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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 - 19 Oct. 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

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:
dioxosilane
Details on test material:
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
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Test animals

Species:
rabbit
Strain:
other: White Russian

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
Dose: 0.5 g
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
3
Details on study design:
The substance (0.5 g) was moistened with 0.5 ml water and placed on a skin area of approx 6.25 cm2.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Remarks:
ID Nr. 2330
Time point:
other: 1 h after exposure
Score:
>= 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Remarks:
ID Nr. 2332
Time point:
other: 1 h after exposure
Score:
>= 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Remarks:
ID Nr. 2344
Time point:
other: 1 h after exposure
Score:
>= 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Remarks:
ID Nr. 2330
Time point:
24/48/72 h
Score:
>= 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Remarks:
ID Nr. 2332
Time point:
24/48/72 h
Score:
>= 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Remarks:
ID Nr. 2344
Time point:
24/48/72 h
Score:
> 0
Max. score:
0
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were not any irritating effects.

Any other information on results incl. tables

No signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No classification (EU and GHS)
Executive summary:

Jahn and Berthold (1991) studied skin irritation of precipitated silica on rabbits by the OECD 404 guideline test method. No irritating effects were observed.