zilongwang/ReadingBank huggingface dataset:
Necropsy day 22 of gestation Method of administration: gaseous in whole body exposure chambers Clinical observations: low incidence of maternal and foetal toxicity at 50 000 ppm, pre and post-implantation loss of foetuses and minor foetal defects such as parietal ossification and liver changes Maternal Mortality: none Test method: according to OECD Guidelines (15) Result: the notified chemical exhibited low developmental toxicity in rats exposed for 10 gestation days Development toxicity in the rabbit (18) Species/strain: rabbits/New Zealand White Number/sex of animals: 24 female for each dose Dose: 0, 5 000, 15 000 and 50 000 ppm Duration: 6 for 13 days (6-18 days of gestation) Necropsy: day 29 of gestation Method of administration: gaseous in whole body exposure chambers Clinical observations: maternal weight loss at 50 000 ppm for 45% of animals from days 8 to 10, recovered after day 10, no treatment related effects on foetuses evident at any dose, possibility of pre-implantation loss at all doses but incidence did not increase with dose Maternal Mortality: none Test method: according to OECD Guidelines (15)
range from 1 200 to 1 400 which indicate low mobility in soil. The notifier indicates that AERO5460 Promoter does not contain any that can undergo dissociation. PURITY OF THE CHEMICAL Degree of Purity: 73-75% Hazardous Impurities: Chemical name: Hexanol, branched and linear CAS No.: 68526-79-4 Weight percentage: 6-24% properties: R41: Risk of Serious Damage to Eyes (notifiers MSDS) Chemical name: Isobutanol Weight percentage: 1-19% CAS No.: 78-83-1 Toxic properties: Hazard Classification (NOHSC, 1999b): R10: Flammable; R20: Harmful by Inhalation. National Exposure Standard (NOHSC, 1995): 50 ppm (152 mg/m3) TWA Non-hazardous Impurities (> 1% by weight): none Additives/Adjuvants: Chemical name: Quinoline CAS No.: 91-22-5 Weight percentage: 1.0%
(24, 48, 72 hours observation): Oedema: 1.3, 0, 0.3. Comment: There were no signs of toxicity or ill health in any rabbit during the observation period. Well-defined erythema with or without very slight to slight oedema was seen in all three animals. Additionally, desquamation of the stratum corneum (characterised by dryness and sloughing of the skin) developed in all rabbits, and resolved completely by either Days 9, 10, or 13. Result: The notified chemical was a moderate irritant to the skin of rabbits. Eye Irritation (HLS, Species/strain: Rabbit/New Zealand White Number/sex of animals: 3 females Observation period: 3 days Method of administration: 0.1 mL of the notified chemical was placed into the everted lid and held in for one second. The contralateral eye served as control. Test method: OECD TG 405 Draize scores of unirrigated eyes: Time after instillation * see Attachment 1 for Draize scales r = redness c = chemosis d = discharge Mean individual (24, 48 and 72 hour observation): Redness of the conjunctivae: 0.3, 0.3, 1; Chemosis: 0, 0, 0. Comment: were no signs of toxicity or ill health in any rabbit during the observation period. No corneal damage or iridial
Summary of the acute toxicity of IPD, m-XDA, DETA and TETA Test Species Outcome Reference acute oral toxicity rat LD50: 660 or 930 mg.kg-1 (m-XDA) 080 mg.kg-1 (DETA) 500 mg.kg-1 (TETA) (1) (1) (2) dermal toxicity rabbit LD50: 2 000 mg.kg-1 (m-XDA) 1 090 mg.kg-1 (DETA) 805 mg.kg-1 (TETA) (1) (1) (2) inhalation toxicity rat LC50 = 3.75 (1 hour) (m- XDA); equivalent to 4 hour LC50 of 1.9 mg.L-1; ocular irritation, lacrimation and dyspnoea observed; lung, liver and kidney macroscopic changes DETA: no mortality after 8 hour exposure to 300 ppm (1) (1) skin irritation guinea pig rabbit corrosive (m-XDA) severe irritant (m-XDA at 10% and 50%) severe irritant (DETA) severe irritant (TETA) (1) (1) (2) (2) eye irritation rabbit irritant (m-XDA) severe irritant (DETA) severe irritant (TETA) (1) (2) (2) skin sensitisation human skin sensitiser: IPD DETA TETA respiratory sensitiser: DETA (3, 4) (1) (1) (5) (1) Repeat Dose Toxicity - 90-Day Feeding Study (6) A 90-day repeat dose toxicity of TETA, a medical chelating agent, in the drinking water of rats and mice was conducted to identify and characterise
9.1.1 Oral Toxicity (2) Species/strain: Number/sex of animals: Observation period: Method of administration: Clinical observations: Mortality: Morphological findings: Test method: rat/Sprague Dawley 5/sex 14 days gavage none related to treatment none none related to treatment similar to OECD guidelines (7) LD50: > 5 000 mg.kg-1 Result: the notified chemical was of low oral toxicity in rats in a limit test - single dose of 5 000 mg.kg-1 9.1.2 Dermal Toxicity (3) Species/strain: rabbit/New Zealand White Number/sex of animals: 5/sex Observation period: 14 days Method of administration: semiocclusive dressing; 24 hour treatment Clinical observations: moderate to marked erythema were noted on 8 rabbits for 48 and on 7 rabbits for 72 moderate to marked oedema were on 5 rabbits for 48 hours and on one rabbit for 72 scaling was observed on the backs of all rabbits up to day 7; all observations resolved by day 14 Mortality: none
Attachment 1 The Draize for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely 1 perceptible) Well-defined erythema 2 Slight oedema (edges of area well- 2 defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised approx. 1 3 mm) Severe erythema (beet redness) 4 Severe oedema (raised more than 1 4 mm and extending beyond area of exposure) The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible Easily visible translucent details of iris slightly obscure 1 slight 25% to 50% 2 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal 0 none No swelling 0 none No discharge 0 none Vessels definitely 1 Any swelling above 1 slight Any amount different 1 slight injected above normal slight normal from normal More diffuse, deeper 2 mod. Obvious swelling 2 mild Discharge with 2 mod. crimson red with with partial eversion moistening of lids individual vessels not of lids and adjacent hairs easily discernible Swelling with lids 3 mod. Discharge with 3 Diffuse beefy red 3 half-closed moistening of lids severe severe Swelling with lids 4 and hairs and considerable area half-closed to completely closed severe around eye IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
1 000 mg.L-1 for 48 hours. After 48 hours, the relative concentrations of Reactive Red 202 (hydroxy) remained constant, whereas a “significant decrease” of the ester was observed, which was almost proportional to the increase of the vinyl.
