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Skin sensitisation

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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:
2001
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

Constituent 1
Chemical structure
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
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.