black AN) UV-VIS, IR, HPLC, 1H-NMR Remarks Spectrum data for the dye product Lugafast Black AN were provided. BASF (2004)
Remarks – Results The test item had a statistically significant inhibitory effect on the growth (biomass and growth rate) of Scenedesmus subspicatus after the exposures period of 72 hours at concentrations of 0.11 mg/L and above. The notified chemical is very toxic to algae. RCC (2002r) 8.2.4. Inhibition of microbial activity Sanitized T99-19 OECD TG 209 Activated Sludge, Respiration Inhibition Test. EC Directive 88/302/EEC C.11 Biodegradation: Activated Sludge Respiration Inhibition Test. Inoculum Synthetic sewage Exposure Period 3 Concentration Nominal 10, 32, 100, 320 and 1000 mg/L Remarks – Method The rate of respiration was determined after 30 minutes and 3 hours contact time and compared to data for the control and a reference material, 3,5-dichlorophenol. IC50 140 mg/L NOEC 32 mg/L Remarks – Results Concentrations of 320 and 1000mg/L the test material was observed to cause foaming. The validation criteria for the control respiration rates and reference material EC50 values have been satisfied. The notified chemical is not harmful to sewage microbes. Safepharm (2000e) 9. RISK ASSESSMENT 9.1. Environment 9.1.1. Environment – exposure assessment The majority of imported notified chemical is expected to be disposed of to landfill, predominantly associated with the end-use items to which it is affixed. In landfill, the notified chemical is expected to degrade by biotic and abiotic means to form simple carbon, nitrogen and silicon based compounds. It is anticipated that up to 3% may be released to sewer from spent dye-bath during use. In order to provide a conservative estimate, a fixation rate of 90% is assumed thus for the purposes of the following calculation 10% of the notified chemical is assumed to be released to the sewer during cleaning. The notifier has provided the following calculations.
Remarks The pH of a 5% solution of the chemical is 2-4. The notified chemical is stable below about pH 4.5. The chemical contains ester linkages that are expected to undergo hydrolysis quickly above pH 4.5 to 5 (Garcia et al., 2000). Partition Coefficient (n-octanol/water) Not determined Remarks The notified chemical is a quaternary ammonium surfactant. As such, it is not possible to measure the partition co-efficient and get meaningful results. Adsorption/Desorption Not determined Remarks The notified chemical is expected to undergo ion exchange in the environment and to adsorb strongly to clays and organic matter. Dissociation Constant Not determined Remarks The chemical is expected to dissociate completely in water at a concentration <20 mg/L. At concentrations >20 mg/L, the chemical is expected to aggregate, form a dispersive solution, and then precipitate. Particle Size Not determined Remarks Paste is not expected to form particles of respirable size. Flash Point 35 oC Pensky Martin closed cup method Remarks Test pressure not provided Not stated. Flammability Limits Not determined Remarks Expected to be combustible but not flammable Autoignition Temperature Not applicable Explosive Properties None Reactivity Stable and non- reactive at normal temperatures and conditions. 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 > 5000 mg/kg bw, low toxicity Rabbit, skin irritation Irritating Rabbit, skin irritation (20% notified chemical in water) Not irritating Rabbit, eye irritation Irritating Rabbit, eye irritation (20% notified chemical in water) Not irritating Guinea pig, skin sensitisation - adjuvant test Inadequate evidence of sensitisation. Guinea pig, skin sensitisation – non-adjuvant test Non-sensitising Skin Sensitisation – Human Repeated Insult Patch Test Non-sensitising Rat, Oral – gavage repeat dose toxicity - 90 days. NOAEL 300 mg/kg Genotoxicity - Bacterial Reverse Mutation Non mutagenic Genotoxicity – in vivo Mammalian Erythrocyte Micronucleus Test Non genotoxic
Safepharm Laboratories (1999g) Irritation – eye Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0 0 0 1 < 24 hours 0 Conjunctiva: chemosis 0 0 0 1 < 24 hours 0 Conjunctiva: discharge 0 0 0 2 < 24 hours 0 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. Remarks - Results No corneal or iridal effects were noted during the study. Moderate conjunctival irritation was note in all treated eyes at 1 hour. All treated eyes appeared normal at the 24 hour observation. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is slightly irritating to the eye. Safepharm Laboratories Irritation – eye Analogue 3 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0 0.3 0.3 2 < 48 hours 0 Conjunctiva: chemosis 0 0 0 1 < 24 hours 0 Conjunctiva: discharge 0 0 0.3 2 < 48 hours 0 Corneal opacity 0 0 0 0 0 0
Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 402 Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/ Sprague-Dawley CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/Sex 2000 0/10 LD50 > 2000 mg/kg bw of Toxicity - Local There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were noted at necroscopy. Remarks - Results There were no deaths during the study. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is of low toxicity via the dermal route. Safepharm Laboratories (1998b) Acute toxicity – dermal Analogue 3 OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/ Sprague-Dawley CD (Crl:CD BR) Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. GLP compliant. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/Sex 2000 0/10 LD50 > 2000 mg/kg bw Signs of Toxicity - Local There were no signs of skin irritation. Signs of Toxicity - Systemic There were no signs of systemic toxicity. All animals showed an expected gain in bodyweight during the study. Effects in Organs No abnormalities were at necroscopy. Remarks - Results There were no deaths during the study. Analogue 3 is of low toxicity via the dermal route. Safepharm Laboratories (1999d) Acute toxicity – dermal Analogue 4
TABLE OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 5 6. HUMAN HEALTH IMPLICATIONS 7 6.1. Exposure assessment 7 6.1.1. Occupational exposure 7 6.1.2. Public exposure 8 6.2. Human health effects assessment 8 6.3. Human health risk characterisation 9 6.3.1. Occupational health and safety 9 6.3.2. Public health 10 7. ENVIRONMENTAL IMPLICATIONS 10 7.1. Environmental Exposure & Fate Assessment 10 7.1.1 Environmental Exposure 10 7.1.2 Environmental fate 10 7.1.3 Predicted Environmental Concentration (PEC) 11 7.2. Environmental effects assessment 11 7.2.1 Predicted No-Effect Concentration 11 7.3. Environmental risk assessment 12 8. CONCLUSIONS – SUMMARY OF RISK ASSESSMENT FOR THE ENVIRONMENT AND HUMAN HEALTH 12 8.1. Hazard classification 12 8.2. Environmental risk assessment 12 8.3. Human health risk assessment 12 8.3.1. Occupational health and safety 12 8.3.2. Public health 12 9. MATERIAL SAFETY DATA SHEET 12 10. RECOMMENDATIONS 13 11. REGULATORY OBLIGATIONS 13 12 . BIBLIOGRAPHY 14 Appendix A: Physico-Chemical Properties 17 Appendix B: Toxicological Investigations 20 B.1. Acute toxicity – oral 20 B.2. toxicity – dermal 20 B.3. Acute toxicity – inhalation 20 B.4. Irritation – skin 21 B.5. Irritation – eye 21 B.6. Skin sensitisation 22 B.7. Repeat dose toxicity 22 B.8. Genotoxicity – bacteria 24 B.9. Genotoxicity – in vitro 25 B.10. Neurotoxicity 26 Appendix C: Environmental Fate and Ecotoxicological Investigations 27 C.1. Environmental Fate 27 C.1.1. Ready biodegradability 27 C.1.2. Bioaccumulation 27 C.1.3. Chemical oxygen demand (COD) 28 C.2. Ecotoxicological Investigations 28 C.2.1. Acute toxicity to fish 28 C.2.2. Acute/chronic toxicity to aquatic invertebrates 29 C.2.3. Algal growth inhibition test 30 C.2.4. Inhibition of microbial activity 31
The notified chemical had no acute effect on various trophic levels tested up to its solubility limit under the strict test conditions. For the details of the environmental effect studies please refer to Appendix C. 7.2.1 Predicted No-Effect Concentration Based on the results of the ecotoxicological testing the Predicted No-Effect Concentration has been calculated as follows: 7.3. Environmental risk assessment Without a PEC, it is not possible to derive a Risk Quotient. The only environmental release expected throughout the life cycle of the notified chemical under the proposed use pattern is through disposal to landfill. In landfill, the notified chemical is expected to be immobile, and overtime degrade to simple organic and nitrogen based compounds. Should the notified chemical be disposed of by incineration, it is expected to be thermally decomposed to form various oxides of carbon and nitrogen and water. While the notified chemical was found to be slightly bioconcentrating, this is not expected to pose a risk to the environment as release to the aquatic environment is not expected. Therefore, the notified chemical is not expected to pose an unacceptable risk to the aquatic environment. 8. CONCLUSIONS – SUMMARY OF RISK ASSESSMENT FOR THE ENVIRONMENT AND HUMAN HEALTH 8.1. Hazard classification Based on the available data the notified chemical is not classified as hazardous under the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). 