Table 3: Predicted Environmental Concentration (PEC) Typical use of product expected per day Amount of Notified Chemical (at 20%) Conc. in wastewater (fixation rate 85%) Quantity of water used incl. wash-off water (100 L/k) Effluent conc. in product- specific wash-water 20.0 kg 20.0 kg 4.0 kg 4.0 kg 0.6 kg 0.6 kg 250 000 L 200 000 L 2.4 mg/L 3.0 mg/L Dilution factor in dyehouse by other wash-waters 1:10 (2.5 ML/day effluent) 1:10 (2 ML/day effluent) Influent concentration 0.24 mg/L 0.3 mg/L Dilution factor in sewage treatment plant1 1:100 (250 ML/day) 1:3 (5-6 ML/day) Conc. balance in effluent from sewage treatment 2.4 g/L 0.1 mg/L Dilution factor in receiving waters 1:0 1:2 (river) PEC in receiving waters 0.24 g/L (0.24 ppb) 50 g/L (50 ppb) Safety factor for exposure to most sensitive aquatic organism, bacteria2 (NOEC > 130 000 640 of 32 mg/L) The dilution at a town could reasonably be expected to be about 5-6 ML/day-, while for a major city, say Sydney, it would be between 150-500 ML/day. The respiration rate of aerobic waste water bacteria was not inhibited up to a test concentration of 32 mg/L. Slight inhibition was noted at the next highest test concentration tested of 50 mg/L These calculations show that the exposure to fish, daphnia, algae and waste water treatment bacteria is at levels unlikely to cause any significant effect. At higher release rates, there is still unlikely to be any significant effect on these species. Once in the aquatic environment, the chemical is expected to swiftly dilute to undetectable concentrations, and undergo biotic and abiotic degradation. The only other source of environmental contamination is from accidental spills and disposal of packaging. The information contained in the MSDS is adequate to enable those disposing of the chemical to limit the environmental exposure and therefore limit the environmental effects.
Dermal Toxicity (Krueger, 1997b) Species/strain: rat/Wistar Number/sex of animals: 5/sex Observation period: 14 days Method of administration: the undiluted notified chemical was given dermally for 24 hours under a semi-occlusive dressing Clinical observations: moderate to severe dermal irritation was observed in animals Mortality: none Morphological findings: none Test method: according to OECD Guidelines (Organisation for Economic Co-operation and Development, 1995- 1996) LD50: > 2 000 mg.kg-1 Result: the notified chemical was of low acute dermal toxicity in rats Skin Irritation (Krueger, 1997c) Species/strain: rabbit/White Russian Number/sex of animals: 3 females Observation period: 14 days Method of administration: a single application to the shorn intact skin under a semi-occlusive dressing for 4 hours
NA/599 FULL PUBLIC REPORT Phosphine oxide, phenylbis (2,4,6-trimethylbenzoyl)- APPLICANT Ciba Specialty Chemicals of 235 Settlement Road THOMASTOWN VIC 3074 has submitted a standard notification statement in support of their application for an assessment certificate for Phosphine oxide, phenylbis (2,4,6-trimethylbenzoyl)- IDENTITY OF THE CHEMICAL Chemical Name: phosphine oxide, phenylbis (2,4,6- trimethylbenzoyl)- Chemical Abstracts Service (CAS) Registry No.: 162881-26-7 Other Names: TKA 40135/CGI 819 Trade Name: Irgacure ® 819 Molecular Formula: C26H27O3P Structural Formula: Molecular Weight: 418.5 Spectral Details: UV/Vis spectrophotometry in neutral, basic, and acid solution: neutral solution: max = 282 nm (max = 7 931) 296 nm (max = 7 953) basic solution: max = 219 nm (max = 27 288) 265 nm (max = 7 281) acidic solution: max = 282 nm (max = 7 908), 297 nm (max = 7 945) shoulder at 233 nm in spectra measured under neutral and acid conditions
Method of administration: a single dose of 5 000 mg/kg administered by gavage; vehicle was 25% (w/w) corn oil Clinical observations: decreased activity and diarrhoea was in one male on day one of dose administration Mortality: none Morphological findings: no abnormalities detected Test method: similar to OECD guidelines – limit test (7) LD50: > 5 000 mg/kg Result: the notified chemical was of very low acute oral toxicity in rats Dermal Toxicity (2) Species/strain: rabbit/New Zealand White Number/sex of animals: 5/sex Observation period: 15 days Method of administration: a dose of 2 000 mg/kg was applied to an intact skin site and covered with semi-occlusive dressing; after 24 hours the dressing and residual test material were removed Clinical observations: one male had soft stools on days 2 and 3; and one female had anorexia from days 2 to 6 Mortality: none Morphological findings: no abnormalities detected Test method: similar to OECD guidelines (7) LD50: > 2 000 mg/kg Result: the notified chemical was of low dermal toxicity in rabbits
material were removed Observation period: 24, 48 and 72 hours after dose administration Test method: similar to OECD guidelines (7) except the test substance was applied to the intact skin for a period of 24 hours instead of 4 hours Comment: Result: none of the animals showed any erythema or oedema; the notified chemical was non irritating to the skin of rabbits Eye Irritation (5) Species/strain: rabbit/New Zealand White Number/sex of animals: 9 Method of administration: Observation period: 100 mg of the test substance was placed in the conjunctival sac of one eye of each rabbit whilst the contralateral eye of each rabbit served as the control; the treated eye of each rabbit was irrigated with physiological saline 30 seconds post treatment 1, 24, 48 and 72 hours after dose administration
