Silicic acid, aluminum calcium sodium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets generally accepted scientific standards, is sufficiently documented, and is considered acceptable for assessment. The study was conducted according to Federal Hazardous Substances Act Section 191.12 (1973). Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Fed. Hazardous Substance Act Section 191.12 (1973)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

Test material form:

not specified

Details on test material:

ZEOLEX 23A - surface area (BET): 65 -80 m2/g, pH 9.8 - 10.6

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):

24, 48, and 72 hours following application.

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24 h

Score:

3.3

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Based on the effects of redness (A), swelling (B) and discharge (C) with (A+B+C)x2/number of animals = 3.3

Irritant / corrosive response data:

Only on day 1, transient slight erythema and edema were noted in all animals (effect score 1), in one animal score 2 for erythema; cornea and iris remained unaffected. No irritating effects any more after 48 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria.

Executive summary:

The eye irritation potential of the test substance was determined in accordance with the test guideline outlined in the Federal Hazardous Substances Act Section 191.12 (1973). 100 mg of the test substance was applied to rabbit eyes and observations made 24, 48 and 72 hours after application. The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.