Registration Dossier
Registration Dossier
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EC number: 442-650-1 | CAS number: 56450-90-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-06-25 to 2001-09-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996-07-30
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed in 2001. Bühler test was good practice at that time
Test material
- Reference substance name:
- -
- EC Number:
- 442-650-1
- EC Name:
- -
- Cas Number:
- 56450-90-9
- Molecular formula:
- F4Mg5Na2O20Si8
- IUPAC Name:
- silanedione hydrofluoride magnesium dihydride sodium hydride
- Test material form:
- solid: particulate/powder
- Details on test material:
- One sample of Sodium Magnesium Fluoride Silicate, Lot No. 91107
EINECS# 442-650-1
CAS# 56450-90-9
Sample submission date: 16.11.2009
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: UNICOOP Japan / 199A
- Expiration date of the lot/batch: 2003-12-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20 °C +/- 3°C, away from direct sunlight
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: Unknown in PEG 300
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Weight at study initiation: 4 - 6 weeks
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
- Indication of any skin lesions: none reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C, +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- "PEG 300"
- Concentration / amount:
- 0.5 ml; 10, 15, 25 and 50 %
- Day(s)/duration:
- Occlusive dressing left in place for 6 h (+/- 15 min)
Challenge
- No.:
- #20
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- "PEG 300"
- Concentration / amount:
- 0.5 ml; 10, 15, 25 and 50 %
- Day(s)/duration:
- Occlusive dressing left in place for 6 h (+/- 15 min)
- No. of animals per dose:
- 20. The test item concentration of 50 % in PEG 300 was considered to be the most qualified. Only that concentration was used for the main study.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: 6 h
- Test groups: 50 % test item
- Control group: yes
- Site: left shoulder
- Frequency of applications: single
- Duration: 6 h
- Concentrations: 50 % test item
B. CHALLENGE EXPOSURE
- No. of exposures: single, 20 animals
- Day(s) of challenge: 2
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 5 animals
- Site: posterior quadrant of the side and back of the animal
- Concentrations: 50 5 test item
- Evaluation (hr after challenge): 24 h and 48 h
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 2-MERCAPTOBENZOTHIAZOLE at O.03 % in mineral oil.
Results and discussion
- Positive control results:
- Valid
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: no data
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse efects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effects.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- control group
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- control group
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
There were no deaths during the course of the study, hence no necropsies were performed.
No symptoms of systemic toxicity were observed in the animals.
No skin effect was observed in three weeks of induction.
No skin reactions vvere observed in the animals treated with the test item at 50 % in PEG 300.
1 animal nof the test group showed a loss of body weight (3.6 %) during the acclimatization period. It recovered between the treatment start and the end of the study. The body weight of the other animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the above mentioned findings in a non-adjuvant sensitization test in guinea pigs and in accordance to the CLP-Regulation, magnesium sodium fluoride silicate applied at a concentration of 50 % in PEG 300 does not have to be classified and Iabelled as a skin sensitizer.
- Executive summary:
The purpose of this skin sensitizing study was to assess the possible allergenic potential of magnesium sodium fluoride silicate when administered topically to albino guinea pigs.
For this purpose the "Bühler Test" modified by Ritz, H.L. and BOhler, E.V. (1 980)" was used. Twenty male animals of the test group were treated topically with magnesium sodium fluoride silicat at 50 % in PEG 300 once a week for a 3 week induction phase. Two weeks after the final induction application the animals were challenged with the same test item concentration of 50 % in
PEG 300 as used for induction.
The ten animals of the control group were not treated during the induction. They were treated once at challenge with
magnesium sodium fluoride silicate at 50 % in PEG 300.
Based on the above mentioned findings in a non-adjuvant sensitization test in guinea pigs and in accordance to the CLP-Regulation, magnesium sodium fluoride silicate applied at a concentration of 50 % in P EG 300 does not have to be classified and labelled as a skin sensitizer.
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