Registration Dossier
Registration Dossier
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EC number: 285-349-9 | CAS number: 85085-18-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test carried out by GLP compliant laboratory to recognised validated methods by trained personnel
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- EC Number:
- 285-349-9
- EC Name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- Cas Number:
- 85085-18-3
- Molecular formula:
- Na(1.00+/-0.99)[(Si8Mg(5.0+/-1.0)Li(1.00+/-0.99) O20 (OH)4-x Fx](1.00+/-0.99); with x=2.5+/-1.5
- IUPAC Name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Positive control substance(s):
- yes
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- From 5% to 25% by weight of the test substance in propylene glycol
25 microlitres of the suspension were applied daily for three consecutive days - No. of animals per dose:
- Four mice per concentration
A control group of 4 mice were treated with propylene glycol alone - Positive control substance(s):
- other: phenylacetaldehyde CAS122-78-1
Results and discussion
- Positive control results:
- At a concentration of 2.5% in propylene glycol, the positive test substance, phenylacetaldehyde, which had been applied to five mice, showed a stimulation index of 18.43 and is known to be a skin sensitiser.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: At 5%w/w in propylene glycol = 0.77 (negative result) At 10%w/w in propylene glycol = 0.56 (negative result) At 25%w/w in propylene glycol = 0.61 (negative result)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test
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