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Toxicological information

Acute Toxicity: oral

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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

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
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:
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 signs of effect by day 5.
Body weight:
All animals that died during the observation period had reduced body weight or no body weight gain. The animals that survived until the study termination, gained weight compared to the initial weight at study start.
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.

Applicant's summary and conclusion

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