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EC number: 215-687-4 | CAS number: 1344-09-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline study with survival of offspring and gross morphological changes as the only parameters examined.
- Principles of method if other than guideline:
- The study was not conducted according to any guideline. For details on test procedure see below.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Duration of treatment / exposure:
- Exposure period: 12 weeks, between weaning and sexual maturity, each generation F0, F1, F2, F3 & F4
Premating exposure period (males): 12 weeks
Premating exposure period (females): 12 weeks
Duration of test: 2.5 years - Frequency of treatment:
- continuous
- Remarks:
- Doses / Concentrations:
79 and 159 mg sodium silicate/kg body weight/d
Basis: - Control animals:
- yes, concurrent no treatment
- Statistics:
- Chi-square Test
- Dose descriptor:
- NOAEL
- Effect level:
- > 159 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- mortality
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Sex:
- male/female
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Reproductive effects observed:
- not specified
Reference
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX: 600 and 1200 mg SiO2/l in drinking water, corresponding to 790 ppm
and 1580 ppm sodium silicate, respectively. This converts to 79 and 159 mg/kg bw/d on the assumption of a mean body weight
of 200 g and a mean daily water consumption of 20 ml/d.
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
-Parental data and F1: No effects on mortality, the only parameter studied, were observed in the parental generation at any
dose level.
Reduced pup survival was observed in the treatment groups.
- Mortality: No effects on length of life of the rats receiving sodium silicate in drinking water after weaning. Offspring from the
treatment groups was frequently stillborn or small and weak, with survival limited to only a few days. Cannibalism was prevalentamong females receiving sodium silicate, especially among those receiving 1200 ppm.
The results from the 4 consecutive breedings are reported in the publication as summed data only:
0 600 1200 ppm SiO2
-----------------------------------------------------------------
Number of matings 77 77 77
Number of litters 54 51 49
Total offspring born 517 346* 414*
Total offspring weaned 182 83* 44*
% of offspring weaned 35% 24% 11%
Difference, % of controls
born - 67% 80%
weaned - 46% 24%
-----------------------------------------------------------------
* Values differ from controls, P<0.001
- Offspring toxicity F1:
- Litter size and weights: On average 9.6, 6.8 and 8.4 animals/litter
(at 0, 600 and 1200 mg SiO2/l). No data on body weights
- Viability index: see table above
- Post natal survival until weaning: 35%, 24% and 11% (at 0, 600
and 1200 mg SiO2/l)
- Effects on offspring: Necrosis of the tail and of the feet
as well in both treated groups. Litters were frequently
stillborn or small and weak.
Additional information
In a 4-generation study with rats, the total number of offspring born at 79 mg/kg bw/d was reduced to 67% of offspring weaned to 46% of the control, respectively (Smith et al., 1973). The NOAEL for parental animals was determined to be > 159 mg/kg bw/day. For the F1 generation no NOAEL was identified. Severe limitations of the study and inter-current deaths, including controls make it however difficult to draw any firm conclusion from this study.
In addition, in oral repeated dose toxicity studies with rats and dogs, the macroscopic and microscopic examination of reproductive organs did not reveal any treatment-related effects (Newberne and Wilson, 1970). The NOAEL for rats and dogs was > 2400 mg/kg bw/day.
Kamboj and Kar (1964) did not find
testicular effects of sodium silicate injected either subcutaneously or
intratesticularly in male rats. The NOAEL was determined to be > 8 mg/kg
bw.
Short description of key information:
NOAEL (rat) > 159 mg/kg bw/d
Effects on developmental toxicity
Description of key information
NOAEL (mouse) > 200 mg/kg bw/d
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No tables provided with report; results only discussed qualitatively. Therefore, limited amount of information available.
- Principles of method if other than guideline:
- Application of Na-metasilicate via gavage from day 0 to 18 of gestation. Examination of fetuses and and newborns.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: JLC-TCR
- Details on test animals or test system and environmental conditions:
- Well developed males and females 8-13 weeks of age and 27-35 g/animal.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17-18 days
- Frequency of treatment:
- daily
- Duration of test:
- 18 days
- Remarks:
- Doses / Concentrations:
12.5, 50 or 200 mg/kg bw/d
Basis:
nominal conc. - Control animals:
- yes
- Details on study design:
- Sex: male/female
- Maternal examinations:
- body weight
- Ovaries and uterine content:
- counting of nidations, corpi lutei and living/dead fetuses
- Fetal examinations:
- weighing of living fetuses and important organs, sex determination, examination of integument anomalies, naked eye examination of other changes
Parameters evaluated were: number of neonates, parturition failures, body weight gain, behavioral development in the Running
and Rod Grasping Test (see below) and skeletal development. - Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 200 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: no advese, dose related effects have been observed
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Parental data and F1:
- Body weight: no treatment-related effects were observed in either
mother animals, fetuses delivered by hysterectomy or
neonates.
