Sodium carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Groups of 5 male and 5 female rats were dosed with a 20% solution of sodium carbonate in water by intubation, in concentrations of 1300, 1800, 2600, 3600, and 5000 mg/kg bw, and LD50 was calculated.

GLP compliance:

no

Test material

Test material information

Constituent 1

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

Details on test material:

Specified test substance: sodium carbonate monohydrate . Without a specification of the purity, the OECD considered the study result reliable/acceptable.

SOURCE: Not reported.
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: The test substance was sodium
carbonate monohydrate.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: Wistar albino rats.
- Source: Marland Breeding Farms, Inc., Hewitt, NJ.
- Age: Not reported.
- Weight at study initiation: 187-296 g.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

1.3, 1.8, 2.6, 3.6, 5.0 g/kg

No. of animals per sex per dose:

5/sex/dose

Details on study design:

CONTROLS: Not reported.
ADMINISTRATION: Oral, by intubation.
- Doses: 1.3, 1.8, 2.6, 3.6 and 5.0 g/kg.
- Doses per time period: One dosing only.
- Volume administered or concentration: The test material was administered by oral intubation as a 20% w/v solution in tap water.
- Post dose observation period: 14 days.
EXAMINATIONS: Following dosing the rats were observed for mortality and overt signs of effects at 0-2 and 4-6 hrs following dosing and daily thereafter for 14 days. Body weight was recorded initially and terminally.

Statistics:

STATISTICAL METHODS: Not reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

Mortality:

The time of death is listed by dose. 1.8 g/kg: day 8. 2.6 g/kg: day 1-2. 3.6 g/kg: day 1. 5.0g/kg: day 1.
Number of deaths at each dose: 1.3 g/kg: 0/10. 1.8 g/kg: 1/10. 2.6 g/kg: 4/10. 3.6 g/kg: 7/10. 5.0 g/kg: 10/10.

Clinical signs:

other: Signs of effects observed included: ataxia, muscle tremors, red nasal discharge, urinary staining of the abdomen, soft stool, piloerection, prostration, lethargy, faecal staining of the abdomen and dyspnoea. All animals surviving the study were clear of

Gross pathology:

NECROPSY FINDINGS: The necropsy findings are listed by dose. 1.3 g/kg: 4/10 rats had a mottled liver only. 1.8 g/kg: 5/10 rats hands a mottled liver, one of these had air filled intestines. 2.6 g/kg: 2/10 had a mottled liver. 4/10 had a mottled liver, mottled or pale kidneys, nasal or oral discharge, red intestines, stomach with a red pyloric region or containing red fluid. 3.6 g/kg: 2/10 had a mottled liver only. The remaining animals, with one exception, had most of the following lesions: mottled or pale kidneys, nasal or oral discharge, red intestines, stomach with a red pyloric region or containing red fluid, mottled or dark red lungs, mottled liver. 5.0 g/kg: The animals in this dosing group all had most of the following lesions: mottled or pale kidneys, nasal or oral discharge, intestines filled with fluid, stomach with a red pyloric region or containing red fluid, mottled or dark red lungs, mottled liver, air in the intestines.

Other findings:

POTENTIAL TARGET ORGANS: Not reported. SEX-SPECIFIC DIFFERENCES: Not reported.