Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Acute toxicity (Oral): Based on an analogue read across approach from synthetic amorphous silicon dioxide and calcium silicate, synthetic amorphous calcium magnesium silicate is considered as acutely non-toxic.

Acute toxicity (Inhalation): Based on an analogue read across approach from synthetic amorphous silicon dioxide , acute toxicity LC0 for synthetic amorphous calcium magnesium silicate is suggested to be >691 mg/m3.

Acute toxicity (Dermal): Based on an analogue read across approach from synthetic amorphous silicon dioxide , acute toxicity LD50 for synthetic amorphous calcium magnesium silicate is suggested to be >5000 mg/kg.

 

Additional acute toxicity measurements are not recommended for reasons of animal welfare.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Report from year 1990.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
In the reference OECD SIDS (2004), the study was assigned realibility 1 (valid without restriction).
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other: Not specified (OECD SIDS, 2004).
Limit test:
yes
Specific details on test material used for the study:
Sident 9, >98% (SiO2), Na20 <1%, Al2O3 <0.2%, SO3 <0.8%, Fe2O3 <0.03%: CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-
8.
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The dose was applied as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml
suspension) containing 1 % CMC.
Doses:
21.5 ml/kg bw = 237 mg silica/ml suspension. Limit test: 5110 mg/kg
No. of animals per sex per dose:
Five male and 5 female animals were used.
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Based on:
not specified
Clinical signs:
other: No clinical symptoms or other findings.
Other findings:
No clinical symptoms or other findings.
Conclusions:
Synthetic amorphous silicon dioxide (precipitated, CAS 112926-00-8) is considered as acutely non-toxic via oral exposure (LD50 > 5110 mg/kg bw using rat as test organism). No clinical symptoms or other findings were observed.
Executive summary:

An acute oral toxicity study with synthetic amorphous silicon dixoide (CAS 112926 -00 -8) was carried out with male and female Wistar rats. The study was done according to OECD Guideline 401 "Acute Oral Toxicity" under GLP conditions. The dose was applied by gavage as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml

suspension) containing 1 % CMC. The LD50 was found to be > 5110 mg/kg and no clinical symtoms or other findings were observed. In conclusion, Synthetic amorphous silicon dioxide is considered as acutely non-toxic (LD50 > 5110 mg/kg bw in rat following oral exposure).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
According to the reference OECD SIDS (2004), the study was assigned realibility 2 (valid with restrictions; Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment).
Principles of method if other than guideline:
The substance was suspended (24.1 % (w/v)) in 0.85 % saline.
Observation period 7 days.
GLP compliance:
no
Specific details on test material used for the study:
FDA-Compound 71-41 = Silene, calcium silicate (hydrated)
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Vehicle:
physiological saline
Details on oral exposure:
The substance was suspended (24.1 % (w/v)) in 0.85 % saline.
Doses:
5000 mg/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Clinical signs:
other: No clinical symptoms or other findings.
Conclusions:
Synthetic amorphous calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic via oral exposure (LD50 > 5000 mg/kg bw using rat as test organism). No clinical symptoms or other findings were observed.
Executive summary:

An acute oral toxicity study with synthetic amorphous calcium silicate (CAS 1344 -95 -2) was carried out with male Sprague-Dawley rats. The substance was suspended (24.1 % (w/v)) in 0.85 % saline and the observation period was 7 days. The LD50 was found to be > 5000 mg/kg and no clinical symtoms or other findings were observed. In conclusion, synthetic amorphous calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Oral administration of calcium silicate prepared as 24.1 % (w7w) suspension to male rats.
GLP compliance:
not specified
Specific details on test material used for the study:
Calcium silicate (CAs 1344-95-2)
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
Single dose of 5000 mg/kg.
No. of animals per sex per dose:
10 males
Control animals:
not specified
Details on study design:
Calcium silicate was prepared as a 24.1 % (w/w) suspension and administred orally to a group of 10 males rats at a single dose of 5000 mg/kg. Animals were observed during a 7-day period whereafter all animals were killed.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No detahs occured.
Clinical signs:
other: No signs of toxicity or abnormal behaviour were observed.
Gross pathology:
On necropsy, no gross findings were observed.
Conclusions:
Calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic following oral exposure (LD50 >5000 mg/kg using rat as test organism ).
Executive summary:

Calcium silicate was adminsitred orally to a group of 10 male rats at a single dose of 5000 mg/kg. No signs of toxicity or abnormal behaviour were observed within a 7 -day period. No deaths occured. LD50 for calcium silicate was considered >5000 mg/kg. In conclusion, calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Reliabality according to OECD SIDS (2004).
Principles of method if other than guideline:
Nose-only exposure system. Five animals each per sex were used. Analysed chamber concentrations ranged from 650 to 725 mg/m3 (note:
Technically, the maximally achievable aerosol concentration due to substance-inherent properties resulting in sedimentation and adsorption to
the equipment.). About 45 % of the aerosol comprised particles with an aerodynamic diameter of <5 um (respirable fraction).
GLP compliance:
yes
Specific details on test material used for the study:
SIPERNAT 22S >98 % (SiO2): CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-8. Surface area: 160 - 195 m2/g.
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
not specified
Duration of exposure:
4 h
Concentrations:
Maximum attainable concentration: 691 mg/m3. Analysed chamber concentrations ranged from 650 to 725 mg/m3.
No. of animals per sex per dose:
Five animals each per sex.
Control animals:
not specified
Details on study design:
Analysed chamber concentrations ranged from 650 to 725 mg/m3 (Technically, the maximally achievable aerosol concentration due to substance-inherent properties resulting in sedimentation and adsorption to
the equipment.). About 45 % of the aerosol comprised particles with an aerodynamic diameter of <5 um (respirable fraction).
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 0.691 mg/L air
Mortality:
None
Clinical signs:
other: No clinical symptoms except some restlessness and eye closing.
Body weight:
No clinical symptoms except some restlessness and eye closing. Body weight gain was not affected in males, but females hardly gained weight
during two days after exposure, however, subsequently, showed normal development.
Gross pathology:
No findings at autopsy after 14 d post-treatment.
Conclusions:
Acute inhaltation toxicity of synthetic amorphous silicon dioxide (precipitated) in rat: LC0 (4 h) >0.691 mg/L.
Executive summary:

An acute inhaltation toxicity study with precipitated synthetic amorphous silicon dioxide was performed using rat as a test organism. Analysed chamber concentrations ranged from 650 to 725 mg/m3 (maximum attainable concentration was 691 mg/m3). No clinical symptoms except some restlessness and eye closing. Body weight gain was not affected in males, but females hardly gained weight during two days after exposure, however, subsequently, showed normal development. No findings at autopsy after 14 d post-treatment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
691 mg/m³ air
Quality of whole database:
LC0 >691 mg/m3

Additional information

Justification for classification or non-classification