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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Year 1957.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
other: Collection of data from published literature and company data.
Title:
Unnamed
Year:
2004

Materials and methods

Principles of method if other than guideline:
Chronic exposure study via oral feed with male and female rats. Exposure period was two years with a daily treatment frequency.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, calcium salt
EC Number:
215-710-8
EC Name:
Silicic acid, calcium salt
Cas Number:
1344-95-2
Molecular formula:
CaO3Si
IUPAC Name:
Silicic acid, calcium salt
Specific details on test material used for the study:
Calcium silicate (Silenen EF).

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on route of administration:
According to the authors the doses were 1.0, 5.0, 7.5 and 10 % (w/w) in feed.
Vehicle:
not specified
Details on oral exposure:
According to the authors the doses were 1.0, 5.0, 7.5 and 10 % (w/w) in feed.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Exposure period: two years.
Frequency of treatment:
Daily.
Doses / concentrationsopen allclose all
Dose / conc.:
1 other: % (w/w) in feed
Dose / conc.:
5 other: % (w/w) in feed
Dose / conc.:
7.5 other: % (w/w) in feed
Dose / conc.:
10 other: % (w/w) in feed
No. of animals per sex per dose:
Not specified.
Control animals:
not specified

Examinations

Observations and examinations performed and frequency:
Hematological and biochemical parameters.
Organ weight.
Investigation for tumors.
Other investigations not further specified.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No gross signs of toxicity.
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
According to the authors, slight elevation of organ weights at the higher dose levels was observed.
Haematological findings:
no effects observed
Description (incidence and severity):
According to the authors, no significant changes of hematological values were observed.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
According to the authors, no significant changes of biochemical values were observed.
Urinalysis findings:
not specified
Description (incidence and severity):
According to the authors, slightly elevated pH of the urine was observed.
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
According to the authors, slight elevation of organ weights at the higher dose levels was observed.
Gross pathological findings:
no effects observed
Description (incidence and severity):
According to the authors, no tumors were observed.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
5 000 other: mg/(kg*d). Not further specified.
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: See "Remarks"

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
NOAEL estimated to be ca 5000 mg/(kg*d) in male and female rats following chronic exposure via oral feed.
Executive summary:

Chronic oral toxicity study on rats has been performed with synthetic amorphous calcium silicate. No deaths, gross signs of toxicity or tumors were observed. NOAEL was determined to 5000 mg/(kg*d).