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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Publication date - 07 May 1982.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Organisation for Economic Co-operation and Development (1979). OECD Short-term and Lone-term Toxicology’ Groups. Final Report: Acute Dermal Irritation/ Corrosivity. 31 December. p. 35.
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
disodium;hexafluorosilicon(2-)
Cas Number:
16893-85-9
Molecular formula:
Na2SiF6
IUPAC Name:
disodium;hexafluorosilicon(2-)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The test was carried out on male albino rabbits of the New Zealand strain, weighing about 2.5 kg and supplied by Roucher SA, Couht. The study was conducted in a single group of six rabbits.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1/24/48/72 h
Score:
0.04
Remarks on result:
other: Reversibility not specified
Irritation parameter:
erythema score
Basis:
other:
Remarks:
Only PDI available.
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not available.
Remarks:
Only PDI available.
Irritation parameter:
edema score
Basis:
other:
Remarks:
Only PDI available
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not available.
Remarks:
Only PDI available.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium fluorosilicate was concluded to be non irritant to the skin.
Executive summary:

The skin irritation potential of sodium fluorosilicate was evaluated by Guillot et al, 1982. The test was carried out on male albino rabbits of the New Zealand strain, weighing about 2.5 kg and supplied by Roucher SA, Couht. The study was conducted in a single group of six rabbits. Each rabbit was clipped over the back and flanks with a fine-toothed electric clipper (Aesculap Type V 42 947).

0.5 g was applied on the shaved skin and the treated skin was covered in each case with a four-layered sterile absorbent-gauze square (2 x 2 cm), which was moistened with 0.5 ml water. The test material and gauze pads were kept in contact with the skin by a patch (Neodermotest Rot SA, Paris) consisting of an occlusive central disc (22 mm in diameter) surrounded by an adhesive hypoallergenit perforated plaster (10 mm wide). Finally an adhesive tape (6 cm wide) was wound round the animal, without restricting respiratory and abdominal movements, to complete the holding of the patches, and the rabbit was placed in a restraining device for at least 4 h. Macroscopic observations were recorded at 1, 24, 48 and 72 h for both after patch removal. Each treated area was scored for erythema and oedema using a numerical system (0-4 in each case according to severity) based on that described by Draize, Woodard & Calvery (1948). The scores obtained for erythema and oedema at both of the treated sites in all six animals at the two or more reading times were totaled. The sum obtained was then divided by the total number of readings to provide a mean score (never greater than 8) termed the primary irritation index (PCI). The following scale was used to interpret the results:

PCI below 0.5: non-irritant; 0.5-3: slightly irritant; 3-5: moderately irritant; 5-8: severely irritant

The primary cutaneous irritation index obtained in this study was 0.04, hence the substance was concluded to be non-irritant to the skin.