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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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)
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
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
Parameter:
other: increase of cell proliferation [%]
Remarks:
value of highest non-irritating test substance concentration: 4%
Value:
40
Parameter:
SI
Test group / Remarks:
2%
Remarks on result:
other: No data on SI according to OECD TG 429 are given.
Parameter:
SI
Test group / Remarks:
4%
Remarks on result:
other: No data on SI according to OECD TG 429 are given.
Parameter:
SI
Test group / Remarks:
6%
Remarks on result:
other: No data on SI according to OECD TG 429 are given.

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.

Interpretation of results:
not sensitising
Endpoint conclusion
Additional information:

The read-across substance, sodium metasilicate, was not sensitizing in the local lymph node assay. In a human case report, contact urticaria induced by sodium silicate was observed in one individual.


Migrated from Short description of key information:
Based on the category approach, sodium silicate is not sensitising.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Not required. No data available.

Justification for classification or non-classification

The available data is conclusive but not sufficient for classification.