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EC number: 215-199-1 | CAS number: 1312-76-1
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Endpoint summary
Administrative data
Description of key information
NOAEL (rats) = 159 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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: see 'Remark'
- Remarks:
- Only two standard parameters were studied: body weight and survival. Background concentration in the diet varied between 0.1 and 1.0% of SiO2 (w/w). Nitrogen and phosphorous retention/excretion was measured only in the males at the end of the exposure period.
- Principles of method if other than guideline:
- Oral exposure of weanling rats via drinking water for 180 days.
The study was conducted to assess the influence of silica in the diet on growth and nutrient balance. - GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: Weanling - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Duration of treatment / exposure:
- 180 d (m-f) + 17 days (m)
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
789.5 and 1587 mg sodium silicate/L
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
600 and 1200 mg SiO2/l
Basis: - No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Mortality: registered with unknown frequency
- Body weight: registered every week
- Urinalysis: nitrogen and phosphorous registered daily from day 181-197 in males. - Other examinations:
- Analysis of faeces: nitrogen and phosphorous registered daily from day 181-197 in males.
- Dose descriptor:
- NOAEL
- Effect level:
- > 159 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Critical effects observed:
- not specified
- 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.
- 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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: 7 weeks - 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
- Remarks:
- Doses / Concentrations:
200, 600 and 1800 ppm
Basis:
nominal in water - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- 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. - Dose descriptor:
- NOAEL
- Effect level:
- > 227 - 237 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Critical effects observed:
- not specified
- 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, study report is unclear in some points.
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: ddy
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: 4 weeks - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continuously
- Remarks:
- Doses / Concentrations:
300, 900, 2700 ppm (males), 333, 1000, 3000 ppm (females)
Basis:
nominal in water - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: registered once daily
- Mortality: registered once daily
- Body weight: registered once a week
- Food consumption: registered once a week
- Water consumption: registered twice a week
- Haematology: erythrocyte count, leucocyte count, haemoglobin, haematocrit, blood serum protein content, leucocyte composition.
- Biochemistry: S-GOT, S-GTP, S-AlP (alkali phosphatase), bilirubin, blood glucose, BUN, cholesterol, A/G, potassium, sodium, chloride.
- Urinalysis: performed at the end of the study. pH, sugar (assumed to be glucose), protein, ketone, blood concentration, urinobilinogen. - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopic: the wet weight of liver, kidney, spleen, suprarenal glands, thyroid glands, testicles, pituitary glands, heart, lung, brain, ovary was registered. The organs of the thoracic and abdominal cavity were examined macroscopically
- Microscopic: liver, kidney, spleen, suprarenal glands, thyroid glands, testicles, pituitary glands, heart, ovary, lung, brain, pancreas, stomach, duodenum, jejenum, ileum, cecum, rectum, urinary bladder, prostate, uterus, mammary glands, arteries, bone marrow, lymphatic glands were fixed in 10% formalin, packed in paraffin, cut into thin sections, subjected to haematoxylin and eosin staining and examined microscopically - Dose descriptor:
- NOAEL
- Effect level:
- 260 - 284 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- LOAEL
- Effect level:
- 716 - 892 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: organ weights
- Critical effects observed:
- not specified
Referenceopen allclose all
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: None
- Clinical signs: no effects
- Body weight gain: Some statistically significant
differences in body weight between experimental groups and
controls were registered, but these were small (6% or less),
not consistent and not dose related.
- Urinalysis: significant, but not dose-related effects on nitrogen and phosphorus retention (p<0.05)
- Other: In the male low dose group nitrogen retention was
50% lower that in the control group, while in the high dose
group no such difference was observed. In a repeat
experiment no clear and significant differences in nitrogen
retention were found. In both experiments phosphorous
retention seemed somewhat increased in the male high dose
groups (approximately 12%), while in the low dose groups no
effect of treatment was seen.
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.
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX:
males:
nominal dose 300 900 2700 ppm
actual intake 2.4-2.5 6.6-7.0 19.4-20.8 mg/animal/d
actual dose 96-100 264-280 776-832 mg/kg bw/d
females:
nominal dose 333 1000 3000 ppm
actual intake 2.2-2.6 6.5-7.1 17.9-22.3 mg/animal/d
actual dose 88-104 260-284 716-892 mg/kg bw/d
(calculations are based on an average body weight for mice of 25 g)
- Time of death: no mortality
- Number of deaths at each dose: no mortality
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: no mortality
- Clinical signs: no treatment-related effects
- Body weight gain: no treatment-related effects
- Food/water consumption: there were no effects on food and
water consumption.
- Clinical chemistry: no effects
- Haematology: There was an increase of the haematocrit level in
the female high dose group. The leucocyte count in females
was significantly reduced in the low and medium dose group,
and reduced in the highest dose group.
- Urinalysis: the protein concentration in all female
exposure groups was slightly increased compared with the control group.
- Organ weights: the relative pituitary gland weight in
females was reduced in all dose groups compared to the control,
statistically significant only in the highest dose group. The
relative liver weight in males was increased in all dose groups comparedto control group,significantly in the low and medium
dose group.
With respect to the reproductive organs examined, the following wet weights (g) were determined:
Testes Ovaries
right left right left
control 0.13 0.14 8.4 7.3
2700 ppm 0.14 0.14 7.7 7.4
900 ppm 0.13 0.13 9.7 9.1
300 ppm 0.13 0.12 8.3 8.4
- Gross pathology: see histopathology
- Histopathology: no treatment-related effects
Additional information
Oral
Repeated oral dose toxicity studies with sodium silicate or sodium metasilicate ranging from 4 weeks to 180 days have been conducted with rats, mice, dogs and turkeys. Here, only the most relevant subchronic studies are described:
While in rats no treatment-related effects were noted, in female mice, a reduced pituitary glands weight was observed at 716 - 892 mg/kg bw/d (sodium metasilicate; 3 months exposure).
From these studies a NOAEL (90 d) of 227 - 237 mg/kg bw/d can be derived for rats. The NOAEL (90 d) for mice is 260 - 284 mg/kg bw/d. The NOAEL (180 d) for rats is 159 mg/kg bw/d.
Justification for classification or non-classification
The available data are conclusive but not sufficient for classification.
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