Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 213-911-5 | CAS number: 1066-33-7
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data taken from EU risk assessment/SIDS; Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 15
- Author:
- OECD
- Year:
- 2 003
- Bibliographic source:
- SIDS Dossier Sodium Bicarbonate, Final July 2003
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1150 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Labs, New Jersey, USA
- 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
- 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 at study initiation: the report states that the rats were young adults, but the exact age is not given
- Weight at study initiation: 224 - 239 g (males), 219 - 226 g (females)
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): in two samplings of two minutes duration 2.9 +/- 1.77 µm and 2.7 +/- 2.04 µm, respectively.
PREPARATION OF PARTICLE:
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. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by gravimetric calculation
- 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
- Frequency of observations and weighing: 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 exposure termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.74 mg/L air
- Exp. duration:
- 4.5 h
- Mortality:
- There was no mortality
- 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 on the one or two aft
- 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
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.