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Toxicological information

Skin sensitisation

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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

Referenceopen allclose all

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 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:
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
Name:
Unnamed
Type:
Constituent
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