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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
other: Publication
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles. Comparable to guideline study with acceptable restrictions. In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned

Data source

Reference
Reference Type:
publication
Title:
Pathologic eefctes in rodents exposed to sodium combustion products
Author:
Busch RH, McDonald KE, Briat JK, Morris JE, Graham TM
Year:
1983
Bibliographic source:
Environmental Research, 31, 138-147

Materials and methods

Principles of method if other than guideline:
Whole body inhalation to establish LC50
GLP compliance:
no
Test type:
other:

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium carbonate
EC Number:
207-838-8
EC Name:
Sodium carbonate
Cas Number:
497-19-8
Molecular formula:
CH2O3.2Na
IUPAC Name:
disodium carbonate
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
91% purity sodium carbonate. Impurity 9.0% NaOH

Test animals

Species:
rat
Strain:
other: Wistar and Sprague Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Source - not reported. Age:Adult. Average weight 365g. 6 trials of 10 animals each

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other:
Details on inhalation exposure:
Type of exposure: Whole body inhalation to aerosols of sodium combustion products.
- Concentrations: 17 concentrations between 800-4600 mg/m3.
- Particle size: median aerodynamic diameter ± GSD: 1.04±1.97 micrometer
- Type or preparation of particles: Sodium combines with oxygen to form combustion products. These react subsequently and rapidly with atmospheric components. In a typical atmosphere the predominant reactions proceed rapidly from the oxide forms to NaOH, then to Na2CO3. They all form in the atmosphere without appreciable settling and produce an aerosol in the order of 1 micrometre aerodynamic equivalent diameter.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
2 h
Concentrations:
800-4600 mg/m3
No. of animals per sex per dose:
60
Control animals:
not specified
Details on study design:
DEVIATIONS FROM OECD GUIDELINE 403: 2h exposure instead of 4h exposure; only males used; reporting less elaborate and complete; assays of cellular immunity were included.
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
2 300 mg/m³ air
Exp. duration:
2 h
Mortality:
Time of death: During and within 1-2 hr after exposure, or beginning at 1 day after exposure, peaking at 5-7 days, and continuing to 9-10 days after exposure. Number of deaths at each dose were not reported.
Clinical signs:
other: Signs of respiratory impairment immediately after exposure. Dyspnea, wheezing, excessive salivation, and distention of the abdomen. In many animals, excessive salivation and repeated swallowing continued during the first 2 hr following exposure. Signs sub
Gross pathology:
Lesions in respiratory tract in animals that died limited to the posterior pharynx, larynx, anterior trachea, and in approximately 3% of the animals, lungs.
Other findings:
POTENTIAL TARGET ORGANS: Respiratory tract.
SEX-SPECIFIC DIFFERENCES: Not relevant.
OTHER OBSERVATIONS: A transitory immunologic repression. This may be, at least in part, contributory to bacteremia.

Applicant's summary and conclusion

Executive summary:

LC50 of 2300 mg/m3