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Diss Factsheets
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EC number: 908-084-9 | 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
- Study period:
- 17 March 2016 - 07 July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- EC Number:
- 908-084-9
- IUPAC Name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Sighting study 11 weeks; main study 8 weeks
- Weight at study initiation: signthing: 402 g (male), 244 g (female); main study
- Fasting period before study: Not recorded
- Housing: Polycarbonate solid floor cages with stainless steel mesh. 5 animals per cage, separated by sex
- Diet: Unrestricted supply
- Water: Unrestricted supply
- Acclimation period: Animals were acclimated to laboratory conditions for 27 days (sighting study) or 14 days (main study) prior to involvement in the study. Animals were also acclimatised to the test apparatus (restrain procedures) for a short period prior to testing in order to lessen the stress during exposure.
ENVIRONMENTAL CONDITIONS
- Temperature: 19.0 - 25.9°C
- Humidity: 34 - 74% RH
- Air changes: At least 15 air changes per hour
- Photoperiod: 12 hours of continuous artificial light in each 24-hour period (from 6.00 a.m. to 6.00 p.m.)
IN-LIFE DATES: From: 12 May 2016 (receipt of first animals) To: 07 July 2016 (last necropsy occasion)
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- >= 1 - <= 4 µm
- Geometric standard deviation (GSD):
- >= 1.5 - <= 3
- Remark on MMAD/GSD:
- Measurements of aerodynamic particle size were performed from the animal’s breathing zone using a cascade impactor.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The test item was aerosolized using a dust generator according to Wright located at the top of the exposure chamber. In this device a fixed blade scrapes continuously the surface of the test item compacted by hydraulic press in a rotating reservoir. Dispersion was carried out by a high velocity air flow inside the outlet nozzle.
Dried compressed air was supplied by means of an oil-free compressor and passed through a suitable filter system prior to introduction to the nebuliser.
TEST ATMOSPHERE
- Brief description of analytical method used: Dust concentration was measured gravimetrically. Samples were collected at 10-20 minute intervals during the 4-hour exposure period
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter): 3.71 µm (sighting study); 3.92 µm (main study) - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- Achieved concentration: 4.23 mg/L sighting study, 4.19 mg/L main study
- No. of animals per sex per dose:
- 5 main study, 1 (sighting study)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked hourly during exposure, 1 hour after exposure and twice daily (early and late in the working day) during the 14-day observation period for morbidity and/or mortality.
- Necropsy of survivors performed: yes
- Other examinations performed:
Individual body weights were recorded prior to treatment on the day of exposure (Day 0) and on Days 1, 3, 7 and 14.
All animals were observed for clinical signs at hourly intervals during exposure whilst the animals were still restrained. Following exposure, clinical observations were performed twice on the day of exposure (following removal from the restrainer and approximately one hour after completion of the exposure) and subsequently once daily for 14 days. Observations included changes in the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somato-motor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.19 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: Fur staining by the test item occurred anywhere in study animals were considered to be related to the restraint and exposure procedures but not to be toxicologically significant. Laboured respiration (slight) was recorded in both animals of the Group 0.1
- Body weight:
- Slight body weight losses, noted in any study animals of both Group 0.1 and Group 1 on Day 0-1, were considered to be related to the restraint and exposure procedures.
From Day 3, positive body weight gain was recorded in all rats of the study. - Gross pathology:
- A single four hours nose-only exposure of B331 to Crl:WI rats followed by a 14-day observation period produced test item-related gross changes. Red discoloration of the non-collapsed lungs and blue/dark blue discoloration of the lung-associated lymph nodes were noted at the concentration of 4.23 mg/L during sighting exposure. In main study, blue diffuse discoloration of the non-collapsed lungs and blue diffuse discoloration of the tails were recorded at the dose level of 4.19 mg/L. The blue discoloration was related to the administration of the test item and was attributed to its appearance (blue powder)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, no mortality occurred in Group 1 (main study) when exposed to a test atmosphere concentration of 4.19 mg/L as a maximum feasible concentration for 4 hours. The acute inhalation median lethal concentration (LC50) of B331 in Crl:WI rats was therefore considered to be above 4.19 mg/L.
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