Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline, but only 1 animal tested. No information on purity of test substance.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal tested
GLP compliance:
yes
Remarks:
Inveresk Research International

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, potassium salt
EC Number:
215-199-1
EC Name:
Silicic acid, potassium salt
Cas Number:
1312-76-1
Molecular formula:
K2O x (SiO2)n with Molar Ratio (MR) (SiO2/K2O): 0.5 – 5 (with exception of MR = 1)
IUPAC Name:
potassium hydroxysilanoylolate
Details on test material:
SOURCE: EKA Kemi AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 36 wt% Potassium Waterglass. Molar ratio 2.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Sex: female 
- Source: Cheshire Rabbit Farms Ltd.
- Age: approx. 11 weeks
- Weight at study initiation: 2.3 - 3.0 kg 

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Concentration: 36 T49-004:wt%; 0.5 mL
Duration of treatment / exposure:
4 hour(s)
Observation period:
5 days
Number of animals:
1
Details on study design:
- Removal of test substance: yes (washed away with water)
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 5 days

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 1, 24, 48, 72 hours and 5 days
Score:
1
Reversibility:
other: Test sample only elicited transient erythema which was clear by day 5.

Any other information on results incl. tables

AVERAGE SCORE:
- Erythema: 1
- Edema: 0

No further details on "results" available.


Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information