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Diss Factsheets
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EC number: - | 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:
- 2013-05-13 to 2013-05-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1998
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Characteristics: clear, colourless, viscous
The density of the test item was 1.0953 g/cm3.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rattus norvegicus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Rattus norvegicus) / CD / Crl: CD(SD)
- Source: Charles River Laboratories, 97633 Sulzfeld, Germany
- Age: males: approx. 7 weeks, females: approx. 9 weeks
- Weight at study initiation: males: 233 - 251 g, females: 217 - 239 g
- Number of animals: 3 males and 3 females
- Fasting period before study: 16 hours
- Housing: groups of two or three
- Diet: ad libitum, ssniff R/m-H V 1534
- Water: ad libitum, tab water
- Acclimatisation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3 °C
- Humidity (%): 55 + / - 15 %
- Photoperiod (hrs dark / hrs light): 12 hours darkness, 12 hours artifical light
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: compressed filtered air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Diluent: Dimethyl sulfoxide (DMSO), the test item is an emulsion with a high viscosity. Hence, a mixture of the test item with DMSO (4 + 1, m/m) was the highest possible concentration to obtain an appropriate aerosol.
- Type of exposure: nose-only, using a dynamic inhalation apparatus, air changes >/= 12/h
- Method of holding animals in test chamber (volume 40 l): separatley in Pyrex tubes at the edge of the chamber in radial position
- Source of air: compressed filtered air
- Method of conditioning air: manometer and air-flow meter (ROTA Yokogawa), flow rates checked once per hour and corrected if necessary
- Oxygen content: 21 %, determined at beginning and end of exposure, Carbon dioxide concentration did not exceed 1 %
- Type or preparation of particles: The aerosol of the test item was obtained using a spray-jet. The spray-jet was fed with compressed air (5.0 bar)
from a compressor and with the test item using a TSE infusion pump. At the bottom of the exposure chamber, the air was sucked off at a lower rate than created by the spray-jet in order to produce a homogenous distribution and a positive pressure in the exposure chamber (inflow 900 L/h,
outflow 800 L/h).
- Analysis of the aerosol concentration: The actual aerosol concentration in the inhalation chamber was measured gravimetrically with an air sample
filter (Minisart SM 17598 0.45 µm) and pump (Vacuubrand, MZ 2C ) controlled by a rotameter. Dust samples were taken once every hour during the exposure
- Method of particle size distribution: An analysis of the particle size distribution was carried out twice during the exposure period using a cascade
impactor according to MAY . The impactor is a device that classifies particles present in a sample of air or gas into known size ranges. It does this by drawing the air sample through a cascade of progressively finer nozzles. The air jets from these nozzles impact on pre-weighed plane sampling
surfaces (slides). The aerosol from the exposure chamber was drawn through the cascade impactor for 5 minutes at a constant flow rate of 5 L/min. The slides were removed from the impactor and weighed on an analytical balance (SARTORIUS, type 1601 004, precision 0.1 mg). The mass median aerodynamic diameter (MMAD) was estimated by means of non-linear regression analysis. The particulate size distribution was analysed using a
cascade impactor. The mass median aerodynamic diameter (MMAD) was determined as 2.598 μm. The Geometric Standard Deviation (GSD) of the
MMAD was calculated as 2.76.
- Temperature, humidity: T: 21.8 +/- 0.05°C, H: 60.3 % +/- 0.09 %, measured once every hour
TEST ATMOSPHERE
- Concentrations: 5.09 mg/l
Air flow entrance (L/h): 900
Air flow exit (L/h): 800
Air change (changes per hour): 22.5 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric determination of aerosol concentrations with an air sample filter. Dust samples were taken once every hour during the exposure.
- Duration of exposure:
- 4 h
- Concentrations:
- The gravimetric aerosol concentration of 5.09±0.03 mg test item/L air was measured at the animals’ nose.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Post dose observation period: 14 days
- body weights: before, 7 and 14 days after treatment
- mortality: once per hour during, and once after treatment on day of exposure; thereafter twice daily
- clinical signs: during and following exposure, observations were made and recorded systematicallye, at least twice daily until all symptoms
subsided, thereafter each working day
- Necropsy: all animals (macroscopic) when found dead or at terminal sacrifice. In addition, the weight of the lungs was determined. - Statistics:
- not necessary
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.09 mg/L air
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Mortality:
- No animal died prematurely.
- Clinical signs:
- other: Slight ataxia and slight dyspnoea immediately until 30 minutes or 3 hours after end of exposure.
- Body weight:
- One of the 3 female animals appeared to be reduced in body weight gain since test day 8.
- Gross pathology:
- None findings
- Other findings:
- no other findings
Any other information on results incl. tables
nominal concentration |
gravimetric concentration (actual) |
mass median aerodynamic diameter (MMAD) |
geometric standard deviation (GSD) |
[µL/L air] |
[mg/L air] |
[µm] |
|
55.56 |
5.09 |
2.598 |
2.76 |
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, LC50-value for CD rats following inhalation of the test item for 4 hours was determined as follows (actual concentration): LC50: exceeding 5.09 mg test item/L air.
- Executive summary:
The aim of the present experiment was to obtain information on the acute toxicity and respiratory irritation, following a single 4-hour inhalation exposure of rats to the test item in an acute inhalation toxicity study.
Rats were exposed to the test item at a concentration of 5.09±0.03 mg test item/L air for 4 hours by inhalation using a dynamic nose-only exposure chamber. The aerosol was generated with the aid of a spray-jet.
Clinical signs/mortality:
Under the present test conditions, a 4-hour inhalation of 5.09 mg test item/L air revealed slight ataxia and slight dyspnoea immediately until 30 minutes or 3 hours after end of exposure. No animal died prematurely. No pathological findings were noted at necropsy.
Body weight:
One of the 3 female animals appeared to be reduced in body weight gain since test day 8.
Aerosol concentration and particle size distribution:
The gravimetric aerosol concentration of 5.09±0.03 mg test item/L air was measured at the animals’ nose. The particulate size distribution was analysed using a cascade impactor. The mass median aerodynamic diameter (MMAD) was determined as 2.598 μm. The Geometric Standard Deviation (GSD) of the MMAD was calculated as 2.76.
Conclusion:
Under the present test conditions, LC50-value for CD rats following inhalation of the test item for 4 hours was determined as follows (actual concentration):
LC50: exceeding 5.09 mg test item/L air.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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