Eye Irritation 9.1.4.1 NT-6 (Allen, 1995d) Species/strain: rabbit/New Zealand White Number/sex of animals: 3 females Observation period: 72 hours Method of administration: 0.1 mL (vehicle unspecified) of the notified chemical was placed into the conjunctival sac of the right eye of each animal Test method: according to OECD TG 405 (Organisation for Economic Co-operation and Development, 1995- 1996) and Commission Directive 92/69/EEC (European Economic Community, 1992) Result: no corneal or iridal effects were seen; slight conjunctival redness was seen at 1 and 24 hours in 2 animals and at 1 hour in the third animal; slight chemosis was seen in 1 animal 1 hour post- instillation and slight discharge in another animal at the same time point the notified chemical was a slight eye irritant in rabbits Toner containing NT-6 (#1015) (Allen, 1996c) Species/strain: rabbit/New Zealand White Number/sex of animals: 2 males, 1 female Observation period: 72 hours Method of administration: 0.1 mL (vehicle unspecified) of the notified chemical was placed into the conjunctival sac of the right eye of each animal Test method: according to OECD TG 405 (Organisation for Economic Co-operation and Development, 1995- 1996) and Commission Directive 92/69/EEC (European Economic Community, 1992)
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Cedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) Well-defined erythema I 2 Very slight oedema (barely perceptible) Slight oedema (edges of area well- 2 defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4 and extending beyond area of exposure) The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity Diffuse area, details of iris clearly 0 none I slight 25% or less (not zero) 25% to 50% 2 visible Easily visible translucent areas, details 2 mild 50% to 75% 3 of iris slightly obscure Opalescent areas, no details of iris 3 Greater than 75% 4 visible, size of pupil barely discernible moderate Opaque, iris invisible 4 severe CONJUNCTIVAF Redness Rating Cheniosis Rating Disc/i arge Rating Vessels normal 0 none No swelling 0 none No discharge 0 none Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red I slight 2 mod. 3 severe Any swelling Obvious swelling with partial eversion of lids Swelling with lids half- closed Swelling with lids half- closed to completely I slight mild mod. severe Any amount different from normal Discharge ~vith moistening of lids and adjacent Discharge with moistening of lids and hairs and considerable area around eve slight mod. severe closed IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light I slight No reaction to haernorrhage, gross destruction 2 severe
Eye Irritation (6) Species/strain: rabbit/not provided Number/sex of animals: 3/not provided Observation period: 72 days Method of administration: undiluted; not provided Draize scores (9) of unirrigated eyes: slight conjunctival redness was observed in all 3 animals, reversible within 48 hours Test method: according to OECD guidelines (8) Result: the notified chemical was a slight eye irritant in rabbits Skin Sensitisation (7) Species/strain: guinea pig/not provided Number of animals: not provided Induction procedure: 5% (w/v) of notified chemical in arachis oil injected; undiluted chemical for topical application (time not recorded) Challenge procedure: occluded application of undiluted notified chemical Challenge outcome: no evidence of contact hypersensitivity (details not provided) Test method: according to OECD guidelines (8) Result: the notified chemical was not a skin sensitiser in albino guinea pigs Repeated Dose Toxicity (11) Species/strain: rat/Wistar Number/sex of animals: 60/sex (5/sex/dose group and 5/sex/ recovery group ) Method of administration: gavage; vehicle polyethylene glycol 400
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely 1 perceptible) Well-defined erythema 2 Slight oedema (edges of area well- 2 defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised approx. 1 3 mm) Severe erythema (beet redness) 4 Severe oedema (raised more than 1 4 mm and extending beyond area of exposure) The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible Easily visible translucent details of iris slightly obscure 1 slight 25% to 50% 2 2 mild 50% to 75% 3 Opalescent no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal 0 none No swelling 0 none No discharge 0 none Vessels definitely 1 Any swelling 1 slight Any amount different 1 slight injected above normal slight normal from normal More diffuse, deeper 2 mod. Obvious swelling 2 mild Discharge with 2 mod. crimson red with with partial eversion moistening of lids individual vessels not of lids and adjacent hairs easily discernible Swelling with lids 3 mod. Discharge with 3 Diffuse beefy red 3 half-closed moistening of lids severe severe Swelling with lids 4 and and considerable area half-closed to completely closed severe around eye IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
