Reaction mass of calcium disilicide and calcium silicide

Repeated dose toxicity: oral

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

Test material information

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.