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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

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
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.