- Fertility index:
Dose [mg/kg bw/d] pregnancies/mated female % pregnancies
---------------------------------------------------------------
0 (control) 20/26 77%
12.5 22/24 92%
50 20/31 65%
200 21/25 84%
- Duration of gestation: 18 days
- Mortality: 2/27 females administered 50 mg/kg and 2/33 females
administered 200 mg/kg died during the exposure period. In
one female of the highest dose group all fetuses died at an early stage. No parturition fatalities were observed when mothers
were allowed to deliver their young naturally.
- Gross pathology incidence and severity: observed skeletal malformations in neonates like cervical vertebrae, tail vertebrae
and vomer adhesion occurred in the controls, too, and did not show a dosage correlation. No malformations of the skeleton or
the inner organs of fetuses delivered by hysterectomy were observed; the frequency of malformations and abnormalities of theexternal integument, like opened eyes, cleft palate and exencephaly showed a slight tendency toward dose dependance, but it
was lower than in the control. No effects on main organs of both mothers and neonates as compared to controls.
- Number of corpora lutea: No significant differences between control and test groups, but actual numbers not reported.
- Organ weight changes: No treatment-related effects of organ weights of mother animals and neonates; not reported for
fetuses delivered by hysterectomy.
- Offspring toxicity F1:
- Litter size and weights: There was a dose-related, but not statistically significant decrease in litter size.
Dose [mg/kg bw/d] average no. of neonates/litter
-----------------------------------------------------
0 (control) 14.7 +- 2.4
12.5 13.8 +- 2
50 12.9 +- 2
200 12.8 +- 2
- Post natal survival until weaning: no treatment-related effects on body weight gain.
- Effects on offspring: a dose-related, but not statistically significant decrease in embryo weight and delayed
ossification process was observed.
- Postnatal growth, growth rate: no treatment related effects
- Other observations: no treatment-related effects in the Running Test and the Rod Grasping Test.
Additional information
There are no data for sodium silicate. However, there are reliable data for the substance disodium metasilicate. Thus, read-across was performed based on a category approach.
In a non-standard study, disodium metasilicate was orally administered to pregnant mice from day 0 to 18 of gestation (Saiwai et al., 1980). Various examinations of fetuses and newborns were performed. No treatment-related effects were observed on body weight, organ weights or the number of pregnancies within all groups. Two dams died in the middle and high dose groups. The observed skeletal malformations in neonates like cervical vertebrae, tail vertebrae and vomer adhesion occurred in the controls, too, and did not show a dosage correlation. No malformations of the skeleton or the inner organs of fetuses delivered by hysterectomy were observed; the frequency of malformations and abnormalities of the external integument, like opened eyes, cleft palate and exencephaly showed a slight tendency toward dose dependance, but it was lower than in the control. No effects on main organs of both mothers and neonates as compared to controls.
Toxicity to reproduction: other studies
Link to relevant study records
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline study with sufficient detail.
- Principles of method if other than guideline:
- Type: other: male reproduction organs
Method: other: no guideline was followed - GLP compliance:
- no
- Type of method:
- in vivo
- Species:
- rat
- Strain:
- other: swiss albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- weight at study initiation: 100-120 g - Route of administration:
- other: intratesticularly or subcutaneously
- Vehicle:
- water
- Details on exposure:
- - Total volume applied: 0.2 mL
- Duration of treatment / exposure:
- once
- Frequency of treatment:
- once
- Duration of test:
- 7 days
- Remarks:
- Doses / Concentrations:
0.08 mmole/kg bw
Basis: - Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOAEL
- Effect level:
- 0.08 other: mmole/kg bw
- Sex:
- male
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 407
- Principles of method if other than guideline:
- Male and female reproduction organs were evaluated in a repeated dose toxicity study (28 days)
- GLP compliance:
- no
- Type of method:
- in vivo
- Species:
- other: dog
- Strain:
- other: Beagle
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- other: feed
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- ad libitum
- Duration of test:
- 4 weeks
- Remarks:
- Doses / Concentrations:
2400 mg/kg bw/d
Basis:
nominal conc. - Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOAEL
- Effect level:
- 2 400 mg/kg bw/day
- Sex:
- male/female
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guiddeline 407
- Principles of method if other than guideline:
- Male and female reproduction organs were evaluated in a repeated dose toxicity study (28 days)
- GLP compliance:
- no
- Type of method:
- in vivo
- Species:
- rat
- Strain:
- other: Charles River Cesarean-Derived (CD)
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- other: feed
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- ad libitum
- Remarks:
- Doses / Concentrations:
2400 mg/kg bw/d
Basis:
nominal conc. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Duration of test: 4 weeks
- Dose descriptor:
- NOAEL
- Effect level:
- 2 400 mg/kg bw/day
- Sex:
- male/female
Referenceopen allclose all
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: - Morphology: no alteration of the rat testis. - Histology: no alteration of the rat testis. - Organ weight: slight reduction in testis weight. - Spermatozoa: no effect on spermatozoa in the ductus deferens of the rats.
No effects on reproductive organs upon histopathological examination.
No effects on reproductive organs upon histopathological examination.
Justification for classification or non-classification
The available data are conclusive but not sufficient for classification.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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