Registration Dossier
Registration Dossier
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EC number: 229-912-9 | CAS number: 6834-92-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Sodium metasilicate hypersensitivity in BALB/c mice.
- Author:
- Karrow, N. A. et al.
- Year:
- 2 002
- Bibliographic source:
- Am. J. Contact. Dermat. 13, 133-139
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 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
- 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
Constituent 1
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
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