8.2. health risk assessment 8.2.1. Occupational health and safety Under the conditions of the occupational settings described, the risk to workers is considered to be acceptable. 8.2.2. Public health When used in the proposed manner the risk to the public is considered to be acceptable. 8.3. Environmental risk assessment The chemical is not considered to pose a risk to the environment based on its reported use pattern. 9. MATERIAL SAFETY SHEET The MSDS of products containing the notified chemical provided by the notifier was reviewed by NICNAS and is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant. The MSDS was to be in accordance with the National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC, 2003). 10. RECOMMENDATIONS
TABLE OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 3 4. PHYSICAL AND CHEMICAL PROPERTIES 4 Discussion of Observed Effects 4 5. INTRODUCTION AND USE INFORMATION 4 6. HUMAN HEALTH IMPLICATIONS 5 6.1. Exposure assessment 5 6.1.1. Occupational exposure 5 6.1.2. Public exposure 6 6.2. Human health effects assessment 6 6.3. Human health risk characterisation 8 6.3.1. Occupational health and safety 8 6.3.2. Public health 9 7. ENVIRONMENTAL IMPLICATIONS 9 7.1. Environmental Exposure & Fate Assessment 9 7.1.1 Environmental Exposure 9 7.1.2 Environmental fate 10 7.1.3 Predicted Environmental Concentration (PEC) 10 7.2. Environmental effects assessment 10 7.2.1 Predicted No-Effect Concentration 10 7.3. Environmental risk assessment 11 8. CONCLUSIONS – SUMMARY OF RISK ASSESSMENT FOR THE ENVIRONMENT AND HUMAN HEALTH 11 8.1. Hazard classification 11 8.2. health risk assessment 11 8.2.1. Occupational health and safety 11 8.2.2. Public health 11 8.3. Environmental risk assessment 11 9. MATERIAL SAFETY DATA SHEET 12 10. RECOMMENDATIONS 12 11. REGULATORY OBLIGATIONS 12 12 . BIBLIOGRAPHY 13 Appendix A: Physico-Chemical Properties 16 Appendix B: Toxicological Investigations 19 B.1. Acute toxicity – oral 19 B.2. Acute toxicity – dermal 19 B.3. Irritation – skin 19 B.4. Irritation – eye 20 B.5. Skin sensitisation 20 B.6. Repeat dose toxicity (14 day) 21 B.7. Repeat dose toxicity (28 day) 22 B.8. Genotoxicity – bacteria 23 B.9. Genotoxicity – in vitro 25 B.10. Genotoxicity – in vivo 25 Appendix C: Environmental Fate and Ecotoxicological Investigations 27 C1. Environmental Fate 27 C.1.1. Ready biodegradability 27 C.1.2. Bioaccumulation 27 C2. Ecotoxicological Investigations 27 C.2.1. Acute toxicity to fish 27 C.2.2. toxicity to aquatic invertebrates 28 C.2.3. Algal growth inhibition test 29 C.2.4. Inhibition of microbial activity 30
the test article utilised in the study was concluded to be non mutagenic. The positive control (with activation) had a range of average number of mutants per dose from approximately 200-400, while the analogue chemical had an average number of mutants of 8-9. Overall, the mutagenic potential of analogue chemical in this study was inconclusive. Under the study conditions, the mutagenic potential of the analogue chemical, was equivocal. Research Laboratories (2001) 7.11. Genotoxicity – in vivo Analogue chemical 6 OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 84/449/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/CD-1 Route of Administration Oral – gavage Vehicle Arachis oil Remarks - Method No deviations from protocol Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time I (vehicle control) 5/sex 0 24, 48, 72 hrs II (low dose) “ 1250 “ III (mid dose) “ 2500 “ IV (high dose) “ 5000 “ V (positive control, CP) “ 50 24 hrs CP=cyclophosphamide. Doses Producing Toxicity No clinical noted. Genotoxic Effects There was no indication of toxicity at any dose level. Remarks - Results There was no statistically significant increase in micronucleated PCEs in any test group when compared to vehicle control. There were no differences in the PCE/NCE ratio in any dose group as compared to the control. Positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes, confirming the system. The analogue chemical was not clastogenic under the conditions of this in vivo mouse micronucleus test.. Safepharm Laboratories Limited 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Durasyn 125, Durasyn 128, Durasyn 223, Durasyn 153 and Durasyn 156 The following is a table summary of results provided. This table summarises biodegradation testing performed on Durasyn 125, 128, 153 and 156 (while the third is the notified chemical, the others have been notified as STD 1243, 1245 1246 and 1247 respectively).
