Silicic acid, sodium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Sodium metasilicate hypersensitivity in BALB/c mice.

Author:

Karrow, N. A. et al.

Year:

2002

Bibliographic source:

Am. J. Contact. Dermat. 13, 133-139

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

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

1-fluoro-2,4-dinitrobenzene (DNFB) as positive control

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Disodium metasilicate

EC Number:

229-912-9

EC Name:

Disodium metasilicate

Cas Number:

6834-92-0

Molecular formula:

H2O3Si.2Na Soluble Silicates Category

IUPAC Name:

disodium oxosilanediolate

Details on test material:

SOURCE: Aldrich Chemical Company, Milwaukee, WI, USA
PURITY: not reported
IMPURITY/ADDITIVE/ETC.: not reported
ANY OTHER INFORMATION: not reported

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS:
- Source: National Cancer Institute, USA
- Age: 45 - 60 days
- Weight at study initiation: 17 - 20 g

Study design: in vivo (LLNA)

Vehicle:

other: 15% ethanol

Concentration:

2, 4 and 6%

Details on study design:

RANGE FINDING TESTS:
- Irritation: A primary irritancy assay was performed to establish the minimal irritating and the maximal non-irritating concentration.

TREATMENT PREPARATION AND ADMINISTRATION:
Test solutions were prepared daily in amber vials using 15% ethanol.

Positive control substance(s):

other: 1-fluoro-2,4-dinitrobenzene (DNFB)

Statistics:

Bartlett's chi-square Test, one-way ANOVA and Dunnett's Multiple Range t Test

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: no data

Any other information on results incl. tables

RESULTS OF PILOT STUDY: minimal irritating concentration: 6%; maximal  non-irritating concentration: 4%

 
RESULTS OF TEST
- Sensitization reaction: sensitization with 2-6% did not significantly  alter cell proliferation in the auricular lymph nodes,

even though an  increase of 30% and 40% at the 4% and 6% treatment levels was measured,  respectively. A greater than

30-fold increase was measured in the  positive control.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information