9.1.5 Eye Irritation (Braun, 1996b) Species/strain: Number/sex of animals: Observation period: Method of administration: rabbit/New Zealand Chbb:NZW(SPF) 1 male, 2 females 21 days 0.1 g the test substance was installed into one eye of the rabbits Draize scores: conjunctiva: chemosis observed in all animals up to 24 hours, all other readings zero; cornea and iris: all scores zero. Other relevant observations: staining in conjunctivae (including nictitating membrane) and sclera was noted in all animals up to day 21, light violet staining of the cornea was noted in 2 of the 3 animals but was reversible by day 7. Test method: OECD TG 405 (Organisation for Economic Co- operation and Development, 1995-1996) Result: FAT 40548/A caused damage to the eyes of rabbits based on its persistent colouration effects. The substance was a slight irritant to rabbit eyes. Skin Sensitisation (Arcelin, 1996c) Species/strain: guinea pig/Ibm: GOHI; SPF Number of animals: 20 (test), 10 (control) Induction procedure: day 1-intradermal induction: 3 pairs of injections (0.1 mL) were made: saline:Freund’s Complete Adjuvant (FCA) (1:1) (v/v) the notified chemical in water (5%, w/v) the notified chemical (5%, w/v) in FCA/saline mixture (1:1)
Number/sex of animals: 5/sex Observation period: 14 days Method of administration: the notified chemical, a viscous liquid, was spread evenly over an area of approximately 25 cm2 and covered with an occlusive dressing for 24 hours Clinical observations: no of systemic reaction to treatment; well defined erythema in nine rats, slight erythema in one rat and slight oedema in male rats were observed on day 2; all animals recovered by day 5 Mortality: none Morphological findings: none Test method: Directive 84/449/EEC (OJ No. L251) Part B Method B.3 (European Economic Community, 1984) LD50: > 2 000 mg/kg Result: the notified chemical was of low acute dermal toxicity in rats Inhalation Toxicity (Jackson, 1994) Species/strain: rat/Sprague-Dawley Number/sex of animals: 5/sex (test and control groups) Observation period: 14 days Dose(Exposure Concentration) 5.32 mg/L Method of administration: snout only exposure to (liquid) aerosol (87% within respirable range) for 4 hours Clinical observations: a soiled appearance of the fur was noted on day 0 for test and control animals; exaggerated respiratory movements, staggering gait and poor grooming noted up to day 3; brown staining around the snout, jaws and around the eyes were persistent after day 3; food consumption of the test group slightly reduced on day 1 Mortality: none
Morphological findings: Test method: none OECD guideline TG 403 (Organisation for Economic Co-operation and Development, 1995- 1996) LC50: > 5.32 mg/L Result: the notified chemical was of very low acute inhalation toxicity in rats 9.1.4 Skin Irritation (Liggett, Species/strain: rabbit/New Zealand Number/sex of animals: 3/females Observation period: 12 days Method of administration: 0.5 mL of the notified chemical applied a 625 mm2 gauze pad under occlusive dressing for 4 hours Draize scores:(Draize, 1959) of unirrigated eyes Time after treatment (days) Animal # Erythema * 1 2 3 4 5 6 7 8 9 1 1 1 2 2 2 2 2 1a 0a 0a 2 1 1 2 2 2 2 2a 1a 0a 0a 3 1 1 2 2 2 2 2a 1a 1a 0a Oedema 1 1 1 1 1 1 1 1 1 0 0 2 1 1 2 2 2 2 1 1 0 0 3 1 1 2 2 2 2 1 1 1 0 see Attachment 1 for Draize scales a=sloughing of epidermis *=approximately 30 minutes after removal of the dressing Test method: Directive 84/449/EEC (OJ No. L251) Part B Method B.4 (European Economic Community, 1984) Result: very slight erythema was observed in all three animals 30 minutes after removal of the dressing; well-defined erythema was seen in all three animals from day 2 to 6 and continued as very slight erythema up to day 7 and in one animal up to day
Oral Toxicity (Frank, 1996a) Species/strain: rat/Cr1:CD BR Number/sex of animals: 5/sex Observation period: 14 days Method of administration: oral (gavage) Clinical observations: 2 females had anogenital staining at the 6 hour after treatment Mortality: nil Morphological findings: 1 female had a dilated pelvis Test method: limit test, OECD TG 401 (Organisation for Economic Co-operation and Development, 1995- 1996) LD50: > 2 000 mg/kg Result: PDN 1204 was of very low oral toxicity in rats Dermal Toxicity (Frank, 1996b) Species/strain: rabbit/New Zealand White Number/sex of animals: 5/sex Observation period: 14 days Method of administration: dermal application of 2 000 mg/kg (3 to 3.5 mL) under occlusive dressing for 24 hours Clinical observations: nil Mortality: nil Morphological findings: 1 male had an unthrifty coat and 1 female had desquamation on the dose site
Dermal Toxicity SP-237 (Gabriel, 1980b) Species/strain: rabbit/New Zealand Number/sex of animals: 2/sex Observation period: 14 days Method of administration: test material was placed on a gauze patch and secured under an occlusive wrap for 24 hours Dose: 4000, 8000, 16000 and 20000 mg/kg Test method: similar to OECD TG 402 Mortality: no deaths occurred during the study Clinical observations: no unusual behavioural signs were noted Morphological gross abnormalities were observed LD50: > 20000 mg/kg Result: SP-237 was of low dermal toxicity in rats Inhalation Toxicity SP-237 (Gabriel, 1980c) Species/strain: rat/not stated Number/sex of animals: 5/sex Observation period: 14 days Dose Range: aerosol, 15.5 mg/L (maximum attainable concentration) Method of administration: whole body, 1 hour exposure, dynamically operated chamber Test method: limit test, similar to OECD TG 403 Clinical observations: no unusual behavioural signs were noted Mortality: no deaths were recorded during the observation period
