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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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:
Report dated 1991.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
According to the secondary literature cited, the study was assigned reliability 1 (valid without restrictions; comparable to guidline study).

Data source

Reference
Reference Type:
other: Collection of data from published literature and company data.
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
Study according to GLP according to secondary literature.

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
Silicon dioxide
Test material form:
solid
Specific details on test material used for the study:
Sident 9, >98% (SiO2), Na20 <1%, Al2O3 <0.2%, SO3 <0.8%, Fe2O3 <0.03%: CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-
8.

Test animals

Species:
rabbit
Strain:
not specified

Test system

Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
Not specified.
Number of animals:
Three animals.
Details on study design:
The substance (0.5 g) was moistened with 0.5 ml water and place on a skin area of approx 6.25 cm2.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: See "Remarks"
Remarks:
Not irritating.
Remarks on result:
no indication of irritation
Remarks:
Not irritating.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: See "Remarks"
Remarks:
Not irritating
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation effects were observed.

Applicant's summary and conclusion

Conclusions:
No signs of skin irritation were observed following exposure of rabbit skin to precipitated synthetic amorphous silicon dioxide.
Executive summary:

The skin irritating potential of precipitated synthetic amorphous silicon dioxide was studied using rabbit as a test organism (OECD 404). Silicon dioxide (0.5 g) was moistened with 0.5 ml water and place on a skin area of approx 6.25 cm2 (three animals). No signs of skin irritation were observed.