Reaction mass of disodium metasilicate and sodium hydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: volunteer study

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, adapted to human conditions. No information on purity of test substance.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1997

Reference 2

Reference Type:

secondary source

Title:

Soluble Silicates. CAS No. 1344-09-8, 6834-92-0, 10213-79-3, 13517-24-3 and 1312-76-1.

Author:

OECD SIDS

Year:

2004

Bibliographic source:

SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004

Materials and methods

Principles of method if other than guideline:

COLIPA open cutaneous test

GLP compliance:

yes

Remarks:

Henkel KGaA Dermatologie

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

SOURCE: Henkel KGaA
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: The test substance is a Natronwasserglas 37/40, a silicate solution of 34.9 wt% and a molar ratio 3.45.

Test animals

Species:

human

Test system

Type of coverage:

open

Vehicle:

water

Amount / concentration applied:

Concentration: 34.9 other: wt%
application of 5, 10, 50% aqueous solutions and undiluted

Duration of treatment / exposure:

30 minute(s), the test substance was reapplied with a glass stick every 30 seconds. The test area on the inner lower arm was 3 cm2. After 30 minutes, the test area was rinsed with water and dried.

Number of animals:

20 volunteers (10 male and 10 female)

Details on study design:

The adverse skin effects were scored for erythema and oedema until 30 minutes after the last application. The range ran from 0 (no reaction) to 4 (very strong redness spreading outside the test site and/or very strong oedema >2 mm). In addition the subjects were questioned to assess the occurrence of burning sensation, itching, pain, heat, cold.

Results and discussion

Any other information on results incl. tables

Clinical signs:

Exposure to undiluted sodium silicate solution did not cause any irritation. It rapidly hardened on the skin, forming a wax-like coating. The 50% aqueous dilution caused slight redness (barely perceptible erythema) in 3/20
volunteers 21-25 minutes after the exposure started, and lasted 15-19 minutes. The 10% aqueous dilution caused slight
redness (barely perceptible erythema) in 2/20 volunteers 21and 25 minutes after the exposure started, and lasted 19 and
15 minutes, respectively. Exposure to 5% dilution resulted in slight redness (barely perceptible erythema) in
2/20 volunteers, which started 25 and 21 minutes after the first exposure and lasted 15 and 19 minutes in total,
respectively. A third volunteer had a slight itch that started right after the exposure ended, and lasted 30
minutes. All the adverse effects were reversible.

Under non-occlusive conditions the 5, 10 and 50% aqueous dilutions of the sodium silicate solution caused slight irritation
(barely perceptible erythema). The undiluted sodium silicate solution did not cause irritation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information