ENVIRONMENTAL EXPOSURE Release The notified polymer will be compounded into hairspray products in at three major cities and is expected to be sold Australia-wide providing a wide exposure of the chemical to the environment. The average per site of the commercial form of the notified polymer in ethanol (Advantage CP/Polymer ACV-4009), is expected to be 10 tonnes per annum based on the maximum estimated import quantities of 100 tonnes per annum and 10 companies likely to be involved in reformulation into hairspray products. Given the high cost of the notified polymer, reformulators are expected to minimise waste levels, with an estimated 0.5% remaining unused in the drums and 0.25% remaining as residue in the batch processing equipment. Drum residues amounting to 25 kg per year per site (50 kg total and 50% polymer) will be disposed of to landfill. Residues from the batch processing equipment amounting to 12.5 kg per year per site will be washed into the plant sewer and precipitated in the sludge of the solids separating system. The dried sludge is expected to be disposed of to landfill. The notified polymer is intended solely for use in hairspray products and, as such, would be expected to be released to the environment via consumer use through washing the residual polymer (assumed to be 100% of that applied) from the hair and into the sewerage system. It is envisaged that the notified polymer will replace existing hairspray polymers which have similar properties resulting in no net environmental effect. Due to its insoluble nature, the notified polymer is likely to be associated with the sludge/solids compartment of sewage where it is expected to be incinerated or spread onto agricultural land. If the notified polymer remains suspended in sewage water, a predicted environmental concentration (PEC) for the polymer in sewage water throughout Australia can be estimated from the assumptions, 100 tonnes maximum annual production, an Australian population of 17 million and a daily per capita water usage volume of 150 L. This provides a PEC of 0.1 ppm in sewage water which would be swiftly reduced to insignificant levels (likely to be below 10 ppb) by precipitation or dilution in rivers, lakes and oceans which act
PURITY OF THE CHEMICAL Degree of Purity: >99 % Toxic or Hazardous Impurities: none Non-hazardous Impurities (> 1% by weight): none Additives/Adjuvants: the notified chemical will be imported as a component, 0.1 % to 25 %, of a number of compounded fragrances; the identity of the other components of the compounded fragrances has not been disclosed USE, VOLUME AND FORMULATION The notified chemical will be used as an aroma chemical and will be blended with other such chemicals to produce compounded fragrances for products such as soaps, detergents and air fresheners. The notified chemical will comprise 0.1 % to 25 % of the compounded fragrances, with a typical level being around 5 %. The end use products will reportedly commonly contain 1-2 % of the fragrance mixture, therefore a maximum of 0.5 % of the notified chemical. This maximum concentration is only likely to be approached in solid air fresheners. The compounded fragrances will not be manufactured in Australia. The import volumes are estimated to be 250 kg per annum in the first 3 years, possibly reaching 500 kg per annum after this time. The import volumes are estimates for the volume of notified chemical in the imported fragrance mixtures. OCCUPATIONAL EXPOSURE The compounded fragrances will be imported in 200 L polythene or lacquer lined steel drums. No exposure of the compounded fragrances containing the notified chemical to waterside, transport or warehouse workers is expected except in the case of an accident involving spillage. The notified chemical is likely to be used as a component of the fragrance for a wide variety of products for household use. The fragrances will be blended into the consumer products by a number of customers a variety of mixing techniques. It is estimated that between 5 and 20 process workers will be exposed to the notified chemical at each production line where it is used. The notifier has provided a description of the type of operation which will be carried out in the production of several types of product containing the notified chemical. The examples
filtered tap water at mean measured concentrations of 0 (control), 0.98, 2.26, 4.12, 5.6, and 22.69 mg/L. The were conducted in a semi-static (renewal) system over a 96 hour period
11) (a) (b) c = 4a + 2 (c) 86 = 4a + 2 4a = 84 a = 21 2 2 2 12) S = D / T S = 0.5 / 2 = 0.25 miles per minute 0.25 x 60 = 15 mph Yes, the van was travelling at a safe speed. 3 13) 25 = 7x + 4 21 = 7x x = 3 2 14) x = 27.8° 3 15) S = D / T S = 28 / 40 = 0.7 per minute 0.7 x 60 = 42 mph 3 16) c2 = a2 + b2 c2 = 1.52 + 52 c2 = 2.25 + 25 c2 = 27.25 c = √27.25 c = 5.22cm 1 earing = 5.22 + 5.22 + 3 =13.44 Pair of earings = 13.44 x 2 = 26.88cm 4 17) (a) Copy and complete the table below. (b) g = 4s + 2 (c) 66 = 4s + 2 64 = 4s s = 16 2 2 2 18) 5m – 3 = 37 + m 4m – 3 = 37 4m = 40 m = 10 3 19) 3
3x = 24 x = 8 28) (a) (b) r = 5s – 1 (c) 79 = 5s – 1 80 = 5s s = 16 2 2 2 29) c2 = a2 + b2 c2 = 1202 + 402 c2 = 14400 + 1600 c2 = 16000 c = c = 126.5cm 4 30) (a) (b) c = 5s + 1 (c) 116 = 5s + 1 115 = 5s s = 23 2 2 2 31) Mean = 79.76 / 8 = 9.97 seconds The 2nd was better than the 1st by 0.01seconds 4 32) 4 33) (a) Complete the table below. (b) L = 2D + 1 (c) 77 = 2D + 1 76 = 2D D = 38 2 2 2 34) c2 = a2 + b2 342 = x2 + 202 1156 = x2 + 400 x2 = 1156 – 400 = 756 x = √756 x = 27.5m 4 35) T = D / S 3
