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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were orally given a dose of 5000 mg/kg on five consecutive days.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Calcium silicate
EC Number:
233-250-6
EC Name:
Calcium silicate
Cas Number:
10101-39-0
IUPAC Name:
calcium oxosilanediolate
Details on test material:
Calcium silicate
FDA Compound 71-41

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Flow laboratories
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 300-350 g
- Fasting period before study: no data
- Housing: 1-5 rats / cage
- Diet (e.g. ad libitum): commercial 4% fat diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
Suspended in 0.85% saline.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 days
Frequency of treatment:
Once per day
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control:
No

Examinations

Observations and examinations performed and frequency:
No data
Sacrifice and pathology:
Animals killed 6 hours after last dose by using carbon dioxide.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 5 000 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
other: No deaths occurred.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No deaths were observed at a dose level of 5000 mg/kg calcium silicate in a five-day subacute study
Executive summary:

In a five-day subacute study, male rats were dosed daily with 5000 mg/kg bw of calcium silicate by gastric intubation (Litton 1974). No deaths occured during this exposure period.