Reaction mass of Silicic acid, calcium salt and Silicic acid, magnesium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study report dated 1991.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

According to the secondary literature cited, the study was assigned reliability 1 (valid without restrictions; comparable to guidline study).

Data source

Reference

Reference Type:

other: Collection of data from published literature and company data.

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

GLP study according to secondary literature cited.

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, magnesium salt

EC Number:

215-681-1

EC Name:

Silicic acid, magnesium salt

Cas Number:

1343-88-0

Molecular formula:

MgO3Si

IUPAC Name:

Silicic acid, magnesium salt

Constituent 2

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

Test material form:

solid: particulate/powder

Details on test material:

CMS is also available in a paste form which generates the powder form following the drying process.

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.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Not specified.

Observation period (in vivo):

72 h.

Number of animals or in vitro replicates:

Not specified.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1).

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Remarks on result:

other: Chemosis and discharge was very slight only 1 h after application (score 1).

Applicant's summary and conclusion

Conclusions:

Exposure of rabbit skin to precipitated synthetic amorphous silicon dioxide gave rise to weakly irritating, but reversible effects. Chemosis and discharge was very slight only 1 h after application. Precipitated synthetic amorphous silicon dioxide is considered not irritating to the eye.

Executive summary:

The eye irritating potential of precipitated synthetic amorphous silicon dioxide was studied using rabbit as a test organism (OECD 405). The substance was tested in a concentration of 100 mg and the observation period covered 72 h. There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1). In conclusion, precipitated synthetic amorphous silicon dioxide was not considered irritating to the eye.