Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 214-185-2 | CAS number: 1111-78-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, EPA Guideline with limited documentation: comparable to OECD 403 (limit test)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (limit test)
- Principles of method if other than guideline:
- METHOD FOLLOWED: EPA/TSCA 40 CFR Part 798.1150
A group containing both sexes of experimental animals are exposed for the defined period of 4.5 hours to a single concentration of the test substance (limit test). Subsequently, observations of effects and deaths are made. Animals which die during the test are necropsied, and at the conclusion of the test surviving animals are sacrificed and necropsied as necessary. - GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- Molecular formula:
- CH2O3.Na
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): Sodium bicarbonate
- Analytical purity > 99.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Hilltop Lab Animals, Scottdale, PA.
- Age: the report states that the rats were young adults, but the exact age is not given
- Weight at study initiation: ♂ 224-239 g, and ♀ 219-226 g.
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION:
Type or preparation of particles: the test substance was ground for 24 hours in a ball mill prior to aerosolisation. Thereafter it was sieved through a 425 micron screen to separate it from the grinding medium and any other large particles which remained.
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.8 µm (2.7 ± 1.77 and 2.9 ± 2.04 µm). 2 measurements with 2 min durations each - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- (gravimetric measurement)
- Duration of exposure:
- 4.5 h
- Concentrations:
- 4.74 ± 1.03 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight was measured prior to exposure and on days 1, 7 and 14. Animals were observed before exposure commenced, every 15 min during the first exposure hour, and every 15 min thereafter through till exposure termination. The animals were individually examined on removal from the chamber. In-chamber animal observations were limited due to the accumulation of test substance on the walls of the chamber which obscured visualisation. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.74 mg/L air
- Exp. duration:
- 4.5 h
- Remarks on result:
- other: No mortality occurred. Clinical signs: reduced movement, hunched posture, ocular and nasal discharge. Effects lasted 3 days
- Mortality:
- No mortality occurred
- Clinical signs:
- other: During the first hour of exposure, reduced movement and hunched posture were noted for most animals. At exposure termination test substance was observed on the fur of two animals, while the same was observed in all the remaining rats one or two days afte
- Body weight:
- All the animals gained body weight during the observation period (body weight males at 14 days, 311-341 g; body weight females at 14 days, 254-267 g).
- Gross pathology:
- The general findings at gross necropsy were unremarkable. One male and one female had moderately red lung tissue, while one male had slightly red lung tissue.
Applicant's summary and conclusion
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