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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:

Test material

Constituent 1
Reference substance name:
silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
EC Number:
Molecular formula:
SinO(3n-1)2(n-1) polymeric anions ionically bonded to Al3+ and K2+ cations
silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
Test material form:
solid - liquid: suspension
migrated information: dispersion
Details on test material:
- Name of test material (as cited in study report): Superwool 1400
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: >99%
- Impurities (identity and concentrations): trace impurities
- Purity test date: March 2011
- Lot/batch No.: BG-11-P19-2563
- Expiration date of the lot/batch: 31/12/2020
- Stability under test conditions: stable
- Storage condition of test material: room temperature, sealed container

Test animals / tissue source

not specified
Details on test animals or tissues and environmental conditions:
Reconstructed Human Cornea-like Epithelium

Test system

unchanged (no vehicle)
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 50mg solid

Duration of treatment / exposure:
6 hours +/- 15 minutes
Duration of post- treatment incubation (in vitro):
18 hours +/- 15 minutes
Number of animals or in vitro replicates:
Details on study design:
- Details of the test procedure used
- RhCE tissue construct used, including batch number
- Doses of test chemical and control substances used
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
- Description of any modifications to the test procedure
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
- Description of the method used to quantify MTT formazan
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable)
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
- Complete supporting information for the specific RhCE tissue construct used
- Reference to historical data of the RhCE tissue construct
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
- Positive and negative control means and acceptance ranges based on historical data
- Acceptable variability between tissue replicates for positive and negative controls
- Acceptable variability between tissue replicates for the test chemical

Results and discussion

In vitro

Irritation parameter:
in vitro irritation score
Run / experiment:
Mean Tissue Viability (%)
ca. 97.6
Vehicle controls validity:
not applicable
Negative controls validity:
Positive controls validity:
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
substance is non-irritating