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EC number: 261-767-7 | CAS number: 59447-55-1
- 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:
- 02/03/2012-04/04/2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- only one dose level was conducted
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- FR-1025M
- IUPAC Name:
- FR-1025M
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Fr-1025M
- Substance type: Monomer
- Physical state:white powder
- Analytical purity: 99.75%
- Lot/batch No.: 930070260
- Storage condition of test material: room temperature, in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation:8-12 weeks
- Weight at study initiation: 200-350g
- Housing: in groups of three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard 'fun tunnels".
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs light/12hrs dark
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: chambers from ADG Developments Ltd., Hitchin, Herts, UK
- Exposure chamber volume: 30 litres
- Method of holding animals in test chamber: in a tapered, polycarbonate restraining tube
- Method of conditioning air: compressed air was passed through a water tap and respiratory quality filter
- System of generating particulates/aerosols:SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany)
- Method of particle size determination: Marple Personal Cascade Impactor (Westech IS Ltd., Beds, UK)
- Temperature, humidity, pressure in air chamber: temperature and relative humidity were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd., Beds, UK)
TEST ATMOSPHERE
- Brief description of analytical method used: the gravimetric method used glass fibre filters placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump. Each filter was weighed before and after samling in order to calculate the weight of collected test item. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: determined three times during the exposure period
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD = 2.80 μm, GSD = 2.22
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: 1.0mg/l as the mean achieved concentration was 102% of target and no deaths occured, no further levels were required. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by weight difference
- Duration of exposure:
- 4 h
- Concentrations:
- 1.0 mg/l
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:at hourly intervals during exposure, immediatly on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- /
Results and discussion
- Preliminary study:
- /
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.02 mg/L air (analytical)
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Signs of hunched posture, pilo-erection and red/brown staining around the snout are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded during exposure. These observation
- Body weight:
- All male animals and two females exhibited slight bodyweight losses on the first day post-exposure. Reasonable bodyweight development was noted for all animals during the remainder of the recovery period.
- Gross pathology:
- No macroscopic abnormalities were detected
- Other findings:
- /
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- No deaths occured in a group of six rats exposed to a mean achieved atmosphere concentration of 1.02mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4hr LC50) of FR-1025M, in the RCCHan:WIST strain rat was greater than 1.02mg/L (GHS - Category 4, > 1-5mg/L.
- Executive summary:
INTRODUCTION
A study was performed to assess the acute inhalation toxicity of the test item. The method was compatible with that described in the OECD No. 436, with the exception that only one dose level was conducted.
METHODS
A group of six RccHan:WIST strain rats (three males, three females) was exposed to a dust atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.
RESULTS
The mean achieved atmosphere concentration was 1.02 mg/L (Std. Dev.: 0.05mg/L, nominal: 9.64 mg/L)
An example calculation for determining test atmosphere concentration is shown below:
Sample number Time (mins) Filter weights (mg) Difference (mg) Sample volume (L) Concentration (mg/l) Pre-sample Post-sample 1 5 32.57 36.61 4.04 4 1.01 The characteristics of the achieved atmosphere were as follows:
Mean achieved atmosphere concentration (mg/L) Mean mass median aerodynamic diameter (µm) Inhalable fraction (% < 4µm) Geometric standard deviation 1.02 2.80 67.4 2.22
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