Registration Dossier
Registration Dossier
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EC number: 241-022-2 | CAS number: 16949-65-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Magnesium hexafluorosilicate hexahydrate
- Cas Number:
- 18972-56-0
- Molecular formula:
- MgSiF6·6H2O
- IUPAC Name:
- Magnesium hexafluorosilicate hexahydrate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JN and CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- Sex: Females (nulliparous and non-pregnant)
Age and weight range (at order): 7 to 8 weeks old, 21 to 25 grams
Weight range at arrival : 19 to 20 grams
Acclimatisation period : At least 5 days
No. of animals/cage : 1/cage during the study; up to 5 during acclimatisation
Housing : Polysulphone solid bottomed cages measuring 35.5 x 23.5 x 19 cm with nesting material
Cage tray control : Daily inspected and changed as necessary (at least twice/week)
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 25, 10, 5 and 2.5% w/w
- No. of animals per dose:
- 6
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1.68
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not measured
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Magnesium hexafluorosilicate hexahydrated is not a skin sensitiser
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