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2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol
EC number: 943-503-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (2009)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document No. 39 (2009)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol
- EC Number:
- 943-503-9
- Molecular formula:
- C4H11NO2 C15H16O2 C20H27NO4 C25H38N2O6 C30H49N3O8
- IUPAC Name:
- 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of 2,2'-iminodiethanol and 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol and 2,2-bis(4-hydroxyphenyl)propane and 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol
- Appearance: viscous, clear, yellowish liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hsd Cpb:WU (SPF)
- Source: Harlan-Nederland, AD Horst, The Netherlands
- Age at study initiation: approximately 2 months
- Weight at study initiation (mean): males 187.4-193.2 g, females 176.8-179.4; at the study start the variation of individual weights did not exceed ± 10 per cent of the mean for each sex.
- Housing: Singly in conventional Makrolon® Type IIIH cages with gnawing sticks.
- Diet and water: ad libitum
- Acclimation period: at least 5 days; during this period, rats were also acclimatized to the restraining tubes.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 60
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Mode of exposure: Animals were nose-only exposed to the aerosolized test article in restrainers made of Plexiglas. Restrainers were chosen that accommodated the animals' size. The type of exposure principle is comparable with a directed-flow exposure design (Moss and Asgharian, Respiratory Drug Delivery IV, 1994, 197) and minimizes re-breathing of exhaled test atmosphere. The ratio between supply and exhaust air was selected so that 85-90 % of the supplied air was extracted via the exhaust air location and, if applicable, via sampling ports.
- Exposure apparatus: The chambers used are commercially available (TSE, Bad Homburg, Germany). Each inhalation chamber segment was suitable to accommodate 20 rats at the perimeter location. For validation see Pauluhn, Journal of Applied Toxicology 14, 55-62, 1994, and Pauluhn & Thiel, Journal of Applied Toxicology 27, 160-167, 2007.
- Source and rate of air: Dry conditioned air, 15 L/min
- Method of conditioning air: Compressed air was supplied by Boge compressors and was conditioned (freed from water, dust and oil) automatically by a BEKO RA 55 compressed air dryer.
- System of generating particulates/aerosols: Atmosphere for inhalation exposure was generated under dynamic conditions using a digitally controlled Harvard PHD 2000 infusion pump or similar equipment and a modified Schlick nozzle Type 970, form-S 3 (Schlick GmbH, Coburg, Germany). The test article (solution) was nebulized under dynamic conditions using conditioned (dry, oil free) compressed air (dispersion pressure approximately 600 kPa), 15 L air/min and inhalation chamber segment.
- Optimization of respirability: In order to increase the efficiency of the generation of fine particles through evaporation of the vehicle and to prevent larger particles from entering the chamber a pre-separator (baffle) system was used (Tillery, Environmental Health Perspectives, 16, 25-40, 1976).
- Inhalation chamber equilibrium concentration: The test atmosphere generation conditions provide an adequate number of air exchanges per hour (15 L/min x 60 min/(3.8 L) = 237, continuous generation of test atmosphere). Under such test conditions chamber equilibrium is attained in less than one minute of exposure. At each exposure port a minimal air flow rate of 0.75 L/min was provided. The test atmosphere can by no means be diluted by bias-air-flows.
- Method of particle size determination: Cascade impactor (Berner critical orifice cascade impactor)
- Treatment of exhaust air: The exhaust air was purified via filter systems.
- Temperature, humidity: Temperature and humidity measurements were performed by the computerized Data Acquisition and Control System using HC-S3 sensors (Rotronic Messgeräte GmbH, Ettlingen, Germany). The position of the probe was at the exposure location of rats.
TEST ATMOSPHERE
- The integrity end stability of the aerosol generation and exposure system was measured by using a RAS-2 real-time aerosol photometer (MIE, Bedford, Massachusetts, USA).