of Irritation Intradermal injection: An examination of the injections was performed one and 24 hours after treatment. On both dates weak dermal reactions were observed at the test group animals and all but three control group animals showed no effects. Topical induction: In the test group animals, one hour after the exposure ended, weak to moderate skin reactions were observed and after 24 hours weak skin reactions were seen. The control group animals also showed weak skin reaction on both times. challenge phase topical: 2% (v/v) with Paraffine perliquid Remarks - Method No significant protocol deviations. The study report was a translation. Animal Challenge Concentration Number of Animals Showing Skin Reactions after challenge 24 h 48 h Test Group 2% 1/20 1/20 Control 0 0/10 0/10 Remarks - Results 24 and 48 hours after termination of the challenge moderate skin reactions were observed in 19 test group animals and in the 10 control group animals. Neither test group animals nor control group animals died during the study and no significant difference was observed in their body weights. The observed effects occurring in both control and test animals may be due to irritation. Such irritation effects would mask any sensitisation effects if they were present. No conclusion can be from this study as to the sensitising potential of the analogue chemical (commercial form). Henkel KGaA (1991a) 7.6.2 Skin sensitisation Analogue chemical (commercial form) OECD TG 406 Skin Sensitisation – Buehler Test. Species/Strain Guinea pig/Pirbright white/Charles River preliminary study Maximum Non-irritating Concentration: topical: 15%,(w/w) in saline (minimally irritating) main study Number of Animals Test 10 Control Group: 10 induction Induction Concentration: Topical: 15% Signs of Irritation One hour terminating the third induction, 6 test group animals showed slight and one moderate effects on the exposed skin area. 24 hours later 9 test group animals showed up to strong effects. The control group animals showed no dermal alterations on the treated skin areas at any time. challenge phase challenge topical: 5% Remarks - Method No positive controls were included in the A rechallenge was not performed.
92/69/EEC A.16 Relative Self-Ignition Temperature for Solids. Remarks The temperature of the test substance did not reach 400oC before the oven temperature was 400oC. B.V. (2006l) Explosive Properties Not predicted to be explosive EC Directive 92/69/EEC A.14 Explosive Properties. Remarks The molecular structure of the notified chemical does not contain any chemically unstable or highly energetic groups that might lead to an explosion. The oxygen balance for the test substance was calculated to be -175oC. However, there are no bond groupings known to confer explosive properties or explosive enhancing groups present in the structure. Overall consideration of the properties does not suggest a risk of explodability for the test substance. Notox B.V. (2006m) Pyrophoric Properties Not pyrophoric EC Directive 92/69/EEC A.13 Pyrophoric Properties of Solids and Liquids. Remarks on the molecular structures of the test substance and on experience in handling, it is not pyrophoric. Notox B.V. (2006m) Oxidising Properties Not oxidizing EC Directive 92/69/EEC A.17 Oxidizing Properties (Solids). Remarks Based on the composition of the test substance and the molecular structures of all three components in which one is the notified chemical, it was concluded that the test substance has no oxidizing properties. B.V. (2006n) Reactivity Stable under normal conditions of use Remarks No incompatible substances have been identified with the test substance. Conditions have not been identified which would contribute to the instability of the test substance and it is considered to be stable under normal conditions of use. Typical decomposition products are oxides of carbon, oxides of nitrogen and hydrogen chloride. No other toxic gases/vapours have been identified.
Notox B.V. (2006w), Acute Toxicity Study in Daphnia Magna (Study Number 449325), Hertogenbosch, The Netherlands. Sponsor: Ciba Specialty Chemicals Inc., Basel, Switzerland (Unpublished report provided by notifier). Notox B.V. (2006x), Reproduction Test with Daphnia Magna (Semi-Static) (Study Number 473671), Hertogenbosch, The Netherlands. Sponsor: Ciba Specialty Chemicals Inc., Basel, Switzerland (Unpublished report provided by notifier). Notox B.V. (2006y), Fresh Water Algal Growth Inhibition Test (Study Number 449336), Hertogenbosch, The Netherlands. Sponsor: Ciba Specialty Chemicals Inc., Basel, Switzerland (Unpublished report provided by notifier).