Silicic acid, aluminum sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: U.S. Fed. Hazardous Substances Act, Section 101.11

GLP compliance:

not specified

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

Molecular formula:

nSiO2*mAl2O3*zNa2O n = 2-4; m = 0.12-3.20; z = 0.11-4.5

IUPAC Name:

aluminium(3+) sodium bis(oxosilanebis(olate))

Test material form:

solid: nanoform, no surface treatment

Remarks:

crystalline-free

Specific details on test material used for the study:

Zeolex 7

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: abraded and intact (shaved)

Vehicle:

not specified

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 h

Observation period:

Scoring after 24 and 72 h after test initiation

Number of animals:

6

Details on study design:

The procedure described in Section 101.11 of the Federal Hazardous Substances Act was followed. Irritation to the skin was measured by the patch test technique using the albino rabbit. Six healthy New Zealand rabbits were used to determine the irritation potential of each test material. Each animal received two applications of the assigned test material; one application to an intact and one application to an abraded skin area clipped free of hair. Surgical gauze (1 inch x 1 inch) secured in place by adhesive tape was used to cover the treated sites. Each animal received 0.5 grams of test material at each test site.

The entire trunk of each animal was then wrapped in plastic to prevent loss of the sample. Contact of the test material with the skin was maintained for 24 hours, after which the plastic and gauze were removed and the treated areas gently cleansed. The treated areas were scored according to the Federal Hazardous Substances Act, 24 and 72 hours after initiation of the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 / 72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 - #6

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal: #1 - #6

Time point:

24 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal: #1 - #6

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal: #1 - #6

Time point:

24 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No evidence of erythema or edema was observed following topical application of the test material to any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No evidence of erythema or edema was observed following topical application of the test material to any of the rabbits.

Executive summary:

The skin irritation potential of the Sodium silicoaluminate Zeolex 7 was investigated in six rabbits according to the Federal Hazardous Substances Act. No evidence of erythema or edema was observed within 72 hours.