Observation period: 7 days Method of administration: 0.5 mL in a single, 4-hour, semi-occluded application Draize* scores (Draize, 1959): Time after Animal # treatment 1 2 3 (days) Erythema 1 hour 1 1 2 1 1 1 2 2 0 1 2 3 7 0 0 1 0d 2 0c Oedema 1 hour 1 2 2 1 0 1 2 2 0 1 2 3 0 0 1 7 0 0 0 * see Attachment 1 for Draize scales; d = desquamation; c = crust formation Test method: OECD guideline TG404 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: the notified chemical was a slight to moderate skin irritant in rabbits Eye Irritation (Miyamoto, 1992b) Species/strain: rabbit/Japanese albino Number/sex of animals: 3/female (eye irrigated group) and 6/female (eye unirrigated group) per test group Observation period: 7 days Method of administration: 100 mg of undiluted test substance or a 10% aqueous suspension into the conjunctival sac of the right eye; 30 seconds later the eyes of 3 rabbits
9.1.3. Acute Inhalation Toxicity (Carpenter, 1966) Test Substance: Silane A-1120 Species/strain: Rats, strain not specified Number/sex of animals: 6 Observation period: Not stated Method of administration: Saturated vapour pressure generated by spreading 50g of test substance over 200 cm2 area on a shallow tray placed near the top of a 120L glass chamber and sealed for 16 hours while a fan intermittently agitated the chamber atmosphere; rats were then introduced into the test chamber via a gasketed drawer type cage Clinical observations: None observed Mortality: nil pathology: unremarkable Test method: Not an established guideline method LC50: > saturated vapour concentration (not stated) Result: Silane A-1120 was of low inhalation toxicity in rabbits Skin Irritation (Stanton, Test Substance: Dow Corning X3-3541 Species/strain: rabbit/New Zealand White Number/sex of animals: 4 male Observation period: 72 Method of administration: Dow Corning X3-3541 (0.5 mL) was applied to intact skin under a semi-occlusive dressing for 4 hours Draize scores: All individual scores were zero for erythema and oedema Test method: OECD TG 404 Result: Dow Corning X3-3541 was non irritating to rabbit skin
Skin Irritation (Carpenter, 1966) Test Substance: Silane A-1120 Species/strain: rabbit/New Zealand White Number/sex of animals: 5 animals, sex not stated Method of administration/Dermal response evaluation : Test substance applied in 0.1 mL amounts to clipped, intact skin of the belly either undiluted or in progressive dilutions of 10, 1, 0.1 or 0.01% solvent. Ten grades are recognised based on appearance of moderate or marked capillary injection, erythema, oedema, necrosis within 24 hours. Grade 1 = No injury from undiluted. Response: Moderate erythema on one animal and from moderate to marked capillary injection on four others. Grade 3. (No individual scores provided) Test method: Not stated Result: Silane A-1120 was moderately irritating to rabbit skin Eye Irritation (Stanton, 1990b) Test Substance: Dow Corning X3-3541 Species/strain: rabbit/New Zealand White Number/sex of animals: 3 male/group Observation period: 14 days (group 1), 7 days 2). Method of administration: Dow Corning X3-3541 (0.1 mL) was instilled into the right eye of each rabbit. Group 1 eyes were dosed and not washed. Group 2 eyes were dosed and washed 30 seconds after treatment. Test method: similar to OECD TG 405
infrared and 1H-nuclear magnetic resonance spectra used to derive structure were provided Method of Detection and Determination: spectroscopy, as noted above PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20°C and 101.3 kPa: red powder Melting Point: approximately 187-194°C (decomposes above 221°C) Specific Gravity: 1.5 at 20°C Vapour Pressure: 4.2 x 10-5 kPa
ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier. The were carried out according to OECD Test Methods. Test Species Results (Nominal)# References Acute Toxicity Static Through 96 hour OECD TG 203 (Organisation for Economic Cooperation and Development, 1992b) Zebra fish (Branchydanio rerio) LC50 > 100 mg/L NOEC* = 100 mg/L Böttcher, 1997 Acute Immobilisation Static 48 hour OECD TG 202 (Organisation for Economic Cooperation and Development, Flea (Daphnia magna) EC50 > 100 mg/L NOEC* 100 mg/L Maetzler, 1997 Growth Inhibition Static 72 hour OECD TG 201† biomass b growth rate µ (Organisation for Economic Cooperation and Development, 1984b) Algae (Scenedesmus subspicatus) Experiment A EµC50 = 109.1 mg/L (79-168 mg/L) EbC50 = 29.6 mg/L (22.8-39.7 mg/L) NOEC* = 3.2 mg/L Experiment B EµC50 = 118.9 mg/L (73.2-260.9 mg/L) EbC50 = 28.1 mg/L (22.1-36.7 mg/L) Hertl, 1997 Respiration Inhibition 30 minute OECD TG 209 (Organisation for Economic Cooperation and Development, Aerobic Water Bacteria EC50 > 1000 mg/L Schnalke, # 95 % confidence limits in brackets. † The method of this test was modified to differentiate between a reduced growth of algae due to real toxic effects of the notified chemical on the algal cells (Experiment A) or due to an indirect effect, a reduced algal growth by light absorption in coloured test solutions (Experiment B). * NOEC - no observable effect concentration
Structural Formula: Molecular Weight: 328.4 (for n = 1); the NAMW for the oligomeric mixture was not provided Method of Detection and Determination: the notified chemical can be detected using HPLC and identified using infrared spectrometry Spectral Data: IR: 3353, 3297, 3054, 2915, 2848, 1606, 1589, 1486, 1456, 1378, 1157, 1114, 1039, 867, 790, 732, 701 cm-1 PHYSICAL AND CHEMICAL PROPERTIES The notified chemical is oligomeric and contains a range of different molecular weight species, including up to 28 % of 1,3-benzenedimethanamine. Several of the physico-chemical properties are estimates based on similar amine compounds. The analogue data are identified where used. Appearance at 20°C and 101.3 kPa: pale yellow viscous liquid Boiling Point: >200°C Specific Gravity: ca. 1.14 at 25°C Vapour Pressure: < 0.004 kPa at 25°C for 1,3-benzenedimethanamine, calculated) Water Solubility: stated to be insoluble for n > 2 Partition Co-efficient (n-octanol/water): log Pow 3.3 (analogue data for isophoronediamine) Hydrolysis as a Function of pH: The notified chemical does not contain any hydrolysable functional groups Adsorption/Desorption: see comments below Dissociation Constant: pKa 11 (analogue data for diethylamine and triethylamine)
