Registration Dossier
Registration Dossier
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EC number: 229-912-9 | CAS number: 6834-92-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Safety of polysodium silicate. Subacute peroral toxicity in rats.
- Author:
- Ito, R. et al.
- Year:
- 1 975
- Bibliographic source:
- J. Med. Sac. Toho. Japan 22(2), 223-227
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Disodium metasilicate
- EC Number:
- 229-912-9
- EC Name:
- Disodium metasilicate
- Cas Number:
- 6834-92-0
- Molecular formula:
- H2O3Si.2Na Soluble Silicates Category
- IUPAC Name:
- disodium oxosilanediolate
- Details on test material:
- SOURCE: Nihon Nohyaku Co., Ltd
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Poly sodium silicate is assumed to be metasilicate (designated in tables and figures as 'meta silicate' and in the text as Na2O.SiO2, indicating a molar ratio of 1.0). Designated by authors as Porikuron, a product based on poly sodium silicate (Na2O.nSiO2).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: 7 weeks
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 600 and 1800 ppm
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- - Clinical signs: daily
- Mortality: daily
- Body weight: once a week
- Food consumption: once a week
- Water consumption: measured daily
- Haematology: after the test period erythrocytes and leukocytes were counted, hemoglobin value, blood cell volume and leukocyte percentage
- Biochemistry: after the test period gamma-GOT, gamma-GPT and alkali phosphatase activity measurement
- Urinalysis: after the test period measurements were made on pH-value, sugar, protein, ketone and blood value. - Sacrifice and pathology:
- - Macroscopic: wet weight of liver, kidney, heart, lung, spleen, suprarenal glands, thymus, thyroid gland, testicles and ovaries. Also dissected: pancreas, intestines, stomachs, bone marrow.
- Microscopic: liver, kidney, heart, lung, spleen, suprarenal glands, thymus, thyroid gland, testicles and ovaries were fixed with 10% formalin, packed in paraffin, cut into thin sections and subjected to hematoxylin and eosin staining.
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 227 - 237 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No clearly treatment related effects at tested dose levels
of 200, 600 and 1800 ppm (corresponding to 26.4, 76.2 and
227.1 mg/kg/day, respectively, for males; and 32.1, 97.6 and 237.2 mg/kg/day, respectively, for females).
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: None
- Clinical signs: No effects
- Body weight gain: No effects
- Food/water consumption: No effects
- Clinical chemistry: No effects
- Haematology: No effects
- Urinalysis: No effects
- Organ weights: No effects
- Gross pathology: No effects
- Histopathology: Except for the kidneys, no morphological changes have been observed in the organs examined. The observed
histological changes in the kidneys (tubule wall calcinosis, glomerular swelling, tubule swelling, weakening of the renal tubule cell
walls and dilation of the tubule lumen) were not dose-related and occurred also in the controls. Cylindrical inclusions in the renal
tubular cells were only observed in the medium dosage group.
Applicant's summary and conclusion
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