- Brief description of analytical method used: gravimetric analysis of filter samples (filter: Glass-Fibre-Filter, Sartorius, Göttingen, Germany; digital balance).
- Samples taken from breathing zone: yes
- Particle size distribution: The particle size distribution was analysed using a BERNER critical orifice cascade impactor. Aerosol mass < 3 µm: 84.4 % at the limit dose.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The respirability of the aerosol was adequate and in compliance with test guidelines, i.e. the average mass median aerodynamic diameter (MMAD) throughout the groups was 1.14 µm, the geometric standard deviation (GSD) was 2.63. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric analysis
- Duration of exposure:
- 4 h
- Concentrations:
- Target concentration: 5000 mg/m³
Analytical concentration: 4263 mg/m³ (technically maximal attainable concentration) - No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, vehicle control
- Details on study design:
- - Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: Bodyweights were recorded prior to exposure and on days 1, 3, and 7, and weekly thereafter. The appearance and behavior of each rat were examined carefully at least two times on the day of exposure and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Reflexes were tested, based on recommendations made by Irwin (Psychopharmacologica 13, 1968, 222-257). Rectal temperatures were measured shortly after cessation of exposure (approximately within ½hour after the end of exposure) using a digital thermometer with a rectal probe for rats. - Statistics:
- Pair-wise Fisher test after the R x C chi-squared test used for necropsy findings (Procedure in accordance with Gad and Weil, Statistics for Toxicologists. Principles and Methods of Toxicology, ed. A.W. Hayes, Raven Press, New York, 280, 1982).
Analysis of variance (ANOVA) used for statistical evaluation (e.g. body weights, rectal temperatures).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 263 other: mg/m³ (maximal technical attainable concentration)
- Exp. duration:
- 4 h
- Mortality:
- One animal died at 4263 mg/m³. The mortality patterns were typical of a lung edema (e.g.: nose: colorless serous discharge; trachea: colorless foamy content).
- Clinical signs:
- other: All rats exposed to 4263 mg/m³ showed clinical signs (bradypnea, dyspnea, labored breathing, breathing sounds, motility reduced, atony, high-legged gait, piloerection, haircoat ungroomed, nasal discharge (serous), nose reddened, nose/muzzle red encrusted,
- Body weight:
- Compared to control significantly decreased body weights were found at 4263 mg/m³.
- Gross pathology:
- Necropsy findings were unremarkable in surviving rats whereas in the rat that succumbed in the course of study the following findings of toxicological importance at 4263 mg/m³ were observed (nose: colorless serous discharge; lung: red and dark-red areas; pharynx: ablation of mucosa; trachea: colorless foamy content; stomach: bloated; esophagus: clear colorless liquid content; heart: hardened, exsanguinous, ventricle walls thickened).
- Other findings:
- Compared to control significantly decreased body temperatures were found at 4263 mg/m³.
Applicant's summary and conclusion
- Executive summary:
A study on the acute inhalation toxicity of the substance was conducted according to OECD TG 403 and OECD GD 39. In this study male and female rats were nose-only exposed to the liquid aerosol of the substance (vehicle ethanol) at the maximal technical attainable concentration of 4263 mg/m³. The respirability of the aerosol was adequate and in compliance with test guidelines (MMAD 1.14 µm, GSD 2.63). Rats of the control group were exposed to the vehicle ethanol under otherwise identical circumstances.
All rats exposed to 4263 mg/m³ showed clinical signs (bradypnea, dyspnea, labored breathing, breathing sounds, motility reduced, atony, high-legged gait, piloerection, haircoat ungroomed, nasal discharge (serous), nose reddened, nose/muzzle red encrusted, stridor, nostrils with red encrustation, tremor, salivation increased). Significantly decreased body temperatures and body weights were found at 4263 mg/m³. One animal died at 4263 mg/m³; the mortality patterns were typical of a lung edema. Necropsy findings were unremarkable in surviving rats.
The LC50 (4 h) was thus concluded to be > 4263 mg/m³.
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