1,3-benzenedimethanamine, rather than the 24-28 % (w/w) in the notified chemical. The aqueous solution used in the test had a pH of 11.5. Species/strain: rat/Wistar Number/sex of animals: Observation period: 14 days Method of administration: gavage, 10 % (w/v) aqueous solution Dose range: males: 415, 490, 578, 682, 805, 950 mg/kg females: 490, 578, 682, 805, 950, mg/kg Test method: OECD TG 401 (Organisation for Economic Cooperation and Development, 1987) Mortality: males dose (mg/kg) mortality 0 (control) 0/10 415 0/10 490 2/10 578 4/10 682 3/10 805 9/10 950 10/10 females dose (mg/kg) mortality 0 (control) 0/10 490 0/10 578 1/10 682 4/10 805 7/10 950 8/10 1121 10/10 Clinical observations: transient signs of excitement were observed in the animals immediately administration; sudden collapse due to ataxia resulting in death was seen in a number of the animals, generally within two hours of administration and always within the first day; partial recovery from the symptoms was seen in the surviving animals by the second day
Test method: OECD TG 401 Mortality: None. Clinical observations: Ataxia, decreased activity, soft stool, wet yellow belly and diarrhea on days 1 and 2. Morphological findings: Not LD50: > 5 000 mg/kg Result: The notified chemical was of very low acute oral toxicity in rats. 9.1.2 Dermal Toxicity (Reagan, & Parent, 1981b) Species/strain: Rabbit/New Zealand (NZW). Number/sex of animals: 5/sex Observation period: 14 days Method of administration: Under occlusive dressing for 24 hours at a dose of 2g/kg on abraded and intact skin. Test method: Similar to OECD TG 402. Mortality: One animal died on day 7. Clinical observations: From day 11 scattered observations of diarrhea, soft stool and loss of appetite. Morphological findings: None given. LD50: > 2 000 mg/kg Result: the notified chemical was of low dermal toxicity in rats 9.1.3 Inhalation Toxicity Not provided. 9.1.4 Skin Irritation (Reagan, Becci & Parent, 1981c) Species/strain: Rabbit/NZW Number/sex of animals: 6/males.
9.1.4 Skin Irritation (Pharma Research Toxicology and Pathology, 1987d) Test Substance: Analogue A Species/strain: Rabbit/New Zealand Albino Number of Animals: 3 Observation period: 7 days Method of Administration: A semi-occlusive application of 0.5 mL undiluted test substance was made on the dorsal skin. After 4 hours, the substance carefully removed with tap water. Test Method: TG 404 Draize scores: Time after Animal # treatment (days) 1 2 3 Erythema 1 a2 2 3 2 2 2 2 3 0 2 2 Oedema 1 1 0 1 2 1 0 1 3 0 0 0 a see Attachment 1 for Draize scales Mean Individual Scores (24,48 & 72 hour observations: Erythema and scab formation: 1.3, 2.0, 2.3. Oedema: 0.7, 0.0, 0.7 Comment: By the seventh day post-treatment, all signs of irritation had disappeared except for one animal, which still had dry and brittle skin. Result: Analogue A was moderately irritating to the skin of rabbits.
9.1.1 Oral Toxicity (Kern, 1999e) Species/strain: rat/Crl:CD(SD)IGS BR Number/sex of animals: 5/sex/dose Observation period: 14 days Method of administration: gavage, dose levels 1183, 1538 and 2000 mg/kg; notified chemical administered as a suspension in corn oil; dose volume 20 mL/kg; dose administered in two halves given 4 hr apart Test method: OECD TG 401 Mortality: 1183 mg/kg 1/10 1538 mg/kg 2/10 2000 mg/kg 2/10 one female in the 1183 mg/kg died prior to administration of the second half of the dose; the other premature decedents died within 2 days of dosing Clinical observations: 29 animals showed discoloured areas due to discharges or excretions (clear, red, yellow or brown) around the nose, mouth, hindlimbs, dorsal rump, ventral trunk, anogenital and/or urogenital area; 27 animals showed abnormalities in excretion (mucoid faeces, soft faeces and/or diarrhoea); hypoactivity was observed in six animals, predominantly in the 2000 mg/kg group prostration, hypothermia and laboured respiration were noted in two of the animals which later died other observations in one or two animals included impaired muscle coordination, clear ocular discharge, swollen nose and hair loss all observations with the exception of hair loss in one animal (till the end) and soft faeces in one animal on day 10 had cleared by day 6 Body weight: no significant body weight changes were observed Morphological findings: three premature decedents had yellow stomach contents, one of these had dark red lungs; no other gross pathological abnormalities were observed in these animals or at scheduled necropsy Comment: significant toxicity was observed at all doses tested
OGA 600 Diluted to 1% OGA 499 in mineral oil. (Covance Laboratories Inc 1998a) 25% Faint erythema reactions were observed with the neat test substance and at 50%. Pinpoint areas of subcutaneous haemorrhaging were also observed at the test sites treated with neat test substance. 2 – INCIDENCE OF DERMAL RESPONSES FOLLOWING CHALLENGE Test substance identity & formulation details Induction Challenge Incidence of Dermal Response Grades 24 hour 48 hour 0 1 2 3 0 1 2 3 SP2043 100% OGA 499. (Hill Top Research 1997) SP2043 undiluted (100% OGA 499) SP2043 undiluted (100% OGA 499) 1st Test 0 5 9 5 1 0 1 8 1 0 10 0 0 0 1 9 0 0 0 Total No. of test animals with positive response: 15/20 19/20 XF661 85% OGA 499 in light aromatic solvent naphtha. (Covance Laboratories Inc 1999a) XF661 Undiluted (85% OGA 499) 10% XF661 in mineral oil (8.5% OGA 499) 1st Test 8 0 0 0 9 8 1 1 0 Non- Naïve 0 0 0 0 6 4 0 0 0 Total No. of test animals with positive response: 0/20 0/20 10% XF661 in mineral oil (8.5% OGA 499) 2nd Test 5 0 0 0 4 1 0 0 6 4 0 0 0 5 4 1 0 0 No. of test animals with positive response: 0/20 1/20 1% XF661 in mineral oil (0.85% OGA 499) 2nd Test 0 0 0 0 0 0 0 0 Naïve 0 0 0 0 9 1 0 0 0 Total No. of test animals with positive response: 0/20 0/20 OX15622 85 wt% OGA 499 in Stoddard solvent & hydrotreated distillates (Covance Laboratories Inc 2000a) OX15622 Undiluted (85% OGA 499) 25% OX15622 in mineral oil (21% OGA 499) 1st Test 0 0 9 1 0 0 7 1 Naïve 0 0 0 0 4 6 0 0 0 Total No. of test animals with positive response: 20/20 20/20
25% OX15622 in mineral oil (21% OGA 499) 2nd Test 0 8 9 3 0 0 5 8 6 1 Naïve 2 5 3 0 0 2 7 1 0 0 Total No. of test animals with positive response: 12/20 15/20 2.5% OX15622 in mineral oil (2.1% OGA 499) 2nd Test 3 0 0 0 4 1 0 0 Naïve 7 3 0 0 0 8 2 0 0 0 Total No. of test animals with positive response: 0/20 1/20 TABLE 2 – INCIDENCE OF DERMAL RESPONSES FOLLOWING CHALLENGE (cont’) Test substance identity & formulation details Induction Concentration Challenge Concentration Animal Incidence of Dermal Responses Result 24 hour 48 hour 0 0.5 1 2 3 0 0.5 1 2 3 OX15623 75 wt% OGA 499 in Stoddard solvent & hydrotreated light distillates (Covance Laboratories Inc 2000b) OX15623 Undiluted (75% OGA 499) 5% OX15623 in mineral oil (3.8% OGA 499) Test1 16 3 0 0 0 17 2 0 0 0 Non- Sensitising Naïve 10 0 0 0 0 8 2 0 0 0 Total No. of test animals with positive response: 0/20 0/20 OX15624 50 wt% OGA 499 in Stoddard solvent & hydrotreated light distillates (Covance Laboratories Inc 2000c) OX15624 Undiluted (50% OGA 499) 10% OX15624 in mineral oil (5% OGA 499) 1st Test 15 5 0 0 0 14 6 0 0 0 Non- Sensitising 10 0 0 0 0 8 2 0 0 0 No. of test animals with positive response: 0/20 0/20 OGA 600 39% OGA 499 in Stoddard solvent, hydrotreated distillates & 10% OGA 574 OGA 600 Undiluted (39% OGA 499) OGA 600 Undiluted (39% OGA 499) Test 0 12 6 1 0 2 13 4 1 0 Naïve 0 9 1 0 0 0 9 1 0 0 Total No. of test animals with positive response: 7/20 5/20 h
Clinical observations: after dosing, the animals showed decreased spontaneous activity, squatting posture and stilted gait; these signs were reversible after 4 to 6 hours Morphological findings: no organ abnormalities were observed at necropsy Comment: no effect on body weight gain was observed LD50: > 2000 mg/kg Result: the notified chemical was of very low acute oral toxicity in rats 9.1.2 Dermal Toxicity No test results were provided by the notifier. 9.1.3 Inhalation Toxicity No test results were provided by the notifier. 9.1.4 Skin Irritation (Kreiling, 1996) Species/strain: rabbit/New Zealand albino Number/sex of animals: 3 female Observation period: 3 days Method of administration: 0.5 mL test substance was applied to a clipped test site under semi-occlusive conditions for 4 hr Test method: OECD TG 404 Comment: no signs of irritation were observed at 30-60 minutes, 24 hr, 48 hr or 72 hr; all Draize scores were zero Result: the notified chemical was not irritating to the skin of rabbits 9.1.5 Eye Irritation (Kreiling, 1996) Species/strain: rabbit/New Zealand albino Number/sex of animals: 3/not stated
Positive controls N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG); 2 g/plate –TA100; 5 g/plate – E. coli WP2; 10 – TA1535 (without metabolic activation) 2-nitro-fluorene (2-NF) 2 g/plate – TA 98; 5 g/plate –TA 1538, (without metabolic activation) 9-aminoacridine (9-AA): 50 g/plate – TA1537 (without metabolic activation) 2-aminoanthracene (2-AA): 5 g/plate - TA100, TA98, TA1538; 20 g/plate – TA1535, TA1537; 40 g/plate – E. coli WP2 (with activation) Comment: toxic effects occurred in the absence of metabolic activation for the highest dose used for all strains; a substantial increase in the number of revertant colonies with an indication of clear dose response occurred for strains TA100 (500-5000 g/plate), TA1535 (1000-5000 g/plate) and E. Coli WP2 (5000 g/plate) in the presence of metabolic activation the positive controls produced clear positive results indicating that the test system responded appropriately Result: the test material was weakly mutagenic in the bacterial strains which detect base substitution (TA100, TA1535 and WP2) in the presence of metabolic activation provided by rat liver S9 fraction Analogue Genotoxicity Results Positive evidence of genotoxicity for the analogue compound TGIC was in a number of studies quoted in the summary of TGIC toxicity provided by the notifier (National Occupational Health and Safety Commission, 1994c). A TGIC Ames test showed it to be a weak mutagen to TA98 and TA100 in the presence and absence of metabolic activation. It was also found to be mutagenic in a mouse lymphoma cell forward mutation assay both in the presence and absence of metabolic activation. It was also found to be damaging to DNA as measured by induction of unscheduled DNA synthesis in rat hepatocytes in vitro, although it was negative in a similar test using human fibroblasts.